0910-AG14 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 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures FDA is currently reviewing regulations promulgated under the Prescription Drug Marketing Act (PDMA). FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities. FDA has extended again the completion date by 1 year and will complete the review by December 2013. Other Significant Previously Published in The Unified Agenda Long-Term Actions Undetermined No Section 610 Review 21 CFR 203 21 CFR 205.3 21 CFR 205.50 21 USC 331 21 USC 333 21 USC 351 to 353 21 USC 360 21 USC 371 21 USC 374 21 USC 381 Statutory Other 12/03/2009 Planned Section 610 Review No Begin Review of Current Regulation 11/24/2008 End Review of Current Regulation 12/00/2013 Includes Retrospective Review under E.O. 13563 with small business burden reduction. Yes Businesses Governmental Jurisdictions Organizations Federal Local State No Yes No Howard Muller 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 pdma610(c)review@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002