[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