HHSAR Class Deviation 2026-22

Signature Date: 9/9/2026

1. EFFECTIVE DATE:

October 1, 2026

2. EXPIRATION DATE:

This CD is effective until incorporated into the HHSAR, superseded, or otherwise rescinded.

3. PURPOSE:

This HHSAR CD implements requirements to comply with EO 14275, Restoring Common Sense to Federal Procurement, and the Revolutionary FAR Overhaul (RFO) initiative. This CD revises HHSAR part 325 and applicable portions of 352 to align with the FAR Council’s RFO model deviation text for FAR parts 25 and 52.

This HHSAR CD supersedes and rescinds the deviation guidance in the HHSAR CD 2023-02, entitled “Department of Health and Human Services (HHS) Class Deviation from the Health and Human Services Acquisition Regulation (HHSAR) – Implementation of the Make Personal Protective Equipment (PPE) in America Act Requirements,” issued on February 9, 2023.

4. APPLICABILITY:

The requirements in this CD are applicable to all HHS Divisions for applicable solicitations and contracts.

5. ROLES AND RESPONSIBILITIES:

Heads of the Contracting Activities (HCAs) must ensure this CD is disseminated to the acquisition workforce and ensure compliance with the requirements in the CD. Additionally, HCAs must review and update any applicable internal procedures and guidance to reflect the policies and guidance contained herein.

6. BACKGROUND:

On April 15, 2025, EO 14275, Restoring Common Sense to Federal Procurement, was signed. Section 2 of the EO establishes the policy that the FAR “should only contain provisions required by statute or essential to sound procurement, and any FAR provisions that do not advance these objectives should be removed.”

Under the RFO initiative, the FAR is being updated to:

• Remove language that is not required by statute
• Remove duplicative or outdated language
• Clarify or provide more plain language
• Revise language for the new FAR framework
• Retain language necessary for governmentwide acquisition standards.

The FAR Council released their RFO FAR part 25 model deviation text and affected part 52 solicitation provisions and contract clauses on September 30, 2025, and updated the model deviation text on March 16, 2026.

These changes flow down to and directly impact the HHSAR and require immediate updates.

41 U.S.C. 1707(a)(1) requires that a procurement policy, regulation, procedure, or form, including an amendment or modification, may not take effect until 60 days after it is published for public comment in the Federal Register if it “(A) relates to the expenditure of appropriated funds; and (B)(i) has a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form; or (ii) has a significant cost or administrative impact on contractors or offerors.”

However, to ensure alignment with recently issued EOs, it is necessary to issue this CD in advance of a proposed rule to ensure HHS solicitations, contracts, and orders consistently reflect the policies and priorities of the Administration. HHS intends on developing a rule after the release of this CD.

7. POLICY/GUIDANCE:

HHS contracting staff must comply with the following:

1. Follow the RFO HHSAR part 325 deviation text, including the corresponding part 352 deviation text, instead of HHSAR parts 325 and corresponding 352 as codified at 48 CFR Chapter 3. The RFO HHSAR deviation text is shown in the Attachment listed in Section 11.
   1. Clean (without markup) versions of RFO HHSAR deviation texts are available at https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar-overhaul/index.html.
2. When issuing new solicitations, contracts, or orders:
   1. Do not include the following clause and provision:
      
      Note: The codified HHSAR part 325 contains no text and therefore has no associated part 352 clauses or provisions. However, this HHSAR CD supersedes and rescinds any previously deviated provision or clause associated with HHSAR part 325. Therefore, the deviated clause and provision below should no longer be used.
      • Clause 352.225.70 Made in America – Personal Protective Equipment (FEB 2023) (Deviated version from the February 9, 2023 HHSAR CD 2023-02 and now superseded and rescinded by this class deviation.)
      • Provision 352.225-71 Made in America Certificate – Personal Protective Equipment (FEB 2023) (Deviated version from the February 9, 2023 HHSAR CD 2023-02 and now superseded and rescinded by this class deviation.)
   2. Include, if applicable, the following deviated clause and provision using the deviated text shown in the Attachment listed in Section 11:
      • Clause 352.225-70 Made in America – Covered Personal Protective Equipment (OCT 2026) (RFO DEVIATION)
      • Provision 352.225-71 Made in America Certificate – Covered Personal Protective Equipment (OCT 2026) (RFO DEVIATION)
3. For open solicitations:
   1. Amend the solicitation to remove the clause and provision listed in B.1 above.
   2. Amend the solicitation to include, if applicable, the clause and provision listed in B.2 above.
4. For existing contracts and orders:
   1. No action needed. Contracting officers can continue to enforce the deviated clause and provision listed in B.1 and associated with the now superseded and rescinded HHSAR CD 2023-02, if the clause and provision were included in contracts or orders awarded prior to October 1, 2026.

8. AUTHORITY:

This CD is issued under the authority of RFO FAR 1.304, Class deviations; RFO HHSAR 301.103, Authority; and RFO HHSAR 301.302, Policy.

9. SUMMARY OF HHSAR CHANGES:

To implement or align with the requirements of the RFO, the HHSAR is deviated, renumbered, revised, and updated with plain language edits. Notable changes are summarized below, and all changes are reflected in the Attachment listed in Section 11.

• HHSAR Part 325 – Foreign Acquisition
  • Subpart 325.70 Restrictions on Foreign Acquisition of Covered PPE
    • Added this new subpart, and underlying sections, to implement section 70953 of the Make PPE in America Act ( L. 117-58, Div. G, Title IX, Subtitle C (Nov. 15, 2021)) requirements that limit buying covered personal protective equipment (PPE) from foreign sources.
  • HHSAR Part 352 – Solicitation Provisions and Contract Clauses
    • 352.225-70 Made in America – Covered Personal Protective Equipment
      • Add a new clause to require delivery of only domestic PPE.
    • 352.225-71 Made in America Certificate – Covered Personal Protective Equipment
      • Add a new provision, which is to be used when the clause at 352.225-70 applies, which requires offerors to identity items of covered PPE that are not domestic PPE end products.

10. CONTACT:

Acquisition workforce members with questions regarding this CD should contact their cognizant Division Acquisition Office or Acquisition Policy Council (APC) Representative(s), as appropriate.

The current list of APC Representatives may be found on the Acquisition Councils and Workgroups Page of the HHS Acquisition Portal (HHSAP). (Note: The HHSAP is accessible only by HHS employees and contractors on the HHS network. It is not publicly accessible.)

All other questions should be directed to Acquisition_Policy@hhs.gov.

11.  ATTACHMENT(S):

Attachment 1 – RFO HHSAR Part 325 & Applicable Part 352 Deviation Text