[Federal Register Volume 70, Number 132 (Tuesday, July 12, 2005)]
[Rules and Regulations]
[Pages 39918-39919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; 
Tulathromycin

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 a new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for the veterinary 
prescription use of tulathromycin solution in cattle and in swine, by 
injection, for the management of respiratory disease. FDA is also 
amending the regulations to add the acceptable daily intake for total 
residues of tulathromycin and tolerances for residues of tulathromycin 
in edible tissues of cattle and swine.

DATES: This rule is effective July 12, 2005.

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: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-244 for DRAXXIN (tulathromycin) Injectable 
Solution. The NADA provides for the veterinary prescription use of 
tulathromycin solution in cattle, by subcutaneous injection, for the 
treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni 
(Haemophilus somnus); for the control of respiratory disease in cattle 
at high risk of developing BRD associated with M. haemolytica, P. 
multocida, and H. somni; and in swine, by intramuscular injection, for 
the treatment of swine respiratory disease (SRD) associated with 
Actinobacillus pleuropneumoniae, P. multocida, Bordetella 
bronchiseptica, and H. parasuis. The application is approved as of May 
24, 2005, and the regulations are amended in part 522 (21 CFR part 522) 
by adding Sec.  522.2630 and in part 556 (21 CFR part 556) by adding 
Sec.  556.745 to reflect the approval. The basis of approval is 
discussed in the freedom of information (FOI) summary.
    In accordance with the FOI 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)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning May 24, 2005.
    The agency has determined under 21 CFR 25.33(d)(5) that these 
actions are of a type that do 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 522.2630 is added to read as follows:


Sec.  522.2630  Tulathromycin.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) tulathromycin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.745 of this chapter.
    (d) Conditions of use--(1) Beef and nonlactating dairy cattle--(i) 
Amount. 2.5 mg per kilogram (/kg) body weight as a single subcutaneous 
injection in the neck.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni (Haemophilus somnus); for the control 
of respiratory disease in cattle at high risk of developing BRD 
associated with M. haemolytica, P. multocida, and H. somni.
    (iii) Limitations. Cattle intended for human consumption must not 
be slaughtered within 18 days from the last treatment. Do not use in 
female dairy cattle 20 months of age or older. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) Swine--(i) Amount. 2.5 mg/kg body weight as a single 
intramuscular injection in the neck.
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobaccillus pleuropneumoniae, P. 
multocida, Bordetella bronchiseptica, and H. parasuis.
    (iii) Limitations. Swine intended for human consumption must not be 
slaughtered within 5 days from the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

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 556.745 is added to read as follows:


Sec.  556.745  Tulathromycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
tulathromycin is 15 micrograms per kilogram of body weight per day.

[[Page 39919]]

    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for CP-60,300 (the marker residue) is 5.5 parts per million 
(ppm).
    (ii) [Reserved]
    (2) Swine--(i) Kidney (the target tissue). The tolerance for CP-
60,300 (the marker residue) is 15 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec.  522.2630 of this chapter.

    Dated: June 20, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-13586 Filed 7-11-05; 8:45 am]
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