[Congressional Record Volume 169, Number 122 (Monday, July 17, 2023)]
[House]
[Pages H3620-H3624]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




    ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2023

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1418

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     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.''.

[[Page H3621]]

       (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

[[Page H3622]]

       ``(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

[[Page H3623]]

       (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.

  The SPEAKER pro tempore (Mr. Van Drew). Pursuant to the rule, the 
gentleman from Florida (Mr. Bilirakis) and the gentlewoman from 
Washington (Ms. Schrier) each will control 20 minutes.
  The Chair recognizes the gentleman from Florida.


                             General Leave

  Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Florida?
  There was no objection.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of H.R. 1418, the Animal Drug 
and Animal Generic Drug User Fee Amendments of 2023, sponsored by my 
good friend, Mr. Pence, and, of course, Ms. Schrier on the Democrat 
side and their members on the Energy and Commerce Committee.
  Our committee has worked hard on this legislation for many months, 
holding a legislative hearing in March and two markups this spring 
before advancing it out of full committee last month by a vote of 49-0.
  At each step, our members worked in a bipartisan fashion to consider 
ways to make improvements to this legislation and keep any 
controversial policies from getting in the way of passing this bill 
before its September deadline. Great work.
  Overall, the ADUFA amendments of 2023 will reauthorize the two user 
fee programs established to support the development and review of 
animal drugs and generics.
  These drugs keep our animals healthy, from our household pets to our 
farm animals, and they ensure that our food supply is safe for humans 
too. That is how important this bill is.
  The bill before us also includes provisions to support the review 
process in getting new drugs to the market faster and adds new 
reporting requirements to improve transparency and accountability 
within the FDA's Center for Veterinary Medicine.
  It also takes steps to support utilizing the conditional approval 
pathway for animal drugs, which will bring more drugs to the market for 
small animal populations with unmet clinical needs.
  There are even more program enhancements contained in these 
agreements, addressing foreign inspections, fiscal responsibility, and 
the need for more innovation.
  If this legislation is not signed into law before September 30, Mr. 
Speaker, the review and approval of the medicines that farmers and pet 
owners rely on will dramatically slow down. We can't let that happen.
  Drugmakers will also face regulatory uncertainty in getting their 
therapies to the market, impacting access to new cures and treatments. 
They are relying on Congress to do its job, and we will, which is why I 
strongly urge support of this legislation and encourage my colleagues 
to vote ``yes.''
  I reserve the balance of my time, Mr. Speaker.
  Ms. SCHRIER. Mr. Speaker, I yield myself such time as I may consume.
  I first thank Chair Rogers, Ranking Member Pallone, Representative 
Bilirakis, and, of course, Representative Pence, who sponsored this 
bill together with me, for their leadership and hard work on this 
bipartisan bill. I am a proud sponsor.
  The Animal Drug User Fee Agreement is important for the safety of 
both animal and human health. This bill will accelerate the development 
of new medications for animals with a predictable and streamlined 
review process.
  It will hold the FDA accountable for performance goals that will 
improve wait times for inspections and provide regulatory certainty for 
innovators and pet and animal owners alike.
  It will ensure that our Nation's food supply is safe by making sure 
the medicines that are administered to food-producing animals are safe.

                              {time}  1645

  I want to underscore that this bill is a win for everyone, but it is 
especially good for farmers.
  In my district, farmers, ranchers, and dairymen rely on these FDA-
approved medications to keep their livestock healthy. For them, keeping 
animals healthy is not just about their affection and responsibility 
for these animals. It is critical for food production, food safety, and 
their very economic survival.
  Having timely access to affordable, effective medications is a key 
part of our domestic food chain, and that is really the heart of our 
rural economies.
  I am happy to go to bat for our rural areas and our agricultural 
communities with this legislation. I encourage my colleagues to vote 
``yes'' on this important bill, Mr. Speaker, and I reserve the balance 
of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to 
the gentleman from Indiana (Mr. Pence), the sponsor of the bill along 
with Ms. Schrier.
  Mr. PENCE. Mr. Speaker, I am proud to champion the fifth 
reauthorization of the Animal Drug User Fee Act with Congresswoman 
Schrier.
  This important legislation is critical to ensuring safe and effective 
drugs for our Nation's livestock industry and farm animals for the next 
5 years. It provides resources for the review of new and generic animal 
drugs, accelerates the development of animal therapeutics, and promotes 
a more predictable and streamlined review process.
  It is important we hold the FDA accountable to performance goals that 
will enhance inspection times and provide regulatory certainty for both 
innovators and pet owners alike.
  Farmers, ranchers, and rural communities across southern Indiana rely 
on veterinary medicines and therapeutics produced by animal drug 
manufacturers. Innovators in the Hoosier State, like Elanco Animal 
Health, are leading the charge to keep American farm animals safe and 
healthy. We need innovation in veterinary medicine to secure the best 
care for our Nation's veterinary patients.
  This legislation would preserve the security of America's food supply 
by making certain the medications administered to food-producing 
animals are safe for animal and human health.
  Mr. Speaker, I urge support for final passage of this legislation.

[[Page H3624]]

  

  Ms. SCHRIER. Mr. Speaker, I yield myself the balance of my time to 
close.
  I thank Mr. Bilirakis and Members on the other side of the aisle for 
working together on this bipartisan bill. I encourage my colleagues to 
vote ``yes'' on this bill to make sure we can speed novel medications 
to animals in this country.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, this is a great bill. It is a necessary 
bill for our farmers but also our animal owners. I used to be the chair 
of the Humane Bond Caucus, and we absolutely love our animals. Mr. 
Pence and Ms. Schrier are doing an excellent job on this particular 
bill, and I urge unanimous passage.
  Mr. Speaker, I yield back the balance of my time.
  Ms. JACKSON LEE. Mr. Speaker, I rise in support of H.R. 1418, the 
``Animal Drug and Animal Generic Drug User Fee Amendments of 2023'', or 
ADUFA and AGDUFA, which will enable the U.S. to lead the world in 
innovation and drug development for animal pharmaceuticals.
  The Animal Drug and Animal Generic Drug User Fee Amendment or AGDUFA 
was designed to enhance the performance of the generic new animal drug 
review process and enable the FDA to more efficiently ensure that 
generic new animal drug products are safe and effective.
  AGDUFA was originally signed into law in 2008 and reauthorized in 
2013 and 2018.
  This bill reauthorizes the FDA to collect user fees for certain 
abbreviated applications for generic new animal drugs, generic new 
animal drug products and from certain sponsors of abbreviated 
applications for generic new animal drugs and investigational 
submissions for generic new animal drugs.
  Specifically, this bill ensures that the Center for Veterinary 
Medicine can continue to meet the needs of the animal drug industry as 
it evolves.
  This bipartisan bill will lead to increased transparency, additional 
pathways for animal drug approvals, and reduced review times for 
pioneer and generic drug applications while maintaining high standards 
for safety and efficacy.
  Veterinarians have far fewer FDA-approved animal drugs compared to 
the number of FDA-approved human drugs.
  My district in Houston is home to hundreds of veterinarians working 
hard to improve the health of animals.
  In fact, Houston ranks fourth among metro areas for dog ownership and 
was named the ``Dog Capital of the World'' in a 2022 study conducted by 
Protect Our Paws.
  Protect Our Paws found that Houston had the highest dog-toperson 
ratio in the world with 52.1 dogs per 100 humans.
  More broadly, with Texas being No. 4 in pet ownership and over 58 
percent of households owning at least one pet, we have thousands ot 
pets and animals to protect.
  I have a vested interest in moving these reauthorizations forward 
because they are critical to animal and human health and well-being.
  FDA continues to make progress to mitigate the growth of 
antimicrobial resistance in food-producing animals, including ending 
over-the-counter access to medically important antibiotics which are 
used in both humans and animals, but more needs to be done.
  I remain fully committed to moving the Animal Drug and Animal Generic 
Drug User Fee Amendments of 2023 through a swift reauthorization before 
the programs expire on September 30th.
  I urge all my colleagues to join me in voting in favor of H.R. 1418, 
the Animal Drug and Animal Generic Drug User Fee Amendments of 2023.''
  Ms. JACKSON LEE. Mr. Speaker, I rise today in support of H.R. 813, 
the Global Investment in American Jobs Act of 2023.
  This bill will direct the Secretary of Commerce to conduct an 
interagency review of and report to Congress on ways to increase the 
global competitiveness of the United States in attracting foreign 
direct investment.
  The report will look at the economic impact of foreign direct 
investments in the United States, focusing on manufacturing, services, 
trade, and jobs in the United States.
  This will allow Congress to better understand trends and challenges 
in global cross-border investments, as well as collaborate with other 
trusted partner countries.
  Specifically, this bill will attract foreign direct investment from 
responsible private-sector entities, which is directly linked to the 
long-term economic prosperity, global competitiveness, and security of 
the United States.
  It will promote polices to ensure that United States remains the 
global leader in developing and deploying cutting-edge technologies, 
such as self-driving vehicle technology and artificial intelligence.
  As digital information becomes increasingly important to the United 
States economy and the development of new technologies and services 
that will be crucial to the country's competitiveness in the 21st 
century global economy, barriers including data localization and 
infringement of intellectual property rights must be further addressed.
  This study will focus on the economic impact of foreign direct 
investment, challenges associated with foreign direct investment by 
state-owned enterprises, and the influence of protectionist policies 
enacted by other countries on the advanced technology economy.
  Further, this bill will allow us to reduce our supply-chain 
dependence on China.
  For the success of our larger economy, national security, and global 
relationships, it is vital that we pass H.R. 813.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Florida (Mr. Bilirakis) that the House suspend the rules 
and pass the bill, H.R. 1418, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________