Oral Dosage Form New Animal Drugs; Amprolium, 40808 [2011-17465]
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40808
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Rules and Regulations
Dated: July 1, 2011.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
9 a.m. and 4 p.m., Monday through
Friday.
FDA 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 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.
[FR Doc. 2011–17494 Filed 7–11–11; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2011–N–0003]
Oral Dosage Form New Animal Drugs;
Amprolium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Cross Vetpharm Group Ltd. The
original ANADA provides for the use of
amprolium soluble powder for the
treatment of coccidiosis in chickens and
turkeys.
DATES: This rule is effective July 12,
2011.
SUMMARY:
John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–488 for the use of
AMPROMED–P (amprolium) for
poultry, a water-soluble powder used
for the treatment of coccidiosis in
chickens and turkeys. Cross Vetpharm
Group Ltd.’s AMPROMED–P for Poultry
is approved as a generic copy of
Huvepharma AD’s AMPROL 128
(amprolium) 20% Soluble Powder,
approved under NADA 33–165. The
ANADA is approved as of May 23, 2011,
and the regulations in 21 CFR 520.100
are amended to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between
jdjones on DSK8KYBLC1PROD with RULES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:10 Jul 11, 2011
Jkt 223001
List of Subjects in 21 CFR Part 520
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 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 520.100, paragraph (b)(4) is
revised to read as follows:
■
§ 520.100
Amprolium.
*
*
*
*
*
(b) * * *
(4) No. 061623 for use of product
described in paragraph (a)(2) of this
section as in paragraphs (d)(1) and (d)(2)
of this section.
*
*
*
*
*
Dated: June 30, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–17465 Filed 7–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2011–0507]
RIN 1625–AA00
Safety Zones; Fireworks Within the
Sector Boston Captain of the Port
Zone
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing temporary safety zones
SUMMARY:
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
within the Sector Boston Captain of the
Port (COTP) Zone for various fireworks
displays. These safety zones are
necessary to provide for the safety of life
on navigable waters during these
fireworks events. Entering into,
transiting through, mooring or
anchoring within these zones is
prohibited unless authorized by the
COTP or the designated on-scene
representative.
DATES: This rule is effective in the CFR
on July 12, 2011 through 11:59 p.m.
September 9, 2011. This rule is effective
with actual notice for purposes of
enforcement beginning at 8:30 p.m. June
27, 2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2011–
0507 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–0507 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ They
are also available for inspection or
copying at the 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,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call or e-mail MST1 David Labadie
of the Waterways Management Division,
U.S. Coast Guard Sector Boston;
telephone 617–223–3010, e-mail
david.j.labadie@uscg.mil. If you have
questions on viewing material related to
the docket, call Renee V. Wright,
Program Manager, Docket Operations,
telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule. The safety
zones listed in this rule are associated
with annual fireworks events. The Coast
Guard intends to make these safety
zones permanent regulations and has
submitted a NPRM for submission to the
Federal Register requesting public
E:\FR\FM\12JYR1.SGM
12JYR1
]]>Agencies
[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Rules and Regulations]
[Page 40808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17465]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2011-N-0003]
Oral Dosage Form New Animal Drugs; Amprolium
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original abbreviated new
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The
original ANADA provides for the use of amprolium soluble powder for the
treatment of coccidiosis in chickens and turkeys.
DATES: This rule is effective July 12, 2011.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-488 for the use of
AMPROMED-P (amprolium) for poultry, a water-soluble powder used for the
treatment of coccidiosis in chickens and turkeys. Cross Vetpharm Group
Ltd.'s AMPROMED-P for Poultry is approved as a generic copy of
Huvepharma AD's AMPROL 128 (amprolium) 20% Soluble Powder, approved
under NADA 33-165. The ANADA is approved as of May 23, 2011, and the
regulations in 21 CFR 520.100 are amended to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA 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
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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.100, paragraph (b)(4) is revised to read as follows:
Sec. 520.100 Amprolium.
* * * * *
(b) * * *
(4) No. 061623 for use of product described in paragraph (a)(2) of
this section as in paragraphs (d)(1) and (d)(2) of this section.
* * * * *
Dated: June 30, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-17465 Filed 7-11-11; 8:45 am]
BILLING CODE 4160-01-P
