116TH CONGRESS 

2D SESSION S. 1636 

AN ACT 

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, 
2 

†S 1636 ES

1 SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL 

2 ENTITY. 

3 (a) IN GENERAL.—Chapter V of the Federal Food, 

4 Drug, and Cosmetic Act is amended— 

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

6 (A) in subsection (c)(3)(E), by striking 

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

8 the active ingredient)’’ each place it appears 

9 and inserting ‘‘active moiety (as defined by the 

10 Secretary in section 314.3 of title 21, Code of 

11 Federal Regulations (or any successor regula12 tions))’’; 

13 (B) in subsection (j)(5)(F), by striking 

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

15 the active ingredient)’’ each place it appears 

16 and inserting ‘‘active moiety (as defined by the 

17 Secretary in section 314.3 of title 21, Code of 

18 Federal Regulations (or any successor regula19 tions))’’; 

20 (C) in subsection (l)(2)(A)— 

21 (i) by amending clause (i) to read as 

22 follows: 

23 ‘‘(i) not later than 30 days after the date 

24 of approval of such applications— 

25 ‘‘(I) for a drug, no active moiety (as 

26 defined by the Secretary in section 314.3 
3 

†S 1636 ES

1 of title 21, Code of Federal Regulations (or 

2 any successor regulations)) of which has 

3 been approved in any other application 

4 under this section; or 

5 ‘‘(II) for a biological product, no ac6 tive ingredient of which has been approved 

7 in any other application under section 351 

8 of the Public Health Service Act; and’’; 

9 and 

10 (ii) in clause (ii), by inserting ‘‘or bio11 logical product’’ before the period; 

12 (D) by amending subsection (s) to read as 

13 follows: 

14 ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—The 

15 Secretary shall— 

16 ‘‘(1) refer a drug or biological product to a 

17 Food and Drug Administration advisory committee 

18 for review at a meeting of such advisory committee 

19 prior to the approval of such drug or biological if it 

20 is— 

21 ‘‘(A) a drug, no active moiety (as defined 

22 by the Secretary in section 314.3 of title 21, 

23 Code of Federal Regulations (or any successor 

24 regulations)) of which has been approved in any 

25 other application under this section; or 
4 

†S 1636 ES

1 ‘‘(B) a biological product, no active ingre2 dient of which has been approved in any other 

3 application under section 351 of the Public 

4 Health Service Act; or 

5 ‘‘(2) if the Secretary does not refer a drug or 

6 biological product described in paragraph (1) to a 

7 Food and Drug Administration advisory committee 

8 prior to such approval, provide in the action letter 

9 on the application for the drug or biological product 

10 a summary of the reasons why the Secretary did not 

11 refer the drug or biological product to an advisory 

12 committee prior to approval.’’; and 

13 (E) in subsection (u)(1), in the matter pre14 ceding subparagraph (A)— 

15 (i) by striking ‘‘active ingredient (in16 cluding any ester or salt of the active in17 gredient)’’ and inserting ‘‘active moiety (as 

18 defined by the Secretary in section 314.3 

19 of title 21, Code of Federal Regulations (or 

20 any successor regulations))’’; and 

21 (ii) by striking ‘‘same active ingre22 dient’’ and inserting ‘‘same active moiety’’; 

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

24 360b(c)(2)(F)), by striking ‘‘active ingredient (in25 cluding any ester or salt of the active ingredient)’’ 
5 

†S 1636 ES

1 each place it appears and inserting ‘‘active moiety 

2 (as defined by the Secretary in section 314.3 of title 

3 21, Code of Federal Regulations (or any successor 

4 regulations))’’; 

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

6 360n(a)(4)), by amending subparagraph (C) to read 

7 as follows: 

8 ‘‘(C) is for— 

9 ‘‘(i) a human drug, no active moiety 

10 (as defined by the Secretary in section 

11 314.3 of title 21, Code of Federal Regula12 tions (or any successor regulations)) of 

13 which has been approved in any other ap14 plication under section 505(b)(1); or 

15 ‘‘(ii) a biological product, no active in16 gredient of which has been approved in any 

17 other application under section 351 of the 

18 Public Health Service Act.’’; 

19 (4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 

20 360ff(a)(4)), by striking subparagraphs (A) and (B) 

21 and inserting the following: 

22 ‘‘(A) is for a drug or biological product 

23 that is for the prevention or treatment of a rare 

24 pediatric disease; 

25 ‘‘(B)(i) is for such a drug— 
6 

†S 1636 ES

1 ‘‘(I) that contains no active moiety (as 

2 defined by the Secretary in section 314.3 

3 of title 21, Code of Federal Regulations (or 

4 any successor regulations)) that has been 

5 previously approved in any other applica6 tion under subsection (b)(1), (b)(2), or (j) 

7 of section 505; and 

8 ‘‘(II) that is the subject of an applica9 tion submitted under section 505(b)(1); or 

10 ‘‘(ii) is for such a biological product— 

11 ‘‘(I) that contains no active ingredient 

12 that has been previously approved in any 

13 other application under section 351(a) or 

14 351(k) of the Public Health Service Act; 

15 and 

16 ‘‘(II) that is the subject of an applica17 tion submitted under section 351(a) of the 

18 Public Health Service Act;’’; and 

19 (5) in section 565A(a)(4) (21 U.S.C. 360bbb– 

20 4a(a)(4)), by amending subparagraph (D) to read as 

21 follows: 

22 ‘‘(D) is for— 

23 ‘‘(i) a human drug, no active moiety 

24 (as defined by the Secretary in section 

25 314.3 of title 21, Code of Federal Regula-
7 

†S 1636 ES

1 tions (or any successor regulations)) of 

2 which has been approved in any other ap3 plication under section 505(b)(1); or 

4 ‘‘(ii) a biological product, no active in5 gredient of which has been approved in any 

6 other application under section 351 of the 

7 Public Health Service Act.’’. 

8 (b) TECHNICAL CORRECTIONS.—Chapter V of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

10 et seq) is amended— 

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

12 (A) in subsection (c)(3)(E), by repealing 

13 clause (i); and 

14 (B) in subsection (j)(5)(F), by repealing 

15 clause (i); and 

16 (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 

17 355a(c)(1)(A)(i)(II)), by striking ‘‘(c)(3)(D)’’ and 

18 inserting ‘‘(c)(3)(E)’’. 

Passed the Senate December 14, 2020. 

Attest: 

Secretary. 
116TH CONGRESS 

2D SESSION S. 1636 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

clusivity. Act with respect to the scope of new chemical ex-