Document ID: FDA-2008-N-0326-0176
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal
Posted Date: 2008-11-26T05:00Z

[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Rules and Regulations]               
[Page 71923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no08-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 530

[Docket No. FDA-2008-N-0326]

 
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug 
Use; Revocation of Order of Prohibition; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the order 
prohibiting the extralabel use of cephalosporin antimicrobial drugs in 
food-producing animals. FDA received many substantive comments on the 
order of prohibition. The agency is taking this action so that it may 
fully consider these comments.

DATES: Effective November 26, 2008, the final rule published July 3, 
2008 (73 FR 38110), for which the effective date was delayed until 
November 30, 2008, in a document published August 18, 2008 (73 FR 
48127), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD, 20855, 240-276-9200, e-mail: neal.bataller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 3, 2008 (73 
FR 38110), FDA published an order prohibiting the extralabel use of 
cephalosporin antimicrobial drugs in food-producing animals, with a 60-
day comment period and a 90-day effective date for the final order. The 
order, that was to take effect on November 30, 2008, would have 
resulted in a change to Sec.  530.41 (21 CFR 530.41) to list 
cephalosporins as prohibited from extralabel use in food-producing 
animals as provided for in 21 CFR 530.25(f).
    In response to publication of this order, the agency received 
requests for a 60-day extension of the comment period. The requests 
conveyed concern that the original 60-day comment period would not 
allow the requesters sufficient time to examine the available evidence, 
consider the impact of the order, and provide constructive comment.
    FDA considered the requests and, in the Federal Register of August 
18, 2008 (73 FR 48127), extended the comment period for the order for 
60 days, until November 1, 2008. Accordingly, FDA also delayed the 
effective date of the final rule 60 days, until November 30, 2008.
    The agency received many substantive comments on the order of 
prohibition. Therefore, to allow more time to fully consider the 
comments, FDA has decided to revoke the order so that it does not take 
effect November 30, 2008. This means that neither the order nor the 
change to Sec.  530.41 that would have listed cephalosporins as 
prohibited from extralabel use will take effect on November 30, 2008. 
If, after considering the comments and other relevant information, FDA 
decides to issue another order of prohibition addressing this matter, 
FDA will follow the procedures in 21 CFR 530.25 that provide for a 
public comment period prior to implementing the order.
    We note that, insofar as withdrawal of the amendment to Sec.  
530.41 might be considered a rule subject to 5 U.S.C. 553(b), the 
agency for good cause finds that prior notice and comment procedures 
are unnecessary because there is no need to amend Sec.  530.41 since 
the order is being revoked.

    Dated: November 21, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-28093 Filed 11-25-08; 8:45 am]

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