```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4955 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 4955

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
                   meaning of a new chemical entity.

_______________________________________________________________________

                    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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Access to Safe and 
Effective Medicines Act of 2019''.

SEC. 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))''.
                                 <all>
```