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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

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.

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

This rule is effective November 5, 2010.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

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 Back to Top
NADA No. Product Established name of drug(s)
NADA 11-141 UNISTAT-2 Type A medicated article nitromide and sulfanitran.
NADA 14-250 NOVASTAT Type A medicated article aklomide and sulfanitran.
NADA 34-536 ALKOMIX Type A medicated article ALKOMIX-3 Type A medicated article aklomide. aklomide, sulfanitran, and roxarsone.
NADA 34-537 NOVASTAT-3 Type A medicated article aklomide, sulfanitran, and roxarsone.
NADA 35-388 NOVASTAT-W Soluble Powder aklomide and sulfanitran.
NADA 39-666 UNISTAT-3 Type A medicated article nitromide, sulfanitran, and roxarsone.
NADA 44-015 TRAMISOL Type A medicated article levamisole.
NADA 45-455 TRAMISOL Type A medicated article levamisole.

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NADA 11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010.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.

List of Subjects Back to Top

begin regulatory text

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 520, 556, and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top

1.The authority citation for 21 CFR part 520 continues to read as follows:

Authority:

21 U.S.C. 360b.

§ 520.2320 [Removed]

2.Remove § 520.2320.

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

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

Authority:

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

§ 556.30 [Removed]

4.Remove § 556.30.

§ 556.220 [Removed]

5.Remove § 556.220.

§ 556.680 [Removed]

6.Remove § 556.680.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Back to Top

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

Authority:

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

§ 558.4 [Amended]

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”.

§ 558.35 [Removed]

9.Remove § 558.35.

§ 558.315 [Removed]

10.Remove § 558.315.

§ 558.376 [Removed]

11.Remove § 558.376.

end regulatory text

Dated: October 8, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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

BILLING CODE 4160-01-P

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