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| HHS/FDA | RIN: 0910-AF79 | Publication ID: Fall 2006 |
| Title: Financial Disclosure by Clinical Investigators(Section 610 Review) | |
| Abstract: FDA is undertaking a review of 21 CFR sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities.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 will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (2) the nature of complaints or comments received concerning the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (3) the complexity of the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (4) the extent to which the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 overlap, duplicate, or conflict with other regulations with other Federal, State, or governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously 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 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64; 21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR 314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21 CFR 807.87; 21 CFR 807.100; 21 CFR 812.43; 21 CFR 812.110; 21 CFR 812.140; 21 CFR 814.20; 21 CFR 814.42; 21 CFR 814.112; 21 CFR 860.123 | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 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 | |
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
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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 Elisa D. Harvey Director, Office of Device Evaluation Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Corp Room 130F (HFZ-215), 1350 Piccard Drive, Rockville, MD 20850 Phone:301 594-1190 Fax:301 594-3076 Email: elisa.harvey@fda.hhs.gov |
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