2012-1753. Oral Dosage Form New Animal Drugs; Gentamicin Sulfate

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 original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of gentamicin sulfate soluble powder used to make medicated drinking water for swine.

DATES:

This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-494 for use of GENTAMED (gentamicin sulfate) Soluble Powder used to make medicated drinking water for swine. Cross Vetpharm Group's Gentamicin Soluble Powder is approved as a generic copy of GARACIN (gentamicin sulfate) Soluble Powder, sponsored by Intervet Inc., under NADA 133-836. The abbreviated application is approved as of December 14, 2011, and the regulations are amended in 21 CFR 520.1044c 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 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 § 520.1044c to read as follows:

§ 520.1044c

Gentamicin sulfate powder.

(a) Specifications. Each gram of powder contains gentamicin sulfate equivalent to:

(1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.

(2) 333.3 mg gentamicin.

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

(1) No. 000061 for products described in paragraph (a)(1) of this section.

(2) Nos. 057561 and 061623 for product described in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.300 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer in drinking water for 3 consecutive days as follows:

(i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day;

(ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs.

(2) Indications for use. For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dysentery associated with Treponema hyodysenteriae.

(3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water.

(4) Withdrawal period. 10 days.

Dated: January 23, 2012.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.