[Federal Register Volume 73, Number 160 (Monday, August 18, 2008)]
[Rules and Regulations]
[Page 48127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18967]
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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: [email protected].
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