Safety and Efficacy of Hypnotic Drugs; Public Meeting, 19375-19376 [2011-8285]
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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 2, 2011, from 8 a.m. to 4
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center, rm. 1503, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking and
transportation may be accessed at: http:
//www.fda.gov/AdvisoryCommittees/
default.htm; under the heading
‘‘Resources for You’’, click on ‘‘White
Oak Conference Center Parking and
Transportation Information for FDA
Advisory Committee Meetings’’. Please
note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Nicole Vesely,
Pharm.D., Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Avenue, WO31–2417, Silver Spring, MD
20993–0002, 301–796–9001, Fax: 301–
847–8533, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On May 2, 2011, the
committees will discuss safety
considerations of ultrasound contrast
agents (materials intended to improve
the clarity of ultrasound imaging),
particularly related to new information
and developments since the prior
Advisory Committee meeting on the
same topic on June 24, 2008. The
discussion will include the results of
required postmarketing safety studies
and data from postmarketing
surveillance. Specific drugs to be
discussed include: (1) New drug
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application (NDA) 21–064, perflutren
lipid microsphere injectable suspension,
Lantheus Medical Imaging, Inc.; (2)
NDA 20–899, perflutren protein-type A
microspheres injectable suspension, GE
Healthcare; and (3) the investigational
new drug (IND) application for sulfur
hexafluoride microbubble injection,
Bracco Diagnostics, Inc. Perflutren lipid
microsphere injectable suspension and
perflutren protein-type A microspheres
injectable suspension are indicated for
use in patients with suboptimal
echocardiograms to opacify the left
ventricular chamber and to improve the
delineation of the left ventricular
endocardial border (improve the clarity
of imaging of specific areas of the left
lower side of the heart).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before April 18, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 8,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 11, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
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19375
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated March 22, 2011.
Leslie Kux,
Acting Associate Commissioner for Policy.
[FR Doc. 2011–8284 Filed 4–6–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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
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mstockstill on DSKH9S0YB1PROD with NOTICES
19376
Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
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 drivingrelated tests.
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Additional information on the
conference, program, and registration
procedures is available on the Internet
at https://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.
I. Summary
The Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (35 FR 3685, February
25, 1970; 60 FR 56605, November 9,
1995; 64 FR 36361, July 6, 1999; and 72
FR 50112, August 30, 2007) is amended
to reflect the restructuring of CDER,
FDA as follows.
Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
II. Organization
CDER is headed by the Director, and
includes the following organizational
unit:
[FR Doc. 2011–8285 Filed 4–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0013]
Statement of Organizations, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has reorganized
the Center for Drug Evaluation and
Research (CDER), Office of Surveillance
and Epidemiology (OSE). This
reorganization includes the
organizations and their substructure
components as listed in this document.
This reorganization includes the
establishment of six Staffs: Executive
Operations and Strategic Planning Staff,
Regulatory Science Staff, Regulatory
Affairs Staff, Program Management and
Analysis Staff, Project Management
Staff, and Technical Information Staff. It
will also include Office of Medication
Error Prevention and Risk Management
(OMEPRM) and Office of
Pharmacovigilance and Epidemiology
(OPE) under OSE. OMEPRM will consist
of the Division of Risk Management and
the Division of Medication Error
Prevention and Analysis. OPE will
consist of the Division of Epidemiology
I and Division of Epidemiology II and
the Division of Pharmacovigilance I and
Division of Pharmacovigilance II. Also
included are the abolishment of
Business Process Improvement Staff,
Regulatory Policy Staff, and Review
Management Staff within OSE
Immediate Office.
FOR FURTHER INFORMATION CONTACT:
Karen Koenick, Center for Drug
Evaluation and Research (HFD–063),
Food and Drug Administration, 11919
Rockville Pike, rm. 324, Rockville, MD
20852, 301–796–4422.
SUMMARY:
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Office of Surveillance and Epidemiology
1. Provides leadership, direction,
planning, budgeting, management, and
supervision of Divisions and Staffs; and
premarketing and postmarketing risk
assessment program operations.
2. Develops and maintains
international and national contact with
regulators.
3. Develops, coordinates, and
implements postmarket risk assessment
policy, guidance, and interpretations.
4. Initiates regulation development
and enhancement.
5. Coordinates and implements
policies and initiatives, including
information management initiatives
across the Agency.
Regulatory Science Staff
1. Provides leadership, direction, and
coordination for OSE regulatory
research activities.
2. Develops and manages
relationships with outside scientific
groups that interface with OSE scientists
on a variety of projects that relate to
OSE’s drug safety mission. These
outside groups include academic
organizations, private organizations, and
other Federal Agencies.
3. Coordinates the access to large
databases for pharmacoepidemiologic
and pharmacovigilance studies, as well
as to the outside scientists with drug
safety expertise to collaborate with
CDER.
4. Develops regulatory research
programs that will support OSE as a
whole, including risk management,
pharmacovigilance, and medication
error detection and prevention; in
addition to epidemiology.
Regulatory Affairs Staff
1. Responsible for the coordination
and implementation of regulatory
policies by staff within OSE by
coordinating the development and
upkeep of guidances, MAPPs, and
standard operating procedures,
answering regulatory questions,
managing the process for waivers of
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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]
BILLING CODE 4160-01-P
