[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)]
[Notices]
[Pages 38206-38207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18556]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0216]
Biomira Diagnostics, Inc.; Premarket Approval of
TRUQUANT BRTM RIA
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 Thomas Tsakeris, Devices and
Diagnostics Consulting Group, Rockville, MD, U.S. Representative for
Biomira Diagnostics Inc., 30 Meridian Rd., Rexdale, ON, Canada, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of TRUQUANT BRTM RIA. After reviewing the
recommendation of the Immunology Devices Panel, FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant, by
letter of March 29, 1996, of the approval of the application.
DATES: Petitions for administrative review by August 22, 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: Peter E. Maxim, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION: On February 24, 1995, Thomas M. Tsakeris,
Devices and Diagnostics Consulting Group, Rockville, MD, U.S.
Representative for Biomira Diagnostics, Inc., Rexdale, ON, Canada,
submitted to CDRH an application for premarket approval of
TRUQUANT BRTM RIA. The device is an in vitro diagnostic
device indicated for quantitative determination of CA 27.29 antigen in
serum or EDTA plasma of patients previously treated for Stage II or
Stage III breast cancer. Serial testing for CA 27.29 antigen with
TRUQUANT BRTM RIA in patients who are clinically free of
disease should be used in conjunction with other clinical methods used
for the early detection of recurrence.
-On September 21, 1995, the Immunology Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On March 29, 1996, CDRH
approved the application by a letter to the applicant from the Director
of the Office of Device Evaluation, CDRH.
-A summary of the safety and effectiveness data on which CDRH 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 CDRH'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 CDRH'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 the 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 August 22, 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.
[[Page 38207]]
-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 Devices and Radiological
Health (21 CFR 5.53).
Dated: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-18556 Filed 7-22-96; 8:45 am]
BILLING CODE 4160-01-F
