Skip to Content

Rule

New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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 notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.

DATES:

This rule is effective April 30, 2007.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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.

In a final rule published elsewhere in this issue of the Federal Register, FDA gives notice that approval of NADA Start Printed Page 19666121-200, NADA 129-159, and NADA 137-484 and all supplements and amendments thereto, is withdrawn, effective April 30, 2007.

Following the withdrawal of approval of these NADAs, Custom Feed Services Corp. is no longer a sponsor of an approved application. Therefore, 21 CFR 510.600(c) is amended to remove entries for this firm. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Start List of Subjects

List of Subjects

End List of Subjects Start Amendment Part

Therefore, under the Federal Food, Drug and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority
[Amended]
Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Custom Feed Services Corp.”; and in the table in paragraph (c)(2) remove the entry for “017473”.

End Amendment Part Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

3. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b, 371.

End Authority
[Amended]
Start Amendment Part

4. In § 558.485, in paragraph (b)(3), remove “017473”.

End Amendment Part
[Amended]
Start Amendment Part

5. In § 558.625, remove and reserve paragraph (b)(68).

End Amendment Part
[Amended]
Start Amendment Part

6. In § 558.630, in paragraph (b)(10), remove “017473”.

End Amendment Part Start Signature

Dated: April 9, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E7-7460 Filed 4-18-07; 8:45 am]

BILLING CODE 4160-01-S