HHS Acquisition Regulation: Regulatory Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 314, 315, 316, 318, 319, 322, 323, 324, 325, 326, 327, 330, 331, 332, 333, 334, 335, 336, 337, 341, 342, 343, 344, 345, 347, 352, and 370</CFR> <RIN>RIN 0991-AC36</RIN> <SUBJECT>HHS Acquisition Regulation: Regulatory Review</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to update and streamline the HHSAR. Under this initiative, all parts of the regulation were reviewed to streamline the regulation, to revise or remove policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any procedural guidance that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as internal policies, guidance, and instructions. The rule would add new coverage to implement agency unique requirements. The HHSAR would also be updated to reflect organizational changes in the Department, incorporate recent statutory changes and government mandates, and to accomplish editorial revisions for clarification. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before December 2, 2024, to be considered in the formulation of the final rule. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit written comments in response to HHSAR Case 2023-002 through the Federal eRulemaking Portal at: <E T="03">https://www.regulations.gov</E> by searching for “HHSAR Case 2023-002”. Select the link “Comment Now” and follow the “Submit a comment” instructions. Please include your name, company name (if any), and indicate they are submitted in response to “RIN 0991-AC36—HHS Acquisition Regulation: Regulatory Review (HHSAR Case 2023-002).” <E T="03">Warning:</E> Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to comments received. <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period will be available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. HHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of <E T="03">https://www.regulations.gov.</E> Follow the search instructions on that website to view the public comments. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Mr. Jarreau Vieira, Chief, Acquisition Rule-Making Branch, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Office of Acquisition Policy, 200 Independence Avenue SW, Washington, DC 20201. Email: <E T="03">acquisition_policy@hhs.gov,</E> Telephone: (202) 731-4625. This is not a toll-free telephone number. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> This rulemaking is being taken under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to authorize the issuance of agency acquisition regulations that implement or supplement the FAR. The OFPP Act, as codified in 41 U.S.C. 1702, provides the authority for the FAR and for the issuance of agency acquisition regulations consistent with the FAR. This authority ensures that Government procurements are handled fairly and consistently, that the Government receives overall best value, and that the Government and contractors both operate under a known set of rules. The statute at 41 U.S.C. 1121(b) provides authority for the FAR, while 41 U.S.C. 1121(e), 1702(b)(3)(e), and 1702(c)(2), when read together, provide authority for the issuance of agency acquisition regulations consistent with the FAR. HHS issues the HHSAR under these authorities. HHS has determined that changes to the HHSAR are necessary to align it to the FAR. As a result, the HHS Acquisition Policy Division Integrated Project Team (IPT) under the direction of the Senior Procurement Executive and composed of representatives from HHS's operating divisions (OPDIVs) and staff divisions (STAFFDIVs) and other agency stakeholders, have participated in reviews of the regulation, resulting in a complete revision of the HHSAR. HHS conducted a comprehensive review of the HHSAR with the goal of updating obsolete coverage, streamlining policies and procedures where applicable consistent with current guidance, and moving internal policies applicable to the HHS acquisition workforce to a new HHS Acquisition Manual (HHSAM). The HHSAM will incorporate portions of the internal procedural guidance removed from the HHSAR, as well as other internal agency acquisition policy. This proposed rule reflects changes that need to be made to the HHSAR to implement and/or supplement the FAR. HHS is proposing to substantially revise and streamline the HHSAR to update or remove references to superseded or obsolete policies, procedures, and organizations and to incorporate electronic links to FAR provisions and other matters referenced in the HHSAR. Other revisions include incorporating additional policies, solicitation provisions, and/or contract clauses into the HHSAR to implement and supplement the FAR and satisfy HHS unique mission needs and responsibilities. This includes incorporating changes in dollar and approval thresholds, definitions, and HHS position titles and offices. The reissued HHSAR proposed in this notice would correct inconsistencies, remove redundant and duplicate material already covered by the FAR, delete outdated material or information, and appropriately renumber HHSAR text, clauses, and provisions where required to comport with FAR format, numbering, and arrangement. All amendments, revisions, and removals have been reviewed and concurred with by a HHSAR revision team from each of the OPDIVs/STAFFDIVs and key agency stakeholders. This effort will create a 2024 edition of the HHSAR. Currently, HHS is tracking a number of new FAR case proposed and final rules, as well as Executive orders (E.O.s) and directives that the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) are reviewing for potential impact to the FAR system. The Executive orders include E.O. 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” (86 FR 7009; Jan. 25, 2021), E.O. 14005, “Ensuring the Future is Made in All of America by All of America's Workers” (86 FR 7475; Jan. 28, 2021), and E.O. 14008, “Tackling the Climate Crisis at Home and Abroad” (86 FR 7619; Feb. 1, 2021). If and when FAR cases and proposed rules are drafted and FAR final rules are published, HHS intends to examine each of these for impact to the HHSAR and any updates that may be required to maintain the HHSAR. HHS is institutionalizing an ongoing, sustained HHSAR refreshment process, so that as FAR proposed and final rules, E.O.s, and other directives are issued, HHS will initiate new HHSAR cases to bring the regulation in alignment and to avoid duplication, as necessary. HHS will examine any FAR final rules that become effective and will take into consideration such FAR changes, as appropriate, in subsequent rulemakings. When needed, HHS will also consider use of an advanced notice of proposed rulemaking (ANPRM) to obtain public input as the agency implements rulemaking to address new and emerging issues that may be identified by the Councils or by HHS as a result of E.O.s and other directives. HHS will use this public input to inform how HHS implements such guidance in the HHSAR. The HHSAR uses the regulatory structure and arrangement of the FAR, and headings and subject areas are broken up consistent with the FAR content. The HHSAR is divided into subchapters, parts (each of which covers a separate aspect of acquisition), subparts, sections, and subsections. When Federal agencies acquire supplies and services using appropriated funds, the purchase is governed by the FAR, set forth at title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through 53, and the agency regulations that implement and supplement the FAR. The HHSAR is set forth at 48 CFR, chapter 3, parts 301 through 370. HHS is proposing to revise the HHSAR to add new policy or regulatory requirements and to remove any guidance that is applicable only to HHS's internal operating processes or procedures. Codified acquisition regulations may be amended and revised only through rulemaking. <HD SOURCE="HD1">Discussion and Analysis</HD> HHS proposes to make the following changes to the HHSAR as a part of its updating and streamlining initiative. For procedural guidance cited below that is proposed to be deleted from the HHSAR, each section cited for removal has been considered for inclusion in HHS's internal agency operating procedures in accordance with FAR 1.301(a)(2). Similarly, delegations of authorities that are removed from the HHSAR will be included in the HHSAM as internal agency guidance. We propose to revise the following parts of the HHSAR, 48 CFR chapter 3: Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 314, 315, 316, 319 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 628k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━