116 HR 4955 IH: Protecting Access to Safe and Effective Medicines Act of 2019 U.S. House of Representatives 2019-10-31 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS1st SessionH. R. 4955IN THE HOUSE OF REPRESENTATIVESOctober 31, 2019Mr. Engel (for himself, Mr. Guthrie, Mr. Schrader, and Mr. Hudson) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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)).