[Federal Register Volume 60, Number 71 (Thursday, April 13, 1995)]
[Notices]
[Pages 18845-18846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9181]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0068]


Polymer Technology Division of Wilmington Partners L. P.; 
Premarket Approval of BOSTON Advance<Register> Comfort Formula 
Conditioning 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 Polymer Technology Division of 
Wilmington Partners L. P., Wilmington, MA, for 

[[Page 18846]]
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the BOSTON Advance<Register> Comfort Formula Conditioning 
Solution. FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of March 1, 1995, of the approval of 
the application.

DATES: Petitions for administrative review by May 15, 1995.

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: David M. Whipple, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1744.

SUPPLEMENTARY INFORMATION: On December 29, 1992, Polymer Technology 
Division of Wilmington Partners L. P., Wilmington, MA 01887, submitted 
to CDRH an application for premarket approval of the BOSTON 
Advance<Register> Comfort Formula Conditioning Solution. The device is 
a disinfecting and soaking solution and is indicated for disinfecting 
and soaking fluoro silicone acrylate and silicone acrylate rigid gas 
permeable 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 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 March 1, 1995, 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 (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 May 15, 1995, 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: March 24, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-9181 Filed 4-12-95; 8:45 am]
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