Drug Manufacturing Innovation Act of 2022
This bill requires the Food and Drug Administration to establish a program to support innovative approaches to pharmaceutical product design and manufacturing, including through grants, regulatory guidance, and working groups.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6988 Introduced in House (IH)]
<DOC>
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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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