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Code · BILL · 116th Congress · S. 4775 (Placed on Calendar Senate) — To provide continued emergency assistance, educational support, and health care response for individuals, families, a... · Sec. 7002

Sec. 7002. Improving and sustaining State medical stockpiles

1,304 words·~6 min read·/bill/116/s/4775/pcs/section-7002·

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Section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ) is amended by adding at the end the following: The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award grants, contracts, or cooperative agreements to eligible entities to maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) to be used during a public health emergency declared by the Governor of a State or by the Secretary under section 319, or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, in order to support the preparedness goals described in paragraphs (2), (3), and
(8)of section 2802(b). To be eligible to receive an award under paragraph (1), an entity shall— be a State or consortium of States that is a recipient of an award under section 319C–1(b); and prepare, in consultation with appropriate health care providers and health officials within the State or consortium of States, and submit to the Secretary an application that contains such information as the Secretary may require, including a plan for the State stockpile and a description of the activities such entity will carry out under the agreement, consistent with the requirements of paragraph (3). The Secretary may make an award under this subsection to not more than one eligible entity in each State. Awards, contracts, or grants awarded under this subsection shall supplement, not supplant, the reserve amounts of medical supplies procured by and for the Strategic National Stockpile under subsection (a). Not more than 5 percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses. An eligible entity receiving an award under this subsection may assign a lead entity to manage the State stockpile, which may be a recipient of an award under section 319C–2(b). Subject to clause (ii), the Secretary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to— for each of fiscal years 2023 and 2024, not less than $1 for each $10 of Federal funds provided in the award; for each of fiscal years 2025 and 2026, not less than $1 for each $5 of Federal funds provided in the award; and for fiscal year 2027 and each fiscal year thereafter, not less than $1 for each $3 of Federal funds provided in the award. The Secretary may, upon the request of a State, waive the requirement under clause
(i)in whole or in part if the Secretary determines that extraordinary economic conditions in the State in the fiscal year involved or in the previous fiscal year justify the waiver. A waiver provided by the Secretary under this subparagraph shall apply only to the fiscal year involved. A recipient of a grant, contract, or cooperative agreement under this subsection shall use such funds to carry out the following: Maintaining a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) to be used during a public health emergency in such numbers, types, and amounts as the State determines necessary, consistent with such State’s stockpile plan. Such a recipient may not use funds to support the stockpiling of countermeasures as defined under subsection (c), unless the eligible entity provides justification for maintaining such products and the Secretary determines such appropriate and applicable. Deploying the stockpile as required by the State to respond to an actual or potential public health emergency. Replenishing and making necessary additions or modifications to the contents of such stockpile or stockpiles, including to address potential depletion. In consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile. Ensuring that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as appropriate. Reviewing and revising, as appropriate, the contents of the stockpile on a regular basis to ensure that to the extent practicable, advanced technologies and medical products are considered. Carrying out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other training for recipients of awards under section 319C–1 or 319C–2, as applicable. Carrying out other activities as the State determines appropriate, to support State efforts to prepare for, and respond to, public health threats. The eligible entity under this subsection shall ensure appropriate coordination of the State stockpile plan developed pursuant to paragraph (2)(A)(ii) and the plans required pursuant to section 319C–1. Not later than 180 days after the date of enactment of this subsection, the Secretary, acting through the Assistant Secretary for Preparedness and Response, shall issue guidance for States related to maintaining and replenishing a stockpile of medical products. The Secretary shall update such guidance as appropriate. The Secretary shall provide assistance to States, including technical assistance, as appropriate, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical products from a State stockpile. Each recipient of an award under this subsection shall ensure that the State stockpile plan developed pursuant to paragraph (2)(A)(ii) contains such information as the Secretary may require related to current inventory of supplies maintained pursuant to paragraph (3), and any plans to replenish such supplies, or procure new or alternative supplies. The Secretary shall use information obtained from State stockpile plans to inform the maintenance and management of the Strategic National Stockpile pursuant to subsection (a). The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall develop and implement a process to review and audit entities in receipt of an award under this subsection, including by establishing metrics to ensure that each entity receiving such an award is carrying out activities in accordance with the applicable State stockpile plan. The Secretary may require entities to— measure progress toward achieving the outcome goals; and at least annually, test, exercise, and rigorously evaluate the stockpile capacity and response capabilities of the entity, and report to the Secretary on the results of such test, exercise, and evaluation, and on progress toward achieving outcome goals, based on criteria established by the Secretary. The Secretary shall develop and implement a process to notify entities that are determined by the Secretary to have failed to meet the requirements of the terms of an award under this subsection. Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to subparagraph (C). Beginning with fiscal year 2022, and in each succeeding fiscal year, the Secretary shall withhold from each entity that has failed substantially to meet the terms of an award under this subsection for at least 1 of the 2 immediately preceding fiscal years (beginning with fiscal year 2022), the amount allowed for administrative expenses described in described in paragraph (2)(D). For the purpose of carrying out this subsection, there are authorized to be appropriated $1,000,000,000 for each of fiscal years 2021 through 2030, to remain available until expended. .
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  • 42 USC 247d–6b
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Sec. 7002
Improving and sustaining State medical stockpiles
Cite42 USC 247d–6b
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