[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Rules and Regulations]
[Pages 31027-31028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15465]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline 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 Pennfield Oil Co. The ANADA provides for 
the use of a generic oxytetracycline injection for beef cattle, non-
lactating dairy cattle, and swine.

EFFECTIVE DATE: June 19, 1996.

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: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68137, filed ANADA 200-154, which provides for use of 200 
milligram per milliliter (mg/mL) oxytetracycline injection for 
intramuscular and intravenous use in beef cattle and non-lactating 
dairy cattle and intramuscular use in swine for control or treatment of 
diseases caused by oxytetracycline susceptible diseases. The drug is 
used in beef cattle and non-lactating dairy cattle for treatment of 
pneumonia and shipping fever complex associated with Pasteurella spp. 
and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) 
caused by Moraxella bovis; foot rot and diphtheria caused by 
Fusobacterium necrophorum; bacterial enteritis (scours) caused by 
Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; 
leptospirosis caused by Leptospira pomona; and wound infections and 
metritis caused by strains of staphylococci and streptococci organisms 
sensitive to oxytetracycline. The drug is used in swine for the 
treatment of bacterial enteritis (scours, colibacillosis) caused by E. 
coli; pneumonia caused by P. multocida; and leptospirosis caused by L. 
pomona; and in sows as an aid in the control of infectious enteritis 
(baby pig scours, colibacillosis) in suckling pigs caused by E. coli.
    ANADA 200-154 for Pennfield Oil Co.'s oxytetracycline injection is 
approved as a generic copy of Pfizer's NADA 113-232 
Liquamycin LA-200 (oxytetracycline) Injection. The ANADA is 
approved as of May 8, 1996, and the regulations are amended in 21 CFR 
522.1660 to reflect the approval. The basis for 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 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, 12420 
Parklawn Dr.,

[[Page 31028]]

rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday 
through Friday.
    The agency has determined under 21 CFR 25.24(d)(l)(i) 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.

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).

Sec. 522.1660  [Amended]

    2. Section 522.1660 Oxytetracycline injection is amended in 
paragraphs (b) and (c)(2)(iii) by adding ``053389,'' after ``000069,''.

    Dated: June 10, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-15465 Filed 6-18-96; 8:45 am]
BILLING CODE 4160-01-F