[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Pages 62419-62420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25918]



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: [email protected]; 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: [email protected].
    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]