[Congressional Record Volume 164, Number 119 (Monday, July 16, 2018)]
[House]
[Pages H6237-H6242]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
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.
____________________