[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Rules and Regulations]
[Page 26670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12284]


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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; 
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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Boehringer Ingelheim 
Vetmedica, Inc. The supplemental ANADA provides for establishment of a 
28-day withdrawal period for subcutaneous use of oxytetracycline 
injection in cattle and for intramuscular use in swine.

EFFECTIVE DATE: May 17, 1999.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7570.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506, filed supplemental ANADA 200-
008 that provides for establishment of a 28-day withdrawal period for 
subcutaneous use in cattle and intramuscular use in swine of 
OxytetTM 200 and Bio-Mycin 200 (oxytetracycline 
injection). The 28-day withdrawal period for the intravenous and 
intramuscular use of oxytetracycline injection in cattle, assigned as 
part of the original approval, remains unchanged. The drug is for 
intramuscular, subcutaneous, or intravenous treatment of beef cattle 
and nonlactating dairy cattle as follows: (1) Bacterial pneumonia and 
shipping fever complex associated with Pasteurella spp. and Haemophilus 
spp.; (2) infectious bovine keratoconjunctivitis (pinkeye) caused by 
Moraxella bovis; (3) foot rot and diptheria caused by Fusobacterium 
necrophorum; (4) bacterial enteritis (scours) caused by Escherichia 
coli; (5) wooden tongue caused by Actinobacillus lignieresii; (6) 
leptospirosis caused by Leptospira pomona; and (7) wound infections and 
acute metritis caused by strains of streptococcal and staphylococcal 
organisms. The drug is for intramuscular use in swine for 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. 
The ANADA is approved as of March 16, 1999, and the regulations are 
amended by revising Sec. 522.1660(d)(2)(iii) (21 CFR 
522.1660(d)(2)(iii)) to reflect the approval. Because the current 
regulation failed to reflect the previously established 36-day 
withdrawal period for subcutaneous use of oxytetracycline injection in 
cattle, no revision to Sec. 522.1660(d)(1)(iii) is required for this 
supplemental approval that establishes a 28-day withdrawal period for 
subcutaneous use of oxytetracycline injection in cattle. 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 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, 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.

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: 21 U.S.C. 360b.

    2. Section 522.1660 is amended by revising paragraph (d)(2)(iii) to 
read as follows:


Sec. 522.1660  Oxytetracycline injection.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Administer intramuscularly. Do not inject more 
than 5 milliliters per site in adult swine. Discontinue treatment at 
least 28 days prior to slaughter when provided by 000010, 000069, 
011722, 053389, 059130, and 061623.

    Dated: May 3, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-12284 Filed 5-14-99; 8:45 am]
BILLING CODE 4160-01-F