Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop, 54351 [2010-22168]
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
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Administration, 5600 Fishers Lane, rm.
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Dated: September 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22198 Filed 9–3–10; 8:45 am]
BILLING CODE 4160–01–S
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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.
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
PO 00000
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54351
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 https://
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 https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetings
Conferences/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 45134–45142,
dated August 2, 2010) is amended to
reflect the reorganization of the Office of
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Operating Officer, Office of the Director,
Centers for Disease Control and
Prevention.
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Page 54351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22168]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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
