Your Input Needed - OLAW Seeks Comments on Proposed Guidance for Reporting Noncompliance

As part of the 21st Century Cures Act OLAW committed to reviewing and revising the guidance for reporting noncompliance. The proposed revisions are now available for public comment through a Request for Information (RFI). The final guidance will be published along with a new webpage once comments have been considered. OLAW expects institutions to comply with NOT-OD-05-034 until the new guidance is finalized. Visit this OLAW website for more details.

The proposed changes can be found here: NOT-OD-23-063

Comments should be submitted online: Submit Here

Comments will be accepted from January 23, 2023 - May 5, 2023

Frequently Asked Questions:

1. What is a Request for Information (RFI)?

The RFI is a notice of the development of new guidance and a request for stakeholder input before it is finalized.

2. When will these changes take effect?

After the comment period, OLAW carefully reviews all the comments and adjusts the proposed guidance as necessary. Institutions are expected to adhere to the current guidance until the final guidance is available.

3. Where should I go for information on the current requirements for reporting noncompliance?

Information on current guidance can be found on the OLAW website on the "Reporting Noncompliance” page.