Federal Register: November 26, 2008 (Volume 73, Number 229)
DOCID: fr26no08-6 FR Doc E8-28093
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 530
Docket ID: [Docket No. FDA-2008-N-0326]
NOTICE: RULES
DOCID: fr26no08-6
DOCUMENT ACTION: Final rule; withdrawal.
SUBJECT CATEGORY:
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal
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which the effective date was delayed until November 30, 2008, in a document published August 18, 2008 (73 FR 48127), is withdrawn.
DOCUMENT SUMMARY:
The Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in foodproducing 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.
SUMMARY:
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal,
SUPPLEMENTAL 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 foodproducing animals, with a 60 day comment period and a 90day 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 foodproducing animals as provided for in 21 CFR 530.25(f).
In response to publication of this order, the agency received requests for a 60day extension of the comment period. The requests conveyed concern that the original 60day 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. E828093 Filed 112508; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Neal Bataller, Center for Veterinary Medicine (HFV230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD, 20855, 2402769200, email: neal.bataller@fda.hhs.gov.