Implantation or Injectable Dosage Form New Animal Drugs; Erythromycin, 69142 [E7-23763]

Agencies

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

[Federal Register Volume 72, Number 235 (Friday, December 7, 2007)]
[Rules and Regulations]
[Page 69142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Erythromycin

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 supplemental new animal drug 
application (NADA) filed by Cross Vetpharm Group Ltd. The supplemental 
NADA provides for use of a 100 milligram per milliliter (mg/mL) 
strength erythromycin injectable solution in cattle for the treatment 
of bovine respiratory disease.

DATES: This rule is effective December 7, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed a supplement to NADA 12-123 for 
GALLIMYCIN-100 (erythromycin) Injection. The supplemental NADA provides 
for use of a 100 mg/mL strength erythromycin injectable solution in 
cattle for the treatment of bovine respiratory disease. The 
supplemental NADA is approved as of November 15, 2007, and the 
regulations in 21 CFR 522.820 are amended to reflect the approval and a 
current format.
    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.
    The agency has determined under 21 CFR 25.33(a)(1) 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 Subject in 21 CFR Part 522

    Animal drugs.

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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 part 522 is 
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. Revise Sec.  522.820 to read as follows:


Sec.  522.820  Erythromycin.

    (a) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (b) Specifications--(1) Each milliliter (mL) of solution contains 
100 milligrams (mg) erythromycin base.
    (2) Each mL of solution contains 200 mg erythromycin base.
    (c) Related tolerances. See Sec.  556.230 of this chapter.
    (d) Conditions of use--(1) Dog. Administer product described in 
paragraph (b)(1) of this section as follows:
    (i) Amount. 3 to 5 mg per pound (/lb) body weight, intramuscularly, 
two to three times daily, for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial pneumonia, 
upper respiratory infections (tonsillitis, bronchitis, tracheitis, 
pharyngitis, pleurisy), endometritis and metritis, and bacterial wound 
infections caused by Staphylococcus spp., Streptococcus spp., and 
Corynebacterium spp., sensitive to erythromycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Administer product described in paragraph (b)(1) of this 
section as follows:
    (i) Amount. 3 to 5 mg/lb body weight, intramuscularly, two to three 
times daily, for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial pneumonia, 
upper respiratory infections (rhinitis, bronchitis), secondary 
infections associated with panleukopenia, and bacterial wound 
infections caused by Staphylococcus spp. and Streptococcus spp., 
susceptible to erythromycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Cattle. Administer products described in paragraph (b) of this 
section as follows:
    (i) Amount. 4 mg/lb body weight by deep intramuscular injection 
once daily for up to 5 days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (shipping fever complex and bacterial pneumonia) associated 
with Pasteurella multocida susceptible to erythromycin.
    (iii) Limitations. Do not use in female dairy cattle over 20 months 
of age. Do not slaughter treated animals within 6 days of last 
treatment. A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in calves to be processed 
for veal. To avoid excess trim, do not slaughter within 21 days of last 
injection.

    Dated: November 30, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23763 Filed 12-6-07; 8:45 am]
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