2010-25527. Implantation and Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.

DATES:

This rule is effective October 12, 2010.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141 235 for EXCEDE (ceftiofur crystalline free acid) for Swine Sterile Suspension. The supplemental NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis in groups of pigs where SRD has been diagnosed. The application is approved as of September 15, 2010, and the regulations are amended in 21 CFR 522.313a to reflect the approval. In addition, the regulations are amended to specify which strength of two approved formulations is approved for use in horses. This is being done to improve the accuracy of the regulations.

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)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 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

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

Authority: 21 U.S.C. 360b.

2. In § 522.313a, add a second sentence to paragraph (e)(1)(ii) and revise paragraph (e)(3) to read as follows:

§ 522.313a

Ceftiofur crystalline free acid.

* * * * *

(e) * * *

(1) * * *

(ii) * * * For the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.

* * * * *

(3) Horses. The formulation described in paragraph (a)(2) of this section is used as follows:

(i) Amount. Two intramuscular injections, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.

(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption.

Dated: October 5, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.