OLAW Seeks Input on Clarifying IACUC Reporting Requirements for Guide Departures

NIH’s Office of Laboratory Animal Welfare (OLAW) requests public input to clarify the Institutional Animal Care and Use Committee (IACUC) reporting requirements for departures from the Guide for the Care and Use of Laboratory Animals (Guide) through the recently issued Request for Information (RFI) on Clarifying the Reporting Requirements for Departures From the Guide for the Care and Use of Laboratory Animals.

Section 2034(d) of the 21st Century Cures Act directed NIH to conduct a review of applicable regulations for the care and use of laboratory animals. As a result, the public identified reporting requirements for departures from the Guide as an area to reduce administrative burden, accomplished by eliminating the Public Health Service (PHS) requirement for compliance with the Guide.

In the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research, developed in response to the 21st Century Cures Act, OLAW committed to clarifying the guidance for the reporting requirements of departures from the Guide. However, the requirement for adherence to the Guide remains in effect for Assured institutions.

Information Requested

PHS Policy IV.B.3. requires that the semiannual reports to the institutional official (IO) include a description of the institution’s adherence to the Guide and the PHS Policy, any departures from the Guide, and reasons for the departures.

NIH seeks input on the following:

• Guide Exceptions list
• Guide Must Statements checklist
• IACUC reporting requirements in the Guide

NIH also invites input on the following clarifications to IACUC reporting requirements for departures from must, should, and may statements in the Guide. Read the RFI linked above for a detailed explanation and a list of examples. Notifications to the IO in a semiannual report are required for the following instances:

• An IACUC-approved deviation from a must statement
• An IACUC-approved deviation from a should statement without an exception to the Guide and lacking established performance standards

IACUC-approved departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues.

Reporting to the IO in the semiannual report is not required for the following deviations:

• Deviations from may statements in the Guide
• A specifically described Guide exception from a should statement
• Deviations from a should statement in the Guide using established performance standards

Again, the requirement for adherence to the Guide still applies to Assured institutions, and they must report noncompliant, unapproved departures from the Guide to OLAW, in addition to the following deviations:

• Deviations from a must statement in the Guide without IACUC approval
• Deviations from a should statement when:
  • Not based on specifically described Guide exception
  • Not based on an established performance standard
  • Not IACUC approved

For additional resources, visit OLAW’s webpage Departures from the Guide.

How To Send a Response

Submit your feedback through Request for Information (RFI) on Clarifying the Reporting Requirements for Departures From the Guide for the Care and Use of Laboratory Animals by November 1, 2021, at 11:59 p.m. Eastern Time. The comments may be published on the OLAW website. Do not include any personally identifiable, proprietary, classified, confidential, or sensitive information in the responses.

Direct all inquiries to Office of Laboratory Animal Welfare.