[Federal Register Volume 77, Number 197 (Thursday, October 11, 2012)]
[Notices]
[Pages 61767-61768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1025]


The Science of Small Clinical Trials; Notice of Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA), together with the National 
Institutes of Health (NIH) Office of Rare Diseases Research, National 
Center for Advancing Translational Sciences, is announcing a course 
entitled ``The Science of Small Clinical Trials.'' The course is 
intended to present an overall framework and provide training in the 
scientific aspects of designing and analyzing clinical trials based on 
small study populations. The course will bring together subject experts 
and stakeholders to identify when such trials should be conducted, 
along with strategies and trial designs that are conducive to 
overcoming the challenges they present.
    The goal of this course is to engage and educate FDA reviewers, NIH 
scientists, clinicians, academics and industry representatives with 
experience in human subject research, seeking to build upon their 
existing knowledge and to obtain a broader

[[Page 61768]]

context of what is known about small clinical trials across medical 
products (e.g. drugs, biologics, and devices).
    Date and Time: The course will be held on November 27, 2012, from 8 
a.m. to 5 p.m., and November 28, 2012, from 8 a.m. to 3 p.m.
    Location: The course will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(rm. 1503), Section A, Silver Spring, MD 20993-0002. Entrance for 
course participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. A live Web cast will be made available for FDA 
participants only. For participants who cannot attend the live course, 
a recorded Web cast will be made available after the course.
    Contact: For information regarding this notice: Francesca Joseph, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
5264, Silver Spring, MD 20993-0002, 301-796-6805, FAX: 301-847-8621, 
email: [email protected].
    For information regarding the course and registration: Megan 
McNamee, ICF International, 530 Gaither Rd., suite 500, Rockville, MD 
20850, 301-407-6627, email: [email protected].
    Registration: Interested participants may register for this course 
at the following Web site: https://events-support.com/events/FDA-NIH_Science_Small_Clinical_Trials.
    If you need sign language interpretation during this course, please 
contact Francesca Joseph at [email protected] by October 26, 
2012.
    The FDA-NIH Science of Small Clinical Trials Course is presented by 
FDA's Office of Orphan Product Development, Center for Drug Evaluation 
and Research, Center for Biologics Evaluation and Research, Center for 
Devices and Radiological Health; the NIH Office of Rare Disease 
Research, National Center for Advancing Translational Sciences; and 
will also include participation from outside experts in the field. This 
educational event will consist of live presentations provided by FDA 
experts from various Centers and Offices, as well as from outside 
experts. It will also include case studies of regulatory trials and 
interactive panel discussions. The course will be recorded for 
subsequent posting on FDA's Web site.
    (FDA has verified the Web site addresses throughout this document, 
but we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

    Dated: October 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24977 Filed 10-10-12; 8:45 am]
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