I 

115TH CONGRESS 

2D SESSION H. R. 5599 

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

conditional approval pathway for more animal drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 24, 2018 

Mr. HUDSON (for himself, Mr. SCHRADER, Mr. BUCSHON, Mr. BUTTERFIELD, 

and Mr. MULLIN) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

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

expand the conditional approval pathway for more animal 

drugs, and for other purposes. 

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 Health and 

5 Innovation Act of 2018’’. 

6 SEC. 2. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS. 

7 Section 571 of the Federal Food, Drug, and Cosmetic 

8 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), 

8 any person may file with the Secretary an applica9 tion for conditional approval of— 

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

11 minor 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 

15 or life-threatening disease or condition or 

16 addresses an unmet animal or human 

17 health need; and 

18 ‘‘(II) for which the Secretary deter19 mines that a demonstration of effectiveness 

20 would require a complex or particularly 

21 difficult study or studies. 

22 ‘‘(B) The Secretary shall, not later than Sep23 tember 30, 2019, issue guidance or regulations fur24 ther clarifying the criteria specified in subparagraph 

25 (A)(ii). 


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1 ‘‘(C) An application under this paragraph shall 

2 comply in all respects with the provisions of section 

3 512 except for subsections (a)(4), (b)(2), (c)(1), 

4 (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such sec5 tion unless otherwise stated in this section, and any 

6 additional provisions of this section. 

7 ‘‘(D) New animal drugs conditionally approved 

8 under this section are subject to application of the 

9 same safety standards that would be applied to new 

10 animal drugs approved under section 512(d) (includ11 ing, for antimicrobial new animal drugs, with respect 

12 to antimicrobial resistance).’’; and 

13 (B) in paragraph (3)— 

14 (i) in subparagraph (A), by striking 

15 the period at the end and inserting ‘‘or a 

16 new animal drug that is an antibiotic 

17 drug;’’; and 

18 (ii) in subparagraph (B), by striking 

19 ‘‘; or’’ and inserting ‘‘; or’’; and 

20 (3) in subsection (f)— 

21 (A) in paragraph (1), in the matter pre22 ceding subparagraph (A), by inserting ‘‘for the 

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

24 (B) in paragraph (2)— 


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

2 inserting ‘‘The Secretary shall, through 

3 regulation or guidance, determine under 

4 what conditions an intended use’’; and 

5 (ii) by striking ‘‘shall not’’ and insert6 ing ‘‘may’’. 

Æ 


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