E7-7461. Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [e-mail].

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that approval of NADA 121-200, NADA 129-159, and NADA 137-484, and all supplements and amendments thereto, are hereby withdrawn, effective April 30, 2007.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.