Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 61082-61083 [2014-24039]
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Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control numbers 0910–0284 and
0910–0645.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: October 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24152 Filed 10–8–14; 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 Advisory Board to the
National Center for Toxicological
Research Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
General Function of the Committee:
To provide advice and
VerDate Sep<11>2014
17:56 Oct 08, 2014
Jkt 235001
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 6, 2014, from 8:15
a.m. to 4:15 p.m. and on November 7,
2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB, 3900 NCTR Rd.,
Conference Room B–12, Jefferson, AR
72079.
Contact Person: Donna Mendrick,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
2208, Silver Spring, MD 20993–0002,
301–796–8892, 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 6, 2014, the
NCTR Director will welcome the
participants and provide a Center-wide
update on scientific initiatives and
accomplishments during the past year.
The SAB will be presented with an
overview of the Division of
Microbiology Subcommittee and the
Subcommittee Site Visit Report.
Following the public session, the SAB
will hear an update from each of
NCTR’s research Divisions, the Office of
Science Coordination, followed by an
update on NCTR’s Global Interactions.
On November 7, 2014, the Office of
the Chief Scientist will update the SAB
on their research needs, and discuss
opportunities for collaboration to help
address these needs, followed by a
report from the National Toxicology
Program of the National Institutes of
Environmental Health Sciences on
current and future collaboration.
The Center for Biological Evaluation
and Research, the Center for Drug
Evaluation and Research, the Center for
Devices and Radiological Health, the
Center for Veterinary Medicine, the
Center for Tobacco Products, the Office
of Regulatory Affairs, and the Center for
Food Safety and Applied Nutrition will
each briefly discuss their Center-specific
research strategic needs.
Following an open discussion of all
the information presented, the open
session of the meeting will close so that
SAB members can discuss personnel
issues at NCTR.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 October 30, 2014.
Oral presentations from the public will
be scheduled between approximately 12
noon to 1 p.m. on November 6, 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 October 22, 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 23, 2014.
Closed Committee Deliberations: On
November 7, 2014, from 12 noon to 2
p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
NCTR.
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 Donna
E:\FR\FM\09OCN1.SGM
09OCN1
Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
Mendrick 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).
Date: September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24039 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD 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: 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 November 6, 2014, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 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: Caleb Briggs, 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:
VerDate Sep<11>2014
17:56 Oct 08, 2014
Jkt 235001
ODAC@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: During the morning session,
the committee will discuss new drug
application (NDA) 205353, panobinostat
capsules, application submitted by
Novartis Pharmaceuticals Corporation.
The proposed indication (use) for this
product is in combination with
bortezomib and dexamethasone, for the
treatment of patients with multiple
myeloma who have received at least one
prior therapy.
During the afternoon session, the
committee will discuss NDA 206317,
ferric pyrophosphate solution, for
administration via hemodialysis
dialysate, application submitted by
Rockwell Medical, Inc. The proposed
indications (uses) for this product are
for the treatment of iron loss or iron
deficiency to maintain hemoglobin in
adult patients with hemodialysisdependent stage 5 chronic kidney
disease and to reduce the prescribed
dose of erythropoiesis stimulating agent
required to maintain desired
hemoglobin levels.
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 October 23, 2014.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m., and 3:30 p.m. to
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
61083
4 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 15, 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 16, 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 Caleb Briggs
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).
September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24038 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0394]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\09OCN1.SGM
Notice.
09OCN1
]]>Agencies
[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Notices]
[Pages 61082-61083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24039]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Science Advisory Board to the National Center for Toxicological
Research 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).
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 6, 2014, from
8:15 a.m. to 4:15 p.m. and on November 7, 2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB, 3900 NCTR Rd., Conference Room B-12, Jefferson,
AR 72079.
Contact Person: Donna Mendrick, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD 20993-0002,
301-796-8892, 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 6, 2014, the NCTR Director will welcome the
participants and provide a Center-wide update on scientific initiatives
and accomplishments during the past year. The SAB will be presented
with an overview of the Division of Microbiology Subcommittee and the
Subcommittee Site Visit Report. Following the public session, the SAB
will hear an update from each of NCTR's research Divisions, the Office
of Science Coordination, followed by an update on NCTR's Global
Interactions.
On November 7, 2014, the Office of the Chief Scientist will update
the SAB on their research needs, and discuss opportunities for
collaboration to help address these needs, followed by a report from
the National Toxicology Program of the National Institutes of
Environmental Health Sciences on current and future collaboration.
The Center for Biological Evaluation and Research, the Center for
Drug Evaluation and Research, the Center for Devices and Radiological
Health, the Center for Veterinary Medicine, the Center for Tobacco
Products, the Office of Regulatory Affairs, and the Center for Food
Safety and Applied Nutrition will each briefly discuss their Center-
specific research strategic needs.
Following an open discussion of all the information presented, the
open session of the meeting will close so that SAB members can discuss
personnel issues at NCTR.
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
October 30, 2014. Oral presentations from the public will be scheduled
between approximately 12 noon to 1 p.m. on November 6, 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
October 22, 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 23,
2014.
Closed Committee Deliberations: On November 7, 2014, from 12 noon
to 2 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be
closed to permit discussion of information concerning individuals
associated with the research programs at NCTR.
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 Donna
[[Page 61083]]
Mendrick 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).
Date: September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-24039 Filed 10-8-14; 8:45 am]
BILLING CODE 4164-01-P
