II 

117TH CONGRESS 

1ST SESSION S. 2925 

To provide for a strategic plan for the domestic manufacture of necessary 

medical supplies or supplies needed to facilitate emergency or medical 

response, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 4, 2021 

Ms. ROSEN (for herself and Mr. CASSIDY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To provide for a strategic plan for the domestic manufacture 

of necessary medical supplies or supplies needed to facilitate emergency or medical response, 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 ‘‘Strategic Planning for 

5 Emergency Medical Manufacturing Act’’. 


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1 SEC. 2. DOMESTIC BACK-UP MANUFACTURING NETWORK. 

2 Title III of the Public Health Service Act is amended 

3 by inserting after section 319F–4 of such Act (42 U.S.C. 

4 247d–6e) the following: 

5 ‘‘SEC. 319F–5. DOMESTIC BACK-UP MANUFACTURING NET6 WORK. 

7 ‘‘(a) IN GENERAL.—The Secretary, acting through 

8 the Assistant Secretary for Preparedness and Response 

9 (referred to in this section as the ‘Assistant Secretary’), 

10 shall develop and maintain a network of manufacturers— 

11 ‘‘(1) whose manufacturing facilities are in the 

12 United States (including small business concerns, as 

13 defined in section 3 of the Small Business Act); 

14 ‘‘(2) who manufacture certain items identified 

15 by the Assistant Secretary, which shall primarily be 

16 medical supplies or supplies needed to facilitate 

17 emergency or medical response; and 

18 ‘‘(3) that have voluntarily opted in for inclusion 

19 in such network, in order to provide for the domestic 

20 manufacture of necessary supplies during times of 

21 emergency or disruption of the usual supply chain. 

22 ‘‘(b) DISTRIBUTION OF NETWORK.—The Assistant 

23 Secretary shall make information about the network de24 scribed in subsection (a) available to States, local govern25 mental entities, Indian Tribes, Tribal organizations, and 

26 urban Indian organizations, medical suppliers, hospitals, 


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1 and other health care providers, as the Assistant Secretary 

2 determines appropriate, when critical supply shortfalls are 

3 anticipated. 

4 ‘‘(c) PLANS DEVELOPED IN CONJUNCTION WITH

5 PARTICIPATING MANUFACTURERS.—Domestic manufac6 turers opting to participate as described in subsection (a) 

7 shall develop, in coordination with the Assistant Secretary, 

8 a comprehensive plan that identifies— 

9 ‘‘(1) the items that the manufacturer could 

10 produce, which may include— 

11 ‘‘(A) items such manufacturer has current 

12 capacity to produce, or the ability to rapidly ex13 pand capacity to produce; and 

14 ‘‘(B) information about the manufacturer’s 

15 general capacity and equipment and willingness 

16 to work with the Assistant Secretary to identify 

17 other products likely to be needed during an 

18 emergency that fit within the manufacturer’s 

19 operational capabilities; 

20 ‘‘(2) manufacturing capacity, including options 

21 for partial operations and full capacity operations, 

22 and the time needed to switch from standard prod23 uct manufacturing to the needed emergency supply; 

24 ‘‘(3) technical assistance needed for production 

25 of items needed during times of emergency, such as 


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1 equipment, staff training, and regulatory compli2 ance, including scope, duration, and the appropriate 

3 Federal agency to provide assistance; and 

4 ‘‘(4) the frequency of testing by the manufac5 turer to ensure that the plan is operational and 

6 meets quality metrics and other obligations under 

7 Federal purchasing contracts (including with respect 

8 to contracts for supplies for the Strategic National 

9 Stockpile under section 319F–2) or to meet other 

10 requirements determined by the Assistant Secretary. 

11 ‘‘(d) GUIDANCE.—The Secretary shall issue guidance 

12 on the quality standards for items identified by the Assist13 ant Secretary as described in subsection (a)(2), by product 

14 type or category, that apply with respect to such items 

15 produced by manufacturers included in the network. 

16 ‘‘(e) COORDINATION WITH OTHER AGENCIES.—The 

17 Secretary shall coordinate with other Federal agencies to 

18 provide contracting opportunities for Federal purchasing 

19 of items identified by the Assistant Secretary as described 

20 in subsection (a)(2), as such items are needed, provided 

21 that such items meet all quality standards and other re22 quirements and are produced as part of an agreement with 

23 the Federal Government. 

24 ‘‘(f) LIMITS ON PARTICIPATION; OPPORTUNITIES

25 FOR CONSIDERATION.— 


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1 ‘‘(1) LIMITS.—The Secretary may limit the 

2 number of manufacturers that have active manufac3 turing plans under subsection (c) and manufacturers 

4 that are active participants in the network described 

5 in subsection (a), taking into account diversity of 

6 product and geography of production facilities. 

7 ‘‘(2) OPPORTUNITIES FOR FUTURE CONSIDER8 ATION.—All manufacturers wishing to participate in 

9 such network shall have access to a point of contact 

10 within the Office of the Assistant Secretary for Pre11 paredness and Response and, if not included in such 

12 network, shall have the option to add their name to 

13 a simplified list for future consideration for such 

14 participation, unless the Assistant Secretary deter15 mines there to be any substantial cause for removal 

16 of the manufacturer from such list.’’. 

Æ 


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