Document ID: FDA-2011-N-0002-0036
Agency: fda
Document Type: Notice
Title: Safety and Efficacy of Hypnotic Drugs: Public Meeting
Posted Date: 2011-04-07T04:00Z

[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19375-19376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8285]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Safety and Efficacy of Hypnotic Drugs; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss the safety and efficacy of drugs for the treatment 
of insomnia. The Division of Neurology Products (DNP) in FDA's Center 
for Drug Evaluation and Research and the Pharmaceutical Education and 
Research Institute (PERI) are cosponsoring the 2-day meeting, with the 
first day centered on issues of efficacy and the second day on safety.
    Date and Time: The public meeting will be held on Tuesday, May 10, 
and Wednesday, May 11, 2011, from 8 a.m. to 5 p.m.
    Location: The public meeting will be held at the Bethesda Marriott, 
5151 Pooks Hill Rd., Bethesda, MD 20814.
    Contact: Margaret Bogie, 703-276-0178, ext. 115, Fax: 703-276-0069; 
or Cathleen Michaloski, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4342, 
Silver Spring, MD 20993, 301-796-1123, e-mail: 
Cathleen.michaloski@fda.hhs.gov.
    Accommodations: Attendees are responsible for their own 
accommodations. Reservations can be

[[Page 19376]]

made on a space available basis at the Bethesda Marriott Pooks Hill 
(see Location).
    Registration: You are encouraged to register at your earliest 
convenience.
    A registration fee will be charged to help defray the costs of 
rental of the meeting spaces, meals and snacks provided, and to cover 
travel costs incurred by invited speakers, and other costs. The cost of 
registration is as follows:

One-Day Rates:
    Government: $475
    Academic: $795
    Industry: $895
Two-Day Rates:
    Government: $875
    Academic: $1,495
    Industry: $1,695

    Registration fees will be waived for invited speakers and members 
of the working group. If you need special accommodations due to a 
disability, please contact Margaret Bogie or Cathleen Michaloski (see 
Contact) at least 7 days in advance of the meeting.
    Registration Instructions: For further details on how to register 
for the public meeting, contact Margaret Bogie or Cathleen Michaloski 
(see Contact).

SUPPLEMENTARY INFORMATION: Insomnia is a common disorder in the United 
States, yet it remains relatively poorly understood. Questions remain, 
for example, about the definition of insomnia and the classification of 
patients with the disorder. A better understanding of insomnia should 
help lead to safer and more effective treatment. A number of 
medications have been approved for insomnia, and many experimental 
medications are currently in development. New concerns have arisen 
about the most appropriate way to evaluate both the safety and the 
efficacy of medications for insomnia, particularly given that they may 
differ in important characteristics, including both pharmacodynamic and 
pharmacokinetic properties.
    DNP and PERI plan for the first day of the meeting to center on 
issues of efficacy, including the evolving definition of insomnia, the 
classification of patients with this disorder, and the measurement of 
clinically relevant outcomes, including the choice of endpoints, 
subjective versus objective assessments, and duration of effect. The 
second day of the meeting will center on safety issues of hypnotic 
drugs, including the nature and prevalence of adverse events (AEs) 
related to the use of hypnotic drugs and evaluation of these AEs with a 
concentration on psychovigilance testing and driving-related tests.
    Additional information on the conference, program, and registration 
procedures is available on the Internet at http://peri.org/course_details.cfm?course=2072. FDA has verified the PERI Web site address, 
but FDA is not responsible for any subsequent changes to the Web site 
after this document publishes in the Federal Register.

    Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8285 Filed 4-6-11; 8:45 am]
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