[Federal Register: November 13, 2002 (Volume 67, Number 219)]
[Rules and Regulations]
[Page 68760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-6]
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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:
lluther@cvm.fda.gov.
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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