[Federal Register Volume 75, Number 21 (Tuesday, February 2, 2010)]
[Notices]
[Pages 5335-5336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Workshop on Pediatric Neurological and Neurocognitive Assessments 
for Cardiovascular Devices; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Workshop on Pediatric Neurological and 
Neurocognitive Assessments for Cardiovascular Devices.'' The purpose of 
the public workshop is to solicit information from clinicians, 
academia, professional societies, other government agencies, and 
industry on various neurological and neurocognitive assessments for 
pediatric patients implanted with cardiovascular devices. The 
information gathered in this and future workshops will help to develop 
future guidance for the administration of these assessments.
    Date and Time: The public workshop will be held on March 25, 2010, 
from 8 a.m. to 5 p.m. Participants are encouraged to arrive early to 
ensure time for parking and security screening before the meeting. 
Security screening will begin at 7:30 a.m. and check-in will begin at 8 
a.m.

[[Page 5336]]

    Location: The public workshop will be held at the Food and Drug 
Administration, White Oak Campus, Bldg. 2, Central Shared Use Building, 
rm. 2047, 10903 New Hampshire Ave., Silver Spring, MD 20903.
    Contact Person: Sonna Patel-Raman, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, rm. 1255, 
10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-6335, FAX: 
301-847-8115, e-mail: [email protected].
    Registration: Registration and seating will be on a first-come, 
first-served basis and discussion preference will be afforded to 
clinical research investigators involved in pediatric clinical device 
trials, health care givers, and patient advocates. E-mail your 
registration information (including name, title, firm name, address, 
telephone and fax numbers) to the contact person by February 25, 2010. 
There is no registration fee to attend the public workshop. Early 
registration is recommended because seating is limited. There will be 
no onsite registration.
    Non-U.S. citizens are subject to additional security screening, and 
they should register as soon as possible. If you need special 
accommodations due to a disability, please contact Sonna Patel-Raman by 
February 25, 2010.

SUPPLEMENTARY INFORMATION: The goal of the workshop is to understand 
and review the current clinical practices for these assessments in the 
pediatric population and to discuss options for standardized practices 
that may be used and validated during pediatric device trials. There 
are several neurological and neurocognitive assessments used in adults 
and pediatric patients. However a lack of sufficient data and validated 
measures, due to the limited pediatric population, has restricted 
growth in the field. Several peer-reviewed journal articles acknowledge 
that there are no standards for the type of test administered or the 
frequency of the assessments. A standardized practice for evaluating 
this critical area will benefit the pediatric cardiovascular device 
community by providing a clear understanding of safety and 
effectiveness of these devices in the pediatric population. Assessments 
that demonstrate a real clinical benefit can provide useful information 
to patients, their families, and the clinical communities when weighing 
the risk involved. Invited experts will address the types of pediatric 
cardiovascular devices being developed, with a particular focus on 
mechanical circulatory support, current types of clinical assessments 
used in the pediatric population, and challenges that face this 
community. After each presentation, there will be a short question and 
answer session allowing workshop participants to interact with the 
speaker. A concluding session will allow for additional interactions 
with speakers.
    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: Please be advised that as soon as a transcript is 
available, it can be obtained 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. A transcript of the public workshop will 
be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

    Dated: January 21, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-2110 Filed 2-1-10; 8:45 am]
BILLING CODE 4160-01-S