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HHS/FDA | RIN: 0910-AG11 | Publication ID: Fall 2008 |
Title: ●Revision of the Requirements for Publication of License Revocation | |
Abstract: The Food and Drug Administration (FDA) is amending the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. We are taking this action as part of our continuing effort to eliminate or modify those regulations that are outdated or otherwise in need of reform without diminishing public health protection. | |
Agency: Department of Health and Human Services(HHS) | Priority: Info./Admin./Other |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 601.8 | |
Legal Authority: 15 USC 1451 to 1561 21 USC 321 21 USC 351 to 353 21 USC 355 21 USC 356b 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 371 21 USC 374 21 USC 379e 21 USC 381 42 USC 216 42 USC 241 42 USC 262 and 263 42 USC 264, sec 122 PL 105-115, 111 Stat. 2322 (21 USC 355 note) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Paul E. Levine Jr. Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852 Phone:301 827-6210 |