SUBCHAPTER VII—GENERAL AUTHORITY
Part A—General Administrative Provisions
§371. Regulations and hearings
(a) Authority to promulgate regulations
The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.
(b) Regulations for imports and exports
The Secretary of the Treasury and the Secretary of Health and Human Services shall jointly prescribe regulations for the efficient enforcement of the provisions of
(c) Conduct of hearings
Hearings authorized or required by this chapter shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.
(d) Effectiveness of definitions and standards of identity
The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.
(e) Procedure for establishment
(1) Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under
(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.
(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.
(f) Review of order
(1) In a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in
(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in
(5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.
(g) Copies of records of hearings
A certified copy of the transcript of the record and proceedings under subsection (e) shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f).
(h) Guidance documents
(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration.
(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents.
(C)(i) For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.
(ii) With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.
(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.
(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.
(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.
(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection.
(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.
(June 25, 1938, ch. 675, §701,
Editorial Notes
Amendments
2012—Subsec. (h)(1)(C).
1997—Subsec. (h).
1994—Subsec. (e)(1).
1993—Subsec. (b).
Subsec. (e)(1).
Subsec. (f)(4).
1992—Subsec. (b).
1990—Subsec. (e)(1).
1960—Subsec. (e).
1958—Subsec. (f)(1).
Subsec. (f)(3).
1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.
1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to
Statutory Notes and Related Subsidiaries
Change of Name
Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1960 Amendment
Amendment by
Construction of Amendments by Pub. L. 101–535
Amendments by
Savings Provision
Savings clause of act Aug. 1, 1956, see note set out under
Transfer of Functions
Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by
Notification of FDA Intent To Regulate Laboratory-Developed Tests
Approval of Supplemental Applications for Approved Products
"(a)
"(b)
"(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;
"(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and
"(3) define supplemental applications that are eligible for priority review.
"(c)
"(1) encouraging the prompt review of supplemental applications for approved articles; and
"(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.
"(d)
Hearings Pending on April 15, 1954, With Respect to Food Standards
Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§372. Examinations and investigations
(a) Authority to conduct
(1)(A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.
(B)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter.
(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved.
(2)(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.
(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.
(C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year—
(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;
(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and
(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.
(3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.
(4) For the purposes of this subsection, the term "United States" means the States and the District of Columbia.
(b) Availability to owner of part of analysis samples
Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.
(c) Records of other departments and agencies
For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection.
(d) Information on patents for drugs
The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required.
(e) Powers of enforcement personnel
Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary—
(1) carry firearms;
(2) execute and serve search warrants and arrest warrants;
(3) execute seizure by process issued pursuant to libel under
(4) make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and
(5) make, prior to the institution of libel proceedings under
(June 25, 1938, ch. 675, §702,
Editorial Notes
Amendments
2009—Subsec. (a)(1).
2002—Subsec. (a).
1999—Subsec. (d).
1993—Subsec. (c).
1992—Subsec. (c).
1970—Subsec. (e).
1965—Subsec. (e).
1962—Subsec. (a).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 1999 Amendment
Amendment by
Effective Date of 1970 Amendment
Amendment by
Effective Date of 1965 Amendment
Amendment by
Savings Provision
Amendment by
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see note set out under
§372a. Transferred
Editorial Notes
Codification
Section, act June 25, 1938, ch. 675, §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712,
§373. Records
(a) In general
For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).
(b) Food transportation records
A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to
(June 25, 1938, ch. 675, §703,
Editorial Notes
Amendments
2009—Subsec. (a).
2005—
1993—
1970—
Statutory Notes and Related Subsidiaries
Effective Date of 2005 Amendment
Amendment by
Effective Date of 1970 Amendment
Amendment by
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§374. Inspection
(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in
(2) The provisions of the third sentence of paragraph (1) shall not apply to—
(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;
(B) practitioners licensed by law to prescribe or administer drugs, or prescribe or use devices, as the case may be, and who manufacture, prepare, propagate, compound, or process drugs, or manufacture or process devices, solely for use in the course of their professional practice;
(C) persons who manufacture, prepare, propagate, compound, or process drugs or manufacture or process devices, solely for use in research, teaching, or chemical analysis and not for sale;
(D) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.
(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of
(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of
(B) required to be maintained under
(4)(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C), shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary's request shall include a sufficient description of the records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.
(B) Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt.
(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.
(D) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.
(5)(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this chapter or the Public Health Service Act [
(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.
(C)(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—
(I) developing an application or other submission to the Secretary under this chapter or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);
(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or
(III) holding any records or other information described in subparagraph (B).
(ii) A person described in this clause is—
(I) the sponsor of an application or submission specified in subparagraph (E);
(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;
(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or
(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).
(D)(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—
(I) permitting the Secretary to record or copy such information for purposes of this paragraph;
(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and
(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.
(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.
(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.
(E) The studies and submissions described in this subparagraph are each of the following:
(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this chapter or the Public Health Service Act for marketing authorization of a product described in paragraph (1).
(ii) Postmarket safety activities conducted under this chapter or the Public Health Service Act.
(iii) Any other clinical investigation of—
(I) a drug subject to
(II) a device subject to
(iv) Any other submissions made under this chapter or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.
(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to December 29, 2022, the Secretary lacked the authority to conduct such inspections, including under this chapter or the Public Health Service Act.
(b) Written report to owner; copy to Secretary
(1) Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (A) consists in whole or in part of any filthy, putrid, or decomposed substance, or (B) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.
(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of
(c) Receipt for samples taken
If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.
(d) Analysis of samples furnished owner
Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.
(e) Accessibility of records
Every person required under
(f) Recordkeeping
(1) An accredited person described in paragraph (3) shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records.
(2) Within 15 days after the receipt of a written request from the Secretary to an accredited person described in paragraph (3) for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.
(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who—
(A) is accredited under subsection (g); or
(B) is accredited under
(g) Inspections by accredited persons
(1) The Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under
(2) The Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited.
(3) An accredited person shall, at a minimum, meet the following requirements:
(A) Such person may not be an employee of the Federal Government.
(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under this chapter and which has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor.
(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.
(D) Such person shall not engage in the design, manufacture, promotion, or sale of articles regulated under this chapter.
(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum the person will—
(i) certify that reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with this chapter, and recommendations made during an inspection or at an inspection's closing meeting;
(ii) limit work to that for which competence and capacity are available;
(iii) treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to the Secretary;
(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and
(v) protect against the use, in carrying out paragraph (1), of any officer or employee of the accredited person who has a financial conflict of interest regarding any product regulated under this chapter, and annually make available to the public disclosures of the extent to which the accredited person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.
(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration.
(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).
(4) The Secretary shall publish on the Internet site of the Food and Drug Administration a list of persons who are accredited under paragraph (2). Such list shall be updated to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. The updating of such list shall be no later than one month after the accreditation of a person under this subsection or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited.
(5)(A) To ensure that persons accredited under this subsection continue to meet the standards of accreditation, the Secretary shall (i) audit the performance of such persons on a periodic basis through the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a device establishment and the performance of accredited persons, and (ii) take such additional measures as the Secretary determines to be appropriate.
(B) The Secretary may withdraw accreditation of any person accredited under paragraph (2), after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the standards of accreditation, poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection. The Secretary may suspend the accreditation of such person during the pendency of the process under the preceding sentence.
(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met:
(i) The Secretary classified the results of the most recent inspection of the establishment as "no action indicated" or "voluntary action indicated".
(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that—
(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection;
(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment;
(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and
(IV) includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment—
(aa) at least 1 of such devices is marketed in the United States; and
(bb) at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments.
(B)(i) Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that—
(I) denies clearance to participate as provided under subparagraph (C); or
(II) makes a request under clause (ii).
(ii) The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice—
(I) compliance data for the establishment in accordance with clause (iii)(I); or
(II) information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II).
The owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request.
(iii)(I) The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of
(II) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1).
(iv) A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C).
(C)(i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence.
(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination.
(iii)(I) The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person.
(II) If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii).
(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.
(7)(A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.
(B) At a minimum, an inspection report under subparagraph (A) shall identify the persons responsible for good manufacturing practice compliance at the inspected device establishment, the dates of the inspection, the scope of the inspection, and shall describe in detail each observation identified by the accredited person, identify other matters that relate to or may influence compliance with this chapter, and describe any recommendations during the inspection or at the inspection's closing meeting.
(C) An inspection report under subparagraph (A) shall be sent to the Secretary and to the designated representative of the inspected device establishment at the same time, but under no circumstances later than three weeks after the last day of the inspection. The report to the Secretary shall be accompanied by all written inspection observations previously provided to the designated representative of the establishment.
(D) Any statement or representation made by an employee or agent of a device establishment to a person accredited under paragraph (2) to conduct inspections shall be subject to
(E) If at any time during an inspection by an accredited person the accredited person discovers a condition that could cause or contribute to an unreasonable risk to the public health, the accredited person shall immediately notify the Secretary of the identification of the device establishment subject to inspection and such condition.
(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.
(8) Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.
(9) Nothing in this subsection affects the authority of the Secretary to inspect any device establishment pursuant to this chapter.
(10)(A) For fiscal year 2005 and each subsequent fiscal year, no device establishment may be inspected during the fiscal year involved by a person accredited under paragraph (2) if—
(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the "first prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and
(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the "second prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year.
(B)(i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the "compliance budget"), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the "inspection budget").
(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the inspection budget any amounts obligated for inspections of device establishments conducted as part of the process of reviewing applications under
(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a report describing the findings made through such determinations.
(C) For purposes of this paragraph:
(i) The term "base amount" means the inspection budget determined under subparagraph (B) for fiscal year 2002.
(ii) The term "adjusted base amount", in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent.
(iii) The term "adjusted base amount", with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted base amount applicable to the preceding year increased by 5 percent.
(11) The authority provided by this subsection terminates on October 1, 2027.
(12) No later than four years after October 26, 2002, the Comptroller General shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate—
(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to
(B) the number of persons who sought accreditation under this subsection, as well as the number of persons who were accredited under this subsection;
(C) the reasons why persons who sought accreditation, but were denied accreditation, were denied;
(D) the number of audits conducted by the Secretary of accredited persons, the quality of inspections conducted by accredited persons, whether accredited persons are meeting their obligations under this chapter, and whether the number of audits conducted is sufficient to permit these assessments;
(E) whether this subsection is achieving the goal of ensuring more information about device establishment compliance is being presented to the Secretary, and whether that information is of a quality consistent with information obtained by the Secretary pursuant to inspections conducted by Federal employees;
(F) whether this subsection is advancing efforts to allow device establishments to rely upon third-party inspections for purposes of compliance with the laws of foreign governments; and
(G) whether the Congress should continue, modify, or terminate the program under this subsection.
(13) The Secretary shall include in the annual report required under
(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in
(15)(A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—
(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under
(ii) establishments required to register pursuant to
(B) Nothing in this paragraph affects—
(i) the authority of the Secretary to inspect any device establishment pursuant to this chapter; or
(ii) the authority of the Secretary to determine the official classification of an inspection.
(h) Improvements to inspections process for device establishments
(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of August 18, 2017, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—
(A) exceptions to such processes and standards, as appropriate;
(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;
(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and
(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.
(2)(A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.
(B) A request described in this subparagraph is a request for feedback—
(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and
(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).
(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.
(June 25, 1938, ch. 675, §704,
Editorial Notes
References in Text
The Public Health Service Act, referred to in subsec. (a)(5), is act July 1, 1944, ch. 373,
Amendments
2022—Subsec. (a)(1).
Subsec. (a)(4)(A).
Subsec. (a)(4)(C), (D).
Subsec. (a)(5).
Subsec. (b).
Subsec. (g)(11).
2020—Subsec. (b).
2017—Subsec. (g)(11).
Subsec. (g)(15).
Subsec. (h).
2012—Subsec. (a)(4).
Subsec. (g)(11).
2011—Subsec. (a)(1).
2009—Subsec. (a)(1).
Subsec. (a)(1)(A).
Subsec. (b).
Subsec. (g)(13).
2007—Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(3)(F), (G).
Subsec. (g)(6).
Subsec. (g)(7)(A).
Subsec. (g)(7)(F).
Subsec. (g)(10)(C)(iii).
2004—Subsec. (g)(1).
Subsec. (g)(5)(B).
Subsec. (g)(6)(A)(i).
Subsec. (g)(6)(A)(ii).
Subsec. (g)(6)(A)(ii)(I).
Subsec. (g)(6)(A)(iii).
Subsec. (g)(6)(A)(iii)(I).
Subsec. (g)(6)(A)(iii)(II).
Subsec. (g)(6)(A)(iv)(I).
Subsec. (g)(6)(A)(iv)(II).
Subsec. (g)(6)(B)(iii).
Subsec. (g)(6)(B)(iv).
Subsec. (g)(6)(C)(ii).
Subsec. (g)(10)(B)(iii).
Subsec. (g)(12)(A).
Subsec. (g)(12)(E).
2002—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(3).
Subsec. (g).
1997—Subsec. (a)(1).
Subsec. (f).
1993—Subsec. (a)(1).
1980—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
1976—Subsec. (a).
Subsec. (e).
1962—Subsec. (a).
Subsec. (b).
1953—Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by sections 210(b) and 412(b) of
Effective Date of 1962 Amendment
Amendment by
Construction of 2011 Amendment
Nothing in amendment by
Review of Processes and Practices; Guidance for Industry
"(1)
"(A) review processes and practices in effect as of the date of enactment of this Act [Dec. 29, 2022] applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act [
"(B) evaluate whether any updates are needed to facilitate the consistency of such processes and practices.
"(2)
"(A)
"(B)
"(i) not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and
"(ii) not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A)."
Unannounced Foreign Facility Inspections Pilot Program
"(a)
"(1) differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (
"(2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;
"(3) barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and
"(4) approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.
"(b)
"(c)
"(d)
"(1) findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;
"(2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and
"(3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act."
Guidance
"(A)
"(i) circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act [
"(ii) processes for responding to such requests electronically or in physical form; and
"(iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
"(B)
"(i) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], issue draft guidance under subparagraph (A); and
"(ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A)."
"(1)
"(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (
"(B) provides for standardized methods for communications described in such paragraphs;
"(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act [
"(i) that occurs over consecutive days; and
"(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and
"(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.
"(2)
Inspections
"Within 6 months of the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (
"(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (
"(A) for which the approval is dependent upon remediation of conditions identified in the report;
"(B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and
"(C) where the drug that is the subject of the application is a drug—
"(i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (
"(ii) that is included on the list under section 506E of such Act (
"(2) address expedited re-inspection of facilities, as appropriate; and
"(3) establish a 6-month timeline for completion of review of such responses to such reports."
Authority of Secretary Prior to October 10, 1962
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§374a. Inspections relating to food allergens
The Secretary of Health and Human Services shall conduct inspections consistent with the authority under
(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and
(2) to ensure that major food allergens are properly labeled on foods.
(
Editorial Notes
Codification
Section was enacted as a part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
§375. Publicity
(a) Reports
The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.
(b) Information regarding certain goods
The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.
(June 25, 1938, ch. 675, §705,
Editorial Notes
Amendments
2009—Subsec. (b).
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§376. Examination of sea food on request of packer; marking food with results; fees; penalties
The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.
(June 25, 1938, ch. 675, §706, formerly §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712,
Editorial Notes
Codification
Section was formerly classified to
Section, which formerly was not a part of the Federal Food, Drug, and Cosmetic Act, originally was classified to
Prior Provisions
A prior section 376, act June 25, 1938, ch. 675, §706,
Amendments
1993—
1992—
Statutory Notes and Related Subsidiaries
Transfer of Functions
Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§377. Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
The Secretary, in carrying into effect the provisions of the Federal Food, Drug, and Cosmetic Act [
(July 12, 1943, ch. 221, title II,
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675,
Codification
Section was enacted as part of the Labor-Federal Security Appropriation Act, 1944, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
Executive Documents
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under
§378. Advertising of foods
(a) Determination of misbranding; notification of Federal Trade Commission by Secretary; contents
(1) Except as provided in subsection (c), before the Secretary may initiate any action under subchapter III—
(A) with respect to any food which the Secretary determines is misbranded under
(B) with respect to a food's advertising which the Secretary determines causes the food to be so misbranded,
the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising.
(2) The notice required by paragraph (1) shall—
(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary's determination that such advertising has caused such food to be misbranded, and
(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.
(b) Action by Federal Trade Commission precluding action by Secretary; exception
(1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under subchapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that—
(A) it has initiated under the Federal Trade Commission Act [
(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 [
(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [
(D) pursuant to section 16(b) of such Act [
the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary's notice to the Federal Trade Commission.
(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—
(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary's notice,
(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or
(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,
the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising.
(c) Secretary's determination of imminent hazard to health as suspending applicability of provisions
The requirements of subsections (a) and (b) do not apply with respect to action under subchapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health.
(d) Coordination of action by Secretary with Federal Trade Commission
For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under subchapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [
(June 25, 1938, ch. 675, §707, as added
Editorial Notes
References in Text
The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311,
§379. Confidential information
(a) Contractors
The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of
(b) Ability to receive and protect confidential information obtained from foreign governments
(1) In general
The Secretary shall not be required to disclose under
(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;
(B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and
(C) the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.
(2) Time limitations
The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of
(3) Disclosures not affected
Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.
(4) Relation to other law
For purposes of
(c) Authority to enter into memoranda of understanding for purposes of information exchange
The Secretary may enter into written agreements to provide information referenced in
(1) Certification
The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.
(2) Written agreement
The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to
(3) Information exchange
The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in
(A) Information concerning the inspection of a facility may be provided to a foreign government if—
(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and
(ii) the written agreement executed under paragraph (2) limits the recipient's use of the information to the recipient's civil regulatory purposes.
(B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
(4) Effect of subsection
Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.
(June 25, 1938, ch. 675, §708, as added
Editorial Notes
Amendments
2012—
§379a. Presumption of existence of jurisdiction
In any action to enforce the requirements of this chapter respecting a device, tobacco product, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.
(June 25, 1938, ch. 675, §709, as added
Editorial Notes
Amendments
2009—
1997—
Statutory Notes and Related Subsidiaries
Effective Date of 1997 Amendment
Amendment by
§379b. Consolidated administrative and laboratory facility
(a) Authority
The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.
(b) Awarding of contract
The Secretary shall solicit contract proposals under subsection (a) from interested parties. In awarding contracts under such subsection, the Secretary shall review such proposals and give priority to those alternatives that are the most cost effective for the Federal Government and that allow for the use of donated land, federally owned property, or lease-purchase arrangements. A contract under this subsection shall not be entered into unless such contract results in a net cost savings to the Federal Government over the duration of the contract, as compared to the Government purchase price including borrowing by the Secretary of the Treasury.
(c) Donations
In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section $100,000,000 for fiscal year 1991, and such sums as may be necessary for each of the subsequent fiscal years, to remain available until expended.
(June 25, 1938, ch. 675, §710, as added
§379c. Transferred
Editorial Notes
Codification
Section, act June 25, 1938, ch. 675, §711, as added Nov. 28, 1990,
§379d. Automation of Food and Drug Administration
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.
(b) Authorization of appropriations
There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.
(June 25, 1938, ch. 675, §711, formerly §712, as added
Editorial Notes
Prior Provisions
A prior section 711 of act June 25, 1938, was renumbered section 731 by
§379d–1. Conflicts of interest
(a) Definitions
For purposes of this section:
(1) Advisory committee
The term "advisory committee" means an advisory committee under
(2) Financial interest
The term "financial interest" means a financial interest under
(b) Recruitment for advisory committees
(1) In general
The Secretary shall—
(A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;
(B) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities;
(C) at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including—
(i) product developers, patient groups, and disease advocacy organizations; and
(ii) relevant—
(I) professional societies;
(II) medical societies;
(III) academic organizations; and
(IV) governmental organizations; and
(D) in carrying out subparagraphs (A) and (B), take into account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees.
(2) Recruitment activities
The recruitment activities under paragraph (1) may include—
(A) advertising the process for becoming an advisory committee member at medical and scientific society conferences;
(B) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and
(C) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person whom the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.
(3) Expertise
In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.
(c) Disclosure of determinations and certifications
Notwithstanding
(1) 15 or more days in advance
As soon as practicable, but (except as provided in paragraph (2)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in
(A) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination or certification applies; and
(B) the reasons of the Secretary for such determination or certification, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter before the advisory committee.
(2) Less than 30 days in advance
In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in
(d) Public record
The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c) (other than information exempted from disclosure under
(e) Annual report
(1) In general
Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives, a report that describes—
(A) with respect to the fiscal year that ended on September 30 of the previous year, the number of persons nominated for participation at meetings for each advisory committee, the number of persons so nominated, and willing to serve, the number of vacancies on each advisory committee, and the number of persons contacted for service as members on each advisory committee meeting for each advisory committee who did not participate because of the potential for such participation to constitute a disqualifying financial interest under
(B) with respect to such year, the number of persons contacted for service as members for each advisory committee meeting for each advisory committee who did not participate because of reasons other than the potential for such participation to constitute a disqualifying financial interest under
(C) with respect to such year, the number of members attending meetings for each advisory committee; and
(D) with respect to such year, the aggregate number of disclosures required under subsection (d) and the percentage of individuals to whom such disclosures did not apply who served on such committee.
(2) Public availability
Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public.
(f) Periodic review of guidance
Not less than once every 5 years, the Secretary shall—
(1) review guidance of the Food and Drug Administration with respect to advisory committees regarding disclosure of conflicts of interest and the application of
(2) update such guidance as necessary to ensure that the Food and Drug Administration receives appropriate access to needed scientific expertise, with due consideration of the requirements of such section 208.
(g) Guidance on reported disclosed financial interest or involvement
The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are disclosed under subsection (c) but that the Secretary determines not to meet the definition of a disqualifying interest under
(June 25, 1938, ch. 675, §712, as added
Editorial Notes
References in Text
The Privacy Act of 1974, referred to in subsec. (c)(3)(A), is
Prior Provisions
A prior section 712 of act June 25, 1938, was renumbered section 711 by
Amendments
2022—Subsec. (a)(1).
Subsec. (c).
2016—Subsec. (e)(1)(B).
2012—Subsecs. (b), (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Effective Date of 2012 Amendment
Effective Date
Section effective Oct. 1, 2007, see section 701(c) of
§379d–2. Policy on the review and clearance of scientific articles published by FDA employees
(a) Definition
In this section, the term "article" means a paper, poster, abstract, book, book chapter, or other published writing.
(b) Policies
The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.
(c) Timing of submission for review
If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.
(d) Timing for review and clearance
The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.
(e) Non-timely review
If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).
(f) Effect
Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.
(June 25, 1938, ch. 675, §713, as added
§379d–3. Streamlined hiring authority
(a) In general
In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).
(b) Activities described
The activities described in this subsection are—
(1) activities under this chapter related to the process for the review of device applications (as defined in
(2) activities under this chapter related to human generic drug activities (as defined in
(c) Objectives specified
The objectives specified in this subsection are—
(1) with respect to the activities under subsection (b)(1), the goals referred to in
(2) with respect to the activities under subsection (b)(2), the goals referred to in
(d) Internal controls
The Secretary shall institute appropriate internal controls for appointments under this section.
(e) Sunset
The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.
(June 25, 1938, ch. 675, §714, as added and amended
Editorial Notes
Amendments
2017—Subsec. (b)(1).
2012—Subsec. (b).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date of 2017 Amendment
Amendment by
Effective Date of 2012 Amendment
Amendment by section 307 of
Effective Date
Section effective Oct. 1, 2012, see section 206 of
§379d–3a. Hiring authority for scientific, technical, and professional personnel
(a) In general
The Secretary may, notwithstanding title 5, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions, including cross-cutting operational positions, that support the development, review, and regulation of medical products and the regulation of food and cosmetics. Such positions shall be within the competitive service.
(b) Compensation
(1) In general
Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of
(A) the annual rate of pay of any individual appointed under subsection (a); and
(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before December 13, 2016.
(2) Limitation
The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in
(3) Public availability
The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.
(c) Rule of construction
The authorities under this section shall not be construed to affect the authority provided under
(d) Report on workforce planning
(1) In general
Not later than 18 months after December 29, 2022, the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(A) an updated analysis of the workforce needs at the Food and Drug Administration and the Secretary's strategic plan for addressing such needs, including through use of the authority under this section;
(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and
(C) an updated recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—
(i) recruitment through nongovernmental recruitment or placement agencies;
(ii) recruitment through academic institutions;
(iii) recruitment or hiring bonuses, if applicable;
(iv) recruitment using targeted direct hiring authorities; and
(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.
(2) Recommendations
The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.
(June 25, 1938, ch. 675, §714A, as added
Editorial Notes
Amendments
2022—Subsec. (a).
Subsec. (d)(1).
Subsec. (d)(1)(A).
Subsec. (d)(1)(B).
Subsec. (d)(1)(C).
§379d–3b. Strategic Workforce Plan and report
(a) In general
Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop, begin implementation of, and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated strategy and report to provide direction for the activities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the development, review, and regulation of medical products. Each such report shall be known as the "Food and Drug Administration Strategic Workforce Plan".
(b) Use of the Food and Drug Administration Strategic Workforce Plan
Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plans developed under subsection (a).
(c) Contents of the Food and Drug Administration Strategic Workforce Plan
Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall—
(1) include agency-wide human capital strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Administration;
(2) establish specific actions the Secretary will take to achieve such strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years;
(3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the actions the Secretary will take to overcome those challenges and mitigate those risks;
(4) establish performance measures, benchmarks, or other elements that the Secretary will use to measure and evaluate progress in achieving such strategic goals and priorities and the effectiveness of such strategic goals and priorities; and
(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.
(d) Considerations
In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider—
(1) the number of employees (including senior leadership and non-senior leadership employees) eligible for retirement, the expertise of such employees, and the employing center of such employees;
(2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates;
(3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results;
(4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve the strategic goals and priorities described in subsection (c);
(5) the statutory hiring authorities used to hire Food and Drug Administration employees, and the time to hire across different hiring authorities; and
(6) any other timely and relevant information, as the Secretary determines appropriate.
(e) Evaluation of progress
Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of—
(1) the progress the Secretary has made, based on the performance measures, benchmarks, and other elements that measure successful recruitment, hiring, training, development, and retention activities; and
(2) whether actions taken in response to the Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities described in subsection (c)(1).
(f) Additional considerations
The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID–19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, including protecting such workforce during public health emergencies.
(June 25, 1938, ch. 675, §714B, as added
§379d–4. Reporting requirements
(a) Generic drugs
Beginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 7 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a generic drug under
(1) the number of such applications that met the goals identified for purposes of subpart 7 of part C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;
(2) the average total time to decision by the Secretary for applications for approval of a generic drug under
(3) the total number of applications under
(4) the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.
(b) Biosimilar biological products
(1) In general
Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 8 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning—
(A) the number of applications for approval filed under
(B) the percentage of applications described in subparagraph (A) that were approved by the Secretary.
(2) Additional information
As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under subpart 2 1 are not used to review an application under
(June 25, 1938, ch. 675, §715, as added and amended
Editorial Notes
Amendments
2012—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2012 Amendment
Amendment by section 408 of
Effective Date
Section effective Oct. 1, 2012, see section 305 of
1 So in original. Probably means subpart 2 of part C.
§379d–5. Guidance document regarding product promotion using the Internet
Not later than 2 years after July 9, 2012, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.
(
Editorial Notes
Codification
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
Part B—Colors
§379e. Listing and certification of color additives for foods, drugs, devices, and cosmetics
(a) Unsafe color additives
A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of
(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.
While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of
(b) Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee
(1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.
(2)(A) Such regulations may list any color additive for use generally in or on food, or in or on drugs or devices, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use.
(B) If the data before the Secretary do not establish that the additive satisfies the requirements for listing such additive on the applicable list pursuant to subparagraph (A) of this paragraph, or if the proposal is for listing such additive for a more limited use or uses, such regulations may list such additive only for any more limited use or uses for which it is suitable and may safely be employed.
(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive).
(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term "food additive" because of its being generally recognized by qualified experts as safe for its intended use, as provided in
(5)(A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors—
(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs or devices, or cosmetics because of the use of the additive;
(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet;
(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and
(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug or device, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive.
(B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d)) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal.
(C)(i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a proposal of the Secretary on his own initiative or by a proposal contained in a petition, the petitioner, or any other person who will be adversely affected by such proposal or by the Secretary's order issued in accordance with paragraph (1) of
(ii) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before it, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. A copy of the foregoing shall be promptly supplied by the Secretary to any person who has filed a petition, or who has requested such referral to the advisory committee. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order confirm or modify any order theretofore issued or, if no such prior order has been issued, shall by order act upon the petition or other proposal.
(iii) Where—
(I) by reason of subparagraph (B) of this paragraph, the Secretary has initiated a proposal to remove from listing a color additive previously listed pursuant to this section; and
(II) a request has been made for referral of such proposal to an advisory committee;
the Secretary may not act by order on such proposal until the advisory committee has made a report and recommendations to him under clause (ii) of this subparagraph and he has considered such recommendations, unless the Secretary finds that emergency conditions exist necessitating the issuance of an order notwithstanding this clause.
(D) The advisory committee referred to in subparagraph (C) of this paragraph shall be composed of experts selected by the National Academy of Sciences, qualified in the subject matter referred to the committee and of adequately diversified professional background, except that in the event of the inability or refusal of the National Academy of Sciences to act, the Secretary shall select the members of the committee. The size of the committee shall be determined by the Secretary. Members of any advisory committee established under this chapter, while attending conferences or meetings of their committees or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by
(6) The Secretary shall not list a color additive under this subsection for a proposed use if the data before him show that such proposed use would promote deception of the consumer in violation of this chapter or would otherwise result in misbranding or adulteration within the meaning of this chapter.
(7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary—
(A) shall not list the additive for such use if he finds that the data before him do not establish that such additive, if used within a safe tolerance limitation, would achieve the intended physical or other technical effect; and
(B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect.
(8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permissible to list a color additive (or pharmacologically related color additives) for all the uses proposed therefor and at the levels of concentration proposed, the Secretary shall, in determining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safety), (A) the relative marketability of the articles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative dependence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by reason of the various uses and levels of concentration proposed; and (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed.
(c) Certification of colors
The Secretary shall further, by regulation, provide (1) for the certification, with safe diluents or without diluents, of batches of color additives listed pursuant to subsection (b) and conforming to the requirements for such additives established by regulations under such subsection and this subsection, and (2) for exemption from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health: Provided, That, with respect to any use in or on food for which a listed color additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b), the requirement of certification shall be deemed not to be necessary in the interest of public health protection.
(d) Procedure for issuance, amendment, or repeal of regulations
The provisions of
(1) if the proceeding is commenced by the filing of a petition, notice of the proposal made by the petition shall be published in general terms by the Secretary within thirty days after such filing, and the Secretary's order (required by paragraph (1) of
(2) any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee appointed pursuant to subparagraph (D) of subsection (b)(5) of this section, shall be made a part of the record of any hearing if relevant and material, subject to the provisions of
(3) the Secretary's order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of
(4) the scope of judicial review of such order shall be in accordance with the fourth sentence of paragraph (2), and with the provisions of paragraph (3), of
(e) Fees
The admitting to listing and certification of color additives, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.
(f) Exemptions
The Secretary shall by regulations (issued without regard to subsection (d)) provide for exempting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or device, or cosmetic bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.
(June 25, 1938, ch. 675, §721, formerly §706,
Editorial Notes
Codification
Section was formerly classified to
In subsec. (d)(2), "
Amendments
1993—Subsec. (b)(5)(D).
1992—Subsec. (b)(5)(C)(i).
1976—Subsec. (a).
Subsec. (b).
Subsec. (f).
1970—Subsec. (b)(5)(D).
1962—Subsec. (b)(5)(B).
1960—
Statutory Notes and Related Subsidiaries
Effective Date of 1962 Amendment
Amendment by
Effective Date of 1960 Amendment, Transitional Provisions, and Effect on Other Laws
"
"
"
"(2) For the purposes of this section, the term 'closing date' means (A) the last day of the two and one-half year period beginning on the enactment date [July 12, 1960] or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing (or deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 [now 721] of the basic Act [this section]. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.
"(b) Subject to the other provisions of this section—
"(1) any color additive which, on the day preceding the enactment date [July 12, 1960], was listed and certifiable for any use or uses under section 406(b), 504, or 604 [
"(2) any color additive which was commercially used or sold prior to the enactment date [July 12, 1960] for any use or uses in or on any food, drug, or cosmetic, and which either, (A), on the day preceding the enactment date [July 12, 1960], was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this subsection, or (B) is the color additive known as synthetic beta-carotene,
shall, beginning on the enactment date [July 12, 1960], be deemed to be provisionally listed under this section as a color additive for such use or uses.
"(c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, under section 406(b), 504, or 604 of the basic Act [
"(d)(1) The Secretary shall, by regulations issued or amended from time to time under this section—
"(A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with respect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect;
"(B) provide for the provisional listing of the color additives and particular uses thereof specified in subsection (c);
"(C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section 706 [now 721] of the basic Act [this section];
"(D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b)(2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and
"(E) provide for the termination of a provisional listing (or deemed provisional listing) of a color additive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health.
"(2)(A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act [subsec. (e) of this section], but for the purposes of the application of section 706(e) [now 721(e)] of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706 [now 721, this section]. Regulations providing for fees (and advance deposits to cover fees), which on the day preceding the enactment date [July 12, 1960] were in effect pursuant to section 706 [now 721] of the basic Act [this section], shall be deemed to be regulations under such section 706 [now 721, this section] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified in such section 706 [now 721] as in effect prior to the enactment date [July 12, 1960] shall be available for the purposes specified in such section 706 [now 721, this section] as so amended.
"(B) If the Secretary, by regulation—
"(i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1)(E) of this subsection; or
"(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional listing (or deemed provisional listing) which listing had become effective prior to such action,
any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.
"(C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provisional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accordance with section 701(f) of the basic Act [
"(D) On and after the enactment date [July 12, 1960], regulations, provisional listings, and certifications (or exemptions from certification) in effect under this section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or exemptions from certification) under section 706 [now 721] of the basic Act [this section]. A regulation, provisional listing or termination thereof, tolerance limitation, or certification or exemption therefrom, under this section shall not be the basis for any presumption or inference in any proceeding under section 706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this section].
"(3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1)(A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as practicable after enactment of this Act [July 12, 1960], afford by public notice a reasonable opportunity to interested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date [July 12, 1960] with a view to prescribing a temporary tolerance or tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation.
"
Effective Date; Acceleration
This section was made "immediately effective" by act May 2, 1939, ch. 107, title I, §1,
Termination of Advisory Committees
Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Part C—Fees
subpart 1—freedom of information fees
§379f. Recovery and retention of fees for freedom of information requests
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs, may—
(1) set and charge fees, in accordance with
(2) retain all fees charged for such requests; and
(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section.
(b) Use of fees
The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this chapter.
(c) Waiver of fees
Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to
(June 25, 1938, ch. 675, §731, formerly §711, as added
Editorial Notes
Codification
Section was formerly classified to
subpart 2—fees relating to drugs
§379g. Definitions
For purposes of this subpart:
(1) The term "human drug application" means an application for—
(A) approval of a new drug submitted under
(B) licensure of a biological product under subsection (a) of
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under
(2) The term "supplement" means a request to the Secretary to approve a change in a human drug application which has been approved.
(3)(A) The term "prescription drug product" means a specific strength or potency of a drug in final dosage form—
(i) for which a human drug application has been approved,
(ii) which may be dispensed only under prescription pursuant to
(iii) which is on the list of products described in
(B) Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under
(C)(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under
(I) the date such request was received; or
(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
(4) The term "final dosage form" means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).
(5) The term "prescription drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term "manufactured" does not include packaging.
(6) The term "process for the review of human drug applications" means the following activities of the Secretary with respect to the review of human drug applications and supplements:
(A) The activities necessary for the review of human drug applications and supplements.
(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.
(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary's review of pending human drug applications and supplements.
(D) Activities necessary for the review of applications for licensure of establishments subject to
(E) Monitoring of research conducted in connection with the review of human drug applications.
(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing
(v) Carrying out
(7) The term "costs of resources allocated for the process for the review of human drug applications" means the expenses in connection with the process for the review of human drug applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors,
(B) management of information, and the acquisition, maintenance, and repair of computer resources,
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
(D) collecting fees under
(8) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 1996.
(9) The term "person" includes an affiliate thereof.
(10) The term "active", with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.
(11) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(12) The term "skin-test diagnostic product"—
(A) means a product—
(i) for prick, scratch, intradermal, or subcutaneous administration;
(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;
(iii) not intended to be a preventive or therapeutic intervention; and
(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—
(I) an allergy to an antimicrobial agent;
(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or
(III) infection with fungal or mycobacterial pathogens; and
(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).
(June 25, 1938, ch. 675, §735, as added
Termination of Section
For termination of section by section 1005(a) of
Editorial Notes
Amendments
2022—Par. (1).
Par. (3).
Par. (12).
2012—Par. (1)(B).
Par. (7).
2010—Par. (1)(B).
2007—
Par. (1).
Par. (1)(A).
Par. (1)(B), (C).
"(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or
"(ii) an indication for a use,
that had not been approved under an application submitted under
Par. (3)(C).
Par. (4).
Par. (6)(F).
Par. (8).
Pars. (9) to (11).
2002—Par. (1).
Par. (3).
Par. (3)(C).
Par. (6)(F).
Par. (8).
1997—Par. (1).
Par. (1)(B) to (D).
Par. (3).
Par. (4).
Par. (5).
"(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and
"(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product."
Par. (7)(A).
Par. (8)(A).
Par. (8)(B).
Par. (9).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2017 Amendment
Effective Date of 2012 Amendment
Amendment by section 407 of
Effective and Termination Dates of 2007 Amendment
Effective and Termination Dates of 2002 Amendment
Amendment by
[
Effective and Termination Dates of 1997 Amendment
[
Termination Date
[
[
[
Savings Provision
Accountability and Reports
"(a)
"(1)
"(2)
"(b)
"(c)
Congressional Findings Concerning Fees Relating to Drugs
"(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;
"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of
"(A) reauthorized for an additional 5 years, with certain technical improvements; and
"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including—
"(i) strengthening and improving the review and monitoring of drug safety;
"(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and
"(iii) developing principles for improving first-cycle reviews; and
"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§501–509) of title V of
"(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications;
"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of
"(A) reauthorized for an additional 5 years, with certain technical improvements; and
"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and
"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§101–107) of title I of
"(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications; and
"(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under
Annual Reports
"(a)
"(b)
"(a)
"(b)
"(c)
Animal Drug User Fee Study
§379h. Authority to assess and use drug fees
(a) Types of fees
Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Human drug application fee
(A) In general
Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:
(i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.
(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the application.
(C) Exception for previously filed application
If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(D) Refund of fee if application refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing.
(E) Fees for applications previously refused for filing or withdrawn before filing
A human drug application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).
(F) Exception for designated orphan drug
A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to
(G) Refund of fee if application withdrawn
If an application is withdrawn after the application was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(H) Exception for skin-test diagnostic products
A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).
(2) Prescription drug program fee
(A) In general
(i) Payment of fees
Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
(ii) Special rule for previously discontinued drug products
If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in
(B) Exception for certain prescription drug products
A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—
(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under
(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under
(iii) a skin-test diagnostic product.
(C) Limitation
A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.
(b) Fee revenue amounts
(1) In general
For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—
(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));
(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));
(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));
(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and
(G) additional dollar amounts for each fiscal year as follows:
(i) $65,773,693 for fiscal year 2023.
(ii) $25,097,671 for fiscal year 2024.
(iii) $14,154,169 for fiscal year 2025.
(iv) $4,864,860 for fiscal year 2026.
(v) $1,314,620 for fiscal year 2027.
(2) Types of fees
Of the total revenue amount determined for a fiscal year under paragraph (1)—
(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and
(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).
(3) Annual base revenue
For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2023, $1,151,522,958; and
(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and
(ii) the inflation adjustment percentage under subparagraph (B).
(B) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—
(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in
(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in
(2) Strategic hiring and retention adjustment
For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:
(A) For fiscal year 2023, $9,000,000.
(B) For each of fiscal years 2024 through 2027, $4,000,000.
(3) Capacity planning adjustment
(A) In general
For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.
(B) Methodology
For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Prescription Drug User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
(C) Limitation
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).
(D) Publication in Federal Register
The Secretary shall publish in the Federal Register notice under paragraph (6) of 1 the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
(4) Operating reserve adjustment
(A) Increase
For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:
(i) For fiscal year 2023, at least 8 weeks of operating reserves.
(ii) For fiscal year 2024, at least 9 weeks of operating reserves.
(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.
(B) Decrease
If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.
(C) Notice of rationale
If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (6) establishing fee revenue and fees for the fiscal year involved.
(5) Additional direct cost adjustment
(A) Increase
The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—
(i) for fiscal year 2023, by $44,386,150; and
(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.
(B) Applicable amounts
The amounts referred to in subparagraph (A)(ii) are the following:
(i) For fiscal year 2024, $60,967,993.
(ii) For fiscal year 2025, $35,799,314.
(iii) For fiscal year 2026, $35,799, 314.
(iv) For fiscal year 2027, $35,799,314.
(6) Annual fee setting
The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2022—
(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(B) publish such fee revenue and fees in the Federal Register.
(7) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.
(d) Fee waiver or reduction
(1) In general
The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—
(A) such waiver or reduction is necessary to protect the public health,
(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or
(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.
(2) Considerations
In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.
(3) Rules relating to small businesses
(A) "Small business" defined
In paragraph (1)(C), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.
(e) Effect of failure to pay fees
A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(f) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human drug applications and prescription drug program fees at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Limitation
Beginning on October 1, 2023, the authorities under
(g) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and
(ii) shall be available—
(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor; and
(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—
(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and
(II) such costs are not more than 5 percent below the level specified in such subparagraph.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees
To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—
(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and
(2) include in the request any legal authorities under which the request is made.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Orphan drugs
(1) Exemption
A drug designated under
(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.
(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as determined under paragraph (2).
(2) Evidence of qualification
An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant's gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—
(A) tax returns submitted to the United States Internal Revenue Service; or
(B) as necessary, other appropriate financial information.
(June 25, 1938, ch. 675, §736, as added
Termination of Section
For termination of section by section 1005(a) of
Editorial Notes
References in Text
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(2)(B)(iv), is
Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsec. (c)(2)(B)(ii)(III), is section 101(b) of
Amendments
2022—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(C).
Subsec. (a)(1)(H).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
"(i) identified on the list compiled under
"(ii) the same product as another product that—
"(I) was approved under an application filed under
"(II) is not in the list of discontinued products compiled under
"(iii) the same product as another product that was approved under an abbreviated application filed under
"(iv) the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."
Subsec. (b)(1).
Subsec. (b)(3).
Subsec. (c)(1)(B)(ii).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (c)(4).
Subsec. (c)(4)(A).
Subsec. (c)(4)(C).
Subsec. (c)(5).
Subsec. (c)(6).
Subsec. (c)(7).
Subsec. (g)(2)(A)(ii).
Subsec. (g)(2)(B).
Subsec. (g)(3).
Subsec. (i).
Subsec. (k)(1)(B).
Subsec. (k)(2).
2017—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (a)(1)(C).
Subsec. (a)(1)(F).
Subsec. (a)(2).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (a)(3).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1)(C), (D).
Subsec. (d)(3).
Subsec. (d)(3)(A).
Subsec. (d)(3)(B).
Subsec. (d)(4).
Subsec. (e).
Subsec. (f)(2).
Subsec. (f)(3).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (k)(1).
2012—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(2)(A).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B), (C).
Subsec. (b)(3), (4).
Subsec. (c).
Subsec. (g)(1).
Subsec. (g)(2)(A)(i).
Subsec. (g)(2)(A)(ii).
Subsec. (g)(2)(C).
Subsec. (g)(3).
Subsec. (g)(4).
2007—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(D).
Subsec. (a)(1)(E) to (G).
Subsec. (a)(2)(A).
Subsec. (a)(2)(C).
Subsec. (a)(3)(A).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(C).
Subsec. (c)(3).
Subsec. (c)(4).
Subsec. (c)(5).
Subsec. (c)(6).
Subsec. (d)(1).
Subsec. (d)(2), (3).
Subsec. (d)(4).
Subsec. (d)(4)(A).
Subsec. (g)(1).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (k).
2002—Subsec. (a).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (a)(1)(F), (G).
Subsec. (a)(2)(A).
Subsec. (a)(3)(A).
"(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under
"(ii) who, after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under
Subsec. (a)(3)(B).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(1)(A).
Subsec. (c)(1)(B).
Subsec. (c)(2) to (5).
Subsec. (d)(1)(C) to (E).
Subsec. (d)(3)(A), (B).
Subsec. (f).
Subsec. (f)(1).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(3)(A) to (E).
"(A) $106,800,000 for fiscal year 1998;
"(B) $109,200,000 for fiscal year 1999;
"(C) $109,200,000 for fiscal year 2000;
"(D) $114,000,000 for fiscal year 2001; and
"(E) $110,100,000 for fiscal year 2002,".
1997—Subsec. (a).
Subsec. (a)(1)(B).
"(i)
"(ii)
"(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in
"(II) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed.
The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable."
Subsec. (a)(1)(D).
Subsec. (a)(1)(E) to (G).
Subsec. (a)(2).
"(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under
"(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year."
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (d).
Subsec. (f)(1).
Subsec. (g)(1).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B).
Subsec. (g)(3), (4).
"(A) $36,000,000 for fiscal year 1993,
"(B) $54,000,000 for fiscal year 1994,
"(C) $75,000,000 for fiscal year 1995,
"(D) $78,000,000 for fiscal year 1996, and
"(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section."
Subsecs. (i), (j).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 102 of
Effective Date of 2012 Amendment
Amendment by
Effective Date of 2007 Amendment
Amendment by
Effective Date of 2002 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Termination Date
Section ceases to be effective Oct. 1, 2027, see section 1005(a) of
Special Rule for Waivers and Refunds
§379h–1. Fees relating to advisory review of prescription-drug television advertising
(a) Types of direct-to-consumer television advertisement review fees
Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Advisory review fee
(A) In general
With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a "DTC advertisement"), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).
(B) Exception for required submissions
A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review.
(C) Notice to Secretary of number of advertisements
Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.
(D) Payment
(i) In general
The fee required by subparagraph (A) (referred to in this section as "an advisory review fee") shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after September 27, 2007, or an earlier date as specified by the Secretary.
(ii) Effect of submission
Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).
(iii) Notice regarding carryover submissions
In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.
(E) Modification of advisory review fee
(i) Late payment
If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after September 27, 2007, or an earlier date specified by the Secretary), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
(ii) Exceeding identified number of submissions
If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
(F) Limits
(i) Submissions
For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.
(ii) No refunds
Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded.
(iii) No waivers, exemptions, or reductions
The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.
(iv) Right to advisory review not transferable
The right to an advisory review under this paragraph is not transferable, except to a successor in interest.
(2) Operating reserve fee
(A) In general
Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee 1 established under subsection (d)(2) (referred to in this section as an "operating reserve fee") for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.
(B) Payment
Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—
(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or
(ii) for fiscal year 2008, 120 days after September 27, 2007, or an earlier date specified by the Secretary.
(C) Late notice of submission
If, in the first fiscal year of a person's participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.
(D) Late payment
(i) In general
Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—
(I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the Secretary; or
(II) in any subsequent year, November 1.
(ii) Complete payment
The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.
(iii) Amount
Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d).
(b) Advisory review fee revenue amounts
Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).
(c) Adjustments
(1) Inflation adjustment
Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—
(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;
(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with
(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.
The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.
(2) Workload adjustment
Beginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:
(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.
(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.
(3) Annual fee setting for advisory review
(A) In general
Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after September 27, 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under subsection (a)(1)(F)(i).
(B) Fiscal year 2008 fee limit
Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.
(C) Annual fee limit
Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.
(D) Limit
The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.
(d) Operating reserves
(1) In general
The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.
(2) Fee setting
The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.
(3) Use of operating reserve
The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.
(4) Refund of operating reserves
Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).
(e) Effect of failure to pay fees
Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.
(f) Effect of inadequate funding of program
(1) Initial funding
If on November 1, 2007, or 120 days after September 27, 2007, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.
(2) Later fiscal years
Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
(g) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section—
(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and
(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.
(B) Review employees
For purposes of subparagraph (A)(ii), the term "full-time equivalent review employees" means the total combined number of full-time equivalent employees in—
(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and
(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.
(3) Authorization of appropriations
For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).
(4) Offset
Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.
(h) Definitions
For purposes of this section:
(1) The term "advisory review" means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.
(2) The term "advisory review fee" has the meaning indicated for such term in subsection (a)(1)(D).
(3) The term "carry over submission" means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.
(4) The term "direct-to-consumer television advertisement" means an advertisement for a prescription drug product (as defined in
(5) The term "DTC advertisement" has the meaning indicated for such term in subsection (a)(1)(A).
(6) The term "operating reserve fee" has the meaning indicated for such term in subsection (a)(2)(A).
(7) The term "person" includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.
(8) The term "process for the advisory review of prescription drug advertising" means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.
(9) The term "resources allocated for the process for the advisory review of prescription drug advertising" means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;
(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and
(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary.
(10) The term "resubmission" means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.
(11) The term "submission for advisory review" means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.
(June 25, 1938, ch. 675, §736A, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of
1 So in original. Probably should be "the fee".
§379h–2. Reauthorization; reporting requirements
(a) Performance report
(1) In general
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning—
(A) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and
(B) the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division—
(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division;
(ii) the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division;
(iii) the number of standard efficacy supplements filed per fiscal year for each review division;
(iv) the number of priority efficacy supplements filed per fiscal year for each review division;
(v) the number of applications filed for review under accelerated approval per fiscal year for each review division;
(vi) the number of applications filed for review as fast track products per fiscal year for each review division;
(vii) the number of applications filed for orphan-designated products per fiscal year for each review division;
(viii) the number of breakthrough designations for a fiscal year for each review division; and
(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.
Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under
(2) Inclusion
The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.
(3) Real time reporting
(A) In general
Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.
(B) Data
The Secretary shall post the following data in accordance with subparagraph (A):
(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.
(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.
(iii) The number of new drug applications and biological licensing applications approved.
(iv) The number of new drug applications and biological licensing applications filed.
(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.
(4) Rationale for PDUFA program changes
The Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to
(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—
(i) drivers of such changes; and
(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;
(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and
(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.
(5) Analysis
For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:
(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—
(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;
(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.
(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.
(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.
(b) Fiscal report
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
(c) Corrective action report
For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
(1) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.
(2) Goals missed
For any of the goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and
(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.
(d) Enhanced communication
(1) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Updates to Congress
The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(5) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(6) Transmittal of recommendations
Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(7) Minutes of negotiation meetings
(A) Public availability
The Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
(B) Content
The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §736B, as added
Termination of Section
For termination of section by section 1005(b) of
Editorial Notes
References in Text
Section 101(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 1001(b) of the Prescription Drug User Fee Amendments of 2022, title I of div. F of
Section 1001(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 1001(b) of title I of div. F of
Amendments
2022—
Subsec. (a)(1).
Subsec. (a)(1)(B)(ix).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B)(v).
Subsec. (a)(4).
Subsec. (a)(4)(A).
Subsec. (a)(4)(B).
Subsec. (a)(4)(D).
Subsec. (b).
Subsec. (c).
Subsec. (f)(1).
Subsec. (f)(4).
Subsec. (f)(5).
Subsec. (f)(6), (7).
Subsec. (f)(7)(A).
Subsec. (f)(7)(B).
2017—Subsec. (a)(1).
Subsec. (a)(1)(A).
Subsec. (a)(3), (4).
Subsec. (a)(5).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
2012—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 103 of
Effective Date of 2012 Amendment
Amendment by
Effective and Termination Dates
[
[
Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of
1 See References in Text note below.
subpart 3—fees relating to devices
§379i. Definitions
For purposes of this subpart:
(1) The term "premarket application" means—
(A) an application for approval of a device submitted under
(B) a product development protocol described in
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(2) The term "premarket report" means a report submitted under
(3) The term "premarket notification submission" means a report submitted under
(4)(A) The term "supplement", with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—
(i) an application or report has been approved under
(ii) a notice of completion has become effective under
(B) The term "panel-track supplement" means a supplement to an approved premarket application or premarket report under
(C) The term "180-day supplement" means a supplement to an approved premarket application or premarket report under
(D) The term "real-time supplement" means a supplement to an approved premarket application or premarket report under
(E) The term "efficacy supplement" means a supplement to an approved premarket application under
(5) The term "30-day notice" means a notice under
(6) The term "request for classification information" means a request made under
(7) The term "annual fee", for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.
(8) The term "de novo classification request" means a request made under
(9) The term "process for the review of device applications" means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests:
(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.
(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.
(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests.
(E) Review of device applications subject to
(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests.
(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under
(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests.
(I) Any activity undertaken under
(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under
(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests.
(10) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.
(11) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2021.
(12) The term "person" includes an affiliate thereof.
(13) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(14) The term "establishment subject to a registration fee" means an establishment that is registered (or is required to register) with the Secretary under
(June 25, 1938, ch. 675, §737, as added
Termination of Section
For termination of section by section 2007(a) of
Editorial Notes
Amendments
2022—Par. (9).
Par. (9)(D).
Par. (9)(F).
Par. (9)(G), (H).
Par. (9)(K).
Par. (11).
2017—Par. (8).
Par. (9).
Par. (10).
Par. (11).
Pars. (12) to (14).
2016—Par. (5).
2012—Par. (9).
Par. (10).
Par. (13).
2007—
Pars. (5) to (9).
Par. (10).
Par. (11).
Par. (12).
Par. (13).
2004—
Par. (4)(B).
Par. (4)(D).
Par. (5)(J).
Par. (8).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Effective Date of 2012 Amendment
Effective and Termination Dates of 2007 Amendment
Effective and Termination Dates
[
[
[
Savings Provisions
Congressional Findings Concerning Fees Relating to Devices
"(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;
"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and
"(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and
Annual Reports
"(a)
"(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of
"(2) the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].
"(b)
"(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and
"(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (
Study
Consultation
"(a)
"(b)
§379j. Authority to assess and use device fees
(a) Types of fees
(1) In general
Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section.
(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device
(A) In general
Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee equal to the fee that applies under clause (i).
(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).
(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).
(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).
(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).
(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).
(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).
(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).
(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).
(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).
(B) Exceptions
(i) Humanitarian device exemption
An application under
(ii) Further manufacturing use
No fee shall be required under subparagraph (A) for the submission of a premarket application under
(iii) State or Federal Government sponsors
No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
(iv) Premarket notifications by third parties
No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to
(v) Pediatric conditions of use
(I) In general
No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
(II) Subsequent proposal of adult conditions of use
In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
(C) Payment
The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to
(D) Refunds
(i) Application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.
(ii) Application withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.
(iii) Application withdrawn before first action
After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.
(iv) Modular applications withdrawn before first action
The Secretary shall refund 75 percent of the application fee paid for an application submitted under
(v) Later withdrawn modular applications
If an application submitted under
(vi) Sole discretion to refund
The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.
(3) Annual establishment registration fee
(A) In general
Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under
(B) Exception
(i) In general
No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act 1 [
(ii) Small businesses fee waiver
(I) Definition of small business
For purposes of this clause, the term "small business" means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
(II) Waiver
The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.
(III) Firms submitting tax returns to the United States Internal Revenue Service
The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.
(IV) Firms not submitting tax returns to the United States Internal Revenue Service
In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment's firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.
(V) Request for waiver
An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.
(C) Payment
The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—
(i) the initial or annual registration (as applicable) of the establishment under
(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(b) Fee Amounts
(1) In general
Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2023 through 2027, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).
(2) Base fee amounts specified
For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:
Fee Type | Fiscal Year 2023 | Fiscal Year 2024 | Fiscal Year 2025 | Fiscal Year 2026 | Fiscal Year 2027 |
---|---|---|---|---|---|
Premarket Application | $425,000 | $435,000 | $445,000 | $455,000 | $470,000 |
Establishment Registration | $6,250 | $6,875 | $7,100 | $7,575 | $8,465 |
(3) Total revenue amounts specified
For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:
(A) $312,606,000 for fiscal year 2023.
(B) $335,750,000 for fiscal year 2024.
(C) $350,746,400 for fiscal year 2025.
(D) $366,486,300 for fiscal year 2026.
(E) $418,343,000 for fiscal year 2027.
(c) Annual fee setting; adjustments
(1) In general
The Secretary shall, 60 days before the start of each fiscal year after September 30, 2022, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.
(2) Inflation adjustments
(A) Adjustment to total revenue amounts
For fiscal year 2023 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.
(B) Applicable inflation adjustment
The applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—
(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and
(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2022.
(C) Base inflation adjustment
(i) In general
Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—
(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and
(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.
(ii) Limitations
For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—
(I) is less than 1, such adjustment shall be considered to be equal to 1; or
(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.
(D) Adjustment to base fee amounts
For each of fiscal years 2023 through 2027, the Secretary shall—
(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and
(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).
(3) Volume-based adjustments to establishment registration base fees
For each of fiscal years 2023 through 2027, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).
(4) Performance improvement adjustment
(A) In general
For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable:
(i) For fiscal year 2025, the product of—
(I) the amount determined under subparagraph (B)(i)(I); and
(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(ii) For fiscal year 2026, the product of—
(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and
(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(iii) For fiscal year 2027, the product of—
(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and
(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(B) Amounts
(i) Presubmission amount
For purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows:
(I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met.
(II) For fiscal year 2026:
(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
(bb) $36,792,200 if such goal for fiscal year 2024 is met.
(III) For fiscal year 2027:
(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.
(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.
(cc) $40,572,600 if such goal for fiscal year 2025 is met.
(ii) De novo classification request amount
For purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows:
(I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met.
(II) For fiscal year 2027:
(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
(bb) $11,765,400 if such goal for fiscal year 2024 is met.
(iii) Premarket notification and premarket approval amount
For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows:
(I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met.
(II) For fiscal year 2027:
(aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met.
(bb) $3,906,000 if the 4 goals for fiscal year 2024 are met.
(C) Performance calculation
For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:
(i) The performance of the Presubmission Written Feedback goal shall be based on data available as of—
(I) for fiscal year 2023, March 31, 2024;
(II) for fiscal year 2024, March 31, 2025; and
(III) for fiscal year 2025, March 31, 2026.
(ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of—
(I) for fiscal year 2023, March 31, 2025; and
(II) for fiscal year 2024, March 31, 2026.
(D) Goals defined
For purposes of this paragraph, the terms "Presubmission Written Feedback goal", "De Novo Decision goal", "510(k) decision goal", "510(k) Shared Outcome Total Time to Decision goal", "PMA decision goal", and "PMA Shared Outcome Total Time to Decision goal" refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.
(5) Hiring adjustment
(A) In general
For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).
(B) Thresholds
The thresholds specified in this subparagraph are as follows:
(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.
(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.
(iii) For fiscal year 2027, the threshold is—
(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or
(II) 75 hires for fiscal year 2025 if such fees are so increased.
(C) Hiring adjustment amount
The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—
(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;
(ii) $72,877; and
(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.
(D) Hiring goals
The hiring goals for each of fiscal years 2023 through 2025 are as follows:
(i) For fiscal year 2023, 144 hires.
(ii) For fiscal year 2024, 42 hires.
(iii) For fiscal year 2025:
(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).
(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).
(E) Number of hires
For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.
(6) Operating reserve adjustment
(A) In general
For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.
(B) Designated amount
Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—
(i) 13 weeks of operating reserves of carryover user fees; and
(ii) 1 month of operating reserves maintained pursuant to paragraph (8).
(C) Excluded amount
For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).
(7) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
(8) Supplement
(A) In general
The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.
(B) Notice to Congress
Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.
(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees
(1) In general
The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term "small business" means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket approval fees
(A) Definition
For purposes of this paragraph, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
(B) Evidence of qualification
(i) In general
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.
(ii) Firms submitting tax returns to the United States Internal Revenue Service
The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
(C) Reduced fees
Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
(D) Request for fee waiver or reduction
An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.
(e) Small businesses; fee reduction regarding premarket notification submissions
(1) In general
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket notification submissions
(A) Definition
For purposes of this subsection, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
(B) Evidence of qualification
(i) In general
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.
(ii) Firms submitting tax returns to the United States Internal Revenue Service
The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
(C) Reduced fees
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).
(D) Request for reduction
An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.
(f) Effect of failure to pay fees
(1) No acceptance of submissions
A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
(2) No registration
Registration information submitted under
(g) Conditions
(1) Performance goals; termination of program
With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—
(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or
(B) fees were not assessed under subsection (a) for the previous fiscal year.
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Limitation
Beginning on October 1, 2023, the authorities under
(h) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and
(ii) shall be available—
(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and
(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.
(B) Compliance
(i) In general
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—
(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and
(bb) such costs are not more than 5 percent below the level specified in such subparagraph.
(ii) More than 5 percent
To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
(A) In general
For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C).
(B) Revenue amount
For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—
(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and
(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.
(C) Amount of reductions
For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—
(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and
(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.
(i) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(j) Written requests for refunds
To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
(k) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §738, as added
Termination of Section
For termination of section by section 2007(a) of
Editorial Notes
References in Text
The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B)(i), probably means the Indian Self-Determination and Education Assistance Act,
Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (c)(4)(A), (C), (D), (5)(E), is section 2001(b) of title II of div. F of
510(k), referred to in subsec. (c)(4)(B)(iii), (C)(ii), (D), means section 510(k) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, which is classified to
Amendments
2022—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(2)(B)(iii).
Subsec. (a)(2)(C).
Subsec. (a)(3)(B).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(B)(ii).
Subsec. (c)(2)(C)(i)(II).
Subsec. (c)(2)(D).
Subsec. (c)(3).
Subsec. (c)(4) to (8).
Subsec. (d)(2)(B)(iii).
Subsec. (e)(2)(B)(iii).
Subsec. (g)(1)(A).
Subsec. (g)(2).
Subsec. (g)(3).
Subsec. (h)(2)(A)(ii).
Subsec. (h)(2)(B)(i).
Subsec. (h)(3).
2017—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(2)(A)(xi).
Subsec. (a)(2)(B)(v)(I).
Subsec. (a)(3)(A).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
"(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and
"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of—
"(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and
"(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014."
Subsec. (c)(2)(C).
Subsec. (c)(2)(D).
Subsec. (c)(3).
Subsec. (d)(1).
Subsec. (d)(2)(C)(i).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (f)(1).
Subsec. (g).
Subsec. (g)(1)(A).
Subsec. (h).
Subsec. (h)(3).
Subsec. (h)(4).
Subsecs. (i) to (l).
2012—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(3)(A).
Subsec. (a)(3)(C).
Subsec. (b).
Subsec. (c).
Subsecs. (f) to (h).
Subsec. (h)(1)(A).
Subsec. (i).
Subsec. (i)(1).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(A)(ii).
Subsec. (i)(2)(C).
Subsec. (i)(3).
Subsec. (i)(4).
Subsecs. (j) to (l).
2007—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(A)(iv).
Subsec. (a)(2)(A)(v).
Subsec. (a)(2)(A)(vi), (vii).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(2)(A)(ix), (x).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D)(iii).
Subsec. (a)(2)(D)(iv) to (vi).
Subsec. (a)(3).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2), (3).
Subsec. (c)(4).
Subsec. (d)(1).
Subsec. (d)(2)(A).
Subsec. (d)(2)(B).
Subsec. (d)(2)(B)(ii).
Subsec. (d)(2)(B)(iii).
Subsec. (d)(2)(C).
Subsec. (e)(1).
Subsec. (e)(2)(A).
Subsec. (e)(2)(B).
Subsec. (e)(2)(B)(ii).
Subsec. (e)(2)(B)(iii).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (h)(3).
Subsec. (h)(4).
2005—Subsec. (a)(2)(A).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (c)(4).
Subsec. (c)(5), (6).
Subsec. (d)(1).
Subsec. (d)(2)(A).
Subsec. (d)(2)(C).
Subsec. (e)(2)(A).
Subsec. (e)(2)(C).
Subsec. (g)(1)(B)(i).
"(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003;
"(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and
"(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005."
Subsec. (g)(1)(B)(ii).
Subsec. (g)(1)(C).
Subsec. (g)(1)(C)(ii).
Subsec. (g)(1)(D)(i).
Subsec. (h)(3)(D), (E).
"(D) $32,615,000 for fiscal year 2006; and
"(E) $35,000,000 for fiscal year 2007,".
2004—
Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(D)(i), (ii).
Subsec. (d)(1).
Subsec. (d)(2)(B).
Subsec. (e)(1).
Subsec. (e)(2)(B).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (h)(2)(B).
Subsec. (j).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendments by
Effective Date of 2017 Amendment
Amendment by section 203 of
Effective Date of 2012 Amendment
Amendment by
Effective Date of 2007 Amendment
Amendment by
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2027, see section 2007(a) of
Section effective Oct. 26, 2002, except for certain premarket fees, see section 106 of
Fee Exemption for Certain Entities Submitting Premarket Reports
"(1) the premarket report is the first such report submitted to the Secretary by the person; and
"(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report."
1 See References in Text note below.
§379j–1. Reauthorization; reporting requirements
(a) Reports
(1) Performance report
(A) In general
(i) General requirements
Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
(ii) Additional information
Beginning with fiscal year 2023, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—
(I) the number of premarket applications filed under
(II) the number of reports submitted under
(III) the number of expedited development and priority review designations under section 360e–3 1 of this title per fiscal year;
(IV) the number of investigational device exemption applications submitted under
(V) the number of expedited development and priority review requests and designations under
Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under
(iii) Real time reporting
(I) In general
Not later than 30 calendar days after the end of the second quarter of fiscal year 2023, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.
(II) Data
The Secretary shall post the following data in accordance with subclause (I):
(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022; and
(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022.
(iv) Rationale for MDUFA program changes
Beginning with fiscal year 2023, the Secretary shall include in the annual report under paragraph (1)—
(I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to
(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—
(aa) drivers of such changes; and
(bb) changes in the average total cost per full-time equivalent in the medical device review program;
(III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and
(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.
(v) Analysis
For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:
(I) The difference between the aggregate number of premarket applications filed under
(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and
(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.
(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.
(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022.
(B) Publication
With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).
(C) Updates
The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.
(2) Corrective action report
Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
(A) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.
(B) Goals missed
For each of the goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(i) a justification for such determination;
(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under
(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and
(iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 2 fiscal year.
(3) Enhanced communication
(A) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(B) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(4) Fiscal report
For fiscal years 2023 through 2027, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
(5) Public availability
The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.
(b) Reauthorization
(1) Consultation
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Updates to Congress
The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(5) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(6) Transmittal of recommendations
Not later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(7) Minutes of negotiation meetings
(A) Public availability
The Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
(B) Content
The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §738A, as added
Termination of Section
For termination of section by section 2007(b) of
Editorial Notes
References in Text
Section 201(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A), (B), (2), probably should be a reference to section 2001(b) of the Medical Device User Fee Amendments of 2022, title II of div. F of
Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A)(iv)(I), is section 2001(b) of title II of div. F of
Amendments
2022—Subsec. (a).
Subsec. (a)(1)(A)(ii).
Subsec. (a)(1)(A)(ii)(IV), (V).
Subsec. (a)(1)(A)(iv).
Subsec. (a)(1)(A)(iv)(I).
Subsec. (a)(1)(A)(iv)(II).
Subsec. (a)(1)(A)(iv)(IV).
Subsec. (a)(1)(A)(v).
Subsec. (a)(4).
Subsec. (b)(1).
Subsec. (b)(4).
Subsec. (b)(5).
Subsec. (b)(6), (7).
Subsec. (b)(7)(A).
Subsec. (b)(7)(B).
2017—Subsec. (a)(1)(A).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(iv).
Subsec. (a)(1)(B).
Subsec. (a)(2), (3).
Subsec. (a)(4).
Subsec. (a)(5).
Subsec. (b)(1).
Subsec. (b)(5).
2012—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b)(1).
Subsec. (b)(5).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 204 of
Effective Date of 2012 Amendment
Amendment by
Effective and Termination Dates
[
Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of
1 See References in Text note below.
subpart 4—fees relating to animal drugs
Termination of Subpart
For termination of subpart by section 2307(a), (b) of
§379j–11. Definitions
For purposes of this subpart:
(1)(A) The term "animal drug application" means—
(i) an application for approval of any new animal drug submitted under
(ii) an application for conditional approval of a new animal drug submitted under
(B) Such term does not include either a new animal drug application submitted under
(2) The term "supplemental animal drug application" means—
(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or
(B) a request to the Secretary to approve a change to an application approved under
(3) The term "animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.
(4) The term "animal drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.
(5) The term "investigational animal drug submission" means—
(A) the filing of a claim for an investigational exemption under
(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.
(6) The term "animal drug sponsor" means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.
(7) The term "final dosage form" means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.
(8) The term "process for the review of animal drug applications" means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:
(A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(B) The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.
(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary's review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(D) Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(E) The development of regulations and policy related to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(F) Development of standards for products subject to review.
(G) Meetings between the agency and the animal drug sponsor.
(H) Review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application, but not after such application has been approved.
(I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval.
(9) The term "costs of resources allocated for the process for the review of animal drug applications" means the expenses in connection with the process for the review of animal drug applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific animal drug applications, supplemental animal drug applications, or investigational animal drug submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;
(B) management of information and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under
(10) The term "adjustment factor" applicable to a fiscal year refers to the formula set forth in
(11) The term "person" includes an affiliate thereof.
(12) The term "affiliate" refers to the definition set forth in
(June 25, 1938, ch. 675, §739, as added
Termination of Section
For termination of section by section 2307(a) of
Editorial Notes
Amendments
2023—Par. (3).
Par. (8)(I).
2018—Par. (1).
Par. (8)(I).
2013—
2008—Par. (6).
Par. (8)(H).
Par. (10).
Pars. (11), (12).
2007—
Par. (11).
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Effective Date of 2018 Amendment
Effective Date of 2013 Amendment
Effective and Termination Dates of 2008 Amendment
Effective Date of 2007 Amendment
Amendment by
Termination Date
Savings Provisions
Findings
Similar provisions were contained in the following prior acts:
Accountability and Reports
"(a)
"(1)
"(2)
"(A) publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry;
"(B) present the recommendations to the Committees referred to in that paragraph;
"(C) hold a meeting at which the public may comment on the recommendations; and
"(D) provide for a period of 30 days for the public to provide written comments on the recommendations.
"(b)
"(c)
§379j–12. Authority to assess and use animal drug fees
(a) Types of fees
Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Animal drug application and supplement fee
(A) In general
Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:
(i) A fee established in subsection (c) for an animal drug application, except an animal drug application subject to the criteria set forth in
(ii) A fee established in subsection (c), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—
(I) a supplemental animal drug application for which safety or effectiveness data are required;
(II) an animal drug application subject to the criteria set forth in
(III) an application for conditional approval under
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application.
(C) Exceptions for previously filed application or supplement
(i) If an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(ii) Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing.
(E) Refund of fee if application withdrawn
If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(2) Animal drug product fee
(A) In general
Each person—
(i) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under
(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,
shall pay for each such animal drug product the annual fee established in subsection (c).
(B) Payment; fee due date
Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable.
(3) Animal drug establishment fee
(A) In general
Each person—
(i) who owns or operates, directly or through an affiliate, an animal drug establishment;
(ii) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under
(iii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,
shall be assessed an annual establishment fee as established in subsection (c) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application.
(B) Payment; fee due date
The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
An establishment shall be assessed only one fee per fiscal year under this section.
(4) Animal drug sponsor fee
(A) In general
Each person—
(i) who meets the definition of an animal drug sponsor within a fiscal year; and
(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission,
shall be assessed an annual sponsor fee as established under subsection (c).
(B) Payment; fee due date
The fee under this paragraph for a fiscal year shall be due upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Each animal drug sponsor shall pay only one such fee each fiscal year.
(b) Fee revenue amounts
(1) In general
Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000.
(2) Types of fees
Of the total revenue amount established for a fiscal year under paragraph (1)—
(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to animal drug applications and supplements);
(B) 27 percent shall be derived from fees under subsection (a)(2) (relating to animal drug products);
(C) 26 percent shall be derived from fees under subsection (a)(3) (relating to animal drug establishments); and
(D) 27 percent shall be derived from fees under subsection (a)(4) (relating to animal drug sponsors).
(c) Annual fee setting; adjustments
(1) Annual fee setting
Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall—
(A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(B) publish such fee revenue amounts and fees in the Federal Register.
(2) Inflation adjustment
(A) For fiscal year 2025 and subsequent fiscal years, the revenue amounts established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
(i) one;
(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.
(B)
(3) Workload adjustments
(A) In general
For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraph (B). With respect to such adjustment—
(i) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;
(ii) such adjustment shall be made for each fiscal year that the adjustment determined by the Secretary is greater than 3 percent, except for the first fiscal year that the adjustment is greater than 3 percent; and
(iii) the Secretary shall publish in the Federal Register notice under paragraph (1) the amount of such adjustment and the supporting methodologies.
(B) Rule of application
Under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).
(4) Operating reserve adjustment
(A) In general
For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall—
(i) increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or
(ii) if the Secretary has an operating reserve in excess of the number of weeks specified in subparagraph (C) for that fiscal year, the Secretary shall 1 decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph (C) for that fiscal year.
(B) Carryover user fees
For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.
(C) Number of weeks of operating reserves
The number of weeks of operating reserves specified in this subparagraph is—
(i) 22 weeks for fiscal year 2025;
(ii) 20 weeks for fiscal year 2026;
(iii) 18 weeks for fiscal year 2027; and
(iv) 16 weeks for fiscal year 2028.
(D) Publication
If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies.
(5) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of animal drug applications.
(d) Fee waiver or reduction; exemptions from fees
(1) Waiver or reduction
The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—
(A) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;
(B) the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of animal drug applications for such person;
(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in—
(i) a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds; or
(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation));
(D) the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or
(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review.
(2) Use of standard costs
In making the finding in paragraph (1)(B), the Secretary may use standard costs.
(3) Rules for small businesses
(A) Definition
In paragraph (1)(E), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.
(C) Certification
The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.
(4) Exemption from fees
Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under
(e) Effect of failure to pay fees
An animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational animal drug submission under
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for animal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(g) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications.
(2) Collections and appropriation Acts
(A) In general
The fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year, and
(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2003 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications—
(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and
(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2024 through 2028, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
(4) Excess collections
If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Abbreviated new animal drug applications
The Secretary shall—
(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications; and
(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.
(June 25, 1938, ch. 675, §740, as added
Termination of Section
For termination of section by section 2307(a) of
Editorial Notes
Amendments
2023—Subsec. (a)(1)(A)(ii)(III).
Subsec. (b)(1).
"(A) for fiscal year 2019, the fees required under subsection (a) shall be established to generate a total revenue amount of $30,331,240; and
"(B) for each of fiscal years 2020 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $29,931,240."
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(A)(iii).
Subsec. (c)(2)(B).
Subsec. (c)(3)(A).
Subsec. (c)(3)(A)(ii), (iii).
Subsec. (c)(3)(B), (C).
Subsec. (c)(4).
Subsec. (d)(4).
Subsec. (g)(3).
Subsec. (g)(5).
2018—Subsec. (a)(1)(C).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (c)(2).
Subsec. (c)(3).
"(A) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;
"(B) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and
"(C) under no circumstances shall such adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted for inflation under paragraph (2)."
Subsec. (c)(4).
Subsec. (d).
Subsec. (d)(1).
Subsec. (d)(4).
Subsec. (g)(3).
Subsec. (g)(4), (5).
2017—Subsec. (a)(3)(C).
"(i)
"(ii)
2013—
2008—Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3) to (5).
Subsec. (g)(3)(A) to (E).
"(A) $5,000,000 for fiscal year 2004;
"(B) $8,000,000 for fiscal year 2005;
"(C) $10,000,000 for fiscal year 2006;
"(D) $10,000,000 for fiscal year 2007; and
"(E) $10,000,000 for fiscal year 2008;".
Subsec. (g)(4).
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Amendment by
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Effective Date of 2008 Amendment
Amendment by
Termination Date
Section to cease to be effective Oct. 1, 2028, see section 2307(a) of
1 So in original. The words "the Secretary shall" also appear at end of introductory provisions.
§379j–13. Reauthorization; reporting requirements
(a) Performance report
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) 1 of the Animal Drug User Fee Amendments of 2023 toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.
(b) Fiscal report
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Health, Education, Labor, and Pensions of the Senate;
(B) the Committee on Energy and Commerce of the House of Representatives;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(5) Transmittal of recommendations
Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4) 2 a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §740A, as added
Termination of Section
For termination of section by section 2307(b) of
Editorial Notes
References in Text
Section 101(b) of the Animal Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2301(b) of the Animal Drug User Fee Amendments of 2023,
Amendments
2023—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2018—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2013—
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Amendment by
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Effective and Termination Dates
Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of
1 See References in Text note below.
2 So in original. Probably should be followed by a comma.
subpart 5—fees relating to generic new animal drugs
Termination of Subpart
For termination of subpart by section 2316(a), (b) of
§379j–21. Authority to assess and use generic new animal drug fees
(a) Types of fees
Beginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Abbreviated application fee
(A) In general
Each person that submits, on or after July 1, 2008, an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection (c) for such an application.
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the abbreviated application.
(C) Exceptions
(i) Previously filed application
If an abbreviated application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(ii) Certain abbreviated applications involving combination animal drugs
An abbreviated application which is subject to the criteria in
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated application which is refused for filing.
(E) Refund of fee if application withdrawn
If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
(2) Generic new animal drug product fee
(A) In general
Each person—
(i) who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under
(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application or supplemental abbreviated application,
shall pay for each such generic new animal drug product the annual fee established in subsection (c).
(B) Payment; fee due date
Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable.
(3) Generic new animal drug sponsor fee
(A) In general
Each person—
(i) who meets the definition of a generic new animal drug sponsor within a fiscal year; and
(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application, a supplemental abbreviated application, or an investigational submission,
shall be assessed an annual generic new animal drug sponsor fee as established under subsection (c).
(B) Payment; fee due date
Such fee shall be due each fiscal year upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Amount of fee
Each generic new animal drug sponsor shall pay only 1 such fee each fiscal year, as follows:
(i) 100 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 6 approved abbreviated applications.
(ii) 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 1 and fewer than 7 approved abbreviated applications.
(iii) 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with 1 or fewer approved abbreviated applications.
(4) Generic investigational new animal drug file fee
(A) In general
(i) New file request
Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).
(ii) New submission to established file
Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).
(B) Payment
(i) New file request
The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.
(ii) New submission to established file
The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file.
(C) Exceptions
(i) Terminating an existing generic investigational new animal drug file
If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.
(ii) Transferring an existing generic investigational new animal drug file
If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.
(b) Fee revenue amounts
(1) In general
Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $25,000,000.
(2) Types of fees
Of the total revenue amount established for a fiscal year under paragraph (1)—
(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug) and fees under subsection (a)(4) (relating to generic investigational new animal drug files);
(B) 40 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and
(C) 40 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors).
(c) Annual fee setting; adjustments
(1) Annual fee setting
The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—
(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;
(B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).
(2) Inflation adjustment
(A) In general
For fiscal year 2025 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
(i) one;
(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available.
(B) Compounded basis
The adjustment made each fiscal year after fiscal year 2025 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.
(3) Workload adjustments
(A) In general
For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—
(i) this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests submitted to the Secretary;
(ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and
(iii) the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
(B) Reduction of workload-based increase by amount of certain excess collections
For each of fiscal years 2026 through 2028, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
(C) Rule of application
Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).
(4) Final year adjustment
For fiscal year 2028, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of abbreviated applications for generic new animal drugs for the first 3 months of fiscal year 2029. If the Food and Drug Administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of 3 months of such operating reserves, then this adjustment shall not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2028.
(5) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of abbreviated applications for generic new animal drugs.
(d) Fee waiver or reduction
The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
(e) Effect of failure to pay fees
An abbreviated application for a generic new animal drug submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2008 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for abbreviated applications, generic new animal drug products, generic new animal drug sponsors, and generic investigational new animal drug files at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(g) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of abbreviated applications for generic new animal drugs.
(2) Collections and appropriation Acts
(A) In general
The fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and
(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2008 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs—
(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and
(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2024 through 2028, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
(4) Excess collections
If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).
(5) Recovery of collection shortfalls
The amount of fees otherwise authorized to be collected under this section shall be increased—
(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);
(B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and
(C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Definitions
In this section and
(1) Abbreviated application for a generic new animal drug
The terms "abbreviated application for a generic new animal drug" and "abbreviated application" mean an abbreviated application for the approval of any generic new animal drug submitted under
(2) Adjustment factor
The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by—
(A) for purposes of subsection (f)(1), such Index for October 2002; and
(B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.
(3) Costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs
The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(4) Final dosage form
The term "final dosage form" means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.
(5) Generic new animal drug
The term "generic new animal drug" means a new animal drug that is the subject of an abbreviated application.
(6) Generic new animal drug product
The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.
(7) Generic new animal drug sponsor
The term "generic new animal drug sponsor" means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.
(8) Generic investigational new animal drug meeting request
The term "generic investigational new animal drug meeting request" means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.
(9) Investigational submission for a generic new animal drug
The terms "investigational submission for a generic new animal drug" and "investigational submission" mean—
(A) the filing of a claim for an investigational exemption under
(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.
(10) Person
The term "person" includes an affiliate thereof (as such term is defined in
(11) Process for the review of abbreviated applications for generic new animal drugs
The term "process for the review of abbreviated applications for generic new animal drugs" means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:
(A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(B) The issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applications, supplemental applications, or submissions in condition for approval.
(C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary's review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(D) Monitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(E) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(F) Development of standards for products subject to review.
(G) Meetings between the agency and the generic new animal drug sponsor.
(H) Review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved.
(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.
(12) Request to establish a generic investigational new animal drug file
The term "request to establish a generic investigational new animal drug file" means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.
(13) Supplemental abbreviated application for generic new animal drug
The terms "supplemental abbreviated application for a generic new animal drug" and "supplemental abbreviated application" mean a request to the Secretary to approve a change in an approved abbreviated application.
(June 25, 1938, ch. 675, §741, as added
Termination of Section
For termination of section by section 2316(a) of
Editorial Notes
Prior Provisions
A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to
Amendments
2023—Subsec. (a)(4).
Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B), (C).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(A)(iii).
Subsec. (c)(2)(B).
Subsec. (c)(3)(A).
Subsec. (c)(3)(A)(i).
Subsec. (c)(3)(A)(ii), (iii).
Subsec. (c)(3)(B).
Subsec. (c)(4).
Subsec. (d).
Subsec. (e).
Subsec. (f)(2).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (g)(5).
Subsec. (k)(8) to (11).
Subsec. (k)(11)(I).
Subsec. (k)(12), (13).
2018—Subsec. (b).
Subsec. (c)(2).
Subsec. (c)(3).
"(A) This adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
"(B) Under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b)."
Former par. (3) redesignated (4).
Subsec. (c)(4).
Subsec. (c)(5).
Subsec. (d).
Subsec. (g)(3), (4).
2013—
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Effective Date of 2018 Amendment
Effective Date of 2013 Amendment
Termination Date
Savings Provisions
Findings
Similar provisions were contained in the following prior acts:
§379j–22. Reauthorization; reporting requirements
(a) Performance reports
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) 1 of the Animal Generic Drug User Fee Amendments of 2023 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.
(b) Fiscal report
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(5) Transmittal of recommendations
Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §742, as added
Termination of Section
For termination of section by section 2316(b) of
Editorial Notes
References in Text
Section 201(b) of the Animal Generic Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2311(b) of the Animal Generic Drug User Fee Amendments of 2023,
Prior Provisions
A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to
Amendments
2023—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2018—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2013—
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Amendment by
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Termination Date
1 See References in Text note below.
subpart 6—fees related to food
§379j–31. Authority to collect and use fees
(a) In general
(1) Purpose and authority
For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—
(A) the responsible party for each domestic facility (as defined in section 350d(b) 1 of this title) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;
(B) the responsible party for a domestic facility (as defined in section 350d(b) 1 of this title) and an importer who does not comply with a recall order under
(C) each importer participating in the voluntary qualified importer program under
(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.
(2) Definitions
For purposes of this section—
(A) the term "reinspection" means—
(i) with respect to domestic facilities (as defined in section 350d(b) 1 of this title), 1 or more inspections conducted under
(ii) with respect to importers, 1 or more examinations conducted under
(B) the term "reinspection-related costs" means all expenses, including administrative expenses, incurred in connection with—
(i) arranging, conducting, and evaluating the results of reinspections; and
(ii) assessing and collecting reinspection fees under this section; and
(C) the term "responsible party" has the meaning given such term in
(b) Establishment of fees
(1) In general
Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.
(2) Fee methodology
(A) Fees
Fees amounts established for collection—
(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;
(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;
(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and
(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.
(B) Other considerations
(i) Voluntary qualified importer program
In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under
(II) 2 Recoupment
In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after January 4, 2011, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under
(ii) Crediting of fees
In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.
(iii) Published guidelines
Not later than 180 days after January 4, 2011, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.
(3) Use of fees
The Secretary shall make all of the fees collected pursuant to clause 3 (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.
(c) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3).
(2) Authority
If—
(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and
(B) at a later date in such fiscal year, such paragraph (1) ceases to apply,
the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Adjustment factor
(A) In general
The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.
(B) Compounded basis
The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.
(4) Limitation on amount of certain fees
(A) In general
Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected—
(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and
(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.
(B) Exception
If a domestic facility (as defined in section 350d(b) 1 of this title) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.
(d) Crediting and availability of fees
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.
(e) Collection of fees
(1) In general
The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.
(2) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of
(f) Annual report to Congress
Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.
(g) Authorization of appropriations
For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.
(June 25, 1938, ch. 675, §743, as added
Editorial Notes
References in Text
Statutory Notes and Related Subsidiaries
Construction
Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see
1 See References in Text note below.
2 So in original. No subcl. (I) has been enacted.
3 So in original. Probably should be "clauses".
subpart 7—fees relating to generic drugs
§379j–41. Definitions
For purposes of this subpart:
(1) The term "abbreviated new drug application"—
(A) means an application submitted under
(B) does not include an application—
(i) for a positron emission tomography drug; or
(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.
(2) The term "active pharmaceutical ingredient" means—
(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—
(i) to be used as a component of a drug; and
(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or
(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).
(3) The term "adjustment factor" means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.
(4) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(5) The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.
(6)(A) The term "facility"—
(i) means a business or other entity—
(I) under one management, either direct or indirect; and
(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and
(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.
(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—
(i) closely related to the same business enterprise;
(ii) under the supervision of the same local management; and
(iii) capable of being inspected by the Food and Drug Administration during a single inspection.
(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
(7) The term "finished dosage form" means—
(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;
(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).
(8) The term "generic drug submission" means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.
(9) The term "human generic drug activities" means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:
(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.
(B) The issuance of—
(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or
(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.
(C) The issuance of letters related to Type II active pharmaceutical drug master files which—
(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or
(ii) document that no deficiencies need to be addressed.
(D) Inspections related to generic drugs.
(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.
(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing
(v) Carrying out
(G) Regulatory science activities related to generic drugs.
(10) The term "positron emission tomography drug" has the meaning given to the term "compounded positron emission tomography drug" in
(11) The term "prior approval supplement" means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.
(12) The term "resources allocated for human generic drug activities" means the expenses for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.
(13) The term "Type II active pharmaceutical ingredient drug master file" means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.
(June 25, 1938, ch. 675, §744A, as added
Termination of Section
For termination of section by section 3004(a) of
Editorial Notes
References in Text
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in par. (1)(A), is
Amendments
2017—Par. (1)(B).
Pars. (5) to (13).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2017 Amendment
Effective and Termination Dates
[
[
Savings Clause
Congressional Findings Concerning Fees Relating to Human Generic Drugs
§379j–42. Authority to assess and use human generic drug fees
(a) Types of fees
Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) One-time backlog fee for abbreviated new drug applications pending on October 1, 2012
(A) In general
Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B).
(B) Method of fee amount calculation
The amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date.
(C) Notice
Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A).
(D) Fee due date
The fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C).
(E) Sunset
This paragraph shall cease to be effective October 1, 2022.
(2) Drug master file fee
(A) In general
Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee.
(B) One-time payment
If a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions.
(C) Notice
Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.
(D) Availability for reference
(i) In general
Subject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary.
(ii) Conditions
A drug master file shall be deemed available for reference by the Secretary if—
(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and
(II) the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.
(iii) List
The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference.
(E) Fee due date
(i) In general
Subject to clause (ii), a drug master file fee shall be due on the earlier of—
(I) the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file; or
(II) the date on which the drug master file holder requests the initial completeness assessment.
(ii) Limitation
No fee shall be due under subparagraph (A) for a fiscal year until the later of—
(I) 30 calendar days after publication of the notice provided for in subparagraph (C); or
(II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(3) Abbreviated new drug application filing fee
(A) In general
Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).
(B) Notice
Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(C) Fee due date
The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.
(D) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received
(i) Applications not considered to have been received and applications withdrawn prior to being received
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of
(ii) Applications no longer received
The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under
(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn
An abbreviated new drug application that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant's withdrawal of the application, be subject to a full fee under subparagraph (A).
(F) Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file
An applicant that submits a generic drug submission on or after October 1, 2017, shall pay a fee, in the amount determined under subsection (d)(2), in addition to the fee required under subparagraph (A), if—
(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and
(ii) a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information.
(4) Generic drug facility fee and active pharmaceutical ingredient facility fee
(A) In general
Facilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:
(i) Generic drug facility
Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.
(ii) Active pharmaceutical ingredient facility
Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.
(iii) Facilities producing both active pharmaceutical ingredients and finished dosage forms
Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.
(B) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (d).
(C) Notice
Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(D) Fee due date
For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such year; or
(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.
(5) Generic drug applicant program fee
(A) In general
A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).
(B) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (d).
(C) Notice
Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(D) Fee due date
For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such fiscal year; or
(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.
(6) Date of submission
For purposes of this chapter, a generic drug submission or Type II pharmaceutical master file is deemed to be "submitted" to the Food and Drug Administration—
(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or
(B) if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration.
(b) Fee revenue amounts
(1) In general
(A) Fiscal year 2023
For fiscal year 2023, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $582,500,000.
(B) Fiscal years 2024 through 2027
(i) In general
For each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c).
(ii) Base revenue amount
The base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).
(2) Types of fees
In establishing fees under paragraph (1) to generate the revenue amounts specified in such paragraph for a fiscal year, such fees shall be derived from the fees under paragraphs (2) through (5) of subsection (a) as follows:
(A) Five percent shall be derived from fees under subsection (a)(2) (relating to drug master files).
(B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).
(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to twenty-four percent of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.
(D) Six percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions.
(E)(i) Thirty-six percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:
(I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.
(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.
(III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.
(ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.
(c) Adjustments
(1) Inflation adjustment
For fiscal year 2024 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied by an amount equal to the sum of—
(A) one;
(B) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years; and
(C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years.
(2) Capacity planning adjustment
(A) In general
Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.
(B) Capacity planning methodology
The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—
(i) be derived from the methodology and recommendations made in the report titled "Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations" announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and
(ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022.
(C) Limitations
(i) In general
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year).
(ii) Additional limitation
An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if—
(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—
(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or
(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022);
(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—
(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);
(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—
(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and
(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—
(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).
(D) Publication in Federal Register
The Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.
(3) Operating reserve adjustment
(A) In general
For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year.
(B) Number of weeks
The number of weeks specified in this subparagraph is—
(i) 8 weeks for fiscal year 2024;
(ii) 9 weeks for fiscal year 2025; and
(iii) 10 weeks for each of fiscal year 2026 and 2027.
(C) Decrease
If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.
(D) Rationale for adjustment
If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved.
(d) Annual fee setting
(1) Fiscal years 2023 through 2027
Not later than 60 days before the first day of each of fiscal years 2023 through 2027, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).
(2) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file
In establishing the fee under paragraph (1), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—
(A) the sum of—
(i) the total number of such active pharmaceutical ingredients in such submission; and
(ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and
(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission.
(e) Limitations
(1) In general
The total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities.
(2) Leasing and necessary equipment
Beginning on October 1, 2023, the authorities under
(f) Identification of facilities
(1) Required submission of facility identification
Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.
(2) Information required to be submitted
At a minimum, the submission required by paragraph (1) shall include for each such facility—
(A) identification of a facility identified in an approved or pending generic drug submission;
(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;
(C) whether or not the facility is located within the United States and its territories and possessions;
(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;
(E) whether the facility manufactures drugs that are not generic drugs; and
(F) whether the facility is a contract manufacturing organization facility.
(3) Certain sites and organizations
(A) In general
Any person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization.
(B) Sites and organizations
A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—
(i) a site in which a bioanalytical study is conducted;
(ii) a clinical research organization;
(iii) a contract analytical testing site; or
(iv) a contract repackager site.
(C) Notice
The Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted.
(D) Inspection authority
The Secretary's inspection authority under
(g) Effect of failure to pay fees
(1) Generic drug backlog fee
Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of
(2) Drug master file fee
(A) Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference.
(B)(i) Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of
(ii) The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C).
(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee.
(ii) If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of
(3) Abbreviated new drug application fee
Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of
(4) Generic drug facility fee and active pharmaceutical ingredient facility fee
(A) In general
Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of
(ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of
(iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under
(B) Application of penalties
The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.
(C) Nonreceival for nonpayment
(i) Notice
If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.
(ii) Nonreceival
If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of
(5) Generic drug applicant program fee
(A) In general
A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:
(i) The Secretary shall place the person on a publicly available arrears list.
(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of
(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under
(B) Application of penalties
The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.
(h) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(i) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for human generic drug activities.
(2) Collections and appropriation Acts
(A) In general
The fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and
(ii) shall be available—
(I) for fiscal year 2023, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in
(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 10 percent below the level specified in such subparagraph.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection.
(j) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(k) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(l) Positron emission tomography drugs
(1) Exemption from fees
Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).
(2) Identification requirement
Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).
(m) Disputes concerning fees
To qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.
(n) Substantially complete applications
An abbreviated new drug application that is not considered to be received within the meaning of
(o) Information on abbreviated new drug applications owned by applicants and their affiliates
(1) In general
By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—
(A) all approved abbreviated new drug applications owned by such person; and
(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.
(2) Format and method
The Secretary shall specify in guidance the format and method for submission of lists under this subsection.
(June 25, 1938, ch. 675, §744B, as added
Termination of Section
For termination of section by section 3004(a) of
Editorial Notes
References in Text
Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (c)(2)(B)(ii), (C)(ii)(I)(bb), is section 3001(b) of title III of div. F of
Amendments
2022—Subsec. (a).
Subsec. (a)(2)(C).
Subsec. (a)(3)(B).
Subsec. (a)(4)(D).
Subsec. (a)(5)(D).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2)(C).
Subsec. (b)(2)(D).
Subsec. (b)(2)(E)(i).
Subsec. (c)(1).
Subsec. (c)(1)(C).
Subsec. (c)(2), (3).
Subsec. (d)(1).
Subsec. (e)(2).
Subsec. (g)(3).
Subsec. (i)(2)(A)(ii).
Subsec. (i)(2)(B).
Subsec. (i)(3).
2017—Subsec. (a).
Subsec. (a)(1)(E).
Subsec. (a)(2)(C).
Subsec. (a)(2)(E)(i).
Subsec. (a)(2)(E)(ii)(I).
Subsec. (a)(3).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B), (C).
Subsec. (a)(3)(D).
Subsec. (a)(3)(E).
Subsec. (a)(3)(F).
Subsec. (a)(4)(A).
Subsec. (a)(4)(A)(i).
Subsec. (a)(4)(A)(ii).
Subsec. (a)(4)(A)(iii).
Subsec. (a)(4)(C), (D).
Subsec. (a)(5), (6).
Subsec. (b)(1)(A).
"(i) $50,000,000 shall be generated by the one-time backlog fee for generic drug applications pending on October 1, 2012, established in subsection (a)(1); and
"(ii) $249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a)."
Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B), (C).
"(B) Twenty-four percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.
"(C) Fifty-six percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions."
Subsec. (b)(2)(D).
Subsec. (b)(2)(E).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (d)(1).
Subsec. (d)(2), (3).
Subsec. (e).
Subsec. (f)(1).
"(A) for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and
"(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year."
Subsec. (f)(2).
Subsec. (f)(2)(A).
Subsec. (f)(2)(F).
Subsec. (f)(3), (4).
Subsec. (g)(1).
Subsec. (g)(2)(C)(ii).
Subsec. (g)(5).
Subsec. (h)(2).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(C).
Subsec (i)(2)(D).
Subsec. (i)(3).
Subsec. (o).
2012—Subsec. (a).
Subsec. (i)(2)(C).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 303 of
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2027, see section 3004(a) of
Section effective Oct. 1, 2012, with fees under this section and
Fees Authorized for Fiscal Year 2013
"(1) Notwithstanding section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (
"(2) Notwithstanding section 744B(a)(3)(C)(ii) of such Act, the fee authorized under section 744B(a)(3) of such Act for fiscal year 2013 shall be due on the later of—
"(A) the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; or
"(B) 30 calendar days after publication of the notice referred to in section 744B(a)(3)(B)(i) of such Act.
"(3) Notwithstanding section 744B(a)(4)(D)(i) of such Act, the fee authorized under section 744B(a)(4) of such Act for fiscal year 2013 shall be due not later than 45 days after the publication of the notice under section 744B(a)(4)(C)(i) of such Act."
§379j–43. Reauthorization; reporting requirements
(a) Performance report
(1) General requirements
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
(2) Real time reporting
(A) In general
Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
(B) Data
The Secretary shall post the following data in accordance with subparagraph (A):
(i) The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022.
(ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022.
(3) Rationale for GDUFA program changes
The Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to
(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including—
(i) identifying drivers of such changes; and
(ii) changes in the total average cost per full-time equivalent in the generic drug review program;
(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and
(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application.
(4) Analysis
For each fiscal year, the Secretary shall include in the report an analysis of the following:
(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—
(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and
(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.
(B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.
(C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022.
(b) Fiscal report
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
(c) Corrective action report
For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
(1) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.
(2) Goals missed
For each of the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and
(B) with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 2 fiscal year.
(d) Enhanced communication
(1) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the generic drug industry.
(2) Prior public input
Prior to beginning negotiations with the generic drug industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Updates to Congress
The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(5) Public review of recommendations
After negotiations with the generic drug industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(6) Transmittal of recommendations
Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(7) Minutes of negotiation meetings
(A) Public availability
The Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry, not later than 30 days after each such negotiation meeting.
(B) Content
The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §744C, as added
Termination of Section
For termination of section by section 3004(b) of
Editorial Notes
References in Text
Section 301(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 3001(b) of the Generic Drug User Fee Amendments of 2022, title III of div. F of
Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (a)(3)(A), is section 3001(b) of title III of div. F of
Amendments
2022—
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (a)(3)(D).
Subsec. (b).
Subsec. (c).
Subsec. (f)(1).
Subsec. (f)(4).
Subsec. (f)(5).
Subsec. (f)(6), (7).
Subsec. (f)(7)(A).
Subsec. (f)(7)(B).
2017—Subsec. (a).
Subsec. (a)(4).
Subsec. (b).
Subsecs. (c) to (e).
Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 304 of
Effective and Termination Dates
[
[
Section effective Oct. 1, 2012, see section 305 of
1 See References in Text note below.
subpart 8—fees relating to biosimilar biological products
§379j–51. Definitions
For purposes of this subpart:
(1) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.
(2) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(3) The term "biosimilar biological product" means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
(4)(A) Subject to subparagraph (B), the term "biosimilar biological product application" means an application for licensure of a biological product under
(B) Such term does not include—
(i) a supplement to such an application;
(ii) an application filed under
(iii) an application filed under
(I) whole blood or a blood component for transfusion;
(II) an in vitro diagnostic biological product; or
(III) a biological product for further manufacturing use only; or
(iv) an application for licensure under
(5) The term "biosimilar biological product development meeting" means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
(6) The term "biosimilar biological product development program" means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.
(7)(A) The term "biosimilar biological product establishment" means a foreign or domestic place of business—
(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
(ii) at which one or more biosimilar biological products are manufactured in final dosage form.
(B) For purposes of subparagraph (A)(ii), the term "manufactured" does not include packaging.
(8) The term "biosimilar initial advisory meeting"—
(A) means a meeting, if requested, that is limited to—
(i) a general discussion regarding whether licensure under
(ii) if so, general advice on the expected content of the development program; and
(B) does not include any meeting that involves substantive review of summary data or full study reports.
(9) The term "costs of resources allocated for the process for the review of biosimilar biological product applications" means the expenses in connection with the process for the review of biosimilar biological product applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under
(10) The term "final dosage form" means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).
(11) The term "financial hold"—
(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of
(B) does not mean that any of the bases for a "clinical hold" under
(12) The term "person" includes an affiliate of such person.
(13) The term "process for the review of biosimilar biological product applications" means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:
(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.
(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary's review of pending biosimilar biological product applications and supplements.
(D) Activities necessary for the release of lots of biosimilar biological products under
(E) Monitoring of research conducted in connection with the review of biosimilar biological product applications.
(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing
(v) Carrying out
(14) The term "supplement" means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in
(June 25, 1938, ch. 675, §744G, as added
Termination of Section
For termination of section by section 4005(a) of
Editorial Notes
Amendments
2022—Par. (1).
Par. (4)(B)(iii)(II) to (IV).
2017—Par. (1).
Par. (3).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2017 Amendment
Effective and Termination Dates
[
[
"(a)
"(1) October 1, 2012; or
"(2) the date of the enactment of this title [July 9, 2012].
"(b)
Savings
Congressional Findings Concerning Fees Relating to Biosimilar Biological Products
§379j–52. Authority to assess and use biosimilar biological product fees
(a) Types of fees
Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Biosimilar biological product development program fees
(A) Initial biosimilar biological product development fee
(i) In general
Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (c)(5).
(ii) Meeting request
The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.
(iii) Clinical protocol for IND
A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of
(iv) Due date
The initial biosimilar biological product development fee shall be due by the earlier of the following:
(I) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.
(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.
(v) Transition rule
Each person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:
(I) Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.
(II) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.
(B) Annual biosimilar biological product development fee
(i) In general
A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (c)(5) for the biosimilar biological product development program (referred to in this section as "annual biosimilar biological product development fee"), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.
(ii) Due date
The annual biosimilar biological product development fee for each fiscal year will be due on the later of—
(I) the first business day on or after October 1 of each such year; or
(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(iii) Exception
The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—
(I) submitted a marketing application for the biological product that was accepted for filing;
(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C); or
(III) been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v).
(iv) Refund
If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is subsequently accepted for filing, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.
(C) Discontinuation of fee obligation
A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—
(i) if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or
(ii) if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).
(D) Reactivation fee
(i) In general
A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from such program for a product under subparagraph (E)(v), shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee (referred to in this section as "reactivation fee") by the earlier of the following:
(I) Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable).
(II) Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.
(ii) Application of annual fee
A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.
(E) Effect of failure to pay fees
(i) No biosimilar biological product development meetings
If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), the Secretary shall not provide a biosimilar biological product development meeting relating to the product for which fees are owed.
(ii) No receipt of investigational new drug applications
Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under
(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and
(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).
(iii) Financial hold
Notwithstanding
(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and
(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D).
(iv) No acceptance of biosimilar biological product applications or supplements
If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), any biosimilar biological product application or supplement submitted by that person shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(v) Administrative removal from the biosimilar biological product development program
If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal.
(F) Limits regarding fees
(i) Refunds
Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).
(ii) No waivers, exemptions, or reductions
The Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable under subparagraph (D).
(2) Biosimilar biological product application fee
(A) In general
Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:
(i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.
(ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).
(B) Rule of applicability; treatment of certain previously paid fees
Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—
(i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and
(ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).
(C) Payment due date
Any fee required by subparagraph (A) shall be due upon submission of the application for which such fee applies.
(D) Exception for previously filed application
If a biosimilar biological product application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a biosimilar biological product application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(E) Refund of application fee if application refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.
(F) Fees for applications previously refused for filing or withdrawn before filing
A biosimilar biological product application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (d).
(3) Biosimilar biological product program fee
(A) In general
Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—
(i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year;
(ii) may be dispensed only under prescription pursuant to
(iii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.
(B) Due date
The biosimilar biological product program fee for a fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such year; or
(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(C) One fee per product per year
The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.
(D) Limitation
A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.
(E) Movement to discontinued list
(i) Date of inclusion
If a written request to place a product on the list referenced in subparagraph (A) of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of—
(I) the date such request was received; or
(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
(ii) Treatment as withdrawn from sale
For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
(iii) Special rule for products removed from discontinued list
If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list referenced in subparagraph (A) of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year.
(b) Fee revenue amounts
(1) In general
For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—
(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2));
(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));
(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));
(F) for fiscal year 2023 an additional amount of $4,428,886; and
(G) for fiscal year 2024 an additional amount of $320,569.
(2) Allocation of revenue amount among fees
(A) Allocation
The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—
(i) initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);
(ii) biosimilar biological product application fees under subsection (a)(2); and
(iii) biosimilar biological product program fees under subsection (a)(3).
(B) Biosimilar biological product development fees
The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
(C) Reactivation fee
The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
(3) Annual base revenue
For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2023, $43,376,922; and
(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and
(ii) the inflation adjustment percentage under subparagraph (B).
(B) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—
(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in
(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in
(2) Strategic hiring and retention adjustment
For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.
(3) Capacity planning adjustment
(A) In general
For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs (1) and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.
(B) Methodology
For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Biosimilar User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
(C) Limitations
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment).
(D) Publication in Federal Register
The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
(4) Operating reserve adjustment
(A) Increase
For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.
(B) Decrease
(i) Fiscal year 2023
For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.
(ii) Fiscal year 2024
For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.
(iii) Fiscal year 2025 and subsequent fiscal years
For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.
(C) Federal Register notice
If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.
(5) Annual fee setting
For fiscal year 2023 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—
(A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(B) publish such fee revenue and fees in the Federal Register.
(6) Limit
The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.
(d) Application fee waiver for small business
(1) Waiver of application fee
The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.
(2) Considerations
In determining whether to grant a waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.
(3) Small business defined
In this subsection, the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in
(e) Effect of failure to pay fees
A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(f) Crediting and availability of fees
(1) In general
Subject to paragraph (2), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of biosimilar biological product applications.
(2) Collections and appropriation Acts
(A) In general
Subject to subparagraphs (C) and (D), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year.
(B) Use of fees and limitations
(i) In general
The fees authorized by this section shall be available—
(I) for fiscal year 2023, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to such fiscal year; and
(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.
(ii) Leasing and necessary equipment
Beginning on October 1, 2023, the authorities under
(C) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 15 percent below the level specified in such subparagraph.
(D) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
(g) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(h) Written requests for waivers and returns; disputes concerning fees
To qualify for consideration for a waiver under subsection (d), or for the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.
(i) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §744H, as added
Termination of Section
For termination of section by section 4005(a) of
Editorial Notes
Amendments
2022—Subsec. (a).
Subsec. (a)(1)(A)(iv)(I), (v)(II).
Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(iii)(III).
Subsec. (a)(1)(B)(iv).
Subsec. (a)(1)(D).
Subsec. (a)(1)(E)(v).
Subsec. (a)(2)(D).
Subsec. (a)(3)(A)(ii), (iii).
Subsec. (a)(3)(E).
Subsec. (a)(4).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(2)(B) to (D).
Subsec. (b)(3), (4).
Subsec. (c)(1)(A).
Subsec. (c)(1)(A)(i).
Subsec. (c)(1)(B)(ii).
Subsec. (c)(2) to (4).
Subsec. (c)(5).
Subsec. (f)(2)(B)(i).
Subsec. (f)(2)(C).
Subsec. (f)(3).
Subsec. (h).
2020—Subsec. (f)(2)(B).
2017—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (a)(1)(B)(iii).
Subsec. (a)(1)(B)(iv).
Subsec. (a)(1)(C).
Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(D)(i)(I).
Subsec. (a)(1)(D)(i)(II).
Subsec. (a)(1)(E).
Subsec. (a)(1)(F).
Subsec. (a)(1)(F)(i).
Subsec. (a)(2).
Subsec. (a)(2)(A), (B).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
Subsec. (a)(2)(F).
Subsec. (a)(3).
Subsec. (a)(4)(A).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (d)(1).
Subsec. (e).
Subsec. (f).
Subsec. (f)(2)(B).
Subsec. (f)(2)(C).
Subsec. (f)(2)(D).
Subsec. (f)(3).
Subsec. (g).
Subsec. (h).
Subsec. (i).
2016—Subsec. (a)(1)(A)(v).
Subsec. (a)(2)(B).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2020 Amendment
Effective Date of 2017 Amendment
Amendment by section 403 of
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2027, see section 4005(a) of
Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of
§379j–53. Reauthorization; reporting requirements
(a) Performance report
(1) General requirements
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.
(2) Additional information
The report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(A) information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;
(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and
(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals 2 letters issued by the agency for such applications.
(3) Real time reporting
(A) In general
Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
(B) Data
The Secretary shall post the following data in accordance with subparagraph (A):
(i) The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022.
(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022.
(4) Rationale for BSUFA program changes
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to
(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying—
(i) drivers of such changes; and
(ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program;
(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and
(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.
(5) Analysis
For each fiscal year, the Secretary shall include in the report an analysis of the following:
(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—
(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and
(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.
(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.
(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022.
(b) Fiscal report
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
(c) Corrective action report
For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
(1) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.
(2) Goals missed
For each of the goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and
(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 2 fiscal year.
(d) Enhanced communication
(1) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization;
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug Administration's website.
(3) Periodic consultation
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Updates to Congress
The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(5) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(6) Transmittal of recommendations
Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(7) Minutes of negotiation meetings
(A) Public availability
The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
(B) Content
The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §744I, as added
Termination of Section
For termination of section by section 4005(b) of
Editorial Notes
References in Text
Section 401(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 4001(b) of the Biosimilar User Fee Amendments of 2022, title IV of div. F of
Section 4001(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 4001(b) of title IV of div. F of
Codification
Amendments made by section 904(d)(2) of
Amendments
2022—
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3)(A).
Subsec. (a)(4)(A).
Subsec. (a)(4)(B).
Subsec. (a)(4)(D).
Subsec. (b).
Subsec. (c).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(3).
Subsec. (f)(4) to (7).
2017—Subsec. (a).
Subsec. (a)(5).
Subsec. (b).
Subsec. (c).
Subsecs. (d), (e).
Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by section 404 of
Effective and Termination Dates
[
[
Section effective Oct. 1, 2012, see section 405 of
1 See References in Text note below.
subpart 9—fees relating to outsourcing facilities
§379j–61. Definitions
In this subpart:
(1) The term "affiliate" has the meaning given such term in
(2) The term "gross annual sales" means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.
(3) The term "outsourcing facility" has the meaning given to such term in
(4) The term "reinspection" means, with respect to an outsourcing facility, 1 or more inspections conducted under
(June 25, 1938, ch. 675, §744J, as added
§379j–62. Authority to assess and use outsourcing facility fees
(a) Establishment and reinspection fees
(1) In general
For fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect—
(A) an annual establishment fee from each outsourcing facility; and
(B) a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year.
(2) Multiple reinspections
An outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection.
(b) Establishment and reinspection fee setting
The Secretary shall—
(1) establish the amount of the establishment fee and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection (c); and
(2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.
(c) Amount of establishment fee and reinspection fee
(1) In general
For each outsourcing facility in a fiscal year—
(A) except as provided in paragraph (4), the amount of the annual establishment fee under subsection (b) shall be equal to the sum of—
(i) $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus
(ii) the small business adjustment factor described in paragraph (3); and
(B) the amount of any reinspection fee (if applicable) under subsection (b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in paragraph (2).
(2) Inflation adjustment factor
(A) In general
For fiscal year 2015 and subsequent fiscal years, the fee amounts established in paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—
(i) 1;
(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years; plus
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years.
(B) Compounded basis
The adjustment made each fiscal year under subparagraph (A) shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under subparagraph (A).
(3) Small business adjustment factor
The small business adjustment factor described in this paragraph shall be an amount established by the Secretary for each fiscal year based on the Secretary's estimate of—
(A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and
(B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the Secretary would have collected if no entity qualified for the small business exception in paragraph (4).
(4) Exception for small businesses
(A) In general
In the case of an outsourcing facility with gross annual sales of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under subsection (b) for a fiscal year shall be equal to \1/3\ of the amount calculated under paragraph (1)(A)(i) for such fiscal year.
(B) Application
To qualify for the exception under this paragraph, a small business shall submit to the Secretary a written request for such exception, in a format specified by the Secretary in guidance, certifying its gross annual sales for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the Secretary not later than April 30 of such immediately preceding fiscal year.
(5) Crediting of fees
In establishing the small business adjustment factor under paragraph (3) for a fiscal year, the Secretary shall—
(A) provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of the small business adjustment factor for such previous fiscal year; and
(B) consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.
(d) Use of fees
The Secretary shall make all of the fees collected pursuant to subparagraphs (A) and (B) of subsection (a)(1) available solely to pay for the costs of oversight of outsourcing facilities.
(e) Supplement not supplant
Funds received by the Secretary pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section.
(f) Crediting and availability of fees
Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the costs of oversight of outsourcing facilities.
(g) Collection of fees
(1) Establishment fee
An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to
(2) Reinspection fee
The Secretary shall specify in the Federal Register notice described in subsection (b)(2) the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the Secretary has conducted a reinspection of the outsourcing facility involved.
(3) Effect of failure to pay fees
(A) Registration
An outsourcing facility shall not be considered registered under
(B) Misbranding
All drugs manufactured, prepared, propagated, compounded, or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid, as required by this section, shall be deemed misbranded under
(4) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of
(h) Annual report to Congress
Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year.
(i) Authorization of appropriations
For fiscal year 2014 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
(June 25, 1938, ch. 675, §744K, as added
subpart 10—fees relating to over-the-counter drugs
§379j–71. Definitions
In this subpart:
(1) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(2) The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
(3) The term "costs of resources allocated for OTC monograph drug activities" means the expenses in connection with OTC monograph drug activities for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under
(4) The term "FDA establishment identifier" is the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).
(5) The term "OTC monograph drug" means a nonprescription drug without an approved new drug application which is governed by the provisions of
(6) The term "OTC monograph drug activities" means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:
(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—
(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;
(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;
(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;
(iv) regulation and policy development activities related to OTC monograph drugs;
(v) development of product standards for products subject to review and evaluation;
(vi) meetings referred to in
(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and
(viii) regulatory science activities related to OTC monograph drugs.
(B) Inspections related to OTC monograph drugs.
(C) Monitoring of clinical and other research conducted in connection with OTC monograph drugs.
(D) Safety activities with respect to OTC monograph drugs, including—
(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
(ii) developing and using improved adverse event data-collection systems, including information technology systems; and
(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.
(E) Other activities necessary for implementation of
(7) The term "OTC monograph order request" means a request for an order submitted under
(8) The term "Tier 1 OTC monograph order request" means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.
(9)(A) The term "Tier 2 OTC monograph order request" means, subject to subparagraph (B), an OTC monograph order request for—
(i) the reordering of existing information in the drug facts label of an OTC monograph drug;
(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);
(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to
(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
(vi) addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).
(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to
(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business or other entity that—
(i) is—
(I) under one management, either direct or indirect; and
(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—
(i) closely related to the same business enterprise;
(ii) under the supervision of the same local management; and
(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.
(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
(11) The term "OTC monograph drug meeting" means any meeting regarding the content of a proposed OTC monograph order request.
(12) The term "person" includes an affiliate of a person.
(13) The terms "requestor" and "sponsor" have the meanings given such terms in
(June 25, 1938, ch. 675, §744L, as added
Statutory Notes and Related Subsidiaries
Finding
§379j–72. Authority to assess and use OTC monograph fees
(a) Types of fees
Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Facility fee
(A) In general
Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).
(B) Exceptions
(i) Facilities that cease activities
A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—
(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and
(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in
(ii) Contract manufacturing organizations
The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.
(C) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (c).
(D) Due date
(i) For first program year
For fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
(I) the first business day of July of 2020; or
(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).
(ii) Subsequent fiscal years
For each fiscal year after fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
(I) the first business day of June of such year; or
(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.
(2) OTC monograph order request fee
(A) In general
Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—
(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and
(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
(B) Due date
The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.
(C) Exception for certain safety changes
A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—
(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
(D) Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request
If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.
(E) Refund of fee if order request refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.
(F) Fees for order requests previously refused for filing or withdrawn before filing
An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.
(G) Refund of fee if order request withdrawn
If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
(3) Refunds
(A) In general
Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).
(B) Disputes concerning fees
To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.
(4) Notice
Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.
(b) Fee revenue amounts
(1) Fiscal year 2021
For fiscal year 2021, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—
(A) the annual base revenue for fiscal year 2021 (as determined under paragraph (3));
(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and
(C) additional direct cost adjustments (as determined under subsection (c)(3)).
(2) Subsequent fiscal years
For each of the fiscal years 2022 through 2025, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—
(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));
(D) additional direct cost adjustments (as determined under subsection (c)(3)); and
(E) additional dollar amounts for each fiscal year as follows:
(i) $7,000,000 for fiscal year 2022.
(ii) $6,000,000 for fiscal year 2023.
(iii) $7,000,000 for fiscal year 2024.
(iv) $3,000,000 for fiscal year 2025.
(3) Annual base revenue
For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2021, $8,000,000; and
(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(2); and
(ii) the inflation adjustment percentage under subparagraph (C).
(B) OTC monograph order request fees
For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and
(ii) the inflation adjustment percentage under subparagraph (C).
(C) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to—
(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and
(ii) for each of fiscal years 2024 and 2025, the sum of—
(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and
(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.
(2) Operating reserve adjustment
(A) In general
For fiscal year 2021 and subsequent fiscal years, for purposes of subsections (b)(1)(B) and (b)(2)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than the number of weeks specified in subparagraph (B).
(B) Number of weeks
The number of weeks specified in this subparagraph is—
(i) 3 weeks for fiscal year 2021;
(ii) 7 weeks for fiscal year 2022;
(iii) 10 weeks for fiscal year 2023;
(iv) 10 weeks for fiscal year 2024; and
(v) 10 weeks for fiscal year 2025.
(C) Decrease
If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.
(D) Rationale for adjustment
If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (4) establishing fee revenue and fees for the fiscal year involved.
(3) Additional direct cost adjustment
The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—
(A) $14,000,000 for fiscal year 2021;
(B) $7,000,000 for fiscal year 2022;
(C) $4,000,000 for fiscal year 2023;
(D) $3,000,000 for fiscal year 2024; and
(E) $3,000,000 for fiscal year 2025.
(4) Annual fee setting
(A) Fiscal year 2021
The Secretary shall, not later than the second Monday in May of 2020—
(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and
(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.
(B) Subsequent fiscal years
The Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—
(i) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—
(I) OTC monograph drug facility fees under subsection (a)(1); and
(II) OTC monograph order request fees under subsection (a)(2); and
(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
(d) Identification of facilities
Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—
(1) be submitted as part of the requirements for drug establishment registration set forth in
(2) include for each such facility, at a minimum, identification of the facility's business operation as that of an OTC monograph drug facility.
(e) Effect of failure to pay fees
(1) OTC monograph drug facility fee
(A) In general
Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
(i) The Secretary shall place the facility on a publicly available arrears list.
(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under
(B) Application of penalties
The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.
(2) Order requests
An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.
(3) Meetings
A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.
(f) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.
(2) Collections and appropriation Acts
(A) In general
Subject to subparagraph (C), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year.
(B) Use of fees and limitation
The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).
(C) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.
(D) Provision for early payments in subsequent years
Payment of fees authorized under this section for a fiscal year (after fiscal year 2021), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2021 through 2025, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.
(g) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(h) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §744M, as added
§379j–73. Reauthorization; reporting requirements
(a) Performance report
Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 3861(b) 1 of the CARES Act during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.
(b) Fiscal report
Not later than 120 calendar days after the end of fiscal year 2021 and each subsequent fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2025, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 calendar days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(3) Transmittal of recommendations
Not later than January 15, 2025, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(June 25, 1938, ch. 675, §744N, as added
Editorial Notes
References in Text
Section 3861(b) of the CARES Act, referred to in subsec. (a), probably means section 3861 of
1 See References in Text note below.
Part D—Information and Education
§379k. Information system
The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.
(June 25, 1938, ch. 675, §745, formerly §741, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
Report on Status of System
§379k–1. Electronic format for submissions
(a) Drugs and biologics
(1) In general
Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of
(2) Guidance contents
In the guidance under paragraph (1), the Secretary may—
(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and
(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
(3) Exception
This subsection shall not apply to submissions described in
(b) Devices
(1) In general
Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under
(2) Guidance contents
In the guidance under paragraph (1), the Secretary may—
(A) provide standards for the electronic copy required under such paragraph; and
(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
(3) Presubmissions and submissions solely in electronic format
(A) In general
Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.
(B) Draft guidance
The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—
(i) any further standards for the submission by electronic format required under subparagraph (A);
(ii) a timetable for the establishment by the Secretary of such further standards; and
(iii) criteria for waivers of and exemptions from the requirements of this subsection.
(C) Final guidance
The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.
(June 25, 1938, ch. 675, §745A, as added
Editorial Notes
Amendments
2017—Subsec. (b)(3).
Statutory Notes and Related Subsidiaries
Effective Date of 2017 Amendment
Amendment by title II of
§379l. Education
(a) In general
The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this chapter, including programs for—
(1) scientific training;
(2) training to improve the skill of officers and employees authorized to conduct inspections under
(3) training to achieve product specialization in such inspections; and
(4) training in administrative process and procedure and integrity issues.
(b) Intramural fellowships and other training programs
The Secretary, acting through the Commissioner, may, through fellowships and other training programs, conduct and support intramural research training for predoctoral and postdoctoral scientists and physicians. Any such fellowships and training programs under this section or under
(June 25, 1938, ch. 675, §746, formerly §742, as added
Editorial Notes
Prior Provisions
A prior section 746 of act June 25, 1938, was renumbered section 749 and is classified to
Amendments
2007—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
Part E—Environmental Impact Review
§379o. Environmental impact
Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this chapter, shall be considered to meet the requirements for a detailed statement under
(June 25, 1938, ch. 675, §749, formerly §746, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics
§379r. National uniformity for nonprescription drugs
(a) In general
Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—
(1) that relates to the regulation of a drug that is not subject to the requirements of
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (
(b) Exemption
(1) In general
Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—
(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;
(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and
(C) would not unduly burden interstate commerce.
(2) Timely action
The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).
(c) Scope
(1) In general
This section shall not apply to—
(A) any State or political subdivision requirement that relates to the practice of pharmacy; or
(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.
(2) Safety or effectiveness
For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.
(d) Exceptions
(1) In general
In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under
(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or
(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.
(2) State initiatives
This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.
(e) No effect on product liability law
Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.
(f) State enforcement authority
Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter.
(June 25, 1938, ch. 675, §751, as added
Editorial Notes
References in Text
The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is
The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is
Amendments
2020—Subsec. (d)(1).
Subsec. (d)(1)(A).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
§379s. Preemption for labeling or packaging of cosmetics
(a) In general
Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (
(b) Exemption
Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that—
(1) protects an important public interest that would otherwise be unprotected;
(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and
(3) would not unduly burden interstate commerce.
(c) Scope
For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.
(d) No effect on product liability law
Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.
(e) State initiative
This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.
(June 25, 1938, ch. 675, §752, as added
Editorial Notes
References in Text
The Poison Prevention Packaging Act of 1970, referred to in subsec. (a), is
The Fair Packaging and Labeling Act, referred to in subsec. (a), is
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
Part G—Safety Reports
§379v. Safety report disclaimers
With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.
(June 25, 1938, ch. 675, §756, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
Part H—Serious Adverse Event Reports
§379aa. Serious adverse event reporting for nonprescription drugs
(a) Definitions
In this section:
(1) Adverse event
The term "adverse event" means any health-related event associated with the use of a nonprescription drug that is adverse, including—
(A) an event occurring from an overdose of the drug, whether accidental or intentional;
(B) an event occurring from abuse of the drug;
(C) an event occurring from withdrawal from the drug; and
(D) any failure of expected pharmacological action of the drug.
(2) Nonprescription drug
The term "nonprescription drug" means a drug that is—
(A) not subject to
(B) not subject to approval in an application submitted under
(3) Serious adverse event
The term "serious adverse event" is an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(4) Serious adverse event report
The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).
(b) Reporting requirement
(1) In general
The manufacturer, packer, or distributor whose name (pursuant to
(2) Retailer
A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in
(c) Submission of reports
(1) Timing of reports
The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in
(2) New medical information
The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
(3) Consolidation of reports
The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
(4) Exemption
The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.
(d) Contents of reports
Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information.
(e) Maintenance and inspection of records
(1) Maintenance
The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.
(2) Records inspection
(A) In general
The responsible person shall permit an authorized person to have access to records required to be maintained under this section, during an inspection pursuant to
(B) Authorized person
For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services who has—
(i) appropriate credentials, as determined by the Secretary; and
(ii) been duly designated by the Secretary to have access to the records required under this section.
(f) Protected information
A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—
(1) a safety report under
(2) a record about an individual under
(g) Rule of construction
The submission of any adverse event report in compliance with this section shall not be construed as an admission that the nonprescription drug involved caused or contributed to the adverse event.
(h) Preemption
(1) In general
No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section.
(2) Effect of section
(A) In general
Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.
(B) Personally-identifiable information
Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—
(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.
(C) Use of safety reports
Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or
(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary.
(June 25, 1938, ch. 675, §760, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of
Modifications
Guidance
§379aa–1. Serious adverse event reporting for dietary supplements
(a) Definitions
In this section:
(1) Adverse event
The term "adverse event" means any health-related event associated with the use of a dietary supplement that is adverse.
(2) Serious adverse event
The term "serious adverse event" is an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(3) Serious adverse event report
The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).
(b) Reporting requirement
(1) In general
The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to
(2) Retailer
A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in
(c) Submission of reports
(1) Timing of reports
The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in
(2) New medical information
The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
(3) Consolidation of reports
The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
(4) Exemption
The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.
(d) Contents of reports
Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.
(e) Maintenance and inspection of records
(1) Maintenance
The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.
(2) Records inspection
(A) In general
The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to
(B) Authorized person
For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services, who has—
(i) appropriate credentials, as determined by the Secretary; and
(ii) been duly designated by the Secretary to have access to the records required under this section.
(f) Protected information
A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—
(1) a safety report under
(2) a record about an individual under
(g) Rule of construction
The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.
(h) Preemption
(1) In general
No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.
(2) Effect of section
(A) In general
Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.
(B) Personally-identifiable information
Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—
(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.
(C) Use of safety reports
Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or
(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary.
(June 25, 1938, ch. 675, §761, as added
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of
Part I—Reagan-Udall Foundation for the Food and Drug Administration
§379dd. Establishment and functions of the Foundation
(a) In general
A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this part as the "Foundation") shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e).1 The Foundation shall not be an agency or instrumentality of the United States Government.
(b) Purpose of Foundation
The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
(c) Duties of the Foundation
The Foundation shall—
(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety;
(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);
(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;
(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in
(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);
(6) release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);
(7) ensure that—
(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;
(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and
(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);
(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency's public health mission;
(9) conduct annual assessments of the unmet needs identified in paragraph (1); and
(10) carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.
(d) Board of Directors
(1) Establishment
(A) In general
The Foundation shall have a Board of Directors (referred to in this part as the "Board"), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.
(B) Ex officio members
The ex officio members of the Board shall be the following individuals or their designees:
(i) The Commissioner.
(ii) The Director of the National Institutes of Health.
(iii) The Director of the Centers for Disease Control and Prevention.
(iv) The Director of the Agency for Healthcare Research and Quality.
(C) Appointed members
(i) In general
The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members—
(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;
(II) 3 shall be representatives of academic research organizations;
(III) 2 shall be representatives of patient or consumer advocacy organizations;
(IV) 1 shall be a representative of health care providers; and
(V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.
(ii) Additional members
The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries.
(iii) Requirements
(I) Expertise
The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.
(II) Federal employees
No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B). For purposes of this section, the term "employee of the Federal Government" does not include a special Government employee, as that term is defined in
(D) Initial meeting
(i) In general
Not later than 30 days after September 27, 2007, the Secretary shall convene a meeting of the ex officio members of the Board to—
(I) incorporate the Foundation; and
(II) appoint the members of the Board in accordance with subparagraph (C).
(ii) Service of ex officio members
Upon the appointment of the members of the Board under clause (i)(II)—
(I) the terms of service of the Director of the Centers for Disease Control and Prevention and of the Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall terminate; and
(II) the Commissioner and the Director of the National Institutes of Health shall continue to serve as ex officio members of the Board, but shall be nonvoting members.
(iii) Chair
The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.
(2) Duties of Board
The Board shall—
(A) establish bylaws for the Foundation that—
(i) are published in the Federal Register and available for public comment;
(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;
(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient of donated funds;
(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under
(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;
(vi) specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;
(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;
(viii) establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;
(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;
(x) specify a process for annual Board review of the operations of the Foundation; and
(xi) establish specific duties of the Executive Director;
(B) prioritize and provide overall direction to the activities of the Foundation;
(C) evaluate the performance of the Executive Director; and
(D) carry out any other necessary activities regarding the functioning of the Foundation.
(3) Terms and vacancies
(A) Term
The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that—
(i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and
(ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.
(B) Vacancy
Any vacancy in the membership of the Board—
(i) shall not affect the power of the remaining members to execute the duties of the Board; and
(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.
(C) Partial term
If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(D) Serving past term
A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.
(4) Compensation
Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.
(e) Incorporation
The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.
(f) Nonprofit status
In carrying out subsection (b), the Board shall establish such policies and bylaws under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be necessary to ensure that the Foundation maintains status as an organization that—
(1) is described in subsection (c)(3) of
(2) is, under subsection (a) of such section, exempt from taxation.
(g) Executive Director
(1) In general
The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.
(2) Compensation
The compensation of the Executive Director shall be fixed by the Board.
(h) Administrative powers
In carrying out this part, the Board, acting through the Executive Director, may—
(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;
(3) prescribe the manner in which—
(A) real or personal property of the Foundation is acquired, held, and transferred;
(B) general operations of the Foundation are to be conducted; and
(C) the privileges granted to the Board by law are exercised and enjoyed;
(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;
(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;
(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);
(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;
(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this part;
(9) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;
(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; and
(12) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this part.
(i) Acceptance of funds from other sources
The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.
(j) Service of Federal employees
Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.
(k) Detail of Government employees; fellowships
(1) Detail from Federal agencies
Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
(2) Voluntary service; acceptance of Federal employees
(A) Foundation
The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.
(B) Food and Drug Administration
The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in
(l) Annual reports
(1) Reports to Foundation
Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.
(2) Report to Congress and the FDA
Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that—
(A) describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;
(B) provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; and
(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.
(m) Separation of funds
The Executive Director shall ensure that the funds received from the Treasury are managed as individual programmatic funds under subsection (i), according to best accounting practices.
(n) Funding
From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $1,250,000 and not more than $5,000,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).
(June 25, 1938, ch. 675, §770, as added
Editorial Notes
Amendments
2022—Subsec. (n).
2016—Subsec. (d)(1)(C)(ii).
Subsec. (d)(1)(C)(iii).
Subsec. (d)(1)(C)(iii)(I).
Subsec. (d)(1)(C)(iii)(II).
Subsec. (d)(3)(A).
Subsec. (g)(2).
Subsec. (m).
1 So in original. Probably should be "subsection (g)."
§379dd–1. Location of Foundation
The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.
(June 25, 1938, ch. 675, §771, as added
§379dd–2. Activities of the Food and Drug Administration
(a) In general
The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under
(b) Report to Congress
Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under
(c) Extramural grants
The provisions of this part and
(June 25, 1938, ch. 675, §772, as added