PUBLIC LAW 117–9—APR. 23, 2021  135 STAT. 256  Public Law 117–9  117th Congress  An Act  To amend the Federal Food, Drug, and Cosmetic Act with respect to the scope  of new chemical exclusivity.  Apr. 23, 2021  [S. 415]  Be it enacted by the Senate and House of Representatives of  the United States of America in Congress assembled,  (a) IN GENERAL.—Chapter V of the Federal Food, Drug, and  Cosmetic Act is amended—  (1) in section 505 (21 U.S.C. 355)—  SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.  (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))’’;  Deadline.  (C) in subsection (l)(2)(A)—  (i) by amending clause (i) to read as follows:  ‘‘(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:  ‘‘(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—  ‘‘(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  Review. 