II 

116TH CONGRESS 

1ST SESSION S. 1636 

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

scope of new chemical exclusivity. 

IN THE SENATE OF THE UNITED STATES 

MAY 23 (legislative day, MAY 22), 2019 

Mr. ROBERTS (for himself, Ms. SMITH, and Mr. CASSIDY) 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 with 

respect to the scope of new chemical exclusivity. 

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 ‘‘Ensuring Innovation 

5 Act’’. 

6 SEC. 2. NEW CHEMICAL EXCLUSIVITY SCOPE. 

7 Chapter V of the Federal Food, Drug, and Cosmetic 

8 Act is amended— 

9 (1) in section 505 (21 U.S.C. 355)— 

10 (A) in subsection (c)(3)(E)— 


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1 (i) in clause (ii), by striking ‘‘active 

2 ingredient (including any ester or salt of 

3 the active ingredient)’’ and inserting ‘‘ac4 tive moiety (as defined by the Secretary in 

5 section 314.3 of title 21, Code of Federal 

6 Regulations (or any successor regula7 tions))’’; and 

8 (ii) in clause (iii), by striking ‘‘active 

9 ingredient (including any ester or salt of 

10 the active ingredient)’’ and inserting ‘‘ac11 tive moiety (as defined by the Secretary in 

12 section 314.3 of title 21, Code of Federal 

13 Regulations (or any successor regula14 tions))’’; 

15 (B) in subsection (j)(5)(F)— 

16 (i) in clause (ii), by striking ‘‘active 

17 ingredient (including any ester or salt of 

18 the active ingredient)’’ and inserting ‘‘ac19 tive moiety (as defined by the Secretary in 

20 section 314.3 of title 21, Code of Federal 

21 Regulations (or any successor regula22 tions))’’; and 

23 (ii) in clause (iii), by striking ‘‘active 

24 ingredient (including any ester or salt of 

25 the active ingredient)’’ and inserting ‘‘acVerDate Sep 11 2014 02:38 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1636.IS S1636

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1 tive moiety (as defined by the Secretary in 

2 section 314.3 of title 21, Code of Federal 

3 Regulations (or any successor regula4 tions))’’; 

5 (C) in subsection (l)(2)(A)(i), by striking 

6 ‘‘active ingredient (including any ester or salt of 

7 the active ingredient)’’ and inserting ‘‘active 

8 moiety (as defined by the Secretary in section 

9 314.3 of title 21, Code of Federal Regulations 

10 (or any successor regulations))’’; 

11 (D) in subsection (s), in the matter pre12 ceding paragraph (1), by striking ‘‘active ingre13 dient (including any ester or salt of the active 

14 ingredient)’’ and inserting ‘‘active moiety (as 

15 defined by the Secretary in section 314.3 of 

16 title 21, Code of Federal Regulations (or any 

17 successor regulations))’’; and 

18 (E) in subsection (u)(1), in the matter pre19 ceding subparagraph (A)— 

20 (i) by striking ‘‘active ingredient (in21 cluding any ester or salt of the active in22 gredient)’’ and inserting ‘‘active moiety (as 

23 defined by the Secretary in section 314.3 

24 of title 21, Code of Federal Regulations (or 

25 any successor regulations))’’; and 


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1 (ii) by striking ‘‘same active ingre2 dient’’ and inserting ‘‘same active moiety’’; 

3 (2) in section 512(c)(2)(F) (21 U.S.C. 

4 360b(c)(2)(F))— 

5 (A) in clause (i), by striking ‘‘active ingre6 dient (including any ester or salt of the active 

7 ingredient)’’ and inserting ‘‘active moiety (as 

8 defined by the Secretary in section 314.3 of 

9 title 21, Code of Federal Regulations (or any 

10 successor regulations))’’; 

11 (B) in clause (ii), by striking ‘‘active ingre12 dient (including any ester or salt of the active 

13 ingredient)’’ and inserting ‘‘active moiety (as 

14 defined by the Secretary in section 314.3 of 

15 title 21, Code of Federal Regulations (or any 

16 successor regulations))’’; and 

17 (C) in clause (v), by striking ‘‘active ingre18 dient (including any ester or salt of the active 

19 ingredient)’’ and inserting ‘‘active moiety (as 

20 defined by the Secretary in section 314.3 of 

21 title 21, Code of Federal Regulations (or any 

22 successor regulations))’’; 

23 (3) in section 524(a)(4)(C) (21 U.S.C. 

24 360n(a)(4)(C)), by striking ‘‘active ingredient (in25 cluding any ester or salt of the active ingredient)’’ 


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1 and inserting ‘‘active moiety (as defined by the Sec2 retary in section 314.3 of title 21, Code of Federal 

3 Regulations (or any successor regulations))’’; 

4 (4) in section 529(a)(4)(A)(ii), by striking ‘‘ac5 tive ingredient (including any ester or salt of the ac6 tive ingredient)’’ and inserting ‘‘active moiety (as de7 fined by the Secretary in section 314.3 of title 21, 

8 Code of Federal Regulations (or any successor regu9 lations))’’; and 

10 (5) in section 565A(a)(4)(D) (21 U.S.C. 

11 360bbb–4a(a)(4)(D)), by striking ‘‘active ingredient 

12 (including any ester or salt of the active ingredient)’’ 

13 and inserting ‘‘active moiety (as defined by the Sec14 retary in section 314.3 of title 21, Code of Federal 

15 Regulations (or any successor regulations))’’. 

Æ 


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