Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine, 71016-71017 [2010-29326]
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Rules and Regulations
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the latter’s regulations or for guidance
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Dated at Arlington, Virginia, November 16,
2010.
Federal Financial Institutions Examination
Council.
Paul Sanford,
Executive Secretary.
[FR Doc. 2010–29282 Filed 11–19–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
[Docket No. FDA–2010–N–0002]
Intramammary Dosage Form New
Animal Drugs; Cloxacillin Benzathine
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplementary new
animal drug application (NADA) filed
by Boehringer Ingelheim Vetmedica,
Inc. The supplement provides for minor
revisions to labeling.
DATES: This rule is effective November
22, 2010.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Highway, St. Joseph,
MO 64506–2002 has filed a supplement
to NADA 55–058 for DRY-CLOX
(cloxacillin benzathine) Intramammary
Infusion for dry dairy cattle. The
supplemental NADA provides for
various minor revisions to labeling. The
supplemental application is approved as
of October 21, 2010, and the regulations
in § 526.464a (21 CFR 526.464a) are
amended to reflect the approval.
In addition, FDA has noticed that
certain portions of § 526.464a were
inadvertently removed when the
regulations were amended to reflect a
change of sponsorship (75 FR 10165,
March 5, 2010). At this time, the
regulations are being amended to reflect
fully the approved conditions of use of
this new animal drug product. This
change is being made to improve the
accuracy of the animal drug regulations.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Rules and Regulations
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 526
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 526 is amended as follows:
■
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 526 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. Revise the heading for part 526 to
read as set forth above.
■
3. In § 526.464a, revise paragraph (c)
to read as follows:
■
§ 526.464a
Cloxacillin benzathine.
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(c) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter for use in
dairy cows.
(1) Amount. Administer aseptically
into each quarter immediately after last
milking.
(2) Indications for use. For the
treatment of mastitis caused by
Staphylococcus aureus and
Streptococcus agalactiae including
penicillin resistant strains in dairy cows
during the dry period.
(3) Limitations. For use in dry cows
only. Not to be used within 30 days of
calving. Animals infused with this
product must not be slaughtered for
food use for 30 days after the latest
infusion. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
Dated: November 16, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
jlentini on DSKJ8SOYB1PROD with RULES
[FR Doc. 2010–29326 Filed 11–19–10; 8:45 am]
BILLING CODE 4160–01–P
33 CFR Part 117
671–2128, e-mail
james.r.wetherington@uscg.mil. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
[Docket No. USCG–2010–0972]
SUPPLEMENTARY INFORMATION:
Drawbridge Operation Regulations;
Bayou Liberty, St. Tammany Parish,
Slidell, LA
Public Participation and Request for
Comments
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
Coast Guard, DHS.
ACTION: Notice of temporary deviation
from regulations; request for comments.
AGENCY:
The Commander, Eighth
Coast Guard District, has issued a
temporary deviation from the regulation
governing the operation of the S433
bridge over Bayou Liberty, mile 2.0, St.
Tammany Parish, Slidell, LA. This
deviation will test a change to the
drawbridge operation schedule to
determine whether a permanent change
to the schedule is needed. It will allow
the bridge to remain unmanned during
most of the day by requiring a two-hour
notice for an opening of the draw. This
deviation will be in conjunction with a
Notice of Proposed Rulemaking to make
this deviation permanent.
DATES: This deviation is effective from
December 7, 2010 through January 6,
2011.
Comments and related material must
be received by the Coast Guard on or
before January 21, 2011.
ADDRESSES: You may submit comments
identified by docket number USCG–
2010–0972 using any one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov.
• Fax: 202–493–2251.
• Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
• Hand delivery: Same as mail
address above, between 9 a.m. and
5 p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
SUMMARY:
If
you have questions on this proposed
rule, call or e-mail Jim Wetherington;
Bridge Administration Branch, Eighth
Coast Guard District, telephone 504–
FOR FURTHER INFORMATION CONTACT:
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We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted,
without change, to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking (USCG–2010–0972),
indicate the specific section of this
document to which each comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online (https://
www.regulations.gov), or by fax, mail or
hand delivery, but please use only one
of these means. If you submit a
comment online via https://
www.regulations.gov, it will be
considered received by the Coast Guard
when you successfully transmit the
comment. If you fax, hand deliver, or
mail your comment, it will be
considered as having been received by
the Coast Guard when it is received at
the Docket Management Facility. We
recommend that you include your name
and a mailing address, an e-mail
address, or a phone number in the body
of your document so that we can contact
you if we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, click on the
‘‘submit a comment’’ box, which will
then become highlighted in blue. In the
‘‘Keyword’’ box insert ‘‘USCG–2010–
0972,’’ click ‘‘Search,’’ and then click on
the balloon shape in the ‘‘Actions’’
column. If you submit your comments
by mail or hand delivery, submit them
in an unbound format, no larger than
81⁄2 by 11 inches, suitable for copying
and electronic filing. If you submit them
by mail and would like to know that
they reached the Facility, please enclose
a stamped, self-addressed postcard or
envelope. We will consider all
comments and material received during
the comment period and may change
the rule based on your comments.
E:\FR\FM\22NOR1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Rules and Regulations]
[Pages 71016-71017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29326]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
[Docket No. FDA-2010-N-0002]
Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplementary new animal drug
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The
supplement provides for minor revisions to labeling.
DATES: This rule is effective November 22, 2010.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002 has filed a supplement to
NADA 55-058 for DRY-CLOX (cloxacillin benzathine) Intramammary Infusion
for dry dairy cattle. The supplemental NADA provides for various minor
revisions to labeling. The supplemental application is approved as of
October 21, 2010, and the regulations in Sec. 526.464a (21 CFR
526.464a) are amended to reflect the approval.
In addition, FDA has noticed that certain portions of Sec.
526.464a were inadvertently removed when the regulations were amended
to reflect a change of sponsorship (75 FR 10165, March 5, 2010). At
this time, the regulations are being amended to reflect fully the
approved conditions of use of this new animal drug product. This change
is being made to improve the accuracy of the animal drug regulations.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required. The Agency has
determined under 21 CFR 25.33 that this action is of a type that does
not individually or cumulatively have a significant effect on the human
environment. Therefore, neither an environmental assessment
[[Page 71017]]
nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 526
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 526 is
amended as follows:
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise the heading for part 526 to read as set forth above.
0
3. In Sec. 526.464a, revise paragraph (c) to read as follows:
Sec. 526.464a Cloxacillin benzathine.
* * * * *
(c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter for
use in dairy cows.
(1) Amount. Administer aseptically into each quarter immediately
after last milking.
(2) Indications for use. For the treatment of mastitis caused by
Staphylococcus aureus and Streptococcus agalactiae including penicillin
resistant strains in dairy cows during the dry period.
(3) Limitations. For use in dry cows only. Not to be used within 30
days of calving. Animals infused with this product must not be
slaughtered for food use for 30 days after the latest infusion. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Dated: November 16, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-29326 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P
