[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5554 Enrolled Bill (ENR)]
H.R.5554
One Hundred Fifteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, two thousand and eighteen
An Act
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug and Animal Generic Drug
User Fee Amendments of 2018''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
TITLE I--FEES RELATING TO ANIMAL DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
TITLE III--MISCELLANEOUS PROVISIONS
Sec. 301. Electronic submissions.
Sec. 302. Index of legally marketed unapproved new animal drugs for
minor species.
Sec. 303. Misbranded drugs and devices.
Sec. 304. Conditional approval of new animal drugs.
Sec. 305. Guidance addressing investigation designs.
Sec. 306. Food additives intended for use in animal food.
(b) References in Act.--Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments
to such section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE I--FEES RELATING TO ANIMAL DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Drug User
Fee Amendments of 2018''.
(b) Finding.--Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
animal drug development process and the review of new and supplemental
animal drug applications and investigational animal drug submissions as
set forth in the goals identified for purposes of part 4 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Energy and Commerce of the House of Representatives
and the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate as set forth in the Congressional Record.
SEC. 102. DEFINITIONS.
Section 739 (21 U.S.C. 379j-11) is amended--
(1) by amending paragraph (1) to read as follows:
``(1)(A) The term `animal drug application' means--
``(i) an application for approval of any new animal drug
submitted under section 512(b)(1); or
``(ii) an application for conditional approval of a new
animal drug submitted under section 571.
``(B) Such term does not include either a new animal drug
application submitted under section 512(b)(2) or a supplemental
animal drug application.''; and
(2) in paragraph (8), by adding at the end the following:
``(I) The activities necessary for implementation of the
United States and European Union Good Manufacturing Practice
Mutual Inspection Agreement with respect to animal drug
products subject to review, including implementation activities
prior to and following product approval.''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Fee Revenue Amounts.--Section 740(b) (21 U.S.C. 379j-12(b)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2014'' and inserting ``2019''; and
(ii) by striking ``$23,600,000'' and inserting
``$30,331,240''; and
(B) in subparagraph (B)--
(i) by striking ``2015 through 2018'' and inserting
``2020 through 2023''; and
(ii) by striking ``$21,600,000'' and inserting
``$29,931,240''; and
(2) in paragraph (2), in the matter preceding subparagraph (A),
by striking ``determined'' and inserting ``established''.
(b) Annual Fee Setting; Adjustments.--
(1) Inflation adjustment.--Section 740(c)(2) (21 U.S.C. 379j-
12(c)(2)) is amended--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``For fiscal year 2015'' and inserting
``(A) For fiscal year 2020''; and
(ii) by inserting ``multiplying such revenue amounts
by'' before ``an amount'';
(B) by redesignating subparagraphs (A), (B), and (C) as
clauses (i), (ii), and (iii), respectively;
(C) by striking the flush text at the end; and
(D) by adding at the end the following new subparagraph:
``(B) Compounded basis.--The adjustment made each fiscal year
after fiscal year 2020 under this paragraph shall be applied on a
compounded basis to the revenue amount calculated under this
paragraph for the most recent previous fiscal year.''.
(2) Workload adjustments.--Paragraph (3) of section 740(c) (21
U.S.C. 379j-12(c)) is amended to read as follows:
``(3) Workload adjustments.--
``(A) In general.--For fiscal year 2020 and subsequent
fiscal years, after the fee revenue amounts established under
subsection (b) are adjusted for inflation in accordance with
paragraph (2), the fee revenue amounts shall be further
adjusted for such fiscal year to reflect changes in the
workload of the Secretary for the process for the review of
animal drug applications, subject to subparagraphs (B) and (C).
With respect to such adjustment--
``(i) such adjustment shall be determined by the
Secretary based on a weighted average of the change in the
total number of animal drug applications, supplemental
animal drug applications for which data with respect to
safety or effectiveness are required, manufacturing
supplemental animal drug applications, investigational
animal drug study submissions, and investigational animal
drug protocol submissions submitted to the Secretary; and
``(ii) the Secretary shall publish in the Federal
Register the fees resulting from such adjustment and the
supporting methodologies.
``(B) Reduction of workload-based increase by amount of
certain excess collections.--For each of fiscal years 2021
through 2023, if application of the workload adjustment under
subparagraph (A) increases the fee revenue amounts otherwise
established for the fiscal year under subsection (b), as
adjusted for inflation under paragraph (2), such fee revenue
increase shall be reduced by the amount of any excess
collections, as described in subsection (g)(4), for the second
preceding fiscal year, up to the amount of such fee revenue
increase.
``(C) Rule of application.--Under no circumstances shall
the workload adjustments under this paragraph result in fee
revenues for a fiscal year that are less than the fee revenues
for that fiscal year established under subsection (b), as
adjusted for inflation under paragraph (2).''.
(3) Final year adjustment.--Section 740(c)(4) (21 U.S.C. 379j-
12(c)(4)) is amended--
(A) by striking ``2018'' each place it appears and
inserting ``2023''; and
(B) by striking ``2019'' and inserting ``2024''.
(c) Exemptions From Fees.--Section 740(d) (21 U.S.C. 379j-12(d)) is
amended--
(1) in the subsection heading, by inserting ``; Exemptions From
Fees'' after ``Reduction'';
(2) by striking the heading of paragraph (1) and inserting
``Waiver or reduction''; and
(3) by adding at the end the following:
``(4) Exemptions from fees.--
``(A) Certain labeling supplements to add number of
approved application.--Fees under this section shall not apply
with respect to any person who--
``(i) not later than September 30, 2023, submits a
supplemental animal drug application relating to a new
animal drug application approved under section 512, solely
to add the new animal drug application number to the
labeling of the drug in the manner specified in section
502(w)(3); and
``(ii) otherwise would be subject to fees under this
section solely on the basis of such supplemental
application.
``(B) Certain animal drug applications.--Fees under
paragraphs (2), (3), and (4) of subsection (a) shall not apply
with respect to any person who is the named applicant or
sponsor of an animal drug application, supplemental animal drug
application, or investigational animal drug submission if such
application or submission involves the intentional genomic
alteration of an animal that is intended to produce a drug,
device, or biological product subject to fees under section
736, 738, 744B, or 744H.''.
(d) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 740(g)(3) (21
U.S.C. 379j-12(g)(3)) is amended--
(A) by striking ``2014 through 2018'' and inserting ``2019
through 2023'';
(B) by striking ``determined'' and inserting
``established''; and
(C) by striking ``paragraph (4)'' and inserting ``paragraph
(5)''.
(2) Excess collections.--Section 740(g) (21 U.S.C. 379j-12(g))
is amended by striking paragraph (4) and inserting the following:
``(4) Excess collections.--If the sum total of fees collected
under this section for a fiscal year exceeds the amount of fees
authorized to be appropriated for such year under paragraph (3),
the excess collections shall be credited to the appropriations
account of the Food and Drug Administration as provided in
paragraph (1).
``(5) Recovery of collection shortfalls.--
``(A) In general.--Subject to subparagraph (B)--
``(i) for fiscal year 2021, the amount of fees
otherwise authorized to be collected under this section
shall be increased by the amount, if any, by which the
amount collected under this section and appropriated for
fiscal year 2019 falls below the amount of fees authorized
for fiscal year 2019 under paragraph (3);
``(ii) for fiscal year 2022, the amount of fees
otherwise authorized to be collected under this section
shall be increased by the amount, if any, by which the
amount collected under this section and appropriated for
fiscal year 2020 falls below the amount of fees authorized
for fiscal year 2020 under paragraph (3); and
``(iii) for fiscal year 2023, the amount of fees
otherwise authorized to be collected under this section
shall be increased by the cumulative amount, if any, by
which the amount collected under this section and
appropriated for fiscal years 2021 and 2022 (including
estimated collections for fiscal year 2022) falls below the
cumulative amount of fees authorized for such fiscal years
under paragraph (3).
``(B) Reduction of shortfall-based fee increase by prior
year excess collections.--
``(i) In general.--Subject to clause (ii), the
Secretary shall, in such manner as the Secretary determines
appropriate, reduce any fee increase otherwise applicable
for a fiscal year under subparagraph (A) by the amount of
any excess collections under this section for preceding
fiscal years (after fiscal year 2018).
``(ii) Workload-based fee accounting.--In applying
clause (i), the Secretary shall account for the reduction
of workload-based fee revenue increases by excess
collections under subsection (c)(3)(B), in such manner as
needed to provide that no portion of any excess collections
described in clause (i) is applied for purposes of reducing
fee increases under both such subsection (c)(3)(B) and this
paragraph.
``(C) Rule of application.--Under no circumstances shall
adjustments under this paragraph result in fee revenues for a
fiscal year that are less than the fee revenues for that fiscal
year established in subsection (b), as adjusted or otherwise
affected under subsection (c).''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A (21 U.S.C. 379j-13) is amended--
(1) in subsection (a), by striking ``2013'' and inserting
``2018'';
(2) by striking ``2014'' each place it appears in subsections
(a) and (b) and inserting ``2019''; and
(3) in subsection (d), by striking ``2018'' each place it
appears and inserting ``2023''.
SEC. 105. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of
enactment of this title, shall continue to be in effect with respect to
animal drug applications and supplemental animal drug applications (as
defined in such part as of such day) that on or after October 1, 2013,
but before October 1, 2018, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2019.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2018, or the date of the enactment of this Act, whichever is later,
except that fees under part 4 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as amended by this title, shall
be assessed for animal drug applications and supplemental animal drug
applications received on or after October 1, 2018, regardless of the
date of the enactment of this Act.
SEC. 107. SUNSET DATES.
(a) Authorization.--Section 740 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-12) shall cease to be effective October 1,
2023.
(b) Reporting Requirements.--Section 740A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-13) shall cease to be effective
January 31, 2024.
(c) Previous Sunset Provision.--Effective October 1, 2018,
subsections (a) and (b) of section 107 of the Animal Drug User Fee
Amendments of 2013 (Public Law 113-14) are repealed.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Generic
Drug User Fee Amendments of 2018''.
(b) Finding.--Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
generic new animal drug development process and the review of
abbreviated applications for generic new animal drugs, supplemental
abbreviated applications for generic new animal drugs, and
investigational submissions for generic new animal drugs as set forth
in the goals identified for purposes of part 5 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
from the Secretary of Health and Human Services to the Chairman of the
Committee on Energy and Commerce of the House of Representatives and
the Chairman of the Committee on Health, Education, Labor and Pensions
of the Senate as set forth in the Congressional Record.
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
(a) Fee Revenue Amounts.--Subsection (b) of section 741 (21 U.S.C.
379j-21) is amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--Subject to subsections (c), (d), (f), and
(g), for each of fiscal years 2019 through 2023, the fees required
under subsection (a) shall be established to generate a total
revenue amount of $18,336,340.
``(2) Types of fees.--Of the total revenue amount established
for a fiscal year under paragraph (1)--
``(A) 25 percent shall be derived from fees under
subsection (a)(1) (relating to abbreviated applications for a
generic new animal drug);
``(B) 37.5 percent shall be derived from fees under
subsection (a)(2) (relating to generic new animal drug
products); and
``(C) 37.5 percent shall be derived from fees under
subsection (a)(3) (relating to generic new animal drug
sponsors).''.
(b) Annual Fee Setting; Adjustments.--
(1) Inflation adjustment.--Section 741(c) (21 U.S.C. 379j-
21(c)) is amended--
(A) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Inflation adjustment.--
``(A) In general.--For fiscal year 2020 and subsequent
fiscal years, the revenue amounts established under subsection
(b) shall be adjusted by the Secretary by notice, published in
the Federal Register, for a fiscal year, by multiplying such
revenue amounts by an amount equal to the sum of--
``(i) one;
``(ii) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 of the
preceding 4 fiscal years for which data are available,
multiplied by the average proportion of personnel
compensation and benefits costs to total Food and Drug
Administration costs for the first 3 of the preceding 4
fiscal years for which data are available; and
``(iii) the average annual percent change that occurred
in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally
adjusted; all items less food and energy; annual index) for
the first 3 of the preceding 4 years for which data are
available multiplied by the average proportion of all costs
other than personnel compensation and benefits costs to
total Food and Drug Administration costs for the first 3 of
the preceding 4 fiscal years for which data are available.
``(B) Compounded basis.--The adjustment made each fiscal
year after fiscal year 2020 under this paragraph shall be
applied on a compounded basis to the revenue amount calculated
under this paragraph for the most recent previous fiscal
year.''.
(2) Workload adjustments.--Paragraph (3) of section 741(c) (21
U.S.C. 379j-21(c)), as redesignated, is amended to read as follows:
``(3) Workload adjustments.--
``(A) In general.--For fiscal year 2020 and subsequent
fiscal years, after the fee revenue amounts established under
subsection (b) are adjusted for inflation in accordance with
paragraph (2), the fee revenue amounts shall be further
adjusted for each such fiscal year to reflect changes in the
workload of the Secretary for the process for the review of
abbreviated applications for generic new animal drugs, subject
to subparagraphs (B) and (C). With respect to such adjustment--
``(i) this adjustment shall be determined by the
Secretary based on a weighted average of the change in the
total number of abbreviated applications for generic new
animal drugs, manufacturing supplemental abbreviated
applications for generic new animal drugs, investigational
generic new animal drug study submissions, and
investigational generic new animal drug protocol
submissions submitted to the Secretary; and
``(ii) the Secretary shall publish in the Federal
Register the fees resulting from this adjustment and the
supporting methodologies.
``(B) Reduction of workload-based increase by amount of
certain excess collections.--For each of fiscal years 2021
through 2023, if application of the workload adjustment under
subparagraph (A) increases the fee revenue amounts otherwise
established for the fiscal year under subsection (b), as
adjusted for inflation under paragraph (2), such fee revenue
increase shall be reduced by the amount of any excess
collections, as described in subsection (g)(4), for the second
preceding fiscal year, up to the amount of such fee revenue
increase.
``(C) Rule of application.--Under no circumstances shall
workload adjustments under this paragraph result in fee
revenues for a fiscal year that are less than the fee revenues
for that fiscal year established under subsection (b), as
adjusted for inflation under paragraph (2).''.
(3) Final year adjustment.--Paragraph (4) of section 741(c) (21
U.S.C. 379j-21(c)), as redesignated, is amended by--
(A) striking ``2018'' each place it appears and inserting
``2023''; and
(B) striking ``2019'' and inserting ``2024''.
(c) Fee Waiver or Reduction; Exemption From Fees.--Subsection (d)
of section 741 (21 U.S.C. 379j-21) is amended to read as follows:
``(d) Fee Waiver or Reduction; Exemption From Fees.--
``(1) Fee waiver or reduction.--The Secretary shall grant a
waiver from or a reduction of one or more fees assessed under
subsection (a) where the Secretary finds that the generic new
animal drug is intended solely to provide for a minor use or minor
species indication.
``(2) Exemption from fees.--Fees under this section shall not
apply with respect to any person who--
``(A) not later than September 30, 2023, submits a
supplemental abbreviated application for a generic new animal
drug approved under section 512, solely to add the application
number to the labeling of the drug in the manner specified in
section 502(w)(3); and
``(B) otherwise would be subject to fees under this section
solely on the basis of such supplemental abbreviated
application.''.
(d) Crediting and Availability of Fees.--Section 741(g) (21 U.S.C.
379j-21) is amended by striking paragraph (3) and inserting the
following paragraphs:
``(3) Authorization of appropriations.--For each of the fiscal
years 2019 through 2023, there is authorized to be appropriated for
fees under this section an amount equal to the total revenue amount
established under subsection (b) for the fiscal year, as adjusted
or otherwise affected under subsection (c).
``(4) Excess collections.--If the sum total of fees collected
under this section for a fiscal year exceeds the amount of fees
authorized to be appropriated for such year under paragraph (3),
the excess collections shall be credited to the appropriations
account of the Food and Drug Administration as provided in
paragraph (1).''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 (21 U.S.C. 379j-22) is amended--
(1) in subsection (a), by striking ``2013'' and inserting
``2018'';
(2) in subsection (b), by striking ``Committee on Health,
Education, Labor, and Pensions'' and inserting ``the Committee on
Health, Education, Labor and Pensions'';
(3) by striking ``2014'' each place it appears in subsections
(a) and (b) and inserting ``2019''; and
(4) in subsection (d), by striking ``2018'' each place it
appears and inserting ``2023''.
SEC. 204. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 5 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-21 et seq.), as in effect on the day before the date of
enactment of this title, shall continue to be in effect with respect to
abbreviated applications for a generic new animal drug and supplemental
abbreviated applications for a generic new animal drug (as defined in
such part as of such day) that on or after October 1, 2013, but before
October 1, 2018, were accepted by the Food and Drug Administration for
filing with respect to assessing and collecting any fee required by
such part for a fiscal year prior to fiscal year 2019.
SEC. 205. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2018, or the date of the enactment of this Act, whichever is later,
except that fees under part 5 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as amended by this title, shall
be assessed for abbreviated applications for a generic new animal drug
and supplemental abbreviated applications for a generic new animal drug
received on or after October 1, 2018, regardless of the date of
enactment of this Act.
SEC. 206. SUNSET DATES.
(a) Authorization.--Section 741 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1,
2023.
(b) Reporting Requirements.--Section 742 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-22) shall cease to be effective
January 31, 2024.
(c) Previous Sunset Provision.--Effective October 1, 2018,
subsections (a) and (b) of section 206 of the Animal Generic Drug User
Fee Amendments of 2013 (Public Law 113-14) are repealed.
TITLE III--MISCELLANEOUS PROVISIONS
SEC. 301. ELECTRONIC SUBMISSIONS.
(a) New Animal Drug Applications and Abbreviated Applications for a
Generic New Animal Drug.--Section 512(b) (21 U.S.C. 360b(b)) is amended
by adding at the end the following:
``(4) Beginning on October 1, 2018, all applications or submissions
pursuant to this subsection shall be submitted by electronic means in
such format as the Secretary may require.''.
(b) Conditional Approval of New Animal Drugs for Minor Use and
Minor Species.--Section 571(a) (21 U.S.C. 360ccc(a)) is amended by
adding at the end the following:
``(4) Beginning on October 1, 2018, all applications or submissions
pursuant to this subsection shall be submitted by electronic means in
such format as the Secretary may require.''.
SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES.
Effective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc-
1(h)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) `LEGAL STATUS--In order to be legally marketed, a new
animal drug intended for a minor species must be Approved,
Conditionally Approved, or Indexed by the Food and Drug
Administration. THIS PRODUCT IS INDEXED--MIF #' (followed by the
applicable minor species index file number and a period) `Extra-
label use is prohibited.';''; and
(2) in paragraph (2), by striking ``other animals'' and
inserting ``food-producing animals''.
SEC. 303. MISBRANDED DRUGS AND DEVICES.
(a) In General.--Section 502(w) (21 U.S.C. 352(w)) is amended--
(1) in subparagraph (1), by striking ``; or'' and inserting
``;'';
(2) in subparagraph (2), by striking the period and inserting
``; or''; and
(3) by adding at the end the following:
``(3) for which an application has been approved under section
512 and the labeling of such drug does not include the application
number in the format: `Approved by FDA under (A)NADA # xxx-xxx',
except that this subparagraph shall not apply to representative
labeling required under section 514.1(b)(3)(v)(b) of title 21, Code
of Federal Regulations (or any successor regulation) for animal
feed bearing or containing a new animal drug.''.
(b) Applicability.--Section 502(w)(3) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), shall apply beginning on
September 30, 2023.
SEC. 304. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS.
(a) In General.--Section 571 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ccc) is amended--
(1) in the section heading, by striking ``species'' and
inserting ``species and certain new animal drugs'';
(2) in subsection (a)--
(A) by amending paragraph (1) to read as follows:
``(1)(A) Except as provided in paragraph (3), any person may file
with the Secretary an application for conditional approval of--
``(i) a new animal drug intended for a minor use or a minor
species; or
``(ii) a new animal drug not intended for a minor use or minor
species--
``(I) that is intended to treat a serious or life-
threatening disease or condition or addresses an unmet animal
or human health need; and
``(II) for which the Secretary determines that a
demonstration of effectiveness would require a complex or
particularly difficult study or studies.
``(B) The Secretary shall, not later than September 30, 2019, issue
guidance or regulations further clarifying the criteria specified in
subparagraph (A)(ii).
``(C) An application under this paragraph shall comply in all
respects with the provisions of section 512 except for subsections
(a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of
such section unless otherwise stated in this section, and any
additional provisions of this section.
``(D) New animal drugs for which conditional approval is sought
under this section are subject to the same safety standards that would
be applied to new animal drugs under section 512(d) (including, for
antimicrobial new animal drugs, with respect to antimicrobial
resistance).''; and
(B) in paragraph (3)--
(i) in subparagraph (B), by striking ``, or'' and
inserting ``; or'';
(ii) by redesignating subparagraphs (A), (B), and (C)
as clauses (i), (ii), and (iii), respectively;
(iii) by striking ``A person may not file'' and
inserting ``(A) A person may not file''; and
(iv) by adding at the end the following new
subparagraph:
``(B) A person may not file an application under paragraph
(1)(A)(ii) if the application seeks conditional approval of a new
animal drug that contains an antimicrobial active ingredient.'';
(3) in subsection (f)--
(A) in paragraph (1), in the matter preceding subparagraph
(A), by inserting ``for the conditionally approved use'' after
``shall''; and
(B) in paragraph (2)--
(i) by striking ``An intended use'' and inserting ``The
Secretary shall, through regulation or guidance, determine
under what conditions an intended use''; and
(ii) by striking ``shall not'' and inserting ``may'';
and
(4) by adding at the end the following new subsection:
``(k) Sunset.--
``(1) The Secretary's authority to grant conditional approval
of new animal drugs not intended for a minor use or minor species
pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028.
``(2) The Secretary--
``(A) may not accept any new applications for such
conditional approval pursuant to subsection (a)(1)(A)(ii) on or
after such date; and
``(B) may continue all activities under this section with
respect to drugs that were conditionally approved pursuant to
(a)(1)(A)(ii) prior to such date.
``(3) The Secretary may, until October 1, 2032, accept
applications for approval under 512 of drugs conditionally approved
pursuant to (a)(1)(A)(ii).''.
(b) Exception From Fees in Case of Certain Previously Submitted
Applications for Conditional Approval.--Section 740(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(C)) is
amended--
(1) in the caption by striking ``Exception'' and inserting
``Exceptions'';
(2) by striking ``If an animal drug'' and inserting the
following:
``(i) If an animal drug''; and
(3) by inserting after clause (i), as so designated, the
following new clause:
``(ii) Beginning with fiscal year 2019, in the case of
an animal drug application submitted by a person under
section 512(b)(1), where such person (or their licensor,
assignor, or predecessor-in-interest) previously submitted
an application for conditional approval under section 571
for the same product and paid the applicable fee under
subparagraph (A), the application under section 512(b)(1)
shall not be subject to a fee under subparagraph (A) if
submitted within the timeframe specified in section
571(h).''.
(c) Report on Incorporating Veterinary Oversight.--Not later than
September 30, 2019, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall submit a report to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor and Pensions of the
Senate identifying how the Food and Drug Administration will
incorporate veterinary oversight for all approved medically important
antimicrobial drugs administered to animals that are not yet subject to
veterinary oversight. Such report shall address requirements related to
revisions of labeling to reflect that medically important antimicrobial
drugs administered to animals shall be subject to veterinary oversight.
(d) GAO Study of Conditional Approval Programs.--
(1) Study.--The Comptroller General of the United States
(referred to in this section as the ``Comptroller General'') shall
conduct a study on the effectiveness and overall impact of the
conditional approval pathway under section 571 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360ccc).
(2) Issuance of report.--Not later than January 1, 2026, the
Comptroller General shall submit to the Committee on Health,
Education, Labor and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report
containing the results of the study under paragraph (1).
(3) Contents of reports.--The report submitted under paragraph
(2) shall address--
(A) for each drug for which a conditional approval has been
awarded since October 1, 2018--
(i) whether the drug was granted conditional approval
pursuant to clause (i) or (ii) of section 571(a)(1)(A) of
the Federal Food, Drug, and Cosmetic Act, as amended by
subsection (a);
(ii) whether the drug was dual labeled during its
conditional approval;
(iii) the indications for which the drug was granted
conditional approval under section 571 of such Act (21
U.S.C. 360ccc) and whether the drug was approved or not
approved under section 512 of such Act (21 U.S.C. 360b);
(iv) the number of years the drug was so conditionally
approved and a description of the complexity of the
investigation to demonstrate the drug's effectiveness;
(v) whether, and to what extent, the conditional
approval pathway under such section 571 (21 U.S.C. 360ccc)
impacted the sponsor's decision to develop the drug or seek
approval of the drug under section 512 of such Act (21
U.S.C. 360b);
(vi) whether, and to what extent, conditional approval
pursuant to clause (ii) of section 571(a)(1)(A) of such Act
(21 U.S.C. 360b(a)(1)(A)) addressed a serious or life-
threatening condition; and
(vii) whether, and to what extent, conditional approval
pursuant to clause (ii) of section 571(a)(1)(A) of such Act
(21 U.S.C. 360b(a)(1)(A)) addressed an unmet animal or
human health need, and whether before such conditional
approval there were available therapies for the disease or
condition involved;
(B) an analysis of the conditional approval program under
section 571 of such Act (21 U.S.C. 360ccc), including--
(i) the resources used by the Food and Drug
Administration in reviewing applications for conditional
approval of drugs pursuant to such program and renewal of
such conditional approval, including the effects of the
program on the Food and Drug Administration's review of
animal drugs for which conditional approval is not used;
(ii) whether any improvements to the program under
section 512 of such Act (21 U.S.C. 360b) are necessary to
incentivize the development of animal drugs that would
likely not otherwise be developed, or developed in as
timely a manner, to address--
(I) serious or life-threatening conditions; and
(II) an unmet animal or human health need; and
(iii) whether the conditional approval pathway has
resulted in a greater number of animal drugs approved under
section 512 of such Act (21 U.S.C. 360b) for serious or
life-threatening conditions or unmet animal or human health
needs than would have otherwise come to market under the
practices and commitments of the Center for Veterinary
Medicine of the Food and Drug Administration as such
practices and commitments existed as of the day before the
date of enactment of this Act; and
(C) how the Center for Veterinary Medicine of the Food and
Drug Administration has utilized complex adaptive or other
novel investigation designs, data from foreign countries, real-
world evidence (including ongoing surveillance activities,
observational studies, and registry data), biomarkers, or
surrogate endpoints--
(i) to support the approval of products under section
512 of such Act (21 U.S.C. 360b), including how many such
products have been approved since October 1, 2018; and
(ii) to support the approval of products under section
512 of such Act (21 U.S.C. 360b) that received conditional
approval under section 571 of such Act (21 U.S.C. 360ccc),
including how many such products have been approved since
October 1, 2018.
SEC. 305. GUIDANCE ADDRESSING INVESTIGATION DESIGNS.
(a) In General.--For purposes of assisting sponsors in
incorporating complex adaptive and other novel investigation designs,
data from foreign countries, real world evidence (including ongoing
surveillance activities, observational studies, and registry data),
biomarkers, and surrogate endpoints (referred to in this section as
``elements of investigations'') into proposed clinical investigation
protocols and applications for new animal drugs under sections 512 and
571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b;
360ccc), the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall issue guidance addressing the
use of such elements of investigations in the development and
regulatory review of such new animal drugs.
(b) Contents.--The guidance under subsection (a) shall address how
the Secretary will evaluate the elements of investigations proposed or
submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug,
and Cosmetic Act or to meet the commitment under section 571(a)(2)(F)
of such Act, and how sponsors of such applications may obtain feedback
from the Secretary on technical issues related to such investigations
prior to the submission of an application to the Secretary.
(c) Meeting.--Prior to issuing the guidance under subsection (a),
the Secretary shall consult with stakeholders, including
representatives of regulated industry, consumer groups, academia,
veterinarians, and food producers, through a public meeting to be held
not later than 1 year after the date of enactment of this Act.
(d) Timing.--The Secretary shall issue a draft guidance under
subsection (a) not later than 1 year after the date of the public
meeting under subsection (c), and shall finalize such guidance not
later than 1 year after the date on which the public comment period on
such draft guidance ends.
SEC. 306. FOOD ADDITIVES INTENDED FOR USE IN ANIMAL FOOD.
(a) Food Additive Petitions for Animal Food.--Section 409 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by
adding at the end the following:
``(k) Food Additives Intended for Use in Animal Food.--(1) In
taking action on a petition under subsection (c) for, or for
recognition of, a food additive intended for use in animal food, the
Secretary shall review reports of investigations conducted in foreign
countries, provided by the petitioner.
``(2) Not later than 12 months after the date of enactment of the
Animal Drug and Animal Generic Drug Use Fee Amendments of 2018, the
Secretary shall post on the internet website of the Food and Drug
Administration--
``(A) the number of petitions for food additives intended for
use in animal food filed under subsection (b) that are pending;
``(B) how long each such petition submitted under subsection
(b) has been pending, including such petitions the Secretary has
extended under subsection (c)(2); and
``(C) the number of study protocols that have been pending
review for over 50 days, and the number that have received an
extension.
``(3) In the case of a food additive petition intended for use in
animal food, the Secretary shall provide information to the petitioner
on the required contents of such petition. If the Secretary requires
additional studies beyond what the petitioner proposed, the Secretary
shall provide the scientific rationale for such requirement.''.
(b) Ensuring the Safety of Pet Food.--Section 1002(a) of the Food
and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is
amended--
(1) by striking paragraph (1); and
(2) by redesignating paragraphs (2) and (3) as paragraphs (1)
and (2), respectively.
(c) Guidance on Pre-Petition Consultation Process for Animal Food
Additives.--
(1) In general.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall publish
draft guidance relating to the voluntary pre-petition consultation
process for food additives intended for use in animal food.
(2) Contents.--The guidance under paragraph (1) shall include--
(A) the recommended format to submit to the Food and Drug
Administration existing data, including any applicable foreign
data, for assessment prior to submission of a food additive
petition for animal food under section 409(b) of the Federal
Food, Drug, and Cosmetic Act;
(B) the manner and the number of days by which the Food and
Drug Administration intends to review and respond to such
existing data, including with respect to providing a scientific
rationale for any additional data request;
(C) circumstances under which the submission of study
protocols is recommended prior to submission of a food additive
petition under such section 409(b);
(D) the manner in which the Secretary intends to inform the
person submitting a study protocol for a food additive if the
review of such study protocol will take longer than 50 days;
and
(E) best practices for communication between the Food and
Drug Administration and industry on the development of pre-
petition submissions of study protocols and existing data for
food additives.
(3) Final guidance.--The guidance under paragraph (1) shall be
finalized, withdrawn, or reissued not later than 1 year after the
close of the comment period on the draft guidance.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.
H.R. 5554 (ENR) - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Bill Metadata
Publish Date: Mar 27, 2024
Scanned and Processed on: Sep 23, 2024
Official Title: To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
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