[Federal Register Volume 61, Number 241 (Friday, December 13, 1996)]
[Notices]
[Page 65580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31744]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0461]
Allergan Optical; Premarket Approval of Refresh CL
Lubricating and Rewetting Drops
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 Allergan Optical, Irvine, CA, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of Refresh CL Lubricating and Rewetting Drops. FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of September 25, 1996, of the approval of the
application.
DATES: Petitions for administrative review by January 13, 1997.
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: James F. Saviola, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration,9200
Corporate Blvd., Rockville, MD 20850, 301-594-1744.
SUPPLEMENTARY INFORMATION: On May 6, 1996, Allergan Optical, Irvine, CA
92713-9534, submitted to CDRH an application for premarket approval of
Refresh CL Lubricating and Rewetting Drops. The device is a
solution indicated for the lubrication and rewetting of soft contact
lenses. The device helps to relieve dryness, discomfort, and irritation
that may be associated with lens wear.
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
Ophthalmic 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 25, 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 (21 U.S.C. 360(g), for
administrative review of CDRH's decision to approve this application. A
petitioner may request either a formal hearing under 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 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 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 January 13, 1997, 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: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-31744 Filed 12-12-96; 8:45 am]
BILLING CODE 4160-01-F
