New Animal Drugs; Ceftiofur, 39545-39546 [E6-10972]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Pages 39545-39546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


New Animal Drugs; Ceftiofur

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 39546]]

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: 
joan.gotthardt@fda.hhs.gov.

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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Amend Sec.  522.315 as follows:
0
a. Redesignate Sec.  522.315 as Sec.  522.313a;
0
b. Revise paragraph (a);
0
c. Redesignate paragraph (d) as paragraph (e);
0
d. Add new paragraph (d); and
0
e. Revise newly redesignated paragraphs (e)(1)(iii) and (e)(2).
    The redesignations, revisions, and addition read as follows:


Sec.  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

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

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


Sec.  556.113  [Amended]

0
4. In Sec.  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.
[FR Doc. E6-10972 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S