Title: Strategic Planning for Emergency Medical Manufacturing Act
Policy area: Health

Summary:
Strategic Planning for Emergency Medical Manufacturing Act
This bill requires the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services (HHS) to maintain a voluntary network of domestic manufacturers that have agreed to produce critical supplies during emergencies and other supply chain disruptions.
As part of maintaining the network, the office must identify critical supplies and share information about the network with state, tribal, and local governments when supply shortfalls are anticipated. In addition, a participating manufacturer must develop a plan that identifies the supplies the manufacturer could produce, its manufacturing capacity, and support it would need to produce the supplies in an emergency.
The bill also requires HHS to issue guidance on applicable quality standards for supplies produced by manufacturers in the network.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2925 Introduced in Senate (IS)]

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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.

    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 ``Strategic Planning for Emergency 
Medical Manufacturing Act''.

SEC. 2. DOMESTIC BACK-UP MANUFACTURING NETWORK.

    Title III of the Public Health Service Act is amended by inserting 
after section 319F-4 of such Act (42 U.S.C. 247d-6e) the following:

``SEC. 319F-5. DOMESTIC BACK-UP MANUFACTURING NETWORK.

    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary for Preparedness and Response (referred to in this section as 
the `Assistant Secretary'), shall develop and maintain a network of 
manufacturers--
            ``(1) whose manufacturing facilities are in the United 
        States (including small business concerns, as defined in 
        section 3 of the Small Business Act);
            ``(2) who manufacture certain items identified by the 
        Assistant Secretary, which shall primarily be medical supplies 
        or supplies needed to facilitate emergency or medical response; 
        and
            ``(3) that have voluntarily opted in for inclusion in such 
        network, in order to provide for the domestic manufacture of 
        necessary supplies during times of emergency or disruption of 
        the usual supply chain.
    ``(b) Distribution of Network.--The Assistant Secretary shall make 
information about the network described in subsection (a) available to 
States, local governmental entities, Indian Tribes, Tribal 
organizations, and urban Indian organizations, medical suppliers, 
hospitals, and other health care providers, as the Assistant Secretary 
determines appropriate, when critical supply shortfalls are 
anticipated.
    ``(c) Plans Developed in Conjunction With Participating 
Manufacturers.--Domestic manufacturers opting to participate as 
described in subsection (a) shall develop, in coordination with the 
Assistant Secretary, a comprehensive plan that identifies--
            ``(1) the items that the manufacturer could produce, which 
        may include--
                    ``(A) items such manufacturer has current capacity 
                to produce, or the ability to rapidly expand capacity 
                to produce; and
                    ``(B) information about the manufacturer's general 
                capacity and equipment and willingness to work with the 
                Assistant Secretary to identify other products likely 
                to be needed during an emergency that fit within the 
                manufacturer's operational capabilities;
            ``(2) manufacturing capacity, including options for partial 
        operations and full capacity operations, and the time needed to 
        switch from standard product manufacturing to the needed 
        emergency supply;
            ``(3) technical assistance needed for production of items 
        needed during times of emergency, such as equipment, staff 
        training, and regulatory compliance, including scope, duration, 
        and the appropriate Federal agency to provide assistance; and
            ``(4) the frequency of testing by the manufacturer to 
        ensure that the plan is operational and meets quality metrics 
        and other obligations under Federal purchasing contracts 
        (including with respect to contracts for supplies for the 
        Strategic National Stockpile under section 319F-2) or to meet 
        other requirements determined by the Assistant Secretary.
    ``(d) Guidance.--The Secretary shall issue guidance on the quality 
standards for items identified by the Assistant Secretary as described 
in subsection (a)(2), by product type or category, that apply with 
respect to such items produced by manufacturers included in the 
network.
    ``(e) Coordination With Other Agencies.--The Secretary shall 
coordinate with other Federal agencies to provide contracting 
opportunities for Federal purchasing of items identified by the 
Assistant Secretary as described in subsection (a)(2), as such items 
are needed, provided that such items meet all quality standards and 
other requirements and are produced as part of an agreement with the 
Federal Government.
    ``(f) Limits on Participation; Opportunities for Consideration.--
            ``(1) Limits.--The Secretary may limit the number of 
        manufacturers that have active manufacturing plans under 
        subsection (c) and manufacturers that are active participants 
        in the network described in subsection (a), taking into account 
        diversity of product and geography of production facilities.
            ``(2) Opportunities for future consideration.--All 
        manufacturers wishing to participate in such network shall have 
        access to a point of contact within the Office of the Assistant 
        Secretary for Preparedness and Response and, if not included in 
        such network, shall have the option to add their name to a 
        simplified list for future consideration for such 
        participation, unless the Assistant Secretary determines there 
        to be any substantial cause for removal of the manufacturer 
        from such list.''.
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