Health Resources Priorities and Allocations System (HRPAS)

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>45 CFR Part 101</CFR> <RIN>RIN 0908-AA00</RIN> <SUBJECT>Health Resources Priorities and Allocations System (HRPAS)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of the Secretary, Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) is issuing a final rule establishing standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This final rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule finalizes the regulations as proposed in the Notice of Proposed Rule Making (NPRM) of August 16, 2023, with minor technical edits based on comments received. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective March 11, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> L. Paige Ezernack, telephone at (202) 260-0365 or via email at <E T="03">aspr.dpa@hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> This final rule implements HHS' administration of priorities and allocations actions with respect to health resources and establishes the Health Resources Priorities and Allocations System (HRPAS). The HRPAS covers health resources pursuant to the authority under section 101(a) of the Defense Production Act (DPA) of 1950 as delegated to the Secretary of HHS (Secretary) by Executive Order (E.O.) 13603. On September 26, 2022, the Secretary delegated to the Assistant Secretary for Preparedness and Response (the ASPR) within the Administration for Strategic Preparedness and Response (ASPR), the authority under section 201 of E.O. 13603 to exercise priorities authority under section 101 of the DPA. This delegation authorized the ASPR, on behalf of the Secretary, to approve DO—[-[M1-M9] priority rating requests for health resources that promote the national defense. This delegation excludes the authority to approve all priorities provisions for health resources that require DX—[-[M1-M9] priority ratings. The Secretary retains all other authorities delegated by the President in E.O. 13603. The HRPAS has two principal components: priorities and allocations. Under the priorities' component, the Secretary is authorized to place priority ratings on contracts or orders for health resources to support programs which have been determined by the Department of Defense, Department of Energy, or Department of Homeland Security as necessary or appropriate to promote the national defense in accordance with section 202 of E.O. 13603. Through the HRPAS rule, HHS may also respond to requests to place priority ratings on contracts or orders (requiring priority performance of contracts or orders) for health resources, as specified in the DPA, if the necessity arises. Under the priorities' component, certain contracts or orders between the government and private parties or between private parties for the production or delivery of health resources are required to be prioritized over other contracts or orders to facilitate expedited production or delivery in promotion of the U.S. national defense. The Secretary retains the authority for allocations. Under the allocations' component, materials, services, and facilities may be allocated to promote the national defense. Such requests must be determined as necessary or appropriate to promote the national defense in accordance with section 202 of E.O. 13603. For both components, the term “national defense” is defined in section 801(j) of E.O. 13603 as “programs for military and energy production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling, space, and any directly related activity.” The term also includes emergency preparedness activities conducted pursuant to title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) and critical infrastructure protection and restoration. See E.O. 13603, section 801(j). Other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation may be re-delegated by the Secretary. <HD SOURCE="HD1">I. Background</HD> HHS published an interim final rule in the <E T="04">Federal Register</E> at 80 FR 42408 on July 17, 2015, to comply with the Part II—Priorities and Allocations, Sec 201(b) of E.O. 13603, dated March 16, 2012, and section 101(d) of the DPA, 50 U.S.C. 4511(d), and received no public comments. Based on the signficant amount of time between the publication of the interim final rule in 2015, HHS published, on August 16, 2023, a NPRM in the <E T="04">Federal Register</E> at 88 FR 55613 to allow for comments based on HHS utilizing DPA authorities and the HRPAS to respond to COVID-19 Public Health Emergency (PHE) from 2020 to 2023 and the infant formula shortage in 2022. <HD SOURCE="HD1">II. Discussion and Analysis</HD> HRPAS is a program established in accordance with the DPA and E.O. 13603 that supports national defense needs (for health resources), including emergency preparedness initiatives, by addressing essential civilian needs through the placing of priority ratings on contracts and orders for items and services or allocating resources, as necessary. Although a specific Presidential disaster declaration is not required, the ability to prioritize or allocate items or services requires a determination be made in accordance with section 202 of E.O. 13603, (except as provided in section 201(e) for use of the allocations authority) that the program or programs are necessary or appropriate to promote national defense, including emergency preparedness. The HRPAS outlines several conditions that must be met in order for HHS to undertake an allocation order, which include a finding, when necessary, under section 101(b) of the DPA that such a material is a scarce and critical material essential to the national defense and that the requirements of the national defense for such material cannot otherwise be met without creating a significant dislocation of the normal distribution of such material in the civilian market to such a degree as to create appreciable hardship. The President must approve the finding, in accordance with section 201(e) of E.O. 13603, before the Secretary may use the allocation authority. Under section 702(14) of the DPA (50 U.S.C. 4552(14)), the term “national defense” includes emergency preparedness activities conducted pursuant to the Stafford Act, and critical infrastructure protection and restoration. Authority for priorities and allocations is specified in the DPA and further defined in E.O. 13603, “National Defense Resources Preparedness,” dated March 16, 2012. E.O. 13603 replaced E.O. 12919 and further defined jurisdictional areas and national defense preparedness roles and responsibilities for specific agencies. E.O. 13603 did not change the intent of the DPA as it applies to HHS' functions in national defense, including emergency preparedness. <HD SOURCE="HD2">Jurisdiction</HD> E.O. 13603 authorizes jurisdictional areas for each agency delegated title I authority under the DPA that is involved in national defense, including emergency preparedness. HHS has jurisdiction for items that fall under the category of health resources which is defined in E.O. 13603 as “drugs, biological products, medical devices, materials, facilities, health supplies, services and equipment required to diagnose, mitigate, or prevent the impairment of, improve, treat, cure, or restore the physical or mental health conditions of the population.” HHS cannot use its DPA authority for items or services not in its jurisdiction. Those entities in need of items or services that do not fall under the jurisdiction of HHS should request priorities assistance from the applicable resource department. HHS will direct the requesters to the appropriate resource agency if the request comes to HHS. HHS intends to work with other resource agencies to address instances where HHS does not have jurisdiction—or where jurisdiction may be overlapping or ambiguous—for items necessary to complete the order. HHS intends to work with the other resource agencies to request prioritization of contracts or orders for other items or services necessary for use in support of programs approved for use by HHS (see next section). <HD SOURCE="HD2">HRPAS Approved Programs</HD> On November 2, 2023, the Department of Homeland Security approved four programs to be eligible for priorities and allocations support in accordance with Section 202 of Executive Order 13603. These programs are listed in Appendix 1. <HD SOURCE="HD1">III. DPA Priorities and Allocations System Authority</HD> The Defense Production Act Reauthorization (DPAR) of 2009 required that HHS, and all other agencies that previously have been delegated priorities and allocations authority under E.O. 13603, publish regulations providing standards and procedures for prioritization of contracts and orders and for allocation of materials, services, and facilities to promote the national defense under both emergency and nonemergency conditions. HHS' regulation, along with regulations promulgated by other agencies, are part of the Federal Priorities and Allocations System (FPAS). On October 1, 2018, Congress amended the DPA through the John S. McCain National Defense Authorization Act (Pub. L. 115-232) which extended non-permanent provisions through September 30, 2025. Section 101(d) of the DPA, as amended, directs all agencies to which the President has delegated priorities and allocations authority under E.O. 13603 to publish final rules establishing st ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 113k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━