[Federal Register Volume 59, Number 240 (Thursday, December 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30759]


[[Page Unknown]]

[Federal Register: December 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0437]

 

Drug Export; AmplicorTM Hepatitis C Virus (HCV) PCR Test

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Roche Molecular Systems, Inc. has filed an application requesting 
approval for the export of the biological product AmplicorTM HCV 
PCR Test to Australia, Belgium, Canada, Denmark, Federal Republic of 
Germany, Ireland, Italy, Japan, Luxembourg, the Netherlands, 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) 
provide 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 Roche Molecular Systems, Inc., 1080 U.S. Hwy. 
202, Branchburg, NJ 08876-1760, has filed an application requesting 
approval for the export of the biological product AmplicorTM HCV 
PCR Test to Australia, Belgium, Canada, Denmark, Federal Republic of 
Germany, Ireland, Italy, Japan, Luxembourg, the Netherlands, Norway, 
Portugal, Spain, Sweden, Switzerland, and the United Kingdom. The 
AmplicorTM HCV Test is a direct DNA Probe test that utilizes a 
nucleic acid amplification called Polymerase Chain Reaction (PCR) and 
nucleic acid hybridization for the detection of HCV in Human serum and 
plasma. The application was received and filed in the Center for 
Biologics Evaluation and Research on November 10, 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 December 27, 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: November 30, 1994.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation 
and Research.
[FR Doc. 94-30759 Filed 12-14-94; 8:45 am]
BILLING CODE 4160-01-F