II 

115TH CONGRESS 

2D SESSION H. R. 5554 

IN THE SENATE OF THE UNITED STATES 

JULY 17, 2018 

Received 

AN ACT 

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

reauthorize user fee programs relating to new animal 

drugs and generic new animal drugs. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Animal Drug and Ani3 mal Generic Drug User Fee Amendments of 2018’’. 

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

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

6 this Act is as follows: 

Sec. 1. Short title. 

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

TITLE I—FEES RELATING TO ANIMAL DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use animal drug fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Savings clause. 

Sec. 106. Effective date. 

Sec. 107. Sunset dates. 

TITLE II—FEES RELATING TO GENERIC ANIMAL DRUGS 

Sec. 201. Short title; finding. 

Sec. 202. Authority to assess and use generic new animal drug fees. 

Sec. 203. Reauthorization; reporting requirements. 

Sec. 204. Savings clause. 

Sec. 205. Effective date. 

Sec. 206. Sunset dates. 

TITLE III—MISCELLANEOUS PROVISIONS 

Sec. 301. Electronic submissions. 

Sec. 302. Index of legally marketed unapproved new animal drugs for minor 

species. 

Sec. 303. Misbranded drugs and devices. 

Sec. 304. Conditional approval of new animal drugs. 

Sec. 305. Guidance addressing investigation designs. 

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

7 (b) REFERENCES IN ACT.—Except as otherwise spec8 ified, amendments made by this Act to a section or other 

9 provision of law are amendments to such section or other 

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

11 (21 U.S.C. 301 et seq.). 


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1 TITLE I—FEES RELATING TO 

2 ANIMAL DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

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

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

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this title will be dedi8 cated toward expediting the animal drug development 

9 process and the review of new and supplemental animal 

10 drug applications and investigational animal drug submis11 sions as set forth in the goals identified for purposes of 

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

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

14 of Health and Human Services to the Chairman of the 

15 Committee on Energy and Commerce of the House of 

16 Representatives and the Chairman of the Committee on 

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

18 set forth in the Congressional Record. 

19 SEC. 102. DEFINITIONS. 

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

21 (1) by amending paragraph (1) to read as fol22 lows: 

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

24 means— 


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

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

3 or 

4 ‘‘(ii) an application for conditional ap5 proval of a new animal drug submitted under 

6 section 571. 

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

8 animal drug application submitted under section 

9 512(b)(2) or a supplemental animal drug applica10 tion.’’; and 

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

12 following: 

13 ‘‘(I) The activities necessary for implemen14 tation of the United States and European 

15 Union Good Manufacturing Practice Mutual In16 spection Agreement with respect to animal drug 

17 products subject to review, including implemen18 tation activities prior to and following product 

19 approval.’’. 

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

21 FEES. 

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

23 U.S.C. 379j–12(b)) is amended— 

24 (1) in paragraph (1)— 

25 (A) in subparagraph (A)— 


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

2 ‘‘2019’’; and 

3 (ii) by striking ‘‘$23,600,000’’ and in4 serting ‘‘$30,331,240’’; and 

5 (B) in subparagraph (B)— 

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

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

8 (ii) by striking ‘‘$21,600,000’’ and in9 serting ‘‘$29,931,240’’; and 

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

11 subparagraph (A), by striking ‘‘determined’’ and in12 serting ‘‘established’’. 

13 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

14 (1) INFLATION ADJUSTMENT.—Section 

15 740(c)(2) (21 U.S.C. 379j–12(c)(2)) is amended— 

16 (A) in the matter preceding subparagraph 

17 (A)— 

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

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

20 and 

21 (ii) by inserting ‘‘multiplying such 

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

23 (B) by redesignating subparagraphs (A), 

24 (B), and (C) as clauses (i), (ii), and (iii), re25 spectively; 


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

2 and 

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

4 subparagraph: 

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

6 made each fiscal year after fiscal year 2020 under 

7 this paragraph shall be applied on a compounded 

8 basis to the revenue amount calculated under this 

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

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

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

12 to read as follows: 

13 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

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

15 and subsequent fiscal years, after the fee rev16 enue amounts established under subsection (b) 

17 are adjusted for inflation in accordance with 

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

19 further adjusted for such fiscal year to reflect 

20 changes in the workload of the Secretary for 

21 the process for the review of animal drug appli22 cations, subject to subparagraphs (B) and (C). 

23 With respect to such adjustment— 

24 ‘‘(i) such adjustment shall be deter25 mined by the Secretary based on a weightVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 ed average of the change in the total num2 ber of animal drug applications, supple3 mental animal drug applications for which 

4 data with respect to safety or effectiveness 

5 are required, manufacturing supplemental 

6 animal drug applications, investigational 

7 animal drug study submissions, and inves8 tigational animal drug protocol submis9 sions submitted to the Secretary; and 

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

11 Federal Register the fees resulting from 

12 such adjustment and the supporting meth13 odologies. 

14 ‘‘(B) REDUCTION OF WORKLOAD-BASED

15 INCREASE BY AMOUNT OF CERTAIN EXCESS

16 COLLECTIONS.—For each of fiscal years 2021 

17 through 2023, if application of the workload ad18 justment under subparagraph (A) increases the 

19 fee revenue amounts otherwise established for 

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

21 for inflation under paragraph (2), such fee rev22 enue increase shall be reduced by the amount of 

23 any excess collections, as described in sub24 section (g)(4), for the second preceding fiscal 


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1 year, up to the amount of such fee revenue in2 crease. 

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

4 circumstances shall the workload adjustments 

5 under this paragraph result in fee revenues for 

6 a fiscal year that are less than the fee revenues 

7 for that fiscal year established under subsection 

8 (b), as adjusted for inflation under paragraph 

9 (2).’’. 

10 (3) FINAL YEAR ADJUSTMENT.—Section 

11 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— 

12 (A) by striking ‘‘2018’’ each place it ap13 pears and inserting ‘‘2023’’; and 

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

15 ‘‘2024’’. 

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

17 U.S.C. 379j–12(d)) is amended— 

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

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

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

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

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

23 ‘‘(4) EXEMPTIONS FROM FEES.— 

24 ‘‘(A) CERTAIN LABELING SUPPLEMENTS

25 TO ADD NUMBER OF APPROVED APPLICAVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 TION.—Fees under this section shall not apply 

2 with respect to any person who— 

3 ‘‘(i) not later than September 30, 

4 2023, submits a supplemental animal drug 

5 application relating to a new animal drug 

6 application approved under section 512, 

7 solely to add the new animal drug applica8 tion number to the labeling of the drug in 

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

10 and 

11 ‘‘(ii) otherwise would be subject to 

12 fees under this section solely on the basis 

13 of such supplemental application. 

14 ‘‘(B) CERTAIN ANIMAL DRUG APPLICA15 TIONS.—Fees under paragraphs (2), (3), and 

16 (4) of subsection (a) shall not apply with re17 spect to any person who is the named applicant 

18 or sponsor of an animal drug application, sup19 plemental animal drug application, or investiga20 tional animal drug submission if such applica21 tion or submission involves the intentional 

22 genomic alteration of an animal that is in23 tended to produce a drug, device, or biological 

24 product subject to fees under section 736, 738, 

25 744B, or 744H.’’. 


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1 (d) CREDITING AND AVAILABILITY OF FEES.— 

2 (1) AUTHORIZATION OF APPROPRIATIONS.— 

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

4 amended— 

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

6 inserting ‘‘2019 through 2023’’; 

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

8 ‘‘established’’; and 

9 (C) by striking ‘‘paragraph (4)’’ and in10 serting ‘‘paragraph (5)’’. 

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

12 U.S.C. 379j–12(g)) is amended by striking para13 graph (4) and inserting the following: 

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

15 of fees collected under this section for a fiscal year 

16 exceeds the amount of fees authorized to be appro17 priated for such year under paragraph (3), the ex18 cess collections shall be credited to the appropria19 tions account of the Food and Drug Administration 

20 as provided in paragraph (1). 

21 ‘‘(5) RECOVERY OF COLLECTION SHORT22 FALLS.— 

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graph (B)— 


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1 ‘‘(i) for fiscal year 2021, 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 2019 falls below the amount 

7 of fees authorized for fiscal year 2019 

8 under 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 

16 under 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 

22 appropriated for fiscal years 2021 and 

23 2022 (including estimated collections for 

24 fiscal 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 COL5 LECTIONS.— 

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) 

11 by the amount of any excess collections 

12 under this section for preceding fiscal 

13 years (after fiscal year 2018). 

14 ‘‘(ii) WORKLOAD-BASED FEE AC15 COUNTING.—In applying clause (i), the 

16 Secretary shall account for the reduction of 

17 workload-based fee revenue increases by 

18 excess collections under subsection 

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

20 provide that no portion of any excess col21 lections described in clause (i) is applied 

22 for purposes of reducing fee increases 

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

24 this paragraph. 


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

2 circumstances shall adjustments under this 

3 paragraph result in fee revenues for a fiscal 

4 year that are less than the fee revenues for that 

5 fiscal year established in subsection (b), as ad6 justed or otherwise affected under subsection 

7 (c).’’. 

8 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

9 Section 740A (21 U.S.C. 379j–13) 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. 105. SAVINGS CLAUSE. 

17 Notwithstanding the amendments made by this title, 

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

19 Drug, and Cosmetic Act (21 U.S.C. 379j–11 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 animal 

22 drug applications and supplemental animal drug applica23 tions (as defined in such part as of such day) that on or 

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

25 accepted by the Food and Drug Administration for filing 


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1 with respect to assessing and collecting any fee required 

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

3 SEC. 106. EFFECTIVE DATE. 

4 The amendments made by this title shall take effect 

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

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

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

8 and Cosmetic Act, as amended by this title, shall be as9 sessed for animal drug applications and supplemental ani10 mal drug applications received on or after October 1, 

11 2018, regardless of the date of the enactment of this Act. 

12 SEC. 107. SUNSET DATES. 

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

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

15 cease to be effective October 1, 2023. 

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

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

18 379j–13) shall cease to be effective January 31, 2024. 

19 (c) PREVIOUS SUNSET PROVISION.—Effective Octo20 ber 1, 2018, subsections (a) and (b) of section 107 of the 

21 Animal Drug User Fee Amendments of 2013 (Public Law 

22 113–14) are repealed. 


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1 TITLE II—FEES RELATING TO 

2 GENERIC ANIMAL DRUGS 

3 SEC. 201. SHORT TITLE; FINDING. 

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

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

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this title will be dedi8 cated toward expediting the generic new animal drug de9 velopment process and the review of abbreviated applica10 tions for generic new animal drugs, supplemental abbre11 viated applications for generic new animal drugs, and in12 vestigational submissions for generic new animal drugs as 

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

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

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

16 Health and Human Services to the Chairman of the Com17 mittee on Energy and Commerce of the House of Rep18 resentatives and the Chairman of the Committee on 

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

20 set forth in the Congressional Record. 

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

22 ANIMAL DRUG FEES. 

23 (a) FEE REVENUE AMOUNTS.—Subsection (b) of sec24 tion 741 (21 U.S.C. 379j–21) is amended to read as fol25 lows: 


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1 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

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

5 shall be established to generate a total revenue 

6 amount of $18,336,340. 

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

8 amount established for a fiscal year under para9 graph (1)— 

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

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

12 applications for a generic new animal drug); 

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

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

15 new animal drug products); and 

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

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

18 new animal drug sponsors).’’. 

19 (b) ANNUAL FEE SETTING; ADJUSTMENTS.— 

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

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

22 (A) by redesignating paragraphs (2) 

23 through (4) as paragraphs (3) through (5), re24 spectively; and 


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

2 following: 

3 ‘‘(2) INFLATION ADJUSTMENT.— 

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

5 and subsequent fiscal years, the revenue 

6 amounts established under subsection (b) shall 

7 be adjusted by the Secretary by notice, pub8 lished in the Federal Register, for a fiscal year, 

9 by multiplying such revenue amounts by an 

10 amount equal to the sum of— 

11 ‘‘(i) one; 

12 ‘‘(ii) the average annual percent 

13 change in the cost, per full-time equivalent 

14 position of the Food and Drug Administra15 tion, of all personnel compensation and 

16 benefits paid with respect to such positions 

17 for the first 3 of the preceding 4 fiscal 

18 years for which data are available, multi19 plied by the average proportion of per20 sonnel compensation and benefits costs to 

21 total Food and Drug Administration costs 

22 for the first 3 of the preceding 4 fiscal 

23 years for which data are available; and 

24 ‘‘(iii) the average annual percent 

25 change that occurred in the Consumer 


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1 Price Index for urban consumers (Wash2 ington-Baltimore, DC–MD–VA–WV; not 

3 seasonally adjusted; all items less food and 

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

5 preceding 4 years for which data are avail6 able multiplied by the average proportion 

7 of all costs other than personnel compensa8 tion and benefits costs to total Food and 

9 Drug Administration costs for the first 3 

10 of the preceding 4 fiscal years for which 

11 data are available. 

12 ‘‘(B) COMPOUNDED BASIS.—The adjust13 ment made each fiscal year after fiscal year 

14 2020 under this paragraph shall be applied on 

15 a compounded basis to the revenue amount cal16 culated under this paragraph for the most re17 cent previous fiscal year.’’. 

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

19 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig20 nated, is amended to read as follows: 

21 ‘‘(3) WORKLOAD ADJUSTMENTS.— 

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

23 and subsequent fiscal years, after the fee rev24 enue amounts established under subsection (b) 

25 are adjusted for inflation in accordance with 


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

2 further adjusted for each such fiscal year to re3 flect changes in the workload of the Secretary 

4 for the process for the review of abbreviated ap5 plications for generic new animal drugs, subject 

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

7 such adjustment— 

8 ‘‘(i) this adjustment shall be deter9 mined by the Secretary based on a weight10 ed average of the change in the total num11 ber of abbreviated applications for generic 

12 new animal drugs, manufacturing supple13 mental abbreviated applications for generic 

14 new animal drugs, investigational generic 

15 new animal drug study submissions, and 

16 investigational generic new animal drug 

17 protocol submissions submitted to the Sec18 retary; and 

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

20 Federal Register the fees resulting from 

21 this adjustment and the supporting meth22 odologies. 

23 ‘‘(B) REDUCTION OF WORKLOAD-BASED

24 INCREASE BY AMOUNT OF CERTAIN EXCESS

25 COLLECTIONS.—For each of fiscal years 2021 


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1 through 2023, if application of the workload ad2 justment under subparagraph (A) increases the 

3 fee revenue amounts otherwise established for 

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

5 for inflation under paragraph (2), such fee rev6 enue increase shall be reduced by the amount of 

7 any excess collections, as described in sub8 section (g)(4), for the second preceding fiscal 

9 year, up to the amount of such fee revenue in10 crease. 

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

12 circumstances shall workload adjustments 

13 under this paragraph result in fee revenues for 

14 a fiscal year that are less than the fee revenues 

15 for that fiscal year established under subsection 

16 (b), as adjusted for inflation under paragraph 

17 (2).’’. 

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

19 of section 741(c) (21 U.S.C. 379j–21(c)), as redesig20 nated, is amended by— 

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

22 and inserting ‘‘2023’’; and 

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


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1 (c) FEE WAIVER OR REDUCTION; EXEMPTION FROM

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

3 21) is amended to read as follows: 

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

5 FROM FEES.— 

6 ‘‘(1) FEE WAIVER OR REDUCTION.—The Sec7 retary shall grant a waiver from or a reduction of 

8 one or more fees assessed under subsection (a) 

9 where the Secretary finds that the generic new ani10 mal drug is intended solely to provide for a minor 

11 use or minor species indication. 

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

13 section shall not apply with respect to any person 

14 who— 

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

16 submits a supplemental abbreviated application 

17 for a generic new animal drug approved under 

18 section 512, solely to add the application num19 ber to the labeling of the drug in the manner 

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

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

22 under this section solely on the basis of such 

23 supplemental abbreviated application.’’. 


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1 (d) CREDITING AND AVAILABILITY OF FEES.—Sec2 tion 741(g) (21 U.S.C. 379j–21) is amended by striking 

3 paragraph (3) and inserting the following paragraphs: 

4 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

5 For each of the fiscal years 2019 through 2023, 

6 there is authorized to be appropriated for fees under 

7 this section an amount equal to the total revenue 

8 amount established under subsection (b) for the fis9 cal year, as adjusted or otherwise affected under 

10 subsection (c). 

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

12 of fees collected under this section for a fiscal year 

13 exceeds the amount of fees authorized to be appro14 priated for such year under paragraph (3), the ex15 cess collections shall be credited to the appropria16 tions account of the Food and Drug Administration 

17 as provided in paragraph (1).’’. 

18 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

21 inserting ‘‘2018’’; 

22 (2) in subsection (b), by striking ‘‘Committee 

23 on Health, Education, Labor, and Pensions’’ and in24 serting ‘‘the Committee on Health, Education, 

25 Labor and Pensions’’; 


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

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

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

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

5 SEC. 204. SAVINGS CLAUSE. 

6 Notwithstanding the amendments made by this title, 

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

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

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

10 title, shall continue to be in effect with respect to abbre11 viated applications for a generic new animal drug and sup12 plemental abbreviated applications for a generic new ani13 mal drug (as defined in such part as of such day) that 

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

15 were accepted by the Food and Drug Administration for 

16 filing with respect to assessing and collecting any fee re17 quired by such part for a fiscal year prior to fiscal year 

18 2019. 

19 SEC. 205. 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 5 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 abbreviated applications for a generic new aniVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 mal drug and supplemental abbreviated applications for 

2 a generic new animal drug received on or after October 

3 1, 2018, regardless of the date of enactment of this Act. 

4 SEC. 206. SUNSET DATES. 

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

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

7 cease to be effective October 1, 2023. 

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

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

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

11 (c) PREVIOUS SUNSET PROVISION.—Effective Octo12 ber 1, 2018, subsections (a) and (b) of section 206 of the 

13 Animal Generic Drug User Fee Amendments of 2013 

14 (Public Law 113–14) are repealed. 

15 TITLE III—MISCELLANEOUS 

16 PROVISIONS 

17 SEC. 301. ELECTRONIC SUBMISSIONS. 

18 (a) NEW ANIMAL DRUG APPLICATIONS AND ABBRE19 VIATED APPLICATIONS FOR A GENERIC NEW ANIMAL

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

21 by adding at the end the following: 

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

23 or submissions pursuant to this subsection shall be sub24 mitted by electronic means in such format as the Sec25 retary may require.’’. 


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1 (b) CONDITIONAL APPROVAL OF NEW ANIMAL

2 DRUGS FOR MINOR USE AND MINOR SPECIES.—Section 

3 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at 

4 the end the following: 

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

6 or submissions pursuant to this subsection shall be sub7 mitted by electronic means in such format as the Sec8 retary may require.’’. 

9 SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED 

10 NEW ANIMAL DRUGS FOR MINOR SPECIES. 

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

12 U.S.C. 360ccc–1(h)) is amended— 

13 (1) by amending paragraph (1) to read as fol14 lows: 

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

16 marketed, a new animal drug intended for a minor 

17 species must be Approved, Conditionally Approved, 

18 or Indexed by the Food and Drug Administration. 

19 THIS PRODUCT IS INDEXED—MIF #’ (fol20 lowed by the applicable minor species index file num21 ber and a period) ‘Extra-label use is prohibited.’;’’; 

22 and 

23 (2) in paragraph (2), by striking ‘‘other ani24 mals’’ and inserting ‘‘food-producing animals’’. 


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1 SEC. 303. MISBRANDED DRUGS AND DEVICES. 

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

3 352(w)) is amended— 

4 (1) in subparagraph (1), by striking ‘‘; or’’ and 

5 inserting ‘‘;’’; 

6 (2) in subparagraph (2), by striking the period 

7 and inserting ‘‘; or’’; and 

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

9 ‘‘(3) for which an application has been ap10 proved under section 512 and the labeling of such 

11 drug does not include the application number in the 

12 format: ‘Approved by FDA under (A)NADA # xxx– 

13 xxx’, except that this subparagraph shall not apply 

14 to representative labeling required under section 

15 514.1(b)(3)(v)(b) of title 21, Code of Federal Regu16 lations (or any successor regulation) for animal feed 

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

18 (b) APPLICABILITY.—Section 502(w)(3) of the Fed19 eral Food, Drug, and Cosmetic Act, as added by sub20 section (a), shall apply beginning on September 30, 2023. 

21 SEC. 304. CONDITIONAL APPROVAL OF NEW ANIMAL 

22 DRUGS. 

23 (a) IN GENERAL.—Section 571 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 360ccc) is amended— 


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1 (1) in the section heading, by striking ‘‘SPE2 CIES’’ and inserting ‘‘SPECIES AND CERTAIN

3 NEW ANIMAL DRUGS’’; 

4 (2) in subsection (a)— 

5 (A) by amending paragraph (1) to read as 

6 follows: 

7 ‘‘(1)(A) Except as provided in paragraph (3), any 

8 person may file with the Secretary an application for con9 ditional approval of— 

10 ‘‘(i) a new animal drug intended for a minor 

11 use or a minor species; or 

12 ‘‘(ii) a new animal drug not intended for a 

13 minor use or minor species— 

14 ‘‘(I) that is intended to treat a serious or 

15 life-threatening disease or condition or address16 es an unmet animal or human health need; and 

17 ‘‘(II) for which the Secretary determines 

18 that a demonstration of effectiveness would re19 quire a complex or particularly difficult study 

20 or studies. 

21 ‘‘(B) The Secretary shall, not later than September 

22 30, 2019, issue guidance or regulations further clarifying 

23 the criteria specified in subparagraph (A)(ii). 

24 ‘‘(C) An application under this paragraph shall com25 ply in all respects with the provisions of section 512 except 


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1 for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), 

2 (e), (h), and (n) of such section unless otherwise stated 

3 in this section, and any additional provisions of this sec4 tion. 

5 ‘‘(D) New animal drugs for which conditional ap6 proval is sought under this section are subject to the same 

7 safety standards that would be applied to new animal 

8 drugs under section 512(d) (including, for antimicrobial 

9 new animal drugs, with respect to antimicrobial resist10 ance).’’; and 

11 (B) in paragraph (3)— 

12 (i) in subparagraph (B), by striking ‘‘, 

13 or’’ and inserting ‘‘; or’’; 

14 (ii) by redesignating subparagraphs 

15 (A), (B), and (C) as clauses (i), (ii), and 

16 (iii), respectively; 

17 (iii) by striking ‘‘A person may not 

18 file’’ and inserting ‘‘(A) A person may not 

19 file’’; and 

20 (iv) by adding at the end the following 

21 new subparagraph: 

22 ‘‘(B) A person may not file an application under 

23 paragraph (1)(A)(ii) if the application seeks conditional 

24 approval of a new animal drug that contains an anti25 microbial active ingredient.’’; 


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1 (3) in subsection (f)— 

2 (A) in paragraph (1), in the matter pre3 ceding subparagraph (A), by inserting ‘‘for the 

4 conditionally approved use’’ after ‘‘shall’’; and 

5 (B) in paragraph (2)— 

6 (i) by striking ‘‘An intended use’’ and 

7 inserting ‘‘The Secretary shall, through 

8 regulation or guidance, determine under 

9 what conditions an intended use’’; and 

10 (ii) by striking ‘‘shall not’’ and insert11 ing ‘‘may’’; and 

12 (4) by adding at the end the following new sub13 section: 

14 ‘‘(k) SUNSET.— 

15 ‘‘(1) The Secretary’s authority to grant condi16 tional approval of new animal drugs not intended for 

17 a minor use or minor species pursuant to subsection 

18 (a)(1)(A)(ii) terminates on October 1, 2028. 

19 ‘‘(2) The Secretary— 

20 ‘‘(A) may not accept any new applications 

21 for such conditional approval pursuant to sub22 section (a)(1)(A)(ii) on or after such date; and 

23 ‘‘(B) may continue all activities under this 

24 section with respect to drugs that were condiVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 tionally approved pursuant to (a)(1)(A)(ii) prior 

2 to such date. 

3 ‘‘(3) The Secretary may, until October 1, 2032, 

4 accept applications for approval under 512 of drugs 

5 conditionally approved pursuant to (a)(1)(A)(ii).’’. 

6 (b) EXCEPTION FROM FEES IN CASE OF CERTAIN

7 PREVIOUSLY SUBMITTED APPLICATIONS FOR CONDI8 TIONAL APPROVAL.—Section 740(a)(1)(C) of the Federal 

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

10 12(a)(1)(C)) is amended— 

11 (1) in the caption by striking ‘‘EXCEPTION’’ 

12 and inserting ‘‘EXCEPTIONS’’; 

13 (2) by striking ‘‘If an animal drug’’ and insert14 ing the following: 

15 ‘‘(i) If an animal drug’’; and 

16 (3) by inserting after clause (i), as so des17 ignated, the following new clause: 

18 ‘‘(ii) Beginning with fiscal year 2019, 

19 in the case of an animal drug application 

20 submitted by a person under section 

21 512(b)(1), where such person (or their li22 censor, assignor, or predecessor-in-interest) 

23 previously submitted an application for 

24 conditional approval under section 571 for 

25 the same product and paid the applicable 


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1 fee under subparagraph (A), the applica2 tion under section 512(b)(1) shall not be 

3 subject to a fee under subparagraph (A) if 

4 submitted within the timeframe specified 

5 in section 571(h).’’. 

6 (c) REPORT ON INCORPORATING VETERINARY OVER7 SIGHT.—Not later than September 30, 2019, the Sec8 retary of Health and Human Services, acting through the 

9 Commissioner of Food and Drugs, shall submit a report 

10 to the Committee on Energy and Commerce of the House 

11 of Representatives and the Committee on Health, Edu12 cation, Labor and Pensions of the Senate identifying how 

13 the Food and Drug Administration will incorporate veteri14 nary oversight for all approved medically important anti15 microbial drugs administered to animals that are not yet 

16 subject to veterinary oversight. Such report shall address 

17 requirements related to revisions of labeling to reflect that 

18 medically important antimicrobial drugs administered to 

19 animals shall be subject to veterinary oversight. 

20 (d) GAO STUDY OF CONDITIONAL APPROVAL PRO21 GRAMS.— 

22 (1) STUDY.—The Comptroller General of the 

23 United States (referred to in this section as the 

24 ‘‘Comptroller General’’) shall conduct a study on the 

25 effectiveness and overall impact of the conditional 


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1 approval pathway under section 571 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc). 

3 (2) ISSUANCE OF REPORT.—Not later than 

4 January 1, 2026, the Comptroller General shall sub5 mit to the Committee on Health, Education, Labor 

6 and Pensions of the Senate and the Committee on 

7 Energy and Commerce of the House of Representa8 tives a report containing the results of the study 

9 under paragraph (1). 

10 (3) CONTENTS OF REPORTS.—The report sub11 mitted under paragraph (2) shall address— 

12 (A) for each drug for which a conditional 

13 approval has been awarded since October 1, 

14 2018— 

15 (i) whether the drug was granted con16 ditional approval pursuant to clause (i) or 

17 (ii) of section 571(a)(1)(A) of the Federal 

18 Food, Drug, and Cosmetic Act, as amend19 ed by subsection (a); 

20 (ii) whether the drug was dual labeled 

21 during its conditional approval; 

22 (iii) the indications for which the drug 

23 was granted conditional approval under 

24 section 571 of such Act (21 U.S.C. 

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1 proved or not approved under section 512 

2 of such Act (21 U.S.C. 360b); 

3 (iv) the number of years the drug was 

4 so conditionally approved and a description 

5 of the complexity of the investigation to 

6 demonstrate the drug’s effectiveness; 

7 (v) whether, and to what extent, the 

8 conditional approval pathway under such 

9 section 571 (21 U.S.C. 360ccc) impacted 

10 the sponsor’s decision to develop the drug 

11 or seek approval of the drug under section 

12 512 of such Act (21 U.S.C. 360b); 

13 (vi) whether, and to what extent, con14 ditional approval pursuant to clause (ii) of 

15 section 571(a)(1)(A) of such Act (21 

16 U.S.C. 360b(a)(1)(A)) addressed a serious 

17 or life-threatening condition; and 

18 (vii) whether, and to what extent, con19 ditional approval pursuant to clause (ii) of 

20 section 571(a)(1)(A) of such Act (21 

21 U.S.C. 360b(a)(1)(A)) addressed an unmet 

22 animal or human health need, and whether 

23 before such conditional approval there were 

24 available therapies for the disease or condi25 tion involved; 


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1 (B) an analysis of the conditional approval 

2 program under section 571 of such Act (21 

3 U.S.C. 360ccc), including— 

4 (i) the resources used by the Food 

5 and Drug Administration in reviewing ap6 plications for conditional approval of drugs 

7 pursuant to such program and renewal of 

8 such conditional approval, including the ef9 fects of the program on the Food and 

10 Drug Administration’s review of animal 

11 drugs for which conditional approval is not 

12 used; 

13 (ii) whether any improvements to the 

14 program under section 512 of such Act (21 

15 U.S.C. 360b) are necessary to incentivize 

16 the development of animal drugs that 

17 would likely not otherwise be developed, or 

18 developed in as timely a manner, to ad19 dress— 

20 (I) serious or life-threatening 

21 conditions; and 

22 (II) an unmet animal or human 

23 health need; and 

24 (iii) whether the conditional approval 

25 pathway has resulted in a greater number 


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1 of animal drugs approved under section 

2 512 of such Act (21 U.S.C. 360b) for seri3 ous or life-threatening conditions or unmet 

4 animal or human health needs than would 

5 have otherwise come to market under the 

6 practices and commitments of the Center 

7 for Veterinary Medicine of the Food and 

8 Drug Administration as such practices and 

9 commitments existed as of the day before 

10 the date of enactment of this Act; and 

11 (C) how the Center for Veterinary Medi12 cine of the Food and Drug Administration has 

13 utilized complex adaptive or other novel inves14 tigation designs, data from foreign countries, 

15 real-world evidence (including ongoing surveil16 lance activities, observational studies, and reg17 istry data), biomarkers, or surrogate 

18 endpoints— 

19 (i) to support the approval of products 

20 under section 512 of such Act (21 U.S.C. 

21 360b), including how many such products 

22 have been approved since October 1, 2018; 

23 and 

24 (ii) to support the approval of prod25 ucts under section 512 of such Act (21 


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1 U.S.C. 360b) that received conditional ap2 proval under section 571 of such Act (21 

3 U.S.C. 360ccc), including how many such 

4 products have been approved since October 

5 1, 2018. 

6 SEC. 305. GUIDANCE ADDRESSING INVESTIGATION DE7 SIGNS. 

8 (a) IN GENERAL.—For purposes of assisting spon9 sors in incorporating complex adaptive and other novel in10 vestigation designs, data from foreign countries, real world 

11 evidence (including ongoing surveillance activities, obser12 vational studies, and registry data), biomarkers, and sur13 rogate endpoints (referred to in this section as ‘‘elements 

14 of investigations’’) into proposed clinical investigation pro15 tocols and applications for new animal drugs under sec16 tions 512 and 571 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 360b; 360ccc), the Secretary of 

18 Health and Human Services (referred to in this section 

19 as the ‘‘Secretary’’) shall issue guidance addressing the 

20 use of such elements of investigations in the development 

21 and regulatory review of such new animal drugs. 

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

23 shall address how the Secretary will evaluate the elements 

24 of investigations proposed or submitted pursuant to sec25 tion 512(b)(1)(A) of the Federal Food, Drug, and CosVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 metic Act or to meet the commitment under section 

2 571(a)(2)(F) of such Act, and how sponsors of such appli3 cations may obtain feedback from the Secretary on tech4 nical issues related to such investigations prior to the sub5 mission of an application to the Secretary. 

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

7 subsection (a), the Secretary shall consult with stake8 holders, including representatives of regulated industry, 

9 consumer groups, academia, veterinarians, and food pro10 ducers, through a public meeting to be held not later than 

11 1 year after the date of enactment of this Act. 

12 (d) TIMING.—The Secretary shall issue a draft guid13 ance under subsection (a) not later than 1 year after the 

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

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

16 on which the public comment period on such draft guid17 ance ends. 

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

19 FOOD. 

20 (a) FOOD ADDITIVE PETITIONS FOR ANIMAL

21 FOOD.—Section 409 of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 348) is amended by adding at the 

23 end the following: 

24 ‘‘(k) FOOD ADDITIVES INTENDED FOR USE IN ANI25 MAL FOOD.—(1) In taking action on a petition under subVerDate Sep 11 2014 01:04 Aug 01, 2018 Jkt 079200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H5554.RDS H5554

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1 section (c) for, or for recognition of, a food additive in2 tended for use in animal food, the Secretary shall review 

3 reports of investigations conducted in foreign countries, 

4 provided by the petitioner. 

5 ‘‘(2) Not later than 12 months after the date of en6 actment of the Animal Drug and Animal Generic Drug 

7 Use Fee Amendments of 2018, the Secretary shall post 

8 on the internet website of the Food and Drug Administra9 tion— 

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

11 intended for use in animal food filed under sub12 section (b) that are pending; 

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

14 under subsection (b) has been pending, including 

15 such petitions the Secretary has extended under sub16 section (c)(2); and 

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

18 been pending review for over 50 days, and the num19 ber that have received an extension. 

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

21 for use in animal food, the Secretary shall provide infor22 mation to the petitioner on the required contents of such 

23 petition. If the Secretary requires additional studies be24 yond what the petitioner proposed, the Secretary shall pro25 vide the scientific rationale for such requirement.’’. 


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

2 1002(a) of the Food and Drug Administration Amend3 ments Act of 2007 (21 U.S.C. 2102(a)) is amended— 

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

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

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

7 (c) GUIDANCE ON PRE-PETITION CONSULTATION

8 PROCESS FOR ANIMAL FOOD ADDITIVES.— 

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

10 after the date of enactment of this Act, the Sec11 retary of Health and Human Services (referred to in 

12 this subsection as the ‘‘Secretary’’) shall publish 

13 draft guidance relating to the voluntary pre-petition 

14 consultation process for food additives intended for 

15 use in animal food. 

16 (2) CONTENTS.—The guidance under para17 graph (1) shall include— 

18 (A) the recommended format to submit to 

19 the Food and Drug Administration existing 

20 data, including any applicable foreign data, for 

21 assessment prior to submission of a food addi22 tive petition for animal food under section 

23 409(b) of the Federal Food, Drug, and Cos24 metic Act; 


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

2 which the Food and Drug Administration in3 tends to review and respond to such existing 

4 data, including with respect to providing a sci5 entific rationale for any additional data request; 

6 (C) circumstances under which the submis7 sion of study protocols is recommended prior to 

8 submission of a food additive petition under 

9 such section 409(b); 

10 (D) the manner in which the Secretary in11 tends to inform the person submitting a study 

12 protocol for a food additive if the review of such 

13 study protocol will take longer than 50 days; 

14 and 

15 (E) best practices for communication be16 tween the Food and Drug Administration and 

17 industry on the development of pre-petition sub18 missions of study protocols and existing data 

19 for food additives. 

20 (3) FINAL GUIDANCE.—The guidance under 

21 paragraph (1) shall be finalized, withdrawn, or 


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1 reissued not later than 1 year after the close of the 

2 comment period on the draft guidance. 

Passed the House of Representatives July 16, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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