HHS issues HHSAR Class Deviation 2026-02 Amendment 1 updating Part 335/352 clauses for human subjects research and live vertebrate animal requirements

HHS published HHSAR Class Deviation 2026-02 Amendment 1, effective immediately upon signature, updating deviated HHSAR text for Part 335 (Research and Development Contracting) and associated Part 352 provisions/clauses. The deviation addresses solicitation/contract clause requirements and compliance artifacts for acquisitions involving human subjects research (e.g., Federalwide Assurance and IRB-related requirements) and the use of live vertebrate animals (e.g., Animal Welfare Assurance and IACUC-related requirements), including instructions on inclusion in solicitations/contracts/orders and treatment of open solicitations/existing contracts. Compliance teams supporting vendors/contractors performing HHS R&D work should review updated clause flowdowns and required assurances/certifications for prime and subcontractor arrangements.