0910-AF36 200410 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 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products Routine and Frequent Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 201 21 CFR 310 21 CFR 330 to 358 21 USC 321p 21 USC 351 to 353 21 USC 355 21 USC 360a 21USC 371a 21 USC 331 21 USC 360 21 USC 360gg to 360ss 21 USC 371 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264 No NPRM (Amendment) (Labeling) 12/00/2004 NPRM (Amendment) (Pediatric) 02/00/2005 NPRM (Amendment) (Combinations with Sodium Bicarbonate) 06/00/2005 Yes Businesses None No NA Not Collected 0910-AA01 Split from Gerald Rachanow M. 0910 Food and Drug Administration FDA 301 827-2241 301 827-2315 gerald.rachanow@fda.hhs.gov HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, Rockville MD 20857