[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28052-28053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0183]


Bausch & Lomb, Inc.; Premarket Approval of Bausch & 
Lomb Soflens66TM (alphafilcon A) Visibility Tinted 
Contact Lens for Extended Wear

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 Bausch & Lomb, Inc., Rochester, NY, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the BAUSCH & LOMB SofLens66TM 
(alphafilcon A) Visibility Tinted Contact Lens for Extended Wear. FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of December 16, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by June 23, 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 June 28, 1996, Bausch & Lomb, Inc., 
Rochester, NY 14692-0450, submitted to CDRH an application for 
premarket approval of the BAUSCH & LOMB 
SofLens66TM (alphafilcon A) Visibility Tinted Contact Lens 
for Extended Wear. The device is a soft (hydrophilic) contact lens and 
is indicated for daily wear or extended wear from 1 to 7 days between 
removals for cleaning and disinfection or disposal of lens, as 
recommended by the eye care practitioner. The lens is indicated for the 
correction of refractive ametropia (myopia and hyperopia) in not-
aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 
diopters or less, that does not interfere with visual acuity.

    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 Devices 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 December 16, 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.
    The labeling of the BAUSCH & LOMB SofLens66TM 
(alphafilcon A) Visibility Tinted Contact Lens for Extended Wear states 
that the lens is to be used only with certain solutions for 
disinfection and other purposes. The restrictive labeling informs new 
users that they must avoid using certain products, such as solutions 
intended for use with hard contact lenses only.

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 June 23, 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

[[Page 28053]]

(21 CFR 5.10) and redelegated to the Director, Center for Devices and 
Radiological Health (21 CFR 5.53).

    Dated: April 22, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-13535 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F