Read about the requirements for an Annual Report to OLAW as stated in the PHS Policy, and find instructions and form to complete and submit the report.
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
Notify OLAW of changes in the Institutional Official, IACUC Chair, or Assurance Key Contacts immediately by emailing the Division of Assurances ([email protected]) with name, credentials (e.g., M.D., Ph.D.), position title, phone number, and email address. Outdated contact information will create delays in receiving information from our office and missed communications.
Reporting Period and Due Date
The Annual Report to OLAW reporting period and annual report deadline changed in 2020 to harmonize with the USDA reporting period per recommendations of the final report (PDF, 928 KB) issued by the 21st Century Cures Act Sec. 2034(d) Working Group.
The harmonized 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).
| Reporting Period | Due date |
|---|---|
| October 1 - September 30 | December 1 |
Instructions
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.
- Report any changes in veterinarians listed in section III.B. of the institution’s Assurance as program changes. An optional Sample Addendum – Change in Veterinarians document is available at the bottom of this website. Complete the new veterinarian information, and append to the Annual Report.
- Since the start of the reporting period (October 1):
- 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.
- Program Evaluations
- Provide all dates (month/day/year) that fall within the reporting period (October 1 - September 30) to reflect the dates that the program reviews occurred.
- For federal institutions, if the 10/1-11/12/2025 shutdown caused the interval between the Semiannual Program Reviews to exceed 6 months and the 30-day grace period, note the government shutdown as the reason for the delay.
- Facility Inspections
- List all available dates of facility inspections that fall within the reporting period (October 1 - September 30).
- For federal institutions, if the 10/1-11/12/2025 shutdown caused the interval between the Semiannual Facility Inspections to exceed 6 months and the 30-day grace period, note the government shutdown as the reason for the delay.
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.
For Item IV, Signatures, include the signature of the current IACUC Chairperson at the time the Annual Report is submitted. If the Chair is unavailable, include the signature of the current Vice Chair. If there have been changes to the IACUC roster, provide the roster that is current at the time the Annual Report is submitted including the name of the Chair, and if applicable, Vice Chair.
Include the signature of the current Institutional Official (IO) at the time the Annual Report is submitted. A designated individual may sign on behalf of the IO with documented signature authority provided to OLAW e.g., signed memo from the IO naming the alternate individual.
Signatures using one of the following methods are acceptable:
- a scan or photo of a document with a wet signature (pen on paper)
- document with a digital signature where the certificate data is embedded in the document file
- document with a drawn signature (not typed) on the document’s signature line
- document with a photo of a signature inserted on the document’s signature line
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 as a single PDF file attachment to [email protected] by December 1 (but no earlier than September 30).
Annual Report Communications
- Email responses to received Annual Reports may look different than previous years. To assist us in efficient handling of your Annual Reports, after your initial submission, please only reply to the last received email and avoid drafting and sending new emails regarding the 2026 Annual Report.
- An OLAW Division of Assurances Program Analyst will send an Annual Report Acknowledgment notification email to institutions whose Annual Report to OLAW has been received and reviewed.
Additional Information
- Notice of Update to the Reporting Period of the Annual Report to OLAW (NOT-OD-20-109)
- For USDA registered institutions, annual reporting information can be found on the USDA annual reporting webpage. For comments or questions regarding the USDA annual report, please contact the USDA.