News
[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Notices]
[Page 51467-51468]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au10-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0423]
ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic
Devices) Study Children Workshop; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ASK (Assess Specific Kinds of CHILDREN Challenges for
Neurologic Devices) Study Children Workshop. The purpose of the public
workshop is to solicit comments from academic investigators and
clinicians associated with the use, research and/or development of
pediatric neuroprostheses regarding approaches for enhancing the
protection and promotion of public health in children and adolescents
with neuroprostheses. The public workshop will provide an overview of
pediatric initiatives across the Agency, neurological and neurosurgical
perspectives on medical devices, a review of pediatric assessments and
outcome measures, and scientific research issues associated with the
use of neuroprotheses in pediatric populations, including cochlear
implants, deep brain stimulators, hydrocephalus shunts, spinal cord
stimulators, and vagus nerve stimulators. Information from this public
workshop will help establish a science-based framework of
recommendations to aid in the development of more efficient strategies
in evaluating pediatric neuroprostheses regulated by the Agency.
Dates and Time: The public workshop will be held on September 13,
2010, from 9 a.m. to 5 p.m.
Location: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Conference Center, rm. 1503, Silver
Spring, MD 20993. For lodging and directions, please refer to the
meeting on the Internet at: http://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/default.htm
Contact Person: Carlos Pe[ntilde]a, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4264, Silver Spring, MD 20993-
0002, 301-796-8521, FAX: 301-847-8617, email: carlos.pena@fda.hhs.gov.
Registration: Registration requests must be received by 5 p.m. on
September 6, 2010. If you wish to attend the public meeting, you must
register online at: http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm
public workshop. Early registration is recommended because seating is
limited. There will be no onsite registration.
If you wish to make an oral presentation at the workshop, you must
indicate this at the time of registration. FDA will do its best to
accommodate requests to speak. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation. FDA will
determine the amount of time allotted to each presenter and the
approximate time that each oral presentation is scheduled to begin.
If you wish to make an oral presentation during the open comment
period at the workshop, you must indicate this at the time of
registration. FDA requests that presentations focus on the areas
described in this notice. You should also identify which discussion
topic you wish to address in
your presentation and you must submit a brief statement that describes
your experience and/or expertise relevant to your proposed
presentation. In order to keep each open session focused on the
discussion topic at hand, each oral presentation should address only
one discussion topic. FDA will do its best to accommodate requests to
speak.
If you need special accommodations due to a disability (such as
wheelchair access or a sign language interpreter), please notify Carlos
Pe[ntilde]a, at least 7 days in advance of the meeting.
Comments: FDA is holding this public workshop to obtain information
about children and adolescents with neuroprostheses. The deadline for
submitting comments regarding this public workshop is September 6,
2010.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments regarding this
document. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville MD 20852. It is only necessary to send one set of comments.
It is no longer necessary to send two copies of mailed comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public Workshop?
The purpose of the public workshop is to solicit information from
academic investigators and clinicians associated with the use, research
and/or development of pediatric neuroprostheses regarding approaches
for enhancing the protection and promotion of public health in children
and adolescents with neuroprostheses. Information from this public
workshop will help establish a science-based framework of
recommendations to aid in the development of more efficient strategies
in evaluating pediatric neuroprostheses regulated by the Agency.
The agency seeks discussion with interested parties regarding the
use of neuroprostheses in pediatric populations. The public workshop
will provide an overview of pediatric initiatives across the Agency,
neurological and neurosurgical perspectives on medical devices, a
review of pediatric assessments and outcome measures, and scientific
research issues associated with the use of neuroprotheses in pediatric
populations, including cochlear implants, deep brain stimulators,
hydrocephalus shunts, spinal cord stimulators, and vagus nerve
stimulators.
Since the Food and Drug Administration Amendments Act of 2007 was
signed into law, there has been increased interest in stimulating
scientifically sound clinical research related to pediatric
populations. However, to date, none of the initiatives has focused
specifically on neuroprosthetic devices for pediatric patients. It is
hoped that this meeting will provide a forum for open discussion and
information exchange among interested parties, FDA, and other
stakeholders to lay a framework for establishing a science-based
framework of recommendations to aid in the development of more
efficient strategies in evaluating pediatric neuroprostheses regulated
by the Agency and stimulating further research into the use of devices
to treat disorders and diseases that affect pediatric patients.
II. What Will Be the Format for the Meeting?
The format for the meeting will include general sessions in the
morning and the afternoon. Invited expert speakers will present
information to stimulate thought regarding current needs and concerns
regarding neuroprosthetic devices that involve pediatric patients.
Presentations will be followed by a focused, moderated comment session.
III. What Are the General Topic Areas We Intend To Address at the
Public Workshop?
We hope to discuss the following topics:
Pediatric initiatives across the Agency
The ASK Children Study
Clinical perspectives
Patient and advocacy group perspectives
Science and research perspectives
The workshop will conclude with an overall open discussion that
will cover the workshop purposes and questions, areas of cooperation,
next steps, and future directions.
IV. What Are the Issues That Will Be Discussed and Considered?
Issues regarding the research and/or development of pediatric
neuroprostheses, current clinical use, and approaches for enhancing the
protection and promotion of public health in children and adolescents
with neuroprostheses will be discussed and considered.
V. Where Can I Find Out More About This Public Workshop?
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
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm
Dated: August 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20659 Filed 8-19-10; 8:45 am]
BILLING CODE 4160-01-S
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