[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
