[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Notices]
[Pages 51467-51468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20659]


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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: [email protected].
    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. There is no registration fee for the 
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

[[Page 51468]]

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