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

The Food and Drug Administration (FDA) published in the Federal Register of January 5, 2004 (69 FR 255), a final rule and final order (January 2004 final rule and final order) amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency. On January 8, 2004 (69 FR 1320), a correction document was published to correct the effective date from "January 4, 2003", to "January 4, 2005." On February 13, 2004 (69 FR 7114), FDA issued a correction document to correct typographical errors in the reference section of the January 2004 final rule and final order. On October 27, 2004, the United States District Court for the District of Columbia (the Court) issued a memorandum opinion vacating and remanding the January 2004 final rule and final order to FDA for reconsideration, following an appropriate notice and comment period. Because the January 2004 final rule and final order were vacated by the Court, FDA is withdrawing the January 2004 final rule and final order. In a proposed rule and proposed order published concurrently with this document, FDA is providing notice and an opportunity to comment on the Bacterial Vaccine and Toxoids efficacy review.