0910-AF36 200904 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 Final Rule Stage No No 21 CFR 201 21 CFR 310 21 CFR 330 to 358 21 USC 321p 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 21 USC 379e No NPRM (Amendment) (Required Warnings and Other Labeling) 12/26/2006 71 FR 77314 NPRM Comment Period End 05/25/2007 NPRM (Amendment) (Overindulgence/Hangover) 05/00/2010 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Combinations With Sodium Bicarbonate) 05/00/2010 NPRM (Amendment) (Miscellaneous Issues) 05/00/2010 Final Action (Required Warnings and Other Labeling) 05/00/2009 Final Action (Internal Analgesics) To Be Determined Yes Businesses Local State Yes Yes No 0910-AA01 Split from Walter Ellenberg J. 0910 Food and Drug Administration FDA 301 796-2090 301 796-9899 walter.ellenberg@fda.hhs.gov Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring MD 20993