Notice of Approval of Supplemental New Animal Drug Application; Moxidectin, 32586 [08-1329]
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Federal Register / Vol. 73, No. 111 / Monday, June 9, 2008 / Notices
Analysis and Services Office, CDC pursuant
to Public Law 92–463. Agenda items are
subject to change as priorities dictate.
Contact Person for More Information: Ms.
Amy Harris, Executive Secretary, ACIPC,
NCIPC, CDC, 4770 Buford Highway, NE., M/
S F–63, Atlanta, Georgia 30341–3724,
telephone (770) 488–4936.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 3, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–12892 Filed 6–6–08; 8:45 am]
Services Office, Centers for Disease Control
and Prevention, pursuant to Section 10(d)
Public Law 92–463.
Matters To Be Discussed: The meeting will
convene to address matters related to the
conduct of Study Section business and to
consider Safety and Occupational HealthRelated Grant Applications.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Price
Connor, PhD, NIOSH Health Scientist, 1600
Clifton Road, NE., Mailstop E–20, Atlanta,
Georgia 30333, Telephone (404) 498–2511,
Fax (404) 498–2571.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: May 30, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–12793 Filed 6–6–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
Safety and Occupational Health Study
Section (SOHSS), National Institute for
Occupational Safety and Health,
(NIOSH)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Times and Dates:
8 a.m.–5 p.m., June 26, 2008 (Closed);
8 a.m.–5 p.m., June 27, 2008 (Closed).
Place: Embassy Suites Hotel, 1900
Diagonal Road, Alexandria, Virginia 22314,
Telephone (703) 684–5900, Fax (703) 684–
1403.
Purpose: The Safety and Occupational
Health Study Section will review, discuss,
and evaluate grant application(s) received in
response to the Institute’s standard grants
review and funding cycles pertaining to
research issues in occupational safety and
health, and allied areas.
It is the intent of NIOSH to support broadbased research endeavors in keeping with the
Institute’s program goals. This will lead to
improved understanding and appreciation for
the magnitude of the aggregate health burden
associated with occupational injuries and
illnesses, as well as to support more focused
research projects, which will lead to
improvements in the delivery of occupational
safety and health services, and the
prevention of work-related injury and illness.
It is anticipated that research funded will
promote these program goals.
These portions of the meeting will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5 U.S.C., and the Determination of
the Director, Management Analysis and
VerDate Aug<31>2005
18:05 Jun 06, 2008
Jkt 214001
Food and Drug Administration
Notice of Approval of Supplemental
New Animal Drug Application;
Moxidectin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: June 2, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 08–1329 Filed 6–5–08; 12:00 pm]
BILLING CODE 4160–01–S
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved a
supplemental new animal drug
application (NADA) filed by Fort Dodge
Animal Health, Division of Wyeth. The
approved NADA provides for the
veterinary prescription use of a
sustained-release injectable moxidectin
formulation for prevention of
heartworm disease and treatment of
existing hookworm infections in dogs.
The supplemental NADA adds animal
safety information to product labeling.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed a supplement to NADA
141–189 that provides for veterinary
prescription use of PROHEART 6
(moxidectin) Sustained Release
PO 00000
Injectable for Dogs, used for prevention
of heartworm disease and treatment of
existing hookworm infections. The
supplemental NADA updates the
warning, precaution, adverse reactions,
and post-approval experience sections
of product labeling. In accordance with
section 512(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(i))
and 21 CFR 514.105(a) and 514.106(a),
the Center for Veterinary Medicine is
providing notice that this supplemental
NADA is approved as of May 23, 2008.
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.
The agency 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.
Frm 00039
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 25, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 73, Number 111 (Monday, June 9, 2008)]
[Notices]
[Page 32586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1329]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Notice of Approval of Supplemental New Animal Drug Application;
Moxidectin
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 Fort Dodge Animal Health, Division of Wyeth. The approved NADA
provides for the veterinary prescription use of a sustained-release
injectable moxidectin formulation for prevention of heartworm disease
and treatment of existing hookworm infections in dogs. The supplemental
NADA adds animal safety information to product labeling.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA
141-189 that provides for veterinary prescription use of PROHEART 6
(moxidectin) Sustained Release Injectable for Dogs, used for prevention
of heartworm disease and treatment of existing hookworm infections. The
supplemental NADA updates the warning, precaution, adverse reactions,
and post-approval experience sections of product labeling. In
accordance with section 512(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), the
Center for Veterinary Medicine is providing notice that this
supplemental NADA is approved as of May 23, 2008.
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.
The agency 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: June 2, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 08-1329 Filed 6-5-08; 12:00 pm]
BILLING CODE 4160-01-S
