E7-7460. New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine

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.

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.

In a final rule published elsewhere in this issue of the Federal Register, FDA gives notice that approval of NADA 121-200, NADA 129-159, and NADA 137-484 and all supplements and amendments thereto, is withdrawn, effective April 30, 2007.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.

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 558

• Animal drugs
• Animal feeds

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, 21 CFR parts 510 and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

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

§ 510.600

[Amended]

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”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR part 558 continues to read as follows:

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

§ 558.485

[Amended]

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

§ 558.625

[Amended]

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

§ 558.630

[Amended]

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

Dated: April 9, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.