[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Notices]
[Pages 57447-57448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28531]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0305]
Epitope, Inc.; Premarket Approval of OraSure HIV-1
Western Blot Kit
Agency: Food and Drug Administration, HHS.
Action: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application submitted by Epitope, Inc., Beaverton, OR,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the OraSure HIV-1 Western Blot Kit. FDA's
Center for Biologics Evaluation and Research (CBER) notified the
applicant, by letter of June 3, 1996, of the approval of the
application.
DATES: Petition for administrative review by December 6, 1996.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Sukza Hwangbo, Center for Biologics
Evaluation and Research (HFM-380), 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-3524.
SUPPLEMENTARY INFORMATION: On June 8, 1995, Epitope, Inc., Beaverton,
OR 97008, submitted to CBER an application for premarket approval of
the OraSure HIV-1 Western Blot Kit (OraSure). The
device is intended for use as an in vitro qualitative assay for the
detection of antibodies to the human immunodeficiency virus Type 1
(HIV-1) in human oral fluid specimens obtained with the
OraSure HIV-1 Oral Specimen Collection Device. The premarket
approval for the OraSure HIV-1 Oral Specimen Collection
Device was announced in the Federal Register of May 24, 1996 (61 FR
26187). The OraSure HIV-1 Western Blot Kit is indicated for
use as an additional, more specific test for HIV-1 antibodies in
OraSure HIV-1 Oral Specimen Collection Device specimens
collected from individuals, found to be repeatedly reactive by the Oral
Fluid Vironostika HIV-1 Microelisa System screening test
manufactured by Organon Teknika Corp. On June 3, 1996, CBER approved
the application by a letter to the applicant from the Director, Office
of Blood Research and Review, CBER.
The June 3, 1996, approval letter included two specific conditions
of approval for the OraSure HIV-1 Western Blot Kit. One
condition states that an expiration dating period of 18 months at 2-8
deg.C was granted for OraSure HIV-1 Western Blot Kit. The
protocol used to establish the expiration dating is an approved
protocol for the purpose of extending the expiration dating as provided
by 21 CFR 814.39(a)(8). The other condition specifies that
OraSure HIV-1 Western Blot Kit is intended for professional
use only and that commercial distribution of the device is limited to
sale for use within a clinical laboratory setting.
FDA has determined that, to ensure safe and effective use, the
device is restricted within the meaning of section 520(e) of the act
(21 U.S.C. 360j(e)) under the authority of section 515(d)(1)(B)(ii) of
the act (21 U.S.C. 360e(d)(1)(B)(ii)) insofar as the device is intended
for professional use only and commercial distribution is limited to
sale for use within a clinical laboratory setting. The sale,
distribution, and use of the device must not violate section 502(q) and
(r) of the act (21 U.S.C. 352(q) and (r)).
A summary of the safety and effectiveness data on which CBER based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity for Administrative Review
Section 515(d)(3) of the act authorizes any interested person to
petition, under section 515(g) of the act, for administrative review of
CBER's decision to approve this application. A petitioner may request
either a formal hearing under part 12 (21 CFR part 12) of FDA's
administrative practices and procedures regulations or a review of the
application and CBER's action by an independent advisory committee of
experts. A petition is to be in the form of a petition for
reconsideration under
[[Page 57448]]
Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form
of review requested (hearing or independent advisory committee) and
shall submit with the petition supporting data and information showing
that there is a genuine and substantial issue of material fact for
resolution through administrative review. After reviewing the petition,
FDA will decide whether to grant or deny the petition and will publish
a notice of its decision in the Federal Register. If FDA grants the
petition, the notice will state the issue to be reviewed, the form of
review to be used, the persons who may participate in the review, the
time and place where the review will occur, and other details.
Petitioners may, at any time on or before December 6, 1996, file
with the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director, Center for Biologics Evaluation and
Research (21 CFR 5.53).
Dated: October 25, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-28531 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F