FLASH Act of 2023

To amend the Public Health Service Act to authorize the Biomedical Advanced Research and Development Authority to award follow-on production contracts or transactions, procure supplies for experimental or test purposes, and acquire innovative commercial products and commercial services, and for other purposes. 1. Short title This Act may be cited as the Fast-track Logistics for Acquiring Supplies in a Hurry Act of 2023 FLASH Act of 2023 2. Authority to award follow-on production contracts or transactions, procure supplies for experimental or test purposes, and acquire innovative commercial products and commercial services Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e (1) in subsection (a)(6)(B), by amending clause (ii) to read as follows: (ii) design and development of— (I) tests and prototypes, including obtaining sufficient quantities for evaluation of such tests and prototypes; and (II) models, including animal models, for such testing and prototypes; ; and (2) in subsection (c)(5)— (A) in subparagraph (A)— (i) by redesignating clause (iv) as clause (v); and (ii) by inserting after clause (iii) the following new clause: (iv) Follow-on production contracts or transactions (I) In general A transaction entered into under this subparagraph for the design or development of a prototype may provide for the award of a follow-on production contract or transaction to the participants in the transaction. (II) Prototype subprojects A transaction entered into under this subparagraph includes all prototype subprojects awarded under the transaction to carry out authorities under this section. (III) Exception to competitive procedures Notwithstanding clause (ii), a follow-on production contract or transaction provided for in a transaction under this clause may be awarded to the participants in the transaction without the use of competitive procedures, even if explicit notification was not listed within the request for proposal for the transaction, if competitive procedures were used for the selection of parties for participation in the initial transaction. ; and (B) by adding at the end the following new subparagraphs: (I) Procurement for experimental or test purposes (i) In general The Secretary may purchase medical countermeasures, products, and supplies, chemical materials and reagents, manufacturing supplies, protective equipment, and such other supplies, including parts and accessories, and designs thereof, as the Secretary determines necessary for experimental or test purposes in the development of supplies that are necessary for national public health and health security. (ii) Procedures Notwithstanding subparagraph (A)(ii), the Secretary may make purchases under this subparagraph by contract, or by entering into a transaction other than a contract, using noncompetitive procedures. (J) Acquisition of innovative commercial products and commercial services using general solicitation competitive procedures (i) In general Notwithstanding subparagraph (A)(ii), the Secretary may acquire innovative commercial products and commercial services through a competitive selection of proposals resulting from a general solicitation and the peer review of such proposals. (ii) Treatment as competitive procedures Use of general solicitation competitive procedures under clause (i) shall be considered to be use of competitive procedures for purposes of chapter 33 (iii) Limitations (I) Transactions in excess of $100,000,000 The Secretary may not enter into a contract or agreement in excess of $100,000,000 using the authority under clause (i), unless the Secretary makes a written determination of the efficacy of the effort to meet mission needs of the Department of Health and Human Services. (II) Fixed-price Contracts or agreements entered into using the authority under clause (i) shall be fixed-price, including fixed-price incentive contracts. (iv) Congressional notification required (I) Submission Not later than 45 days after the award of a contract for an amount exceeding $100,000,000 using the authority under clause (i), the Secretary shall provide notification of such award to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. (II) Contents Notification of an award under subclause (I) shall include the following: (aa) Description of the innovative commercial product or commercial service acquired. (bb) Description of the requirement, capability gap, or potential technological advancement with respect to which the innovative commercial product or commercial service acquired provides a solution or a potential new capability. (cc) Amount of the contract awarded. (dd) Identification of the contractor awarded the contract. (v) Innovative defined In this subparagraph, the term innovative (I) any technology, process, or method, including research and development, that is new as of the date of submission of a proposal; or (II) with respect to a technology, process, or method, including research and development, existing as of the date of submission of a proposal, any application of such technology, process, or method that is new to the Federal Government as of such date. .

Summary: Fast-track Logistics for Acquiring Supplies in a Hurry Act of 2023 or the FLASH Act of 2023This bill expands federal contracting and other authorities to support the development and acquisition of products and supplies that are necessary for national public health and health security.Specifically, the Department of Health and Human Services (HHS) may use noncompetitive procedures to procure medical countermeasures (e.g., vaccines), chemical materials and reagents, manufacturing supplies, and similar items that are needed to develop products for national public health and health security.Additionally, HHS may acquire, subject to dollar limits and other conditions, innovative commercial products and services by soliciting proposals and selecting proposals through peer review.Further, the bill expands the activities of the Biomedical Advanced Research and Development Authority (BARDA) to include supporting the design and development of prototypes for products to diagnose, mitigate, prevent, treat, or otherwise respond to biological, chemical, radiological, or nuclear threats, including pandemics or epidemics. If BARDA enters an initial transaction to design or develop such a test or prototype using competitive procedures, BARDA may use noncompetitive procedures for a follow-on transaction to produce the test or prototype.