[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]
BILLING CODE 4160-01-F
