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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determine whether the regulations in part 54 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities.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
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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