0910-AG29 201010 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 Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 814 21 USC 321, 331, 351, 352, 360e, 360e-1, 360j, and 371 No NPRM 04/01/2010 75 FR 16365 Direct Final Rule 04/01/2010 75 FR 16347 NPRM Comment Period End 06/15/2010 Notice of Withdrawal of Direct Final Rule 07/20/2010 75 FR 41986 Final Rule 06/00/2011 No No None No No No No Paul Gadiock 0910 Food and Drug Administration FDA 301 796-5736 301 847-8145 paul.gadiock@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432, Silver Spring MD 20993-0002