[Federal Register Volume 59, Number 88 (Monday, May 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11069]
[[Page Unknown]]
[Federal Register: May 9, 1994]
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FEDERAL TRADE COMMISSION
Food and Drug Administration
[Docket No. 94N-0161]
Drug Export; RIBATM HIV-1/HIV-2 Strip Immunoblot Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Chiron Corp. has filed an application requesting approval for the
export of the biological product RIBATM HIV-1/HIV-2 Strip
Immunoblot Assay (SIA) to Australia, Austria, Belgium, Canada, Denmark,
Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy,
Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal,
Spain, Sweden, Switzerland, 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
human biological products under the Drug Export Amendments Act of 1986
should also be directed to the contact person.
FOR FURTHER INFORMATION CONTACT: Frederick W. Blumenschein, Center for
Biologics Evaluation and Research (HFM-660), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
1070.
SUPPLEMENTARY INFORMATION: The drug export provisions in section 802 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382)
provides that FDA may approve applications for the export of biological
products 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 Chiron Corp., 4560 Horton St., Emeryville, CA
94608-2916, has filed an application requesting approval for the export
of the biological product RIBATM HIV-1/HIV-2 Strip Immunoblot
Assay (SIA) to Australia, Austria, Belgium, Canada, Denmark, Federal
Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan,
Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain.
Sweden, Switzerland, and the United Kingdom.
The RIBATM HIV-1/HIV-2 Strip Immunoblot Assay (SIA) is an in
vitro qualitative enzyme immunoassay for the detection of antibodies to
Human Immunodeficiency Virus Types 1 and 2 in human serum or plasma.
The application was received and filed in the Center for Biologics
Evaluation and Research on March 11, 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 May 19, 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 Biologics Evaluation and Research (21 CFR 5.44).
Dated: April 25, 1994.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation
and Research.
[FR Doc. 94-11069 Filed 5-6-94; 8:45 am]
BILLING CODE 4160-01-F
