This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - Agenda XML Reports
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AF77 Publication ID: Spring 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 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is to determine if any of the regulations in part 801 should be continued without change, or should be amended or rescinded, consistent with stated objectives and applicable statutes, to minimize any significant economic impact on a substantial number of small entities.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. 
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 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 
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:
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

About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us