[115th Congress Public Law 234]
[From the U.S. Government Publishing Office]



[[Page 132 STAT. 2427]]

Public Law 115-234
115th Congress

                                 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. <<NOTE: Aug. 14, 2018 -  [H.R. 5554]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Animal Drug and 
Animal Generic Drug User Fee Amendments of 2018.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>>  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. <<NOTE: 21 USC 301 note.>>  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.).

[[Page 132 STAT. 2428]]

   TITLE I-- <<NOTE: Animal Drug User Fee Amendments of 2018.>> FEES 
RELATING TO ANIMAL DRUGS
SEC. 101. <<NOTE: 21 USC 301 note.>>  SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Animal Drug User 
Fee Amendments of 2018''.
    (b) Finding.-- <<NOTE: 21 USC 379j-11 note.>> 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)--

[[Page 132 STAT. 2429]]

                          (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) <<NOTE: Determination.>>  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) <<NOTE: Federal Register, 
                      publication.>>  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''.

[[Page 132 STAT. 2430]]

    (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) <<NOTE: Deadline.>>  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

[[Page 132 STAT. 2431]]

                      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. <<NOTE: Time period. 21 USC 379j-11 note.>>  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.

[[Page 132 STAT. 2432]]

SEC. 106. <<NOTE: 21 USC 379j-11 note.>>  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.-- <<NOTE: 21 USC 379j-12 note.>> 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.-- <<NOTE: 21 USC 379j-13 note.>> 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) <<NOTE: Repeals. 21 USC 379j-12 note.>>  Previous Sunset 
Provision.-- <<NOTE: Animal Generic Drug User Fee Amendments of 
2018.>> 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-- <<NOTE: Animal Generic Drug User Fee Amendments of 
2018.>> FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.

    (a) Short Title.-- <<NOTE: 21 USC 301 note.>> This title may be 
cited as the ``Animal Generic Drug User Fee Amendments of 2018''.

    (b) Finding.-- <<NOTE: 21 USC 379j-21 note.>> 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);

[[Page 132 STAT. 2433]]

                    ``(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.-- <<NOTE: Notice. Federal 
                Register, publication.>> 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

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                drugs, subject to subparagraphs (B) and (C). With 
                respect to such adjustment--
                          ``(i) <<NOTE: Determination.>>  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) <<NOTE: Federal Register, 
                      publication.>>  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) <<NOTE: Deadline.>> 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:

[[Page 132 STAT. 2435]]

            ``(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. <<NOTE: Time period. 21 USC 379j-21 note.>>  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. <<NOTE: 21 USC 379j-21 note.>>  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.-- <<NOTE: 21 USC 379j-21 note.>> 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.-- <<NOTE: 21 USC 379j-22 note.>> 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) <<NOTE: Repeals. 21 USC 379j-21 note.>>  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.

[[Page 132 STAT. 2436]]

                   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) <<NOTE: Effective date.>>  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) <<NOTE: Effective date.>>  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.

<<NOTE: Effective date. 21 USC 360ccc-1 note.>>     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.-- <<NOTE: Effective date. 21 USC 352 
note.>> 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'';

[[Page 132 STAT. 2437]]

            (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) <<NOTE: Deadline. Guidance. Regulations.>>  The Secretary 
shall, not later than September 30, 2019, issue guidance or regulations 
further clarifying the criteria specified in subparagraph (A)(ii).

    ``(C) <<NOTE: Compliance.>>  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) <<NOTE: Regulations. Guidance. Determination.>> 
                       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--

[[Page 132 STAT. 2438]]

                    ``(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) <<NOTE: Deadline.>>  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) <<NOTE: Effective date.>>  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--

[[Page 132 STAT. 2439]]

                    (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) <<NOTE: Analysis.>>  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

[[Page 132 STAT. 2440]]

                      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. <<NOTE: 21 USC 360b note.>>  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.-- <<NOTE: Consultation. Deadline.>> 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.-- <<NOTE: Deadlines.>> 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

[[Page 132 STAT. 2441]]

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) <<NOTE: Deadline. Web posting.>>  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) <<NOTE: Deadlines. 21 USC 348 note.>>  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

[[Page 132 STAT. 2442]]

                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.

    Approved August 14, 2018.

LEGISLATIVE HISTORY--H.R. 5554 (S. 2434):
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 164 (2018):
            July 16, considered and passed House.
            July 31, considered and passed Senate.

                                  <all>