[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