Document ID: FDA-1980-N-0049-0093
Agency: fda
Document Type: Notice
Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal
Posted Date: 2005-01-06T05:00Z

[Federal Register: December 29, 2004 (Volume 69, Number 249)]
[Rules and Regulations]               
[Page 78279-78280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de04-17]                         

[[Page 78279]]

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Part V

Department of Health and Human Services

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Food and Drug Administration

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26 CFR Parts 201 and 610

Biological Products; Bacterial Vaccines and Toxoids; Implementation of 
Efficacy Review; Withdrawl; Final Rule and Proposed Rule

[[Page 78280]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 610

[Docket No. 1980N-0208]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule and final order; withdrawal.

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SUMMARY:  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.

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5, 2004), is withdrawn as of December 29, 2004.

FOR FURTHER INFORMATION CONTACT: 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.
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.

    Dated: December 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28459 Filed 12-23-04; 11:16 am]

BILLING CODE 4160-01-S