[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14302-14303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7542]


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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 a supplemental new animal drug 
application (NADA) filed by Boehringer Ingelheim Animal Health, Inc. 
The supplemental NADA provides for the subcutaneous use (in addition to 
the approved intravenous and intramuscular use) of 100 milligrams/
milliliter (mg/mL) of oxytetracycline hydrochloride injection in cattle 
for the treatment of diseases caused by oxytetracycline susceptible 
organisms, for a 2-day withdrawal period following the subcutaneous 
use, and for a 13-day withdrawal period following the intramuscular and 
intravenous use.

EFFECTIVE DATE:  March 26, 1997.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION:  Boehringer Ingelheim Animal Health, Inc., 
2621 North Belt Hwy., St. Joseph, MO 64502, is the sponsor of NADA 97-
452, formerly sponsored by Fermenta Animal Health Co. The firm has 
filed a supplement to NADA 97-452, which provides for subcutaneous use 
of 100 mg/mL of oxytetracycline hydrochloride injection in addition to 
the approved intravenous and intramuscular use in beef and nonlactating 
dairy cattle for the treatment of pneumonia and shipping fever 
associated with Pasteurella spp., Haemophilus spp., and Klebsiella 
spp., caused by organisms susceptible to oxytetracycline. In cattle, a 
2-day withdrawal period is required following subcutaneous use, and a 
13-day withdrawal period is required following intramuscular and 
intravenous use. The product is also approved for intramuscular and 
intravenous use in swine. The supplemental NADA is approved as of 
February 21, 1997, and the regulations are amended in 21 CFR 
522.1662a(g)(3)(i)(c) 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 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning February 21, 1997, because the supplemental application 
contains substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety, or, in the case of food-
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for approval of the supplement and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(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.

[[Page 14303]]

    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 (g)(3)(i)(c) 
to read as follows:

 Sec. 522.1662a   Oxytetracycline hydrochloride injection.

 *   *   *   *   *
     (g) * * *
     (3) * * *
     (i) * * *
     (c) Limitations. Administer by intramuscular, intravenous, or 
subcutaneous injection. In severe forms of the indicated diseases, 
administer 5 milligrams of oxytetracycline per pound of body weight per 
day. Continue treatment 24 to 48 hours following remission of disease 
symptoms, not to exceed a total of 4 consecutive days. If no 
improvement is noted within 48 hours, consult a veterinarian. Do not 
inject more than 10 milliliters per injection site intramuscularly in 
adult cattle; no more than 1 milliliter per site in calves weighing 100 
pounds or less. Do not slaughter cattle for 13 days after intramuscular 
or intravenous treatment, or 2 days after subcutaneous treatment. 
Exceeding the highest recommended dosage or duration of treatment (not 
more than 4 consecutive days) may result in residues beyond the 
withdrawal period. A withdrawal period has not been established for use 
of this product in preruminating calves. Do not use in calves to be 
processed for veal.
 *   *   *   *   *

    Dated: March 14, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7542 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F