[Federal Register Volume 66, Number 185 (Monday, September 24, 2001)]
[Notices]
[Pages 48885-48886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23805]


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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://www.fda.gov/dockets/ecomments.
    Registration: Submit registration information by close of business 
on October 17, 2001, electronically at 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: [email protected] or 
[email protected].

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://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