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Restricted Awards for Contracts Involving Animals

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

Standard Operating Procedure Table of Contents

Purpose

To allow restricted 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.

Until the offeror provides this documentation, 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 expenditure of contract funds on the care and use of live vertebrate animals.

NIH policy requires 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.

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.
    • A separate section of the Technical Proposal titled the Vertebrate Animal Section (VAS), including a concise (e.g., one or two pages) discussion addressing the five points stated in the Care of Live Vertebrate Animals provision of the solicitation's Technical Proposal Instructions.
  • 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? on How to Write an Application Involving Research Animals.

Scientific Review Program Staff

  • Ensure that all participating scientific review group (SRG) members rate each proposal as "acceptable" or "unacceptable" based on whether the Vertebrate Animal Section's response to the five points is scientifically adequate.
    • Proposals that fail to adequately address the five points of the VAS will be considered unacceptable with regard to the Live Vertebrate Animals Evaluation provision in Section M of the solicitation.
    • SRG members must note their rating on the Technical Evaluation Score Sheets (TESS).
    • Ensure that if a participating SRG member finds a proposal’s response to any of the five points to be “unacceptable” that they also provide written comments supporting their 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).

Contracting Officer's Representative (COR)

  • 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.
  • Help the contracting officer determine the acceptability of the revised VAS of the Technical Proposal.
  • 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

  • At the peer review meeting, provide reviewers with instructions for reviewing the VAS (e.g., Worksheet – PDF, Section M of the solicitation), noting that all points must be evaluated as appropriate for the VAS to be “acceptable.”
  • After peer review, determine the competitive range, as applicable, and if discussions are held, provide the offeror with the opportunity to address concerns regarding the VAS raised by the peer reviewers. Use questions provided by the contracting officer's representative (COR), based on the comments in the TER, and any concerns identified in contracting officer's representative’s (COR) review of the proposal to form the basis of discussions regarding the VAS.
  • With the advice of the contracting officer's representative (COR) and OLAW, as necessary, determine if the concerns have been resolved and the VAS section of the Technical Proposal can be considered “acceptable.” 
  • If award will be made to an offer that is still considered unacceptable in terms of the VAS response, include language restricting the expenditure of contract funds on the care and use of live vertebrate animals  in Section H, Special Contract Requirements, of the contract.
  • Confirm whether the offeror has an OLAW-approved Assurance and IACUC approval.
  • 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.
    • Email to the OLAW Division of Assurances at olawdoa@mail.nih.gov. Do not send requests to individual members of the Division of Assurances.
    • Include the contract number, project title, name of principal investigator, name of contractor, and performance sites, if applicable, in the email or as an attachment.
    • For more guidance on issuing restricted awards, see OLAW'sLock icon: This link will not work for public visitors.Policy Topic: Animal Welfare.
  • 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 contracting officer's representative (COR) 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.

Lock icon: This link will not work for public visitors.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

OLAW Public Health Service Policy on Humane Care and Use of Laboratory Animals

What Investigators Need to Know About the Use of Animals

Last Updated March 27, 2012

Last Reviewed March 27, 2012