I 116th CONGRESS 1st Session H. R. 4955 IN THE HOUSE OF REPRESENTATIVES October 31, 2019 Mr. Engel (for himself, Mr. Guthrie , Mr. Schrader , and Mr. Hudson ) 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 clarify the meaning of a new chemical entity.

1. Short title This Act may be cited as the Protecting Access to Safe and Effective Medicines Act of 2019 . 2. Clarifying the meaning of new chemical entity Chapter V of the Federal Food, Drug, and Cosmetic Act is amended— (1) in section 505 ( 21 U.S.C. 355 )— (A) in subsection (c)(3)(E)— (i) in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (ii) in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) 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)— (i) in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (ii) in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) 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), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; (D) in subsection (s), in the matter preceding paragraph (1), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (E) in subsection (u)(1), in the matter preceding subparagraph (A)— (i) by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (ii) by striking same active ingredient and inserting same active moiety ; (2) in section 512(c)(2)(F) ( 21 U.S.C. 360b(c)(2)(F) )— (A) in clause (i), by striking active ingredient (including any ester or salt of the active ingredient) 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 clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (C) in clause (v), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; (3) in section 524(a)(4)(C) ( 21 U.S.C. 360n(a)(4)(C) ), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; (4) in section 529(a)(4)(A)(ii) ( 21 U.S.C. 360ff(a)(4)(A)(ii) ), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) .