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Rule

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran

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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.

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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 eight 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 November 5, 2010.

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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.

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SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, a Division of Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has requested that FDA withdraw approval of the eight NADAs listed in Table 1 of this document because they are no longer manufactured or marketed.

Table 1

NADA No.ProductEstablished name of drug(s)
NADA 11-141UNISTAT-2 Type A medicated articlenitromide and sulfanitran.
NADA 14-250NOVASTAT Type A medicated articleaklomide and sulfanitran.
NADA 34-536ALKOMIX Type A medicated article ALKOMIX-3 Type A medicated articleaklomide. aklomide, sulfanitran, and roxarsone.
NADA 34-537NOVASTAT-3 Type A medicated articleaklomide, sulfanitran, and roxarsone.
NADA 35-388NOVASTAT-W Soluble Powderaklomide and sulfanitran.
NADA 39-666UNISTAT-3 Type A medicated articlenitromide, sulfanitran, and roxarsone.
NADA 44-015TRAMISOL Type A medicated articlelevamisole.
NADA 45-455TRAMISOL Type A medicated articlelevamisole.

In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals 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.

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List of Subjects

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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,

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Remove § 520.2320.

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

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3. The authority citation for

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

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4. Remove § 556.30.

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5. Remove § 556.220.

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6. Remove § 556.680.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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7. The authority citation for

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

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8. In § 558.4, in paragraph (d), in the “Category I” table, remove the listing for “Aklomide”; and in the “Category II” table, remove the listings for “Levamisole”, “Nitromide” immediately followed in sequence by “Sulfanitran”, “Nitromide” immediately followed in sequence by “Sulfanitran” and by “Roxarsone”; “Sulfanitran” immediately followed in sequence by “Aklomide”, and the two listings for “Sulfanitran” immediately followed in sequence by “Aklomide” and by “Roxarsone”.

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9. Remove § 558.35.

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10. Remove § 558.315.

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11. Remove § 558.376.

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Dated: October 8, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2010-27011 Filed 10-25-10; 8:45 am]

BILLING CODE 4160-01-P