[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34853-34854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0195]


Ciba Corning Diagnostics Corp.; Premarket Approval of ACSTM 
AFP

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 Ciba Corning Diagnostics Corp., 
Medfield, MA, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of ACSTM AFP. FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant by letter of 
September 29, 1995, 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 October 18, 1993, Ciba Corning 
Diagnostics Corp., Medfield, MA 02052-1688, submitted to CDRH an 
application for premarket approval of ACSTM AFP. The device is a 
two-site chemiluminescence immunoassay and is indicated for the 
quantitative determination of alpha-fetoprotein (AFP) in human serum 
and in amniotic fluid from specimens obtained at 15 to 20 weeks 
gestation as an aid in detecting open neural tube defects (NTD's) when 
used in conjunction with ultrasonography and amniography; and in human 
serum, as an aid in managing nonseminomatous testicular cancer, when 
used in conjunction with physical examination, histology/pathology, and 
other clinical evaluation procedures, using the Ciba Corning ACS:180 
automated chemiluminescence 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 panel.
    -On September 29, 1995, 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

[[Page 34854]]

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 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: June 13, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-16885 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F