[Federal Register: September 24, 2001 (Volume 66, Number 185)]
[Notices]
[Page 48885-48886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se01-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0397]
Transportation Safety and Potentially Sedating or Impairing
Medications; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to gather data on the potential public health consequences
related to sedating or impairing medications. This meeting will be
jointly sponsored with the National Transportation Safety Board (NTSB).
The meeting will be held to determine what data are available to define
the role of sedating or impairing medications in accidents and related
injuries, how the potential for medications to cause impairment might
be best assessed, and how this risk would be most effectively
communicated to the public.
DATES: The meeting will be held on November 14, 2001, from 8 a.m. to 5
p.m. and November 15, 2001, from 8 a.m. to 4 p.m. Persons desiring to
make oral presentations during the meeting must register by October 17,
2001. Submit written or electronic comments by December 17, 2001.
ADDRESSES: The public meeting will be held at the National
Transportation Safety Board (NTSB) Board Room, 429 L'Enfant Plaza, SW.,
Washington, DC 20594. Submit written comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Registration: Submit registration information by close of business
on October 17, 2001, electronically at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Once on this Internet
site, select Docket No. 01N-0397 and follow the directions. Submit
registration information by mail to Dockets Management Branch (address
above).
FOR FURTHER INFORMATION CONTACT: Lee Lemley or Anne M Food and Drug
Administration,. Henig, Center for Drug Evaluation and Research (HFD-
006), Food and Drug Administration, 5600 Fishers Lane Rockville, MD
20857, 301-594-6779, e-mail: lemleyl@cder.fda.gov or
heniga@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background Information
Why is FDA/NTSB holding this meeting?
FDA/NTSB is holding this joint meeting in response to NTSB Safety
Recommendation I-00-5, requesting that FDA (1) Establish a clear,
consistent, easily recognizable warning label for all prescription and
over-the-counter medications that may interfere with an individual's
ability to operate a vehicle and (2) require that the label be
prominently displayed on all packaging of such medications.
On what issues does FDA seek comment?
What data are available to show that sedating or impairing
medications contribute to accidents?
If data are available, can the public health impact of any
such effect be delineated? What type of testing would best define the
potential for a medication to contribute to accidents? Are there
validated test methods for assessing the degree of risk associated with
the use of medications that are sedating or impairing?
What would be the most effective manner of communicating
the risk of performance impairment (e.g., labeling, pictogram,
educational programs, or other manner of communication)?
What is the experience of other institutions (local,
national, and international; public and private) in assessing,
communicating, and preventing the risk of sedating or impairing
medications in vehicle operators? How are currently applicable laws and
regulations enforced?
II. Registration and Requests to Make Oral Presentations
If you would like to make an oral presentation during the meeting,
you must register by close of business on October 17, 2001, either
electronically or by mail (information above). There is no registration
fee, but you must register. You must provide your name, title, business
affiliation (if applicable), address, telephone number, fax number, e-
mail address, and the type of organization you represent (e.g.,
industry, consumer organization). Registered persons should check in
before the meeting. Persons requiring a sign language interpreter or
other special accommodations should notify Lee Lemley or Anne M. Henig
at 301-594-6779 by October 31, 2001.
If you are making an oral presentation during the meeting, you must
indicate this on your registration form and submit: (1) A brief written
statement of the general nature of the views you wish to present and
(2) the names and addresses of all persons who will participate in the
presentation.
Depending on the number of people who register to make
presentations, we will limit the time allotted for each presentation
(from 3 to 5 minutes). It is anticipated that, during the meeting,
persons attending the meeting will have the opportunity to ask
questions through question cards that will be handed out.
III. Comments
Interested persons may submit to the Dockets Management Branch
(addresses above) written or electronic comments regarding the topics
addressed at the public meeting by December 17, 2001. Two copies of any
written comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Transcripts
You may access a copy of the transcript on the FDA Internet site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov, request a transcript of the meeting from the
Freedom of Information Office (HFI-35), Food and
[[Page 48886]]
Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD
20857, approximately 20 working days after the meeting, at a cost of 10
cents per page, or examine a transcript of the meeting after December
17, 2001, at the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23805 Filed 9-21-01; 8:45 am]
BILLING CODE 4160-01-S