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Standard Operating Procedure Table of Contents
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Purpose
To enable NIAID to restrict the use of award funds for an otherwise apparent successful offeror that does not meet all requirements for conducting research involving live vertebrate animals.
Procedure
An offeror may not conduct work involving care and use of live vertebrate animals without an NIH Office of Laboratory Animal Welfare (OLAW)-approved assurance and valid institutional animal care and use committee (IACUC) approval. NIH policy will not allow NIAID to issue an award without both approvals unless OLAW grants special approval and the contract contains language restricting the care and use of live vertebrate animals until such documentation is provided.
NIH policy does not require the evaluation of proposals involving the care and use of live vertebrate animals on the five points stated in the Care of Live Vertebrate Animals provision of the solicitation’s technical proposal instructions.
However, NIAID’s policy requires evaluation of proposals as “acceptable” or “unacceptable” for the five points. For proposals that receive an “unacceptable” rating, NIAID and the offeror will resolve the issues in negotiations, as they may affect NIAID’s assessment of the risk of a proposal when determining best value.
Offerors
- If you expect a contract to involve live vertebrate animals, follow the instructions in the Care of Live Vertebrate Animals provision in the technical proposal instructions of the solicitation.
- Your technical proposal should include:
- The number of the approved Animal Welfare Assurance filed with OLAW for your organization and any proposed subcontracts involving live vertebrate animals.
- The date your organization and relevant subcontractors last received an assurance letter from OLAW.
- Certification of IACUC approval of the parts of the proposal related to the care and use of live vertebrate animals.
- Evidence of valid Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation, if required by the Statement of Work.
- Information addressing the five points stated in the Care of Live Vertebrate Animals provision of the solicitation's technical proposal instructions. NIAID may discuss your response to these five points during negotiations later.
- If your organization or a proposed subcontractor for animal work does not have an OLAW-approved assurance and your proposal is selected for award, the contracting officer will arrange to have OLAW send you an application and negotiate an assurance. Alternatively, 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?
Scientific Review Program Staff
- Ensure that scientific review group (SRG) members rate each proposal as “acceptable” or “unacceptable” for the five points in the Care of Live Vertebrate Animals provision of the solicitation’s technical proposal instructions.
- Instruct SRG members to note their ratings on the Technical Evaluation Score Sheet (TESS).
- If an SRG member finds a proposal’s response to the five points "unacceptable," ensure he or she provides written comments supporting the finding.
- Document final SRG rating of each proposal against the five points and include an explanatory statement for that rating in the technical evaluation report (TER).
Project Officers
- In the acquisition plan, identify whether you expect the resultant contract or contracts to involve live vertebrate animals.
- Review proposals to identify any concerns regarding the care and use of live vertebrate animals and determine whether the offeror has both an OLAW-approved assurance and IACUC approval.
- Use the comments in the TER and any concerns identified in the 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.
- Confirm whether the offeror has an OLAW-approved assurance and IACUC approval, then provide your findings in writing to the contracting officer.
- During discussions, work with the contracting officer to ensure the offeror's revisions adequately resolve any concerns raised by the SRG.
- After award, monitor the contractor’s performance with the contracting officer to ensure that the contractor is not conducting activities involving animal use until the contractor has obtained an OLAW-approved assurance and IACUC approval.
- Review any new or modified research to identify situations that require an additional OLAW-approved assurance or IACUC approval, for example, a new subcontract.
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 discuss the use and care of the live vertebrate animals.
- Request OLAW approval to issue a restricted award to an organization that does not have both an OLAW-approved assurance and IACUC approval in place at the time of award.
- If OLAW approves an 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, Special Contract Requirements, of the contract. Email olawdoa@mail.nih.gov when a restricted award is made.
- After issuing the restricted contract award, monitor with the project officer to ensure that contractors are not conducting activities involving live vertebrate animals before obtaining an OLAW-approved assurance and IACUC approval.
- Email olawdoa@mail.nih.gov when the restriction has been lifted.
Contacts
Offerors, see the Office of Acquisitions staff listing for the appropriate contract specialist.
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
HHSAR 352.270-9, Care of Laboratory Animals
Institutional Animal Care and Use Committee Guidebook
NIH OLAW Policy on Humane Care and Use of Laboratory Animals
What Investigators Need to Know About the Use of Animals |
