[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1844 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 174
118th CONGRESS
  1st Session
                                S. 1844

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs and generic new animal drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 7, 2023

Ms. Baldwin (for herself and Mr. Mullin) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                             July 26, 2023

               Reported by Mr. Sanders, with an amendment
                  [Insert the part printed in italic]

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs and generic new animal drugs.

    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.
Sec. 304. Regulation of zootechnical animal food substances.

                 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 office 
                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.

SEC. 304. REGULATION OF ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.

    (a) Definition.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(tt)(1) The term `zootechnical animal food substance' means a 
substance that--
            ``(A) is added to the food or drinking water of animals;
            ``(B) is intended to--
                    ``(i) affect the byproducts of the digestive 
                process of an animal;
                    ``(ii) reduce the presence of foodborne pathogens 
                of human health significance in an animal intended to 
                be used for food; or
                    ``(iii) affect the structure or function of the 
                body of the animal, other than by providing nutritive 
                value, by altering the animal's gastrointestinal 
                microbiome; and
            ``(C) achieves its intended effect by acting solely within 
        the gastrointestinal tract of the animal.
    ``(2) Such term does not include a substance that--
            ``(A) is intended for use in the diagnosis, cure, 
        mitigation, treatment, or prevention of disease in an animal;
            ``(B) is a hormone;
            ``(C) is an active moiety in an animal drug, which, prior 
        to the filing of a petition under section 409 was approved 
        under section 512, conditionally approved under section 571, or 
        indexed under section 572, or for which substantial clinical 
        investigations have been instituted and for which the existence 
        of such investigations has been made public;
            ``(D) is an ionophore; or
            ``(E) is otherwise excluded from the definition based on 
        criteria established by the Secretary through notice and 
        comment rulemaking.
    ``(3) A zootechnical animal food substance shall be deemed to be a 
food additive within the meaning of paragraph (s) and its introduction 
into interstate commerce shall be in accordance with a regulation 
issued under section 409. A zootechnical animal food substance shall 
not be considered a drug under paragraph (g)(1)(C) solely because the 
substance has an intended effect described in subparagraph (1).''.
    (b) Food Additives.--Section 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 348) is amended--
            (1) in subsection (b)--
                    (A) by redesignating paragraphs (3) through (5) as 
                paragraphs (4) through (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) In the case of a zootechnical animal food substance, 
        such petition shall, in addition to any explanatory or 
        supporting data, contain--
                    ``(A) all relevant data bearing on the effect the 
                zootechnical animal food substance is intended to have 
                and the quantity of such substance required to produce 
                the intended effect; and
                    ``(B) full reports of investigations made with 
                respect to the intended use of such substance, 
                including full information as to the methods and 
                controls used in conducting such investigations.'';
            (2) in subsection (c)--
                    (A) by amending subparagraph (A) of paragraph (1) 
                to read as follows:
            ``(A)(i) by order establish a regulation (whether or not in 
        accord with that proposed by the petitioner) prescribing--
                    ``(I) with respect to one or more proposed uses of 
                the food additive involved, the conditions under which 
                such additive may be safely used (including 
                specifications as to the particular food or classes of 
                food in or on which such additive may be used, the 
                maximum quantity which may be used or permitted to 
                remain in or on such food, the manner in which such 
                additive may be added to or used in or on such food, 
                and any directions or other labeling or packaging 
                requirements for such additive as the Secretary 
                determines necessary to assure the safety of such use); 
                and
                    ``(II) in the case of a zootechnical animal food 
                substance, the conditions under which such substance 
                may be used to achieve the intended effect; and
            ``(ii) notify the petitioner of such order and the reasons 
        for such action; or''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (A), by striking ``; 
                        or'' and inserting a semicolon;
                            (ii) in subparagraph (B), by striking the 
                        period and inserting ``; or''; and
                            (iii) by adding at the end the following:
            ``(C) in the case of a zootechnical animal food substance, 
        fails to establish that the proposed use of the substance, 
        under the conditions of use to be specified in the regulation, 
        will achieve the intended effect.''; and
            (3) by adding at the end the following:
    ``(l) Zootechnical Animal Food Substances.--The labeling of a 
zootechnical animal food substance--
            ``(1) shall include the statement: `Not for use in the 
        diagnosis, cure, mitigation, treatment, or prevention of 
        disease in animals.'; and
            ``(2) may include statements regarding the intended effect 
        of the substance on the structure or function of the body of 
        animals, as set forth in section 201(tt)(1).''.
    (c) Misbranded Food.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(z) If it is a zootechnical animal food substance and the 
labeling of the food does not include the statement required by section 
409(l)(1).''.
    (d) Rule of Construction.--Nothing in this section, or the 
amendments made by this section, shall be construed to authorize the 
Secretary of Health and Human Services to require the use of any 
zootechnical food substance or food additive (as those terms are 
defined in section 201 of the Federal Food, Drug, and Cosmetic Act, as 
amended by subsection (a)).
                                                       Calendar No. 174

118th CONGRESS

  1st Session

                                S. 1844

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs and generic new animal drugs.

_______________________________________________________________________

                             July 26, 2023

                       Reported with an amendment