E6-10972. 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 a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The supplemental NADA provides for use of ceftiofur crystalline free acid suspension via a new injection site in beef and nonlactating dairy cattle, for use in lactating dairy cattle for the treatment of respiratory disease, and for the establishment of a 13-day pre-slaughter withdrawal period in cattle. FDA is also amending the regulations to revise the tolerance for residues of ceftiofur in bovine kidney to accommodate these new conditions of use.

DATES:

This rule is effective July 13, 2006.

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., a Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017, filed a supplement to NADA 141-209 for EXCEDE (ceftiofur crystalline free acid) Sterile Suspension, approved for veterinary prescription use by injection in cattle for respiratory disease. The supplemental application provides for subcutaneous injection in beef and nonlactating dairy cattle in the posterior aspect of the ear where it attaches to the head (base of the ear), for use in lactating dairy cattle by subcutaneous injection in the base of the ear for the treatment of bovine respiratory disease, and for the establishment of a 13-day pre-slaughter withdrawal period in cattle. FDA is also amending the regulations to revise the tolerance for residues of ceftiofur in bovine kidney to accommodate these new conditions of use. The application is approved as of June 2, 2006, 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 the 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 (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning June 2, 2006. The 3 years of marketing exclusivity applies only to the new administration site and new indication for which this supplement is approved.

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 Parts 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. Amend § 522.315 as follows:

a. Redesignate § 522.315 as § 522.313a;

b. Revise paragraph (a);

c. Redesignate paragraph (d) as paragraph (e);

d. Add new paragraph (d); and

e. Revise newly redesignated paragraphs (e)(1)(iii) and (e)(2).

The redesignations, revisions, and addition read as follows:

§ 522.313a

Ceftiofur crystalline free acid.

(a) Specifications. The product is a suspension of ceftiofur crystalline free acid.

(1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents.

(2) Each mL contains 200 mg ceftiofur equivalents.

* * * * *

(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) * * *

(1) * * *

(iii) Limitations. Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required.

(2) * * *

(i) Amount. 6.6 mg ceftiofur equivalents per kg of body weight as a single injection. For subcutaneous injection in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where it attaches to the head (base of the ear) in beef and non-lactating dairy cattle. For subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

(iii) Limitations. Following label use as a single treatment, a 13-day pre-slaughter withdrawal period is required. 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.

§ 556.113

[Amended]

4. In § 556.113, in paragraph (b)(3)(i) remove “8” and add in its place “0.4”; remove paragraph (b)(3)(iv); and redesignate paragraph (b)(3)(v) as paragraph (b)(3)(iv).

Dated: June 30, 2006.

Steven D. Vaughn,

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