
[Federal Register: September 7, 2010 (Volume 75, Number 172)]
[Notices]               
[Page 54351]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se10-42]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Cell and Gene Therapy Clinical Trials in Pediatric Populations; 
Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER) is announcing a public workshop entitled 
``Cell and Gene Therapy Clinical Trials in Pediatric Populations.'' The 
purpose of the workshop is to gather information from Institutional 
Review Boards (IRBs), gene and cellular therapy clinical researchers, 
and other stakeholders regarding best practices related to cell and 
gene therapy clinical trials in pediatric populations, as well as 
challenges and considerations in the review of these clinical trials.
    Date and Time: The public workshop will be held on November 2, 
2010, from 8 a.m. to 5:30 p.m.
    Location: The public workshop will be held at the Bethesda North 
Marriott Hotel and Conference Center, 5701 Marinelli Rd., North 
Bethesda, MD 20852.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation 
and Research (HFM-43), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX 301-827-
3079; email: CBERTraining@fda.hhs.gov (Subject line: Pediatrics Ethics 
Workshop).
    Registration: Email, mail or fax your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to the contact person by October 1, 2010. There is no registration fee 
for the public workshop. Early registration is recommended because 
seating is limited. Registration on the day of the public workshop will 
be provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Bernadette Kawaley (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: The workshop will include presentations on 
cell and gene therapy clinical trials in pediatric populations. The 
workshop will include panel discussions regarding best practices 
related to cell and gene therapy clinical trials in pediatric 
populations including those related to: (1) Evaluating these novel 
therapeutic products prior to initiating pediatric clinical studies; 
(2) identifying and minimizing risks associated with the administration 
of cell and gene therapy products in pediatric populations; (3) 
obtaining informed consent and assent; and (4) conducting continuing 
review of cell and gene therapy products in pediatric populations. The 
workshop also will include panel discussions addressing the challenges 
and considerations in the review of cell and gene therapy clinical 
trials in pediatric populations and the role of IRBs.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available 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/
BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.

    Dated: August 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22168 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-01-S

