2011-23874. New Animal Drugs; Gamithromycin

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 new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for the veterinary prescription use of gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending the regulations to add the established tolerances for residues of gamithromycin in edible tissues of cattle.

DATES:

This rule is effective September 19, 2011.

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, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 filed NADA 141-328 that provides for the veterinary prescription use of ZACTRAN (gamithromycin), an injectable solution, in beef and non-lactating dairy cattle for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica and P. multocida. The application is approved as of June 16, 2011, and the regulations are amended in 21 CFR parts 522 and 556 to reflect the approval.

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)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.

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

21 CFR Part 522

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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 522 and 556 are amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. Section 522.1014 is added to read as follows:

§ 522.1014

Gamithromycin.

(a) Specifications. Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin.

(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.292 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous injection in the neck.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.

(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 35 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

3. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

4. Section 556.292 is added to read as follows:

§ 556.292

Gamithromycin.

(a) Acceptable Daily Intake (ADI). The ADI for total residues of gamithromycin is 10 micrograms per kilogram of body weight per day.

(b) Tolerances. The tolerances for gamithromycin (the marker residue) are:

(1) Cattle—(i) Liver (the target tissue): 500 parts per billion (ppb).

(ii) Muscle. 150 ppb.

(2) [Reserved]

(c) Related conditions of use. See § 522.1014 of this chapter.

Dated: September 13, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.