HHSAR PART 352 – SOLICITATION PROVISIONS AND CONTRACT CLAUSES (RFO DEVIATION)

Note: This page shows only the HHSAR provisions and clauses associated with HHSAR parts that have been overhauled/deviated. Unless otherwise noted, all provisions and clauses listed on this page have been deviated. Each HHSAR provision and clause will indicate the effective date and associated HHSAR class deviation. Please continue to monitor this page for updates.

Subpart 352.2 – Text of Provisions and Clauses
352.203-70       Anti-Lobbying.
352.208-70       Printing and Duplication.
352.211-1         Public Accommodations and Commercial Facilities.
352.211-2         Conference Sponsorship Requests and Conference Materials Disclaimer.
352.211-3         Paperwork Reduction Act.
352.215-70       Late Proposals and Revisions – R&D Acquisitions.
352.216-70       Allowable Cost and Payment for Hospitals (Profit or Non-Profit).
352.219-70       [Reserved]
352.219-71       [Reserved]
352.219-72       HHS Section 8(a) Award.
352.222-70       [Reserved] 
352.223-70       Safety and Health.
352.223-71       [Reserved]
352.225-70       Made in America – Covered Personal Protective Equipment.
352.225-71       Made in America Certificate – Covered Personal Protective Equipment.
352.226-70       Indian Preference.
352.226-71       Indian Preference Program.
352.226-72       Native American Graves Protection and Repatriation Act.
352.226-73       Notice of Indian Small Business Economic Enterprise Set-Aside.
352.226-74       Notice of Indian Economic Enterprise Set-Aside.
352.226-75       Indian Economic Enterprise Subcontracting Limitations.
352.226-76       Indian Economic Enterprise Representation.
352.227-11       [Reserved]
352.227-14       [Reserved]
352.227-70       Patent Rights – Supplement – Exceptional Circumstances.
352.227-71       Rights in Data – Supplement – Exceptional Circumstances.
352.227-72       Publications and Publicity.
352.231-70       Salary Rate Limitation.
352.232-70       [Reserved]
352.232-71       Electronic Submission of Payment Requests. 
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.
352.236-70       Design-Build Contracts.
352.237-70       Nonsmoking Policy – Delivery of Services to Children.
352.237-71       Reporting of Child Abuse.
352.237-72       Requirement for Background Checks.
352.237-73       Indian Child Protection and Family Violence Act—Background Investigations.
352.237-74       [Reserved]
352.237-75       Key Personnel.
352.270-4a       [Reserved]
352.270-5a       [Reserved]
352.270-5b       [Reserved]
352.270-6         [Reserved]
352.270-9         [Reserved]
352.270-10       [Reserved]
352.270-11       [Reserved]
352.270-12       [Reserved]
352.270-13       [Reserved]
352.270-70       Non-Discrimination for Conscience.

Subpart 352.2 – Text of Provisions and Clauses

352.203-70 Anti-Lobbying.

Effective Date: 06/10/2026 (see HHSAR CD 2026-11)

As prescribed in 303.808-70, insert the following clause:

ANTI-LOBBYING (JUN 2026) (RFO DEVIATION)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor must not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in paragraphs (a), (b), and (c) of this clause include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

352.208-70 Printing and Duplication.

Effective Date: 02/07/2026 (see HHSAR CD 2026-02)

As prescribed in HHSAR 308.570, insert the following clause:

PRINTING AND DUPLICATION (FEB 2026) (RFO DEVIATION)

(a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor must submit camera-ready copies to the Contracting Officer's Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 3⁄4 by 14 1⁄4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

(c) Approval for all printing, as well as duplicating/copying in excess of the stated limits, must be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

(End of clause)

352.211-1 Public Accommodations and Commercial Facilities.

Effective Date: 11/21/2025 (see HHSAR CD 2026-01)

As prescribed in HHSAR 311.7102, the contracting officer must insert the following clause:

PUBLIC ACCOMMODATIONS AND COMMERCIAL FACILITIES (NOV 2025) (RFO DEVIATION)

The Contractor agrees as follows:

(a) Except for ad hoc meetings necessary or incidental to contract performance, the Contractor must develop a plan to assure that any event held pursuant to this contract will meet or exceed the minimum accessibility standards set forth in 28 CFR part 36—Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities. The Contractor must submit the plan to the Contracting Officer and must receive approval prior to the event. The Contractor may submit a consolidated or master plan for contracts requiring numerous events in lieu of separate plans.

(b) The Contractor must manage the contract in accordance with the standards set forth in 28 CFR part 36.

(End of clause)

352.211-2 Conference Sponsorship Requests and Conference Materials Disclaimer.

Effective Date: 11/21/2025 (see HHSAR CD 2026-01)

As prescribed in HHSAR 311.7202, the Contracting Officer must insert the following clause:

CONFERENCE SPONSORSHIP REQUEST AND CONFERENCE MATERIALS DISCLAIMER (NOV 2025) (RFO DEVIATION)

(a) Prior to the Contractor claiming HHS conference sponsorship, the Contractor must submit a written request (including rationale) to the Contracting Officer for permission to claim such HHS sponsorship.

(b) The Contractor must include the following statement on conference materials, including promotional materials, agendas, and Web sites:

“This conference was funded, in whole or in part, through a contract (insert contract number) with the Department of Health and Human Services (HHS) (insert name of Division). The views expressed in written conference materials and by speakers and moderators at this conference, do not necessarily reflect the official policies of HHS, nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

(c) Unless authorized in writing by the Contracting Officer, the Contractor must not display the HHS logo on any conference materials.

(d) The Contractor must not reference the product(s) or service(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

(End of clause)

352.211-3 Paperwork Reduction Act.

Effective Date: 11/21/2025 (see HHSAR CD 2026-01)

As prescribed in HHSAR 311.7301, the contracting officer must insert the following clause:

PAPERWORK REDUCTION ACT (NOV 2025) (RFO DEVIATION)

(a) This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) must apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer's Representative must be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.

(b) The Contractor must not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor must allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.

(End of clause)

352.215-70   Late Proposals and Revisions – R&D Solicitations.

Effective Date: 06/30/2026 (see HHSAR CD 2026-13)

As prescribed in 315.110-70, insert the following provision:

LATE PROPOSALS AND REVISIONS – R&D ACQUISITIONS (JUN 2026) (RFO DEVIATION)

Notwithstanding the procedures contained in the provision at FAR 52.215-1, Instructions to Offerors-Competitive Acquisition, the Government may consider a proposal received for biomedical or behavioral research and development (R&D) after the date specified for receipt if—

(a) It appears to offer significant cost or technical advantage to the Government; and

(b) It was received before proposals were distributed for evaluation; or

(c) It was received within 5 calendar days after the exact time specified for receipt, whichever is earlier.

(End of provision)

352.216-70 Allowable Cost and Payment for Hospitals (Profit or Non-Profit).

Effective Date: 03/29/2026 (see HHSAR CD 2026-05)

As prescribed in 316.305(a)(1), insert the following clause:

ALLOWABLE COST AND PAYMENT FOR HOSPITALS (PROFIT OR NON-PROFIT) (MAR 2026) (RFO DEVIATION)

Payments under this contract are allowable if the Contracting Officer determines the costs are allowable in accordance with FAR 52.216-7, FAR subpart 31.2, and 2 CFR part 300 (including Appendix IX).

(End of clause)

352.219-70 [Reserved]

Effective Date: 10/01/2026 (See HHSAR CD 2026-23)

(OCT 2026) (RFO DEVIATION)

352.219-71 [Reserved]

Effective Date: 10/01/2026 (See HHSAR CD 2026-23)

(OCT 2026) (RFO DEVIATION)

352.219-72 HHS Section 8(a) Award.

Effective Date: 10/01/2026 (See HHSAR CD 2026-23)

As prescribed in 319.108-70(a), insert the following clause:

HHS SECTION 8(A) AWARD (OCT 2026) (RFO DEVIATION)

(a) Pursuant to the Partnership Agreement between the Small Business Administration (SBA) and the Department of Health and Human Services, the SBA has delegated HHS the authority to enter directly into contracts with an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(1) Any award resulting from this solicitation will be made directly by the Contracting Officer to the 8(a) Offeror instead of to the SBA. Although the SBA is not identified as such in the award form, the SBA is still the Prime Contractor and the 8(a) participant remains the SBA’s subcontractor in accordance with the HHS and SBA Partnership Agreement.

(2) For the purposes of this contract and contract performance, the 8(a) participant is the Offeror/Contractor.

(b) The contracting activity—

(1) Is responsible for administering the contract and taking any action on behalf of the Government under the terms and conditions of the contract.

(2) Will give advance notice to the SBA before it issues a final notice terminating performance, either in whole or in part, under the contract.

(3) Will obtain the SBA's approval prior to processing any novation agreement(s).

(4) May assign contract administration functions to a contract administration office.

(c) The Contractor agrees—

(1) To fulfill and perform all of the requirements of the contract.

(2) To notify the Contracting Officer, simultaneous with its notification to the SBA, when the owner or owners upon whom 8(a) eligibility is based plan to relinquish ownership or control of the concern.

(3) Consistent with 15 U.S.C. 637(a)(21), transfer of ownership or control must result in termination of the contract for convenience, unless the SBA waives the requirement for termination prior to the actual relinquishing of ownership and control.

(4) It will adhere to the requirements of FAR 52.219-14, Limitations on Subcontracting, and other requirements in 13 CFR part 124 and 13 CFR 125.6, as applicable.

(End of clause)

Alternate I (OCT 2026) (RFO DEVIATION). As prescribed in 319.108-70(b), substitute the following paragraph (a)(1) for paragraph (a)(1) of the basic clause:

(a)(1) Notwithstanding paragraph (c) of FAR 52.219-18, any award resulting from this solicitation will be made directly by the Contracting Officer to the successful 8(a) Offeror instead of to the SBA. Although the SBA is not identified as such in the award form, the SBA is still the Prime Contractor and the 8(a) participant remains the SBA’s subcontractor in accordance with the HHS and SBA Partnership Agreement.

352.222-70   [Reserved]

Effective Date: 10/01/2026 (see HHSAR CD 2026-15)

(OCT 2026) (RFO DEVIATION) 

352.223-70 Safety and Health.

Effective Date: 10/01/2026 (See HHSAR CD 2026-17)

As prescribed in 323.304-70, insert the following clause:

Safety and Health (OCT 2026) (RFO DEVIATION)

(a) The Contractor must comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA), and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) The Contractor must comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR 1910. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

(i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at https://www.cdc.gov/labs/bmbl/index.html.

(ii) Prudent Practices in the Laboratory (2011), National Research Council, (US) Committee on Prudent Practices in the Laboratory, National Academies Press. This publication is available at https://www.ncbi.nlm.nih.gov/books/NBK55878/.

(b) The Contractor must take additional safety measures as the Contracting Officer determines to be reasonably necessary.

(c) The Contractor must maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report must include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report must also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer will take action using the appropriate FAR part procedures.

(e) The Contractor must insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations.

(End of clause)

352.223-71 [Reserved]

Effective Date: 10/01/2026 (See HHSAR CD 2026-17)

(OCT 2026) (RFO DEVIATION)

352.225-70 Made in America – Covered Personal Protective Equipment.

Effective Date: 10/01/2026 (See HHSAR CD 2026-22)

As prescribed in 325.7004(a), insert the following clause:

Made in America – COVERED Personal Protective Equipment (OCT 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause—

Component means as defined in FAR 25.003.

Covered personal protective equipment (PPE) means surgical masks, respirators, powered air purifying respirators (and required filters), face shields, protective eyewear, gloves, gowns (disposable or reusable), head and foot coverings, and other gear that protects people from disease.

Domestic PPE end product means a covered PPE, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.

Foreign-assembled domestic PPE end product means a covered PPE that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States.

Foreign PPE end product means a covered PPE that is other than a domestic PPE end product or foreign-assembled domestic PPE end product.

Wholly foreign PPE end product means a foreign PPE end product that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced outside the United States.

(b) Requirement. The Contractor must deliver only domestic PPE end products unless the Contractor identified the item, during the solicitation stage and as part of its proposal submission, in the provision at 352.225-71, Made in America Certificate – Covered Personal Protective Requirement.

(c) Postaward reporting. During performance of this contract, if the Contractor determines that any other item of covered PPE to be delivered under this contract is other than domestic PPE, and the item was not previously listed in the provision at 352.227-71, the Contractor must—

(1) Immediately update the list and submit it to the Contracting Officer; and

(2) Not deliver the items of covered PPE until approved by the Contracting Officer .

(d) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (d), in all subcontracts.

(End of clause)

352.225-71 Made in America Certificate – Covered Personal Protective Equipment.

Effective Date: 10/01/2026 (See HHSAR CD 2026-22)

As prescribed in 325.7004(b), insert the following provision:

Made In America Certificate – COVERED Personal Protective Equipment (OCT 2026) (RFO DEVIATION)

(a) The terms “component,” “covered personal protective equipment (PPE),” “domestic PPE end product,” “foreign-assembled domestic PPE end product,” “foreign PPE end product,” and “wholly foreign PPE end product” are defined in the clause at 352.225-70, Made in America – Covered Personal Protective Equipment, in this solicitation.

(b) The Offeror/Vendor certifies that each item of covered PPE proposed to be delivered on any contract resulting from this solicitation, including under any proposed subcontractors, except those listed in paragraph (c) of this provision, is a domestic PPE end product.

(c) Covered PPE not a Domestic PPE End Products: (The Offeror/Vendor to list any PPE that is not fully domestic, whether the item is to be delivered by Offeror or through a proposed subcontractor. If the covered PPE doesn't qualify as domestic end item, list it in the table below.)

(d) This certificate is valid for 30 days for the same products listed in paragraph (c) of this provision.

(End of provision)

352.226-70 Indian Preference.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

As prescribed in 326.7004(a), insert the following clause:

Indian Preference (OCT 2026) (RFO DEVIATION)

(End of clause)

352.226-71 Indian Preference Program.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Indian Preference Program (OCT 2026) (rfo deviation)

(End of clause)

352.226-72 Native American Graves Protection and Repatriation Act.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Native American Graves Protection and Repatriation Act (OCT 2026) (rfo deviation)

(End of clause)

352.226-73 Notice of Indian Small Business Economic Enterprise Set-Aside.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Notice of Indian Small Business Economic Enterprise Set-Aside (OCT 2026) (RFO DEVIATION)

(End of provision)

352.226-74 Notice of Indian Economic Enterprise Set-Aside.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Notice of Indian Economic Enterprise Set-Aside (OCT 2026) (RFO DEVIATION)

(End of clause)

352.226-75 Indian Economic Enterprise Subcontracting Limitations.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Indian Economic Enterprise Subcontracting Limitations (OCT 2026) (RFO DEVIATION)

(End of clause)

352.226-76 Indian Economic Enterprise Representation.

Effective Date: 10/01/2026 (See HHSAR CD 2026-25)

Indian Economic Enterprise Representation (OCT 2026) (RFO DEVIATION)

(End of provision)

352.227-11   [Reserved]

Effective Date: 06/30/2026 (see HHSAR CD 2026-14)

(JUN 2026) (RFO DEVIATION)

352.227-14   [Reserved]

Effective Date: 06/30/2026 (see HHSAR CD 2026-14)

(JUN 2026) (RFO DEVIATION)

352.227-70 Patent Rights – Supplement – Exceptional Circumstances.

Effective Date: 06/30/2026 (see HHSAR CD 2026-14)

As prescribed in 327.303(b), insert a clause substantially the same as the following:

PATENT RIGHTS – SUPPLEMENT – EXCEPTIONAL CIRCUMSTANCES (JUN 2026) (RFO DEVIATION)

• (a) Definitions. This clause incorporates the definitions used in FAR 52.227-14, Patent Rights-Ownership by the Contractor. In addition, as used in this clause—

• Agency means the HHS division or office that is entering into this contract.

• Class 1 Subject Invention means a subject invention described and defined in the Determination of Exceptional Circumstances (DEC) that will be assigned to a third party assignee, or assigned as directed by the agency.

• Class 2 Subject Invention means a subject invention described and defined in the DEC.

• Class 3 Subject Invention means a subject invention that does not fall into Class 1 or Class 2 as defined in this clause.

• DEC means the Determination of Exceptional Circumstances signed by [insert approving official] __________ on [insert date] __________ and titled [insert title] __________.

• Material means any proprietary material, method, product, composition, compound, or device, whether patented or unpatented, which is provided to the Contractor under this contract.

• Small business concern means the term as defined in FAR 2.101.

• Third party assignee means any entity or organization that may, as described in the DEC, be assigned Class 1 Subject Inventions.

• (b) General. This clause applies to all Contractor and subcontractor (at all tiers) Subject Inventions.

• (c) Allocation of principal rights.

  • (1) Retention of pre-existing rights. Third party assignees must retain all preexisting rights to Material in which the third party assignee has a proprietary interest.

  • (2) Allocation of Subject Invention rights.

    • (i) Disposition of Class 1 Subject Inventions.

      • (A) Assignment to the third party assignee or as directed by the agency. The Contractor must assign to the third party assignee designated by the agency the entire right, title, and interest throughout the world to each Subject Invention, or otherwise dispose of or transfer those rights as directed by the agency, except to the extent that rights are retained by the Contractor under paragraph (c)(3) of this clause. 

        • (1) Any such assignment or other disposition or transfer of rights will be subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the U.S. Government to practice or have practiced the Subject Invention for or on behalf of the U.S. throughout the world. 

        • (2) Any assignment must additionally be subject to the “March-in rights” of 35 U.S.C. 203. 

        • (3) If the Contractor is a U.S. nonprofit organization it may retain a royalty free, nonexclusive, nontransferable license to practice the invention for all nonprofit research including for educational purposes, and to permit other U.S. nonprofit organizations to do so.

    • (ii) Disposition of Class 2 Subject Inventions. Class 2 Subject Inventions are governed by FAR clause 52.227-11, Patent Rights-Ownership by the Contractor, (May 2014) (incorporated herein by reference). However, the Contractor must grant a license in the Class 2 Subject Inventions to the provider of the Material or other party designated by the agency as follows: [insert description of license to Class 2 inventions] __________

    • (iii) Disposition of Class 3 Subject Inventions. Class 3 Subject Inventions are governed by FAR clause 52.227-11, Patent Rights-Ownership by the Contractor (May 2014).

  • (3) Greater Rights Determinations. The Contractor, or an employee-inventor after consultation by the agency with the Contractor, may request greater rights than are provided in paragraph (c)(1) of this clause in accordance with the procedures of FAR 27.304-1(c). 

    • (i) In addition to the considerations set forth in FAR 27.304-1(c), the agency may consider whether granting the requested greater rights will interfere with rights of the Government or any third party assignee or otherwise impede the ability of the Government or the third party assignee to, for example, develop and commercialize new compounds, dosage forms, therapies, preventative measures, technologies, or other approaches with potential for the diagnosis, prognosis, prevention, and treatment of human diseases.

    • (ii) A request for a determination of whether the Contractor or the employee-inventor is entitled to retain such greater rights must be submitted to the Contracting Officer at the time of the first disclosure of the invention pursuant to paragraph (d)(1) of this clause, or not later than 8 months thereafter, unless a longer period is authorized in writing by the Contracting Officer for good cause shown in writing by the Contractor.

    • (iii) Each determination of greater rights under this contract is subject to paragraph (c) of FAR clause 52.227-13, Patent Rights-Ownership by the Government, (Dec 2007) (incorporated herein by reference), and to any reservations and conditions deemed to be appropriate by the agency such as the requirement to assign or exclusively license the rights to Subject Inventions to the third party assignee.

    • (iv) A determination by the agency denying a request by the Contractor for greater rights in a Subject Invention may be appealed within 30 days of the date the Contractor is notified of the determination to an agency official at a level above the individual who made the determination. If greater rights are granted, the Contractor must file a patent application on the invention. Upon request, the Contractor must provide the filing date, serial number and title, a copy of the patent application (including an English-language version if filed in a language other than English), and patent number and issue date for any subject invention in any country for which the Contractor has retained title. Upon request, the Contractor must furnish the Government an irrevocable power to inspect and make copies of the patent application file.

• (d) Invention disclosure by Contractor. The Contractor must disclose in writing each Subject Invention to the Contracting Officer, iEdison, or any other individual or system, by the means specified in the contract or as otherwise directed by the Contracting Officer, as provided in paragraph (j) of this clause within 2 months after the inventor discloses it in writing to Contractor personnel responsible for patent matters.

  • (1) The disclosure must be in the form of a written report and—

    • (i) Identify the contract under which the invention was made and all inventors;

    • (ii) Be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the invention; and

    • (iii) Identify any publication, on sale (offer for sale), or public use of the invention and whether a manuscript describing the invention has been submitted for publication, and if so, whether it has been accepted for publication at the time of disclosure.

  • (2) After disclosure to the agency, the Contractor must promptly notify the Contracting Officer, as well as any other individual or office by the means specified in the contract or as otherwise directed by the Contracting Officer in writing of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the Contractor. 

  • (3) If the Contractor assigns a Subject Invention to the third party assignee, then the Contractor and its employee inventors must assist the third party assignee in securing patent protection. All costs of securing the patent, including the cost of the Contractor's assistance, are at the third party's expense. Any assistance provided by the Contractor and its employee inventors to the third party assignee or other costs incurred in securing patent protection must be solely at the third party's expense and not billable to the contract.

• (e) Contractor action to protect the third party assignee's and the Government's interest. The Contractor must—

  • (1) Execute or to have executed and promptly deliver to the agency all instruments necessary to—

    • (i) Establish or confirm the rights the Government has throughout the world in Subject Inventions pursuant to paragraph (c) of this clause; 

    • (ii) Convey title to a third party assignee in accordance with paragraph (c) of this clause; and 

    • (iii) Enable the third party assignee to obtain patent protection throughout the world in that Subject Invention.

  • (2) Require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in Contractor’s format, each Subject Invention “made” under contract in order that the Contractor can comply with the disclosure provisions of paragraph (d) of this clause, and to execute all papers necessary to file patent applications on Subject Inventions and to establish the Government's rights or a third party assignee's rights in the Subject Inventions. 

    • (i) The disclosure format should require, as a minimum, the information required by paragraph (d)(1) of this clause. 

    • (ii) The Contractor must instruct such employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.

  • (3) If granted greater rights, include, within the specification of any United States non-provisional patent application it files, and any patent issuing thereon, covering a Subject Invention the following statement: “This invention was made with Government support under (identify the Contract) awarded by (identify the specific agency). The Government has certain rights in the invention.”

  • (4) To provide a final invention statement and certification prior to the closeout of the contract listing all Subject Inventions or stating that there were none.

• (f) Reporting on utilization of Subject Inventions in the event greater rights are granted to the Contractor. 

  • (1) The Contractor agrees to submit, on request, periodic reports no more frequently than annually on the utilization of a Subject Invention or on efforts at obtaining such utilization that are being made by the Contractor or its licensees or assignees when a request under paragraph (c)(3) of this clause has been granted by the agency. Such reports must include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Contractor, and such other data and information as the agency may reasonably specify. 

  • (2) The Contractor also agrees to provide additional reports as may be requested by the agency in connection with any march-in proceeding undertaken by the agency in accordance with paragraph (h) of this clause. As required by 35 U.S.C. 202(c)(5), the agency agrees it will not disclose such information to persons outside the Government without permission of the Contractor.

• (g) Preference for United States industry in the event greater rights are granted to the Contractor. Notwithstanding any other provision of this clause, the Contractor agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any Subject Invention in the United States unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

• (h) March-in rights in the event greater rights are granted to the Contractor. The Contractor acknowledges that, with respect to any Subject Invention in which it has acquired ownership through the exercise of the rights specified in paragraph (c)(3) of this clause, the agency has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any agency supplemental regulations in effect on the date of contract award.

• (i) Special provisions for contracts with nonprofit organizations in the event greater rights are granted to the Contractor. If the Contractor is a nonprofit organization, it must—

  • (1) Not assign rights to a Subject Invention in the United States without the written approval of the agency, except where an assignment is made to an organization that has as one of its primary functions the management of inventions, provided that the assignee must be subject to the same provisions as the Contractor;

  • (2) Share royalties collected on a Subject Invention with the inventor, including Federal employee co-inventors (but through their agency if the agency deems it appropriate) when the Subject Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10;

  • (3) Use the balance of any royalties or income earned by the Contractor with respect to Subject Inventions, after payment of expenses (including payments to inventors) incidental to the administration of Subject Inventions for the support of scientific research or education;

  • (4) Make efforts that are reasonable under the circumstances to attract licensees of Subject Inventions that are small business concerns, and give a preference to a small business concern when licensing a Subject Invention if the Contractor determines that the small business concern has a plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business concerns; provided, that the Contractor is also satisfied that the small business concern has the capability and resources to carry out its plan or proposal. The decision whether to give a preference in any specific case will be at the discretion of the Contractor; and

  • (5) Allow the Secretary of Commerce to review the Contractor’s licensing program and decisions regarding small business applicants, and negotiate changes to its licensing policies, procedures, or practices with the Secretary of Commerce when the Secretary's review discloses that the Contractor could take reasonable steps to more effectively implement the requirements of paragraph (i)(4) of this clause.

• (j) Communications. 

  • (1) All invention disclosures and requests for greater rights must be in writing and sent to the Contracting Officer and any other individual or office specified in the contract or as otherwise directed by the Contracting Officer. 

  • (2) A copy of all disclosures, confirmatory licenses to the Government, face page of the patent applications, waivers and other routine communications under this contract, at all tiers, must be sent to:
    [Insert Agency Address] __________
    Agency Invention Reporting website: https://www.nist.gov/iedison/about-iedison

• (k) Subcontracts.

  • (1) The Contractor must include the substance of this clause, including this paragraph (k), in all subcontracts, regardless of tier, for experimental, developmental, or research work.

  • (2) At all tiers, the clause must be modified to identify the parties as follows:

    • (i) References to the Government are not changed, and the subcontractor has all rights and obligations of the Contractor in the clause.

    • (ii) The Contractor must not, as part of the consideration for awarding the contract, obtain rights in the subcontractor's subject inventions.

  • (3) In subcontracts, at any tier, the agency, the subcontractor, and the Contractor agree that the mutual obligations of the parties created by this clause constitute a contract between the subcontractor and the agency with respect to the matters covered by the clause; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (h) of this clause.

(End of clause)

352.227-71 Rights in Data – Supplement – Exceptional Circumstances.

Effective Date: 06/30/2026 (see HHSAR CD 2026-14)

• As prescribed in 327.409-70(a), insert a clause substantially the same as the following:

RIGHTS IN DATA – SUPPLEMENT – EXCEPTIONAL CIRCUMSTANCES (JUN 2026) (RFO DEVIATION)

• (a) Applicability.

  • (1) FAR 52.227-14, Rights in Data-General, including any specified Alternates, applies to this contract.

  • (2) In addition to the requirements of FAR 52.227-14, this clause sets forth additional requirements that apply to data subject to the executed Determination of Exceptional Circumstances (DEC) that is identified in the contract and incorporated by reference.

• (b) Publication review and delay of public disclosure. To ensure that information concerning possible inventions made under this contract is not prematurely published thereby adversely affecting the ability to obtain patent protection on such inventions, the Contractor must—

  • (1) Provide the Contracting Officer a copy of any publication or other public disclosure relating to the work performed under this contract at least 30 days in advance of the disclosure; and

  • (2) Upon the Contracting Officer's request, agree to delay the public disclosure of such data or publication of a specified paper for a reasonable time specified by the Contracting Officer, not to exceed 6 months, to allow for the filing of domestic and international patent applications in accordance with clause 352.227-70, Patent Rights – Supplement – Exceptional Circumstances.

• (c) Data on Material(s). Proprietary data on material(s) provided to the Contractor under or through this contract must be used only for the purpose for which they were provided, including screening, evaluation, or optimization, and for no other purpose.

• (d) Confidentiality.

  • (1) The Contractor must—

    • (i) Take all reasonable precautions to maintain Confidential Information as confidential, but no less than the steps Contractor takes to secure its own confidential information; and 

    • (ii) Maintain Confidential Information as confidential unless specifically authorized otherwise in writing by the Contracting Officer.

  • (2) Confidential Information includes/does not include [Government may define confidential information here] __________. 

• (e) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (e), in all subcontracts where a subcontractor may generate, access, or use DEC-covered data.

(End of clause)

352.227-72   Publications and Publicity.

Effective Date: 06/30/2026 (see HHSAR CD 2026-14)

• As prescribed in 327.409-70(b), insert the following clause:

PUBLICATIONS AND PUBLICITY (JUN 2026) (RFO DEVIATION)

• (a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor must promptly send to the Contracting Officer's Representative—

  • (1) A copy of each article submitted for publication;

  • (2) Information of when the article or other publication is published; and 

  • (3) A copy of the published article.

• (b) Unless authorized in writing by the Contracting Officer, the Contractor must not display the HHS logo or seal, including Division logos or seals, on any publications.

• (c) The Contractor must not reference the product(s) or service(s) awarded under this contract in advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

• (d) The Contractor must include the substance of this clause, including this paragraph (d), in all subcontracts where the subcontractor may propose publishing the results of its work under a subcontract.

(End of clause)

352.231-70 Salary Rate Limitation.

Effective Date: 02/07/2026 (see HHSAR CD 2026-02)

As prescribed in HHSAR 331.170(c), insert the following clause:

SALARY RATE LIMITATION (FEB 2026) (RFO DEVIATION)

(a) The Contractor must not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services (HHS) contract or order; it merely limits the portion of that salary that may be paid with contract funds.

(c) The salary rate limitation also applies to individuals under subcontracts.

(d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.

(e) See the salaries and wages pay tables on the Office of Personnel Management web site for Federal Executive Schedule (EX) salary levels at www.opm.gov.

(f) The Contractor must insert the substance of this clause, including this paragraph (f), in all subcontracts.

(End of clause)

352.232-70 [Reserved]

Effective Date: 04/23/2026 (see HHSAR CD 2026-07)

(APR 2026) (RFO DEVIATION)

352.232-71 Electronic Submission of Payment Requests.

Effective Date: 04/23/2026 (see HHSAR CD 2026-07)

As prescribed in HHSAR 332.7002, insert the following clause:

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (APR 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause –

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b) and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

352.235-70 Notice to Offerors – Protection of Human Subjects.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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.

Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)

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)

352.236-70 Design-Build Contracts.

Effective Date: 02/07/2026 (see HHSAR CD 2026-02)

As prescribed in HHSAR 336.101-70, insert the following clause:

DESIGN-BUILD CONTRACTS (FEB 2026) (RFO DEVIATION)

(a) General.

(1) The contract constitutes and defines the entire agreement between the Contractor and the Government. This contract includes the standard or special contract clauses and schedules included at the time of award. This contract incorporates by reference:

(i) The solicitation in its entirety (with the exception of instructions to offerors and evaluation criteria which do not become part of the award document);

(ii) The specifications and statement of work;

(iii) All drawings, cuts and illustrations, included in the solicitation and any amendments during all proposal phases leading up to award;

(iv) Exhibits and other attachments; and

(v) The successful Offeror's accepted proposal.

(2) In the event of conflict or inconsistency between any of the requirements of the various portions of this contract, precedence must be given in the following order:

(i) Betterments: Any portions of the Offeror's proposal which exceed the requirements of the solicitation and which go beyond repair and improve the value of the property.

(ii) The contract clauses and schedules included during the solicitation or at the time of award.

(iii) All requirements (other than betterments) of the accepted proposal.

(iv) Any design products, including but not limited to plans, specifications, engineering studies and analyses, shop drawings, equipment installation drawings, etc. These are “deliverables” under the contract and are not part of the contract itself.

(3) Design products must conform to all requirements of the contract, in the order of precedence stated here.

(b) Responsibility of the contractor for design. The Contractor's responsibilities include the responsibilities of the Architect-Engineer Contractor, as specified in RFO FAR 52.236-23.

(c) Sequence of design—construction.

(1) After receipt of the Contract Award, the Contractor must initiate design, comply with all design submission requirements, and obtain Government review of each submission. No construction may be started until the Government reviews the Final Design submission and determines it satisfactory for purposes of beginning construction. The Contracting Officer will notify the Contractor when the design is cleared for construction. The Government will not grant any time extension for any design resubmittal required when, in the opinion of the Contracting Officer, the initial submission failed to meet the minimum quality requirements as set forth in the Contract.

(2) If the Government allows the Contractor to proceed with limited construction based on pending minor revisions to the reviewed Final Design submission, no payment will be made for any completed or in-progress construction related to the pending revisions until they are completed, resubmitted, and are satisfactory to the Government.

(3) No payment will be made for any completed or in-progress construction until all required submittals have been made, reviewed, and are satisfactory to the Government.

(d) Constructor's role during design. The Contractor's construction management key personnel must be actively involved during the design process to effectively integrate the design and construction requirements of this contract. In addition to the typical required construction activities, the constructor's involvement includes, but is not limited to actions such as: integrating the design schedule into the Master Schedule to maximize the effectiveness of fast-tracking design and construction (within the limits, if any, allowed in the contract), ensuring constructability and economy of the design, integrating the shop drawing and installation drawing process into the design, executing the material and equipment acquisition programs to meet critical schedules, effectively interfacing the construction Quality Control (QC) program with the design QC program, and maintaining and providing the design team with accurate, up-to-date redline and as-built documentation. The Contractor must require and manage the active involvement of key trade subcontractors in the above activities.

(e) Payment for design under fixed-price design-build contracts.

(1) The Contracting Officer may approve progress payments for work performed during the project design phase up to the maximum amount of ____ (Contracting Officer to insert percent figure. If none stated, the amount is four (4) percent) percent of the contract price.

(2) Contractor invoices for payment must be accompanied by satisfactory documentation supporting the amounts for which payments are requested. Progress payments approved by the Contracting Officer during the project design phase in no way constitute an acceptance of functional and aesthetic design elements nor acceptance of a final settlement amount in the event of a buy-out nor a waiver of any contractual requirements.

(f) Unscheduled jobsite shutdowns. Due to security reasons during the life of this contract the Government may on an unscheduled basis require the contractor to shut down its jobsite for 2 days per year at no additional cost. This does not constitute a suspension of work under FAR 52.242-14, Suspension of Work.

(End of clause)

352.237-70 Nonsmoking Policy – Delivery of Services to Children.

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

As prescribed in 337.570(a), insert the following clause:

NONSMOKING POLICY – DELIVERY OF SERVICES TO CHILDREN (OCT 2026) (RFO DEVIATION)

(a) Prohibition. Smoking is prohibited in facilities where certain federally funded children's services are provided pursuant to the Pro-Children Act of 2001 (20 U.S.C. 7971-7974)). Accordingly, smoking is prohibited within any indoor facility (or portion thereof), whether owned, leased, or contracted for, or involving indoor facilities that are constructed, operated, or maintained with Federal funds, that is used for the routine or regular provision of—

(1) Kindergarten, elementary, or secondary education, or library services; or

(2) Health or day care services that are provided to children under the age of 18.

(b) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with the requirements of the Act and the prohibition of smoking in facilities as specified in paragraph (a) of this clause. The Contractor must enforce the provisions of this clause and ensure that each of its employees, subcontractors and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act.

(c) Penalties. Failure to comply with the Act may result in the imposition of a civil monetary penalty in an amount not to exceed $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible party. Each day a violation continues constitutes a separate violation. In the case of any civil penalty assessed, the total amount must not exceed 50 percent of the amount of Federal funds received by the Contractor for the fiscal year in which the continuing violation occurred. Penalties will be imposed only after appropriate written notice, or an administrative compliance order may be issued by the designated HHS official only after an opportunity for a hearing in accordance with 5 U.S.C. 554. Before making such assessment or issuing such order, or both, the Secretary of HHS or designee will give written notice of the assessment or order to the Contractor by certified mail with return receipt and provide information in the notice of an opportunity to request in writing, not later than 30 days after the date of receipt of such notice, such hearing. Notwithstanding any specific civil penalties and compliance orders referenced herein, the Contracting Officer may take other remedies under the contract for failure to comply with the terms and conditions of the contract.

(d) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor is responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth in paragraphs (a) through (c) of this clause.

(End of clause)

352.237-71 Reporting of Child Abuse.

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

As prescribed in 337.570(b), insert the following clause:

REPORTING OF CHILD ABUSE (OCT 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause -

Child abuse means the physical or mental injury, sexual abuse or exploitation, or negligent treatment of a child.

Covered professionals means individuals working in professions or activities identified in the Crime Control Act of 1990 (34 U.S.C. 20341), including, but not limited to, teachers, social workers, physicians, dentists, medical residents or interns, hospital personnel and administrators, nurses, health care practitioners, chiropractors, osteopaths, pharmacists, optometrists, podiatrists, emergency medical technicians, ambulance drivers, alcohol or drug treatment personnel, psychologists, psychiatrists, mental health professionals, child care workers and administrators, and commercial film and photo processors.

(b) Responsibility to report suspected child abuse. The Crime Control Act of 1990 (34 U.S.C. 20341) requires covered professionals who work on Federal land or in a Federally-operated or contracted facility to report suspected child abuse when the individual has reason to believe a child has suffered an incident of child abuse.

(c) Reporting requirements. Individuals performing covered professional activities under an HHS contract or subcontract must immediately report suspected child abuse, regardless of the purpose of the contract or subcontract. When an individual suspects that a child has been harmed, the individual must contact the appropriate State child abuse hotline, local child protective services agency, or law enforcement agency. Contractors may contact the Childhelp USA National Child Abuse Hotline at 1-800-4-A-CHILD for information about reporting child abuse. A covered professional who knowingly fails to make a timely report may be subject to penalties under the Crime Control Act of 1990. Contractors must train such individuals on reporting requirements and the identification of abused and neglected children at least annually.

(d) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with the requirements of the Act. The Act also applies to all applicable subcontracts awarded under this contract. Accordingly, the Contractor must ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act.

(e) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (e), in subcontracts at any tier.  The Contractor is responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth in paragraphs (a) through (d) of this clause.

(End of clause)

352.237-72 Requirement for Background Checks.

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

As prescribed in 337.570(c), insert the following clause:

REQUIREMENT FOR BACKGROUND CHECKS (OCT 2026) (RFO DEVIATION)

(a) Definition. As used in this clause—

Child care services means the definition set forth in FAR 37.501.

(b) Requirement for background checks.  The Crime Control Act of 1990 (34 U.S.C. 20351) requires criminal history background checks for all individuals who provide child care services to children under age 18. The Government may deny employment or require removal of an individual who provides child care services if the individual has been conviction of a sex crime, an offense involving a child victim, or a drug felony.

(c) Background check protocols. The Contracting Officer will provide the necessary information to the Contractor regarding the process for obtaining the background check. The Contractor may hire a staff person provisionally prior to the completion of a background check, if at all times prior to the receipt of the background check during which children are in the care of the newly-hired person, the person is within the sight and under the supervision of a previously investigated staff person.

(d) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with the requirements of the Act. The Act also applies to all applicable subcontracts awarded under this contract. Accordingly, the Contractor must ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act.

(e) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (e), in subcontracts at any tier. The Contractor is responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth in paragraphs (a) through (d) of this clause.

(End of clause)

352.237-73 Indian Child Protection and Family Violence Act—Background Investigations.

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

As prescribed in 337.570(d), insert the following clause:

INDIAN CHILD PROTECTION AND FAMILY VIOLENCE ACT—BACKGROUND INVESTIGATIONS (OCT 2026) (RFO DEVIATION)

(a) Requirement for background checks. This contract is subject to the Indian Child Protection and Family Violence Act, Pub. L. 101-630 (25 U.S.C. 3201, et seq.). The duties and responsibilities required by this contract may involve individuals working in positions involving regular contact with or control over Indian children. The Act prohibits contractors from assigning individuals to work in positions involving regular contact with or control over Indian children if those individuals have been convicted of, or entered a plea of nolo contendere or guilty to crimes of violence and other offenses (see 25 U.S.C. 3207(b) for entire list). Any such conviction should immediately be brought to the attention of the Contracting Officer. Performance under this contract requires a Contractor and its employees and subcontractors to be subject to a background investigation.

(b) Background check protocols. The Contractor and its employees and subcontractors, at any tier, will be subject to a character and background investigation, conducted by the Indian Health Service, Office of Human Resources. Until such time as the Contractor or its employees and subcontractors have been notified of completion of the investigation, the Contractor and its employees and subcontractors must have no unsupervised contact with Indian children. In order to initiate this background investigation, the Contractor and its employees and subcontractors must provide information as required in this contract or as directed by the Contracting Officer.

(c) Signed declaration prerequisite. As a prerequisite to providing services under this contract, the Contractor is required to complete and sign the declaration found in Section J of this contract.

(d) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor must be responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth in paragraphs (a) through (c) of this clause.

(End of clause)

352.237-74 [Reserved]

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

(OCT 2026) (RFO DEVIATION)

352.237-75 Key Personnel.

Effective Date: 10/01/2026 (See HHSAR CD 2026-21)

As prescribed in 337.802-570, insert the following clause:

KEY PERSONNEL (OCT 2026) (RFO DEVIATION)

Key personnel specified in this contract are essential to work performance under the contract. The Contractor must obtain the written consent of the Contracting Officer prior to diverting, replacing, or announcing any key personnel substitutions. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor must submit requests for changes in key personnel to the Contracting Officer in writing. The request must identify the circumstances, proposed replacement, a resume and explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. When advance notice is not practicable because of termination for cause, other voluntary separation or another circumstance outside the Contractor’s reasonable control, the Contractor must notify the Contracting Officer as soon as practicable.

(End of clause)

352.270-4a [Reserved]

(MAR 2026) (RFO DEVIATION)

352.270-4b [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-5a [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-5b [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-6 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-9 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-10 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-11 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-12 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-13 [Reserved]

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

(MAR 2026) (RFO DEVIATION)

352.270-70 Non-Discrimination for Conscience.

Effective Date: 03/29/2026 (see HHSAR CD 2026-06)

As prescribed in HHSAR 370.701, insert the following provision:

NON-DISCRIMINATION FOR CONSCIENCE (MAR 2026) (RFO DEVIATION)

(a) Section 301(d) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act, as amended, provides that an organization, including a faith-based organization, that is otherwise eligible to receive assistance under section 104A of the Foreign Assistance Act of 1961, under the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, or under any amendment to the foregoing Acts for HIV/AIDS prevention, treatment, or care—

(1) Must not be required, as a condition of receiving such assistance, to—

(i) Endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS; or

(ii) Endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection.

(2) Must not be discriminated against under the provisions of law in paragraph (a) for refusing to meet any requirement described in paragraph (a)(1) in this solicitation.

(b) Accordingly, an offeror who believes this solicitation contains work requirements requiring it endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS, or endorse, utilize, make referral to, become integrated with, or otherwise participate in a program or activity to which it has a religious or moral objection, must identify those work requirements it excluded in its technical proposal.

(c) The Government acknowledges that an offeror has specific rights, as cited in paragraph (b), to exclude certain work requirements in this solicitation from its proposal. However, the Government reserves the right to not make an award to an offeror whose proposal does not comply with the salient work requirements of the solicitation. Any exercise of that Government right will be made by the Head of the Contracting Activity.

(End of provision)