[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