0910-AF37 200510 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--Labeling of Drug Products for OTC Human Use The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. 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 371 21 USC 358 21 USC 360gg to 360ss 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264 No NPRM (Convenience Sizes) 12/00/2005 Yes Businesses None 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