2010-27011. Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran

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.

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: [e-mail].

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11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010.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

21 CFR Part 520

• Animal drugs

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 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

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

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

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.

Dated: October 8, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.