0910-AG29 200910 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 Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 814.1(a) 21 CFR 814.2 21 CFR 814.20(b)(3)(i) 21 CFR 814.37(b) 21 CFR 814.39(h) 21 CFR 814.44(e)(1) 21 CFR 814.100(a)(c) 21 CFR 814.104(b) 21 CFR 814.116(c) ... Title III of the Food Drug Administration Amendments Act of 2007, which includes new section 515A, is also known as the pediatric Medical Device Safety and Improvement Act of 2007. No NPRM 09/00/2010 Direct Final Rule 09/00/2010 No No None Undetermined 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