E6-15889. Oral Dosage Form New Animal Drugs; Neomycin

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 an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate soluble powder in livestock for the treatment and control of bacterial enteritis.

DATES:

This rule is effective September 28, 2006.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, filed ANADA 200-378 for the use of Neomycin Soluble Powder in cattle, swine, sheep, goats, and turkeys for the treatment and control of bacterial enteritis. Sparhawk Laboratories, Inc.'s Neomycin Soluble Powder is approved as a generic copy of NEOMIX 325 (neomycin sulfate) Soluble Powder, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 11-315. The ANADA is approved as of August 31, 2006, and the regulations in 21 CFR 520.1484 and 520.1485 are amended to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

In addition, a label statement warning against the use of these products in calves to be processed for veal was not codified at the time supplemental NADAs or ANADAs for oral neomycin products were approved. At this time, FDA is amending the animal drug regulations to reflect required food safety warning statements.

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.

FDA has determined under 21 CFR 25.33(a)(1) 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 520

• 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 part 520 is 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.

2. Revise § 520.1484 to read as follows:

§ 520.1484

Neomycin.

(a) Specifications—(1) Each ounce of powder contains 20.3 grams (g) neomycin sulfate (equivalent to 14.2 g neomycin base).

(2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 000069 and 054925 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.

(2) Nos. 000009, 046573, 058005, and 061623 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section.

(3) Nos. 000009, 054925, and 059130 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section.

(c) Related tolerances. See § 556.430 of this chapter.

(d) Special labeling considerations. Labeling shall bear the following warning statements: “A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”

(e) Conditions of use—(1) Cattle, swine, sheep, and goats—(i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days.

(ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.

(iii) Limitations. Add powder to drinking water or milk; not for use in liquid supplements. Administer solution undiluted or in drinking water. Prepare a fresh solution in drinking water daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days.

(2) Turkeys—(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days.

(ii) Indications for use. For the control of mortality associated with E. coli susceptible to neomycin sulfate in growing turkeys.

(iii) Limitations. Add to drinking water; not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 5 consecutive days.

§ 520.1485

[Removed]

3. Remove § 520.1485.

Dated: September 12, 2006.

Stephen F. Sundlof

Director, Center for Veterinary Medicine.