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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objectives and applicable statutes, whether the regulations in part 801 should be continued without change, amended, or rescinded in order to minimize any significant economic impact on a substantial number of small entities.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:
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
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Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6248 Fax:301 847-8145 Email: nancy.pirt@fda.hhs.gov |
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