II 

Calendar No. 341 

115TH CONGRESS 

2D SESSION S. 2434 

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 

fee programs relating to new animal drugs and generic new animal drugs. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 15, 2018 

Mr. ALEXANDER introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

MARCH 7, 2018 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

reauthorize user fee programs relating to new animal 

drugs and generic new animal drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Animal Drug and Ani5 mal Generic Drug User Fee Amendments of 2018’’. 


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1 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

2 (a) TABLE OF CONTENTS.—The table of contents for 

3 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. 

4 (b) REFERENCES IN ACT.—Except as otherwise spec5 ified, amendments made by this Act to a section or other 

6 provision of law are amendments to such section or other 

7 provision of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 301 et seq.). 

9 TITLE I—FEES RELATING TO 

10 ANIMAL DRUGS 

11 SEC. 101. SHORT TITLE; FINDING. 

12 (a) SHORT TITLE.—This title may be cited as the 

13 ‘‘Animal Drug User Fee Amendments of 2018’’. 


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1 (b) FINDING.—Congress finds that the fees author2 ized by the amendments made in this title will be dedi3 cated toward expediting the animal drug development 

4 process and the review of new and supplemental animal 

5 drug applications and investigational animal drug submis6 sions as set forth in the goals identified for purposes of 

7 part 4 of subchapter C of chapter VII of the Federal Food, 

8 Drug, and Cosmetic Act, in the letters from the Secretary 

9 of Health and Human Services to the Chairman of the 

10 Committee on Energy and Commerce of the House of 

11 Representatives and the Chairman of the Committee on 

12 Health, Education, Labor, and Pensions of the Senate as 

13 set forth in the Congressional Record. 

14 SEC. 102. DEFINITIONS. 

15 Section 739 (21 U.S.C. 379j–11) is amended— 

16 (1) by amending paragraph (1) to read as fol17 lows: 

18 ‘‘(1)(A) The term ‘animal drug application’ 

19 means— 

20 ‘‘(i) an application for approval of any new 

21 animal drug submitted under section 512(b)(1); 

22 or 

23 ‘‘(ii) an application for conditional ap24 proval of a new animal drug submitted under 

25 section 571. 


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1 ‘‘(B) Such term does not include either a new 

2 animal drug application submitted under section 

3 512(b)(2) or a supplemental animal drug applica4 tion.’’; and 

5 (2) in paragraph (8), by adding at the end the 

6 following: 

7 ‘‘(I) The activities necessary for implemen8 tation of the United States and European 

9 Union Good Manufacturing Practice Mutual In10 spection Agreement with respect to animal drug 

11 products subject to review, including implemen12 tation activities prior to and following product 

13 approval.’’. 

14 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

15 FEES. 

16 (a) FEE REVENUE AMOUNTS.—Section 740(b) (21 

17 U.S.C. 379j–12(b)) is amended— 

18 (1) in paragraph (1)— 

19 (A) in subparagraph (A)— 

20 (i) by striking ‘‘2014’’ and inserting 

21 ‘‘2019’’; and 

22 (ii) by striking ‘‘$23,600,000’’ and in23 serting ‘‘$30,331,240’’; and 

24 (B) in subparagraph (B)— 


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1 (i) by striking ‘‘2015 through 2018’’ 

2 and inserting ‘‘2020 through 2023’’; and 

3 (ii) by striking ‘‘$21,600,000’’ and in4 serting ‘‘$29,931,240’’; and 

5 (2) in paragraph (2), in the matter preceding 

6 subparagraph (A), by striking ‘‘determined’’ and in7 serting ‘‘established’’. 

8 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

9 (1) INFLATION ADJUSTMENT.—Section 

10 740(c)(2) (21 U.S.C. 379j–12(c)(2)) is amended— 

11 (A) in the matter preceding subparagraph 

12 (A)— 

13 (i) by striking ‘‘For fiscal year 2015’’ 

14 and inserting ‘‘(A) For fiscal year 2020’’; 

15 and 

16 (ii) by inserting ‘‘multiplying such 

17 revenue amounts by’’ before ‘‘an amount’’; 

18 (B) by redesignating subparagraphs (A), 

19 (B), and (C) as clauses (i), (ii), and (iii), re20 spectively; 

21 (C) by striking the flush text at the end; 

22 and 

23 (D) by adding at the end the following new 

24 subparagraph: 


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1 ‘‘(B) COMPOUNDED BASIS.—The adjustment 

2 made each fiscal year after fiscal year 2020 under 

3 this paragraph shall be applied on a compounded 

4 basis to the revenue amount calculated under this 

5 paragraph for the most recent previous fiscal year.’’. 

6 (2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 

7 of section 740(c) (21 U.S.C. 379j–12(c)) is amended 

8 to read as follows: 

9 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

10 ‘‘(A) IN GENERAL.—For fiscal year 2020 

11 and subsequent fiscal years, after the fee rev12 enue amounts established under subsection (b) 

13 are adjusted for inflation in accordance with 

14 paragraph (2), the fee revenue amounts shall be 

15 further adjusted for such fiscal year to reflect 

16 changes in the workload of the Secretary for 

17 the process for the review of animal drug appli18 cations, subject to subparagraphs (B) and (C). 

19 With respect to such adjustment— 

20 ‘‘(i) such adjustment shall be deter21 mined by the Secretary based on a weight22 ed average of the change in the total num23 ber of animal drug applications, supple24 mental animal drug applications for which 

25 data with respect to safety or effectiveness 


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1 are required, manufacturing supplemental 

2 animal drug applications, investigational 

3 animal drug study submissions, and inves4 tigational animal drug protocol submis5 sions submitted to the Secretary; and 

6 ‘‘(ii) the Secretary shall publish in the 

7 Federal Register the fees resulting from 

8 such adjustment and the supporting meth9 odologies. 

10 ‘‘(B) REDUCTION OF WORKLOAD-BASED

11 INCREASE BY AMOUNT OF CERTAIN EXCESS

12 COLLECTIONS.—For each of fiscal years 2021 

13 through 2023, if application of the workload ad14 justment under subparagraph (A) increases the 

15 fee revenue amounts otherwise established for 

16 the fiscal year under subsection (b), as adjusted 

17 for inflation under paragraph (2), such fee rev18 enue increase shall be reduced by the amount of 

19 any excess collections, as described in sub20 section (g)(4), for the second preceding fiscal 

21 year, up to the amount of such fee revenue in22 crease. 

23 ‘‘(C) RULE OF APPLICATION.—Under no 

24 circumstances shall the workload adjustments 

25 under this paragraph result in fee revenues for 


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1 a fiscal year that are less than the fee revenues 

2 for that fiscal year established under subsection 

3 (b), as adjusted for inflation under paragraph 

4 (2).’’. 

5 (3) FINAL YEAR ADJUSTMENT.—Section 

6 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— 

7 (A) by striking ‘‘2018’’ each place it ap8 pears and inserting ‘‘2023’’; and 

9 (B) by striking ‘‘2019’’ and inserting 

10 ‘‘2024’’. 

11 (c) EXEMPTIONS FROM FEES.—Section 740(d) (21 

12 U.S.C. 379j–12(d)) is amended— 

13 (1) in the subsection heading, by inserting ‘‘; 

14 EXEMPTIONS FROM FEES’’ after ‘‘REDUCTION’’; 

15 (2) by striking the heading of paragraph (1) 

16 and inserting ‘‘WAIVER OR REDUCTION’’; and 

17 (3) by adding at the end the following: 

18 ‘‘(4) EXEMPTIONS FROM FEES.— 

19 ‘‘(A) CERTAIN LABELING SUPPLEMENTS

20 TO ADD NUMBER OF APPROVED APPLICA21 TION.—Fees under this section shall not apply 

22 with respect to any person who— 

23 ‘‘(i) not later than September 30, 

24 2023, submits a supplemental animal drug 

25 application relating to a new animal drug 


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1 application approved under section 512, 

2 solely to add the new animal drug applica3 tion number to the labeling of the drug in 

4 the manner specified in section 502(w)(3); 

5 and 

6 ‘‘(ii) otherwise would be subject to 

7 fees under this section solely on the basis 

8 of such supplemental application. 

9 ‘‘(B) CERTAIN ANIMAL DRUG APPLICA10 TIONS.—Fees under paragraphs (2), (3), and 

11 (4) of subsection (a) shall not apply with re12 spect to any person who is the named applicant 

13 or sponsor of an animal drug application, sup14 plemental animal drug application, or investiga15 tional animal drug submission if such applica16 tion or submission involves the intentional 

17 genomic alteration of an animal that is in18 tended to produce a drug, device, or biological 

19 product subject to fees under section 736, 738, 

20 744B, or 744H.’’. 

21 (d) CREDITING AND AVAILABILITY OF FEES.— 

22 (1) AUTHORIZATION OF APPROPRIATIONS.— 

23 Section 740(g)(3) (21 U.S.C. 379j–12(g)(3)) is 

24 amended— 


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1 (A) by striking ‘‘2014 through 2018’’ and 

2 inserting ‘‘2019 through 2023’’; 

3 (B) by striking ‘‘determined’’ and inserting 

4 ‘‘established’’; and 

5 (C) by striking ‘‘paragraph (4)’’ and in6 serting ‘‘paragraph (5)’’. 

7 (2) EXCESS COLLECTIONS.—Section 740(g) (21 

8 U.S.C. 379j–12(g)) is amended by striking para9 graph (4) and inserting the following: 

10 ‘‘(4) EXCESS COLLECTIONS.—If the sum total 

11 of fees collected under this section for a fiscal year 

12 exceeds the amount of fees authorized to be appro13 priated for such year under paragraph (3), the ex14 cess collections shall be credited to the appropria15 tions account of the Food and Drug Administration 

16 as described in paragraph (1). 

17 ‘‘(5) RECOVERY OF COLLECTION SHORT18 FALLS.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graph (B)— 

21 ‘‘(i) for fiscal year 2021, the amount 

22 of fees otherwise authorized to be collected 

23 under this section shall be increased by the 

24 amount, if any, by which the amount col25 lected under this section and appropriated 


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1 for fiscal year 2019 falls below the amount 

2 of fees authorized for fiscal year 2019 

3 under paragraph (3); 

4 ‘‘(ii) for fiscal year 2022, the amount 

5 of fees otherwise authorized to be collected 

6 under this section shall be increased by the 

7 amount, if any, by which the amount col8 lected under this section and appropriated 

9 for fiscal year 2020 falls below the amount 

10 of fees authorized for fiscal year 2020 

11 under paragraph (3); and 

12 ‘‘(iii) for fiscal year 2023, the amount 

13 of fees otherwise authorized to be collected 

14 under this section shall be increased by the 

15 cumulative amount, if any, by which the 

16 amount collected under this section and 

17 appropriated for fiscal years 2021 and 

18 2022 (including estimated collections for 

19 fiscal year 2022) falls below the cumulative 

20 amount of fees authorized for such fiscal 

21 years under paragraph (3). 

22 ‘‘(B) REDUCTION OF SHORTFALL-BASED

23 FEE INCREASE BY PRIOR YEAR EXCESS COL24 LECTIONS.— 


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1 ‘‘(i) IN GENERAL.—Subject to clause 

2 (ii), the Secretary shall, in such manner as 

3 the Secretary determines appropriate, re4 duce any fee increase otherwise applicable 

5 for a fiscal year under subparagraph (A) 

6 by the amount of any excess collections 

7 under this section for preceding fiscal 

8 years (after fiscal year 2018). 

9 ‘‘(ii) WORKLOAD-BASED FEE AC10 COUNTING.—In applying clause (i), the 

11 Secretary shall account for the reduction of 

12 workload-based fee revenue increases by 

13 excess collections under subsection 

14 (c)(3)(B), in such manner as needed to 

15 provide that no portion of any excess col16 lections described in clause (i) is applied 

17 for purposes of reducing fee increases 

18 under both such subsection (c)(3)(B) and 

19 this paragraph. 

20 ‘‘(C) RULE OF APPLICATION.—Under no 

21 circumstances shall adjustments under this 

22 paragraph result in fee revenues for a fiscal 

23 year that are less than the fee revenues for that 

24 fiscal year established in subsection (b), as adVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6401 E:\BILLS\S2434.RS S2434

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1 justed or otherwise affected under subsection 

2 (c).’’. 

3 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

4 Section 740A (21 U.S.C. 379j–13) is amended— 

5 (1) in subsection (a), by striking ‘‘2013’’ and 

6 inserting ‘‘2018’’; 

7 (2) by striking ‘‘2014’’ each place it appears in 

8 subsections (a) and (b) and inserting ‘‘2019’’; and 

9 (3) in subsection (d), by striking ‘‘2018’’ each 

10 place it appears and inserting ‘‘2023’’. 

11 SEC. 105. SAVINGS CLAUSE. 

12 Notwithstanding the amendments made by this title, 

13 part 4 of subchapter C of chapter VII of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as 

15 in effect on the day before the date of enactment of this 

16 title, shall continue to be in effect with respect to animal 

17 drug applications and supplemental animal drug applica18 tions (as defined in such part as of such day) that on or 

19 after October 1, 2013, but before October 1, 2018, were 

20 accepted by the Food and Drug Administration for filing 

21 with respect to assessing and collecting any fee required 

22 by such part for a fiscal year prior to fiscal year 2019. 

23 SEC. 106. EFFECTIVE DATE. 

24 The amendments made by this title shall take effect 

25 on October 1, 2018, or the date of the enactment of this 


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1 Act, whichever is later, except that fees under part 4 of 

2 subchapter C of chapter VII of the Federal Food, Drug, 

3 and Cosmetic Act, as amended by this title, shall be as4 sessed for animal drug applications and supplemental ani5 mal drug applications received on or after October 1, 

6 2018, regardless of the date of the enactment of this Act. 

7 SEC. 107. SUNSET DATES. 

8 (a) AUTHORIZATION.—Section 740 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall 

10 cease to be effective October 1, 2023. 

11 (b) REPORTING REQUIREMENTS.—Section 740A of 

12 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 379j–13) shall cease to be effective January 31, 2024. 

14 (c) PREVIOUS SUNSET PROVISION.—Effective Octo15 ber 1, 2018, subsections (a) and (b) of section 107 of the 

16 Animal Drug User Fee Amendments of 2013 (Public Law 

17 113–14) are repealed. 

18 TITLE II—FEES RELATING TO 

19 GENERIC ANIMAL DRUGS 

20 SEC. 201. SHORT TITLE; FINDING. 

21 (a) SHORT TITLE.—This title may be cited as the 

22 ‘‘Animal Generic Drug User Fee Amendments of 2018’’. 

23 (b) FINDING.—Congress finds that the fees author24 ized by the amendments made in this title will be dedi25 cated toward expediting the generic new animal drug deVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6401 E:\BILLS\S2434.RS S2434

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1 velopment process and the review of abbreviated applica2 tions for generic new animal drugs, supplemental abbre3 viated applications for generic new animal drugs, and in4 vestigational submissions for generic new animal drugs as 

5 set forth in the goals identified for purposes of part 5 of 

6 subchapter C of chapter VII of the Federal Food, Drug, 

7 and Cosmetic Act, in the letters from the Secretary of 

8 Health and Human Services to the Chairman of the Com9 mittee on Energy and Commerce of the House of Rep10 resentatives and the Chairman of the Committee on 

11 Health, Education, Labor, and Pensions of the Senate as 

12 set forth in the Congressional Record. 

13 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

14 ANIMAL DRUG FEES. 

15 (a) FEE REVENUE AMOUNTS.—Subsection (b) of sec16 tion 741 (21 U.S.C. 379j–21) is amended to read as fol17 lows: 

18 ‘‘(b) FEE REVENUE AMOUNTS.— 

19 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

20 (d), (f), and (g), for each of fiscal years 2019 

21 through 2023, the fees required under subsection (a) 

22 shall be established to generate a total revenue 

23 amount of $18,336,340. 


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1 ‘‘(2) TYPES OF FEES.—Of the total revenue 

2 amount established for a fiscal year under para3 graph (1)— 

4 ‘‘(A) 25 percent shall be derived from fees 

5 under subsection (a)(1) (relating to abbreviated 

6 applications for a generic new animal drug); 

7 ‘‘(B) 37.5 percent shall be derived from 

8 fees under subsection (a)(2) (relating to generic 

9 new animal drug products); and 

10 ‘‘(C) 37.5 percent shall be derived from 

11 fees under subsection (a)(3) (relating to generic 

12 new animal drug sponsors).’’. 

13 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

14 (1) INFLATION ADJUSTMENT.—Section 741(c) 

15 (21 U.S.C. 379j–21(c)) is amended— 

16 (A) by redesignating paragraphs (2) 

17 through (4) as paragraphs (3) through (5), re18 spectively; and 

19 (B) by inserting after paragraph (1) the 

20 following: 

21 ‘‘(2) INFLATION ADJUSTMENT.— 

22 ‘‘(A) IN GENERAL.—For fiscal year 2020 

23 and subsequent fiscal years, the revenue 

24 amounts established under subsection (b) shall 

25 be adjusted by the Secretary by notice, pubVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6401 E:\BILLS\S2434.RS S2434

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1 lished in the Federal Register, for a fiscal year, 

2 by multiplying such revenue amounts by an 

3 amount equal to the sum of— 

4 ‘‘(i) one; 

5 ‘‘(ii) the average annual percent 

6 change in the cost, per full-time equivalent 

7 position of the Food and Drug Administra8 tion, of all personnel compensation and 

9 benefits paid with respect to such positions 

10 for the first 3 of the preceding 4 fiscal 

11 years for which data are available, multi12 plied by the average proportion of per13 sonnel compensation and benefits costs to 

14 total Food and Drug Administration costs 

15 for the first 3 of the preceding 4 fiscal 

16 years for which data are available; and 

17 ‘‘(iii) the average annual percent 

18 change that occurred in the Consumer 

19 Price Index for urban consumers (Wash20 ington-Baltimore, DC–MD–VA–WV; not 

21 seasonally adjusted; all items less food and 

22 energy; annual index) for the first 3 of the 

23 preceding 4 years for which data are avail24 able multiplied by the average proportion 

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1 tion and benefits costs to total Food and 

2 Drug Administration costs for the first 3 

3 of the preceding 4 fiscal years for which 

4 data are available. 

5 ‘‘(B) COMPOUNDED BASIS.—The adjust6 ment made each fiscal year after fiscal year 

7 2020 under this paragraph shall be applied on 

8 a compounded basis to the revenue amount cal9 culated under this paragraph for the most re10 cent previous fiscal year.’’. 

11 (2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 

12 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig13 nated, is amended to read as follows: 

14 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

15 ‘‘(A) IN GENERAL.—For fiscal year 2020 

16 and subsequent fiscal years, after the fee rev17 enue amounts established under subsection (b) 

18 are adjusted for inflation in accordance with 

19 paragraph (2), the fee revenue amounts shall be 

20 further adjusted for each such fiscal year to re21 flect changes in the workload of the Secretary 

22 for the process for the review of abbreviated ap23 plications for generic new animal drugs, subject 

24 to subparagraphs (B) and (C). With respect to 

25 such adjustment— 


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1 ‘‘(i) this adjustment shall be deter2 mined by the Secretary based on a weight3 ed average of the change in the total num4 ber of abbreviated applications for generic 

5 new animal drugs, manufacturing supple6 mental abbreviated applications for generic 

7 new animal drugs, investigational generic 

8 new animal drug study submissions, and 

9 investigational generic new animal drug 

10 protocol submissions submitted to the Sec11 retary; and 

12 ‘‘(ii) the Secretary shall publish in the 

13 Federal Register the fees resulting from 

14 this adjustment and the supporting meth15 odologies. 

16 ‘‘(B) REDUCTION OF WORKLOAD-BASED

17 INCREASE BY AMOUNT OF CERTAIN EXCESS

18 COLLECTIONS.—For each of fiscal years 2021 

19 through 2023, if application of the workload ad20 justment under subparagraph (A) increases the 

21 fee revenue amounts otherwise established for 

22 the fiscal year under subsection (b), as adjusted 

23 for inflation under paragraph (2), such fee rev24 enue increase shall be reduced by the amount of 

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1 section (g)(4), for the second preceding fiscal 

2 year, up to the amount of such fee revenue in3 crease. 

4 ‘‘(C) RULE OF APPLICATION.—Under no 

5 circumstances shall workload adjustments 

6 under this paragraph result in fee revenues for 

7 a fiscal year that are less than the fee revenues 

8 for that fiscal year established under subsection 

9 (b), as adjusted for inflation under paragraph 

10 (2).’’. 

11 (3) FINAL YEAR ADJUSTMENT.—Paragraph (4) 

12 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig13 nated, is amended by— 

14 (A) striking ‘‘2018’’ each place it appears 

15 and inserting ‘‘2023’’; and 

16 (B) striking ‘‘2019’’ and inserting ‘‘2024’’. 

17 (c) FEE WAIVER OR REDUCTION; EXEMPTION FROM

18 FEES.—Subsection (d) of section 741 (21 U.S.C. 379j– 

19 21) is amended to read as follows: 

20 ‘‘(d) FEE WAIVER OR REDUCTION; EXEMPTION

21 FROM FEES.— 

22 ‘‘(1) FEE WAIVER OR REDUCTION.—The Sec23 retary shall grant a waiver from or a reduction of 

24 1 or more fees assessed under subsection (a) where 

25 the Secretary finds that the generic new animal drug 


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1 is intended solely to provide for a minor use or 

2 minor species indication. 

3 ‘‘(2) EXEMPTION FROM FEES.—Fees under this 

4 section shall not apply with respect to any person 

5 who— 

6 ‘‘(A) not later than September 30, 2023, 

7 submits a supplemental abbreviated application 

8 for a generic new animal drug approved under 

9 section 512, solely to add the application num10 ber to the labeling of the drug in the manner 

11 specified in section 502(w)(3); and 

12 ‘‘(B) otherwise would be subject to fees 

13 under this section solely on the basis of such 

14 supplemental abbreviated application.’’. 

15 (d) CREDITING AND AVAILABILITY OF FEES.—Sec16 tion 741(g) (21 U.S.C. 379j–21) is amended by striking 

17 paragraph (3) and inserting the following paragraphs: 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

19 For each of the fiscal years 2019 through 2023, 

20 there is authorized to be appropriated for fees under 

21 this section an amount equal to the total revenue 

22 amount established under subsection (b) for the fis23 cal year, as adjusted or otherwise affected under 

24 subsection (c). 


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1 ‘‘(4) EXCESS COLLECTIONS.—If the sum total 

2 of fees collected under this section for a fiscal year 

3 exceeds the amount of fees authorized to be appro4 priated for such year under paragraph (3), the ex5 cess collections shall be credited to the appropria6 tions account of the Food and Drug Administration 

7 as described in paragraph (1).’’. 

8 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

9 Section 742 (21 U.S.C. 379j–22) is amended— 

10 (1) in subsection (a), by striking ‘‘2013’’ and 

11 inserting ‘‘2018’’; 

12 (2) by striking ‘‘2014’’ each place it appears in 

13 subsections (a) and (b) and inserting ‘‘2019’’; and 

14 (3) in subsection (d), by striking ‘‘2018’’ each 

15 place it appears and inserting ‘‘2023’’. 

16 SEC. 204. SAVINGS CLAUSE. 

17 Notwithstanding the amendments made by this title, 

18 part 5 of subchapter C of chapter VII of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as 

20 in effect on the day before the date of enactment of this 

21 title, shall continue to be in effect with respect to abbre22 viated applications for a generic new animal drug and sup23 plemental abbreviated applications for a generic new ani24 mal drug (as defined in such part as of such day) that 

25 on or after October 1, 2013, but before October 1, 2018, 


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1 were accepted by the Food and Drug Administration for 

2 filing with respect to assessing and collecting any fee re3 quired by such part for a fiscal year prior to fiscal year 

4 2019. 

5 SEC. 205. EFFECTIVE DATE. 

6 The amendments made by this title shall take effect 

7 on October 1, 2018, or the date of the enactment of this 

8 Act, whichever is later, except that fees under part 5 of 

9 subchapter C of chapter VII of the Federal Food, Drug, 

10 and Cosmetic Act, as amended by this title, shall be as11 sessed for abbreviated applications for a generic new ani12 mal drug and supplemental abbreviated applications for 

13 a generic new animal drug received on or after October 

14 1, 2018, regardless of the date of enactment of this Act. 

15 SEC. 206. SUNSET DATES. 

16 (a) AUTHORIZATION.—Section 741 of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 

18 cease to be effective October 1, 2023. 

19 (b) REPORTING REQUIREMENTS.—Section 742 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

21 22) shall cease to be effective January 31, 2024. 

22 (c) PREVIOUS SUNSET PROVISION.—Effective Octo23 ber 1, 2018, subsections (a) and (b) of section 206 of the 

24 Animal Generic Drug User Fee Amendments of 2013 

25 (Public Law 113–14) are repealed. 


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1 TITLE III—MISCELLANEOUS 

2 PROVISIONS 

3 SEC. 301. ELECTRONIC SUBMISSIONS. 

4 (a) NEW ANIMAL DRUG APPLICATIONS AND ABBRE5 VIATED APPLICATIONS FOR A GENERIC NEW ANIMAL

6 DRUG.—Section 512(b) (21 U.S.C. 360b(b)) is amended 

7 by adding at the end the following: 

8 ‘‘(4) Beginning on October 1, 2018, all applications 

9 or submissions pursuant to this subsection shall be sub10 mitted by electronic means in such format as the Sec11 retary may require.’’. 

12 (b) CONDITIONAL APPROVAL OF NEW ANIMAL

13 DRUGS FOR MINOR USE AND MINOR SPECIES.—Section 

14 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at 

15 the end the following: 

16 ‘‘(4) Beginning on October 1, 2018, all applications 

17 or submissions pursuant to this subsection shall be sub18 mitted by electronic means in such format as the Sec19 retary may require.’’. 

20 SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED 

21 NEW ANIMAL DRUGS FOR MINOR SPECIES. 

22 Effective on October 1, 2018, section 572(h) (21 

23 U.S.C. 360ccc–1(h)) is amended— 

24 (1) by amending paragraph (1) to read as fol25 lows: 


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1 ‘‘(1) ‘LEGAL STATUS—In order to be legally 

2 marketed, a new animal drug intended for a minor 

3 species must be Approved, Conditionally Approved, 

4 or Indexed by the Food and Drug Administration. 

5 THIS PRODUCT IS INDEXED—MIF.’ (followed 

6 by the applicable minor species index file number 

7 and a period) ‘Extra-label use is prohibited.’;’’; and 

8 (2) in paragraph (2), by striking ‘‘other ani9 mals’’ and inserting ‘‘food-producing animals’’. 

10 SEC. 303. MISBRANDED DRUGS AND DEVICES. 

11 (a) IN GENERAL.—Section 502(w) (21 U.S.C. 

12 352(w)) is amended— 

13 (1) in paragraph (1), by striking ‘‘; or’’ and in14 serting ‘‘;’’; 

15 (2) in paragraph (2), by striking the period and 

16 inserting ‘‘; or’’; and 

17 (3) by adding at the end the following: 

18 ‘‘(3) for which an application has been ap19 proved under section 512 and the labeling of such 

20 drug does not include the application number in the 

21 format: ‘Approved by FDA under (A)NADA # xxx22 xxx’, except that this subparagraph shall not apply 

23 to representative labeling required under section 

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1 lations (or any successor regulation) for animal feed 

2 bearing or containing a new animal drug.’’. 

3 (b) APPLICABILITY.—Section 502(w)(3) of the Fed4 eral Food, Drug, and Cosmetic Act, as added by sub5 section (a), shall apply beginning on September 30, 2023. 

6 SECTION 1. SHORT TITLE. 

7 This Act may be cited as the ‘‘Animal Drug and Ani8 mal Generic Drug User Fee Amendments of 2018’’. 

9 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

10 (a) TABLE OF CONTENTS.—The table of contents for 

11 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. Issuance of recommendations. 

Sec. 305. Guidance addressing investigation designs. 

Sec. 306. Food additives intended for use in animal food. 


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1 (b) REFERENCES IN ACT.—Except as otherwise speci2 fied, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 301 et seq.). 

6 TITLE I—FEES RELATING TO 

7 ANIMAL DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

9 (a) SHORT TITLE.—This title may be cited as the 

10 ‘‘Animal Drug User Fee Amendments of 2018’’. 

11 (b) FINDING.—Congress finds that the fees authorized 

12 by the amendments made in this title will be dedicated to13 ward expediting the animal drug development process and 

14 the review of new and supplemental animal drug applica15 tions and investigational animal drug submissions as set 

16 forth in the goals identified for purposes of part 4 of sub17 chapter C of chapter VII of the Federal Food, Drug, and 

18 Cosmetic Act, in the letters from the Secretary of Health 

19 and Human Services to the Chairman of the Committee on 

20 Energy and Commerce of the House of Representatives and 

21 the Chairman of the Committee on Health, Education, 

22 Labor, and Pensions of the Senate as set forth in the Con23 gressional Record. 

24 SEC. 102. DEFINITIONS. 

25 Section 739 (21 U.S.C. 379j–11) is amended— 


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1 (1) by amending paragraph (1) to read as fol2 lows: 

3 ‘‘(1)(A) The term ‘animal drug application’ 

4 means— 

5 ‘‘(i) an application for approval of any new 

6 animal drug submitted under section 512(b)(1); 

7 or 

8 ‘‘(ii) an application for conditional ap9 proval of a new animal drug submitted under 

10 section 571. 

11 ‘‘(B) Such term does not include either a new 

12 animal drug application submitted under section 

13 512(b)(2) or a supplemental animal drug applica14 tion.’’; and 

15 (2) in paragraph (8), by adding at the end the 

16 following: 

17 ‘‘(I) The activities necessary for implemen18 tation of the United States and European Union 

19 Good Manufacturing Practice Mutual Inspection 

20 Agreement with respect to animal drug products 

21 subject to review, including implementation ac22 tivities prior to and following product ap23 proval.’’. 


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1 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

2 FEES. 

3 (a) FEE REVENUE AMOUNTS.—Section 740(b) (21 

4 U.S.C. 379j–12(b)) is amended— 

5 (1) in paragraph (1)— 

6 (A) in subparagraph (A)— 

7 (i) by striking ‘‘2014’’ and inserting 

8 ‘‘2019’’; and 

9 (ii) by striking ‘‘$23,600,000’’ and in10 serting ‘‘$30,331,240’’; and 

11 (B) in subparagraph (B)— 

12 (i) by striking ‘‘2015 through 2018’’ 

13 and inserting ‘‘2020 through 2023’’; and 

14 (ii) by striking ‘‘$21,600,000’’ and in15 serting ‘‘$29,931,240’’; and 

16 (2) in paragraph (2), in the matter preceding 

17 subparagraph (A), by striking ‘‘determined’’ and in18 serting ‘‘established’’. 

19 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

20 (1) INFLATION ADJUSTMENT.—Section 740(c)(2) 

21 (21 U.S.C. 379j–12(c)(2)) is amended— 

22 (A) in the matter preceding subparagraph 

23 (A)— 

24 (i) by striking ‘‘For fiscal year 2015’’ 

25 and inserting ‘‘(A) For fiscal year 2020’’; 

26 and 


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1 (ii) by inserting ‘‘multiplying such 

2 revenue amounts by’’ before ‘‘an amount’’; 

3 (B) by redesignating subparagraphs (A), 

4 (B), and (C) as clauses (i), (ii), and (iii), respec5 tively; 

6 (C) by striking the flush text at the end; 

7 and 

8 (D) by adding at the end the following new 

9 subparagraph: 

10 ‘‘(B) COMPOUNDED BASIS.—The adjustment 

11 made each fiscal year after fiscal year 2020 under 

12 this paragraph shall be applied on a compounded 

13 basis to the revenue amount calculated under this 

14 paragraph for the most recent previous fiscal year.’’. 

15 (2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 

16 of section 740(c) (21 U.S.C. 379j–12(c)) is amended 

17 to read as follows: 

18 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

19 ‘‘(A) IN GENERAL.—For fiscal year 2020 

20 and subsequent fiscal years, after the fee revenue 

21 amounts established under subsection (b) are ad22 justed for inflation in accordance with para23 graph (2), the fee revenue amounts shall be fur24 ther adjusted for such fiscal year to reflect 

25 changes in the workload of the Secretary for the 


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1 process for the review of animal drug applica2 tions, subject to subparagraphs (B) and (C). 

3 With respect to such adjustment— 

4 ‘‘(i) such adjustment shall be deter5 mined by the Secretary based on a weighted 

6 average of the change in the total number of 

7 animal drug applications, supplemental 

8 animal drug applications for which data 

9 with respect to safety or effectiveness are re10 quired, manufacturing supplemental ani11 mal drug applications, investigational ani12 mal drug study submissions, and investiga13 tional animal drug protocol submissions 

14 submitted to the Secretary; and 

15 ‘‘(ii) the Secretary shall publish in the 

16 Federal Register the fees resulting from such 

17 adjustment and the supporting methodolo18 gies. 

19 ‘‘(B) REDUCTION OF WORKLOAD-BASED IN20 CREASE BY AMOUNT OF CERTAIN EXCESS COL21 LECTIONS.—For each of fiscal years 2021 

22 through 2023, if application of the workload ad23 justment under subparagraph (A) increases the 

24 fee revenue amounts otherwise established for the 

25 fiscal year under subsection (b), as adjusted for 


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1 inflation under paragraph (2), such fee revenue 

2 increase shall be reduced by the amount of any 

3 excess collections, as described in subsection 

4 (g)(4), for the second preceding fiscal year, up to 

5 the amount of such fee revenue increase. 

6 ‘‘(C) RULE OF APPLICATION.—Under no 

7 circumstances shall the workload adjustments 

8 under this paragraph result in fee revenues for 

9 a fiscal year that are less than the fee revenues 

10 for that fiscal year established under subsection 

11 (b), as adjusted for inflation under paragraph 

12 (2).’’. 

13 (3) FINAL YEAR ADJUSTMENT.—Section 

14 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— 

15 (A) by striking ‘‘2018’’ each place it ap16 pears and inserting ‘‘2023’’; and 

17 (B) by striking ‘‘2019’’ and inserting 

18 ‘‘2024’’. 

19 (c) EXEMPTIONS FROM FEES.—Section 740(d) (21 

20 U.S.C. 379j–12(d)) is amended— 

21 (1) in the subsection heading, by inserting ‘‘; 

22 EXEMPTIONS FROM FEES’’ after ‘‘REDUCTION’’; 

23 (2) by striking the heading of paragraph (1) and 

24 inserting ‘‘WAIVER OR REDUCTION’’; and 

25 (3) by adding at the end the following: 


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1 ‘‘(4) EXEMPTIONS FROM FEES.— 

2 ‘‘(A) CERTAIN LABELING SUPPLEMENTS TO

3 ADD NUMBER OF APPROVED APPLICATION.—Fees 

4 under this section shall not apply with respect to 

5 any person who— 

6 ‘‘(i) not later than September 30, 2023, 

7 submits a supplemental animal drug appli8 cation relating to a new animal drug appli9 cation approved under section 512, solely to 

10 add the new animal drug application num11 ber to the labeling of the drug in the man12 ner specified in section 502(w)(3); and 

13 ‘‘(ii) otherwise would be subject to fees 

14 under this section solely on the basis of such 

15 supplemental application. 

16 ‘‘(B) CERTAIN ANIMAL DRUG APPLICA17 TIONS.—Fees under paragraphs (2), (3), and (4) 

18 of subsection (a) shall not apply with respect to 

19 any person who is the named applicant or spon20 sor of an animal drug application, supplemental 

21 animal drug application, or investigational ani22 mal drug submission if such application or sub23 mission involves the intentional genomic alter24 ation of an animal that is intended to produce 


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1 a drug, device, or biological product subject to 

2 fees under section 736, 738, 744B, or 744H.’’. 

3 (d) CREDITING AND AVAILABILITY OF FEES.— 

4 (1) AUTHORIZATION OF APPROPRIATIONS.—Sec5 tion 740(g)(3) (21 U.S.C. 379j–12(g)(3)) is amend6 ed— 

7 (A) by striking ‘‘2014 through 2018’’ and 

8 inserting ‘‘2019 through 2023’’; 

9 (B) by striking ‘‘determined’’ and inserting 

10 ‘‘established’’; and 

11 (C) by striking ‘‘paragraph (4)’’ and insert12 ing ‘‘paragraph (5)’’. 

13 (2) EXCESS COLLECTIONS.—Section 740(g) (21 

14 U.S.C. 379j–12(g)) is amended by striking paragraph 

15 (4) and inserting the following: 

16 ‘‘(4) EXCESS COLLECTIONS.—If the sum total of 

17 fees collected under this section for a fiscal year ex18 ceeds the amount of fees authorized to be appropriated 

19 for such year under paragraph (3), the excess collec20 tions shall be credited to the appropriations account 

21 of the Food and Drug Administration as provided in 

22 paragraph (1). 

23 ‘‘(5) RECOVERY OF COLLECTION SHORTFALLS.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (B)— 


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1 ‘‘(i) for fiscal year 2021, the amount of 

2 fees otherwise authorized to be collected 

3 under this section shall be increased by the 

4 amount, if any, by which the amount col5 lected under this section and appropriated 

6 for fiscal year 2019 falls below the amount 

7 of fees authorized for fiscal year 2019 under 

8 paragraph (3); 

9 ‘‘(ii) for fiscal year 2022, the amount 

10 of fees otherwise authorized to be collected 

11 under this section shall be increased by the 

12 amount, if any, by which the amount col13 lected under this section and appropriated 

14 for fiscal year 2020 falls below the amount 

15 of fees authorized for fiscal year 2020 under 

16 paragraph (3); and 

17 ‘‘(iii) for fiscal year 2023, the amount 

18 of fees otherwise authorized to be collected 

19 under this section shall be increased by the 

20 cumulative amount, if any, by which the 

21 amount collected under this section and ap22 propriated for fiscal years 2021 and 2022 

23 (including estimated collections for fiscal 

24 year 2022) falls below the cumulative 


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1 amount of fees authorized for such fiscal 

2 years under paragraph (3). 

3 ‘‘(B) REDUCTION OF SHORTFALL-BASED

4 FEE INCREASE BY PRIOR YEAR EXCESS COLLEC5 TIONS.— 

6 ‘‘(i) IN GENERAL.—Subject to clause 

7 (ii), the Secretary shall, in such manner as 

8 the Secretary determines appropriate, re9 duce any fee increase otherwise applicable 

10 for a fiscal year under subparagraph (A) by 

11 the amount of any excess collections under 

12 this section for preceding fiscal years (after 

13 fiscal year 2018). 

14 ‘‘(ii) WORKLOAD-BASED FEE ACCOUNT15 ING.—In applying clause (i), the Secretary 

16 shall account for the reduction of workload17 based fee revenue increases by excess collec18 tions under subsection (c)(3)(B), in such 

19 manner as needed to provide that no por20 tion of any excess collections described in 

21 clause (i) is applied for purposes of reduc22 ing fee increases under both such subsection 

23 (c)(3)(B) and this paragraph. 

24 ‘‘(C) RULE OF APPLICATION.—Under no 

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1 graph result in fee revenues for a fiscal year that 

2 are less than the fee revenues for that fiscal year 

3 established in subsection (b), as adjusted or oth4 erwise affected under subsection (c).’’. 

5 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

6 Section 740A (21 U.S.C. 379j–13) is amended— 

7 (1) in subsection (a), by striking ‘‘2013’’ and in8 serting ‘‘2018’’; 

9 (2) by striking ‘‘2014’’ each place it appears in 

10 subsections (a) and (b) and inserting ‘‘2019’’; and 

11 (3) in subsection (d), by striking ‘‘2018’’ each 

12 place it appears and inserting ‘‘2023’’. 

13 SEC. 105. SAVINGS CLAUSE. 

14 Notwithstanding the amendments made by this title, 

15 part 4 of subchapter C of chapter VII of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in 

17 effect on the day before the date of enactment of this title, 

18 shall continue to be in effect with respect to animal drug 

19 applications and supplemental animal drug applications 

20 (as defined in such part as of such day) that on or after 

21 October 1, 2013, but before October 1, 2018, were accepted 

22 by the Food and Drug Administration for filing with re23 spect to assessing and collecting any fee required by such 

24 part for a fiscal year prior to fiscal year 2019. 


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1 SEC. 106. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

3 on October 1, 2018, or the date of the enactment of this 

4 Act, whichever is later, except that fees under part 4 of sub5 chapter C of chapter VII of the Federal Food, Drug, and 

6 Cosmetic Act, as amended by this title, shall be assessed for 

7 animal drug applications and supplemental animal drug 

8 applications received on or after October 1, 2018, regardless 

9 of the date of the enactment of this Act. 

10 SEC. 107. SUNSET DATES. 

11 (a) AUTHORIZATION.—Section 740 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall 

13 cease to be effective October 1, 2023. 

14 (b) REPORTING REQUIREMENTS.—Section 740A of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

16 13) shall cease to be effective January 31, 2024. 

17 (c) PREVIOUS SUNSET PROVISION.—Effective October 

18 1, 2018, subsections (a) and (b) of section 107 of the Animal 

19 Drug User Fee Amendments of 2013 (Public Law 113–14) 

20 are repealed. 

21 TITLE II—FEES RELATING TO 

22 GENERIC ANIMAL DRUGS 

23 SEC. 201. SHORT TITLE; FINDING. 

24 (a) SHORT TITLE.—This title may be cited as the 

25 ‘‘Animal Generic Drug User Fee Amendments of 2018’’. 


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1 (b) FINDING.—Congress finds that the fees authorized 

2 by the amendments made in this title will be dedicated to3 ward expediting the generic new animal drug development 

4 process and the review of abbreviated applications for ge5 neric new animal drugs, supplemental abbreviated applica6 tions for generic new animal drugs, and investigational 

7 submissions for generic new animal drugs as set forth in 

8 the goals identified for purposes of part 5 of subchapter C 

9 of chapter VII of the Federal Food, Drug, and Cosmetic Act, 

10 in the letters from the Secretary of Health and Human 

11 Services to the Chairman of the Committee on Energy and 

12 Commerce of the House of Representatives and the Chair13 man of the Committee on Health, Education, Labor, and 

14 Pensions of the Senate as set forth in the Congressional 

15 Record. 

16 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

17 ANIMAL DRUG FEES. 

18 (a) FEE REVENUE AMOUNTS.—Subsection (b) of sec19 tion 741 (21 U.S.C. 379j–21) is amended to read as follows: 

20 ‘‘(b) FEE REVENUE AMOUNTS.— 

21 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

22 (d), (f), and (g), for each of fiscal years 2019 through 

23 2023, the fees required under subsection (a) shall be 

24 established to generate a total revenue amount of 

25 $18,336,340. 


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1 ‘‘(2) TYPES OF FEES.—Of the total revenue 

2 amount established for a fiscal year under paragraph 

3 (1)— 

4 ‘‘(A) 25 percent shall be derived from fees 

5 under subsection (a)(1) (relating to abbreviated 

6 applications for a generic new animal drug); 

7 ‘‘(B) 37.5 percent shall be derived from fees 

8 under subsection (a)(2) (relating to generic new 

9 animal drug products); and 

10 ‘‘(C) 37.5 percent shall be derived from fees 

11 under subsection (a)(3) (relating to generic new 

12 animal drug sponsors).’’. 

13 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

14 (1) INFLATION ADJUSTMENT.—Section 741(c) 

15 (21 U.S.C. 379j–21(c)) is amended— 

16 (A) by redesignating paragraphs (2) 

17 through (4) as paragraphs (3) through (5), re18 spectively; and 

19 (B) by inserting after paragraph (1) the fol20 lowing: 

21 ‘‘(2) INFLATION ADJUSTMENT.— 

22 ‘‘(A) IN GENERAL.—For fiscal year 2020 

23 and subsequent fiscal years, the revenue amounts 

24 established under subsection (b) shall be adjusted 

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1 eral Register, for a fiscal year, by multiplying 

2 such revenue amounts by an amount equal to the 

3 sum of— 

4 ‘‘(i) one; 

5 ‘‘(ii) the average annual percent 

6 change in the cost, per full-time equivalent 

7 position of the Food and Drug Administra8 tion, of all personnel compensation and ben9 efits paid with respect to such positions for 

10 the first 3 of the preceding 4 fiscal years for 

11 which data are available, multiplied by the 

12 average proportion of personnel compensa13 tion and benefits costs to total Food and 

14 Drug Administration costs for the first 3 of 

15 the preceding 4 fiscal years for which data 

16 are available; and 

17 ‘‘(iii) the average annual percent 

18 change that occurred in the Consumer Price 

19 Index for urban consumers (Washington20 Baltimore, DC–MD–VA–WV; not seasonally 

21 adjusted; all items less food and energy; an22 nual index) for the first 3 of the preceding 

23 4 years for which data are available multi24 plied by the average proportion of all costs 

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1 efits costs to total Food and Drug Adminis2 tration costs for the first 3 years of the pre3 ceding 4 fiscal years for which data are 

4 available. 

5 ‘‘(B) COMPOUNDED BASIS.—The adjustment 

6 made each fiscal year after fiscal year 2020 

7 under this paragraph shall be applied on a com8 pounded basis to the revenue amount calculated 

9 under this paragraph for the most recent pre10 vious fiscal year.’’. 

11 (2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 

12 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig13 nated, is amended to read as follows: 

14 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

15 ‘‘(A) IN GENERAL.—For fiscal year 2020 

16 and subsequent fiscal years, after the fee revenue 

17 amounts established under subsection (b) are ad18 justed for inflation in accordance with para19 graph (2), the fee revenue amounts shall be fur20 ther adjusted for each such fiscal year to reflect 

21 changes in the workload of the Secretary for the 

22 process for the review of abbreviated applications 

23 for generic new animal drugs, subject to sub24 paragraphs (B) and (C). With respect to such 

25 adjustment— 


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1 ‘‘(i) this adjustment shall be deter2 mined by the Secretary based on a weighted 

3 average of the change in the total number of 

4 abbreviated applications for generic new 

5 animal drugs, manufacturing supplemental 

6 abbreviated applications for generic new 

7 animal drugs, investigational generic new 

8 animal drug study submissions, and inves9 tigational generic new animal drug protocol 

10 submissions submitted to the Secretary; and 

11 ‘‘(ii) the Secretary shall publish in the 

12 Federal Register the fees resulting from this 

13 adjustment and the supporting methodolo14 gies. 

15 ‘‘(B) REDUCTION OF WORKLOAD-BASED IN16 CREASE BY AMOUNT OF CERTAIN EXCESS COL17 LECTIONS.—For each of fiscal years 2021 

18 through 2023, if application of the workload ad19 justment under subparagraph (A) increases the 

20 fee revenue amounts otherwise established for the 

21 fiscal year under subsection (b), as adjusted for 

22 inflation under paragraph (2), such fee revenue 

23 increase shall be reduced by the amount of any 

24 excess collections, as described in subsection 


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1 (g)(4), for the second preceding fiscal year, up to 

2 the amount of such fee revenue increase. 

3 ‘‘(C) RULE OF APPLICATION.—Under no 

4 circumstances shall workload adjustments under 

5 this paragraph result in fee revenues for a fiscal 

6 year that are less than the fee revenues for that 

7 fiscal year established under subsection (b), as 

8 adjusted for inflation under paragraph (2).’’. 

9 (3) FINAL YEAR ADJUSTMENT.—Paragraph (4) 

10 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig11 nated, is amended by— 

12 (A) striking ‘‘2018’’ each place it appears 

13 and inserting ‘‘2023’’; and 

14 (B) striking ‘‘2019’’ and inserting ‘‘2024’’. 

15 (c) FEE WAIVER OR REDUCTION; EXEMPTION FROM

16 FEES.—Subsection (d) of section 741 (21 U.S.C. 379j–21) 

17 is amended to read as follows: 

18 ‘‘(d) FEE WAIVER OR REDUCTION; EXEMPTION FROM

19 FEES.— 

20 ‘‘(1) FEE WAIVER OR REDUCTION.—The Sec21 retary shall grant a waiver from or a reduction of 1 

22 or more fees assessed under subsection (a) where the 

23 Secretary finds that the generic new animal drug is 

24 intended solely to provide for a minor use or minor 

25 species indication. 


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1 ‘‘(2) EXEMPTION FROM FEES.—Fees under this 

2 section shall not apply with respect to any person 

3 who— 

4 ‘‘(A) not later than September 30, 2023, 

5 submits a supplemental abbreviated application 

6 for a generic new animal drug approved under 

7 section 512, solely to add the application number 

8 to the labeling of the drug in the manner speci9 fied in section 502(w)(3); and 

10 ‘‘(B) otherwise would be subject to fees 

11 under this section solely on the basis of such sup12 plemental abbreviated application.’’. 

13 (d) CREDITING AND AVAILABILITY OF FEES.—Section 

14 741(g) (21 U.S.C. 379j–21) is amended by striking para15 graph (3) and inserting the following paragraphs: 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

17 each of the fiscal years 2019 through 2023, there is 

18 authorized to be appropriated for fees under this sec19 tion an amount equal to the total revenue amount es20 tablished under subsection (b) for the fiscal year, as 

21 adjusted or otherwise affected under subsection (c). 

22 ‘‘(4) EXCESS COLLECTIONS.—If the sum total of 

23 fees collected under this section for a fiscal year ex24 ceeds the amount of fees authorized to be appropriated 

25 for such year under paragraph (3), the excess collecVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6203 E:\BILLS\S2434.RS S2434

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1 tions shall be credited to the appropriations account 

2 of the Food and Drug Administration as provided in 

3 paragraph (1).’’. 

4 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

5 Section 742 (21 U.S.C. 379j–22) is amended— 

6 (1) in subsection (a), by striking ‘‘2013’’ and in7 serting ‘‘2018’’; 

8 (2) by striking ‘‘2014’’ each place it appears in 

9 subsections (a) and (b) and inserting ‘‘2019’’; and 

10 (3) in subsection (d), by striking ‘‘2018’’ each 

11 place it appears and inserting ‘‘2023’’. 

12 SEC. 204. SAVINGS CLAUSE. 

13 Notwithstanding the amendments made by this title, 

14 part 5 of subchapter C of chapter VII of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in 

16 effect on the day before the date of enactment of this title, 

17 shall continue to be in effect with respect to abbreviated ap18 plications for a generic new animal drug and supplemental 

19 abbreviated applications for a generic new animal drug (as 

20 defined in such part as of such day) that on or after October 

21 1, 2013, but before October 1, 2018, were accepted by the 

22 Food and Drug Administration for filing with respect to 

23 assessing and collecting any fee required by such part for 

24 a fiscal year prior to fiscal year 2019. 


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1 SEC. 205. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

3 on October 1, 2018, or the date of the enactment of this 

4 Act, whichever is later, except that fees under part 5 of sub5 chapter C of chapter VII of the Federal Food, Drug, and 

6 Cosmetic Act, as amended by this title, shall be assessed for 

7 abbreviated applications for a generic new animal drug and 

8 supplemental abbreviated applications for a generic new 

9 animal drug received on or after October 1, 2018, regardless 

10 of the date of enactment of this Act. 

11 SEC. 206. SUNSET DATES. 

12 (a) AUTHORIZATION.—Section 741 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 

14 cease to be effective October 1, 2023. 

15 (b) REPORTING REQUIREMENTS.—Section 742 of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

17 22) shall cease to be effective January 31, 2024. 

18 (c) PREVIOUS SUNSET PROVISION.—Effective October 

19 1, 2018, subsections (a) and (b) of section 206 of the Animal 

20 Generic Drug User Fee Amendments of 2013 (Public Law 

21 113–14) are repealed. 

22 TITLE III—MISCELLANEOUS 

23 PROVISIONS 

24 SEC. 301. ELECTRONIC SUBMISSIONS. 

25 (a) NEW ANIMAL DRUG APPLICATIONS AND ABBRE26 VIATED APPLICATIONS FOR A GENERIC NEW ANIMAL


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1 DRUG.—Section 512(b) (21 U.S.C. 360b(b)) is amended by 

2 adding at the end the following: 

3 ‘‘(4) Beginning on October 1, 2018, all applications 

4 or submissions pursuant to this subsection shall be sub5 mitted by electronic means in such format as the Secretary 

6 may require.’’. 

7 (b) CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS

8 FOR MINOR USE AND MINOR SPECIES.—Section 571(a) (21 

9 U.S.C. 360ccc(a)) is amended by adding at the end the fol10 lowing: 

11 ‘‘(4) Beginning on October 1, 2018, all applications 

12 or submissions pursuant to this subsection shall be sub13 mitted by electronic means in such format as the Secretary 

14 may require.’’. 

15 SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED 

16 NEW ANIMAL DRUGS FOR MINOR SPECIES. 

17 Effective on October 1, 2018, section 572(h) (21 U.S.C. 

18 360ccc–1(h)) is amended— 

19 (1) by amending paragraph (1) to read as fol20 lows: 

21 ‘‘(1) ‘LEGAL STATUS—In order to be legally 

22 marketed, a new animal drug intended for a minor 

23 species must be Approved, Conditionally Approved, or 

24 Indexed by the Food and Drug Administration. THIS 

25 PRODUCT IS INDEXED—MIF.’ (followed by the 


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1 applicable minor species index file number and a pe2 riod) ‘Extra-label use is prohibited.’;’’; and 

3 (2) in paragraph (2), by striking ‘‘other ani4 mals’’ and inserting ‘‘food-producing animals’’. 

5 SEC. 303. MISBRANDED DRUGS AND DEVICES. 

6 (a) IN GENERAL.—Section 502(w) (21 U.S.C. 352(w)) 

7 is amended— 

8 (1) in paragraph (1), by striking ‘‘; or’’ and in9 serting ‘‘;’’; 

10 (2) in paragraph (2), by striking the period and 

11 inserting ‘‘; or’’; and 

12 (3) by adding at the end the following: 

13 ‘‘(3) for which an application has been approved 

14 under section 512 and the labeling of such drug does 

15 not include the application number in the format: 

16 ‘Approved by FDA under (A)NADA # xxx-xxx’, ex17 cept that this subparagraph shall not apply to rep18 resentative labeling required under section 

19 514.1(b)(3)(v)(b) of title 21, Code of Federal Regula20 tions (or any successor regulation) for animal feed 

21 bearing or containing a new animal drug.’’. 

22 (b) APPLICABILITY.—Section 502(w)(3) of the Federal 

23 Food, Drug, and Cosmetic Act, as added by subsection (a), 

24 shall apply beginning on September 30, 2023. 


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1 SEC. 304. ISSUANCE OF RECOMMENDATIONS. 

2 Not later than September 30, 2019, the Secretary of 

3 Health and Human Services (referred to in this section as 

4 the ‘‘Secretary’’) shall issue recommendations that the Sec5 retary, in the letters described in section 101(b) of the Ani6 mal Drug User Fee Amendments of 2013 (Public Law 113– 

7 14), agreed to develop regarding the feasibility of pursuing 

8 statutory revisions that may expand the use of conditional 

9 approval of new animal drugs under section 571 of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) to 

11 appropriate categories of new animal drugs. 

12 SEC. 305. GUIDANCE ADDRESSING INVESTIGATION DE13 SIGNS. 

14 (a) IN GENERAL.—For purposes of assisting sponsors 

15 in incorporating complex adaptive and other novel inves16 tigation designs, data from foreign countries, real world 

17 evidence (including ongoing surveillance activities, observa18 tional studies, and registry data), biomarkers, and surro19 gate endpoints (referred to in this section as ‘‘elements of 

20 investigations’’) into proposed clinical investigation proto21 cols and applications for new animal drugs under sections 

22 512 and 571 of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 360b; 360ccc), the Secretary of Health and 

24 Human Services (referred to in this section as the ‘‘Sec25 retary’’) shall issue guidance addressing the use of such eleVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6203 E:\BILLS\S2434.RS S2434

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1 ments of investigations in the development and regulatory 

2 review of such new animal drugs. 

3 (b) CONTENTS.—The guidance under subsection (a) 

4 shall address how the Secretary will evaluate the elements 

5 of investigations proposed or submitted pursuant to section 

6 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act 

7 or to meet the commitment under section 571(a)(2)(F) of 

8 such Act, and how sponsors of such applications may obtain 

9 feedback from the Secretary on technical issues related to 

10 such investigations prior to the submission of an applica11 tion to the Secretary. 

12 (c) MEETING.—Prior to issuing the guidance under 

13 subsection (a), the Secretary shall consult with stakeholders, 

14 including representatives of regulated industry, consumer 

15 groups, academia, veterinarians, and food producers, 

16 through a public meeting to be held not later than 1 year 

17 after the date of enactment of this Act. 

18 (d) TIMING.—The Secretary shall issue a draft guid19 ance under subsection (a) not later than 1 year after the 

20 date of the public meeting under subsection (c), and shall 

21 finalize such guidance not later than 1 year after the date 

22 on which the public comment period on such draft guidance 

23 ends. 


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1 SEC. 306. FOOD ADDITIVES INTENDED FOR USE IN ANIMAL 

2 FOOD. 

3 (a) FOOD ADDITIVE PETITIONS FOR ANIMAL FOOD.— 

4 Section 409 of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 348) is amended by adding at the end the fol6 lowing: 

7 ‘‘(k) FOOD ADDITIVES INTENDED FOR USE IN ANIMAL

8 FOOD.—(1) In taking action on a petition under subsection 

9 (c) for, or for recognition of, a food additive intended for 

10 use in animal food, the Secretary shall review reports of 

11 investigations conducted in foreign countries, provided by 

12 the petitioner. 

13 ‘‘(2) The Secretary shall post on the internet website 

14 of the Food and Drug Administration, no later than March 

15 1 of each year, on— 

16 ‘‘(A) the number of petitions for food additives 

17 intended for use in animal food filed under subsection 

18 (b) that are pending; 

19 ‘‘(B) how long each such petition submitted 

20 under subsection (b) has been pending, including such 

21 petitions the Secretary has extended under subsection 

22 (c)(2); and 

23 ‘‘(C) the number of study protocols that have 

24 been pending review for over 50 days, and the number 

25 that have received an extension. 


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1 ‘‘(3) In the case of a food additive petition intended 

2 for use in animal food, the Secretary shall provide informa3 tion to the petitioner on the required contents of such peti4 tion. If the Secretary requires additional studies beyond 

5 what the petitioner proposed, the Secretary shall provide 

6 the scientific rationale for such requirement.’’. 

7 (b) ENSURING THE SAFETY OF PET FOOD.—Section 

8 1002(a) of the Food and Drug Administration Amendments 

9 Act of 2007 (21 U.S.C. 2102(a)) is amended— 

10 (1) by striking paragraph (1); and 

11 (2) by redesignating paragraphs (2) and (3) as 

12 paragraphs (1) and (2), respectively. 

13 (c) GUIDANCE ON PRE-PETITION CONSULTATION

14 PROCESS FOR ANIMAL FOOD ADDITIVES.— 

15 (1) IN GENERAL.—Not later than 18 months 

16 after the date of enactment of this Act, the Secretary 

17 of Health and Human Services (referred to in this 

18 subsection as the ‘‘Secretary’’) shall publish draft 

19 guidance relating to the voluntary pre-petition con20 sultation process for food additives intended for use in 

21 animal food. 

22 (2) CONTENTS.—The guidance under paragraph 

23 (1) shall include— 

24 (A) the recommended format to submit to 

25 the Food and Drug Administration existing 


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1 data, including any applicable foreign data, for 

2 assessment prior to submission of a food additive 

3 petition for animal food under section 409(b) of 

4 the Federal Food, Drug, and Cosmetic Act; 

5 (B) the manner and the number of days by 

6 which the Food and Drug Administration in7 tends to review and respond to such existing 

8 data, including with respect to providing a sci9 entific rationale for any additional data request; 

10 (C) circumstances under which the submis11 sion of study protocols is recommended prior to 

12 submission of a food additive petition under such 

13 section 409(b); 

14 (D) the manner in which the Secretary in15 tends to inform the person submitting a study 

16 protocol for a food additive if the review of such 

17 study protocol will take longer than 50 days; and 

18 (E) best practices for communication be19 tween the Food and Drug Administration and 

20 industry on the development of pre-petition sub21 missions of study protocols and existing data for 

22 food additives. 

23 (3) FINAL GUIDANCE.—The guidance under 

24 paragraph (1) shall be finalized, withdrawn, or reVerDate Sep 11 2014 22:39 Mar 07, 2018 Jkt 079200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6203 E:\BILLS\S2434.RS S2434

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1 issued not later than 1 year after the close of the com2 ment period on the draft guidance. 


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Calendar No. 341 

115TH CONGRESS 

2D SESSION S. 2434 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

new animal drugs and generic new animal drugs. Act to reauthorize user fee programs relating to 

MARCH 7, 2018 

Reported with an amendment 


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