HHSAR CLASS DEVIATION 2026-02 Amendment 1

Signature Date: March 29, 2026

1. EFFECTIVE DATE:

Immediately upon signature.

2. EXPIRATION DATE:

This CD is effective until incorporated into the HHSAR, superseded, or otherwise rescinded.

3. PURPOSE:

HHSAR CD 2026-02, issued and effective on February 7, 2026, implemented requirements to comply with EO 14275, Restoring Common Sense to Federal Procurement, and the Revolutionary FAR Overhaul (RFO) initiative by revising HHSAR parts 307, 308, 331, 335, 336, and applicable portions of 352 to align with the FAR Council’s RFO model deviation text for FAR parts 7, 8, 31, 35, 36, and 52.

Amendment 1 to HHSAR CD 2026-02 provides updated deviation text for HHSAR part 335, which was previously reserved on February 7, 2026, under HHSAR CD 2026-02.

• Amendment 1 updates the deviation text for HHSAR part 335 and updates HHSAR part 352 to include the new provisions and clauses associated with HHSAR part 335.
• The guidance in HHSAR CD 2026-02 related to HHSAR parts 307, 308, 331, and 336, including any provisions and clauses associated with those parts, remain unchanged.

4. APPLICABILITY:

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

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• Remove duplicative or outdated language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 model deviation text and affected part 52 solicitation provisions and contract clauses for the following parts, as applicable, on the dates as shown:

• FAR part 7 and affected FAR part 52 - June 27, 2025
• FAR part 8 and affected FAR part 52 – August 14, 2025
• FAR part 31 – July 17, 2025
• FAR part 35 – July 24, 2025
• FAR part 36 and affected FAR part 52 – July 24, 2025.

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.

On February 7, 2026, HHS issued HHSAR CD 2026-02 approving a class deviation to HHSAR parts 307, 308, 331, 335, and 336 and associated HHSAR part 352 provisions and clauses.

7. POLICY/GUIDANCE:

HHS contracting staff must continue to comply with the policy/guidance as stated in HHSAR CD 2026-02, issued and effective on February 7, 2026, except where updated below:

1. A. Follow the updated RFO HHSAR part 335 deviation text, including the corresponding part 352 deviation text, instead of the previously issued RFO HHSAR part 335 deviation text or HHSAR 335 as codified at 48 CFR Chapter 3. The updated RFO HHSAR part 335 deviation text is shown in the Attachment listed in Section 11.
   • 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. B. When issuing new solicitations, contracts, or orders:
   1. Do not include the following provisions and clauses:
      • N/A – The updated RFO HHSAR part 335 does not remove any provisions or clauses.
   2. Include, if applicable, the following deviated provisions and clauses using the deviated text shown in the Attachment listed in Section 11:
      • 352.235-70 Notice to Offerors – Protection of Human Subjects (MAR 2026) (RFO DEVIATION)
      • 352.235-71 Protection of Human Subjects (MAR 2026) (RFO DEVIATION)
      • 352.235-72 Needle Exchange (MAR 2026) (RFO DEVIATION)
      • 352.235-73 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research (MAR 2026) (RFO DEVIATION)
      • 352.235-74 Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (MAR 2026) (RFO DEVIATION)
      • 352.235-75 Care of Live Vertebrate Animals (MAR 2026) (RFO DEVIATION)
3. C. For open solicitations:
   1. Amend the solicitation to remove the provisions and clauses listed in B.1 above.
   2. Amend the solicitation to include, if applicable, the deviated provisions and clauses listed in B.2 above.
4. D. For existing contracts and orders, at the next available opportunity:
   1. Modify the contract or order to remove the provisions and clauses listed in B.1 above.
   2. Modify the contract or order to include, if applicable, the deviated provisions and clauses listed in B.2 above.

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.

HHSAR CD 2026-02, issued and effective on February 7, 2026, identified notable changes for HHSAR parts 307, 308, 331, 335, 336, and 352.

Amendment 1 to HHSAR CD 2026-02 provides updated deviated text for HHSAR parts 335 and 352. Notable changes from the February 7, 2026, deviation text are summarized below, and these changes are reflected in the Attachment listed in Section 11.

• HHSAR Part 335 – Research and Development Contracting

  HHSAR CD 2026-02 previously reserved part 335 in its entirety. Amendment 1 to HHSAR CD 2026-02 updates part 335 as follows:

  • Subpart 335.70 – Acquisitions Involving Human Subjects
    • This is a newly added subpart that includes content relocated from HHSAR subpart 370.3.
    • The original text from 370.3 has been revised for plain language and clarity, with consolidation and restructuring where appropriate, while maintaining the core policy intent and requirements. Provisions and clauses were also consolidated where appropriate, and removed if no longer applicable.
  • Subpart 335.71 – Acquisitions Involving the Use of Laboratory Animals
    • This is a newly added subpart that includes content relocated from HHSAR subpart 370.4.
    • The original text from 370.4 has been revised for plain language and clarity, with consolidation and restructuring where appropriate, while maintaining the core policy intent and requirements.
• HHSAR Part 352 – Solicitation Provisions and Contract Clauses
  • 352.235-70 Notice to Offerors – Protection of Human Subjects
    • This provision incorporates the substance of the provision previously at 352.270-4a, with revisions.
    • Revisions include plain language edits; restructuring and redesignation of paragraphs to improve readability; and updates to regulation citations for currency.
  • 352.235-71, Protection of Human Subjects
    • This clause consolidates and incorporates the substance of the clauses previously at 352.270-4b and 352.270-71, with revisions.
    • Revisions include plain language edits; restructuring of paragraphs to improve readability; and strengthening applicability at the subcontract level through the addition of subcontract flowdown requirements.
  • 352.235-72, Needle Exchange
    • This clause incorporates the substance of the clause previously at 352.270-12, with plain language edits.
  • 352.235-73, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research
    • This clause incorporates the substance of the clause previously at 352.270-13, with revisions.
    • Revisions include plain language edits and restructuring of paragraphs to improve readability.
  • 352.235-74, Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals
    • This provision incorporates the substance of the provision previously at 352.270-5a, with revisions.
    • Revisions include plain language edits and the addition of paragraph designations to improve readability.
  • 352.235-75, Care of Live Vertebrate Animals
    • This clause incorporates the substance of the clause previously at 352.270-5b, with revisions.
    • Revisions include plain language edits; the addition of a paragraph designation to a previously unnumbered note to improve readability; and updating a website reference for currency.

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 335 & Applicable Part 352 Deviation Text