HR 5554 RDS
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(Public Law 113–14) are repealed.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.’’. 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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’’. 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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— 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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.’’; 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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-
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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 sub-
mit to the Committee on Health, Education, Labor 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives a report containing the results of the study 
under paragraph (1). 
(3) CONTENTS OF REPORTS.—The report sub-
mitted 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 con-
ditional approval pursuant to clause (i) or 
(ii) of section 571(a)(1)(A) of the Federal 
Food, Drug, and Cosmetic Act, as amend-
ed 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 ap-
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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; 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00034
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00035
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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-
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
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-
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
section (c) for, or for recognition of, a food additive in-
tended 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 en-
actment 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 Administra-
tion— 
‘‘(A) the number of petitions for food additives 
intended for use in animal food filed under sub-
section (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 sub-
section (c)(2); and 
‘‘(C) the number of study protocols that have 
been pending review for over 50 days, and the num-
ber that have received an extension. 
‘‘(3) In the case of a food additive petition intended 
for use in animal food, the Secretary shall provide infor-
mation to the petitioner on the required contents of such 
petition. If the Secretary requires additional studies be-
yond what the petitioner proposed, the Secretary shall pro-
vide the scientific rationale for such requirement.’’. 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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; 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
(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 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00040
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS
HR 5554 RDS
reissued 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: 
KAREN L. HAAS, 
Clerk. 
VerDate Sep 11 2014 
01:04 Aug 01, 2018
Jkt 079200
PO 00000
Frm 00041
Fmt 6652
Sfmt 6201
E:\BILLS\H5554.RDS
H5554
lotter on DSKBCFDHB2PROD with BILLS