2011-7216. New Animal Drugs; Oxytetracycline

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and fingerlings.

DATES:

This rule is effective March 28, 2011.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed a supplement to ANADA 200-026 that provides for use of PENNOX 343 (oxytetracycline HCl) Soluble Powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and fingerlings by immersion. The supplemental ANADA is approved as of December 6, 2010, and the regulations in 21 CFR 520.1660d and 529.1660 are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 in 21 CFR Parts 520 and 529

• Animal drugs

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 and 529 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.

§ 520.1660d

[Amended]

2. In paragraph (b)(6) of § 520.1660d, remove “cattle, and sheep” and in its place add “cattle, sheep, and honey bees.”

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 529 continues to read as follows:

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

§ 529.1660

[Amended]

4. In paragraph (b)(2) of § 529.1660, remove “Nos. 000069 and 059130” and in its place add “Nos. 000069, 048164, and 059130”.

Dated: March 23, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.