Science of Abuse Liability Assessment; Public Workshop, 62419-62420 [2011-25918]
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
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.)
Dated: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–25976 Filed 10–6–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 1, 2011, from 8 a.m.
to 6 p.m.
Location: Hilton Washington, DC
North/Gaithersburg, Salons A, B, C and
D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Avena Russell, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, rm.
1535, Silver Spring, MD 20993–0002,
301–796–3805,
Avena.Russell@fda.hhs.gov, or FDA
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hot line/phone line to learn about
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Jkt 226001
possible modifications before coming to
the meeting.
Agenda: On December 1, 2011, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application, sponsored by
Contura, Inc., for AQUAMID, a new
material (polyacrylamide) for use as a
dermal filler for aesthetic treatment of
wrinkles in the face. The AQUAMID
dermal filler is intended for use in midto-deep sub-dermal implantation for the
aesthetic treatment of moderate to
severe facial wrinkles and folds, such as
the nasolabial folds. 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 committee. Written
submissions may be made to the contact
person on or before November 22, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m., immediately following
lunch. 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 November 14, 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
November 15, 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
meetings and will make every effort to
accommodate persons with physical
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62419
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, 301–796–5966, 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/
AdvisoryCommittees/
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: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–25969 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0695]
Science of Abuse Liability
Assessment; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
to discuss the science of abuse liability
assessment. The Controlled Substance
Staff (CSS) in FDA’s Center for Drug
Evaluation and Research, Office of the
Center Director; the National Institute
on Drug Abuse (NIDA) at the National
Institutes of Health; and the College on
Problems of Drug Dependence (CPDD) at
the Temple University School of
Medicine are cosponsoring the 1-day
workshop.
Date and Time: The public workshop
will be held on Thursday, November 10,
2011, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at The Legacy Hotel and
Meeting Centre, 1775 Rockville Pike,
Rockville, MD 20852, 301–881–2300,
accessible on the Metro Red Line,
Twinbrook Station.
Contact Person: Ellen B. Geller,
CPDD, Temple University School of
Medicine, 3400 North Broad Street,
Philadelphia, PA 19140, 215–707–5307,
e-mail: ebgeller@temple.edu; or Corinne
P. Moody, Center for Drug Evaluation
and Research, Food and Drug
E:\FR\FM\07OCN1.SGM
07OCN1
jlentini on DSK4TPTVN1PROD with NOTICES
62420
Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5144, Silver Spring,
MD 20993–0002, 301–796–5402, e-mail:
Corinne.moody@fda.hhs.gov.
Accommodations: Attendees are
responsible for their own
accommodations. Reservations can be
made on a space-available basis at The
Legacy Hotel and Meeting Centre (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,
travel expenses incurred by invited
speakers, and other costs. The
registration fee is $325. Registration fees
will be waived for invited speakers and
administrative personnel.
The registration process, including
payment of the registration fee, will be
handled by CPDD. Additional
information on the workshop, program
agenda, and registration procedures is
available on the Internet at https://
www.seiservices.com/nida/1014102/.
(FDA has verified the NIDA Web site
address, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
If you need special accommodations
due to a disability, please contact Ellen
B. Geller or Corinne Moody (see Contact
Person) at least 7 days in advance of the
workshop.
Comments: FDA is holding this public
workshop to obtain information about
the science of abuse liability
assessment. The workshop will center
on status, needs, new approaches, and
paradigms regarding preclinical studies,
challenges associated with human
subject abuse potential studies, and
adverse events that signal abuse
potential during clinical trials. The
deadline for submitting comments about
this public workshop is January 10,
2012.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic or written
comments regarding the issues
presented at the workshop. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
VerDate Mar<15>2010
16:33 Oct 06, 2011
Jkt 226001
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 27, 2010 (75
FR 4400), FDA announced the
publication of a draft guidance for
industry on ‘‘Assessment of Abuse
Potential of Drugs,’’ and requested
comments on the draft guidance. There
were 23 submissions to the docket with
approximately 750 comments received
from academia, industry, and the
government. General and specific
comments were received on every
section of the draft guidance. The
comment period has closed and FDA is
gathering current information that may
relate to some of the comments
received. Questions remain, for
example, about when abuse potential
studies should be conducted, and about
the signals of abuse or potential abuse
observed in clinical trials. This
workshop is another mechanism for
continuation of discussion with
interested stakeholders before FDA
finalizes the draft guidance.
Transcripts: Please be advised that as
soon as a transcript is available it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: October 3, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–25918 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 76 FR 54236 dated
August 31, 2011).
This notice reflects organizational
changes to the Health Resources and
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Services Administration. Specifically,
this notice updates the Office of
Information Technology (RB5)
functional statement. The update to the
functional statement will better align
functional responsibility with improved
security management capabilities and
improved alignment of current security
initiatives within the Office of
Information Technology (RB5).
Chapter RB5—Office of Information
Technology
Section RB5–10, Organization
The Office of Information Technology
(RB5) is headed by the Director and
Chief Information Officer, who reports
directly to the Chief Operating Officer.
Section RB5–20, Functions
(1) Delete the functional statement for
the Office of the Director (RB5) and
replace in its entirety; and (2) delete the
functional statement for the Division of
IT Operational Support Services (RB58)
and replace in its entirety.
Office of the Director (RB5)
The Chief Information Officer (CIO) is
responsible for the organization,
management, and administrative
functions necessary to carry out the
responsibilities of the CIO including: (1)
Provides organizational development,
investment control, budget formulation
and execution, policy development,
strategic and tactical planning, and
performance monitoring; (2) provides
leadership in the development, review
and implementation of policies and
procedures to promote improved
information technology management
capabilities and best practices
throughout HRSA; and (3) coordinates
IT workforce issues and works closely
with the departmental Office of Human
Resources Management on IT
recruitment and training issues.
The Chief Information Security
Officer (CISO), reporting to the CIO,
provides leadership for, and
collaborates with, Agency staff to
oversee the implementation of security
and privacy policy in the management
of their IT systems, and plans all
activities associated with Federal
Information Security Management Act
(FISMA) or other agency security and
privacy initiatives, and also carries out
the responsibilities including: (1)
Implements, coordinates, and
administers security and privacy
programs to protect the information
resources of HRSA in compliance with
legislation, Executive Orders, directives
of the Office of Management and Budget
(OMB), or other mandated requirements
e.g., Presidential Decision Directive 63,
E:\FR\FM\07OCN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62419-62420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0695]
Science of Abuse Liability Assessment; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop to discuss the science of abuse liability assessment. The
Controlled Substance Staff (CSS) in FDA's Center for Drug Evaluation
and Research, Office of the Center Director; the National Institute on
Drug Abuse (NIDA) at the National Institutes of Health; and the College
on Problems of Drug Dependence (CPDD) at the Temple University School
of Medicine are cosponsoring the 1-day workshop.
Date and Time: The public workshop will be held on Thursday,
November 10, 2011, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at The Legacy Hotel and
Meeting Centre, 1775 Rockville Pike, Rockville, MD 20852, 301-881-2300,
accessible on the Metro Red Line, Twinbrook Station.
Contact Person: Ellen B. Geller, CPDD, Temple University School of
Medicine, 3400 North Broad Street, Philadelphia, PA 19140, 215-707-
5307, e-mail: ebgeller@temple.edu; or Corinne P. Moody, Center for Drug
Evaluation and Research, Food and Drug
[[Page 62420]]
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5144, Silver
Spring, MD 20993-0002, 301-796-5402, e-mail: Corinne.moody@fda.hhs.gov.
Accommodations: Attendees are responsible for their own
accommodations. Reservations can be made on a space-available basis at
The Legacy Hotel and Meeting Centre (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,
travel expenses incurred by invited speakers, and other costs. The
registration fee is $325. Registration fees will be waived for invited
speakers and administrative personnel.
The registration process, including payment of the registration
fee, will be handled by CPDD. Additional information on the workshop,
program agenda, and registration procedures is available on the
Internet at https://www.seiservices.com/nida/1014102/. (FDA has verified
the NIDA Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
If you need special accommodations due to a disability, please
contact Ellen B. Geller or Corinne Moody (see Contact Person) at least
7 days in advance of the workshop.
Comments: FDA is holding this public workshop to obtain information
about the science of abuse liability assessment. The workshop will
center on status, needs, new approaches, and paradigms regarding
preclinical studies, challenges associated with human subject abuse
potential studies, and adverse events that signal abuse potential
during clinical trials. The deadline for submitting comments about this
public workshop is January 10, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments regarding the issues
presented at the workshop. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 27, 2010
(75 FR 4400), FDA announced the publication of a draft guidance for
industry on ``Assessment of Abuse Potential of Drugs,'' and requested
comments on the draft guidance. There were 23 submissions to the docket
with approximately 750 comments received from academia, industry, and
the government. General and specific comments were received on every
section of the draft guidance. The comment period has closed and FDA is
gathering current information that may relate to some of the comments
received. Questions remain, for example, about when abuse potential
studies should be conducted, and about the signals of abuse or
potential abuse observed in clinical trials. This workshop is another
mechanism for continuation of discussion with interested stakeholders
before FDA finalizes the draft guidance.
Transcripts: Please be advised that as soon as a transcript is
available it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: October 3, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-25918 Filed 10-6-11; 8:45 am]
BILLING CODE 4160-01-P
