[Federal Register Volume 60, Number 66 (Thursday, April 6, 1995)]
[Notices]
[Pages 17534-17535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0082]
Animal Drug Export; Deslorelin Acetate Implant
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Peptide Technology Ltd. has filed an application requesting approval
for the export of the animal drug OvuplantTM (deslorelin acetate)
to Canada.
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-114), 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 Peptide Technology Ltd., 4-10 Inman Rd., Dee Why
2099, Australia, has filed application number 8019 requesting approval
for the export of the animal drug OvuplantTM (2.1 milligrams of
deslorelin per implant, as the acetate) to Canada. The drug is a
subcutaneous implant providing sustained release of a gonadotropin
releasing hormone analog. It is indicated for inducing ovulation in the
oestrus mare. The application was received and filed in the Center for
Veterinary Medicine on March 20, 1995, [[Page 17535]] 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 April 17, 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: March 24, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-8451 Filed 4-5-95; 8:45 am]
BILLING CODE 4160-01-F
