[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:
reuse@cdrh.fda.gov.
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
