E8-18094. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride

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 new animal drug application (NADA) filed by Pharmacia and Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of a ceftiofur hydrochloride injectable suspension for treatment of various bacterial infections in swine and cattle.

DATES:

This rule is effective August 6, 2008.

FOR FURTHER INFORMATION CONTACT:

Donald A. Prater, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed NADA 141-288 that provides for veterinary prescription use of EXCENEL RTU EZ (ceftiofur hydrochloride) Sterile Suspension, used for treatment of various bacterial infections in swine and cattle. The NADA is approved as of July 1, 2008, and the regulations are amended in 21 CFR 522.313b to reflect the approval. A swine pathogen is also being revised to reflect current scientific nomenclature.

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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The agency has determined under § 25.33(a)(1) 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 Subject 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. In § 522.313b, revise paragraphs (a), (e)(1)(ii), and (e)(2)(i) to read as follows:

§ 522.313b

Ceftiofur hydrochloride.

(a) Specifications. Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) ceftiofur equivalents in either a peanut oil or caprylic/capric triglyceride suspension.

* * * * *

(e) Conditions of use—

(1) * * *

(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, and Streptococcus suis.

* * * * *

(2) * * *

(i) Amount. For bovine respiratory disease and acute bovine interdigital necrobacillosis, administer 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease only, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis only, administer 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days. Product in peanut oil suspension may be administered by either intramuscular or subcutaneous injection. Product in caprylic/capric triglyceride suspension may be administered by subcutaneous injection only.

* * * * *

Dated: July 28, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.