Advertisement
News
Advertisement

Federal Register: ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) Study Children Workshop; Public Workshop; Request for Comments

Fri, 08/20/2010 - 5:34am
U.S. Food & Drug Administration

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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. 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

SOURCE

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading