New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal, 71923 [E8-28093]
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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]
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16:53 Nov 25, 2008
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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
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Fmt 4700
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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]
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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
]]>Agencies
[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.
-----------------------------------------------------------------------
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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