0910-AF77 200710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-Containing Medical Device 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objectives and applicable statutes, whether the regulations in part 801 should be continued without change, amended, or rescinded in order to minimize any significant economic impact on a substantial number of small entities.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. Other Significant Previously Published in The Unified Agenda Prerule Stage Undetermined No Section 610 Review 21 CFR 801.437 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 Statutory Other 09/30/2007 Planned section 610 review No Final Action 09/30/1997 62 FR 51021 Final Action Effective 09/30/1998 Begin Review of Current Regulation 01/02/2007 End Review of Current Regulation 12/00/2007 No None Undetermined Yes Not Collected Nancy Pirt 0910 Food and Drug Administration FDA 301 796-6248 301 847-8145 nancy.pirt@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring MD 20993