0910-AG88 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 314.81 21 CFR 314.91 secs 506c, 506c-1, 506d, and 506f of the FDA&C Act, as amended by title X (Drug Shortages) of FDASIA, PL 112-144, July 9, 2012 Statutory NPRM 01/09/2014 Not later than 18 months after the date of enactment of FDASIA, FDA must adopt the final regulation implementing section 506C as amended. Section 1001 of FDASIA states that not later than 18 months after the date of enactment of FDASIA, the Secretary shall adopt a final regulation implementing section 506(c) as amended. Yes NPRM 11/04/2013 78 FR 65904 NPRM Comment Period End 01/03/2014 Final Action 01/00/2015 Undetermined None No No No Valerie Jensen 0910 Food and Drug Administration FDA 301 796-0737 Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 6202, Silver Spring MD 20903