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HHS/FDA | RIN: 0910-AC56 | Publication ID: Fall 2003 |
Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | |
Abstract: The final rule amends the FDA biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 201.59 21 CFR 610.21 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360b to 360d 21 USC 360h 21 USC 360i 21 USC 360gg to 360ss 21 USC 371 21 USC 372 21 USC 374 21 USC 381 42 USC 216 42 USC 262 42 USC 263 42 USC 264 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Agency Contact: Astrid L. Szeto Director Regulatory Review Officer Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Phone:301 827-6210 Fax:301 827-9434 Email: astrid.szeto@fda.hhs.gov |