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 spe-
cies. 
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, amend-
ments 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.).
H. R. 5554—2 
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)—
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(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 subpara-
graph: 
‘‘(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 fur-
ther 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 sub-
mitted 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 work-
load adjustment under subparagraph (A) increases the fee 
revenue amounts otherwise established for the fiscal year 
under subsection (b), as adjusted for inflation under para-
graph (2), such fee revenue 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 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 sub-
section (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’’.
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(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, supple-
mental 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 ‘‘estab-
lished’’; and 
(C) by striking ‘‘paragraph (4)’’ and inserting ‘‘para-
graph (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 para-
graph (3), the excess collections shall be credited to the appro-
priations account of the Food and Drug Administration as pro-
vided in paragraph (1). 
‘‘(5) RECOVERY OF COLLECTION SHORTFALLS.— 
‘‘(A) IN GENERAL.—Subject to subparagraph (B)— 
‘‘(i) for fiscal year 2021, the amount of fees other-
wise 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 other-
wise authorized to be collected under this section shall
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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 other-
wise 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 Sec-
retary shall, in such manner as the Secretary deter-
mines 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 reve-
nues 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.
H. R. 5554—6 
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, supple-
mental 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 estab-
lished for a fiscal year under paragraph (1)— 
‘‘(A) 25 percent shall be derived from fees under sub-
section (a)(1) (relating to abbreviated applications for a 
generic new animal drug);
H. R. 5554—7 
‘‘(B) 37.5 percent shall be derived from fees under 
subsection (a)(2) (relating to generic new animal drug prod-
ucts); and 
‘‘(C) 37.5 percent shall be derived from fees under 
subsection (a)(3) (relating to generic new animal drug spon-
sors).’’. 
(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 sub-
section (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 propor-
tion 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 con-
sumers (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 compensa-
tion and benefits costs to total Food and Drug Adminis-
tration 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 fur-
ther 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
H. R. 5554—8 
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 supple-
mental 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 work-
load adjustment under subparagraph (A) increases the fee 
revenue amounts otherwise established for the fiscal year 
under subsection (b), as adjusted for inflation under para-
graph (2), such fee revenue 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 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 sub-
section (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.—Sub-
section (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:
H. R. 5554—9 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 
fiscal years 2019 through 2023, there is authorized to be appro-
priated 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 para-
graph (3), the excess collections shall be credited to the appro-
priations account of the Food and Drug Administration as pro-
vided 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 applica-
tions 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.
H. R. 5554—10 
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 submis-
sions 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 submis-
sions 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’’;
H. R. 5554—11 
(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-threat-
ening disease or condition or addresses an unmet animal 
or human health need; and 
‘‘(II) for which the Secretary determines that a dem-
onstration 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 subpara-
graph (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—
H. R. 5554—12 
‘‘(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 fol-
lowing: 
‘‘(i) If an animal drug’’; and 
(3) by inserting after clause (i), as so designated, the fol-
lowing 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) pre-
viously 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 adminis-
tered 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 Represent-
atives a report containing the results of the study under para-
graph (1). 
(3) CONTENTS OF REPORTS.—The report submitted under 
paragraph (2) shall address—
H. R. 5554—13 
(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 condi-
tionally approved and a description of the complexity 
of the investigation to demonstrate the drug’s effective-
ness; 
(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 condi-
tional 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
H. R. 5554—14 
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 sec-
tion 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 sec-
tion 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 incor-
porating 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 develop-
ment 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 pro-
posed 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 applica-
tions may obtain feedback from the Secretary on technical issues 
related to such investigations prior to the submission of an applica-
tion to the Secretary. 
(c) MEETING.—Prior to issuing the guidance under subsection 
(a), the Secretary shall consult with stakeholders, including rep-
resentatives of regulated industry, consumer groups, academia, vet-
erinarians, 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
H. R. 5554—15 
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 sub-
section (b) has been pending, including such petitions the Sec-
retary 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 peti-
tioner 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 require-
ment.’’. 
(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
H. R. 5554—16 
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.