Additionally, offerors must follow the instructions stated in the Care of Live Vertebrate Animals provision in the Technical Proposal Instructions of the solicitation. Also see the following guidelines:

Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System, October 10, 2008, Federal Register Notice
NIH Chimpanzee Management Program (ChiMP)
Enrichment for Nonhuman Primates, 2005 (will need to scroll down)

NIH policy does not allow the award of a contract involving the use of live vertebrate animals to an offeror without an NIH Office of Laboratory Animal Welfare (OLAW)-approved assurance and valid institutional animal care and use committee (IACUC) approval unless OLAW provides special approval and the contract contains language restricting the use of animals.

Find more information on animal research requirements and at Animals in Research on the Research Funding Web site.

Offerors

If contract performance is expected to involve research on live vertebrate animals, follow the instructions stated in the Care of Live Vertebrate Animals provision in the Technical Proposal Instructions of the solicitation. The Technical Proposal should include the following:
- The number of the approved Animal Welfare Assurance on file with the OLAW for your organization and any proposed subcontractors.
- The date your organization was last certified by OLAW (i.e., assurance letter from OLAW).
- Certification of IACUC approval of those components of the proposal related to the care and use of animals.
- Evidence of valid Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation, if required by the Statement of Work contained in the solicitation.
- Information addressing the five points stated in the Care of Live Vertebrate Animals provision of the solicitation Technical Proposal Instructions. Your response to these five points can form the basis of discussions.
Contractors have additional requirements if the work involves nonhuman primates. For example, you would need AAALAC accreditation.
If work with live research animals will be subcontracted or performed using the facilities at another institution, ensure that the subcontractor or other institution has an approved assurance on file with OLAW. Alternatively, you may amend your assurance to cover the other organization.
If your organization or a proposed subcontractor does not have an OLAW-approved assurance and your organization is selected for contract award, the contracting officer will arrange to have OLAW send you an application and negotiate an assurance. Alternately, you may amend your assurance to cover the proposed subcontractor.
Obtain an inter-institutional assurance if your organization has no assurance and you're collaborating with an assured institution. For instructions see Is Your Institution Assured by OLAW?
For domestic awards, renew your IACUC approval every three years. See IACUCs Monitor Your Progress and You'll Have Semiannual Reviews and Inspections for more information.
Annually, submit a report to OLAW that describes any changes in your program of animal use and care. For information on the content of this annual report, see What is the annual report to OLAW and when is it due?
Foreign organizations do not need to submit certification of IACUC approval, but they do need to negotiate an animal assurance with OLAW. Also, foreign organizations must comply with the animal research regulations of their own countries.
No funds for activities with live vertebrate animals can be expended if a contractor does not have an approved Animal Welfare Assurance and IACUC approval on file. If a contractor conducts animal research without an approved assurance and IACUC approval on file, costs for such activities billed to NIAID will be disallowed.

Scientific Review Officers

If required by the Evaluation Factors for Award in Section M of the solicitation, ensure that all participating scientific review group (SRG) members rate each proposal as “adequate” or “inadequate” with regard to the response to the five points stated in the Care of Live Vertebrate Animals provision of the solicitation’s Technical Proposal Instructions. SRG members must note their rating on the technical evaluation score sheets.
Ensure that if a participating SRG member finds a proposal’s response to any of the five points stated in the Care of Live Vertebrate Animals provision to be "inadequate" that they also provide written comments supporting their finding.
Include the rating of each proposal with regard to the five points stated in the Care of Live Vertebrate Animals provision, as well as the reviewers’ comments, in the technical evaluation report (TER).

Project Officers

In the acquisition plan, identify whether you expect the contract or contracts to involve live vertebrate animals.
Confirm whether the offeror has an OLAW-approved assurance and IACUC approval. Notify the contracting officer in writing.
Review proposals to identify any concerns regarding the care and use of live vertebrate animals.
Use the comments in the TER and any concerns identified in your proposal review to develop questions that will form the basis of discussions with the offeror regarding animal care and use. Provide the written questions to the contracting officer.
During discussions, work with the contracting officer to ensure the offeror's proposal revisions adequately resolve any concerns regarding animal care and use.
After award, work with the contracting officer to monitor the contractor's performance regarding animal care and use.
If a restricted award has been issued, ensure that the contractor is not conducting activities involving animal use until the contractor has obtained an OLAW-approved assurance and IACUC approval. See the Restricted Awards for Contracts Involving Animals SOP.
Review any new or modified research to identify situations, such as a new subcontract, that would require an additional OLAW-approved assurance or IACUC approval.

Contracting Officers

Use questions provided by the project officer, based on the comments in the TER and any concerns identified in project officer’s review of the proposal, during negotiations to form the basis of discussions with an offeror regarding the use and care of the live vertebrate animals.
Contact OLAW, Attention: Director, Division of Assurances, to request approval when awarding to an organization that does not have an OLAW-approved assurance and a valid IACUC approval. For more information, go to the OLAW Web site.
If OLAW provides approval to award to an offeror not covered by both an appropriate assurance and a valid IACUC approval, issue a restricted award by including the Restriction from use of Live Vertebrate Animals article in Section H of the contract. See the Restricted Awards for Contracts Involving Animals SOP.
Monitor a restricted contract award, with the project officer, to ensure that the contractor is not conducting activities involving the use of live vertebrate animals until such time as both an OLAW-approved assurance and IACUC approval have been obtained.
Notify OLAW when the restriction regarding the care of live vertebrate animals in the contract has been lifted.

Contacts

Offerors with questions should ask the primary contact listed in the solicitation. See the Extramural R&D Solicitations list, or see the Office of Acquisitions staff listing.

Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Restricted Awards for Contracts Involving Animals SOP

Vertebrate Animals in Research questions and answers

Disaster Planning and Response Resources: OLAW

OLAW site on NIH intranet

Look It Up

See the Glossary for more terms.