[Federal Register: February 2, 2010 (Volume 75, Number 21)] [Notices] [Page 5335-5336] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02fe10-83]
———————————————————————–
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.
———————————————————————–
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.
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: sonna.patel@fda.hhs.gov.
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
https://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 https://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
