[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Rules and Regulations]
[Page 68760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28716]


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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; 
Gonadorelin Diacetate Tetrahydrate

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 gonadorelin diacetate tetrahydrate solution by 
injection in dairy cattle for the treatment of ovarian cysts.

DATES: This rule is effective November 13, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
069 that provides for veterinary prescription use of FERTELIN 
(gonadorelin diacetate tetrahydrate) Injection by intramuscular or 
intravenous injection in dairy cattle for the treatment of ovarian 
cysts. Phoenix's FERTELIN Injection is approved as a generic copy of 
Merial, Ltd.'s CYSTORELIN, approved under NADA 98-379. ANADA 200-069 is 
approved as of August 26, 2002, and the regulations are amended in 
Sec.  522.1078 (21 CFR 522.1078) to reflect the approval. Section 
522.1078 is also being revised to reflect a current format. 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 Subject 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 522.1078 is revised to read as follows:


Sec.  522.1078  Gonadorelin diacetate tetrahydrate.

    (a) Specifications. Each milliliter of solution contains 50 
micrograms ([micro]g) of gonadorelin diacetate tetrahydrate.
    (b) Sponsors. See Nos. 050604, 057926, and 059130 in Sec.  
510.600(c) of this chapter.
    (c) Conditions of use in cattle. It is used as follows:
    (1) Amount. 100 [micro]g per cow as a single intramuscular or 
intravenous injection.
    (2) Indications for use. For the treatment of ovarian cysts in 
dairy cattle.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: October 28, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-28716 Filed 11-12-02; 8:45 am]
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