Document ID: FDA-2008-N-0326-0049
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition; Extension of Comment Period; Delay of Effective Date of Final Rule
Posted Date: 2008-08-18T04:00Z

[Federal Register: August 18, 2008 (Volume 73, Number 160)]
[Rules and Regulations]               
[Page 48127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au08-4]                         

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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; Order of Prohibition; Extension of Comment Period; Delay of 
Effective Date of Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Extension of comment period; delay of effective date of final 
rule.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
November 1, 2008, the comment period for the order of prohibition. FDA 
is also delaying the effective date of this final rule to November 30, 
2008. In the final rule, FDA requested comments on the document. The 
agency is taking this action in response to requests for an extension 
to allow additional time to submit comments.

DATES: The effective date of the rule amending 21 CFR 530.41 published 
at 73 FR 38110, July 3, 2008 is delayed until November 30, 2008. Submit 
written and electronic comments by November 1, 2008.

ADDRESSES: You may submit comments, identified by [Docket No. FDA-2008-
N-0326], by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Request for Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

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:

I. Background

    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 rule.
    The agency has received requests for a 60-day extension of the 
comment period for the order of prohibition. The requests conveyed 
concern that the current 60-day comment period does not allow 
sufficient time to examine the available evidence, consider the impact 
of the ruling, and provide constructive comment.
    FDA has considered the requests and is extending the comment period 
for the order for 60 days, until November 1, 2008. Accordingly, FDA is 
also delaying the effective date of the final rule 60 days, until 
November 30, 2008. The agency believes that a 60-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying implementation of the final rule.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: July 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18967 Filed 8-15-08; 8:45 am]

BILLING CODE 4160-01-S