Apr. 23, 2021 

[S. 415] 

Deadline. 

Review. 

# Public Law 117–9 117th Congress 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. 

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

## SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY. 

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended— 

‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—The Secretary shall— 

‘‘(1) refer a drug or biological product to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is— 

(1) in section 505 (21 U.S.C. 355)— 

(A) in subsection (c)(3)(E), by striking ‘‘active ingredient (including any ester or salt of the active ingredient)’’ each place it appears and inserting ‘‘active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))’’; 

(B) in subsection (j)(5)(F), by striking ‘‘active ingredient (including any ester or salt of the active ingredient)’’ each place it appears and inserting ‘‘active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))’’; 

(C) in subsection (l)(2)(A)— 

‘‘(i) not later than 30 days after the date of approval of such applications— 

‘‘(I) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Fed- eral Regulations (or any successor regulations)) of which has been approved in any other application under this section; or 

‘‘(II) for a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act; and’’; and 

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

(D) by amending subsection (s) to read as follows: 

‘‘(A) a drug, no active moiety (as defined by the Sec- retary in section 314.3 of title 21, Code of Federal Regula- tions (or any successor regulations)) of which has been approved in any other application under this section; or 

(i) by amending clause (i) to read as follows: 

# An Act 

