[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Page 34854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0199]


Bayer Corp.; Premarket Approval of Technicon Immuno 1<Register> 
CEA Assay

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 Bayer Corp., 511 Benedict Ave., 
Tarrytown, NY, for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of Immuno 1 CEA Assay. FDA's Center for 
Devices and Radiological Health (CDRH) notified the applicant, by 
letter of January 30, 1996, of the approval of the application.

DATES: Petitions for administrative review by August 2, 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 September 29, 1994, Miles, Inc., 
Tarrytown, NY 10591, submitted to CDRH an application for premarket 
approval of Immuno 1<Register> CEA Assay. The device is an in vitro 
diagnostic device intended to quantitatively measure carcinoembryonic 
antigen (CEA) in human serum on the Technicon Immuno 1<Register> 
system. Measurements of CEA aid in the management of cancer patients by 
monitoring CEA concentrations. This diagnostic method is not intended 
for use on any other system.
    In accordance with the provisions of section 515(c)(2) of the act 
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
1990, this premarket approval application (PMA) was not referred to the 
Immunology Devices Panel of the Medical Devices Advisory Committee, an 
FDA advisory committee, for review and recommendation because the 
information in the PMA substantially duplicates information previously 
reviewed by this committee.
    On January 30, 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 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 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 2, 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 Devices and Radiological 
Health (21 CFR 5.53).

    Dated: April 9, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-16972 Filed 7-2-96; 8:45 am]
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