I 
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) intro-
duced 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 Representa-
tives 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’’. 
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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 fol-
lowing: 
‘‘SEC. 566A. EMERGING TECHNOLOGY PROGRAM. 
‘‘(a) PROGRAM ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a program to support the adoption of, and im-
prove 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 phar-
maceutical product design and manufacturing; 
‘‘(B) solicit information regarding, and 
conduct or support research on, innovative ap-
proaches to pharmaceutical product design and 
manufacturing; 
‘‘(C) convene meetings with representatives 
of industry, academia, other Federal agencies, 
international agencies, and other interested per-
sons, as appropriate; 
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‘‘(D) convene working groups to support 
pharmaceutical product design and manufac-
turing research and development; 
‘‘(E) support education and training for 
regulatory staff and scientists related to innova-
tive approaches to pharmaceutical product de-
sign and manufacturing; 
‘‘(F) conduct research and testing to de-
velop or validate innovative approaches to phar-
maceutical product design and manufacturing; 
‘‘(G) advance regulatory science related to 
the development and review of innovative ap-
proaches 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 manufac-
turing; 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— 
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