[Federal Register Volume 60, Number 73 (Monday, April 17, 1995)]
[Notices]
[Pages 19264-19265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0098]
Drug Export; Vironostika HTLV-I/II Microelisa System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Organon Teknika Corp. has filed an application requesting approval for
the export of the human biological product Vironostika HTLV-
I/II Microelisa System to The Netherlands.
[[Page 19265]] 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, 301-594-1070.
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 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 Organon Teknika Corp.,
100 Akzo Ave., Durham, NC 27712, has filed an application requesting
approval for the export of the human biological product
Vironostika HTLV-I/II Microelisa System to The Netherlands.
The Vironostika HTLV-I/II Microelisa System is an in vitro
diagnostic test kit for the detection of antibodies to Human T-
Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus
Type II (HTLV-II) in human serum or plasma. The application was
received and filed in the Center for Biologics Evaluation and Research
on March 2, 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
onthe application to do so by April 27, 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: March 22, 1995.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation
and Research.
[FR Doc. 95-9413 Filed 4-14-95; 8:45 am]
BILLING CODE 4160-01-F
