[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6988 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6988

   To amend the Federal Food, Drug, and Cosmetic Act to authorize a 
  program to support the adoption of, and improve the development of, 
      innovative approaches to pharmaceutical product design and 
                 manufacturing, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2022

  Mr. Levin of California (for himself and Mr. Joyce of Pennsylvania) 
 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 authorize a 
  program to support the adoption of, and improve the development of, 
      innovative approaches to pharmaceutical product design and 
                 manufacturing, and for other purposes.

    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 ``Drug Manufacturing Innovation Act of 
2022''.

SEC. 2. EMERGING TECHNOLOGY PROGRAM.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
201 et seq.) is amended by inserting after section 566 of such Act (21 
U.S.C. 360bbb-5) the following:

``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

    ``(a) Program Establishment.--
            ``(1) In general.--The Secretary shall establish a program 
        to support the adoption of, and improve the development of, 
        innovative approaches to pharmaceutical product design and 
        manufacturing.
            ``(2) Actions.--In carrying out the program under paragraph 
        (1), the Secretary may--
                    ``(A) facilitate and increase communication between 
                public and private entities, consortia, and individuals 
                with respect to innovative pharmaceutical product 
                design and manufacturing;
                    ``(B) solicit information regarding, and conduct or 
                support research on, innovative approaches to 
                pharmaceutical product design and manufacturing;
                    ``(C) convene meetings with representatives of 
                industry, academia, other Federal agencies, 
                international agencies, and other interested persons, 
                as appropriate;
                    ``(D) convene working groups to support 
                pharmaceutical product design and manufacturing 
                research and development;
                    ``(E) support education and training for regulatory 
                staff and scientists related to innovative approaches 
                to pharmaceutical product design and manufacturing;
                    ``(F) conduct research and testing to develop or 
                validate innovative approaches to pharmaceutical 
                product design and manufacturing;
                    ``(G) advance regulatory science related to the 
                development and review of innovative approaches to 
                pharmaceutical product design and manufacturing;
                    ``(H) convene working groups to support the 
                harmonization of international regulatory requirements 
                related to innovative approaches to pharmaceutical 
                product design and manufacturing; and
                    ``(I) award grants or contracts to carry out or 
                support the program under paragraph (1).
            ``(3) Grants and contracts.--To seek a grant or contract 
        under this section, an entity shall submit an application--
                    ``(A) in such form and manner as the Secretary may 
                require; and
                    ``(B) containing such information as the Secretary 
                may require, including a description of--
                            ``(i) how the entity will conduct the 
                        activities to be supported through the grant or 
                        contract; and
                            ``(ii) how such activities will further 
                        research and development related to, or 
                        adoption of, innovative approaches to 
                        pharmaceutical product design and 
                        manufacturing.
    ``(b) Guidance.--The Secretary shall--
            ``(1) issue or update guidance to help facilitate the 
        adoption of, and advance the development of, innovative 
        approaches to pharmaceutical product design and manufacturing; 
        and
            ``(2) include in such guidance descriptions of--
                    ``(A) any regulatory requirements related to the 
                development or review of technologies related to 
                innovative approaches to pharmaceutical product design 
                and manufacturing, including regulatory requirements 
                necessary for updates and improvements to such 
                technologies after product approval; and
                    ``(B) data required to demonstrate the identity, 
                safety, purity, and potency of drugs manufactured using 
                such technologies.
    ``(c) Report to Congress.--Not later than 4 years after the date of 
enactment of this section, the Secretary shall submit to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the Senate a 
report containing--
            ``(1) an annual accounting of the allocation of funds made 
        available to carry out this section;
            ``(2) the number of full-time equivalent staff dedicated to 
        the program under subsection (a)(1);
            ``(3) the number of meetings held by the Food and Drug 
        Administration, including meetings convened as part of a 
        working group described in subparagraph (D) or (H) of paragraph 
        (2) of subsection (a), and the topics of each such meeting; and
            ``(4) the number of products approved or licensed, after 
        the date of enactment of this section, using an innovative 
        approach to pharmaceutical product design and manufacturing.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $20,000,000 for each fiscal year 
2023 through 2027.''.
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