Annual Report to OLAW

Introduction Reporting period and due date Instructions How to submit Download form and instructions

Introduction

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals IV.F.1., 2., and 4. require that at least once every 12 months the IACUC, through the Institutional Official (IO), must report to OLAW.

Information to be reported includes:

• Any change in the institution’s accreditation status
• Any change in the institution’s program of animal care and use or facilities
• Any change in the IO
• Any changes in the IACUC membership
• The dates that the IACUC conducted its semiannual evaluations of the program and facilities
• Any minority views filed by members of the IACUC

NEW A memorandum of understanding (MOU) between the OLAW and the National Aeronautics and Space Administration (NASA) was signed in 2020 (NOT-OD-20-195). Therefore, information regarding NASA funding or utilization of the International Space Station is requested in the 2020 Annual Report to OLAW.

Reporting period and due date

The Annual Report to OLAW reporting period and annual report deadline have changed to harmonize with the USDA Reporting Period per recommendations of the final report issued by the 21st Century Cures Act Sec. 2034(d) Working Group.

For 2020, the reporting period is January 1 to September 30, 2020 (a partial year) with the annual report due on or before December 1 (but no earlier than September 30).

Starting in 2021, the reporting period will be the federal fiscal year, October 1 to September 30, with the annual report due on or before December 1 (but no earlier than September 30).

Instructions for the 2020 Annual Report

The Annual Report form includes additional information and instructions in brackets [like this] that should be deleted from your final document.

In Item I, Program Changes, select A (no changes) or B (changes have occurred). If B is selected, at least one additional selection must be made under B.

• Select the appropriate AAALAC accreditation status items only if there has been a change in the institution’s status.
• If there are changes in the institution’s program for animal care and use, provide descriptions with sufficient detail to replace information in the currently approved Assurance. Do not submit a revised Assurance document.
  • Do not include program changes that were only implemented temporarily and/or revisions to your institution’s disaster plan unless needed to update information currently included in your Assurance.
  • Include any permanent program changes that may have been adopted to address the COVID-19 pandemic (e.g., conducting IACUC business by telecommunications) if not currently included in your Assurance.
  • Indicate if your institution receives NASA funding and/or utilizes the International Space Station for research involving live vertebrate animals. This information is being requested due to the recent MOU between OLAW and NASA.
• Since the start of the reporting period (January 1, 2020):
  • If a change in IO occurred, provide the information for the current IO (the IO signing the Annual Report to OLAW) in Item V.
  • If the IACUC membership has changed, provide an updated roster that reflects current membership (members as of the day of Annual Report submission) in Item IV.

In Item II, Semiannual Evaluations, provide available dates and additional information, if applicable, as instructed below.

1. Program Evaluations

• Due to the partial year reporting period for the 2020 Annual Report to OLAW, you may only have one date. Please list it. Otherwise, provide at least two dates (month/day/year) to reflect the dates that the program review occurred.

2. Facility Inspections

• Due to the COVID-19 pandemic, you may only have one or no date for facility inspections. OLAW expects institutions granted waivers to conduct the inspections that were postponed as soon as the IACUC can safely do so. List any available dates of facility inspections and state if your institution received a waiver from OLAW for facility inspections per NIH Guide Notice NOT-OD-20-088.
• For institutions that did not receive a waiver from OLAW for facility inspections, due to the partial year reporting period for the 2020 Annual Report to OLAW, you may only have one date. Please list it. Otherwise, provide at least two dates (month/day/year) to reflect the dates that the facilities inspections occurred.

In Item III, Minority Views, select A (none) or B (minority views submitted). If B is selected, attach the minority view(s) exactly as submitted by the IACUC member(s) i.e., in the submitting IACUC member’s words. If the minority view is only available as part of the meeting minutes or semiannual report to the IO, submit only the minority view portion. Please do not submit meeting minutes or semiannual reports in their entirety. For further information on reporting minority views, refer to FAQ C6.

Statement of Burden for Annual Report Form (OMB Number 0925-0765)

Public reporting burden for this collection of information is estimated to average 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0765). Do not return the completed form to this address.

How to submit

E-mail the signed annual report in PDF format to olawarp@mail.nih.gov by December 1 (but no earlier than September 30).

Resources

• OLAW Webinar: Update to the Reporting Period of the Annual Report to OLAW - June 17, 2020
• Notice of Update to the Reporting Period of the Annual Report to OLAW (NOT-OD-20-109)
• 2020 Annual Report to OLAW - Reporting Examples for Semiannual Dates (PDF - 802 KB)

Download the Annual Report form and instructions

This form includes additional information and instructions in brackets [like this] that should be deleted from your final document.

Annual Report (Word - 164 KB)

Instructions for the 2020 Annual Report to OLAW (PDF - 134 KB)

Questions?

Contact the Division of Assurances by phone at 301-496-7163 or e-mail olawdoa@mail.nih.gov.