Science of Abuse Liability Assessment; Public Workshop
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@example.com; or Corinne P. Moody, Center for Drug Evaluation and Research, Food and DrugAdministration, 10903 New Hampshire Ave., Bldg. 51, rm. 5144, Silver Spring, MD 20993-0002, 301-796-5402, e-mail:Corinne.firstname.lastname@example.org.
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.
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.