Notice Number: NOT-OD-16-006

Key Dates
Release Date: October 13, 2015

Issued by
National Institutes of Health (NIH)

Purpose

This Notice is to inform potential applicants and offerors that the requirements of the Vertebrate Animals Section (VAS) of grant applications, cooperative agreements and contract proposals has changed. The changes have been made to remove redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

Updated VAS Requirements
If live vertebrate animals are to be used, federal policy requires applicants to address the following criteria:

• Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.
• Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
• Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.
• Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

Anticipated Implementation
These requirements, as applicable, will take effect for all grant applications except Fellowship (F series) and Training (T series) grants for due dates on or after January 25, 2016, and will take effect for all applications for due dates on or after May 25, 2016. For contracts, see individual Requests for Proposals (RFPs) for details.

Summary of Changes
The VAS criteria are simplified by the following changes:

• A description of veterinary care is no longer required.
• Justification for the number of animals has been eliminated.
• A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.

Application Review Criteria
As applicable for the project proposed, reviewers will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of procedures involving animals including species, strains, ages, sex and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for the euthanasia method if not consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals.

Resources
See the Vertebrate Animals Section webpage for more information on the VAS requirements. Here you will find a checklist, detailed instructions, plus links to worksheets.

Inquiries

For questions or further information, contact:

Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email: [email protected]