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HHS/FDA RIN: 0910-AG14 Publication ID: 2012 
Title: Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures(Section 610 Review) 
Abstract: 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 FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities.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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 203; 21 CFR 205.3; 21 CFR 205.50 
Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351 to 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 
Legal Deadline:
Action Source Description Date
Other  Statutory  Planned Section 610 Review  12/03/2009 
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  11/24/2008   
End Review of Current Regulation  12/00/2013   
Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Howard Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: pdma610(c)review@fda.hhs.gov

 
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