New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal, 71923 [E8-28093]

Download as PDF Federal Register / Vol. 73, No. 229 / Wednesday, November 26, 2008 / Rules and Regulations PART 270—RULES AND REGULATIONS, INVESTMENT COMPANY ACT OF 1940 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1. The authority citation for Part 270 is amended by adding the following citation to read as follows: ■ 21 CFR Part 530 [Docket No. FDA–2008–N–0326] Authority: 15 U.S.C. 80a–1 et seq., 80a– 34(d), 80a–37, and 80a–39, unless otherwise noted. * * * * * Section 270.22e–3T is also issued under 15 U.S.C. 80a–6(c) and 80a–37(a). * * * * * 2. Section 270.22e–3T is added to read as follows: ■ § 270.22e–3T Temporary exemption for liquidation of certain money market funds. (a) A registered investment company, or a series thereof (‘‘fund’’), is exempt from the requirements of section 22(e) of the Act (15 U.S.C. 80a–22(e)) if: (1) The fund has a currently effective agreement (‘‘Agreement’’) with the U.S. Department of the Treasury (‘‘Treasury’’) to participate in the Temporary Guaranty Program for Money Market Funds (‘‘Program’’); (2) The fund has delivered to Treasury a notice indicating that it has experienced a guarantee event, and will promptly commence liquidation of the fund under the terms of the Agreement; and (3) The fund has not cured the guarantee event as provided under the terms of the Agreement. (b) For the protection of security holders of a fund, the Commission may issue an order to rescind or modify the exemption provided by this section as to that fund, after appropriate notice and opportunity for hearing in accordance with section 40 of the Act (15 U.S.C. 80a–39). (c) This section will expire on October 18, 2009, unless the Commission publishes a notice in the Federal Register announcing an earlier termination date in connection with termination of the Guaranty Program. mstockstill on PROD1PC66 with RULES Dated: November 20, 2008. By the Commission. Florence E. Harmon, Acting Secretary. [FR Doc. E8–28050 Filed 11–25–08; 8:45 am] BILLING CODE 8011–01–P VerDate Aug<31>2005 16:53 Nov 25, 2008 Jkt 217001 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. 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, email: 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 § 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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 71923 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 § 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 § 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 § 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] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2008–0984] RIN 1625–AA00 Safety Zone, Bayfront Park New Year’s Eve Celebration, Biscayne Bay, FL AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a Safety Zone east of the Intracoastal Waterway at the Port of Miami, Florida for the Bayfront Park New Year’s Eve Ceremony. This temporary zone is intended to restrict vessels from entering waters within the zone unless specifically authorized by the Captain of the Port Miami, Florida, or a designated representative. This rule is necessary to provide for the safety of life on the navigable waters of the United States, and protect participants, spectators, and mariner traffic from potential hazards associated with E:\FR\FM\26NOR1.SGM 26NOR1

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[Federal Register Volume 73, Number 229 (Wednesday, November 26, 2008)]
[Rules and Regulations]
[Page 71923]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28093]


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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]
BILLING CODE 4160-01-S