[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]
BILLING CODE 4160-01-F
