[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48650-48651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23250]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Hydrochloride Injection

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 abbreviated new animal drug 
application (ANADA) filed by Phoenix Pharmaceutical, Inc. The ANADA 
provides for intravenous use of oxytetracycline hydrochloride injection 
in cattle for treatment of certain diseases caused by pathogens 
sensitive to oxytetracycline.
EFFECTIVE DATE: September 20, 1995.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Phoenix Pharmaceutical, Inc., 4621 Easton 
Rd., P.O. Box 6457 Farleigh Station, St. Joseph, MO 64506-0457, filed 
ANADA 200-068, which provides for intravenous use of oxytetracycline 
hydrochloride injection in cattle for the treatment of bacterial 
pneumonia and shipping fever complex associated with Pasteurella spp., 
bacterial enteritis (scours) caused by Escherichia coli, necrotic 
pododermatitis (foot rot) and calf diphtheria caused by Spherophorus 
necrophorus, wooden tongue caused by Actinobacillu lignieresii, wound 
infection and traumatic injury caused by oxytetracycline susceptible 
strains of streptococcal and staphylococcal bacteria.
    Phoenix Pharmaceutical, Inc.'s, ANADA 200-068 for oxytetracycline 
hydrochloride injection is approved as a generic copy of Fermenta's 
NADA 108-963 for Medamycin-100. The ANADA is approved as of 
July 31, 1995, and the regulations are amended in 21 CFR 522.1662a(h) 
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 part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a 
summary of 

[[Page 48651]]
safety and effectiveness data and information submitted to support 
approval of this application may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday 
through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 522

    Animal drugs.
    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

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.1662a is amended by revising paragraph (h)(2) to 
read as follows:


Sec. 522.1662a  Oxytetracycline hydrochloride injection.

* * * * *
    (h) * * *
    (2) Sponsors. See 054273 in Sec. 510.600(c) of this chapter for use 
of 50 and 100 milligrams/milliliter solution, and see No. 057319 in 
Sec. 510.600(c) for use of 100 milligrams/milliliter solution.
* * * * *

    Dated: September 1, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23250 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-F