[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20347]
[[Page Unknown]]
[Federal Register: August 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0301]
Animal Drug Export; Fenbendazole 10% Suspension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that Vet-
A-Mix, Inc., has filed an application requesting approval for export of
the animal drug fenbendazole 10 percent suspension for cattle and sheep
to Ireland for sale in Ireland and the United Kingdom.
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
food animal drugs under the Drug Export Amendments Act of 1986 should
also be directed to the contact person.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
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 Vet-A-Mix, Inc., P.O. Box A, 604 West Thomas
Ave., Shenandoah, IA 51601-0148, has filed application number 8320
requesting approval for export to Ireland for sale in Ireland and the
United Kingdom of the animal drug fenbendazole 10 percent suspension.
The product is intended for use in cattle and sheep for the control of
certain gastrointestinal roundworm and lungworm infections. The
application was received and filed in the Center for Veterinary
Medicine on August 8, 1994, 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 29, 1994, 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: August 11, 1994.
Richard H. Teske,
Deputy Director, Pre-market Review, Center for Veterinary Medicine.
[FR Doc. 94-20347 Filed 8-17-94; 8:45 am]
BILLING CODE 4160-01-F
