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HHS/FDA | RIN: 0910-AF62 | Publication ID: Fall 2005 |
Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | |
Abstract: On December 13, 1985, the Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004 (69 FR 255). On October 27, 2004, the United States District Court for the District of Columbia vacated the January 5, 2004, final rule and final order. On December 29, 2004 (69 FR 78280), FDA published a withdrawal of the January 5, 2004, final rule and final order. Concurrently with the withdrawal of the final rule and final order, FDA published again a proposed rule and proposed order (December 2004 proposal) (69 FR 78281) to provide notice and to give interested persons an opportunity to comment. FDA is proposing to amend the biologics regulations in response to the report and recommendations of the Panel and in consideration of comments submitted to the Division of Dockets Management. FDA intends to classify 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). The December 2004 proposal included a proposed order for Anthrax Vaccine Absorbed. The final order Anthrax Vaccine Absorbed will be published separately in the same issue of the Federal Register as the final rule and final order for the other products included in the December 2004 proposal. | |
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 379e 21 USC 381 42 USC 216 42 USC 241 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 |
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 | |
Agency Contact: Astrid L. Szeto Senior Regulatory Review Officer 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 Fax:301 827-9434 |