[House Report 118-104]
[From the U.S. Government Publishing Office]


118th Congress   }                                      {       Report
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                      {      118-104

======================================================================



 
    ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2023

                                _______
                                

  June 9, 2023.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 1418]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1418) to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize user fee programs relating to new 
animal drugs and generic new animal drugs, having considered 
the same, reports favorably thereon with an amendment and 
recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Background and Need for Legislation..............................     9
Committee Action.................................................    10
Committee Votes..................................................    10
Oversight Findings and Recommendations...........................    12
New Budget Authority, Entitlement Authority, and Tax Expenditures    12
Congressional Budget Office Estimate.............................    12
Federal Mandates Statement.......................................    12
Statement of General Performance Goals and Objectives............    12
Duplication of Federal Programs..................................    12
Related Committee and Subcommittee Hearings......................    12
Committee Cost Estimate..........................................    13
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    13
Advisory Committee Statement.....................................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    15

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Animal Drug and Animal Generic Drug 
User Fee Amendments of 2023''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents for this Act is the following:

Sec. 1. Short title.
Sec. 2. Table of contents.

                 TITLE I--FEES RELATING TO ANIMAL DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.

            TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.

             TITLE III--SUPPORTING ANIMAL AND HUMAN HEALTH

Sec. 301. Reporting requirements.
Sec. 302. Definition of major species.
Sec. 303. Antimicrobial resistance.

                 TITLE I--FEES RELATING TO ANIMAL DRUGS

SEC. 101. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Animal Drug User 
Fee Amendments of 2023''.
  (b) Finding.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
animal drug development process and the review of new and supplemental 
animal drug applications and investigational animal drug submissions as 
set forth in the goals identified for purposes of part 4 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-11 et seq.), in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Energy and Commerce of the 
House of Representatives and the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate as set forth in the 
Congressional Record.

SEC. 102. DEFINITIONS.

  Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-11) is amended--
          (1) in paragraph (3), by striking ``national drug code'' and 
        inserting ``National Drug Code''; and
          (2) by amending paragraph (8)(I) to read as follows:
                  ``(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.''.

SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

  (a) In General.--Section 740(a)(1)(A)(ii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(A)(ii)) is amended--
          (1) in subclause (I), by striking ``and'' at the end;
          (2) in subclause (II), by striking the period at the end and 
        inserting ``; and''; and
          (3) by adding at the end the following:
                                  ``(III) an application for 
                                conditional approval under section 571 
                                of a new animal drug for which an 
                                animal drug application submitted under 
                                section 512(b)(1) has been previously 
                                approved under section 512(d)(1) for 
                                another intended use.''.
  (b) Fee Revenue Amounts.--Section 740(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-12(b)(1)) is amended to read as 
follows:
          ``(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.''.
  (c) Annual Fee Setting; Adjustments.--
          (1) Annual fee setting.--Section 740(c)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(1)) is 
        amended to read as follows:
          ``(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.--Section 740(c)(2) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(2)) is 
        amended--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``2020'' and inserting ``2025''; and
                          (ii) in clause (iii), by striking 
                        ``Baltimore'' and inserting ``Arlington-
                        Alexandria''; and
                  (B) in subparagraph (B), by striking ``2020'' and 
                inserting ``2025''.
          (3) Workload adjustments.--Section 740(c)(3) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(3)) is 
        amended--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i)--
                                  (I) by striking ``2020'' and 
                                inserting ``2025''; and
                                  (II) by striking ``subparagraphs (B) 
                                and (C)'' and inserting ``subparagraph 
                                (B)'';
                          (ii) in clause (i) by striking ``and'' at the 
                        end; and
                          (iii) by striking clause (ii) and inserting 
                        the following:
                          ``(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) by striking subparagraph (B); and
                  (C) by redesignating subparagraph (C) as subparagraph 
                (B).
          (4) Final year adjustment.--Section 740(c)(4) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(c)(4)) is 
        amended to read as follows:
          ``(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 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.''.
  (d) Exemption From Fees.--Section 740(d)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-12(d)(4)) is amended to read as 
follows:
          ``(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 section 736, 738, 
        744B, or 744H.''.
  (e) Crediting and Availability of Fees.--
          (1) Authorization of appropriations.--Section 740(g)(3) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        12(g)(3)) is amended by striking ``2019 through 2023'' and 
        inserting ``2024 through 2028''.
          (2) Collection shortfalls.--Section 740(g) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(g)) is 
        amended--
                  (A) in paragraph (3), by striking ``and paragraph 
                (5)''; and
                  (B) by striking paragraph (5).

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-13) is amended--
          (1) in subsection (a), by striking ``2018'' and inserting 
        ``2023'';
          (2) by striking ``2019'' each place it appears in subsections 
        (a) and (b) and inserting ``2024''; and
          (3) in subsection (d)--
                  (A) in paragraph (1), by striking ``2023'' and 
                inserting ``2028''; and
                  (B) in paragraph (5), by striking ``2023'' and 
                inserting ``2028''.

SEC. 105. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 4 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of 
enactment of this title, shall continue to be in effect with respect to 
animal drug applications and supplemental animal drug applications (as 
defined in such part as of such day) that on or after October 1, 2018, 
but before October 1, 2023, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2024.

SEC. 106. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2023, or the date of the enactment of this Act, whichever is later, 
except that fees under part 4 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as 
amended by this title, shall be assessed for animal drug applications 
and supplemental animal drug applications received on or after October 
1, 2023, regardless of the date of the enactment of this Act.

SEC. 107. SUNSET DATES.

  (a) Authorization.--Sections 739 and 740 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 21 U.S.C. 379j-11; 379j-12) shall cease to 
be effective October 1, 2028.
  (b) Reporting Requirements.--Section 740A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-13) shall cease to be effective 
January 31, 2029.
  (c) Previous Sunset Provision.--Effective October 1, 2023, 
subsections (a) and (b) of section 107 of the Animal Drug User Fee 
Amendments of 2018 (Public Law 115-234) are repealed.

            TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

SEC. 201. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Animal Generic 
Drug User Fee Amendments of 2023''.
  (b) Finding.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated 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 as set forth 
in the goals identified for purposes of part 5 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-21 et seq.), in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Energy and Commerce of the 
House of Representatives and the Chairman of the Committee on Health, 
Education, Labor and Pensions of the Senate as set forth in the 
Congressional Record.

SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.

  (a) Generic Investigational New Animal Drug File Fee.--Section 741(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(a)) is 
amended by adding at the end the following:
          ``(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.--Section 741(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-21(b)) is amended--
          (1) in paragraph (1)--
                  (A) by striking ``2019 through 2023'' and inserting 
                ``2024 through 2028''; and
                  (B) by striking ``$18,336,340'' and inserting 
                ``$25,000,000''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (A)--
                          (i) by striking ``25 percent'' and inserting 
                        ``20 percent''; and
                          (ii) by inserting before the semicolon at the 
                        end the following: ``and fees under subsection 
                        (a)(4) (relating to generic investigational new 
                        animal drug files)'';
                  (B) in subparagraph (B), by striking ``37.5 percent'' 
                and inserting ``40 percent''; and
                  (C) in subparagraph (C), by striking ``37.5 percent'' 
                and inserting ``40 percent''.
  (c) Annual Fee Setting; Adjustments.--
          (1) Annual fee setting.-- Section 741(c)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(1)) is 
        amended to read as follows:
          ``(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.--Section 741(c)(2) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(2)) is 
        amended--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``2020'' and inserting ``2025''; and
                          (ii) in clause (iii), by striking 
                        ``Baltimore'' and inserting ``Arlington-
                        Alexandria''; and
                  (B) in subparagraph (B), by striking ``2020'' and 
                inserting ``2025''.
          (3) Workload adjustment.--Section 741(c)(3) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(3)) is 
        amended--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``2020'' and inserting ``2025'';
                          (ii) in clause (i)--
                                  (I) by striking ``and investigational 
                                generic new animal drug protocol 
                                submissions'' and inserting 
                                ``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''; and
                                  (II) by striking ``; and'' and 
                                inserting a semicolon;
                          (iii) by redesignating clause (ii) as clause 
                        (iii); and
                          (iv) by inserting after clause (i) the 
                        following:
                          ``(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''; and
                  (B) in subparagraph (B), by striking ``2021 through 
                2023'' and inserting ``2026 through 2028''.
          (4) Final year adjustment.--Section 741(c)(4) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(4)) is 
        amended--
                  (A) by striking ``2023'' each place it appears and 
                inserting ``2028''; and
                  (B) by striking ``2024'' and inserting ``2029''.
  (d) Fee Waiver or Reduction; Exemption From Fees.--Subsection (d) of 
section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-21) is amended to read as follows:
  ``(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.--Section 741(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(e)) is amended by 
striking ``The Secretary may discontinue'' and inserting ``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''.
  (f) Assessment of Fees.--Section 741(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-21(f)(2)) is amended by striking 
``sponsors, and generic new animal drug products at any time'' and 
inserting ``products, generic new animal drug sponsors, and generic 
investigational new animal drug files at any time''.
  (g) Crediting and Availability of Fees.--Section 741(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(g)) is 
amended--
          (1) in paragraph (3), by striking ``2019 through 2023'' and 
        inserting ``2024 through 2028'';
          (2) by striking the second paragraph (4) (relating to 
        Offset), as added by section 202 of the Animal Generic Drug 
        User Fee Amendments of 2013 (Public Law 113-14); and
          (3) by adding at the end the following:
          ``(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) Definitions.--Section 741(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-21(k)) is amended--
          (1) by redesignating paragraphs (8), (9), (10), and (11) as 
        paragraphs (9), (10), (11), and (13), respectively;
          (2) by inserting after paragraph (7) the following:
          ``(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.'';
          (3) in paragraph (11) (as so redesignated), by adding at the 
        end the following:
                  ``(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.''; and
          (4) by inserting after paragraph (11) (as so redesignated) 
        the following:
          ``(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.''.

SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-22) is amended--
          (1) in subsection (a), by striking ``2018'' and inserting 
        ``2023'';
          (2) by striking ``2019'' each place it appears in subsections 
        (a) and (b) and inserting ``2024''; and
          (3) in subsection (d), by striking ``2023'' each place it 
        appears and inserting ``2028''.

SEC. 204. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 5 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-21 et seq.), as in effect on the day before the date of 
enactment of this title, shall continue to be in effect with respect to 
abbreviated applications for a generic new animal drug and supplemental 
abbreviated applications for a generic new animal drug (as defined in 
such part as of such day) that on or after October 1, 2018, but before 
October 1, 2023, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required by 
such part for a fiscal year prior to fiscal year 2024.

SEC. 205. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2023, or the date of the enactment of this Act, whichever is later, 
except that fees under part 5 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), as 
amended by this title, shall be assessed for abbreviated applications 
for a generic new animal drug and supplemental abbreviated applications 
for a generic new animal drug received on or after October 1, 2023, 
regardless of the date of enactment of this Act.

SEC. 206. SUNSET DATES.

  (a) Authorization.--Section 741 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1, 
2028.
  (b) Reporting Requirements.--Section 742 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-22) shall cease to be effective 
January 31, 2029.
  (c) Previous Sunset Provision.--Effective October 1, 2023, 
subsections (a) and (b) of section 206 of the Animal Generic Drug User 
Fee Amendments of 2018 (Public Law 115-234) are repealed.

             TITLE III--SUPPORTING ANIMAL AND HUMAN HEALTH

SEC. 301. REPORTING REQUIREMENTS.

  Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-13), as amended by section 104, is further amended--
          (1) in subsection (a)--
                  (A) by striking ``Beginning with'' and inserting the 
                following:
          ``(1) In general.--Beginning with''; and
                  (B) by adding at the end the following:
          ``(2) Contents.--The report under paragraph (1) shall include 
        the following:
                  ``(A) Data, analysis and discussion of the changes in 
                the number of individuals hired and funded by fees 
                collected pursuant to section 740, and data, analysis, 
                and discussion of the number of full-time equivalents 
                in the animal drug review program, including a 
                breakdown by funding from fees collected pursuant to 
                section 740 versus budget authority, and by each 
                division within the Center for Veterinary Medicine, the 
                Office of Regulatory Affairs, and the Office of the 
                Commissioner.
                  ``(B) Data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for the process 
                for the review of animal drug applications, including 
                identifying--
                          ``(i) the drivers of such changes; and
                          ``(ii) changes in the total cost per full-
                        time equivalent in the animal drug review 
                        program.
                  ``(C) Data, analysis, and discussion of changes in 
                the average full-time equivalent hours required to 
                complete review of each type of animal drug 
                application.
                  ``(D) For fiscal years 2024 and 2025, of the meeting 
                requests from animal drug 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.''; and
          (2) in subsection (d)--
                  (A) in paragraph (5), by inserting a comma after 
                ``paragraph (4)'';
                  (B) by redesignating paragraph (6) as paragraph (7);
                  (C) by inserting after paragraph (5) the following:
          ``(6) 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.''; and
                  (D) in paragraph (7) (as so redesignated)--
                          (i) in subparagraph (A)--
                                  (I) by striking ``Before presenting 
                                the recommendations developed under 
                                paragraphs (1) through (5) to Congress, 
                                the Secretary'' and inserting ``The 
                                Secretary''; and
                                  (II) by inserting before the period 
                                at the end the following: ``, not later 
                                than 30 days after each such 
                                negotiation meeting''; and
                          (ii) in subparagraph (B), by inserting ``, in 
                        sufficient detail,'' after ``shall summarize''.

SEC. 302. DEFINITION OF MAJOR SPECIES.

  Section 201(nn) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(nn)) is amended by inserting ``, or remove species from,'' 
after ``add species to''.

SEC. 303. ANTIMICROBIAL RESISTANCE.

  (a) Report on Antimicrobial Stewardship.--Not later than December 31, 
2023, the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall 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 
describing--
          (1) activities conducted by the Center for Veterinary 
        Medicine of the Food and Drug Administration (referred to in 
        this section as ``the Center'') during the period of fiscal 
        years 2019 through 2023 to support antimicrobial stewardship in 
        veterinary settings, including ongoing activities and the 
        targeted completion date of such activities; and
          (2) with respect to antimicrobial stewardship in veterinary 
        settings--
                  (A) the goals of the Center regarding supporting 
                antimicrobial stewardship in veterinary settings;
                  (B) activities the Center plans to execute during the 
                period of fiscal years 2024 through 2028 to support 
                such goals, including targeted completion dates for 
                such activities; and
                  (C) metrics the Center plans to use to evaluate 
                progress toward its goals regarding supporting 
                antimicrobial stewardship in veterinary settings.
  (b) Annual Progress Reports.--Not later than 120 days after the end 
of each fiscal year during which fees are collected under section 740, 
the Secretary shall 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 that includes--
          (1) a description of activities conducted by the Center in 
        the prior fiscal year to support antimicrobial stewardship in 
        veterinary settings, including progress made toward goals and 
        activities specified in subsection (a)(2);
          (2) in the case of an incomplete activity described in 
        subsection (a)(2)(B) for which the target completion date has 
        passed--
                  (A) an explanation for why such target completion 
                date was not met; and
                  (B) if applicable, the updated expected completion 
                date for such activity;
          (3) a description of emerging challenges related to 
        antimicrobial stewardship in veterinary settings that impact 
        Center activities; and
          (4) a description of activities undertaken to incentivize the 
        development of new drugs for the treatment, prevention, or 
        control of bacterial diseases in animals.

                          Purpose and Summary

    H.R. 1418 reauthorizes provisions of the Animal Drug User 
Fee Act (ADUFA) and the Animal Generic Animal Drug User Fee Act 
(AGDUFA) through fiscal year (FY) 2028. Specifically, the bill 
would allow the Food and Drug Administration (FDA) to continue 
to collect and obligate user fees, paid by regulated industry 
to supplement Congressional appropriations, for the review of 
animal drugs and animal generic drugs. It also includes 
provisions that improve upon the review and development of 
animal health products and support activities regarding the 
development and stewardship of animal antimicrobials.

                  Background and Need for Legislation

    The Federal Food, Drug, and Cosmetic Act (FFDCA) provides 
FDA authorities over the review and regulation of brand-name 
(pioneer) and generic animal drugs. These authorities are 
funded through annual discretionary appropriations and further 
supplemented by user fees paid by regulated industry. The 
revenue generated by user fees supports FDA in providing 
greater regulatory certainty to animal application sponsors and 
in improving upon the animal product development and review 
process. In determining recommended fee amounts, FDA commits to 
meet certain performance and application review goals, which 
are negotiated with the regulated industry and submitted to 
Congress.
    Authorities to collect user fees for pioneer animal drugs 
were first provided for by Congress in the Animal Drug User Fee 
Act of 2003 (referred to as ADUFA I, P.L. 108-130) for FY2004 
to FY2008. The user fee program established under ADUFA I was 
modeled after FDA's prescription drug user fee program, which 
had improved the timeliness and predictability of FDA's review 
of certain human drugs. Congress later granted FDA authorities 
over the review of generic animal drugs for FY2009 in the 
Animal Generic Drug User Fee Act of 2008 (AGDUFA I, P.L. 110-
316), which was passed alongside the first reauthorization of 
ADUFA II. Authorities for AGDUFA have been reauthorized three 
times since and will sunset September 30, 2023.
    Previous reauthorizations of ADUFA and AGDUFA have included 
additional provisions intended to improve upon FDA's review and 
regulation of certain animal health products. This legislation 
proposes several policies to build upon the programs, including 
new reporting requirements to enhance transparency into the 
review and reauthorization processes, amendment of the `major 
species' definition to support utilization of approval pathways 
for unmet animal health needs, and codification of reporting 
dates for FDA on activities relating to stewardship over animal 
antimicrobials.
    ADUFA IV and AGDUFA III will expire at the end of FY2023 
and must be reauthorized for FDA to continue collecting and 
obligating user fee towards the review of animal drug and 
generic animal drug applications. This legislation will 
reauthorize both programs through FY2028 and support the 
implementation of additional provisions considered within this 
legislation.

                            Committee Action

    On March 30, 2023, the Subcommittee on Health held a 
hearing on H.R. 1418. The Subcommittee received testimony from:
           Ms. Tracey Forfa, J.D., Director, Center for 
        Veterinary Medicine (CVM), U.S. Food and Drug 
        Administration (FDA);
           Ms. Rachel Cumberbatch, DVM, Director, 
        Regulatory Affairs, Animal Drugs, Animal Health 
        Institute (AHI);
           Ms. Stephanie Batliner, Chair, Generic 
        Animal Drug Alliance (GADA); and
           Ms. Lori Teller, DVM, President, American 
        Veterinary Medical Association (AVMA)
    On May 17, 2023, the Subcommittee on Health met in open 
markup session and forwarded H.R. 1418, as amended, to the full 
Committee by a record vote of 29 yeas and 0 nays. On May 24, 
2023, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 1418, as amended, favorably 
reported to the House by a record vote of 49 yeas and 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R 1418 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
reauthorize the FDA animal drug user fee programs and improve 
the review of products regulated by FDA.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 1418 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

              Related Committee and Subcommittee Hearings

    Pursuant to clause 3(c)(6) of rule XIII,
         (1) the following hearing was used to develop or 
        consider H.R. 1418:
           On March 30, 2023, the Subcommittee on 
        Health held a hearing on H.R. 1418. The Subcommittee 
        received testimony from:
                   Ms. Tracey Forfa, J.D., 
                Director, Center for Veterinary Medicine (CVM), 
                U.S. Food and Drug Administration (FDA);
                   Ms. Rachel Cumberbatch, DVM, 
                Director, Regulatory Affairs, Animal Drugs, 
                Animal Health Institute (AHI);
                   Ms. Stephanie Batliner, Chair, 
                Generic Animal Drug Alliance (GADA); and
                   Ms. Lori Teller, DVM, President, 
                American Veterinary Medical Association (AVMA).

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974. At the time this report was 
filed, the estimate was not available.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 1418 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


                 TITLE I: FEES RELATING TO ANIMAL DRUGS

Section 1. Short title

    Section 1 provides a short title for the legislation, the 
``Animal Drug and Animal Generic User Fee Amendments of 2023.''

Section 2. Table of contents

    Section 2 provides a table of contents for the legislation.

                 TITLE I: FEES RELATING TO ANIMAL DRUGS

Section 101. Short title; finding

    Section 101 establishes a short title for Title I, the 
``Animal Dug User Fee Amendments of 2023.'' It also dedicates 
fees authorized by this title toward expediting the animal drug 
development process and review of animal drug applications as 
set forth by statute.

Section 102. Definitions

    Section 102 adds to the definition of ``process for the 
review of abbreviated applications for new animal drugs'' 
activities necessary to implement US-EU and US-UK mutual 
recognition agreements, with respect to new animal drug 
products subject to review.

Section 103. Authority to assess and use animal drug fees

    Section 103 reauthorizes FDA's animal drug user fee program 
through 2028 and updates the base revenue amount for ADUFA V. 
It also provides for the negotiated resource levels and updated 
fee-setting process.

Section 104. Reauthorization; reporting requirements

    Section 104 reauthorizes FDA reporting requirements to 
Congress relating to the agency's progress in implementing its 
user fee authorities and in meeting performance goals, as set 
forth in the commitment letter submitted to the Congressional 
Record.

Section 105. Savings clause

    Section 105 preserves authorities to assess fees pursuant 
to part 4 of subchapter C of chapter VII of FFDCA, effective 
until enactment of this title.

Section 106. Effective date

    Section 106 provides that amendments made by this title 
shall take effect October 1, 2023, or the date of enactment, 
whichever is later.

Section 107. Sunset dates

    Section 107 provides that reporting requirements and 
authorities to collect and assess user fees for the process of 
the review of new animal drugs shall cease to be effective 
October 1, 2028.

            TITLE II: FEES RELATING TO GENERIC ANIMAL DRUGS

Section 201. Short title; finding

    Section 201 establishes a short title for Title II, 
``Animal Generic Drug User Fee Amendments of 2023.'' It also 
dedicates fees authorized by this title toward expediting the 
generic new animal drug development process and review of 
abbreviated applications for generic new animal drug 
applications as set forth by statute.

Section 202. Authority to assess and use generic new animal drug fees

    Section 202 reauthorizes FDA's generic animal drug user fee 
program through 2028 and updates the base revenue amount for 
AGDUFA IV. It establishes a new fee type for generic 
investigational new animal drug files and provides for 
negotiated resource levels. It also adds to the definition of 
``process for the review of abbreviated applications for 
generic new animal drugs'' activities necessary to implement 
US-EU and US-UK mutual recognition agreements with respect to 
generic new animal drug products subject to review.

Section 203. Reauthorization; reporting requirements

    Section 203 reauthorizes FDA reporting requirements to 
Congress relating to the agency's progress in implementing its 
user fee authorities and in meeting performance goals, as set 
forth in the commitment letter submitted to the Congressional 
Record.

Section 204. Savings clause

    Section 204 preserves authorities to assess fees pursuant 
to part 5 of subchapter C of chapter VII of FFDCA, effective 
until enactment of this title.

Section 205. Effective date

    Section 205 provides that amendments made by this title 
shall take effect October 1, 2023, or the date of enactment, 
whichever is later.

Section 206. Sunset dates

    Section 206 provides that reporting requirements and 
authorities to assess user fees for the process of the review 
of generic new animal drugs shall cease to be effective October 
1, 2028.

             TITLE III: SUPPORTING ANIMAL AND HUMAN HEALTH

Section 301. Reporting requirements

    Section 301 updates requirements for FDA reporting to 
Congress to include data regarding the review process for 
animal drug applications and sponsor requests for in-person, 
face-to-face meetings in FY2024 and FY2025.

Section 302. Major species

    Section 302 amends the definition of ``major species'' in 
the Federal Food, Drug, and Cosmetic Act to allow for the 
Secretary, through rulemaking, to add or remove species from 
the definition.

Section 303. Antimicrobial resistance

    Section 303 requires FDA, not later than December 31, 2023, 
to submit to Congress a report describing activities conducted 
by FDA's Center for Veterinary Medicine (CVM) during FY2019 
through FY2023 to support antimicrobial stewardship in 
veterinary settings. FDA must also report its goals to support 
antimicrobial stewardship in veterinary settings, activities it 
plans to execute in FY2024 through FY2028 to support those 
goals, and metrics it plans to use to evaluate progress toward 
those goals. Section 303 also requires FDA to submit, not later 
than 120 days after the end of each fiscal year in which animal 
drug user fees are collected, annual progress reports regarding 
antimicrobial stewardship and activities undertaken to 
incentivize the development of new animal antimicrobials.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a)(1) The term ``State'', except as used in the last 
sentence of section 702(a), means any State or Territory of the 
United States, the District of Columbia, and the Commonwealth 
of Puerto Rico.
  (2) The term ``Territory'' means any Territory or possession 
of the United States, including the District of Columbia, and 
excluding the Commonwealth of Puerto Rico and the Canal Zone.
  (b) The term ``interstate commerce'' means (1) commerce 
between any State or Territory and any place outside thereof, 
and (2) commerce within the District of Columbia or within any 
other Territory not organized with a legislative body.
  (c) The term ``Department'' means the Department of Health 
and Human Services.
  (d) The term ``Secretary'' means the Secretary of Health and 
Human Services.
  (e) The term ``person'' includes individual, partnership, 
corporation, and association.
  (f) The term ``food'' means (1) articles used for food or 
drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article.
  (g)(1) The term ``drug'' means (A) articles recognized in the 
official United States Pharmacopeia, official Homeopathic 
Pharmacopeia of the United States, or official National 
Formulary, or any supplement to any of them; and (B) articles 
intended for use in the diagnosis, cure, mitigation, treatment, 
or prevention of disease in man or other animals; and (C) 
articles (other than food) intended to affect the structure or 
any function of the body of man or other animals; and (D) 
articles intended for use as a component of any articles 
specified in clause (A), (B), or (C). A food or dietary 
supplement for which a claim, subject to sections 403(r)(1)(B) 
and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is 
made in accordance with the requirements of section 403(r) is 
not a drug solely because the label or the labeling contains 
such a claim. A food, dietary ingredient, or dietary supplement 
for which a truthful and not misleading statement is made in 
accordance with section 403(r)(6) is not a drug under clause 
(C) solely because the label or the labeling contains such a 
statement.
  (2) The term ``counterfeit drug'' means a drug which, or the 
container or labeling of which, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a drug manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such drug and which thereby falsely purports or is 
represented to be the product of, or to have been packed or 
distributed by, such other drug manufacturer, processor, 
packer, or distributor.
  (h)(1) The term ``device'' (except when used in paragraph (n) 
of this section and in sections 301(i), 403(f), 502(c), and 
602(c)) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, 
which is--
  (A) recognized in the official National Formulary, or the 
United States Pharmacopeia, or any supplement to them,
  (B) intended for use in the diagnosis of disease or other 
conditions, or in the cure, mitigation, treatment, or 
prevention of disease, in man or other animals, or
  (C) intended to affect the structure or any function of the 
body of man or other animals, and
which does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals 
and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes. The term 
``device'' does not include software functions excluded 
pursuant to section 520(o).
  (2) The term ``counterfeit device'' means a device which, or 
the container, packaging, or labeling of which, without 
authorization, bears a trademark, trade name, or other 
identifying mark or imprint, or any likeness thereof, or is 
manufactured using a design, of a device manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such device and which thereby falsely purports or 
is represented to be the product of, or to have been packed or 
distributed by, such other device manufacturer, processor, 
packer, or distributor.
  (i) The term ``cosmetic'' means (1) articles intended to be 
rubbed, poured, sprinkled, or sprayed on, introduced into, or 
otherwise applied to the human body or any part thereof for 
cleansing, beautifying, promoting attractiveness, or altering 
the appearance, and (2) articles intended for use as a 
component of any such articles; except that such term shall not 
include soap.
  (j) The term ``official compendium'' means the official 
United States Pharmacopeia, official Homeopathic Pharmacopeia 
of the United States, official National Formulary, or any 
supplement to any of them.
  (k) The term ``label'' means a display of written, printed, 
or graphic matter upon the immediate container of any article; 
and a requirement made by or under authority of this Act that 
any word, statement, or other information appear on the label 
shall not be considered to be complied with unless such word, 
statement, or other information also appears on the outside 
container or wrapper, if any there be, of the retail package of 
such article, or is easily legible through the outside 
container or wrapper.
  (l) The term ``immediate container'' does not include package 
liners.
  (m) The term ``labeling'' means all labels and other written, 
printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.
  (n) If an article is alleged to be misbranded because the 
labeling or advertising is misleading, then in determining 
whether the labeling or advertising is misleading there shall 
be taken into account (among other things) not only 
representations made or suggested by statement, word, design, 
device, or any combination thereof, but also the extent to 
which the labeling or advertising fails to reveal facts 
material in the light of such representations or material with 
respect to consequences which may result from the use of the 
article to which the labeling or advertising relates under the 
conditions of use prescribed in the labeling or advertising 
thereof or under such conditions of use as are customary or 
usual.
  (o) The representation of a drug, in its labeling, as an 
antiseptic shall be considered to be a representation that it 
is a germicide, except in the case of a drug purporting to be, 
or represented as, an antiseptic for inhibitory use as a wet 
dressing, ointment, dusting powder, or such other use as 
involves prolonged contact with the body.
  (p) The term ``new drug'' means--
          (1) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug is not 
        generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof, 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new drug'' if at any time prior to the 
        enactment of this Act it was subject to the Food and 
        Drugs Act of June 30, 1906, as amended, and if at such 
        time its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug, as a 
        result of investigations to determine its safety and 
        effectiveness for use under such conditions, has become 
        so recognized, but which has not, otherwise than in 
        such investigations, been used to a material extent or 
        for a material time under such conditions.
  (q)(1)(A) Except as provided in clause (B), the term 
``pesticide chemical'' means any substance that is a pesticide 
within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of 
such pesticide. Notwithstanding any other provision of law, the 
term ``pesticide'' within such meaning includes ethylene oxide 
and propylene oxide when such substances are applied on food.
  (B) In the case of the use, with respect to food, of a 
substance described in clause (A) to prevent, destroy, repel, 
or mitigate microorganisms (including bacteria, viruses, fungi, 
protozoa, algae, and slime), the following applies for purposes 
of clause (A):
          (i) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is applied for such use on food, or 
        the substance is included for such use in water that 
        comes into contact with the food, in the preparing, 
        packing, or holding of the food for commercial 
        purposes. The substance is not excluded under this 
        subclause from such definition if the substance is 
        ethylene oxide or propylene oxide, and is applied for 
        such use on food. The substance is not so excluded if 
        the substance is applied for such use on a raw 
        agricultural commodity, or the substance is included 
        for such use in water that comes into contact with the 
        commodity, as follows:
                  (I) The substance is applied in the field.
                  (II) The substance is applied at a treatment 
                facility where raw agricultural commodities are 
                the only food treated, and the treatment is in 
                a manner that does not change the status of the 
                food as a raw agricultural commodity (including 
                treatment through washing, waxing, fumigating, 
                and packing such commodities in such manner).
                  (III) The substance is applied during the 
                transportation of such commodity between the 
                field and such a treatment facility.
          (ii) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is a food contact substance as defined 
        in section 409(h)(6), and any of the following 
        circumstances exist: The substance is included for such 
        use in an object that has a food contact surface but is 
        not intended to have an ongoing effect on any portion 
        of the object; the substance is included for such use 
        in an object that has a food contact surface and is 
        intended to have an ongoing effect on a portion of the 
        object but not on the food contact surface; or the 
        substance is included for such use in or is applied for 
        such use on food packaging (without regard to whether 
        the substance is intended to have an ongoing effect on 
        any portion of the packaging). The food contact 
        substance is not excluded under this subclause from 
        such definition if any of the following circumstances 
        exist: The substance is applied for such use on a 
        semipermanent or permanent food contact surface (other 
        than being applied on food packaging); or the substance 
        is included for such use in an object that has a 
        semipermanent or permanent food contact surface (other 
        than being included in food packaging) and the 
        substance is intended to have an ongoing effect on the 
        food contact surface.
With respect to the definition of the term ``pesticide'' that 
is applicable to the Federal Insecticide, Fungicide, and 
Rodenticide Act, this clause does not exclude any substance 
from such definition.
  (2) The term ``pesticide chemical residue'' means a residue 
in or on raw agricultural commodity or processed food of--
          (A) a pesticide chemical; or
          (B) any other added substance that is present on or 
        in the commodity or food primarily as a result of the 
        metabolism or other degradation of a pesticide 
        chemical.
  (3) Notwithstanding subparagraphs (1) and (2), the 
Administrator may by regulation except a substance from the 
definition of ``pesticide chemical'' or ``pesticide chemical 
residue'' if--
          (A) its occurrence as a residue on or in a raw 
        agricultural commodity or processed food is 
        attributable primarily to natural causes or to human 
        activities not involving the use of any substances for 
        a pesticidal purpose in the production, storage, 
        processing, or transportation of any raw agricultural 
        commodity or processed food; and
          (B) the Administrator, after consultation with the 
        Secretary, determines that the substance more 
        appropriately should be regulated under one or more 
        provisions of this Act other than sections 402(a)(2)(B) 
        and 408.
  (r) The term ``raw agricultural commodity'' means any food in 
its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form 
prior to marketing.
  (s) The term ``food additive'' means any substance the 
intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food (including 
any substance intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding food; and including any source of 
radiation intended for any such use), if such substance is not 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use; 
except that such term does not include--
          (1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
          (2) a pesticide chemical; or
          (3) a color additive; or
          (4) any substance used in accordance with a sanction 
        or approval granted prior to the enactment of this 
        paragraph pursuant to this Act, the Poultry Products 
        Inspection Act (21 U.S.C. 451 and the following) or the 
        Meat Inspection Act of March 4, 1907 (34 Stat. 1260), 
        as amended and extended (21 U.S.C. 71 and the 
        following);
          (5) a new animal drug; or
          (6) an ingredient described in paragraph (ff) in, or 
        intended for use in, a dietary supplement.
  (t)(1) The term ``color additive'' means a material which--
          (A) is a dye, pigment, or other substance made by a 
        process of synthesis or similar artifice, or extracted, 
        isolated, or otherwise derived, with or without 
        intermediate or final change of identity, from a 
        vegetable, animal, mineral, or other source, and
          (B) when added or applied to a food, drug, or 
        cosmetic, or to the human body or any part thereof, is 
        capable (alone or through reaction with other 
        substance) of imparting color thereto;
except that such term does not include any material which the 
Secretary, by regulation, determines is used (or intended to be 
used) solely for a purpose or purposes other than coloring.
  (2) The term ``color'' includes black, white, and 
intermediate grays.
  (3) Nothing in subparagraph (1) of this paragraph shall be 
construed to apply to any pesticide chemical, soil or plant 
nutrient, or other agricultural chemical solely because of its 
effect in aiding, retarding, or otherwise affecting, directly 
or indirectly, the growth or other natural physiological 
processes of produce of the soil and thereby affecting its 
color, whether before or after harvest.
  (u) The term ``safe,'' as used in paragraph (s) of this 
section and in sections 409, 512, 571, and 721, has reference 
to the health of man or animal.
  (v) The term ``new animal drug'' means any drug intended for 
use for animals other than man, including any drug intended for 
use in animal feed but not including such animal feed--
          (1) the composition of which is such that such drug 
        is not generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of animal drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof; 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new animal drug'' if at any time prior 
        to June 25, 1938, it was subject to the Food and Drug 
        Act of June 30, 1906, as amended, and if at such time 
        its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) the composition of which is such that such drug, 
        as a result of investigations to determine its safety 
        and effectiveness for use under such conditions, has 
        become so recognized but which has not, otherwise than 
        in such investigations, been used to a material extent 
        or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor 
species that is not the subject of a final regulation published 
by the Secretary through notice and comment rulemaking finding 
that the criteria of paragraphs (1) and (2) have not been met 
(or that the exception to the criterion in paragraph (1) has 
been met) is a new animal drug.
  (w) The term ``animal feed'', as used in paragraph (w) of 
this section, in section 512, and in provisions of this Act 
referring to such paragraph or section, means an article which 
is intended for use for food for animals other than man and 
which is intended for use as a substantial source of nutrients 
in the diet of the animal, and is not limited to a mixture 
intended to be the sole ration of the animal.
  (x) The term ``informal hearing'' means a hearing which is 
not subject to section 554, 556, or 557 of title 5 of the 
United States Code and which provides for the following:
          (1) The presiding officer in the hearing shall be 
        designated by the Secretary from officers and employees 
        of the Department who have not participated in any 
        action of the Secretary which is the subject of the 
        hearing and who are not directly responsible to an 
        officer or employee of the Department who has 
        participated in any such action.
          (2) Each party to the hearing shall have the right at 
        all times to be advised and accompanied by an attorney.
          (3) Before the hearing, each party to the hearing 
        shall be given reasonable notice of the matters to be 
        considered at the hearing, including a comprehensive 
        statement of the basis for the action taken or proposed 
        by the Secretary which is the subject of the hearing 
        and a general summary of the information which will be 
        presented by the Secretary at the hearing in support of 
        such action.
          (4) At the hearing the parties to the hearing shall 
        have the right to hear a full and complete statement of 
        the action of the Secretary which is the subject of the 
        hearing together with the information and reasons 
        supporting such action, to conduct reasonable 
        questioning, and to present any oral or written 
        information relevant to such action.
          (5) The presiding officer in such hearing shall 
        prepare a written report of the hearing to which shall 
        be attached all written material presented at the 
        hearing. The participants in the hearing shall be given 
        the opportunity to review and correct or supplement the 
        presiding officer's report of the hearing.
          (6) The Secretary may require the hearing to be 
        transcribed. A party to the hearing shall have the 
        right to have the hearing transcribed at his expense. 
        Any transcription of a hearing shall be included in the 
        presiding officer's report of the hearing.
  (y) The term ``saccharin'' includes calcium saccharin, sodium 
saccharin, and ammonium saccharin.
  (z) The term ``infant formula'' means a food which purports 
to be or is represented for special dietary use solely as a 
food for infants by reason of its simulation of human milk or 
its suitability as a complete or partial substitute for human 
milk.
  (aa) The term ``abbreviated drug application'' means an 
application submitted under section 505(j) for the approval of 
a drug that relies on the approved application of another drug 
with the same active ingredient to establish safety and 
efficacy, and--
          (1) in the case of section 306, includes a supplement 
        to such an application for a different or additional 
        use of the drug but does not include a supplement to 
        such an application for other than a different or 
        additional use of the drug, and
          (2) in the case of sections 307 and 308, includes any 
        supplement to such an application.
  (bb) The term ``knowingly'' or ``knew'' means that a person, 
with respect to information--
          (1) has actual knowledge of the information, or
          (2) acts in deliberate ignorance or reckless 
        disregard of the truth or falsity of the information.
  (cc) For purposes of section 306, the term ``high managerial 
agent''--
          (1) means--
                  (A) an officer or director of a corporation 
                or an association,
                  (B) a partner of a partnership, or
                  (C) any employee or other agent of a 
                corporation, association, or partnership,
        having duties such that the conduct of such officer, 
        director, partner, employee, or agent may fairly be 
        assumed to represent the policy of the corporation, 
        association, or partnership, and
          (2) includes persons having management responsibility 
        for--
                  (A) submissions to the Food and Drug 
                Administration regarding the development or 
                approval of any drug product,
                  (B) production, quality assurance, or quality 
                control of any drug product, or
                  (C) research and development of any drug 
                product.
  (dd) For purposes of sections 306 and 307, the term ``drug 
product'' means a drug subject to regulation under section 505, 
512, or 802 of this Act or under section 351 of the Public 
Health Service Act.
  (ee) The term ``Commissioner'' means the Commissioner of Food 
and Drugs.
  (ff) The term ``dietary supplement''--
          (1) means a product (other than tobacco) intended to 
        supplement the diet that bears or contains one or more 
        of the following dietary ingredients:
                  (A) a vitamin;
                  (B) a mineral;
                  (C) an herb or other botanical;
                  (D) an amino acid;
                  (E) a dietary substance for use by man to 
                supplement the diet by increasing the total 
                dietary intake; or
                  (F) a concentrate, metabolite, constituent, 
                extract, or combination of any ingredient 
                described in clause (A), (B), (C), (D), or (E);
          (2) means a product that--
                  (A)(i) is intended for ingestion in a form 
                described in section 411(c)(1)(B)(i); or
                  (ii) complies with section 411(c)(1)(B)(ii);
                  (B) is not represented for use as a 
                conventional food or as a sole item of a meal 
                or the diet; and
                  (C) is labeled as a dietary supplement; and
          (3) does--
                  (A) include an article that is approved as a 
                new drug under section 505 or licensed as a 
                biologic under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) and was, prior to 
                such approval, certification, or license, 
                marketed as a dietary supplement or as a food 
                unless the Secretary has issued a regulation, 
                after notice and comment, finding that the 
                article, when used as or in a dietary 
                supplement under the conditions of use and 
                dosages set forth in the labeling for such 
                dietary supplement, is unlawful under section 
                402(f); and
                  (B) not include--
                          (i) an article that is approved as a 
                        new drug under section 505, certified 
                        as an antibiotic under section 507, or 
                        licensed as a biologic under section 
                        351 of the Public Health Service Act 
                        (42 U.S.C. 262), or
                          (ii) an article authorized for 
                        investigation as a new drug, 
                        antibiotic, or biological for which 
                        substantial clinical investigations 
                        have been instituted and for which the 
                        existence of such investigations has 
                        been made public,
        which was not before such approval, certification, 
        licensing, or authorization marketed as a dietary 
        supplement or as a food unless the Secretary, in the 
        Secretary's discretion, has issued a regulation, after 
        notice and comment, finding that the article would be 
        lawful under this Act.
Except for purposes of sections 201(g) and 417, a dietary 
supplement shall be deemed to be a food within the meaning of 
this Act.
  (gg) The term ``processed food'' means any food other than a 
raw agricultural commodity and includes any raw agricultural 
commodity that has been subject to processing, such as canning, 
cooking, freezing, dehydration, or milling.
  (hh) The term ``Administrator'' means the Administrator of 
the United States Environmental Protection Agency.
  (ii) The term ``compounded positron emission tomography 
drug''--
          (1) means a drug that--
                  (A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons 
                and is used for the purpose of providing dual 
                photon positron emission tomographic diagnostic 
                images; and
                  (B) has been compounded by or on the order of 
                a practitioner who is licensed by a State to 
                compound or order compounding for a drug 
                described in subparagraph (A), and is 
                compounded in accordance with that State's law, 
                for a patient or for research, teaching, or 
                quality control; and
          (2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target 
        material, electronic synthesizer, or other apparatus or 
        computer program to be used in the preparation of such 
        a drug.
  (jj) The term ``antibiotic drug'' means any drug (except 
drugs for use in animals other than humans) composed wholly or 
partly of any kind of penicillin, streptomycin, 
chlortetracycline, chloramphenicol, bacitracin, or any other 
drug intended for human use containing any quantity of any 
chemical substance which is produced by a micro-organism and 
which has the capacity to inhibit or destroy micro-organisms in 
dilute solution (including a chemically synthesized equivalent 
of any such substance) or any derivative thereof.
          (kk) Priority supplement.--The term ``priority 
        supplement'' means a drug application referred to in 
        section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997 (111 Stat. 2298).
  (ll)(1) The term ``single-use device'' means a device that is 
intended for one use, or on a single patient during a single 
procedure.
  (2)(A) The term ``reprocessed'', with respect to a single-use 
device, means an original device that has previously been used 
on a patient and has been subjected to additional processing 
and manufacturing for the purpose of an additional single use 
on a patient. The subsequent processing and manufacture of a 
reprocessed single-use device shall result in a device that is 
reprocessed within the meaning of this definition.
  (B) A single-use device that meets the definition under 
clause (A) shall be considered a reprocessed device without 
regard to any description of the device used by the 
manufacturer of the device or other persons, including a 
description that uses the term ``recycled'' rather than the 
term ``reprocessed''.
  (3) The term ``original device'' means a new, unused single-
use device.
  (mm)(1) The term ``critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact normally sterile tissue or body spaces during use.
  (2) The term ``semi-critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact intact mucous membranes and not penetrate normally 
sterile areas of the body.
  (nn) The term ``major species'' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary 
may add species to, or remove species from, this definition by 
regulation.
  (oo) The term ``minor species'' means animals other than 
humans that are not major species.
  (pp) The term ``minor use'' means the intended use of a drug 
in a major species for an indication that occurs infrequently 
and in only a small number of animals or in limited 
geographical areas and in only a small number of animals 
annually.
  (qq) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), 
        tree nuts (e.g., almonds, pecans, or walnuts), wheat, 
        peanuts, soybeans, and sesame.
          (2) A food ingredient that contains protein derived 
        from a food specified in paragraph (1), except the 
        following:
                  (A) Any highly refined oil derived from a 
                food specified in paragraph (1) and any 
                ingredient derived from such highly refined 
                oil.
                  (B) A food ingredient that is exempt under 
                paragraph (6) or (7) of section 403(w).
  (rr)(1) The term ``tobacco product'' means any product made 
or derived from tobacco, or containing nicotine from any 
source, that is intended for human consumption, including any 
component, part, or accessory of a tobacco product (except for 
raw materials other than tobacco used in manufacturing a 
component, part, or accessory of a tobacco product).
  (2) The term ``tobacco product'' does not mean an article 
that is a drug under subsection (g)(1), a device under 
subsection (h), or a combination product described in section 
503(g).
  (3) The products described in paragraph (2) shall be subject 
to chapter V of this Act.
  (4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act 
(including a drug, biologic, food, cosmetic, medical device, or 
a dietary supplement).
  (5) The term ``tobacco product'' does not mean an article 
that is a food under paragraph (f), if such article contains no 
nicotine, or no more than trace amounts of naturally occurring 
nicotine.
  (ss) The term ``critical food'' means a food that is--
          (1) an infant formula; or
          (2) a medical food, as defined in section 5(b)(3) of 
        the Orphan Drug Act.

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CHAPTER VII--GENERAL AUTHORITY

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Subchapter C--Fees

           *       *       *       *       *       *       *



                 PART 4--FEES RELATING TO ANIMAL DRUGS

SEC. 739. DEFINITIONS.

  For purposes of this part:
          (1)(A) The term ``animal drug application'' means--
                  (i) an application for approval of any new 
                animal drug submitted under section 512(b)(1); 
                or
                  (ii) an application for conditional approval 
                of a new animal drug submitted under section 
                571.
          (B) Such term does not include either a new animal 
        drug application submitted under section 512(b)(2) or a 
        supplemental animal drug application.
          (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 section 
                512(c)(2) for which data with respect to safety 
                or effectiveness are required.
          (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] 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 section 512(j) 
                for a new animal drug intended to be the 
                subject of an animal drug application or a 
                supplemental animal drug application; or
                  (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 Good Manufacturing Practice 
                Mutual Inspection Agreement with respect to 
                animal drug products subject to review, 
                including implementation activities prior to 
                and following product approval.]
                  (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 section 740 and 
                accounting for resources allocated for the 
                review of animal drug applications, 
                supplemental animal drug applications, and 
                investigational animal drug submissions.
          (10) The term ``adjustment factor'' applicable to a 
        fiscal year refers to the formula set forth in section 
        735(8) with the base or comparator month being October 
        2002.
          (11) The term ``person'' includes an affiliate 
        thereof.
          (12) The term ``affiliate'' refers to the definition 
        set forth in section 735(11).

SEC. 740. 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 
                        section 512(d)(4).
                          (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; [and]
                                  (II) an animal drug 
                                application subject to the 
                                criteria set forth in section 
                                512(d)(4)[.]; and
                                  (III) an application for 
                                conditional approval under 
                                section 571 of a new animal 
                                drug for which an animal drug 
                                application submitted under 
                                section 512(b)(1) has been 
                                previously approved under 
                                section 512(d)(1) for another 
                                intended use.
                  (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 
                        section 512(b)(1), where such person 
                        (or their licensor, assignor, or 
                        predecessor-in-interest) previously 
                        submitted an application for 
                        conditional approval under section 571 
                        for the same product and paid the 
                        applicable fee under subparagraph (A), 
                        the application under section 512(b)(1) 
                        shall not be subject to a fee under 
                        subparagraph (A) if submitted within 
                        the timeframe specified in section 
                        571(h).
                  (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 
                        section 510; and
                          (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 section 510, or is submitted for 
                relisting under section 510 if the animal drug 
                product has been withdrawn from listing and 
                relisted. After such fee is paid for that 
                fiscal year, such fee shall be due each 
                subsequent fiscal year that the product remains 
                listed, 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.--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 
                        section 510; and
                          (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)--
                  [(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.]
          (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.--The Secretary shall 
        establish, 60 days before the start of each fiscal year 
        beginning after September 30, 2003, 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.]
          (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 [2020] 
        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-[Baltimore] 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) Compounded basis.--The adjustment made each 
        fiscal year after fiscal year [2020] 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 [2020] 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 
                [subparagraphs (B) and (C)] 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; [and]
                          [(ii) the Secretary shall publish in 
                        the Federal Register the fees resulting 
                        from such adjustment and the supporting 
                        methodologies.]
                          (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) Reduction of workload-based increase by 
                amount of certain excess collections.--For each 
                of fiscal years 2021 through 2023, 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)] (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) Final year adjustment.--For fiscal year 2023, 
        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 
        animal drug applications for the first 3 months of 
        fiscal year 2024. If the Food and Drug Administration 
        has carryover balances for the process for the review 
        of animal drug applications in excess of 3 months of 
        such operating reserves, then this adjustment will 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 2023.]
          (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 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) Exemptions from fees.--
                  [(A) Certain labeling supplements to add 
                number of approved application.--Fees under 
                this section shall not apply with respect to 
                any person who--
                          [(i) not later than September 30, 
                        2023, submits a supplemental animal 
                        drug application relating to a new 
                        animal drug application approved under 
                        section 512, solely to add the new 
                        animal drug application number to the 
                        labeling of the drug in the manner 
                        specified in section 502(w)(3); and
                          [(ii) otherwise would be subject to 
                        fees under this section solely on the 
                        basis of such supplemental application.
                  [(B) Certain animal drug applications.--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 
                section 736, 738, 744B, or 744H.]
          (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 section 736, 738, 744B, 
        or 744H.
  (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 section 
739(5)(B) 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. The Secretary may discontinue 
review of any animal drug application, supplemental animal drug 
application or investigational animal drug submission 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 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 [2019 through 2023] 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) [and paragraph (5)].
          (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.--
                  [(A) In general.--Subject to subparagraph 
                (B)--
                          [(i) for fiscal year 2021, the amount 
                        of fees otherwise authorized to be 
                        collected under this section shall be 
                        increased by the amount, if any, by 
                        which the amount collected under this 
                        section and appropriated for fiscal 
                        year 2019 falls below the amount of 
                        fees authorized for fiscal year 2019 
                        under paragraph (3);
                          [(ii) for fiscal year 2022, the 
                        amount of fees otherwise authorized to 
                        be collected under this section shall 
                        be increased by the amount, if any, by 
                        which the amount collected under this 
                        section and appropriated for fiscal 
                        year 2020 falls below the amount of 
                        fees authorized for fiscal year 2020 
                        under paragraph (3); and
                          [(iii) for fiscal year 2023, the 
                        amount of fees otherwise authorized to 
                        be collected under this section shall 
                        be increased by the cumulative amount, 
                        if any, by which the amount collected 
                        under this section and appropriated for 
                        fiscal years 2021 and 2022 (including 
                        estimated collections for fiscal year 
                        2022) falls below the cumulative amount 
                        of fees authorized for such fiscal 
                        years under paragraph (3).
                  [(B) Reduction of shortfall-based fee 
                increase by prior year excess collections.--
                          [(i) In general.--Subject to clause 
                        (ii), the Secretary shall, in such 
                        manner as the Secretary determines 
                        appropriate, reduce any fee increase 
                        otherwise applicable for a fiscal year 
                        under subparagraph (A) by the amount of 
                        any excess collections under this 
                        section for preceding fiscal years 
                        (after fiscal year 2018).
                          [(ii) Workload-based fee 
                        accounting.--In applying clause (i), 
                        the Secretary shall account for the 
                        reduction of workload-based fee revenue 
                        increases by excess collections under 
                        subsection (c)(3)(B), in such manner as 
                        needed to provide that no portion of 
                        any excess collections described in 
                        clause (i) is applied for purposes of 
                        reducing fee increases under both such 
                        subsection (c)(3)(B) and this 
                        paragraph.
                  [(C) Rule of application.--Under no 
                circumstances shall adjustments under this 
                paragraph 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 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 chapter 37 of title 31, United States Code.
  (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.

SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--[Beginning with]
          (1) In general._Beginning with  fiscal year [2019] 
        2024, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this 
        part, 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) of the Animal Drug User Fee 
        Amendments of [2018] 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.
          (2) Contents.--The report under paragraph (1) shall 
        include the following:
                  (A) Data, analysis and discussion of the 
                changes in the number of individuals hired and 
                funded by fees collected pursuant to section 
                740, and data, analysis, and discussion of the 
                number of full-time equivalents in the animal 
                drug review program, including a breakdown by 
                funding from fees collected pursuant to section 
                740 versus budget authority, and by each 
                division within the Center for Veterinary 
                Medicine, the Office of Regulatory Affairs, and 
                the Office of the Commissioner.
                  (B) Data, analysis, and discussion of the 
                changes in the fee revenue amounts and costs 
                for the process for the review of animal drug 
                applications, including identifying--
                          (i) the drivers of such changes; and
                          (ii) changes in the total cost per 
                        full-time equivalent in the animal drug 
                        review program.
                  (C) Data, analysis, and discussion of changes 
                in the average full-time equivalent hours 
                required to complete review of each type of 
                animal drug application.
                  (D) For fiscal years 2024 and 2025, of the 
                meeting requests from animal drug 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.
  (b) Fiscal Report.--Beginning with fiscal year [2019] 2024, 
not later than 120 days after the end of each fiscal year 
during which fees are collected under this part, 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 [2023] 2028, and for the 
        reauthorization of this part 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 part, 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 part; 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 part 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, [2023] 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) 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.
          [(6)] (7) Minutes of negotiation meetings.--
                  (A) Public availability.--[Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to Congress, the Secretary] 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, 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.

           PART 5--FEES RELATING TO GENERIC NEW ANIMAL DRUGS

SEC. 741. 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 section 
                        512(d)(4) and submitted on or after 
                        October 1, 2013 shall be subject to a 
                        fee equal to 50 percent of the amount 
                        of the abbreviated application fee 
                        established in subsection (c).
                  (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 section 510; and
                          (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 section 510, or is 
                submitted for relisting under section 510 if 
                the generic new animal drug product has been 
                withdrawn from listing and relisted. After such 
                fee is paid for that fiscal year, such fee 
                shall be due each subsequent fiscal year that 
                the product remains listed, 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.--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 [2019 through 
        2023] 2024 through 2028, the fees required under 
        subsection (a) shall be established to generate a total 
        revenue amount of [$18,336,340] $25,000,000.
          (2) Types of fees.--Of the total revenue amount 
        established for a fiscal year under paragraph (1)--
                  (A) [25 percent] 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) [37.5 percent] 40 percent shall be 
                derived from fees under subsection (a)(2) 
                (relating to generic new animal drug products); 
                and
                  (C) [37.5 percent] 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, 60 days before the start of each fiscal year 
        beginning after September 30, 2008, for that fiscal 
        year, abbreviated application fees, 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.]
          (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 [2020] 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-[Baltimore] 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 [2020] 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 [2020] 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, [and investigational 
                        generic new animal drug protocol 
                        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[; and];
                          (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
                          [(ii)] (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 [2021 through 2023] 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 [2023] 
        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 
        [2024] 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 [2023] 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; Exemption From Fees.--
          [(1) 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.
          [(2) Exemption from fees.--Fees under this section 
        shall not apply with respect to any person who--
                  [(A) not later than September 30, 2023, 
                submits a supplemental abbreviated application 
                for a generic new animal drug approved under 
                section 512, solely to add the application 
                number to the labeling of the drug in the 
                manner specified in section 502(w)(3); and
                  [(B) otherwise would be subject to fees under 
                this section solely on the basis of such 
                supplemental abbreviated application.]
  (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. [The Secretary may discontinue] 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 [sponsors, and 
        generic new animal drug products at any time] 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 [2019 through 2023] 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).
          [(4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for the fiscal years 
        2014 through 2016 and the amount of fees estimated to 
        be collected under this section for fiscal year 2017 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2014 through 2017, 
        the excess amount 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 authorized to be collected under this 
        section pursuant to appropriation Acts for fiscal year 
        2018.]
          (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 chapter 37 of title 31, United States Code.
  (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 section 742:
          (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 
        section 512(b)(2). Such term does not include a 
        supplemental abbreviated application for a generic new 
        animal drug.
          (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.
          [(8)] (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 section 512(j) 
                for a generic new animal drug intended to be 
                the subject of an abbreviated application or a 
                supplemental abbreviated application; or
                  (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.
          [(9)] (10) Person.--The term ``person'' includes an 
        affiliate thereof (as such term is defined in section 
        735(11)).
          [(10)] (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.
          [(11)] (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.

SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Reports.--Beginning with fiscal year [2019] 
2024, not later than 120 days after the end of each fiscal year 
during which fees are collected under this part, 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) of the Animal Generic Drug User Fee Amendments 
of [2018] 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 [2019] 2024, 
not later than 120 days after the end of each fiscal year 
during which fees are collected under this part, 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 [2023] 2028, and for the reauthorization of this 
        part 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 part, 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 part; 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 part 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, [2023] 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.

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                ANIMAL DRUG USER FEE AMENDMENTS OF 2018



           *       *       *       *       *       *       *
TITLE I--FEES RELATING TO ANIMAL DRUGS

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SEC. 107. SUNSET DATES.

  [(a) Authorization.--Section 740 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-12) shall cease to be 
effective October 1, 2023.
  [(b) Reporting Requirements.--Section 740A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13) shall cease to 
be effective January 31, 2024.]
  (c) Previous Sunset Provision.--Effective October 1, 2018, 
subsections (a) and (b) of section 107 of the Animal Drug User 
Fee Amendments of 2013 (Public Law 113-14) are repealed.

           *       *       *       *       *       *       *

                              ----------                              


            ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018



           *       *       *       *       *       *       *
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

           *       *       *       *       *       *       *


SEC. 206. SUNSET DATES.

  [(a) Authorization.--Section 741 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-21) shall cease to be 
effective October 1, 2023.
  [(b) Reporting Requirements.--Section 742 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-22) shall cease to 
be effective January 31, 2024.]
  (c) Previous Sunset Provision.--Effective October 1, 2018, 
subsections (a) and (b) of section 206 of the Animal Generic 
Drug User Fee Amendments of 2013 (Public Law 113-14) are 
repealed.

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