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| HHS/FDA | RIN: 0910-AF62 | Publication ID: Spring 2006 |
| 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, including anthrax vaccine absorbed, 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. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 610.21 | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264 | |
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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 | |
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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 |
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