| 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 We are taking this action as part of our continuing effort to eliminate or modify those regulations that are outdated or otherwise in need of reform without diminishing public health protection. |
| Priority: Info./Admin./Other | Agenda Stage of Rulemaking: Proposed Rule |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 601.8
(To search for a specific CFR, visit the
Code of Federal Regulations
)
|
| 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 |
| Timetable: |
| |
Action
| |
Date
| |
FR Cite
|
| | Direct Final Rule
| | 06/00/2009
| |
|
| | NPRM-Companion to Direct Final Rule
| | 06/00/2009
| |
|
|
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: No |
| Small Entities Affected: No | Federalism: 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 1401 Rockville Pike Suite 200N (HFM-17)
Rockville
,
MD
20852
Phone:
301 827-6210
E-Mail:
paul.levine@fda.hhs.gov
|