0910-AF36 201404 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 Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector 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 Final Action (Required Warnings and Other Labeling) 04/29/2009 74 FR 19385 Final Action (Correction) 06/30/2009 74 FR 31177 Final Action (Technical Amendment) 11/25/2009 74 FR 61512 NPRM (Amendment) (Pediatric) 12/00/2014 NPRM (Amendment) (Acetaminophen) 12/00/2014 Yes Businesses Local State Yes Yes No 0910-AA01 Split from Janice Adams-King 0910 Food and Drug Administration FDA 301 796-3713 301 796-9899 janice.adams-king@fda.hhs.gov Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring MD 20993