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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5554 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5554

_______________________________________________________________________

                                 AN ACT

 
 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 2018''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

    (a) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
                 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--MISCELLANEOUS PROVISIONS

Sec. 301. Electronic submissions.
Sec. 302. Index of legally marketed unapproved new animal drugs for 
                            minor species.
Sec. 303. Misbranded drugs and devices.
Sec. 304. Conditional approval of new animal drugs.
Sec. 305. Guidance addressing investigation designs.
Sec. 306. Food additives intended for use in animal food.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

                 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 2018''.
    (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, 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 (21 U.S.C. 379j-11) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(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.''; and
            (2) in paragraph (8), by adding at the end the following:
                    ``(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.''.

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

    (a) Fee Revenue Amounts.--Section 740(b) (21 U.S.C. 379j-12(b)) is 
amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) by striking ``2014'' and inserting 
                        ``2019''; and
                            (ii) by striking ``$23,600,000'' and 
                        inserting ``$30,331,240''; and
                    (B) in subparagraph (B)--
                            (i) by striking ``2015 through 2018'' and 
                        inserting ``2020 through 2023''; and
                            (ii) by striking ``$21,600,000'' and 
                        inserting ``$29,931,240''; and
            (2) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``determined'' and inserting ``established''.
    (b) Annual Fee Setting; Adjustments.--
            (1) Inflation adjustment.--Section 740(c)(2) (21 U.S.C. 
        379j-12(c)(2)) is amended--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``For fiscal year 2015'' 
                        and inserting ``(A) For fiscal year 2020''; and
                            (ii) by inserting ``multiplying such 
                        revenue amounts by'' before ``an amount'';
                    (B) by redesignating subparagraphs (A), (B), and 
                (C) as clauses (i), (ii), and (iii), respectively;
                    (C) by striking the flush text at the end; and
                    (D) by adding at the end the following new 
                subparagraph:
            ``(B) Compounded basis.--The adjustment made each fiscal 
        year after fiscal year 2020 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.''.
            (2) Workload adjustments.--Paragraph (3) of section 740(c) 
        (21 U.S.C. 379j-12(c)) is amended to read as follows:
            ``(3) Workload adjustments.--
                    ``(A) In general.--For fiscal year 2020 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). 
                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.
                    ``(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) 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).''.
            (3) Final year adjustment.--Section 740(c)(4) (21 U.S.C. 
        379j-12(c)(4)) is amended--
                    (A) by striking ``2018'' each place it appears and 
                inserting ``2023''; and
                    (B) by striking ``2019'' and inserting ``2024''.
    (c) Exemptions From Fees.--Section 740(d) (21 U.S.C. 379j-12(d)) is 
amended--
            (1) in the subsection heading, by inserting ``; Exemptions 
        From Fees'' after ``Reduction'';
            (2) by striking the heading of paragraph (1) and inserting 
        ``Waiver or reduction''; and
            (3) by adding at the end the following:
            ``(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.''.
    (d) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 740(g)(3) (21 
        U.S.C. 379j-12(g)(3)) is amended--
                    (A) by striking ``2014 through 2018'' and inserting 
                ``2019 through 2023'';
                    (B) by striking ``determined'' and inserting 
                ``established''; and
                    (C) by striking ``paragraph (4)'' and inserting 
                ``paragraph (5)''.
            (2) Excess collections.--Section 740(g) (21 U.S.C. 379j-
        12(g)) is amended by striking paragraph (4) and inserting the 
        following:
            ``(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).''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 740A (21 U.S.C. 379j-13) is amended--
            (1) in subsection (a), by striking ``2013'' and inserting 
        ``2018'';
            (2) by striking ``2014'' each place it appears in 
        subsections (a) and (b) and inserting ``2019''; and
            (3) in subsection (d), by striking ``2018'' each place it 
        appears and inserting ``2023''.

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, 2013, 
but before October 1, 2018, 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 2019.

SEC. 106. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2018, 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, as amended by this title, shall 
be assessed for animal drug applications and supplemental animal drug 
applications received on or after October 1, 2018, regardless of the 
date of the enactment of this Act.

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.

            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 2018''.
    (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, 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) Fee Revenue Amounts.--Subsection (b) of section 741 (21 U.S.C. 
379j-21) is amended to read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--Subject to subsections (c), (d), (f), 
        and (g), for each of fiscal years 2019 through 2023, the fees 
        required under subsection (a) shall be established to generate 
        a total revenue amount of $18,336,340.
            ``(2) Types of fees.--Of the total revenue amount 
        established for a fiscal year under paragraph (1)--
                    ``(A) 25 percent shall be derived from fees under 
                subsection (a)(1) (relating to abbreviated applications 
                for a generic new animal drug);
                    ``(B) 37.5 percent shall be derived from fees under 
                subsection (a)(2) (relating to generic new animal drug 
                products); and
                    ``(C) 37.5 percent shall be derived from fees under 
                subsection (a)(3) (relating to generic new animal drug 
                sponsors).''.
    (b) Annual Fee Setting; Adjustments.--
            (1) Inflation adjustment.--Section 741(c) (21 U.S.C. 379j-
        21(c)) is amended--
                    (A) by redesignating paragraphs (2) through (4) as 
                paragraphs (3) through (5), respectively; and
                    (B) by inserting after paragraph (1) the following:
            ``(2) Inflation adjustment.--
                    ``(A) In general.--For fiscal year 2020 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, 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 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.''.
            (2) Workload adjustments.--Paragraph (3) of section 741(c) 
        (21 U.S.C. 379j-21(c)), as redesignated, is amended to read as 
        follows:
            ``(3) Workload adjustments.--
                    ``(A) In general.--For fiscal year 2020 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 submitted to 
                        the Secretary; and
                            ``(ii) 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, 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).''.
            (3) Final year adjustment.--Paragraph (4) of section 741(c) 
        (21 U.S.C. 379j-21(c)), as redesignated, is amended by--
                    (A) striking ``2018'' each place it appears and 
                inserting ``2023''; and
                    (B) striking ``2019'' and inserting ``2024''.
    (c) Fee Waiver or Reduction; Exemption From Fees.--Subsection (d) 
of section 741 (21 U.S.C. 379j-21) is amended to read as follows:
    ``(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) Crediting and Availability of Fees.--Section 741(g) (21 U.S.C. 
379j-21) is amended by striking paragraph (3) and inserting the 
following paragraphs:
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2019 through 2023, 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).''.

SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 742 (21 U.S.C. 379j-22) is amended--
            (1) in subsection (a), by striking ``2013'' and inserting 
        ``2018'';
            (2) in subsection (b), by striking ``Committee on Health, 
        Education, Labor, and Pensions'' and inserting ``the Committee 
        on Health, Education, Labor and Pensions'';
            (3) by striking ``2014'' each place it appears in 
        subsections (a) and (b) and inserting ``2019''; and
            (4) in subsection (d), by striking ``2018'' each place it 
        appears and inserting ``2023''.

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, 2013, but before 
October 1, 2018, 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 2019.

SEC. 205. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2018, 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, 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, 2018, 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, 
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.

                  TITLE III--MISCELLANEOUS PROVISIONS

SEC. 301. ELECTRONIC SUBMISSIONS.

    (a) New Animal Drug Applications and Abbreviated Applications for a 
Generic New Animal Drug.--Section 512(b) (21 U.S.C. 360b(b)) is amended 
by adding at the end the following:
    ``(4) Beginning on October 1, 2018, all applications or submissions 
pursuant to this subsection shall be submitted by electronic means in 
such format as the Secretary may require.''.
    (b) Conditional Approval of New Animal Drugs for Minor Use and 
Minor Species.--Section 571(a) (21 U.S.C. 360ccc(a)) is amended by 
adding at the end the following:
    ``(4) Beginning on October 1, 2018, all applications or submissions 
pursuant to this subsection shall be submitted by electronic means in 
such format as the Secretary may require.''.

SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR 
              MINOR SPECIES.

    Effective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc-
1(h)) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(1) `LEGAL STATUS--In order to be legally marketed, a new 
        animal drug intended for a minor species must be Approved, 
        Conditionally Approved, or Indexed by the Food and Drug 
        Administration. THIS PRODUCT IS INDEXED--MIF #' (followed by 
        the applicable minor species index file number and a period) 
        `Extra-label use is prohibited.';''; and
            (2) in paragraph (2), by striking ``other animals'' and 
        inserting ``food-producing animals''.

SEC. 303. MISBRANDED DRUGS AND DEVICES.

    (a) In General.--Section 502(w) (21 U.S.C. 352(w)) is amended--
            (1) in subparagraph (1), by striking ``; or'' and inserting 
        ``;'';
            (2) in subparagraph (2), by striking the period and 
        inserting ``; or''; and
            (3) by adding at the end the following:
            ``(3) for which an application has been approved under 
        section 512 and the labeling of such drug does not include the 
        application number in the format: `Approved by FDA under 
        (A)NADA # xxx-xxx', except that this subparagraph shall not 
        apply to representative labeling required under section 
        514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or 
        any successor regulation) for animal feed bearing or containing 
        a new animal drug.''.
    (b) Applicability.--Section 502(w)(3) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), shall apply beginning on 
September 30, 2023.

SEC. 304. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS.

    (a) In General.--Section 571 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ccc) is amended--
            (1) in the section heading, by striking ``species'' and 
        inserting ``species and certain new animal drugs'';
            (2) in subsection (a)--
                    (A) by amending paragraph (1) to read as follows:
    ``(1)(A) Except as provided in paragraph (3), any person may file 
with the Secretary an application for conditional approval of--
            ``(i) a new animal drug intended for a minor use or a minor 
        species; or
            ``(ii) a new animal drug not intended for a minor use or 
        minor species--
                    ``(I) that is intended to treat a serious or life-
                threatening disease or condition or addresses an unmet 
                animal or human health need; and
                    ``(II) for which the Secretary determines that a 
                demonstration of effectiveness would require a complex 
                or particularly difficult study or studies.
    ``(B) The Secretary shall, not later than September 30, 2019, issue 
guidance or regulations further clarifying the criteria specified in 
subparagraph (A)(ii).
    ``(C) An application under this paragraph shall comply in all 
respects with the provisions of section 512 except for subsections 
(a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of 
such section unless otherwise stated in this section, and any 
additional provisions of this section.
    ``(D) New animal drugs for which conditional approval is sought 
under this section are subject to the same safety standards that would 
be applied to new animal drugs under section 512(d) (including, for 
antimicrobial new animal drugs, with respect to antimicrobial 
resistance).''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (B), by striking ``, 
                        or'' and inserting ``; or'';
                            (ii) by redesignating subparagraphs (A), 
                        (B), and (C) as clauses (i), (ii), and (iii), 
                        respectively;
                            (iii) by striking ``A person may not file'' 
                        and inserting ``(A) A person may not file''; 
                        and
                            (iv) by adding at the end the following new 
                        subparagraph:
    ``(B) A person may not file an application under paragraph 
(1)(A)(ii) if the application seeks conditional approval of a new 
animal drug that contains an antimicrobial active ingredient.'';
            (3) in subsection (f)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by inserting ``for the conditionally 
                approved use'' after ``shall''; and
                    (B) in paragraph (2)--
                            (i) by striking ``An intended use'' and 
                        inserting ``The Secretary shall, through 
                        regulation or guidance, determine under what 
                        conditions an intended use''; and
                            (ii) by striking ``shall not'' and 
                        inserting ``may''; and
            (4) by adding at the end the following new subsection:
    ``(k) Sunset.--
            ``(1) The Secretary's authority to grant conditional 
        approval of new animal drugs not intended for a minor use or 
        minor species pursuant to subsection (a)(1)(A)(ii) terminates 
        on October 1, 2028.
            ``(2) The Secretary--
                    ``(A) may not accept any new applications for such 
                conditional approval pursuant to subsection 
                (a)(1)(A)(ii) on or after such date; and
                    ``(B) may continue all activities under this 
                section with respect to drugs that were conditionally 
                approved pursuant to (a)(1)(A)(ii) prior to such date.
            ``(3) The Secretary may, until October 1, 2032, accept 
        applications for approval under 512 of drugs conditionally 
        approved pursuant to (a)(1)(A)(ii).''.
    (b) Exception From Fees in Case of Certain Previously Submitted 
Applications for Conditional Approval.--Section 740(a)(1)(C) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(C)) is 
amended--
            (1) in the caption by striking ``Exception'' and inserting 
        ``Exceptions'';
            (2) by striking ``If an animal drug'' and inserting the 
        following:
                            ``(i) If an animal drug''; and
            (3) by inserting after clause (i), as so designated, the 
        following new clause:
                            ``(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).''.
    (c) Report on Incorporating Veterinary Oversight.--Not later than 
September 30, 2019, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall submit a report to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor and Pensions of the 
Senate identifying how the Food and Drug Administration will 
incorporate veterinary oversight for all approved medically important 
antimicrobial drugs administered to animals that are not yet subject to 
veterinary oversight. Such report shall address requirements related to 
revisions of labeling to reflect that medically important antimicrobial 
drugs administered to animals shall be subject to veterinary oversight.
    (d) GAO Study of Conditional Approval Programs.--
            (1) Study.--The Comptroller General of the United States 
        (referred to in this section as the ``Comptroller General'') 
        shall conduct a study on the effectiveness and overall impact 
        of the conditional approval pathway under section 571 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc).
            (2) Issuance of report.--Not later than January 1, 2026, 
        the Comptroller General shall 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 containing the results of the study 
        under paragraph (1).
            (3) Contents of reports.--The report submitted under 
        paragraph (2) shall address--
                    (A) for each drug for which a conditional approval 
                has been awarded since October 1, 2018--
                            (i) whether the drug was granted 
                        conditional approval pursuant to clause (i) or 
                        (ii) of section 571(a)(1)(A) of the Federal 
                        Food, Drug, and Cosmetic Act, as amended by 
                        subsection (a);
                            (ii) whether the drug was dual labeled 
                        during its conditional approval;
                            (iii) the indications for which the drug 
                        was granted conditional approval under section 
                        571 of such Act (21 U.S.C. 360ccc) and whether 
                        the drug was approved or not approved under 
                        section 512 of such Act (21 U.S.C. 360b);
                            (iv) the number of years the drug was so 
                        conditionally approved and a description of the 
                        complexity of the investigation to demonstrate 
                        the drug's effectiveness;
                            (v) whether, and to what extent, the 
                        conditional approval pathway under such section 
                        571 (21 U.S.C. 360ccc) impacted the sponsor's 
                        decision to develop the drug or seek approval 
                        of the drug under section 512 of such Act (21 
                        U.S.C. 360b);
                            (vi) whether, and to what extent, 
                        conditional approval pursuant to clause (ii) of 
                        section 571(a)(1)(A) of such Act (21 U.S.C. 
                        360b(a)(1)(A)) addressed a serious or life-
                        threatening condition; and
                            (vii) whether, and to what extent, 
                        conditional approval pursuant to clause (ii) of 
                        section 571(a)(1)(A) of such Act (21 U.S.C. 
                        360b(a)(1)(A)) addressed an unmet animal or 
                        human health need, and whether before such 
                        conditional approval there were available 
                        therapies for the disease or condition 
                        involved;
                    (B) an analysis of the conditional approval program 
                under section 571 of such Act (21 U.S.C. 360ccc), 
                including--
                            (i) the resources used by the Food and Drug 
                        Administration in reviewing applications for 
                        conditional approval of drugs pursuant to such 
                        program and renewal of such conditional 
                        approval, including the effects of the program 
                        on the Food and Drug Administration's review of 
                        animal drugs for which conditional approval is 
                        not used;
                            (ii) whether any improvements to the 
                        program under section 512 of such Act (21 
                        U.S.C. 360b) are necessary to incentivize the 
                        development of animal drugs that would likely 
                        not otherwise be developed, or developed in as 
                        timely a manner, to address--
                                    (I) serious or life-threatening 
                                conditions; and
                                    (II) an unmet animal or human 
                                health need; and
                            (iii) whether the conditional approval 
                        pathway has resulted in a greater number of 
                        animal drugs approved under section 512 of such 
                        Act (21 U.S.C. 360b) for serious or life-
                        threatening conditions or unmet animal or human 
                        health needs than would have otherwise come to 
                        market under the practices and commitments of 
                        the Center for Veterinary Medicine of the Food 
                        and Drug Administration as such practices and 
                        commitments existed as of the day before the 
                        date of enactment of this Act; and
                    (C) how the Center for Veterinary Medicine of the 
                Food and Drug Administration has utilized complex 
                adaptive or other novel investigation designs, data 
                from foreign countries, real-world evidence (including 
                ongoing surveillance activities, observational studies, 
                and registry data), biomarkers, or surrogate 
                endpoints--
                            (i) to support the approval of products 
                        under section 512 of such Act (21 U.S.C. 360b), 
                        including how many such products have been 
                        approved since October 1, 2018; and
                            (ii) to support the approval of products 
                        under section 512 of such Act (21 U.S.C. 360b) 
                        that received conditional approval under 
                        section 571 of such Act (21 U.S.C. 360ccc), 
                        including how many such products have been 
                        approved since October 1, 2018.

SEC. 305. GUIDANCE ADDRESSING INVESTIGATION DESIGNS.

    (a) In General.--For purposes of assisting sponsors in 
incorporating complex adaptive and other novel investigation designs, 
data from foreign countries, real world evidence (including ongoing 
surveillance activities, observational studies, and registry data), 
biomarkers, and surrogate endpoints (referred to in this section as 
``elements of investigations'') into proposed clinical investigation 
protocols and applications for new animal drugs under sections 512 and 
571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 
360ccc), the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall issue guidance addressing the 
use of such elements of investigations in the development and 
regulatory review of such new animal drugs.
    (b) Contents.--The guidance under subsection (a) shall address how 
the Secretary will evaluate the elements of investigations proposed or 
submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, 
and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) 
of such Act, and how sponsors of such applications may obtain feedback 
from the Secretary on technical issues related to such investigations 
prior to the submission of an application to the Secretary.
    (c) Meeting.--Prior to issuing the guidance under subsection (a), 
the Secretary shall consult with stakeholders, including 
representatives of regulated industry, consumer groups, academia, 
veterinarians, and food producers, through a public meeting to be held 
not later than 1 year after the date of enactment of this Act.
    (d) Timing.--The Secretary shall issue a draft guidance under 
subsection (a) not later than 1 year after the date of the public 
meeting under subsection (c), and shall finalize such guidance not 
later than 1 year after the date on which the public comment period on 
such draft guidance ends.

SEC. 306. FOOD ADDITIVES INTENDED FOR USE IN ANIMAL FOOD.

    (a) Food Additive Petitions for Animal Food.--Section 409 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by 
adding at the end the following:
    ``(k) Food Additives Intended for Use in Animal Food.--(1) In 
taking action on a petition under subsection (c) for, or for 
recognition of, a food additive intended for use in animal food, the 
Secretary shall review reports of investigations conducted in foreign 
countries, provided by the petitioner.
    ``(2) Not later than 12 months after the date of enactment of the 
Animal Drug and Animal Generic Drug Use Fee Amendments of 2018, the 
Secretary shall post on the internet website of the Food and Drug 
Administration--
            ``(A) the number of petitions for food additives intended 
        for use in animal food filed under subsection (b) that are 
        pending;
            ``(B) how long each such petition submitted under 
        subsection (b) has been pending, including such petitions the 
        Secretary has extended under subsection (c)(2); and
            ``(C) the number of study protocols that have been pending 
        review for over 50 days, and the number that have received an 
        extension.
    ``(3) In the case of a food additive petition intended for use in 
animal food, the Secretary shall provide information to the petitioner 
on the required contents of such petition. If the Secretary requires 
additional studies beyond what the petitioner proposed, the Secretary 
shall provide the scientific rationale for such requirement.''.
    (b) Ensuring the Safety of Pet Food.--Section 1002(a) of the Food 
and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is 
amended--
            (1) by striking paragraph (1); and
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (1) and (2), respectively.
    (c) Guidance on Pre-Petition Consultation Process for Animal Food 
Additives.--
            (1) In general.--Not later than 18 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this subsection as the ``Secretary'') 
        shall publish draft guidance relating to the voluntary pre-
        petition consultation process for food additives intended for 
        use in animal food.
            (2) Contents.--The guidance under paragraph (1) shall 
        include--
                    (A) the recommended format to submit to the Food 
                and Drug Administration existing data, including any 
                applicable foreign data, for assessment prior to 
                submission of a food additive petition for animal food 
                under section 409(b) of the Federal Food, Drug, and 
                Cosmetic Act;
                    (B) the manner and the number of days by which the 
                Food and Drug Administration intends to review and 
                respond to such existing data, including with respect 
                to providing a scientific rationale for any additional 
                data request;
                    (C) circumstances under which the submission of 
                study protocols is recommended prior to submission of a 
                food additive petition under such section 409(b);
                    (D) the manner in which the Secretary intends to 
                inform the person submitting a study protocol for a 
                food additive if the review of such study protocol will 
                take longer than 50 days; and
                    (E) best practices for communication between the 
                Food and Drug Administration and industry on the 
                development of pre-petition submissions of study 
                protocols and existing data for food additives.
            (3) Final guidance.--The guidance under paragraph (1) shall 
        be finalized, withdrawn, or reissued not later than 1 year 
        after the close of the comment period on the draft guidance.

            Passed the House of Representatives July 16, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5554

_______________________________________________________________________

                                 AN ACT

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