04-16760. New Animal Drugs; Ceftiofur

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 new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The NADA provides for veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the treatment of swine respiratory disease (SRD).

DATES:

This rule is effective July 23, 2004.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed NADA 141-235 for EXCEDE (ceftiofur crystalline free acid) for Swine Sterile Suspension. The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the treatment of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. The application is approved as June 18, 2004, and the regulations are amended in 21 CFR 522.315 and 556.113 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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 June 18, 2004.

The agency has determined under 21 CFR 25.33(d)(5) 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 522

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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 522 and 556 are 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. Section 522.315 is amended by revising paragraphs (a) and (d) to read as follows:

§ 522.315

Ceftiofur crystalline free acid.

(a) Specifications—(1) Each milliliter (mL) of suspension contains 100 milligrams (mg) ceftiofur equivalents (CE).

(2) Each mL of suspension contains 200 mg CE.

* * * * *

(d) Conditions of use—(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:

(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.

(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Following label use as a single treatment, a 14-day preslaughter withdrawal period is required.

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

(i) Amount. 6.6 mg CE per kg of body weight by a single, subcutaneous injection in the middle third of the posterior aspect of the ear.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD), shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somnus.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

3. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

4. Section 556.113 is amended in paragraph (b)(1) by removing “ Swine, poultry,” and by adding in its place “Poultry”; by redesignating paragraph (b)(2) as paragraph (b)(3); by adding new paragraph (b)(2); and by revising newly redesignated paragraph (b)(3) to read as follows:

§ 556.113

Ceftiofur.

* * * * *

(b) * * *

(2) Swine. The tolerances for desfuroylceftiofur (marker residue) are:

(i) Kidney (target tissue). 0.25 parts per million (ppm).

(ii) Liver. 3 ppm.

(iii) Muscle. 2 ppm.

(3) Cattle. The tolerances for desfuroylceftiofur (marker residue) are:

(i) Kidney (target tissue). 8 ppm.

(ii) Liver. 2 ppm.

(iii) Muscle. 1 ppm.

(iv) Injection site muscle. 166 ppm.

(v) Milk. 0.1 ppm.

Dated: July 13, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.