[Federal Register Volume 63, Number 193 (Tuesday, October 6, 1998)]
[Rules and Regulations]
[Pages 53577-53578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26648]
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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; Iron
Dextran 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 Phoenix Scientific, Inc. The ANADA
provides for use of iron dextran injection in baby pigs for prevention
or treatment of iron deficiency anemia.
EFFECTIVE DATE: October 6, 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: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
256 that provides for use of iron dextran injection-200 in baby pigs
for prevention or treatment of iron deficiency anemia.
Approval of Phoenix Scientific, Inc.'s ANADA 200-256 for iron
dextran injection is as a generic copy of Boehringer Ingelheim
Vetmedica, Inc.'s NADA 134-708 iron dextran complex injection. The
ANADA is approved as of August 17, 1998, and the regulations are
amended in 21 CFR 522.1182(b)(2) 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
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,
[[Page 53578]]
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.
Sec. 522.1182 [Amended]
2. Section 522.1182 Iron dextran complex injection is amended in
paragraph (b)(2)(i) by removing ``No. 000010'' and adding in its place
``Nos. 000010 and 059130''.
Dated: September 23, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-26648 Filed 10-5-98; 8:45 am]
BILLING CODE 4160-01-F
