[Federal Register Volume 60, Number 105 (Thursday, June 1, 1995)]
[Notices]
[Pages 28616-28617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13295]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0137]


Drug Export; Antibody to Hepatitis B Surface Antigen (Human) 
OrthoTM Antibody to HBsAg Elisa Confirmatory Test

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 Antibody to 
Hepatitis B Surface Antigen (human) ORTHOTM Antibody to HBsAg 
ELISA Confirmatory Test to 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: Cathy 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 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 US Hwy. 202, Raritan, NJ 08869, has filed an 
application requesting approval for the export of the human biological 
product Antibody to Hepatitis B Surface Antigen (human) ORTHOTM 
Antibody to HBsAg ELISA Confirmatory Test to 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 Antibody to Hepatitis B Surface Antigen (human) 
[[Page 28617]] ORTHOTM Antibody to HBsAg ELISA Confirmatory Test 
is a third generation assay to be used to confirm the presence of 
Hepatitis B Surface Antigen (HBsAg) in specimens found repeatedly 
reactive in ORTHOTM Antibody to HBsAg ELISA Test System 3. The 
application was received and filed in the Center for Biologics 
Evaluation and Research on May 4, 1995, 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 June 12, 1995, 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: May 9, 1995.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation 
and Research.
[FR Doc. 95-13295 Filed 5-31-95; 8:45 am]
BILLING CODE 4160-01-F