[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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