Skip to Content


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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 78280


Food and Drug Administration, HHS.


Final rule and final order; 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.


The final rule and final order published at 69 FR 255 (January 5, 2004), is withdrawn as of December 29, 2004.

Start Further Info


Astrid Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

End Further Info

AUTHORITY: Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the final rule and final order published on January 5, 2004 (69 FR 255) is withdrawn.

Start Signature

Dated: December 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Preamble

[FR Doc. 04-28459 Filed 12-23-04; 11:16 am]