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) 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Manufacturing 

5 Innovation Act of 2022’’. 


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1 SEC. 2. EMERGING TECHNOLOGY PROGRAM. 

2 Chapter V of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 201 et seq.) is amended by inserting after 

4 section 566 of such Act (21 U.S.C. 360bbb–5) the fol5 lowing: 

6 ‘‘SEC. 566A. EMERGING TECHNOLOGY PROGRAM. 

7 ‘‘(a) PROGRAM ESTABLISHMENT.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall estab9 lish a program to support the adoption of, and im10 prove the development of, innovative approaches to 

11 pharmaceutical product design and manufacturing. 

12 ‘‘(2) ACTIONS.—In carrying out the program 

13 under paragraph (1), the Secretary may— 

14 ‘‘(A) facilitate and increase communication 

15 between public and private entities, consortia, 

16 and individuals with respect to innovative phar17 maceutical product design and manufacturing; 

18 ‘‘(B) solicit information regarding, and 

19 conduct or support research on, innovative ap20 proaches to pharmaceutical product design and 

21 manufacturing; 

22 ‘‘(C) convene meetings with representatives 

23 of industry, academia, other Federal agencies, 

24 international agencies, and other interested per25 sons, as appropriate; 


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1 ‘‘(D) convene working groups to support 

2 pharmaceutical product design and manufac3 turing research and development; 

4 ‘‘(E) support education and training for 

5 regulatory staff and scientists related to innova6 tive approaches to pharmaceutical product de7 sign and manufacturing; 

8 ‘‘(F) conduct research and testing to de9 velop or validate innovative approaches to phar10 maceutical product design and manufacturing; 

11 ‘‘(G) advance regulatory science related to 

12 the development and review of innovative ap13 proaches to pharmaceutical product design and 

14 manufacturing; 

15 ‘‘(H) convene working groups to support 

16 the harmonization of international regulatory 

17 requirements related to innovative approaches 

18 to pharmaceutical product design and manufac19 turing; and 

20 ‘‘(I) award grants or contracts to carry out 

21 or support the program under paragraph (1). 

22 ‘‘(3) GRANTS AND CONTRACTS.—To seek a 

23 grant or contract under this section, an entity shall 

24 submit an application— 


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1 ‘‘(A) in such form and manner as the Sec2 retary may require; and 

3 ‘‘(B) containing such information as the 

4 Secretary may require, including a description 

5 of— 

6 ‘‘(i) how the entity will conduct the 

7 activities to be supported through the 

8 grant or contract; and 

9 ‘‘(ii) how such activities will further 

10 research and development related to, or 

11 adoption of, innovative approaches to phar12 maceutical product design and manufac13 turing. 

14 ‘‘(b) GUIDANCE.—The Secretary shall— 

15 ‘‘(1) issue or update guidance to help facilitate 

16 the adoption of, and advance the development of, in17 novative approaches to pharmaceutical product de18 sign and manufacturing; and 

19 ‘‘(2) include in such guidance descriptions of— 

20 ‘‘(A) any regulatory requirements related 

21 to the development or review of technologies re22 lated to innovative approaches to pharma23 ceutical product design and manufacturing, in24 cluding regulatory requirements necessary for 


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1 updates and improvements to such technologies 

2 after product approval; and 

3 ‘‘(B) data required to demonstrate the 

4 identity, safety, purity, and potency of drugs 

5 manufactured using such technologies. 

6 ‘‘(c) REPORT TO CONGRESS.—Not later than 4 years 

7 after the date of enactment of this section, the Secretary 

8 shall submit to the Committee on Energy and Commerce 

9 of the House of Representatives and the Committee on 

10 Health, Education, Labor, and Pensions of the Senate a 

11 report containing— 

12 ‘‘(1) an annual accounting of the allocation of 

13 funds made available to carry out this section; 

14 ‘‘(2) the number of full-time equivalent staff 

15 dedicated to the program under subsection (a)(1); 

16 ‘‘(3) the number of meetings held by the Food 

17 and Drug Administration, including meetings con18 vened as part of a working group described in sub19 paragraph (D) or (H) of paragraph (2) of subsection 

20 (a), and the topics of each such meeting; and 

21 ‘‘(4) the number of products approved or li22 censed, after the date of enactment of this section, 

23 using an innovative approach to pharmaceutical 

24 product design and manufacturing. 


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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there is authorized to be appro3 priated $20,000,000 for each fiscal year 2023 through 

4 2027.’’. 

Æ 


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