Science Board to the Food and Drug Administration; Notice of Meeting, 30317-30318 [2013-12152]
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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Notices
or written comments to the Division of
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comments. Identify comments with the
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DATES). Received comments may be seen
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VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: May 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–12124 Filed 5–21–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
TKELLEY on DSK3SPTVN1PROD 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: 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 FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
VerDate Mar<15>2010
16:59 May 21, 2013
Jkt 229001
keeping pace with technical and
scientific developments including in
regulatory science; and input into the
Agency’s research agenda; and 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 Monday, June 24, 2013, from
approximately 1 p.m. to 3:45 p.m.
Location: Food and Drug
Administration, White Oak Bldg. 31,
Rm. 1503, section A, 10903 New
Hampshire Ave., Silver Spring, MD
20993. This meeting will be held via
teleconference (301–796–4100 or 866–
901–3913; passcode: 665127) and via
Adobe Connect (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, White Oak Bldg. 32,
Rm. 4286, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
4627, email:
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 June 24, 2013, the
Science Board will be provided draft
final reports from the Center for Devices
and Radiological Health Research
Review subcommittee, and the Global
Health subcommittee. A revised charge
(initially proposed at the October 3,
2012, Science Board meeting) regarding
a new subcommittee to evaluate the
Agency’s continuing work to address
the challenges identified in the Science
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
30317
Board’s 2007 ‘‘Science and Mission at
Risk’’ Report will be presented.
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 Monday, June 17,
2013. Oral presentations from the public
will be scheduled between
approximately 1:15 p.m. and 1:45 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 Friday, June 7, 2013. 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
Monday, June 10, 2013.
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
E:\FR\FM\22MYN1.SGM
22MYN1
30318
Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Notices
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: May 16, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–12152 Filed 5–21–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegeneration.
Date: June 12, 2013.
Time: 3:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Toby Behar, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4136,
MSC 7850, Bethesda, MD 20892, (301) 435–
4433, behart@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Surgical Sciences and
Bioengineering.
Date: June 17, 2013.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Malgorzata Klosek, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7849, Bethesda, MD 20892, (301) 435–
2211, klosekm@csr.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cancer Drug Developments &
Therapeutics.
Date: June 18–19, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lilia Topol, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, 301–451–
0131, ltopol@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; SBIB
Pediatric and Fetal Applications.
Date: June 18, 2013.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: John Firrell, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5118,
MSC 7854, Bethesda, MD 20892, 301–435–
2598, firrellj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Virology.
Date: June 18, 2013.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kenneth M Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge, Rm 3204, MSC 7808,
Bethesda, MD 20892, 301–496–6980,
izumikm@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Cardiac Contractility, Hypertrophy,
and Failure Study Section.
Date: June 19, 2013.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Chicago Downtown/River
North, 30 East Hubbard, Chicago, IL 60611.
Contact Person: Olga A Tjurmina, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4030B,
MSC 7814, Bethesda, MD 20892, (301) 451–
1375, ot3d@nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Cellular
Aspects of Diabetes and Obesity Study
Section.
Date: June 19, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Inn of Chicago, 162 East Ohio Street,
Chicago, IL 60611.
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Contact Person: Robert Garofalo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 6156,
MSC 7892, Bethesda, MD 20892, 301–435–
1043, garofalors@csr.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Societal and Ethical Issues in Research Study
Section.
Date: June 19, 2013.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Tremont Suites Hotel and Grand
Historic Venue, 222 St. Paul Place, Baltimore,
MD 21202.
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
MSC 7770, Bethesda, MD 20892, 301–254–
9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–10–
260: Global Infectious Disease Research
Training.
Date: June 19, 2013.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kenneth M. Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge, Room 3204, MSC
7808, Bethesda, MD 20892, 301–496–6980,
izumikm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Center for Computational MassSpectrometry.
Date: June 19–21, 2013.
Time: 7:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: La Jolla Shores Hotel, 8110 Camino
Del Oro, La Jolla, CA 92037.
Contact Person: Raymond Jacobson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858,
MSC 7849, Bethesda, MD 20892, 301–996–
7702, jacobsonrh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Radiation Therapy.
Date: June 19, 2013.
Time: 12:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Syed M. Quadri, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6210,
MSC 7804, Bethesda, MD 20892, 301–435–
1211, quadris@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
E:\FR\FM\22MYN1.SGM
22MYN1
Agencies
[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Notices]
[Pages 30317-30318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Science Board to the Food and Drug Administration; 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 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; and input into
the Agency's research agenda; and 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 Monday, June 24, 2013,
from approximately 1 p.m. to 3:45 p.m.
Location: Food and Drug Administration, White Oak Bldg. 31, Rm.
1503, section A, 10903 New Hampshire Ave., Silver Spring, MD 20993.
This meeting will be held via teleconference (301-796-4100 or 866-901-
3913; passcode: 665127) and via Adobe Connect (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, White Oak
Bldg. 32, Rm. 4286, 10903 New Hampshire Ave., Silver Spring, MD 20993,
301-796-4627, email: 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 June 24, 2013, the Science Board will be provided draft
final reports from the Center for Devices and Radiological Health
Research Review subcommittee, and the Global Health subcommittee. A
revised charge (initially proposed at the October 3, 2012, Science
Board meeting) regarding a new subcommittee to evaluate the Agency's
continuing work to address the challenges identified in the Science
Board's 2007 ``Science and Mission at Risk'' Report will be presented.
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
Monday, June 17, 2013. Oral presentations from the public will be
scheduled between approximately 1:15 p.m. and 1:45 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
Friday, June 7, 2013. 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 Monday,
June 10, 2013.
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
[[Page 30318]]
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: May 16, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-12152 Filed 5-21-13; 8:45 am]
BILLING CODE 4160-01-P