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HHS/FDA

RIN: 0910-AF77

Publication ID: Fall 2006

Title: Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-Containing Medical Device(Section 610 Review)
Abstract: FDA is initiating a review of the regulations in part 801 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine, consistent with stated objectives and applicable statutes, whether the regulations in part 801 should be continued without change, amended, or rescinded in order to minimize any significant economic impact on a substantial number of small entities. FDA will consider and is soliciting comments on the following: 1) The continued need for the regulation; 2) the nature of complaints or comments received concerning the regulation; 3) the complexity of the regulation; 4) the extent to which a regulation in part 801 overlaps, duplicates, or conflicts with other Federal rules, and to the extent feasible, with State and local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation.
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 801.437
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 357 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374

Legal Deadline:

Action	Source	Description	Date
Other	Statutory	Planned Section 610 Review	09/30/2007

Timetable:

Action	Date	FR Cite
Final Action	09/30/1997	62 FR 51021
Final Action Effective	09/30/1998
End Review of Current Regulation	12/00/2006

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov