Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting, 60856-60857 [2014-24001]
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60856
Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD 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: Drug Safety and
Risk Management (DSaRM) 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 November 18, 2014, from 9 a.m.
to 4 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: Kristina Toliver,
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, email: DSaRM@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the Food and Drug Administration
VerDate Sep<11>2014
17:27 Oct 07, 2014
Jkt 235001
Amendments Act of 2007 which
requires FDA to bring, at least annually,
one or more drugs with Risk Evaluation
and Mitigation Strategies (REMS) with
elements to assure safe use (ETASU)
before the DSaRM Advisory Committee.
The Agency plans to discuss the risk
management of eculizumab (SOLIRIS).
The Agency will seek public input
whether the REMS with ETASU for this
drug assures safe use of the drug, is not
unduly burdensome on patient access to
the drug, and to the extent practicable,
minimizes the burden on the health care
delivery system.
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 meeting
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 3, 2014.
Oral presentations from the public will
be scheduled between approximately 1
p.m. 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 October
24, 2014. 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 27, 2014.
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
require special accommodations due to
a disability, please contact Kristina
Toliver 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 2, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24002 Filed 10–7–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No: FDA–2014–N–0001]
Science Board to the Food and Drug
Administration 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 scientific
and technical issues important to the
FDA and its mission, including
emerging issues within the scientific
community. Additionally, the Science
Board provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, and advice
on upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
intramural and extramural scientific
research programs.
Date and Time: The meeting will be
held on Wednesday, November 19,
2014, from approximately 8:30 a.m. to
E:\FR\FM\08OCN1.SGM
08OCN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices
5:30 p.m., and Thursday, November 20,
2014, from approximately 8:30 a.m. to
12:45 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Sections B and C, Silver
Spring, Maryland 20993. 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, Bldg. 32, Rm. 4286,
10903 New Hampshire Ave., Silver
Spring, Maryland 20993, 301–796–4627,
martha.monser@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On November 19, 2014, the
Science Board will review the existing
nonclinical and clinical data related to
the use and potential toxicity of
anesthetics and sedation drugs in the
pediatric population. The Science Board
will be asked to make recommendations
on steps the FDA should take to further
evaluate and to mitigate the risks
associated with the use of these drugs in
the pediatric population and
mechanisms to best communicate with
the public regarding this issue.
On November 20, 2014, the Science
Board will be provided with progress
reports from two subcommittees, the
Commissioner’s Fellowship Program
Evaluation subcommittee and the
Science Moving Forward subcommittee.
The Board will be asked to support the
formation of a new subcommittee to
evaluate the Office of Regulatory Affairs’
current investments in the Food
VerDate Sep<11>2014
17:27 Oct 07, 2014
Jkt 235001
Emergency Response Network
cooperative agreement program and
funding for state laboratories to achieve
International Organization for
Standardization accreditation. The
Board will also be asked to support the
formation of a new subcommittee to
evaluate the Centers of Excellence in
Regulatory Science and Innovation
program. A recipient of one of the fiscal
year 2013 Scientific Achievement
Awards (selected by the Board) will
provide an overview of the activities for
which the award was given.
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 pertaining to issues before
the Board on November 19, 2014, may
be made to the contact person on or
before Wednesday, November 12, 2014.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on November 19, 2014.
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 Tuesday, November 4, 2014.
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 at the
November 19, 2014, meeting by
Wednesday, November 5, 2014.
Written submissions pertaining to
issues before the Board on November
20, 2014, may be made to the contact
person on or before Thursday,
November 13, 2014. Oral presentations
from the public will be scheduled
between approximately 12 p.m. and
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
60857
12:30 p.m. on November 20, 2014.
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 Wednesday, November 5,
2014. 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 at the November 20,
2014, meeting by Thursday, November
6, 2014.
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.
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 2, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24001 Filed 10–7–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0967]
Prescription Drug User Fee Act
Patient-Focused Drug Development;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Pages 60856-60857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24001]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No: FDA-2014-N-0001]
Science Board to the Food and Drug Administration 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 scientific and technical
issues important to the FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice to the Agency on keeping pace with technical and
scientific developments including in regulatory science, input into the
Agency's research agenda, and advice on upgrading its scientific and
research facilities and training opportunities. It will also provide,
where requested, expert review of Agency sponsored intramural and
extramural scientific research programs.
Date and Time: The meeting will be held on Wednesday, November 19,
2014, from approximately 8:30 a.m. to
[[Page 60857]]
5:30 p.m., and Thursday, November 20, 2014, from approximately 8:30
a.m. to 12:45 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Sections B and C,
Silver Spring, Maryland 20993. 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, Bldg. 32, Rm.
4286, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, 301-796-
4627, martha.monser@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On November 19, 2014, the Science Board will review the
existing nonclinical and clinical data related to the use and potential
toxicity of anesthetics and sedation drugs in the pediatric population.
The Science Board will be asked to make recommendations on steps the
FDA should take to further evaluate and to mitigate the risks
associated with the use of these drugs in the pediatric population and
mechanisms to best communicate with the public regarding this issue.
On November 20, 2014, the Science Board will be provided with
progress reports from two subcommittees, the Commissioner's Fellowship
Program Evaluation subcommittee and the Science Moving Forward
subcommittee. The Board will be asked to support the formation of a new
subcommittee to evaluate the Office of Regulatory Affairs' current
investments in the Food Emergency Response Network cooperative
agreement program and funding for state laboratories to achieve
International Organization for Standardization accreditation. The Board
will also be asked to support the formation of a new subcommittee to
evaluate the Centers of Excellence in Regulatory Science and Innovation
program. A recipient of one of the fiscal year 2013 Scientific
Achievement Awards (selected by the Board) will provide an overview of
the activities for which the award was given.
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 pertaining to issues before the Board on November
19, 2014, may be made to the contact person on or before Wednesday,
November 12, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on November 19, 2014. 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
Tuesday, November 4, 2014. 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 at the
November 19, 2014, meeting by Wednesday, November 5, 2014.
Written submissions pertaining to issues before the Board on
November 20, 2014, may be made to the contact person on or before
Thursday, November 13, 2014. Oral presentations from the public will be
scheduled between approximately 12 p.m. and 12:30 p.m. on November 20,
2014. 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
Wednesday, November 5, 2014. 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 at the
November 20, 2014, meeting by Thursday, November 6, 2014.
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.
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 2, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-24001 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P
