0910-AF81 201210 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 Current Good Manufacturing Practice for Combination Products Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 4, subchapter A 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 360l 21 USC 360hh to 360ss 21 USC 360aaa to 360bbb 21 USC 371a 21 USC 372 to 374 21 USC 379e 21 USC 381 21 USC 394 42 USC 216 42 USC 262 42 USC 263a 42 USC 264 42 USC 271 No NPRM 09/23/2009 74 FR 48423 NPRM Comment Period End 12/22/2009 NPRM Extension of Comment Period 11/10/2009 74 FR 57973 Final Action 12/00/2012 Includes Retrospective Review under E.O. 13563. No Businesses State Yes No No John Weiner Barlow 0910 Food and Drug Administration FDA 301 796-8941 john.weiner@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, W032, Room 5130, Silver Spring MD 20993