[Federal Register: April 19, 2007 (Volume 72, Number 75)]
[Notices]               
[Page 19716]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap07-38]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0077]

 
Withdrawal of Approval of New Animal Drug Applications; Pyrantel; 
Tylosin; Tylosin and Sulfamethazine

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of three new animal drug applications (NADAs) for intermediate 
premixes used to manufacture Type C medicated feeds. 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.

FOR FURTHER INFORMATION CONTACT:  Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: 
pamela.esposito@fda.hhs.gov.


SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th 
St., Norfolk, NE 68701, has requested that FDA withdraw approval of 
NADA 121-200 for Tylosin 10 Premix (tylosin), NADA 129-159 for TYLAN 40 
Sulfa-G (tylosin and sulfamethazine), and NADA 137-484 for Swine Guard-
BN (pyrantel). All are intermediate premixes used to manufacture Type C 
medicated feeds. This action is requested because the products are no 
longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.115 Withdrawal of approval of applications, 
notice is given that approval of NADA 121-200, NADA 129-159, and NADA 
137-484, and all supplements and amendments thereto, are hereby 
withdrawn, effective April 30, 2007.
    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: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7461 Filed 4-18-07; 8:45 am]

BILLING CODE 4160-01-S