Product Development Program for Interventions in Patients With Severe Bleeding Due to Trauma or Other Causes; Public Workshop, 64314-64315 [2010-26212]
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Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Paul Tran
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: October 14, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–26251 Filed 10–18–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSKH9S0YB1PROD with NOTICES
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on December 2, 2010, from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability, visitor
parking, and transportation may be accessed
at https://www.fda.gov/AdvisoryCommittees/
default.htm; under the heading ‘‘Resources
for You’’, click on ‘‘White Oak Conference
Center Parking and Transportation
Information for FDA Advisory Committee
Meetings’’.
Contact Person: Nicole Vesely, Center for
Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–847–
8533, e-mail: Nicole.vesely@fda.hhs.gov, or
FDA Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 301–451–2542.
Please call the Information Line for up-todate information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
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announced advisory committee meeting
cannot always be published quickly enough
to provide timely notice. Therefore, you
should always check the Agency’s Web site
and call the appropriate advisory committee
hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On December 2, 2010, during the
morning session, the committee will discuss
biologics license application (BLA) 125377,
with the proposed trade name Yervoy
(ipilimumab), manufactured by Bristol-Myers
Squibb Company. The proposed indication
(use) for this product is for the treatment of
advanced melanoma in patients who have
received prior therapy. During the afternoon
session, the committee will discuss new drug
application (NDA) 022–405, with the
proposed trade name Zictifa (vandetanib)
Tablets, manufactured by iPR
Pharmaceuticals, Inc., represented by
AstraZeneca Pharmaceuticals LP (authorized
U.S. agent). The proposed indication (use) for
this product is for the treatment of patients
with unresectable (non-operable) locally
advanced or metastatic medullary thyroid
cancer.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
November 16, 2010. Oral presentations from
the public will be scheduled between
approximately 10:30 a.m. and 11 a.m. and
between approximately 3:30 p.m. and 4 p.m.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of the
general nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and an
indication of the approximate time requested
to make their presentation on or before
November 8, 2010. Time allotted for each
presentation may be limited. If the number of
registrants requesting to speak is greater than
can be reasonably accommodated during the
scheduled open public hearing session, FDA
may conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 9, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
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due to a disability, please contact Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: October 14, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–26247 Filed 10–18–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0487]
Product Development Program for
Interventions in Patients With Severe
Bleeding Due to Trauma or Other
Causes; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a 2-day public
workshop entitled ‘‘Product
Development Program for Interventions
in Patients with Severe Bleeding Due to
Trauma or Other Causes.’’ The purpose
of this public workshop is to discuss
possible paradigms for the evaluation of
products indicated for use to stop severe
bleeding. The workshop has been
planned in partnership with the
Department of Health and Human
Services, Office of Public Health and
Science; the National Heart, Lung and
Blood Institute; and the Department of
Defense. The public workshop will
include presentations and panel
discussions by experts from academic
institutions, government agencies, and
industry.
Dates and Times: The public
workshop will be held on December 9,
2010, from 8 a.m. to 5:30 p.m. and
December 10, 2010, from 8 a.m. to
1 p.m.
Location: The public workshop will
be held at the Masur Auditorium, 10
Center Dr., Bldg. 10, Clinical Center,
National Institutes of Health, Bethesda,
MD 20892.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
E:\FR\FM\19OCN1.SGM
19OCN1
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
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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]
[Pages 64314-64315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0487]
Product Development Program for Interventions in Patients With
Severe Bleeding Due to Trauma or Other Causes; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a 2-day public
workshop entitled ``Product Development Program for Interventions in
Patients with Severe Bleeding Due to Trauma or Other Causes.'' The
purpose of this public workshop is to discuss possible paradigms for
the evaluation of products indicated for use to stop severe bleeding.
The workshop has been planned in partnership with the Department of
Health and Human Services, Office of Public Health and Science; the
National Heart, Lung and Blood Institute; and the Department of
Defense. The public workshop will include presentations and panel
discussions by experts from academic institutions, government agencies,
and industry.
Dates and Times: The public workshop will be held on December 9,
2010, from 8 a.m. to 5:30 p.m. and December 10, 2010, from 8 a.m. to 1
p.m.
Location: The public workshop will be held at the Masur Auditorium,
10 Center Dr., Bldg. 10, Clinical Center, National Institutes of
Health, Bethesda, MD 20892.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
[[Page 64315]]
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.
SUPPLEMENTARY INFORMATION: 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 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 non-trauma
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/WorkshopsMeetingsConferences/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
