[Federal Register Volume 62, Number 112 (Wednesday, June 11, 1997)]
[Notices]
[Pages 31831-31832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15167]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0186]


Millenium Medical Supply, Inc.; Premarket Approval of Needle-
EaseTM 2501

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application submitted by Louise N. Howe of the law firm 
HALE and DORR, as the U.S. Representative on behalf of Millenium 
Medical Supply, Inc., Ontario, Canada, for premarket approval, under 
the Federal Food, Drug, and Cosmetic Act (the act), of Needle-
EaseTM 2501. FDA's Center for Devices and Radiological 
Health (CDRH) notified the applicant, by letter of March 6, 1997, of 
the approval of the application.

DATES: Petitions for administrative review by July 11, 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: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION: On December 6, 1996, Louise N. Howe of the 
law firm HALE and DORR, as the U.S. Representative on behalf of 
Millenium Medical Supply, Inc., Ontario, Canada, N3T 5M1, submitted to 
CDRH an application for premarket approval of Needle-EaseTM 
2501. This device is a sharps needle destruction device that is 
intended for home use by diabetics to reduce the incidence of 
needlesticks by the incineration of 28-30 gauge needles, 29 and 30 
gauge diabetic ``pen tips,'' and 23-26 gauge diabetic lancets.
    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 
General Hospital and Personal Use 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 6, 
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

[[Page 31832]]

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 
(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 the 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 July 11, 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 (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. 97-15167 Filed 6-10-97; 8:45 am]
BILLING CODE 4160-01-F