[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Notices]
[Page 23470-23471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap08-98]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Towards an Artificial Pancreas: A Food and Drug Administration,
National Institutes of Health, Juvenile Diabetes Research Foundation
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA), in collaboration with
the National Institutes of Health (NIH) and the Juvenile Diabetes
Research Foundation (JDRF), is holding a public workshop focused upon
the state of the art in the research and development of an artificial
pancreas. The public workshop entitled ``Towards an Artificial
Pancreas: A Food and Drug Administration, National Institutes of
Health, and Juvenile Diabetes Research Foundation Workshop'' will
provide a public forum for discussing the progress and remaining
challenges in the development of closed-loop systems designed to
regulate glycemic control, as an aid in the management of diabetes
mellitus. It is intended to provide stakeholders with information that
will accelerate the development of an artificial pancreas.
DATES: The public workshop will be held on July 21, 2008, from 7:55
a.m. to 6 p.m., and on July 22, 2008, from 8 a.m. to 12:45 p.m.
Registration is available until 5 p.m. on June 20, 2008 (See
REGISTRATION TO ATTEND THE PUBLIC WORKSHOP).
ADDRESSES: The public workshop will be held at the Lister Hill
Auditorium on the NIH Campus (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/science/campus/index.html) located at 9000 Rockville Pike, Bethesda, MD 20892.
Parking on the NIH campus is limited. Attendees are encouraged to
take public transportation. There is limited parking available at the
Natcher Building. See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/directions.htm for more
information.
FOR FURTHER INFORMATION CONTACT: Arleen Pinkos, Center for Devices and
Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville, MD 20850,
240-276-0702, FAX 240-276-0651, e-mail: arleen.pinkos@fda.hhs.gov.
REGISTRATION TO ATTEND THE PUBLIC WORKSHOP: Those interested in
attending the public workshop may register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.blsmeetings.net/artificialpancreas08/reg.cfm. There is no
registration fee to attend the meeting; however, all participants must
submit a registration form. Space is limited, so please submit your
registration early to reserve a space. Registration will be accepted
through June 20, 2008; however, onsite registration will be permitted
on a space-available basis.
Persons without Internet access may call Akia Richardson at 301-
313-0244 ext. 49, by June 20, 2008, to register for onsite attendance.
If you need special accommodations due to a disability, please
contact L'Tonya Frazier at 301-594-4453 at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
The artificial pancreas is one of FDA's Critical Path Initiatives,
a program dedicated to accelerating the availability of much needed
medical products. The Interagency Artificial Pancreas Working Group, a
group of multi-disciplined scientists and clinicians from FDA and NIH,
was established to support this initiative. The goals of the Artificial
Pancreas Initiative are twofold: to provide infrastructure for
narrowing the gap between basic biomedical knowledge and clinical
application of novel technologies, and to cross-fertilize and partner
with stakeholders in order to identify and overcome the clinical and
scientific challenges to the development of an artificial pancreas.
Through collaborative efforts, such as this workshop, the group strives
to develop innovative strategies to achieve their goals.
II. Agenda
World renowned experts will present information on topics that are
instrumental to the development of an artificial pancreas, and each
session will be followed by roundtable discussions. Session topics will
include:
State of the art design of closed-loop glycemic control
systems
Results of recently conducted clinical trials
Clinical trial design, including how to define successes
and failures of closed-loop systems
[[Page 23471]]
Algorithms and in silico models
Engineering challenges
Patient considerations
Metabolic monitoring
Use of closed-loop systems in non-diabetic intensive care
patients
Paths for developing marketable closed-loop systems
The agenda for this public workshop is available on the internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.blsmeetings.net/artificialpancreas08/agenda.pdf.
More information about this public workshop is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.blsmeetings.net/artificialpancreas08.
Dated: April 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-9375 Filed 4-29-08; 8:45 am]
BILLING CODE 4160-01-S