0910-AG31 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 Unique Device Identification Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Undetermined 21 CFR 16, 801, 803, 806, 810, 814, 820, 821, 15 USC 1451 to 1461 21 USC 141 to 149, 321 to 394, 467f, 679, 821, 1034 28 USC 2112 42 USC 201 to 262, 263a and 263b, 264, 271, 364 Yes NPRM 06/00/2011 Yes Businesses Undetermined Undetermined No Yes Yes John Crowley J. 0910 Food and Drug Administration FDA 301 980-1936 jay.crowley@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring MD 20993