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[Federal Register: April 15, 2002 (Volume 67, Number 72)]
[Rules and Regulations]               
[Page 18086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap02-2]                         


[[Page 18086]]

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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; 
Furosemide

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 furosemide solution by intramuscular or intravenous 
injection in horses, cattle, dogs, and cats.

DATES: This rule is effective April 15, 2002.

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, e-mail: 
<A HREF="mailto:lluther@cvm.fda.gov">lluther@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
293 that provides for veterinary prescription use of Furosemide 
Injection 5% by intramuscular or intravenous administration in horses, 
cattle, dogs, and cats. Phoenix's Furosemide Injection 5% is approved 
as a generic copy of Intervet, Inc.'s LASIX Injectable Solution, 
approved under NADA 34-478. ANADA 200-293 is approved as of December 
18, 2001, and the regulations are amended in 21 CFR 522.1010 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, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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. 522.1010  [Amended]

    2. Section 522.1010 Furosemide is amended in paragraph (b)(3) by 
removing ``No. 057926'' and by adding in its place ``Nos. 057926 and 
059130''.

    Dated: March 1, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-9014 Filed 4-12-02; 8:45 am]
BILLING CODE 4160-01-S

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