[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Page 11490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4545]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0033]
Withdrawal of Approval of New Animal Drug Applications;
Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight 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 March 14, 2011.
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: [email protected].
SUPPLEMENTARY INFORMATION: The sponsors in table 1 have requested that
FDA withdraw approval of the three NADAs listed because the products
are no longer manufactured or marketed.
Table 1--Voluntary Requests for Withdrawal of Approval (WOA) of Three
NADAs
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NADA No. product 21 CFR Section
Sponsor (established name of affected (sponsor
drug) drug labeler code)
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First Priority, Inc., 1590 NADA 48-647, 520.1720a (058829).
Todd Farm Dr., Elgin, IL Phenylbutazone
60123. boluses
(phenylbutazone).
Yoder Feed, Division of NADA 96-161, Hy-Con 558.625 (035369).
Yoder, Inc., Kalona, IA TYLAN Premix
52247. (tylosin phosphate).
Triple ``F'', Inc., 10104 NADA 119-062, Cadco- 558.485 (011490).
Douglas Ave., Des Moines, BN-10 BANMINTH
IA 50322. Premix (pyrantel
tartrate).
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Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow),
has informed FDA that it is the sponsor of five feed premix NADAs
previously owned by milling companies, which it purchased. NADA 100-352
was owned by NutriBasics Co., last doing business at P.O. Box 1014,
Willmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco,
Inc., also last doing business at P.O. Box 1014, Willmar, MN 56201.
NADA 133-833 and NADA 135-243 were owned by Southern Micro-Blenders,
Inc., last doing business at 3801 North Hawthorne St., Chattanooga, TN
37406. Truow has requested that FDA withdraw approval of the five NADAs
in table 2 because they are no longer manufactured or marketed.
Table 2--Voluntary Requests for WOA of Five NADAs by Truow Nutrition, Inc.
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NADA No., product (established 21 CFR section affected (sponsor
Previous sponsor name of drug) drug labeler code)
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NutriBasics Co., North Highway 71, P.O. NADA 100-352, Seeco T-10 Premix 558.625 (053740).
Box 1014, Willmar, MN 56201. (tylosin phosphate).
Seeco, Inc., P.O. Box 1014, North NADA 107-002, Seeco TYLAN-Sulfa Not codified.
Highway 71, Willmar, MN 56201. 10 Premix (tylosin phosphate
and sulfamethazine).
Seeco, Inc., P.O. Box 1014, North NADA 123-000, Super Swine Wormer 558.485 (011749).
Highway 71, Willmar, MN 56201. B-9 BANMINTH (pyrantel
tartrate).
Southern Micro-Blenders, Inc., 3801 NADA 133-833, TYLAN 10 Premix 558.625 (049685).
North Hawthorne St., Chattanooga, TN (tylosin phosphate).
37406.
Southern Micro-Blenders, Inc., 3801 NADA 135-243, Swine Guard-BN 558.485 (049685).
North Hawthorne St., Chattanooga, TN BANMINTH Premix (pyrantel
37406. tartrate).
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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
48-647, 96-161, 100-352, 107-002, 119-062, 123-000, 133-833, and 135-
243, and all supplements and amendments thereto, is hereby withdrawn,
effective March 14, 2011.
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: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4545 Filed 3-1-11; 8:45 am]
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