Notice: Towards an Artificial Pancreas: A Food and Drug Administration, 
National Institutes of Health, Juvenile Diabetes Research Foundation 
Public Workshop

Federal Register: April 30, 2008 (Volume 73, Number 84)           
                  Page 23470-23471

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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