Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate and Sulfamethazine, 55810 [2010-22809]
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Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 7, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
Withdrawal of Approval of New Animal
Drug Applications; Chloramphenicol,
Lincomycin, Pyrantel Tartrate, and
Tylosin Phosphate and Sulfamethazine
Food and Drug Administration
[Docket No. FDA–2010–N–0425]
AGENCY:
[FR Doc. 2010–22844 Filed 9–13–10; 8:45 am]
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ACTION:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new animal drug
applications (NADAs). In a final rule
published elsewhere in this issue of the
Federal Register, FDA is amending the
SUMMARY:
regulations to remove portions reflecting
approval of these NADAs.
DATES: Withdrawal of approval is
effective September 24, 2010.
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.
SUPPLEMENTARY INFORMATION: John J.
Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc.,
7706 ‘‘I’’ Plaza, Omaha, NE 68127; and
Feed Service Co., Inc., 303 Lundin
Blvd., P.O. Box 698, Mankato, MN
56001 have requested that FDA
withdraw approval of the four NADAs
listed in table 1 because they are no
longer manufactured or marketed:
TABLE 1.
Sponsor
21 CFR Cite (Sponsor’s Drug Labeler
Code)
NADA Number Product (Established Name of Drug)
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611
NADA 65–137 AMPHICOL–V Capsules (chloramphenicol)
§ 520.390b (058034)
International Nutrition, Inc., 7706 ‘‘I’’ Plaza,
Omaha, NE 68127
NADA 121–337 INI Swine Ban-Wormer B–9.6 BA.
(pyrantel tartrate)
§ 558.485 (043733)
International Nutrition, Inc., 7706 ‘‘I’’ Plaza,
Omaha, NE 68127
NADA 132–923 LINCO 8/LINCO 20 (lincomycin)
§ 558.325 (043733)
Feed Service Co., Inc., 303 Lundin Blvd.,
P.O. Box 698, Mankato, MN 56001
NADA 138–342 TYLAN 5 Sulfa-G Premix (tylosin
and sulfamethazine)
§ 558.630 (030841)
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 65–137, 121–337, 132–923,
and 138–342, and all supplements and
amendments thereto, is hereby
withdrawn, effective September 24,
2010.
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: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
jlentini on DSKJ8SOYB1PROD with NOTICES
[FR Doc. 2010–22809 Filed 9–13–10; 8:45 am]
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16:38 Sep 13, 2010
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–3315–
EM; Docket ID FEMA–2010–0002]
Massachusetts; Emergency and
Related Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This is a notice of the
Presidential declaration of an
emergency for the Commonwealth of
Massachusetts (FEMA–3315–EM), dated
September 2, 2010, and related
determinations.
DATES: Effective Date: September 2,
2010.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Recovery Directorate,
Federal Emergency Management
Agency, 500 C Street, SW., Washington,
DC 20472, (202) 646–3886.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
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September 2, 2010, the President issued
an emergency declaration under the
authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121–5207
(the Stafford Act), as follows:
I have determined that the emergency
conditions in certain areas of the
Commonwealth of Massachusetts resulting
from Hurricane Earl beginning on September
1, 2010, and continuing, are of sufficient
severity and magnitude to warrant an
emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (‘‘the
Stafford Act’’). Therefore, I declare that such
an emergency exists in the Commonwealth of
Massachusetts.
You are authorized to provide appropriate
assistance for required emergency measures,
authorized under Title V of the Stafford Act,
to save lives and to protect property and
public health and safety, and to lessen or
avert the threat of a catastrophe in the
designated areas. Specifically, you are
authorized to provide assistance for
emergency protective measures (Category B),
including direct Federal assistance, under the
Public Assistance program. This assistance
excludes regular time costs for subgrantees’
regular employees.
Consistent with the requirement that
Federal assistance is supplemental, any
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[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Page 55810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0425]
Withdrawal of Approval of New Animal Drug Applications;
Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate
and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new animal drug applications (NADAs). In a final rule published
elsewhere in this issue of the Federal Register, FDA is amending the
regulations to remove portions reflecting approval of these NADAs.
DATES: Withdrawal of approval is effective September 24, 2010.
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.
SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,
Mankato, MN 56001 have requested that FDA withdraw approval of the four
NADAs listed in table 1 because they are no longer manufactured or
marketed:
Table 1.
------------------------------------------------------------------------
NADA Number Product 21 CFR Cite
Sponsor (Established Name of (Sponsor's Drug
Drug) Labeler Code)
------------------------------------------------------------------------
John J. Ferrante, 11 NADA 65-137 AMPHICOL-V Sec. 520.390b
Fairway Lane, Capsules (058034)
Trumbull, CT 06611 (chloramphenicol)
------------------------------------------------------------------------
International NADA 121-337 INI Swine Sec. 558.485
Nutrition, Inc., 7706 Ban-Wormer B-9.6 BA. (043733)
``I'' Plaza, Omaha, (pyrantel tartrate)
NE 68127
------------------------------------------------------------------------
International NADA 132-923 LINCO 8/ Sec. 558.325
Nutrition, Inc., 7706 LINCO 20 (lincomycin) (043733)
``I'' Plaza, Omaha,
NE 68127
------------------------------------------------------------------------
Feed Service Co., NADA 138-342 TYLAN 5 Sec. 558.630
Inc., 303 Lundin Sulfa-G Premix (tylosin (030841)
Blvd., P.O. Box 698, and sulfamethazine)
Mankato, MN 56001
------------------------------------------------------------------------
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
65-137, 121-337, 132-923, and 138-342, and all supplements and
amendments thereto, is hereby withdrawn, effective September 24, 2010.
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: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
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