[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]


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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.

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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