Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review

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) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the U.S. District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004 (69 FR 78281). The purpose of this final rule and final order is to amend the biologics regulations, issue a final order in response to the report and recommendations of the Panel; and, respond to comments on the previously published proposed rule and proposed order submitted to the Division of Dockets Management. This final rule and final order does not address Anthrax Vaccine Adsorbed (AVA). The final order concerning AVA is published elsewhere in this issue of the Federal Register. 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).