[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36290-36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17541]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 Animal
Health, Inc. The supplemental ANADA provides for the subcutaneous use
of oxytetracycline injection in cattle for treatment of diseases caused
by oxytetracycline susceptible organisms.
EFFECTIVE DATE: July 10, 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: Boehringer Ingelheim Animal Health, Inc.,
2621 North Belt Hwy., St. Joseph, MO 64506, has filed supplemental
ANADA 200-008, which provides for subcutaneous use of oxytetracycline
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. 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 acute metritis caused by
strains of staphylococci and streptococci organisms sensitive to
oxytetracycline. The product is also approved for intramuscular use in
swine.
Boehringer Ingelheim's supplemental ANADA 200-008 for subcutaneous
use of oxytetracycline injection (OXY-TET 200/BIO-MYCIN 200) in cattle
is approved as of May 22, 1996, and the regulations are amended in 21
CFR 522.1660 (c)(1)(iii) 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., 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)(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.
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).
[[Page 36291]]
Sec. 522.1660 [Amended]
2. Section 522.1660 Oxytetracycline injection is amended in
paragraph (c)(1)(iii) by revising the first sentence to read
``Administer intramuscularly, intravenously, or subcutaneously at 3 to
5 milligrams level, intramuscularly or subcutaneously at 9 milligrams
level.'' * * *
Dated: June 25, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-17541 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
