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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 522

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

DATES: This rule is effective March 9, 2007.

DOCUMENT 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.

SUMMARY: Enrofloxacin; implantation or injectable dosage form,

SUPPLEMENTAL 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. 801808.
[[Page 10597]]
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 522IMPLANTATION 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 Sec. 522.812 to read as follows:
Sec. 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 Sec. 510.600(c) of this chapter. (c) Related tolerance. See Sec. 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 extralabel use of this drug in foodproducing 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. Singledose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL per 100 pounds) by subcutaneous injection. Multipleday 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 preruminating 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.
[FR Doc. E74206 Filed 3807; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Joan C. Gotthardt, Center for Veterinary Medicine (HFV130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277571, email:
joan.gotthardt@fda.hhs.gov.