National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 64315 [2010-26321]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person (see Contact Person) by
November 19, 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
Rhonda Dawson (see CONTACT
PERSON) at least 7 days in advance.
Severe
bleeding may be encountered in both
traumatic and non-traumatic clinical
situations. New products for the
treatment of severe bleeding are needed
to reduce the need for blood
transfusions, minimize complications
resulting from blood loss, and improve
patient outcomes. The development and
approval of new products for use in
treatment of severe bleeding,
particularly severe bleeding resulting
from trauma, has been complicated by
the lack of a consensus definition of
severe bleeding as well as the need to
identify appropriate clinical endpoints
for assessment of product safety and
efficacy. Clinical endpoints may vary
depending on the product indications,
patient characteristics, nature of injury,
whether the product acts locally or
systemically, the nature of the product
(e.g., device, drug, biologic, or
combination), and conditions of use.
Because it may not always be feasible
to obtain standard informed consent,
clinical trials of products used for the
treatment of life-threatening severe
bleeding resulting from trauma may
raise significant ethical and legal
considerations. Researchers studying
products for use in such circumstances
may need guidance to carry out
appropriate consultation with
representatives of the communities in
which the clinical investigation will be
conducted and from which the study
participants will be selected. Clinical
trials on products intended for use in
trauma are also complicated by the
difficulty of identifying patients who
may meet study inclusion criteria.
Given these challenges, further
discussion is needed about how
products approved for use for treatment
of severe bleeding occurring during
surgery or due to non-surgical
conditions may best be evaluated for use
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:24 Oct 18, 2010
Jkt 223001
in treatment of severe bleeding in
trauma.
The first day of the workshop will
include presentations and panel
discussions on the following topics:
(1) Current clinical scientific knowledge
concerning the pathophysiology of
trauma and assessment of severe
bleeding; (2) currently available locally
acting and systemic products used to
treat severe bleeding in trauma and nontrauma settings; (3) animal models for
pre-clinical evaluation of products; (4)
ethical considerations for clinical trials
to evaluate products used in treatment
of severe bleeding in trauma; and (5)
clinical evaluation of products for
bleeding interventions, including
clinical trials and endpoints. The
second day of the workshop will
include a discussion of whether
products with an indication for use in
severe bleeding due to trauma can be
evaluated in clinical settings other than
a trauma clinical trial and a summary of
the sessions presented at the workshop.
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/BiologicsBloodVaccines/
NewsEvents/Workshops
MeetingsConferences/
TranscriptsMinutes/default.htm.
Dated: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26212 Filed 10–18–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
64315
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, SPOTRIAS.
Date: December 15, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852. (Telephone
Conference Call.)
Contact Person: Richard D. Crosland, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Room 3208,
MSC 9529, Bethesda, MD 20892–9529. 301–
496–0635. Rc218u@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: October 13, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26321 Filed 10–18–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, Medicinal Chemistry.
Date: November 9–10, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 75, Number 201 (Tuesday, October 19, 2010)]
[Notices]
[Page 64315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice
of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel, SPOTRIAS.
Date: December 15, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852. (Telephone Conference
Call.)
Contact Person: Richard D. Crosland, PhD, Scientific Review
Administrator, Scientific Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd.,
Room 3208, MSC 9529, Bethesda, MD 20892-9529. 301-496-0635.
Rc218u@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
Dated: October 13, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-26321 Filed 10-18-10; 8:45 am]
BILLING CODE 4140-01-P
