[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Rules and Regulations]
[Pages 41419-41420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20698]
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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;
Ampicillin Trihydrate For Sterile Suspension
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 G. C. Hanford Manufacturing Co. The ANADA
provides for subcutaneous and/or intramuscular use of ampicillin
trihydrate sterile powder when reconstituted as a sterile suspension,
for treatment of dogs, cats, cattle, and calves including nonruminating
(veal) calves.
EFFECTIVE DATE: August 4, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: G. C. Hanford Manufacturing Co., 304 Oneida
St., P.O. Box 1017, Syracuse, NY 13201, is sponsor of ANADA 200-180
that provides for the subcutaneous or intramuscular use of ampicillin
trihydrate sterile powder for reconstitution as a sterile suspension
for treatment of respiratory, urinary tract, gastrointestinal, skin,
soft-tissue, and post-surgical infections of dogs and cats, and
intramuscular use for the treatment of respiratory infections in cattle
and calves including nonruminating (veal) calves. The drug is limited
to use by or on the order of a licensed veterinarian. G. C. Hanford
Manufacturing Co.'s ANADA 200-180 is approved as a generic copy of Fort
Dodge Animal Health's NADA 55-030 for Polyflex.
[[Page 41420]]
The ANADA is approved as of April 24, 1998, and the regulations in 21
CFR 522.90b(b) are amended to reflect the approval. 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, 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 25.33(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 522.90b is amended by revising paragraph (b) to read as
follows:
Sec. 522.90b Ampicillin trihydrate for sterile suspension.
* * * * *
(b) Sponsor. (1) See 000856 in Sec. 510.600(c) of this chapter for
use of 50, 100, and 250 milligrams per milliliter ampicillin
suspension.
(2) See 010515 in Sec. 510.600(c) of this chapter for use of 100
and 250 milligrams per milliliter ampicillin suspension.
* * * * *
Dated: June 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-20698 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F