II 

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 

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’’. 

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

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

8 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 


amozie on DSK30RV082PROD with BILLS
2 

•S 2434 IS

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. 

1 (b) REFERENCES IN ACT.—Except as otherwise spec2 ified, 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 

5 (21 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 author12 ized by the amendments made in this title will be dedi13 cated toward expediting the animal drug development 

14 process and the review of new and supplemental animal 


amozie on DSK30RV082PROD with BILLS
3 

•S 2434 IS

1 drug applications and investigational animal drug submis2 sions as set forth in the goals identified for purposes of 

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

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

5 of Health and Human Services to the Chairman of the 

6 Committee on Energy and Commerce of the House of 

7 Representatives and the Chairman of the Committee on 

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

9 set forth in the Congressional Record. 

10 SEC. 102. DEFINITIONS. 

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

12 (1) by amending paragraph (1) to read as fol13 lows: 

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

15 means— 

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

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

18 or 

19 ‘‘(ii) an application for conditional ap20 proval of a new animal drug submitted under 

21 section 571. 

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

23 animal drug application submitted under section 

24 512(b)(2) or a supplemental animal drug applica25 tion.’’; and 


amozie on DSK30RV082PROD with BILLS
4 

•S 2434 IS

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

2 following: 

3 ‘‘(I) The activities necessary for implemen4 tation of the United States and European 

5 Union Good Manufacturing Practice Mutual In6 spection Agreement with respect to animal drug 

7 products subject to review, including implemen8 tation activities prior to and following product 

9 approval.’’. 

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

11 FEES. 

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

13 U.S.C. 379j–12(b)) is amended— 

14 (1) in paragraph (1)— 

15 (A) in subparagraph (A)— 

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

17 ‘‘2019’’; and 

18 (ii) by striking ‘‘$23,600,000’’ and in19 serting ‘‘$30,331,240’’; and 

20 (B) in subparagraph (B)— 

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

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

23 (ii) by striking ‘‘$21,600,000’’ and in24 serting ‘‘$29,931,240’’; and 


amozie on DSK30RV082PROD with BILLS
5 

•S 2434 IS

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

2 subparagraph (A), by striking ‘‘determined’’ and in3 serting ‘‘established’’. 

4 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

5 (1) INFLATION ADJUSTMENT.—Section 

6 740(c)(2) (21 U.S.C. 379j–12(c)(2)) is amended— 

7 (A) in the matter preceding subparagraph 

8 (A)— 

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

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

11 and 

12 (ii) by inserting ‘‘multiplying such 

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

14 (B) by redesignating subparagraphs (A), 

15 (B), and (C) as clauses (i), (ii), and (iii), re16 spectively; 

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

18 and 

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

20 subparagraph: 

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

22 made each fiscal year after fiscal year 2020 under 

23 this paragraph shall be applied on a compounded 

24 basis to the revenue amount calculated under this 

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


amozie on DSK30RV082PROD with BILLS
6 

•S 2434 IS

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

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

3 to read as follows: 

4 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

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

6 and subsequent fiscal years, after the fee rev7 enue amounts established under subsection (b) 

8 are adjusted for inflation in accordance with 

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

10 further adjusted for such fiscal year to reflect 

11 changes in the workload of the Secretary for 

12 the process for the review of animal drug appli13 cations, subject to subparagraphs (B) and (C). 

14 With respect to such adjustment— 

15 ‘‘(i) such adjustment shall be deter16 mined by the Secretary based on a weight17 ed average of the change in the total num18 ber of animal drug applications, supple19 mental animal drug applications for which 

20 data with respect to safety or effectiveness 

21 are required, manufacturing supplemental 

22 animal drug applications, investigational 

23 animal drug study submissions, and inves24 tigational animal drug protocol submis25 sions submitted to the Secretary; and 


amozie on DSK30RV082PROD with BILLS
7 

•S 2434 IS

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

2 Federal Register the fees resulting from 

3 such adjustment and the supporting meth4 odologies. 

5 ‘‘(B) REDUCTION OF WORKLOAD-BASED

6 INCREASE BY AMOUNT OF CERTAIN EXCESS

7 COLLECTIONS.—For each of fiscal years 2021 

8 through 2023, if application of the workload ad9 justment under subparagraph (A) increases the 

10 fee revenue amounts otherwise established for 

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

12 for inflation under paragraph (2), such fee rev13 enue increase shall be reduced by the amount of 

14 any excess collections, as described in sub15 section (g)(4), for the second preceding fiscal 

16 year, up to the amount of such fee revenue in17 crease. 

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

19 circumstances shall the workload adjustments 

20 under this paragraph result in fee revenues for 

21 a fiscal year that are less than the fee revenues 

22 for that fiscal year established under subsection 

23 (b), as adjusted for inflation under paragraph 

24 (2).’’. 


amozie on DSK30RV082PROD with BILLS
8 

•S 2434 IS

1 (3) FINAL YEAR ADJUSTMENT.—Section 

2 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— 

3 (A) by striking ‘‘2018’’ each place it ap4 pears and inserting ‘‘2023’’; and 

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

6 ‘‘2024’’. 

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

8 U.S.C. 379j–12(d)) is amended— 

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

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

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

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

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

14 ‘‘(4) EXEMPTIONS FROM FEES.— 

15 ‘‘(A) CERTAIN LABELING SUPPLEMENTS

16 TO ADD NUMBER OF APPROVED APPLICA17 TION.—Fees under this section shall not apply 

18 with respect to any person who— 

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

20 2023, submits a supplemental animal drug 

21 application relating to a new animal drug 

22 application approved under section 512, 

23 solely to add the new animal drug applica24 tion number to the labeling of the drug in 


amozie on DSK30RV082PROD with BILLS
9 

•S 2434 IS

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

2 and 

3 ‘‘(ii) otherwise would be subject to 

4 fees under this section solely on the basis 

5 of such supplemental application. 

6 ‘‘(B) CERTAIN ANIMAL DRUG APPLICA7 TIONS.—Fees under paragraphs (2), (3), and 

8 (4) of subsection (a) shall not apply with re9 spect to any person who is the named applicant 

10 or sponsor of an animal drug application, sup11 plemental animal drug application, or investiga12 tional animal drug submission if such applica13 tion or submission involves the intentional 

14 genomic alteration of an animal that is in15 tended to produce a drug, device, or biological 

16 product subject to fees under section 736, 738, 

17 744B, or 744H.’’. 

18 (d) CREDITING AND AVAILABILITY OF FEES.— 

19 (1) AUTHORIZATION OF APPROPRIATIONS.— 

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

21 amended— 

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

23 inserting ‘‘2019 through 2023’’; 

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

25 ‘‘established’’; and 


amozie on DSK30RV082PROD with BILLS
10 

•S 2434 IS

1 (C) by striking ‘‘paragraph (4)’’ and in2 serting ‘‘paragraph (5)’’. 

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

4 U.S.C. 379j–12(g)) is amended by striking para5 graph (4) and inserting the following: 

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

7 of fees collected under this section for a fiscal year 

8 exceeds the amount of fees authorized to be appro9 priated for such year under paragraph (3), the ex10 cess collections shall be credited to the appropria11 tions account of the Food and Drug Administration 

12 as described in paragraph (1). 

13 ‘‘(5) RECOVERY OF COLLECTION SHORT14 FALLS.— 

15 ‘‘(A) IN GENERAL.—Subject to subpara16 graph (B)— 

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

18 of fees otherwise authorized to be collected 

19 under this section shall be increased by the 

20 amount, if any, by which the amount col21 lected under this section and appropriated 

22 for fiscal year 2019 falls below the amount 

23 of fees authorized for fiscal year 2019 

24 under paragraph (3); 


amozie on DSK30RV082PROD with BILLS
11 

•S 2434 IS

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

2 of 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 2020 falls below the amount 

7 of fees authorized for fiscal year 2020 

8 under paragraph (3); and 

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

10 of fees otherwise authorized to be collected 

11 under this section shall be increased by the 

12 cumulative amount, if any, by which the 

13 amount collected under this section and 

14 appropriated for fiscal years 2021 and 

15 2022 (including estimated collections for 

16 fiscal year 2022) falls below the cumulative 

17 amount of fees authorized for such fiscal 

18 years under paragraph (3). 

19 ‘‘(B) REDUCTION OF SHORTFALL-BASED

20 FEE INCREASE BY PRIOR YEAR EXCESS COL21 LECTIONS.— 

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

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

24 the Secretary determines appropriate, re25 duce any fee increase otherwise applicable 


amozie on DSK30RV082PROD with BILLS
12 

•S 2434 IS

1 for a fiscal year under subparagraph (A) 

2 by the amount of any excess collections 

3 under this section for preceding fiscal 

4 years (after fiscal year 2018). 

5 ‘‘(ii) WORKLOAD-BASED FEE AC6 COUNTING.—In applying clause (i), the 

7 Secretary shall account for the reduction of 

8 workload-based fee revenue increases by 

9 excess collections under subsection 

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

11 provide that no portion of any excess col12 lections described in clause (i) is applied 

13 for purposes of reducing fee increases 

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

15 this paragraph. 

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

17 circumstances shall adjustments under this 

18 paragraph result in fee revenues for a fiscal 

19 year that are less than the fee revenues for that 

20 fiscal year established in subsection (b), as ad21 justed or otherwise affected under subsection 

22 (c).’’. 

23 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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


amozie on DSK30RV082PROD with BILLS
13 

•S 2434 IS

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

2 inserting ‘‘2018’’; 

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

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

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

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

7 SEC. 105. SAVINGS CLAUSE. 

8 Notwithstanding the amendments made by this title, 

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

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

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

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

13 drug applications and supplemental animal drug applica14 tions (as defined in such part as of such day) that on or 

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

16 accepted by the Food and Drug Administration for filing 

17 with respect to assessing and collecting any fee required 

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

19 SEC. 106. EFFECTIVE DATE. 

20 The amendments made by this title shall take effect 

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

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

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

24 and Cosmetic Act, as amended by this title, shall be as25 sessed for animal drug applications and supplemental aniVerDate Sep 11 2014 22:57 Feb 20, 2018 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2434.IS S2434

amozie on DSK30RV082PROD with BILLS
14 

•S 2434 IS

1 mal drug applications received on or after October 1, 

2 2018, regardless of the date of the enactment of this Act. 

3 SEC. 107. SUNSET DATES. 

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

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

6 cease to be effective October 1, 2023. 

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

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

9 379j–13) shall cease to be effective January 31, 2024. 

10 (c) PREVIOUS SUNSET PROVISION.—Effective Octo11 ber 1, 2018, subsections (a) and (b) of section 107 of the 

12 Animal Drug User Fee Amendments of 2013 (Public Law 

13 113–14) are repealed. 

14 TITLE II—FEES RELATING TO 

15 GENERIC ANIMAL DRUGS 

16 SEC. 201. SHORT TITLE; FINDING. 

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

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

19 (b) FINDING.—Congress finds that the fees author20 ized by the amendments made in this title will be dedi21 cated toward expediting the generic new animal drug de22 velopment process and the review of abbreviated applica23 tions for generic new animal drugs, supplemental abbre24 viated applications for generic new animal drugs, and in25 vestigational submissions for generic new animal drugs as 


amozie on DSK30RV082PROD with BILLS
15 

•S 2434 IS

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

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

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

4 Health and Human Services to the Chairman of the Com5 mittee on Energy and Commerce of the House of Rep6 resentatives and the Chairman of the Committee on 

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

8 set forth in the Congressional Record. 

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

10 ANIMAL DRUG FEES. 

11 (a) FEE REVENUE AMOUNTS.—Subsection (b) of sec12 tion 741 (21 U.S.C. 379j–21) is amended to read as fol13 lows: 

14 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

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

18 shall be established to generate a total revenue 

19 amount of $18,336,340. 

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

21 amount established for a fiscal year under para22 graph (1)— 

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

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

25 applications for a generic new animal drug); 


amozie on DSK30RV082PROD with BILLS
16 

•S 2434 IS

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

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

3 new animal drug products); and 

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

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

6 new animal drug sponsors).’’. 

7 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

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

9 (21 U.S.C. 379j–21(c)) is amended— 

10 (A) by redesignating paragraphs (2) 

11 through (4) as paragraphs (3) through (5), re12 spectively; and 

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

14 following: 

15 ‘‘(2) INFLATION ADJUSTMENT.— 

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

17 and subsequent fiscal years, the revenue 

18 amounts established under subsection (b) shall 

19 be adjusted by the Secretary by notice, pub20 lished in the Federal Register, for a fiscal year, 

21 by multiplying such revenue amounts by an 

22 amount equal to the sum of— 

23 ‘‘(i) one; 

24 ‘‘(ii) the average annual percent 

25 change in the cost, per full-time equivalent 


amozie on DSK30RV082PROD with BILLS
17 

•S 2434 IS

1 position of the Food and Drug Administra2 tion, of all personnel compensation and 

3 benefits paid with respect to such positions 

4 for the first 3 of the preceding 4 fiscal 

5 years for which data are available, multi6 plied by the average proportion of per7 sonnel compensation and benefits costs to 

8 total Food and Drug Administration costs 

9 for the first 3 of the preceding 4 fiscal 

10 years for which data are available; and 

11 ‘‘(iii) the average annual percent 

12 change that occurred in the Consumer 

13 Price Index for urban consumers (Wash14 ington-Baltimore, DC–MD–VA–WV; not 

15 seasonally adjusted; all items less food and 

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

17 preceding 4 years for which data are avail18 able multiplied by the average proportion 

19 of all costs other than personnel compensa20 tion and benefits costs to total Food and 

21 Drug Administration costs for the first 3 

22 of the preceding 4 fiscal years for which 

23 data are available. 

24 ‘‘(B) COMPOUNDED BASIS.—The adjust25 ment made each fiscal year after fiscal year 


amozie on DSK30RV082PROD with BILLS
18 

•S 2434 IS

1 2020 under this paragraph shall be applied on 

2 a compounded basis to the revenue amount cal3 culated under this paragraph for the most re4 cent previous fiscal year.’’. 

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

6 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig7 nated, is amended to read as follows: 

8 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

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

10 and subsequent fiscal years, after the fee rev11 enue amounts established under subsection (b) 

12 are adjusted for inflation in accordance with 

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

14 further adjusted for each such fiscal year to re15 flect changes in the workload of the Secretary 

16 for the process for the review of abbreviated ap17 plications for generic new animal drugs, subject 

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

19 such adjustment— 

20 ‘‘(i) this adjustment shall be deter21 mined by the Secretary based on a weight22 ed average of the change in the total num23 ber of abbreviated applications for generic 

24 new animal drugs, manufacturing supple25 mental abbreviated applications for generic 


amozie on DSK30RV082PROD with BILLS
19 

•S 2434 IS

1 new animal drugs, investigational generic 

2 new animal drug study submissions, and 

3 investigational generic new animal drug 

4 protocol submissions submitted to the Sec5 retary; and 

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

7 Federal Register the fees resulting from 

8 this 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 workload adjustments 

25 under this paragraph result in fee revenues for 


amozie on DSK30RV082PROD with BILLS
20 

•S 2434 IS

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.—Paragraph (4) 

6 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig7 nated, is amended by— 

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

9 and inserting ‘‘2023’’; and 

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

11 (c) FEE WAIVER OR REDUCTION; EXEMPTION FROM

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

13 21) is amended to read as follows: 

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

15 FROM FEES.— 

16 ‘‘(1) FEE WAIVER OR REDUCTION.—The Sec17 retary shall grant a waiver from or a reduction of 

18 1 or more fees assessed under subsection (a) where 

19 the Secretary finds that the generic new animal drug 

20 is intended solely to provide for a minor use or 

21 minor species indication. 

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

23 section shall not apply with respect to any person 

24 who— 


amozie on DSK30RV082PROD with BILLS
21 

•S 2434 IS

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

2 submits a supplemental abbreviated application 

3 for a generic new animal drug approved under 

4 section 512, solely to add the application num5 ber to the labeling of the drug in the manner 

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

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

8 under this section solely on the basis of such 

9 supplemental abbreviated application.’’. 

10 (d) CREDITING AND AVAILABILITY OF FEES.—Sec11 tion 741(g) (21 U.S.C. 379j–21) is amended by striking 

12 paragraph (3) and inserting the following paragraphs: 

13 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

14 For each of the fiscal years 2019 through 2023, 

15 there is authorized to be appropriated for fees under 

16 this section an amount equal to the total revenue 

17 amount established under subsection (b) for the fis18 cal year, as adjusted or otherwise affected under 

19 subsection (c). 

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

21 of fees collected under this section for a fiscal year 

22 exceeds the amount of fees authorized to be appro23 priated for such year under paragraph (3), the ex24 cess collections shall be credited to the appropriaVerDate Sep 11 2014 22:57 Feb 20, 2018 Jkt 079200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S2434.IS S2434

amozie on DSK30RV082PROD with BILLS
22 

•S 2434 IS

1 tions account of the Food and Drug Administration 

2 as described in paragraph (1).’’. 

3 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

4 Section 742 (21 U.S.C. 379j–22) 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. 204. SAVINGS CLAUSE. 

12 Notwithstanding the amendments made by this title, 

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

14 Drug, and Cosmetic Act (21 U.S.C. 379j–21 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 abbre17 viated applications for a generic new animal drug and sup18 plemental abbreviated applications for a generic new ani19 mal drug (as defined in such part as of such day) that 

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

21 were accepted by the Food and Drug Administration for 

22 filing with respect to assessing and collecting any fee re23 quired by such part for a fiscal year prior to fiscal year 

24 2019. 


amozie on DSK30RV082PROD with BILLS
23 

•S 2434 IS

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 

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

6 and Cosmetic Act, as amended by this title, shall be as7 sessed for abbreviated applications for a generic new ani8 mal drug and supplemental abbreviated applications for 

9 a generic new animal drug received on or after October 

10 1, 2018, regardless 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 Octo19 ber 1, 2018, subsections (a) and (b) of section 206 of the 

20 Animal Generic Drug User Fee Amendments of 2013 

21 (Public Law 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


amozie on DSK30RV082PROD with BILLS
24 

•S 2434 IS

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

2 by 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 Sec6 retary may require.’’. 

7 (b) CONDITIONAL APPROVAL OF NEW ANIMAL

8 DRUGS FOR MINOR USE AND MINOR SPECIES.—Section 

9 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at 

10 the end the following: 

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 Sec14 retary 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 

18 U.S.C. 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, 

24 or Indexed by the Food and Drug Administration. 

25 THIS PRODUCT IS INDEXED—MIF.’ (followed 


amozie on DSK30RV082PROD with BILLS
25 

•S 2434 IS

1 by the applicable minor species index file number 

2 and a period) ‘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. 

7 352(w)) 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 ap14 proved under section 512 and the labeling of such 

15 drug does not include the application number in the 

16 format: ‘Approved by FDA under (A)NADA # xxx17 xxx’, except that this subparagraph shall not apply 

18 to representative labeling required under section 

19 514.1(b)(3)(v)(b) of title 21, Code of Federal Regu20 lations (or any successor regulation) for animal feed 

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

22 (b) APPLICABILITY.—Section 502(w)(3) of the Fed23 eral Food, Drug, and Cosmetic Act, as added by sub24 section (a), shall apply beginning on September 30, 2023. 

Æ 


amozie on DSK30RV082PROD with BILLS