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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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.                          ( print 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:                     *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                     *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