[Federal Register Volume 61, Number 77 (Friday, April 19, 1996)]
[Notices]
[Pages 17307-17308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0118]
Drug Export; ORTHOTM HIV-1/HIV-2 Ab-Capture ELISA Test
System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Ortho Diagnostic Systems, Inc., has filed an application requesting
approval for the export of the human biological product ORTHOTM
HIV-1/HIV-2 Ab-Capture ELISA Test System to Australia, Austria,
Belgium, Canada, Denmark, The 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,
12420 Parklawn Dr., rm. 1-23, 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: Cathy E. Conn, Center for Biologics
Evaluation and Research (HFM-610), Food and Drug Administration, -1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-2006.
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 human
biological products that are not currently approved in the
[[Page 17308]]
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 Ortho Diagnostic
Systems, Inc., 1001 U.S. Hwy. 202, Raritan, NJ 08869, has filed an
application requesting approval for the export of the human biological
product ORTHOTM HIV-1/HIV-2 Ab-Capture ELISA Test System to
Australia, Austria, Belgium, Canada, Denmark, The 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 ORTHOTM HIV-1/HIV-2 Ab-
Capture ELISA Test System is a qualitative, enzyme-linked,
immunosorbent assay for the detection of antibodies to human
immunodeficiency virus types 1 and/or (HIV-1 and HIV-2) in human serum
or plasma. The application was received and filed in the Center for
Biologics Evaluation and Research on March 18, 1996, 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 29, 1996, 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: March 26, 1996.
James C. Simmons,
Director, Office of Compliance, Center for Biologics Evaluation and
Research.
[FR Doc. 96-9673 Filed 4-18-96; 8:45 am]
BILLING CODE 4160-01-F
