[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 47819-47820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Workshop on Optimizing Clinical Trial Design for the Development
of Pediatric Cardiovascular Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) and National Institutes of
Health (NIH), with support from the American Academy of Pediatrics
(AAP), the American College of Cardiology (ACC), and the Society for
Cardiovascular Angiography and Interventions (SCAI) are announcing a
public workshop entitled ``Optimizing Clinical Trial Design for the
Development of Pediatric Cardiovascular Devices.'' The topic to be
discussed is pediatric cardiovascular device development. The purpose
of the public workshop is to solicit information from clinicians,
academia, professional societies, other government agencies, and
industry on various efficient and pragmatic clinical trial designs that
are conducive to overcoming the challenges in developing devices for
the pediatric cardiology market. The information gathered in this and
future workshops will help to develop future guidance on optimal
designs for pediatric cardiology device trials.
Date and Time: The public workshop will be held on September 30,
2010, from 8 a.m. to 5:30 p.m.
Location: The public workshop will be held at Moscone Center, 747
Howard St., San Francisco, CA 94103.
Contact Person: Francesca Joseph, Office of Orphan Products
Development, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 5277, Silver Spring, MD 20903, 301-796-6805, FAX: 301-
847-8621, e-mail: [email protected].
Registration: Registration information will be posted on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
[[Page 47820]]
If you need special accommodations due to a disability, please
contact Lynn Colegrove by phone 847-434-7820 at least 7 days in
advance.
Registration and seating will be on a first-come, first-served
basis. A discussion preference will be afforded to clinical research
investigators involved in pediatric clinical device trials, health care
givers, and patient advocates. There is no registration fee to attend
the public workshop. Early registration is recommended because seating
is limited. There will be no onsite registration.
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 (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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 Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: In the medical device industry, rarely have
devices been developed, evaluated, and approved specifically for
treatment of children with congenital heart disease. The small,
heterogeneous population, need for long-term followup, lack of market
incentive, and misperceptions of regulatory requirements and costs are
a few of the issues that make a standard randomized control trial
difficult to conduct in pediatric cardiology. The goal of the workshop
is to educate the medical device industry and pediatric clinical
community about device development and regulatory approval processes,
and to identify clinical trial designs that lend themselves to
overcoming the challenges in pediatric cardiovascular device
development. Subsequently making this information available to
industry, the clinical community, and the public is imperative to
furthering the development of pediatric cardiovascular devices and
alleviating this critical unmet need. The marketing approval of more
cardiovascular devices specifically designed and/or labeled for
pediatric patients would have a significant impact on public health.
Invited experts will address types of clinical trials with a particular
focus on trial designs and statistical analysis methods, as well as
alternative sources of clinical data, that can help to address the
challenges in this particular patient population. After each section
there will be an audience question and answer session and panel
discussion allowing workshop participants to interact with the speakers
and panelists. A concluding session will allow for additional
interactions.
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
Dated: August 4, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-19530 Filed 8-6-10; 8:45 am]
BILLING CODE 4160-01-S