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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 FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities.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