[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] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 96M-0199] Bayer Corp.; Premarket Approval of Technicon Immuno 1CEA Assay AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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 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 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] BILLING CODE 4160-01-F