0910-AH09 201404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Current Good Manufacturing Practice for Outsourcing Facilities Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Not Yet Determined 21 USC 351 PL 113-54, 127 Stat 587 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 11/00/2014 Undetermined Undetermined Undetermined Undetermined No No Ashley Boam 0910 Food and Drug Administration FDA 301 796-6341 ashley.boam@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring MD 20993