E7-4206. Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

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 Bayer HealthCare LLC. The supplemental NADA provides for changing scientific nomenclature for a bovine respiratory pathogen on labeling for enrofloxacin injectable solution.

DATES:

This rule is effective March 9, 2007.

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:

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement to NADA 141 068 for BAYTRIL 100 (enrofloxacin) Injectable Solution used for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for changing a pathogen name from Pasteurella haemolytica to Mannheimia haemolytica on product labeling. The supplemental NADA is approved as of February 15, 2007, and the regulations in 21 CFR 522.812 are amended to reflect the approval and a current format.

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 522

• 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 522 is 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. Revise § 522.812 to read as follows:

§ 522.812

Enrofloxacin.

(a) Specifications. Each milliliter (mL) of solution contains:

(1) 22.7 milligrams (mg) enrofloxacin or

(2) 100 mg enrofloxacin.

(b) Sponsor. See No. 000859 in § 510.600(c) of this chapter.

(c) Related tolerance. See § 556.228 of this chapter.

(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

(e) Conditions of use—(1) Dogs. Use the product described in paragraph (a)(1) of this section as follows:

(i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per pound) as a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 10 days.

(ii) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.

(2) Cattle. Use the product described in paragraph (a)(2) of this section as follows:

(i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL per 100 pounds) by subcutaneous injection. Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL per 100 pounds) by subcutaneous injection once daily for 3 to 5 days.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus.

(iii) Limitations. Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. The effect of enrofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined.

Dated: February 28, 2007.

Steven D. Vaughn,

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