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HHS/FDA RIN: 0910-AF79 Publication ID: Spring 2008 
Title: Financial Disclosure by Clinical Investigators(Completion of a Section 610 Review) 
Abstract: FDA has reviewed 21 CFR part 54, under section 610 of the Regulatory Flexibility Act. FDA received no comments during the review period mandated by section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations in part 54 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA considered and solicited comments on the following: (1) The continued need for the regulations in part 54; (2) the nature of complaints or comments received concerning the regulations in part 54; (3) the complexity of the regulations in part 54, (4) the extent to which the regulations in part 54 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for those affected by the regulations in part 54. The section 610 review has been carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. FDA did not receive any comments during the review period mandated by section 610 of the Regulatory Flexibility Act. Therefore, no changes will be made to 21 CFR part 54. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: 21 CFR 54   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c to 360j    21 USC 371    21 USC 372    21 USC 373    21 USC 374    21 USC 375    21 USC 376    21 USC 379    42 USC 262   
Legal Deadline:
Action Source Description Date
Other  Statutory  Planned section 610 review  02/02/2006 
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  12/01/2006    
End Review  12/31/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: howard.mullerjr@fda.hhs.gov

Stephen M. Ripley
Team Leader
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17),
Rockville, MD 20852-1448
Phone:301 827-6210

Paul Gadiock
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432,
Silver Spring, MD 20993-0002
Phone:301 796-5736
Fax:301 847-8145
Email: paul.gadiock@fda.hhs.gov

 
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