The following resources are provided to assist Public Health Service (PHS) awardee institutions in meeting reporting requirements.

Introduction

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The PHS Policy, section IV.F.3., requires that:

“The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

• any serious or continuing noncompliance with this Policy;
• any serious deviation from the provisions of the Guide; or
• any suspension of an activity by the IACUC.”

All institutions with Animal Welfare Assurances (Assurance) are required to comply with the provisions of PHS Policy IV.F.3. NIH Guide Notice NOT-OD-05-034 provides the following guidance on these reporting requirements. Here you will find:

• Examples of reportable situations
• Examples of situations not normally reported
• Timeframe for reporting
• Information to be reported

Preliminary report

Institutions should notify OLAW promptly of reportable situations. As such, it is appropriate to submit a preliminary report until a full investigation and correction plan has been completed. Preliminary reports may be phoned, faxed, or e-mailed to the Division of Compliance Oversight. The following information is requested:

• Name and contact information of person reporting
• Name of institution
• Assurance number (see list of domestic and foreign Assured institutions)
• Funding component and if contacted (for situations related to PHS-supported activities)
• Brief description of incident (e.g., species, category of personnel involved, dates, times, animal deaths)
• Plan and schedule for correction and prevention (if known)
• Timeframe for final report from the Institutional Official

Final report

Institutions should provide a final report that includes a detailed explanation of the circumstances and actions taken. A final report must be signed by the Institutional Official and should specify:

• Name of institution
• Assurance number (see list of domestic and foreign Assured institutions)
• Reporting requirement: Identify the reporting requirement of the PHS Policy IV.F.3. under which the incident qualifies (i.e., serious or continuing noncompliance with the PHS Policy, serious deviation from the provisions of the Guide, or suspension of an activity by the IACUC).
• Preliminary report: Note when, by whom, and to whom a preliminary report was made, if applicable.
• Explanation of incident: Explain in detail what happened, when and where, the species of animals(s) involved, and the category (but not the names) of the individuals involved.
• Corrective actions: Describe the corrective and preventative actions taken to address the situation. Include all the short or long-term corrective plans along with the implementation schedule. Indicate whether the IACUC reviewed and accepted the corrective actions submitted by the responsible party as well as any ongoing actions taken by the IACUC (e.g., enhanced oversight).
• Grant/contract number: Include the relevant grant or contract number (for situations related to PHS-supported activities).
• Impact on PHS-supported activities: Describe any potential or actual effect on PHS-supported activities. This also applies to incidents that have occurred in a functional, programmatic, or physical area not supported by the PHS that could affect PHS-supported activities (see also NOT-OD-05-034).
• Compliance with terms and conditions: If the incident involved PHS-supported activities and was not compliant with the terms and conditions of grant award, confirm that the situation was reported to the funding component and that all unauthorized costs initially paid from the grant have been removed and covered by other sources (see also NOT-OD-10-081). Or, state that PHS funds had not been used.

Example final report

An example of a final report is provided to assist institutions in preparing a noncompliance report. Click on one of the versions below to view or download.

• PDF (368 KB)
• Word (38 KB)
• HTML

Submit final report

Submit your final report to the Division of Compliance Oversight by fax to 301-915-9466, by e-mail to olawdco@mail.nih.gov, or mail to the address provided at the bottom of this page.

Additional references

• Compliance Oversight Procedures, 2007 (PDF - 128 KB) - this memorandum updates and summarizes the procedures utilized by OLAW in conducting compliance oversight activities.
• Reporting Noncompliance - this section of the Topic Index provides additional guidance on reporting noncompliance found in Commentaries, Articles, FAQs, and NIH Guide Notices.
• Terms & Conditions - this section of the Topic Index provides guidance to grantees when animal activities have been conducted which do not meet the terms and conditions of grant award.

Questions?

Not sure what to report? Call or e-mail the Division of Compliance Oversight for answers to your questions.

Division of Compliance Oversight

Phone: 301-594-2061
E-mail: olawdco@mail.nih.gov
Fax: 301-915-9466

Mailing Address:

Director, Division of Compliance Oversight
Office of Laboratory Animal Welfare
National Institutes of Health
Rockledge 1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
[20817 zip code for mail delivery service]

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.