[Federal Register Volume 60, Number 155 (Friday, August 11, 1995)]
[Notices]
[Page 41079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19886]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0232]


Animal Drug Export; PERCORTEN-V (Desoxycorticosterone 
Pivalate) Sterile Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Ciba-Geigy Corp. has filed an application requesting approval for 
export to Canada of the animal drug Percorten-V 
(desoxycorticosterone pivalate) sterile suspension for use as an 
injectable for dogs.

ADDRESSES: Relevant information on this application may be directed to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact 
person identified below. Any future inquiries concerning the export of 
animal drugs under the Drug Export Amendments Act of 1986 should also 
be directed to the contact person.

FOR FURTHER INFORMATION CONTACT: Gregory S. Gates, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: The drug export provisions in section 802 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382) 
provide that FDA may approve applications for the export of drugs that 
are not currently approved in the United States. Section 802(b)(3)(B) 
of the act sets forth the requirements that must be met in an 
application for approval. Section 802(b)(3)(C) of the act requires that 
the agency review the application within 30 days of its filing to 
determine whether the requirements of section 802(b)(3)(B) have been 
satisfied. Section 802(b)(3)(A) of the act requires that the agency 
publish a notice in the Federal Register within 10 days of the filing 
of an application for export to facilitate public participation in its 
review of the application. To meet this requirement, the agency is 
providing notice that Ciba-Geigy Corp., Animal Health Div., P.O. Box 
18300, Greensboro, NC 27419-8300, has filed application number 6321 
requesting approval for export to Canada of the animal drug 
Percorten-V (desoxycorticosterone pivalate) sterile 
suspension. The product is intended for use in dogs as partial 
mineralocorticoid replacement therapy in cases of adrenocortical 
insufficiency. The application was received and filed in the Center for 
Veterinary Medicine on July 20, 1995, which shall be considered the 
filing date for purposes of the act.

    Interested persons may submit relevant information on the 
application to the Dockets Management Branch (address above) in two 
copies (except that individuals may submit single copies) and 
identified with the docket number found in brackets in the heading of 
this document. These submissions may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    The agency encourages any person who submits relevant information 
on the application to do so by August 21, 1995, and to provide an 
additional copy of the submission directly to the contact person 
identified above, to facilitate consideration of the information during 
the 30-day review period.This notice is issued under the Federal Food, 
Drug, and Cosmetic Act (sec. 802 (21 U.S.C. 382)) and under authority 
delegated to the Commissioner of Food and Drugs (21 CFR 5.10) and 
redelegated to the Center for Veterinary Medicine (21 CFR 5.44).

    Dated: July 26, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.

[FR Doc. 95-19886 Filed 8-10-95; 8:45 am]
BILLING CODE 4160-01-F