[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]
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