[Federal Register Volume 59, Number 136 (Monday, July 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17373]


[[Page Unknown]]

[Federal Register: July 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94M-0220]

 

Wesley-Jessen; Premarket Approval of Wesley-Jessen 
Multi-Purpose Solution

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 Wesley-Jessen, Des Plaines, IL, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Wesley-Jessen Multi-Purpose Solution. FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of June 1, 1994, of the approval of the 
application.

DATES: Petitions for administrative review by August 17, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: James F. Saviola, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1744.

SUPPLEMENTARY INFORMATION: On December 19, 1991, Wesley-Jessen, Des 
Plaines, IL 60018, submitted to CDRH an application for premarket 
approval of the Wesley-Jessen Multi-Purpose Solution. The 
device is a chemical disinfection solution and is indicated for use in 
the chemical (NOT HEAT) disinfection, cleaning, rinsing, and storage of 
soft (hydrophilic) contact lenses.
     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, an FDA advisory panel, for review and 
recommendation because the information in the PMA substantially 
duplicates information previously reviewed by this panel.
    On June 1, 1994, CDRH approved the application by a letter to the 
applicant from the Acting 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 (21 U.S.C. 360e(d)(3)) 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 17, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: July 1, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-17373 Filed 7-15-94; 8:45 am]
BILLING CODE 4160-01-F