[Federal Register Volume 61, Number 135 (Friday, July 12, 1996)]
[Notices]
[Pages 36733-36734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17687]
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Food and Drug Administration
[Docket No. 96M-0219]
Abbott Laboratories; Premarket Approval of Abbott PGR-ICA
Monoclonal
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 Abbott Laboratories, Abbott
Park, IL, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act
[[Page 36734]]
(the act), of Abbott PGR-ICA Monoclonal. FDA's Center for Devices and
Radiological Health (CDRH) notified the applicant, by letter of
September 26, 1995, of the approval of the application.
DATES: Petitions for administrative review by August 12, 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: Cornelia B. Rooks, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION: On February 6, 1992, Abbott Laboratories,
Abbott Park, IL 60064-3500, submitted to CDRH an application for
premarket approval of Abbott PGR-ICA Monoclonal. The device is for the
detection of human progesterone receptor (PgR) in breast tumor tissue
to be used as an aid in assessing the likelihood of response to
hormonal therapy, and as an aid in the prognosis and management of
breast cancer patients.
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
Clinical Chemistry and Clinical Toxicology 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
26, 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 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 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 12, 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 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-17687 Filed 7-11-96; 8:45 am]
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