E6-20398. 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 new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of a florfenicol Type A medicated article by veterinary feed directive to formulate swine feed used for the control of respiratory disease.

DATES:

This rule is effective December 4, 2006.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-264 that provides for use of NUFLOR (florfenicol), an antibiotic, a Type A medicated article by veterinary feed directive to formulate Type C medicated feeds used for the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD. The NADA is approved as of November 3, 2006, and the regulations are amended in 21 CFR 558.4 and 558.261 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning November 3, 2006.

The agency has determined under 21 CFR 25.33(d)(5) 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.

2. In paragraph (d) of § 558.4, in the “Category II” table, revise the entry for “Florfenicol” to read as follows:

§ 558.4

Requirement of a medicated feed mill license.

(d) * * *

CATEGORY II

Drug	Assay limits percent1 Type A	Type B maximum (100x)	Assay limits percent1 Type B/C2
*         *         *         *         *         *         *
Florfenicol	90-110	Swine feed: n/a	Swine feed: 85-115
		Catfish feed: n/a	Catfish feed: 80-110
*         *         *         *         *         *         *
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

3. In § 558.261, revise paragraphs (a) and (c)(2); redesignate paragraph (e)(1) as paragraph (e)(2); and add new paragraphs (c)(3) and (e)(1) to read as follows:

§ 558.261

Florfenicol.

(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:

(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.

(2) 500 grams per kilogram for use as in paragraph (e)(2) of this section.

(c) * * *

(2) The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds:

(i) For catfish must not exceed 15 days from the date of issuance;

(ii) For swine must not exceed 90 days from the date of issuance.

(3) VFDs for florfenicol shall not be refilled.

(e) * * *

(1) Swine—(i) Amount. Feed 182 grams per ton of feed (200 parts per million) continuously as the sole ration for 5 days.

(ii) Indications for use. For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.

(iii) Limitations. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation has not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter.

Dated: November 17, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.