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Animals in Research Contracts

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 ensure contracts comply with PHS and NIH policies involving the care and use of live vertebrate research animals.

Procedure

To receive an NIH contract, offerors proposing work with live vertebrate research animals must base their animal care and use programs on the Guide for the Care and Use of Laboratory Animals and abide by the PHS Policy on Humane Care and Use of Laboratory Animals. PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals.

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.

Additionally, NIH policy requires evaluation of proposals as "acceptable" or "unacceptable" with regard to the five points stated in the Care of Live Vertebrate Animals provision in the technical proposal instructions of the solicitation.

Also see the following guidance:

Find more information 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.
  • Your technical proposal should include:
    • The number of the approved Animal Welfare Assurance on file with OLAW for your organization and any proposed subcontractors.
    • The date your organization and any relevant subcontractors proposed to conduct work involving care and use of live vertebrate animals last received an 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.
    • 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.
      • We encourage you to familiarize yourself with the required elements to complete your vertebrate animal section in the Contract Proposal Vertebrate Animal Section Worksheet (PDF).
      • If the government includes your proposal in the competitive range (for competitive proposals), or if the government holds discussions with the selected source (for sole source acquisitions), you will have the opportunity to address the concerns raised by reviewers.
      • You will be able to further discuss and/or clarify your position until you submit your Final Proposal Revision (FPR).
      • Once discussions are closed with the submission of your FPR, and if your proposed description under the VAS is still found to be unacceptable, then your proposal may not be considered further for award
  • If your organization or subcontractor proposed to conduct work involving care and use of live vertebrate animals 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. 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? on How to Write an Application Involving Research Animals.
  • 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

  • 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 the reviewers' comments in the technical evaluation report (TER).

Contracting Officer's Representatives

  • In the acquisition plan, identify whether you expect the contract or contracts to involve the care and use of 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 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.
  • 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 a VAS of the Technical Proposal revised during negotiations.
  • 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.
  • Review any new or modified research to identify situations that would 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, based on the comments in the TER, and any concerns identified in contracting officer's representative’s review of the proposal to form the basis of discussions regarding the VAS.
  • With the advice of the contracting officer's representative 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. See the Restricted Awards for Contracts Involving Animals SOP.
  • 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 the OLAW Division of Assurances at olawdoa@mail.nih.gov. Do not send requests to individual members of the Division of Assurances.
    • In the email or as an attachment, include the contract number, project title, name of principal investigator, name of contractor, and performance sites, if applicablet.
    • 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 the contract with the contracting officer's representative to ensure that the contractor is not conducting activities involving live vertebrate animals before obtaining 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 352.270-5 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

Vertebrate Animals in Research questions and answers

Disaster Planning and Response Resources: OLAW

Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals

American Veterinary Medical Association (AVMA) Guidelines on Euthanasia

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

Last Updated December 13, 2013

Last Reviewed March 27, 2012