[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Rules and Regulations]
[Pages 43891-43892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16760]


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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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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: 
[email protected].

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

[[Page 43892]]

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.

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


Sec.  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

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

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

0
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:


Sec.  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.
[FR Doc. 04-16760 Filed 7-22-04; 8:45 am]
BILLING CODE 4160-01-S