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.). 
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)— 
H. R. 5554—3 

(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’’. 
H. R. 5554—4 

(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 
H. R. 5554—5 

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. 
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, 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); 
H. R. 5554—7 

‘‘(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 
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 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: 
H. R. 5554—9 

‘‘(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. 
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 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’’; 
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-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— 
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 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— 
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 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 
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 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 
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 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 
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.