Science Board Advisory Committee; Notice of Meeting, 42714-42715 [2011-18063]
Download as PDF
<![CDATA[
42714
Federal Register / Vol. 76, No. 138 / Tuesday, July 19, 2011 / Notices
1–800–741–8138 (301–443–0572 in the
Washington DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 7, 2011, FDA
announced that a meeting of the General
and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee
would be held on August 30 and 31,
2011. On page 39883, in the first
column, the Contact Person portion of
the document is changed to read as
follows:
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1609, Silver Spring, MD 20993–0002,
301–796–6313, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–18064 Filed 7–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Science Board Advisory Committee;
Notice of Meeting
sroberts on DSK5SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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.
VerDate Mar<15>2010
17:20 Jul 18, 2011
Jkt 223001
Name of Committee: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice
primarily to the Commissioner of Food
and Drugs and other appropriate
officials on specific complex and
technical issues, as well as emerging
issues within the scientific community
in industry and academia. Additionally,
the Science Board provides advice to
the Agency on keeping pace with
technical and scientific evolutions in
the fields of regulatory science, on
formulating an appropriate research
agenda, and on upgrading its scientific
and research facilities to keep pace with
these changes. It will also provide the
means for critical review of Agencysponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be
held on Friday, August 19, 2011, from
9 a.m. to 3 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. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://
collaboration.fda.gov/scienceboard/.
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 ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Martha Monser,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4286, Silver Spring,
MD 20993–0002, 301–796–4627, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 August 19, 2011, the
Science Board will discuss the FDA’s
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
draft Strategic Plan for Regulatory
Science. The Board will be provided
with an update on the FDA’s Medical
Countermeasures Initiative program
plans. The Board will also initiate the
charges to the subcommittees for: (1) A
science review of the Center for Devices
and Radiological Health, and (2) a
Medical and Biological Engineering
review.
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 Friday, August 12,
2011. Oral presentations from the public
will be scheduled between
approximately 1 and 2 p.m. Those
individuals interested in making 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 Thursday, August 4, 2011.
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
Friday, August 5, 2011.
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 Martha
Monser, at least 7 days in advance of the
meeting.
E:\FR\FM\19JYN1.SGM
19JYN1
Federal Register / Vol. 76, No. 138 / Tuesday, July 19, 2011 / Notices
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.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: July 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–18063 Filed 7–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
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: Arthritis
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 September 13, 2011, from 8 a.m.
to 5:30 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 ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Philip A. Bautista,
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:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
VerDate Mar<15>2010
17:20 Jul 18, 2011
Jkt 223001
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 September 13, 2011, the
committee will discuss the anti-nerve
growth factor (Anti-NGF) drug class that
is currently under development and the
safety issues possibly related to these
drugs. These drugs are being developed
for the treatment of a variety of chronic
painful conditions including
osteoarthritis, chronic lower back pain,
diabetic peripheral neuropathy, postherpetic neuralgia, chronic pancreatitis,
endometriosis, interstitial cystitis,
vertebral fracture, thermal injury, and
cancer pain. The committee will be
asked to determine whether reports of
joint destruction represent a safety
signal related to the Anti-NGF class of
drugs, and whether the risk benefit
balance for these drugs favors continued
development of the drugs as analgesics.
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 August 29, 2011.
Oral presentations from the public will
be scheduled between approximately
1:30 and 2:30 p.m. Those individuals
interested in making 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 August
19, 2011. Time allotted for each
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
42715
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 August 22, 2011.
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 Philip A.
Bautista 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: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–18062 Filed 7–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Quarantine Release Errors in Blood
Establishments; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Quarantine Release Errors in
Blood Establishments.’’ The purpose of
this public workshop is to provide a
forum for discussion of quarantine
release errors (QREs) and provide FDA
and industry with information
necessary to reduce the rates of QREs.
The workshop will focus on the extent
and characteristics of QREs in blood
establishments and the specifications of
blood establishment computer software
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42714-42715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18063]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Science Board Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: 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: Science Board to the Food and Drug
Administration (Science Board).
General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex and technical issues, as well
as emerging issues within the scientific community in industry and
academia. Additionally, the Science Board provides advice to the Agency
on keeping pace with technical and scientific evolutions in the fields
of regulatory science, on formulating an appropriate research agenda,
and on upgrading its scientific and research facilities to keep pace
with these changes. It will also provide the means for critical review
of Agency-sponsored intramural and extramural scientific research
programs.
Date and Time: The meeting will be held on Friday, August 19, 2011,
from 9 a.m. to 3 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. For those unable to attend in person, the meeting will also
be Web cast. The link for the Web cast is available at https://collaboration.fda.gov/scienceboard/. 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 ``Public Meetings at
the FDA White Oak Campus.'' Please note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Martha Monser, Office of the Chief Scientist,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993-0002, 301-
796-4627, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), and follow the prompts to
the desired center or product area. 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 August 19, 2011, the Science Board will discuss the
FDA's draft Strategic Plan for Regulatory Science. The Board will be
provided with an update on the FDA's Medical Countermeasures Initiative
program plans. The Board will also initiate the charges to the
subcommittees for: (1) A science review of the Center for Devices and
Radiological Health, and (2) a Medical and Biological Engineering
review.
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
Friday, August 12, 2011. Oral presentations from the public will be
scheduled between approximately 1 and 2 p.m. Those individuals
interested in making 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 Thursday, August 4,
2011. 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 Friday, August 5, 2011.
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 Martha Monser, at
least 7 days in advance of the meeting.
[[Page 42715]]
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/default.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: July 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-18063 Filed 7-18-11; 8:45 am]
BILLING CODE 4160-01-P
