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HHS/FDA

RIN: 0910-AG14

Publication ID: Fall 2008

Title: ●Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures(Section 610 Review)
Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763).
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time 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 21 USC 352 21 USC 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	11/00/2008
End Review of Current Regulation	12/00/2009

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 P. Muller Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), 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: howard.mullerjr@fda.hhs.gov