Notice Number: NOT-OD-10-049
Key Dates
Release Date: April 19, 2010
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
Other Relevant Notice
October 18, 2021 -- See Notice NOT-OD-22-006 Notice of Clarification of Offeror Responsibilities Regarding Contract to Protocol Congruence Review
October 13, 2015 See Notice NOT-OD-16-006 Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals
March 17, 2010: see NOT-OD-10-027, Instructions for Completion and Peer Review of the Vertebrate Animal Section (VAS) in NIH Grant Applications and Cooperative Agreements.Purpose
This Notice is to clarify the information that must be included in a separate section of the Technical Proposal titled the Vertebrate Animal Section (VAS) of contract proposals for biomedical and behavioral Research and Development (R&D), research training, and biological testing activities that use live vertebrate animals. It also explains how the VAS is evaluated as part of the NIH technical evaluation process for award of a contract. Distinction is made between the oversight role of the Institutional Animal Care and Use Committee (IACUC) and review responsibility of the NIH Scientific Review Group (SRG).
Background
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) specifies the information required in all contract proposals submitted to the NIH that involve live vertebrate animals. The PHS Policy derives its authority from the Health Research Extension Act of 1985. The PHS Policy incorporates the principles and procedures described in the following documents:
The Guide for the Care and Use of Laboratory Animals (National Academy of Sciences)
http://www.nap.edu/openbook.php?record_id=5140
American Veterinary Medical Association (AVMA) Guidelines on Euthanasia
http://www.avma.org/issues/animal_welfare/euthanasia.pdf (PDF)
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciples
This PHS Policy is implemented by the HHSAR at 370.4.
This Notice summarizes and clarifies current requirements.
Table of Contents
Section I. Required Elements of the VAS Five Points
Section II. Review of the VAS Responsibilities of Offerors, SRGs, and NIH Staff
Section III. Role of the IACUC in the Oversight of Animal Care and Use Protocols
- Required Elements of the VAS
Any proposed use of vertebrate animals for experimental research including use as a source of tissues constitutes research involving use of live vertebrate animals and requires completion of the VAS. Federal policy requires that the following five points are addressed in all contract proposals involving live vertebrate animals. Potential offering organizations are strongly encouraged to familiarize themselves with the required elements for completion of the VAS in the Contract Proposal VAS Worksheet (PDF).
- Detailed description of the proposed use of the animals, including species, strains, ages, sex and number to be used
- Justification for the use of animals, choice of species, and numbers to be used
- Information on the veterinary care of the animals
- Description of procedures for minimizing discomfort, distress, pain, and injury
- Method of euthanasia and the reasons for its selection
A concise (e.g., 1-2 pages), complete description of the animals and proposed procedures must be provided within the VAS of contract proposals. While additional details may be included in other sections of the contract proposal, the description of the proposed procedures within the VAS must be cohesive and include sufficient detail to allow evaluation by reviewers and NIH staff.
- Review of the VAS: Responsibilities of Offerors, SRGs, and NIH Staff
Overview: As part of the technical evaluation of contract proposals for scientific and technical merit, SRGs verify that any proposed research involving vertebrate animals is scientifically appropriate. Proposals lacking the completed five points of the VAS will be considered unacceptable with regard to the Care of Live Vertebrate Animals provision of the solicitation’s Technical Proposal Instructions. If the offeror is included in the competitive range, the unacceptable VAS may be discussed and the offeror may be permitted to revise its proposal. If the offer is still considered unacceptable in terms of the VAS response, the offeror may not be considered for award of a contract.
If there are concerns related to the VAS, these must be resolved during the discussions with the offeror regarding animal care and use. The Project Officer and the Office of Laboratory Welfare (OLAW) may advise the Contracting Officer, who will obtain additional information or a revised proposal from the offeror to resolve all concerns and assure that the research involving animals will be conducted in compliance with PHS Policy. Prior to contract award, the Contracting Officer will confirm whether the offeror has an Animal Welfare Assurance (Assurance) on file with OLAW, and that verification of approval by the Institutional Animal Care and Use Committee (IACUC) has been provided. After award, the contract will be coded in the Departmental Contracts Information System (DCIS) as a contract where animals will be used.
Although contractors are primarily responsible for the proper care and use of animals used in activities performed under the contract, the responsibilities of individuals associated with the NIH contract acquisition and technical evaluation processes are described briefly.
Offeror responsibilities: As indicated in the Care of Live Vertebrate Animals provision of the solicitation's Technical Proposal, each of the five points must be addressed in the VAS of the contract proposal. The discussion of all of the five points must be addressed and evaluated by reviewers as acceptable for the VAS portion to be considered acceptable . The VAS portion must be considered as acceptable prior to award.
SRG responsibilities: The SRG will evaluate the involvement of live vertebrate animals as part of the technical evaluation of proposals submitted to NIH according to the following five points: 1) proposed use of animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. The results of the VAS review may result in a rating of unacceptable requiring revision of the VAS prior to award, or as acceptable , which would require no further discussion on this topic.
NIH Staff responsibilities:
- Contracting Officer a) provides 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 ; b) subsequent to SRG review, determines the competitive range, as applicable, and if discussions are held, provides the offeror with the opportunity to address the concerns raised by the reviewers; c) with the advice of the Project Officer and OLAW, as necessary, determines if the concerns have been resolved and the VAS section of the Technical Proposal can be considered acceptable ; d) confirms whether the offeror has an OLAW-approved Assurance and IACUC approval; e) makes contract awards.
- Project Officer assists the Contracting Officer in determining the acceptability of the revised VAS of the Technical Proposal.
- Role of the IACUC and in the Oversight of Animal Care and Use Protocols
Organizations receiving NIH funding for research involving vertebrate animals must negotiate an Assurance with OLAW. Approval by OLAW of an organization’s animal care and use program requires that their facilities and procedures conform to PHS Policy, and that all research involving animals within their facilities is monitored by a requisite IACUC.
A fundamental component of the Assurance is the IACUC, which is responsible for the review of proposed research and oversight of individual animal care and use protocols at each organization. IACUC approval indicates that the proposed protocol has been determined by the organization’s IACUC to conform to PHS Policy. While the IACUC considers the appropriateness of the proposed protocol to the investigator’s scientific goals, the primary goal of the IACUC’s detailed evaluation and oversight of the protocol, is to assure that the procedures involving animals conform to all federal animal welfare requirements and PHS Policy.
Inquiries
For questions or further information, contact:
Office of Laboratory Animal Welfare
National Institutes of Health
Rockledge 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982
phone: 301-496-7163
fax: 301-915-9481
e-mail: [email protected]
web: http://olaw.nih.gov/
and Human Services (HHS)
