‘‘(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 ad-
justed 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 applica-
tions (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 as-
sessed for animal drug applications and supplemental ani-
mal 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 Octo-
ber 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113–14) are repealed.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 author-
ized by the amendments made in this title will be dedi-
cated toward expediting the generic new animal drug de-
velopment process and the review of abbreviated applica-
tions for generic new animal drugs, supplemental abbre-
viated applications for generic new animal drugs, and in-
vestigational 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 Com-
mittee on Energy and Commerce of the House of Rep-
resentatives 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 sec-
tion 741 (21 U.S.C. 379j–21) is amended to read as fol-
lows:
‘‘(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 para-
graph (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), re-
spectively; 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, pub-
lished 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 Administra-
tion, 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, multi-
plied by the average proportion of per-
sonnel 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 (Wash-
ington-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 avail-
able multiplied by the average proportion 
of all costs other than personnel compensa-
tion 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 adjust-
ment made each fiscal year after fiscal year 
2020 under this paragraph shall be applied on 
a compounded basis to the revenue amount cal-
culated under this paragraph for the most re-
cent previous fiscal year.’’. 
(2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 
of section 741(c) (21 U.S.C. 379j–21(c)), as redesig-
nated, is amended to read as follows: 
‘‘(3) WORKLOAD ADJUSTMENTS.— 
‘‘(A) IN GENERAL.—For fiscal year 2020 
and subsequent fiscal years, after the fee rev-
enue amounts established under subsection (b) 
are adjusted for inflation in accordance with
through 2023, if application of the workload ad-
justment 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 rev-
enue increase shall be reduced by the amount of 
any excess collections, as described in sub-
section (g)(4), for the second preceding fiscal 
year, up to the amount of such fee revenue in-
crease. 
‘‘(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 redesig-
nated, 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 Sec-
retary 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 ani-
mal 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 num-
ber 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.—Sec-
tion 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 fis-
cal 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 appro-
priated for such year under paragraph (3), the ex-
cess collections shall be credited to the appropria-
tions 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 in-
serting ‘‘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 abbre-
viated applications for a generic new animal drug and sup-
plemental abbreviated applications for a generic new ani-
mal 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 re-
quired 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 as-
sessed for abbreviated applications for a generic new ani-
mal 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 Octo-
ber 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 ABBRE-
VIATED 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 sub-
mitted by electronic means in such format as the Sec-
retary 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 sub-
mitted by electronic means in such format as the Sec-
retary 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 fol-
lows: 
‘‘(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 #’ (fol-
lowed by the applicable minor species index file num-
ber and a period) ‘Extra-label use is prohibited.’;’’; 
and 
(2) in paragraph (2), by striking ‘‘other ani-
mals’’ 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 ap-
proved 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 Regu-
lations (or any successor regulation) for animal feed 
bearing or containing a new animal drug.’’. 
(b) APPLICABILITY.—Section 502(w)(3) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by sub-
section (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 ‘‘SPE-
CIES’’ 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 con-
ditional 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 address-
es an unmet animal or human health need; and 
‘‘(II) for which the Secretary determines 
that a demonstration of effectiveness would re-
quire 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 com-
ply 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 sec-
tion. 
‘‘(D) New animal drugs for which conditional ap-
proval 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 resist-
ance).’’; 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 anti-
microbial active ingredient.’’;
(3) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding 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 insert-
ing ‘‘may’’; and 
(4) by adding at the end the following new sub-
section: 
‘‘(k) SUNSET.— 
‘‘(1) The Secretary’s authority to grant condi-
tional 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 sub-
section (a)(1)(A)(ii) on or after such date; and 
‘‘(B) may continue all activities under this 
section with respect to drugs that were condi-
tionally 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 CONDI-
TIONAL 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 insert-
ing the following: 
‘‘(i) If an animal drug’’; and 
(3) by inserting after clause (i), as so des-
ignated, 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 li-
censor, 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 applica-
tion 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 OVER-
SIGHT.—Not later than September 30, 2019, the Sec-
retary 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, Edu-
cation, Labor and Pensions of the Senate identifying how 
the Food and Drug Administration will incorporate veteri-
nary oversight for all approved medically important anti-
microbial 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 PRO-
GRAMS.— 
(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
proved 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, con-
ditional 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, con-
ditional 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 condi-
tion 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 ap-
plications for conditional approval of drugs 
pursuant to such program and renewal of 
such conditional approval, including the ef-
fects 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 ad-
dress— 
(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 seri-
ous 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 Medi-
cine of the Food and Drug Administration has 
utilized complex adaptive or other novel inves-
tigation designs, data from foreign countries, 
real-world evidence (including ongoing surveil-
lance activities, observational studies, and reg-
istry 
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 prod-
ucts under section 512 of such Act (21
U.S.C. 360b) that received conditional ap-
proval 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 DE-
SIGNS. 
(a) IN GENERAL.—For purposes of assisting spon-
sors in incorporating complex adaptive and other novel in-
vestigation designs, data from foreign countries, real world 
evidence (including ongoing surveillance activities, obser-
vational studies, and registry data), biomarkers, and sur-
rogate endpoints (referred to in this section as ‘‘elements 
of investigations’’) into proposed clinical investigation pro-
tocols and applications for new animal drugs under sec-
tions 512 and 571 of the Federal Food, Drug, and Cos-
metic 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 sec-
tion 512(b)(1)(A) of the Federal Food, Drug, and Cos-
metic Act or to meet the commitment under section 
571(a)(2)(F) of such Act, and how sponsors of such appli-
cations may obtain feedback from the Secretary on tech-
nical issues related to such investigations prior to the sub-
mission of an application to the Secretary. 
(c) MEETING.—Prior to issuing the guidance under 
subsection (a), the Secretary shall consult with stake-
holders, including representatives of regulated industry, 
consumer groups, academia, veterinarians, and food pro-
ducers, 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 guid-
ance 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 guid-
ance 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 Cos-
metic Act (21 U.S.C. 348) is amended by adding at the 
end the following: 
‘‘(k) FOOD ADDITIVES INTENDED FOR USE IN ANI-
MAL FOOD.—(1) In taking action on a petition under sub-
(b) ENSURING THE SAFETY OF PET FOOD.—Section 
1002(a) of the Food and Drug Administration Amend-
ments 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 Sec-
retary 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 para-
graph (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 addi-
tive petition for animal food under section 
409(b) of the Federal Food, Drug, and Cos-
metic Act;
(B) the manner and the number of days by 
which the Food and Drug Administration in-
tends to review and respond to such existing 
data, including with respect to providing a sci-
entific rationale for any additional data request; 
(C) circumstances under which the submis-
sion 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 in-
tends 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 be-
tween the Food and Drug Administration and 
industry on the development of pre-petition sub-
missions of study protocols and existing data 
for food additives. 
(3) FINAL
GUIDANCE.—The guidance under 
paragraph (1) shall be finalized, withdrawn, or re-
issued not later than 1 year after the close of the 
comment period on the draft guidance. 
Passed the House of Representatives July 16, 2018. 
Attest: 
Clerk.
115TH CONGRESS 
2D SESSION 
H. R. 5554 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize user fee programs relating to 
new animal drugs and generic new animal drugs.