E9-16734. New Animal Drugs; Ceftiofur Sodium

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 Cephazone Pharma, LLC. The ANADA provides for the use of ceftiofur sodium powder for injection as a solution in dogs, horses, cattle, swine, day old chickens, turkey poults, sheep, and goats as therapy for various bacterial infections.

DATES:

This rule is effective July 15, 2009.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767, filed ANADA 200-420 that provides for use of Ceftiofur Sodium Sterile Powder, as an injectable solution, in dogs, horses, cattle, swine, day-old chickens, turkey poults, sheep, and goats as therapy for various bacterial infections. Cephazone Pharma, LLC's Ceftiofur Sodium Sterile Powder is approved as a generic copy of NAXCEL (ceftiofur sodium) Sterile Powder for Injection, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 140-338. The ANADA is approved as of May 27, 2009, and the regulations are amended in 21 CFR 522.313c to reflect the approval.

In addition, Cephazone Pharma, LLC, has not been previously listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this firm.

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

21 CFR Part 510

Administrative practice and procedure
Animal drugs
Labeling
Reporting and recordkeeping requirements

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 parts 510 and 522 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1) alphabetically add an entry for “Cephazone Pharma, LLC”; and in the table in paragraph (c)(2) numerically add an entry for “068330” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

(1) * * *