[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
