Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide, 36241 [E9-17408]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices
Contact Person For More Information:
Wendy Vance, HICPAC, Division of
Healthcare Quality Promotion, NCPDCID,
CDC, 1600 Clifton Road, NE., Mailstop D–10,
Atlanta, Georgia 30333 Telephone (404) 639–
2891 or HICPAC@cdc.gov.
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: July 17, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office,Centers for Disease Control and
Prevention (CDC).
[FR Doc. E9–17514 Filed 7–21–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0302]
Withdrawal of Approval of New Animal
Drug Applications; Ketamine; S–
Methoprene; Nitazoxanide
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of two new animal drug
applications (NADAs) and an
abbreviated new animal drug
application (ANADA) listed in table 1 of
this document. In a final rule published
36241
elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to remove portions
reflecting approval of these NADAs and
ANADA.
DATES: Withdrawal of approval is
effective August 3, 2009.
FOR FURTHER INFORMATION CONTACT: John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov.
The
following sponsors have requested that
FDA withdraw approval of the two
NADAs and ANADA listed in table 1 of
this document because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
TABLE 1.
Sponsor
NADA/ANADA Number
Product (Drug)
21 CFR Cite Affected
(Sponsor Drug Labeler Code)
Wellmark International, 1501 East Woodfield
Rd., suite 200, West Schaumburg, IL 60173
NADA 141–162
Zodiac Fleatrol Flea Caps (S-methoprene)
520.1390 (011536)
NADA 141–178
NAVIGATOR Paste (nitazoxanide)
520.1498 (065274)
ANADA 200–279
KETAFLO Injection (ketamine HCl, USP)
522.1222a (000074)
IDEXX Pharmaceuticals, Inc., 7009 Albert
Pick Rd., Greensboro, NC 27409
Abbott Laboratories, North Chicago, IL 60064
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 141–162 and 141–178, and
ANADA 200–279, and all supplements
and amendments thereto, are hereby
withdrawn, effective August 3, 2009.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
these NADAs.
Dated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–17408 Filed 7–21–09; 8:45 am]
jlentini on DSKJ8SOYB1PROD with NOTICES
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:04 Jul 21, 2009
Jkt 217001
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0095; No
Form.
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a proposed revision of a
currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
Notice seeks comments concerning the
process for the appeal of decisions of
flood insurance claims issued through
the National Flood Insurance Program
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
(NFIP). The appeal process establishes a
formal mechanism to allow
policyholders to appeal the decisions of
any insurance agent, adjuster, insurance
company, or any FEMA employee or
contractor, in cases or unsatisfactory
decisions on claims, proof of loss, and
loss estimates.
DATES: Comments must be submitted on
or before September 21, 2009.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:
(1) Online. Submit comments at
https://www.regulations.gov under
docket ID FEMA–2009–0001. Follow the
instructions for submitting comments.
(2) Mail. Submit written comments to
Office of Chief Counsel, Regulation and
Policy Team, DHS/FEMA, 500 C Street,
SW., Room 835, Washington, DC 20472–
3100.
(3) Facsimile. Submit comments to
(703) 483–2999.
(4) E-mail. Submit comments to
FEMA-POLICY@dhs.gov. Include docket
ID FEMA–2009–0001 in the subject line.
All submissions received must
include the agency name and docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 74, Number 139 (Wednesday, July 22, 2009)]
[Notices]
[Page 36241]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0302]
Withdrawal of Approval of New Animal Drug Applications; Ketamine;
S-Methoprene; Nitazoxanide
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADAs) and an abbreviated new
animal drug application (ANADA) listed in table 1 of this document. In
a final rule published elsewhere in this issue of the Federal Register,
FDA is amending the animal drug regulations to remove portions
reflecting approval of these NADAs and ANADA.
DATES: Withdrawal of approval is effective August 3, 2009.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the two NADAs and ANADA listed in table 1 of
this document because the products are no longer manufactured or
marketed:
Table 1.
------------------------------------------------------------------------
21 CFR Cite Affected
Sponsor NADA/ANADA Number (Sponsor Drug Labeler
Product (Drug) Code)
------------------------------------------------------------------------
Wellmark International, NADA 141-162 520.1390 (011536)
1501 East Woodfield Zodiac Fleatrol Flea
Rd., suite 200, West Caps (S-methoprene)
Schaumburg, IL 60173
------------------------------------------------------------------------
IDEXX Pharmaceuticals, NADA 141-178 520.1498 (065274)
Inc., 7009 Albert Pick NAVIGATOR Paste
Rd., Greensboro, NC (nitazoxanide)
27409
------------------------------------------------------------------------
Abbott Laboratories, ANADA 200-279 522.1222a (000074)
North Chicago, IL KETAFLO Injection
60064 (ketamine HCl, USP)
------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
141-162 and 141-178, and ANADA 200-279, and all supplements and
amendments thereto, are hereby withdrawn, effective August 3, 2009.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these NADAs.
Dated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17408 Filed 7-21-09; 8:45 am]
BILLING CODE 4160-01-S
