[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Notices]
[Pages 15527-15528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0120]
Angelini Pharmaceuticals, Inc.; Premarket Approval of the 2-In-1
Drop
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 Angelini Pharmaceuticals, Inc., River
Edge, NJ, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of the 2-In-1 Drop. FDA's Center for Devices
and Radiological Health (CDRH) notified the applicant, by letter of
February 13, 1997, of the approval of the application.
DATES: Petitions for administrative review by May 1, 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 25, 1994, Angelini Pharmaceuticals,
Inc., River Edge, NJ 07661, submitted to CDRH an application for
premarket approval of the 2-In-1 Drop. The device is a contact lens
drop, packaged in a single-use container, that is indicated for use
with soft (hydrophilic) contact lenses (including disposables) and
rigid gas permeable contact lenses as a lubricating and rewetting agent
during the wearing period and as a wetting agent to cushion lenses
prior to placement on the eye. The 2-In-1 Drop may also be used in
place of a daily cleaner as part of an appropriate chemical
disinfection regimen.
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 application was not referred to the Ophthalmic Devices Panel
of the Medical Device Advisory Committee, an FDA advisory committee,
for review and recommendation because the information in the
application substantially duplicates information previously reviewed by
this panel.
On February 13, 1997, 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 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 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 May 1, 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
[[Page 15528]]
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: March 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-8169 Filed 3-31-97; 8:45 am]
BILLING CODE 4160-01-F
