[Federal Register Volume 68, Number 204 (Wednesday, October 22, 2003)]
[Rules and Regulations]
[Page 60296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26569]



[[Page 60296]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Crystalline Free Acid

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 new animal drug application 
(NADA) filed by Pharmacia & Upjohn Co. The NADA provides for the 
veterinary prescription use of ceftiofur crystalline free acid 
suspension in beef and nonlactating dairy cattle, by subcutaneous 
injection in the ear, for the treatment and control of bovine 
respiratory disease (BRD).

DATES:  This rule is effective October 22, 2003.

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 141-209 for NAXCEL XT (ceftiofur 
crystalline free acid) Sterile Suspension. The NADA provides for the 
veterinary prescription use of ceftiofur crystalline free acid 
suspension in beef and nonlactating dairy cattle, by subcutaneous 
injection in the ear, for the treatment of BRD (shipping fever, 
pneumonia) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Haemophilus somnus and for the control of respiratory 
disease in cattle at high risk of developing BRD associated with M. 
haemolytica, P. multocida, and H. somnus. The application is approved 
as of September 5, 2003, and the regulations are amended in 21 CFR part 
522 by adding new Sec.  522.315 to reflect the approval. In addition, 
21 CFR 556.113 is being amended to add an acceptable single-dose intake 
for residues of ceftiofur at the injection site and a tolerance for 
residues at the injection site. 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 September 5, 2003.
    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.

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 added to read as follows:


Sec.  522.315   Ceftiofur crystalline free acid.

    (a) Specifications. Each milliliter of suspension contains 200 
milligrams (mg) ceftiofur equivalents (CE).
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.113 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 6.6 mg CE per kilogram 
of body weight by a single, subcutaneous injection in the middle third 
of the posterior aspect of the ear.
    (2) 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.
    (3) 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 by redesignating paragraph (a) as 
paragraph (a)(1); by adding a new header to paragraph (a); by adding 
new paragraph (a)(2); and by adding a new sentence to the end of 
paragraph (b)(2) to read as follows:


Sec.  556.113   Ceftiofur.

    (a) Acceptable daily intake and acceptable single-dose intake--(1) 
Acceptable daily intake (ADI).* * *
    (2) Acceptable single-dose intake (ASDI). The ASDI total residues 
of ceftiofur is 0.830 milligrams per kilogram of body weight. The ASDI 
is the amount of total residues of ceftiofur that may safely be 
consumed in a single meal. The ASDI is used to derive the tolerance for 
residues of desfuroylceftiofur at the injection site.
    (b) * * *
    (1) * * *
    (2) * * * The tolerance for residues of desfuroylceftiofur in 
injection site muscle is 166 parts per million.

    Dated: October 2, 2003.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-26569 Filed 10-21-03; 8:45 am]
BILLING CODE 4160-01-S