[Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
[Notices]
[Pages 63818-63819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4491]


Reuse of Single Use Devices; FDA's Proposed Strategy; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA) is announcing the following 
meeting: Reuse of Single Use Devices--FDA's Proposed Strategy. The 
topic to be discussed is the current practice of reprocessing and 
reusing devices that are labeled, or otherwise intended, for only one 
use and FDA's proposed strategy to address concerns regarding this 
practice.
Date and Time: The meeting will be held on December 14, 1999, 8 a.m. to 
5:30 p.m.
Location: The meeting will be held at the University of Maryland 
Auditorium, 9640 Gudelsky Dr., Rockville, MD.

FOR FURTHER INFORMATION CONTACT: Heather Howell, Center for Devices and 
Radiological Health (HFZ-205), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD, 20850, 301-594-3252, FAX 301-443-7185, 
Internet site: http://www.fda.gov/cdrh/reuse, e-mail: 
[email protected].
Registration and Requests for Oral Presentations: Please register 
online on the Internet at http://www.fda.gov/cdrh/reuse by December 1, 
1999. There is no charge to attend this meeting, but advance 
registration is requested due to limited seating. Those desiring to 
make formal oral presentations should submit a brief statement of the 
general nature of their presentation, the names and addresses of the 
proposed participants, and an indication of the approximate time 
requested to make their presentation. The time allotted for each 
presentation is limited.
    Written comments may be submitted to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, by December 1, 1999.
    If you need special accommodations due to a disability, please 
contact Heather Howell at least 7 days in advance of the meeting.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA announced the availability of a document entitled ``FDA's 
Proposed Strategy on Reuse of Single-Use Devices'' in the Federal 
Register of November 3, 1999 (64 FR 59782). The document presents the 
agency's current thinking about the best way to address the concerns 
regarding the practice of reprocessing and reusing devices that are 
labeled, or otherwise intended, for only one use. The agency is 
interested in discussing this proposed strategy, and it is soliciting 
comments, proposals for alternative approaches, and information on this 
issue.

II. Electronic Access

    In order to receive ``FDA's Proposed Strategy on Reuse of Single 
Use

[[Page 63819]]

Devices`` via your fax machine, call the CDRH Facts-On-Demand system at 
800-899-0381 or 800-827-0111 from a touch-tone telephone. At the first 
voice prompt press 1 to access DSMA Facts, at the second voice prompt 
press 2, and then enter the document number 2525 followed by the pound 
sign (#). Then follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of ``FDA's Proposed Strategy 
on Reuse of Single Use Devices'' may also do so using the Internet. 
CDRH maintains an entry on the Internet for easy access to information 
including text, graphics, and files that may be downloaded to a 
personal computer with access to the Internet. Updated on a regular 
basis, the CDRH home page includes ``FDA's Proposed Strategy on Reuse 
of Single Use Devices,'' device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh.

    Dated: November 12, 1999.
David W. Feigal, Jr.,
Director, Center for Devices and Radiological Health.
[FR Doc. 99-30303 Filed 11-19-99; 8:45 am]
BILLING CODE 4160-01-F