The 21st Century Cures Act Working Group identified harmonizing the OLAW and USDA annual reporting schedules as an opportunity to decrease administrative burden. The reporting period for the Annual Report to OLAW has been harmonized with that of USDA.
The reporting period is now October 1 – September 30 of each year and must be submitted to OLAW by December 1.
Policies and Laws
PHS Policy IV.F.1.: "At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW:
- any change in the institution’s program or facilities that would place the institution in a different category than specified in its Assurance (see IV.A.2. of this Policy);
- any change in the description of the institution’s program for animal care and use as required by IV.A.1.a.-i. of this Policy;
- any changes in the IACUC membership12; and
- notice of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities and submitted the evaluations to the Institutional Official."
PHS Policy IV.F.2. "At least once every 12 months, the IACUC, at an institution which has no changes to report as specified in IV.F.1.a.-c. of this Policy, shall report to OLAW in writing, through the Institutional Official, that there are no changes and shall inform OLAW of the dates of the required IACUC evaluations and submissions to the Institutional Official."
The requirement for Annual Reports stems from the HREA Section 495.(b)(3)(C)(ii) but the details for implementation of the law are clarified in the PHS Policy IV.F.1-2. Assured institutions are required to follow the PHS Policy.
Health Research Extension Act Sec. 495.(b)(3)(C) "Each animal care committee of a research entity shall, for each review conducted under subparagraph (A), file with the Director of NIH at least annually
- A certification that the review has been conducted…
Reports filed under subparagraph (C) shall include any minority views filed by members of the committee."
Reporting period and due date
The reporting period is 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).
October 1 - September 30
Download the Annual Report form
This form includes additional information and instructions in brackets [like this] that should be deleted from your final document. Use this form even if the OMB expiration date has passed.
How to submit
E-mail the signed annual report in PDF format to firstname.lastname@example.org by December 1 (but no earlier than September 30).
Examples Based on Reporting Category
The Annual Report form includes additional information and instructions in brackets [like this] that should be deleted from your final document.
- 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.
- Since the start of the reporting period (October 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.
- Program Evaluations: Please provide at least two dates (month/day/year) that fall within the reporting period (October 1 - September 30) to reflect the dates that the program review occurred.
- Facility Inspections: List any available dates of facility inspections that fall within the reporting period (October 1 - September 30). If inspections were unable to be completed within 6 months and 30 days of each other due to the COVID-19 pandemic, please state if your institution received a waiver from OLAW for facility inspections per NIH Guide Notice NOT-OD-20-088. Note: Approved COVID-19 waivers for semiannual inspections expire October 1, 2022 (see NIH Guide Notice NOT-OD-22-207. The 2022 Annual Report is the last opportunity to indicate facility inspections were unable to be completed with an approved waiver due to the COVID-19 pandemic.
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.
FAQ C.1 What is the Annual Report to OLAW and when is it due?
The Annual Report is a document prepared by the IACUC and submitted to OLAW through the Institutional Official. It describes any changes in the institution’s program of animal care and use, AAALAC International accreditation status, changes of Institutional Official and in IACUC membership, the dates that the IACUC conducted its semiannual evaluations of the program and facilities, and any minority views.
Descriptions of program changes should be comprehensive and in sufficient detail to replace information in the currently approved Assurance. If there are no changes, then a statement to that effect must be provided. Annual Reports must represent the consensus of the IACUC and include any minority views filed by members of the IACUC.
The Annual Report to OLAW reporting period and Annual Report deadline changed in 2020 to harmonize with the USDA reporting period. Beginning in 2021, the reporting period for the Annual Report to OLAW is 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).
To learn more and for the Annual Report form, see the Annual Report to OLAW.
|Webinar Link||Webinar Date|
|Update to the Reporting Period of the Annual Report to OLAW||June 11, 2020|
Sample Documents and Landing Pages
Annual Report to OLAW webpage, including instructions and Annual Report form.