[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
