[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Gonadorelin Diacetate Tetrahydrate 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 Intervet, Inc. The ANADA provides for 
intramuscular and intravenous use of a sterile injectable solution of 
gonadorelin diacetate tetrahydrate for treating ovarian cysts in female 
dairy cattle of breeding age.

EFFECTIVE DATE: July 19, 1996.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 405 State St., P.O. Box 318, 
Millsboro, DE 19966-0318, filed ANADA 200-134, which provides for 
intramuscular and intravenous use of Fertagyl (gonadorelin 
diacetate tetrahydrate injection) for treatment of ovarian cysts in 
female dairy cattle of breeding age.
    Approval of ANADA 200-134 is as a generic copy of Rhone Merieux's 
NADA 98-379 for Cystorelin (gonadorelin diacetate 
tetrahydrate injection). The ANADA is approved as of June 17, 1996, and 
the regulations are amended by revising 21 CFR 522.1078(b) to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 522.1078  [Amended]

    2. Section 522.1078 Gonadorelin diacetate tetrahydrate injection is 
amended in paragraph (b) by removing ``No. 050604'' and adding in its 
place ``Nos. 050604 and 057926''.

    Dated: July 11, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-18350 Filed 7-18-96; 8:45 am]
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