2010-14611. New Animal Drugs for Use in Animal Feeds; Florfenicol

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 new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the manufacture of florfenicol Type B medicated swine feeds.

DATES:

This rule is effective June 17, 2010.

FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, filed a supplement to NADA 141-264 for use of NUFLOR (florfenicol) Antibiotic Type A Medicated Article for Swine by veterinary feed directive that provides for the manufacture of Type B medicated swine feeds. The supplemental NADA is approved as of May 13, 2010, and the regulations are amended in 21 CFR 558.4 to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

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 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 part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

§ 558.4

[Amended]

2. In paragraph (d) of § 558.4, in the “Category II” table, in the “Type B maximum (100x)” column, in the entry for “Florfenicol”, remove “Swine feed: n/a” and in its place add “Swine feed: 9.1 g/lb (2.0%)”.

Dated: June 14, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.