I 

117TH CONGRESS 

1ST SESSION H. R. 70 

To support the advanced manufacturing technologies program of the Food 

and Drug Administration, to establish National Centers of Excellence 

in Advanced Pharmaceutical Manufacturing, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 4, 2021 

Mr. BUCHANAN introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish 

National Centers of Excellence in Advanced Pharmaceutical 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 ‘‘Securing America’s 

5 Medicine Cabinet Act of 2021’’. 


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1 SEC. 2. ADVANCED MANUFACTURING TECHNOLOGIES PRO2 GRAM. 

3 Subchapter A of chapter V of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by adding at the end the following: 

6 ‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 

7 PROGRAM. 

8 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

9 date of enactment of the Securing America’s Medicine 

10 Cabinet Act of 2021, the Secretary shall continue in effect 

11 the program to evaluate and approve new drug manufac12 turing technologies that are included in an application, or 

13 supplement to an application, for a drug under subsection 

14 (b) or (j) of section 505 of this Act or for a biological 

15 product submitted under subsection (a) or (k) of section 

16 351 of the Public Health Service Act. 

17 ‘‘(b) DESIGNATION.—The Secretary shall designate a 

18 method of manufacturing a drug as an advanced manufac19 turing technology under this section if the drug manufac20 turer demonstrates that such technology is likely to— 

21 ‘‘(1) prevent or resolve a drug shortage; 

22 ‘‘(2) maintain an adequate supply of critical 

23 medications for national emergencies; or 

24 ‘‘(3) promote the adoption of innovative ap25 proaches to drug product design and manufacturing. 


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1 ‘‘(c) CONSULTATION.—If the Secretary designates a 

2 method of manufacturing as an advanced manufacturing 

3 technology under this section, the Secretary shall take ac4 tions to expedite the development and implementation of 

5 such method of manufacture for purposes of approval of 

6 the application under subsection (c) or (j) of section 505 

7 of this Act or subsection (a) or (k) of section 351 of the 

8 Public Health Service Act, which may include, as appro9 priate— 

10 ‘‘(1) holding meetings between the sponsor of 

11 the application and appropriate Food and Drug Ad12 ministration staff throughout the development of the 

13 technology; 

14 ‘‘(2) providing timely advice to, and interactive 

15 communication with, the sponsor regarding the de16 velopment of the technology; and 

17 ‘‘(3) involving senior managers and experienced 

18 staff of the Food and Drug Administration, as ap19 propriate, in a collaborative, cross-disciplinary review 

20 of the method of manufacturing. 

21 ‘‘(d) EVALUATION OF AN ADVANCED MANUFAC22 TURING TECHNOLOGY.— 

23 ‘‘(1) PACKAGE.—A sponsor who receives des24 ignation of an advanced manufacturing technology 

25 under this section shall provide the Secretary with a 


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1 package of scientific evidence supporting the imple2 mentation of the advanced manufacturing technology 

3 in a particular context-of-use. 

4 ‘‘(2) EVALUATION.—Within 90 days of receiv5 ing the package, the Secretary shall determine 

6 whether a designated advanced manufacturing tech7 nology is validated for the proposed context of use 

8 based on the scientific merit the supporting evidence 

9 provided by the sponsor. 

10 ‘‘(3) EFFECT OF APPROVAL.—Upon approval, 

11 the same sponsor may rely upon the advanced man12 ufacturing technology for use across multiple manu13 facturing product lines within the same context-of14 use without having to re-submit data to the Sec15 retary validating the underlying technology. 

16 ‘‘(e) IMPLEMENTATION AND REPORTING.— 

17 ‘‘(1) PUBLIC MEETING.—The Secretary shall 

18 publish in the Federal Register a notice of a public 

19 meeting to be held no later than 1 year after the 

20 date of enactment of the Securing America’s Medi21 cine Cabinet Act of 2021 to discuss and obtain input 

22 and recommendations from stakeholders regarding 

23 the goals and scope of, and a suitable framework 

24 and procedures and requirements for, the program 

25 under this section. 


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1 ‘‘(2) PROGRAM GUIDANCE.—The Secretary 

2 shall— 

3 ‘‘(A) not later than 1 year after the date 

4 of enactment of the Securing America’s Medi5 cine Cabinet Act of 2021, issue draft guidance 

6 regarding the goals and implementation of the 

7 program under this section; and 

8 ‘‘(B) not later than 2 years after the date 

9 of enactment of the Securing America’s Medi10 cine Cabinet Act of 2021, issue final guidance 

11 with respect to the implementation of such pro12 gram. 

13 ‘‘(3) REPORT.—The Secretary shall make avail14 able on the internet website of the Food and Drug 

15 Administration an annual report on the progress of 

16 the program under this section.’’. 

17 SEC. 3. NATIONAL CENTER OF EXCELLENCE IN ADVANCED 

18 PHARMACEUTICAL MANUFACTURING. 

19 Chapter X of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

21 end the following: 


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1 ‘‘SEC. 1015. NATIONAL CENTER OF EXCELLENCE IN AD2 VANCED PHARMACEUTICAL MANUFAC3 TURING. 

4 ‘‘(a) IN GENERAL.—The Secretary shall designate in5 stitutions of higher education as National Centers of Ex6 cellence in Advanced Pharmaceutical Manufacturing, in7 cluding continuous pharmaceutical manufacturing. 

8 ‘‘(b) ELIGIBILITY.—To be eligible for designation 

9 under subsection (a) an entity shall— 

10 ‘‘(1) be an institution of higher education; 

11 ‘‘(2) demonstrate— 

12 ‘‘(A) the physical and technical capacity 

13 for research and development of advanced phar14 maceutical manufacturing; 

15 ‘‘(B) a record of transferring scientific 

16 knowledge to the marketplace; 

17 ‘‘(C) scalable manufacturing knowledge, 

18 which may be through collaborations of other 

19 institutions of higher education, biopharma20 ceutical manufacturers, or other entities; 

21 ‘‘(D) the ability to train a future workforce 

22 for research on and implementation of advanced 

23 pharmaceutical manufacturing; and 

24 ‘‘(E) the ability to support Federal agen25 cies with technical assistance for advanced 

26 pharmaceutical technologies, with an emphasis 


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1 on creating a secure national pharmaceutical 

2 stockpile and the ability to rapidly address drug 

3 shortages; and 

4 ‘‘(3) submit an application to the Secretary at 

5 such time, in such form, and in such manner as the 

6 Secretary may require. 

7 ‘‘(c) TERMINATION.—The Secretary may terminate 

8 the designation of an entity designated under subsection 

9 (a) upon a determination that the entity no longer meets 

10 the requirements of subsection (b). 

11 ‘‘(d) ANNUAL REPORT.—Not later than 1 year after 

12 the date on which the first designation is made under sub13 section (a), and annually thereafter, the Secretary shall 

14 submit a report to Congress on the activities of the entities 

15 designated under such subsection. 

16 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

17 carry out this section, there are authorized to be appro18 priated $100,000,000 for the period of fiscal years 2022 

19 through 2025.’’. 

Æ 


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