Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

DATES:

This rule is effective May 17, 2010.

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: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 has requested that FDA withdraw approval of NADA 42-117 for Purina 6 Day Worm-Kill Concentrate (coumaphos) because the product is no longer manufactured or marketed.

In addition, Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has requested that FDA withdraw approval of NADA 45-738 for use of LINCOMIX (lincomycin) and BONAID (buquinolate) single-ingredient Type A medicated articles to make two-way, combination drug Type C medicated broiler feed because buquinolate is no longer manufactured or marketed.

In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 42-117 and NADA 45-738, and all supplements and amendments thereto, is withdrawn, effective May 17, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval.

In 1995, the approval of NADA 34 716 for BONAID Type A medicated article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and approved conditions of use for buquinolate and all its approved combinations in 21 CFR 558.105, including combination with lincomycin under NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this time, the tolerances for residues of buquinolate in edible products of chickens and its listing as a Category I drug in 21 CFR 558.4 are being removed.

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 556

• Animal drugs
• Foods

21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 558 are amended as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

1. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Remove § 556.90.

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.

4. In § 558.4, in paragraph (d), in the “Category I” table, remove the entry for “Buquinolate”.

5. In § 558.185, remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2).