OHRP and FDA Extend the Comment Period on the Draft Guidance on Minutes of IRB Meetings

December 14, 2015

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are extending the comment period for the joint draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” A notice of availability requesting comments on the draft guidance document previously appeared in the Federal Register of November 5, 2015. The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments. This joint draft guidance is available on OHRP’s website at http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html, and on FDA's website at http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm. Comments are due by February 3, 2016

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