[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]
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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.
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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 http://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 http://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 http://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]
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