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HHS/FDA | RIN: 0910-AG14 | Publication ID: Fall 2013 |
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 FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities.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 November 2013. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Prerule Stage |
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:
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Timetable:
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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 |