ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018; Congressional Record Vol. 164, No. 119
(House of Representatives - July 16, 2018)

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    ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018

  Mr. MULLIN. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5554) to amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize user fee programs relating to new animal drugs and generic 
new animal drugs, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5554

       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

[[Page H6238]]

       (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

[[Page H6239]]

     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 three 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 three 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 three 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 three 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--

[[Page H6240]]

       (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)

[[Page H6241]]

     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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Oklahoma (Mr. Mullin) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Oklahoma.


                             General Leave

  Mr. MULLIN. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Oklahoma?
  There was no objection.
  Mr. MULLIN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I am proud of this legislation to reauthorize the Animal 
Drug User Fee Act, ADUFA, which will continue agreements between the 
FDA and the animal drug industry to pay user fees that will help speed 
the approval of new drugs.
  Farmers, ranchers, families, and veterinarians need ADUFA so they can 
keep their animals and pets safe and healthy.
  In the rural and agricultural communities across the country, 
including my home State of Oklahoma, ADUFA is critical to farmers, 
ranchers, and all American consumers. These animals are a major food 
source for our communities and our families, so it is vitally important 
that we move quickly today and reauthorize ADUFA.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.


 =========================== NOTE =========================== 

  
  July 16, 2018, on page H6241, the following appeared: Mr. GREEN 
of Texas. Mr. Speaker, I yield myself such time as I may consume.
  
  The online version has been corrected to read: Mr. GENE GREEN of 
Texas. Mr. Speaker, I yield myself such time as I may consume.


 ========================= END NOTE ========================= 

  Mr. Speaker, I rise in support of H.R. 5554, the Animal Drug and 
Animal Generic Drug User Fee Amendments of 2018.
  This bill reauthorizes the Food and Drug Administration's animal drug 
and animal generic drug user fee programs and ensures that the FDA 
continues to have the tools it needs to approve animal drugs to help 
our pets and livestock live healthier lives.
  Mr. Speaker, I include in the Record the remainder of my statement.
  Mr. Speaker, I rise in support of H.R. 5554, the Animal Drug and 
Animal Generic Drug User Fee Amendments of 2018.
  This bill reauthorizes the Food and Drug Administration's Animal Drug 
and Animal Generic Drug User Fee Programs and ensures the FDA continues 
to have the tools it needs to approve animal drugs to help our pets and 
livestock live healthier lives.
  This legislation reauthorizes the FDA's authority to collect user 
fees from the animal drug and generic animal drug industries for 
additional five years and reflects bipartisan agreement and 
recommendations negotiated between the FDA and the animal drug industry 
with input from farmers and ranchers, veterinarians, food and feed 
producers, and other public health stakeholders.
  These critical user fee agreements have helped to accelerate the 
development of animal drugs, reduce application review times at the 
FDA, and create a more predictable and streamlined process for getting 
animal drugs to market.
  It is critical that we pass H.R. 5554 today as the current 
authorization for these programs will expire on September 30th of this 
year. If ADUFA and AGDUFA are not reauthorized by the deadline, the FDA 
will lack the resources and subject matter experts it needs to do this 
important work.
  This will be the fourth reauthorization of ADUFA and the third 
reauthorization of AGDUFA. These user fee programs have proven to be 
highly successful and allow the Center for Veterinary Medicine at FDA 
to meet and exceed its performance goals.
  The FDA's gold standard for safety and efficacy extends beyond 
products just for humans, but also for animal drugs. Safe and effective 
animal medications, as approved by FDA, protect our companion animals 
and keep our food supply safe. Reauthorizing ADUFA and AGDUFA ensures 
this continues.
  As a result of our bipartisan compromise, this bill also creates a 
conditional approval pathway for certain new animal drugs that are 
intended to treat a serious or life-threatening disease or condition or 
address an unmet health need for which ongoing efficacy studies are 
complex or particularly difficult. I am

[[Page H6242]]

pleased we have reached consensus on this policy and that the provision 
includes a 10-year sunset.
  The Energy and Commerce Committee has worked in a strong bipartisan 
fashion to move this bill forward. I commend my colleagues, Rep. Kurt 
Schrader and Rep. Markwayne Mullin, for introducing this important 
legislation and advancing it for floor consideration.
  I urge my colleagues to join me and vote in support of the Animal 
Drug and Animal Generic Drug User Fee Amendments of 2018.
  Mr. Speaker, I reserve the balance of my time.
  Mr. MULLIN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Texas (Mr. Burgess), the chairman.
  Mr. BURGESS. Mr. Speaker, I thank the gentleman for yielding.
  Mr. Speaker, I rise to speak in support of this critical bill to 
reauthorize the Animal Drug User Fee Act and the Animal Generic Drug 
User Fee Act for an additional 5 years. Among other things, these user 
fees provide critical resources to the Food and Drug Administration's 
Center for Veterinary Medicine to ensure efficient and timely review of 
animal drug applications, quality assurance measures for animal feed, 
and surveillance of the safety and efficacy of animal drugs on the 
market.
  In addition to reauthorizing these user fee programs, this 
legislation also includes new authority to facilitate greater 
innovation in the animal drug space.
  Mr. Speaker, these user fee programs must be reauthorized by 
September 30 to avoid a major disruption of the operations of the 
Center for Veterinary Medicine. The clock is ticking. The agency must 
start sending pink slips to employees 60 calendar days before the end 
of the fiscal year. That is the end of this month.
  We are talking about real consequences for animal health and for the 
American people. House passage of this bill today is an important step, 
and I urge the Senate to do its work and promptly take up and pass this 
bill so that President Trump can sign it into law. I thank the 
gentleman for the recognition.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield 1\1/2\ minutes to the 
gentleman from Oregon (Mr. Schrader), our colleague from the Energy and 
Commerce Committee.


 =========================== NOTE =========================== 

  
  July 16, 2018, on page H6242, the following appeared: Mr. GREEN 
of Texas. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman 
from Oregon (Mr. Schrader), our colleague from the Energy and 
Commerce Committee.
  
  The online version has been corrected to read: Mr. GENE GREEN of 
Texas. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from 
Oregon (Mr. Schrader), our colleague from the Energy and Commerce 
Committee.


 ========================= END NOTE ========================= 

  Mr. SCHRADER. Mr. Speaker, H.R. 5554 is a bipartisan bill to 
reauthorize the animal drug and animal generic drug user fee programs, 
and I am proud to lead it with my colleague, Mr. Mullin.
  ADUFA and AGDUFA are crucial to FDA's work to review and approve 
applications for animal drugs. Over the past several years, animal drug 
user fee programs have streamlined the approval process for 
pharmaceuticals and eliminated the FDA's application backlog, reduced 
review times, and created a more predictable process.
  As a veterinarian from Oregon, I am particularly grateful to see this 
bill come to the floor. I am acutely aware of the great innovations 
that are occurring in the human health sphere, and I want to ensure our 
four-footed friends also have access to the latest and greatest medical 
innovations. That is why I am particularly pleased with this bill and 
its language to expand conditional approval for animal drugs with major 
uses in major species.

                              {time}  1830

  Conditional approval is a careful, deliberative process based on 
similar pathways for drugs for minor uses and minor species that was 
already established in 2004.
  Conditional approval is critical for veterinary medicine since it is 
not cost-effective for drug companies to pursue large, complete 
clinical trials, given the small population of intended beneficiaries, 
without some initial interest and success under the conditional 
approval program.
  Before being conditionally approved, drugs must demonstrate a 
reasonable expectation of effectiveness and meet every other FDA 
standard for approval, including safety. They still need to get 
complete FDA approval within 5 years and must apply for annual renewal.
  I thank Chairman Walden; Ranking Member Pallone; Mr. Green; my 
colleague from North Carolina (Mr. Hudson), who worked very hard on the 
bill; and certainly Mr. Mullin for his partnership in leading this way.
  Mr. Speaker, I urge my colleagues to support this important bill.
  Mr. GENE GREEN of Texas. Mr. Speaker, I have no further speakers, and 
I yield back the balance of my time.
  Mr. MULLIN. Mr. Speaker, I thank my colleagues on both sides of the 
aisle for their bipartisan approach, and I urge a ``yes'' vote from all 
my colleagues.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BUTTERFIELD. Mr. Speaker, I rise in support of H.R. 5554, the 
Animal Drug and Animal Generic Drug User Fee Act of 2018. These user 
fee agreements are important to millions of North Carolinians living 
with companion animals. They are also important to the agricultural 
community. Some of you may not be aware that North Carolina is the 
second largest pork producer, the second largest turkey producer, and 
the third largest poultry producer in the country. Our agricultural 
community and family farms are essential to feeding our nation and they 
depend on medicines to keep animals healthy.
  I am pleased that the final legislation includes language that I have 
worked on with my colleagues including Representatives Hudson and 
Schrader to enable conditional approval of innovative veterinary drugs 
that have been demonstrated to be safe to use and have a reasonable 
expectation of effectiveness. The FDA already has this authority for 
unmet medical needs in minor uses and minor species, and this expanded 
authority can help improve protections for animal and human health.
  This legislation must be passed before Congress adjourns for August 
or the FDA will be required to halt the programs. I urge my colleagues 
to support this important legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Oklahoma (Mr. Mullin) that the House suspend the rules 
and pass the bill, H.R. 5554, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________