Implantation or Injectable Dosage Form New Animal Drugs:

Federal Register: April 22, 2011 (Volume 76, Number 78)

Rules and Regulations

Page 22610-22611

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr22ap11-4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 522

Docket No. FDA-2011-N-0003

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 the addition of a pathogen to the indications for use of enrofloxacin solution in cattle, as a single injection, for the treatment of respiratory disease.

DATES: This rule is effective April 22, 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: cindy.burnsteel@fda.hhs.gov.

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), an injectable solution.

The supplemental NADA provides for the addition of Mycoplasma bovis to the pathogens in the indication for use of enrofloxacin solution in cattle, as a single injection, for the treatment of bovine respiratory disease (BRD). The supplemental NADA is approved as of March 10, 2011, and the regulation in 21 CFR 522.812 is amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and Sec. 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3

Page 22611

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

Authority: 21 U.S.C. 360b. 0 2. In Sec. 522.812, revise paragraph (e)(2)(ii) to read as follows:

Sec. 522.812 Enrofloxacin.

* * * * *

(e) * * *

(2) * * *

(ii) Indications for use--(A) Single-dose therapy: For the treatment of bovine respiratory disease (BRD) associated with

Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and

Mycoplasma bovis in beef and non-lactating dairy cattle.

(B) Multiple-day therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.

* * * * *

Dated: April 15, 2011.

Steven D. Vaughn,

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

Medicine.

FR Doc. 2011-9765 Filed 4-21-11; 8:45 am

BILLING CODE 4160-01-P