[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19375-19376]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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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