Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting, 55803-55804 [2010-22805]
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Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Epi-Centers for
the Prevention of HealthcareAssociated Infections, Antimicrobial
Resistance and Adverse Events,
Funding Opportunity Announcement,
CI11–001, Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date
8 a.m.–5 p.m., November 8, 2010 (Closed).
Place: Sheraton Gateway Hotel Atlanta
Airport, 1900 Sullivan Road, Atlanta, Georgia
30337, Telephone: (770) 997–1100.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law
92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Epi-Centers for the Prevention of
Healthcare-Associated Infectious,
Antimicrobial Resistance and Adverse
Events, FOA CI11–001.’’
Contact Person for More Information:
Gregory Anderson, M.S., M.P.H., Scientific
Review Officer, CDC, 1600 Clifton Road, NE.,
Mailstop E60, Atlanta, Georgia 30333,
Telephone: (404) 498–2293.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–22759 Filed 9–13–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on DSKJ8SOYB1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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16:38 Sep 13, 2010
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Notice.
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: Neurological
Devices Panel of the Medical Devices
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 October 8, 2010, from 8 a.m. to
6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: James Engles, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512513. Please call the
Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
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 October 8, 2010, the
committee will discuss and make
recommendations regarding clinical
trial design issues for devices indicated
for the treatment of depression.
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 September 30, 2010.
Oral presentations from the public will
be scheduled at approximately 1 p.m.,
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55803
immediately following lunch. 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
September 22, 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 September 23, 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 due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 301–796–5966 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/Advisory
Committees/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: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22804 Filed 9–13–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Transmissible Spongiform
Encephalopathies Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
E:\FR\FM\14SEN1.SGM
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jlentini on DSKJ8SOYB1PROD with NOTICES
55804
Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Transmissible
Spongiform Encephalopathies 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 October 28, 2010, from 8:30
a.m. to approximately 5 p.m. and on
October 29, 2010, from 8:30 a.m. to
approximately 12:30 p.m.
Location: Holiday Inn, Gaithersburg, 2
Montgomery Village Ave., Gaithersburg,
MD, 20879.
Contact Person: Bryan Emery or
Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512392. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously 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 October 28, 2010, the
Committee will discuss: (1) FDA’s risk
assessment for potential exposure to the
variant Creutzfeldt-Jakob disease (vCJD)
agent in U.S.-licensed plasma-derived
Factor VIII and (2) labeling of blood and
blood components and plasma-derived
products, including plasma-derived
albumin and products containing
plasma-derived albumin, to address the
possible risk of transmission of vCJD.
On October 29, 2010, the Committee
will hear informational presentations
related to FDA’s geographic donor
deferral policy to reduce the possible
risk of transmission of CJD and vCJD by
blood and blood products and human
cells, and tissue and cellular and tissue
based products. The Committee will
also hear updates on the following
topics: The development of devices to
remove transmissible spongiform
encephalopathy agents from blood
components and chronic wasting
disease.
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
VerDate Mar<15>2010
16:38 Sep 13, 2010
Jkt 220001
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 October 21, 2010.
Oral presentations from the public will
be scheduled on October 28, 2010,
between approximately 11 a.m. and
11:45 a.m. and between approximately
3:30 p.m. and 4 p.m. and on October 29,
2010, between approximately 10:30 a.m.
and 11 a.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 October 13, 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
October 14, 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 due to
a disability, please contact Bryan Emery
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/Advisory
Committees/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).
PO 00000
Frm 00069
Fmt 4703
Sfmt 9990
Dated: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22805 Filed 9–13–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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 material,
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
General Medical Sciences Special Emphasis
Panel, Phase II Clinical Trial in Septic Shock.
Date: October 7, 2010.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of General
Medical Sciences, National Institutes of
Health, 45 Center Drive, Room 3AN18K,
Bethesda, MD 20892. (Telephone Conference
Call.)
Contact Person: Brian R. Pike, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18B, Bethesda, MD
20892. 301–594–3907. pikbr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: September 8, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22843 Filed 9–13–10; 8:45 am]
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]]>Agencies
[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55803-55804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Transmissible Spongiform Encephalopathies Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee
[[Page 55804]]
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committee: Transmissible Spongiform Encephalopathies
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 October 28, 2010, from
8:30 a.m. to approximately 5 p.m. and on October 29, 2010, from 8:30
a.m. to approximately 12:30 p.m.
Location: Holiday Inn, Gaithersburg, 2 Montgomery Village Ave.,
Gaithersburg, MD, 20879.
Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512392. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
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 October 28, 2010, the Committee will discuss: (1) FDA's
risk assessment for potential exposure to the variant Creutzfeldt-Jakob
disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII and
(2) labeling of blood and blood components and plasma-derived products,
including plasma-derived albumin and products containing plasma-derived
albumin, to address the possible risk of transmission of vCJD. On
October 29, 2010, the Committee will hear informational presentations
related to FDA's geographic donor deferral policy to reduce the
possible risk of transmission of CJD and vCJD by blood and blood
products and human cells, and tissue and cellular and tissue based
products. The Committee will also hear updates on the following topics:
The development of devices to remove transmissible spongiform
encephalopathy agents from blood components and chronic wasting
disease.
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
October 21, 2010. Oral presentations from the public will be scheduled
on October 28, 2010, between approximately 11 a.m. and 11:45 a.m. and
between approximately 3:30 p.m. and 4 p.m. and on October 29, 2010,
between approximately 10:30 a.m. and 11 a.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 October 13, 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 October 14, 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 due to a disability, please contact Bryan Emery 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: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22805 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S
