Effective Date: 03/29/2026
HHSAR Text Baseline is the RFO HHSAR part 335 deviation text issued under HHSAR CD 2026-02 on February 7, 2026.
Changes to baseline shown as [bolded, bracketed additions] and strikethrough deletions.
For HHSAR part 352, only the provisions and clauses associated with part 335 are shown.
HHSAR PART 335 – RESEARCH AND DEVELOPMENT CONTRACTING [RESERVED] [(RFO DEVIATION)]
[Subpart 335.70 – Acquisitions Involving Human Subjects
335.7000 Scope of subpart.
335.7001 Policy.
335.7002 Federal-wide Assurance (FWA).
335.7003 General procedures.
335.7004 Solicitation provision and contract clauses.
Subpart 335.71 – Acquisitions Involving the Use of Laboratory Animals
335.7100 Scope of subpart.
335.7101 Policy.
335.7102 Assurances.
335.7103 General procedures.
335.7104 Solicitation provision and contract clause.]
[RESERVED]
[Subpart 335.70 – Acquisitions Involving Human Subjects
335.7000 Scope of subpart.
This subpart implements the Federal Policy for the Protection of Human Subjects adopted by HHS at 45 CFR part 46 and applies to all research activities conducted under contracts involving human subjects.
335.7001 Policy.
(a) The HHS Office for Human Research Protections (OHRP) administers the assurance covering all HHS-supported or HHS-conducted activities involving human subjects.
(b) The contracting officer must not award a contract involving human subjects until the prospective contractor provides assurance that the activity will undergo initial and continuing review by an appropriate Institutional Review Board (IRB) to the extent required by HHS regulations at 45 CFR part 46.
(c) The contracting officer must require a Federal-wide assurance (FWA), approved by OHRP, of each contractor, subcontractor, or institution engaged in human subjects research in performance of a contract.
335.7002 Federal-wide Assurance (FWA).
(a) OHRP-Approved FWAs are available at http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.
(b) A contractor, subcontractor, or institution must submit all FWAs (including new submissions, updates, and renewals) using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/. If a contractor, subcontractor, or institution cannot submit its FWA electronically, it must contact OHRP by telephone or email (see https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why a FWA cannot be submitted electronically.
335.7003 General procedures.
(a) Normally a contractor, subcontractor, or institution must provide approval of a FWA before a contract is awarded.
- (1) If a contractor, subcontractor, or institution does not currently hold an approved FWA, it must submit an explanation with its proposal and an FWA application prior to submitting a proposal.
- (2) The contracting officer, on a case-by-case basis, may make award without an approved assurance in consultation with OHRP.
(b) The contracting officer generally will not request FWAs for contractors, subcontractors, or institutions prior to selecting a contract proposal for negotiation.
- (1) When a contractor submits an FWA, it provides certification for the initial contract period; no additional documentation is required.
- (2) If the contract provides for additional years to complete the project, the contractor must certify annually in accordance with HHSAR 352.235-71. Unless otherwise stated, the annual certification must be provided on/by the anniversary date of the contract award.
(d) Additional review and approval requirements. If research involving human subjects is subject to reviews and approvals that are not outlined in this subpart or the prescribed provisions and clauses, these requirements will be specified in the contract.
335.7004 Solicitation provision and contract clauses.
(a) Insert the provision at 352.235-70, Notice of Offerors – Protection of Human Subjects, in solicitations that involve or may involve human subjects. Use the provision with its Alternate I when the agency is prescribing a date later than the proposal submission by which the offeror must have an approved FWA.
(b) Insert the following clauses in solicitations, contracts, and orders that involve or may involve human subjects:
- (1) 352.235-71, Protection of Human Subjects.
- (2) 352.235-72, Needle Exchange.
- (3) 352.235-73, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research.
Subpart 335.71 – Acquisitions Involving the Use of Laboratory Animals
335.7100 Scope of subpart.
This subpart applies to all research, research training, biological testing, housing and maintenance, and other activities involving live vertebrate animals conducted under contract. Additional information can be found in Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) at http://grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf.
335.7101 Policy.
(a) The National Institutes of Health (NIH), Office of Laboratory Animal Welfare (OLAW) negotiates assurances covering all HHS/PHS-supported or HHS/PHS-conducted activities involving the care and use of live vertebrate animals.
(b) Contracting officers must—
- (1) Not award a contract involving live vertebrate animals until the contractor provides acceptable assurance that the contract work is subject to initial and continuing review by an appropriate Institutional Animal Care and Use Committee (IACUC) as described in the PHS Policy at IV.B.6 and 7.
- (2) Require an applicable Animal Welfare Assurance approved by OLAW of each contractor, subcontractor, or institution having responsibility for animal care and use involved in performance of the contract.
- (i) The assurance must be approved before award; however, the contracting officer, on a case-by-case basis, may make a contract award without an approved assurance in consultation with OLAW. For additional information see PHS Policy II., IV.A, and V.B.
(c) Offerors proposing use of live vertebrate animals must address all required elements in the Vertebrate Animals Section (VAS) of the Technical Proposal. For additional information see PHS Policy and use Contract Proposal VAS Worksheet. See https://olaw.nih.gov/policies-laws/phs-policy.htm#InformationRequiredinApplications-ProposalsforAwardsSubmittedtoPHS and http://grants.nih.gov/grants/olaw/VAScontracts.pdf.
335.7102 Assurances.
(a) Animal Welfare Assurances include:
- (1) Domestic Assurance (DA). A DA describes the institution's animal care and use program, including but not limited to the lines of authority and responsibility, veterinary care, IACUC composition and procedures, occupational health and safety, training, facilities, and species housed. A DA listed in OLAW's list of institutions with an approved DA is acceptable for purposes of this policy.
- (2) Inter-institutional Assurance (IA). The offeror, its proposed subcontractor, or institution must submit an IA when it does not have a proprietary animal care and use program, facilities to house animals or IACUC, and does not conduct animal research on-site. The offeror will perform the animal activity at an institution with an Animal Welfare Assurance named as a performance site. An IA approval extends to the full period of contract performance (up to 5 years) limited to the specific award or single project.
- (3) Foreign Assurance (FA). The Foreign Assurance is required for institutions outside the U.S. that receive PHS funds directly through a contract award. The Foreign Assurance also applies to institutions outside the U.S. that receive PHS funds indirectly (named as a performance site). An FA listed in OLAW's list of institutions with an approved FA is acceptable for purposes of this policy.
(b) Contractors providing animal care services at an institution with an Animal Welfare Assurance, such as a Government-owned, Contractor-operated (GOCO) site, does not need a separate assurance if covered by the site’s assurance.
335.7103 General procedures.
(a) Offerors having a DA on file with OLAW must submit IACUC approval of the use of animals in the manner required by the solicitation, but prior to award. The date of IACUC approval must not be more than 36 months prior to award.
(b) It is not necessary for offerors lacking an Animal Welfare Assurance to submit assurances or IACUC approval with proposals. OLAW will contact contractors, subcontractors, and institutions to negotiate necessary assurances and verify IACUC approvals when requested by the contracting officer.
(c) Contracting officers must send proposals selected for negotiation and requiring an assurance to OLAW at olawdoa@od.nih.gov, as early as possible to secure the necessary assurances.
(d) Normally the assurance must be approved before award. The contracting officer, on a case-by-case basis, may make award without an approved assurance in consultation with OLAW. For additional information see PHS Policy II., IV.A, and V.B.
335.7104 Solicitation provision and contract clause.
(a) Insert the provision at 352.235-74, Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, in solicitations involving live vertebrate animals.
(b) Insert the clause at 352.235-75, Care of Live Vertebrate Animals, in solicitations, contracts, and orders involving live vertebrate animals.]
HHSAR PART 352 – SOLICITATION PROVISIONS AND CONTRACT CLAUSES [(RFO DEVIATION)]
Subpart 352.2 – Texts of Provisions and Clauses
[352.235-70 Notice to Offerors – Protection of Human Subjects.
352.235-71 Protection of Human Subjects.
352.235-72 Needle Exchange.
352.235-73 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research.
352.235-74 Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
352.235-75 Care of Live Vertebrate Animals.]
Subpart 352.2 – Texts of Provisions and Clauses
[352.235-70 Notice to Offerors – Protection of Human Subjects.
As prescribed in 335.7004(a), insert the following provision:
NOTICE TO OFFERORS – PROTECTION OF HUMAN SUBJECTS (MAR 2026) (RFO DEVIATION)
(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.
- (1) These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.
(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.
(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.104(d)(1)-(8) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.
(e) In accordance with 45 CFR part 46, Offerors considered for award must file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board must ensure that: The risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP Web site (at http://www.hhs.gov/ohrp/assurances/index.html).
(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting officer may offer information concerning a solicitation.
(g) The Offeror must document in its proposal the approved or active FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research.
- (1) If the Offeror does not have an approved FWA from OHRP, the Offeror must obtain an FWA before the deadline for proposal submission.
(h) When possible, the Offeror must also certify the IRB's review and approval of the research. If the Offeror cannot obtain this certification by the time of proposal submission, they must include an explanation in their proposal.
(i) Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research's review and approval by the IRB.
(End of provision)
Alternate I (MAR 2026) (RFO DEVIATION).
As prescribed in HHSAR 335.7004(a), substitute the following paragraph (g)(1) for paragraph (g)(1) of the basic clause.
- (1) If the Offeror does not have an active FWA from OHRP, the Offeror must take all necessary steps to obtain an FWA prior to the proposal submission deadline. If the Offeror cannot obtain an FWA before the proposal submission deadline, the proposal must indicate the steps/actions the Offeror will take to obtain OHRP approval within (Contracting Officer insert a time period in which the FWA must be obtained). Upon obtaining FWA approval, submit the approval notice to the Contracting Officer.
352.235-71 Protection of Human Subjects.
As prescribed in 335.7004(b)(1), insert the following clause:
PROTECTION OF HUMAN SUBJECTS (MAR 2026) (RFO DEVIATION)
(a) The Contractor must—
- (1) Protect the rights and welfare of human subjects involved in research under this contract in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services;
- (2) Provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance; and
- (3) Ensure that other agencies or institutions the Contractor involves in activities considered to be engaged in research involving human subjects—
- (i) Obtain their own FWA if they are routinely engaged in research involving human subjects; or
- (ii) Are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Web site at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).
(b) The Contractor—
- (1) Bears full responsibility for the performance of all work and services involving the use of human subjects under this contract and must ensure that work is conducted in a proper manner and as safely as is feasible.
- (2) Retains the right to control and direct the performance of all work under this contract. Nothing in this contract must create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever.
- (3) Will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.
(c) The Contractor must not expend funds under this contract for research involving human subjects or engage in any human subjects research activity prior to the Contracting Officer's receipt of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) registered with OHRP.
- (1) This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.
(d) If the Contractor fails to comply with any of the requirements of this clause, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance.
- (1) The Contracting Officer will communicate the notice of suspension in writing or by telephone with confirmation in writing.
- (2) If the Contractor fails to complete corrective action(s) within the period of time designated in the written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.
(e) The Contractor must include the substance of this clause, including this paragraph (e), in all subcontracts that may include research involving human subjects.
(End of clause)
352.235-72 Needle Exchange.
As prescribed in 335.7004(b)(2), insert the following clause:
NEEDLE EXCHANGE (MAR 2026) (RFO DEVIATION)
The Contractor must not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
(End of clause)
352.235-73 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research.
As prescribed in 335.7004(b)(3), insert the following clause:
CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH (MAR 2026) (RFO DEVIATION)
(a) The Contractor must not use any funds obligated under this contract for—
- (1) Any abortion,
- (2) Cloning of human beings, or
- (3) For the following:
- (i) The creation of a human embryo or embryos for research purposes; or
- (ii) Research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero under 45 CFR part 46 and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).
(b) The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR part 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes of human diploid cells.
(End of clause)
352.235-74 Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
As prescribed in HHSAR 335.7104(a), insert the following provision:
NOTICE TO OFFERORS – REQUIREMENT FOR COMPLIANCE WITH THE PUBLIC HEALTH SERVICE POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS (MAR 2026) (RFO DEVIATION)
(a) The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals.
(b) Before awarding a contract to an offeror, the organization must file, with the National Institutes of Health (NIH), Office of Laboratory Animal Welfare (OLAW), , a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC).
(c) In accordance with the PHS Policy, Offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals.
(d) No award involving the use of animals must be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer.
(e) Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval.
(f) For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (Email: olaw@od.nih.gov; Phone: 301-496-7163).
(End of provision)
352.235-75 Care of Live Vertebrate Animals.
As prescribed in HHSAR 335.7104(b), insert the following clause:
CARE OF LIVE VERTEBRATE ANIMALS (MAR 2026) (RFO DEVIATION)
(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United States Department of Agriculture (USDA), the Contractor must register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor must furnish evidence of the registration to the Contracting Officer.
(b) The Contractor must acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1-2.11, or from a source that is exempt from licensing under those sections.
(c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract must conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard must govern.
(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.
(e) The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email: ace@aphis.usda.gov; Web site: https://www.aphis.usda.gov/awa/apply).
(End of clause)]