[Federal Register Volume 61, Number 102 (Friday, May 24, 1996)]
[Notices]
[Pages 26186-26187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13176]



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[[Page 26187]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0212]


Epitope, Inc.; Premarket Approval of OraSure HIV-1 Oral 
Specimen Collection Device

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 by Epitope, Inc., Beaverton, OR, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the OraSure HIV-1 Oral Specimen Collection Device. 
FDA's Center for Biologics Evaluation and Research (CBER) notified the 
applicant, by letter of December 23, 1994, of the approval of the 
application. A revised approval letter was issued on October 18, 1995.

DATES: Petitions for administrative review by June 24, 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 May 9, 1991, Epitope, Inc., Beaverton, OR 
97008, submitted to CBER an application for premarket approval of the 
OraSure HIV-1 Oral Specimen Collection Device. The device is 
intended for use in the collection of oral fluid specimens by properly 
trained individuals for the purpose of testing for the presence of 
antibodies to human immunodeficiency virus Type 1 (HIV-1). The 
OraSure HIV-1 Oral Specimen Collection Device consists of 
both an absorbent cotton fiber pad treated with a proprietary salt 
solution and gelatin affixed to a plastic stick, and a preservative 
solution supplied in a plastic container. OraSure HIV-1 oral 
fluid specimens are intended to be used only with the Oral Fluid 
Vironostika HIV-1 Microelisa System screening test manufactured by 
Organon Teknika Corp. The device is intended for use with subjects 13 
years of age or older.
    On December 19, 1992, the premarket approval application (PMA) was 
referred to the Blood Products Advisory Committee, an FDA advisory 
committee, for review and recommendation. On June 22, 1994, the PMA was 
referred to the same advisory committee for discussion of post-approval 
requirements for surveillance studies.
    On December 23, 1994, CBER approved the application by a letter to 
the applicant from the Acting Director, Office of Blood Research and 
Review, CBER. In response to additional discussions between the 
manufacturer and FDA, a revised approval letter was issued on October 
18, 1995.
    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: (1) Before shipping 
the device to any customer, Epitope, Inc., must have on file a ``Letter 
of Agreement for Physician'' signed by the physician who agrees to 
assume the outlined responsibilities on behalf of the customer; (2) the 
administration of the device is restricted to individuals who have been 
trained in the use of the device according to approved labeling; (3) 
testing of OraSure samples for HIV-1 antibodies is restricted 
to the Oral Fluid Vironostika HIV-1 Microelisa System screening test 
manufactured by Organon Teknika Corp.; (4) the device is not to be 
provided to subjects for home use; (5) the device is not to be used to 
screen blood donors; and (6) prior to specimen collection, a test 
subject must receive a copy of the subject information sheet. The sale, 
distribution, and use of the device must not violate sections 502(q) 
and (r) of the act (21 U.S.C. 352(q) and 352(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 (21 U.S.C. 360e(d)(3)) 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 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 June 24, 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: May 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13176 Filed 5-23-96; 8:45 am]
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