[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Page 44384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22229]
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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
Hydrogenated 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 intramuscular use of iron hydrogenated dextran injection
in baby pigs for prevention or treatment of iron deficiency anemia.
EFFECTIVE DATE: August 19, 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-
254 that provides for intramuscular use of iron hydrogenated dextran
injection in baby pigs for prevention or treatment of iron deficiency
anemia.
Approval of Phoenix Scientific, Inc.'s ANADA 200-254 for iron
hydrogenated dextran injection is as a generic copy of Boehringer
Ingelheim Vetmedica, Inc.'s NADA 106-772 iron dextran complex
injection. The ANADA is approved as of July 14, 1998, and the
regulations are amended in Sec. 522.1183(e)(1) (21 CFR 522.1183(e)(1))
to reflect the approval. The basis of approval is discussed in the
freedom of information summary.
In addition, Sec. 522.1183(b) provides for the National Academy of
Sciences/National Research Council (NAS/NRC) status of the product.
With enactment of the Generic Animal Drug and Patent Term Restoration
Act of 1996, that paragraph is outdated. Therefore, paragraph (b) is
removed and reserved.
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 the 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, 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. 522.1183 [Amended]
2. Section 522.1183 Iron hydrogenated dextran injection is amended
by removing and reserving paragraph (b), and in paragraph (e)(1) by
removing ``Nos. 000010, 017287, and 050604,'' and adding in its place
``Nos. 000010, 017287, 050604, and 059130''.
Dated: July 29, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-22229 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F
