Last month, we analyzed the draft guidance regarding Institutional Review Board (IRB) minutes (Draft Guidance) proposed by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). The Draft Guidance is intended to assist institutions and IRBs in preparing IRB meeting minutes that comply with regulatory requirements, and is available on the OHRP and FDA websites or by clicking here.
The original deadline to submit comments on the Draft Guidance was January 4, 2016. On December 16, 2015, HHS is publishing a notice announcing that the FDA and OHRP are extending the deadline for an additional 30 days, until February 3, 2016. The Agencies noted that the original “due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders.” The extension, therefore, allows these and other interested groups additional time to submit comments.
Anyone planning to comment on the Draft Guidance should calendar this new deadline and take advantage of this welcome extension.