0910-AF79 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Financial Disclosure by Clinical Investigators 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determine whether the regulations in part 54 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities.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. Other Significant Previously Published in The Unified Agenda Completed Actions No No Completion of a Section 610 Review 21 CFR 54 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 Statutory Other 02/02/2006 Planned section 610 review No Begin Review of Current Regulation 12/01/2006 End Review 12/31/2007 No None Yes Not Collected Howard Muller P. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 howard.mullerjr@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002 Stephen Ripley M. 0910 Food and Drug Administration FDA 301 827-6210 Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville MD 20852-1448 Nancy Pirt 0910 Food and Drug Administration FDA 301 796-6248 301 847-8145 nancy.pirt@fda.hhs.gov 10903 New Hampshire Avenue, W0-66, Room 4438, Silver Spring MD 20993-0002