0910-AH08 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Department of Health and Human Services HHS Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 216.24 21 USC 351 21 USC 352 21 USC 353a PL 113-54, 127 Stat 587 21 USC 355 21 USC 371 Statutory Final Not more than 18 months following publication of the proposed rule. Section 104 of the Drug Quality and Security Act (DQSA) requires that in promulgating any regulations to implement the DQSA (e.g., section 503B of the FD&C Act), at least 60 days be provided for comments on a proposed regulation and the final regulation be published not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation. No NPRM 07/02/2014 79 FR 37687 NPRM Comment Period End 09/02/2014 Final Rule 06/00/2015 No None No No No Olivia Ziolkowski 0910 Food and Drug Administration FDA 301 796-2888 301 847-8440 olivia.ziolkowski@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6210, Silver Spring MD 20993