0910-AF77 200604 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 under section 610 of the Regulatory Flexibility Act for the regulations in part 801. The purpose of this review is to determine if any of the regulations in part 801 should be continued without change, or should be amended or rescinded, consistent with stated objectives and applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 801; 2) the nature of complaints or comments received concerning a regulation in part 801; 3) the complexity of a regulation in part 801; 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 a regulation in part 801. Other Significant First Time 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 End Review of Current Regulation 12/00/2006 No None Undetermined NA 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