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
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 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).
October 1 - September 30
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
- Report any changes in veterinarians listed in section III.B. of the institution’s Assurance as program changes.
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 at least two dates (month/day/year) that fall within the reporting period (October 1 - September 30) to reflect the dates that the program reviews occurred.
- Facility Inspections
- List any available dates of facility inspections that fall within the reporting period (October 1 - September 30).
- All previously approved COVID-19 waivers for semiannual inspections expired October 1, 2022 (see NIH Guide Notice NOT-OD-22-207) and do not excuse intervals between required facility inspections that exceed the six-month interval and 30-day grace period.
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 email@example.com by December 1 (but no earlier than September 30).
Annual Report Acknowledgement Communications
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.
- Notice of Update to the Reporting Period of the Annual Report to OLAW (NOT-OD-20-109)
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.
2023 Annual Report (Word - 54 KB)
Contact the Division of Assurances by phone at 301-496-7163 or e-mail firstname.lastname@example.org.