Notice of Approval of Supplemental New Animal Drug Application; Ivermectin and Praziquantel Paste, 70079 [05-22941]
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Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Notices
70079
FEE SCHEDULE JANUARY 1, 2006–SEPTEMBER 30, 2006
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Notice of Approval of Supplemental
New Animal Drug Application;
Ivermectin and Praziquantel Paste
Food and Drug Administration,
HHS.
ACTION:
<3,001
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15,001–30,000
30,001–60,000
>60,000
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7,800
10,400
register tonnage in cubic feet, as shown in Lloyd’s Register of Shipping.
Inspections and reinspections involve the
same procedure, require the same amount of
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rate.
[FR Doc. 05–22967 Filed 11–18–05; 8:45 am]
AGENCY:
Fee
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved a
supplemental new animal drug
application (NADA) filed by Merial, Ltd.
The NADA provides for oral use of an
ivermectin and praziquantel paste as an
over-the-counter product for the
treatment and control of various
parasitic conditions of horses. This
supplemental NADA reduces the
minimum age for administration from 5
months to 2 months of age.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Merial,
Ltd., 3239 Satellite Blvd., bldg. 500,
Duluth, GA 30096–4640, filed a
supplement to NADA 141–214 for
ZIMECTERIN GOLD (ivermectin 1.55%/
praziquantel 7.75%) Paste, an over-thecounter product used for the oral
treatment and control of various
parasitic conditions of horses. This
supplemental NADA reduces the
minimum age for administration from 5
months to 2 months of age. In
accordance with section 512(i) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(i)) and part 514
(21 CFR part 514) in §§ 514.105(a) and
514.106(a), the Center for Veterinary
Medicine is providing notice that this
VerDate Aug<31>2005
15:51 Nov 18, 2005
Jkt 208001
supplemental NADA is approved as of
October 28, 2005. The basis of approval
is discussed in the freedom of
information summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and § 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(d)(1) 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.
Dated: November 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–22941 Filed 11–18–05; 8:45 am]
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, Gene Therapy
Clinical Trial.
Date: November 21, 2005.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Gateway Hotel Los Angeles
Airport, 6101 W Century Blvd., Los Angeles,
CA 90045.
Contact Person: Samuel Rawlings, PhD,
Chief, Scientific Review Branch, Division of
Extramural Research, National Eye Institute,
5635 Fishers Lane, Suite 1300, MSC 9300,
Bethesda, MD 20892–9300, 301–451–2020.
(Catalogue of Federal Domestic
Assistance Program No. 93.867, Vision
Research, National Institutes of Health,
HHS)
Dated: November 14, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–22932 Filed 11–18–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
National Institutes of Health
DEPARTMENT OF HEALTH AND
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National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors, NHLBI.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual grant
applications conducted by the National
Heart, Lung, and Blood Institute,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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Name of Committee: Board of Scientific
Counselors, NHLBI.
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]]>Agencies
[Federal Register Volume 70, Number 223 (Monday, November 21, 2005)]
[Notices]
[Page 70079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22941]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Notice of Approval of Supplemental New Animal Drug Application;
Ivermectin and Praziquantel Paste
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice
that it has approved a supplemental new animal drug application (NADA)
filed by Merial, Ltd. The NADA provides for oral use of an ivermectin
and praziquantel paste as an over-the-counter product for the treatment
and control of various parasitic conditions of horses. This
supplemental NADA reduces the minimum age for administration from 5
months to 2 months of age.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail:
melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Merial, Ltd., 3239 Satellite Blvd., bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-214 for
ZIMECTERIN GOLD (ivermectin 1.55%/praziquantel 7.75%) Paste, an over-
the-counter product used for the oral treatment and control of various
parasitic conditions of horses. This supplemental NADA reduces the
minimum age for administration from 5 months to 2 months of age. In
accordance with section 512(i) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(i)) and part 514 (21 CFR part 514) in
Sec. Sec. 514.105(a) and 514.106(a), the Center for Veterinary
Medicine is providing notice that this supplemental NADA is approved as
of October 28, 2005. The basis of approval is discussed in the freedom
of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and Sec. 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(d)(1) 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.
Dated: November 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-22941 Filed 11-18-05; 8:45 am]
BILLING CODE 4160-01-S
