Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 8463-8464 [2014-02943]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
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: Jennifer Shepherd,
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, AIDAC@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
applications (NDAs) 205–435 and 205–
436, tedizolid phosphate tablets and
tedizolid phosphate injection, submitted
by Trius Therapeutics, respectively, for
the proposed indication of treatment of
acute bacterial skin and skin structure
infections.
During the afternoon session, the
committee will discuss NDA 021–883,
dalbavancin hydrochloride for
intravenous injection, submitted by
Durata Therapeutics International B.V.,
for the proposed indication of treatment
of acute bacterial skin and skin structure
infections.
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 March 17, 2014.
Oral presentations from the public will
be scheduled between approximately
VerDate Mar<15>2010
17:59 Feb 11, 2014
Jkt 232001
10:45 a.m. to 11:15 a.m., and 3:45 p.m.
to 4:15 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 March 7,
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 March 10, 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 Jennifer
Shepherd 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: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–02942 Filed 2–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00035
Fmt 4703
Sfmt 4703
8463
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: Vaccines and
Related Biological Products 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 March 20, 2014, from 11:30 a.m.
to approximately 3:20 p.m.
Location: Rockwall II, Conference
Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is
welcome to attend the meeting at the
specified location where a
speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room.
Contact Person: Prabha Atreya or
Denise Royster, 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). 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 March 20, 2014, the
committee will meet in open session to
hear updates of the research programs in
the Laboratory of Respiratory and
Special Pathogens, Division of Bacterial,
Parasitic and Allergenic Products, and
in the Laboratory of Hepatitis Viruses,
Division of Viral Products, Center for
Biologics Evaluation and Research,
FDA.
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/
E:\FR\FM\12FEN1.SGM
12FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
8464
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On March 20, 2014, from
11:30 a.m. to approximately 2:10 p.m.,
the meeting is open to the public.
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
March 13, 2014. Oral presentations from
the public will be scheduled between
approximately 1:10 p.m. and 2:10 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 March 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 by March 5, 2014.
Closed Committee Deliberations: On
March 20, 2014, from approximately
2:10 p.m. to approximately 3:20 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)). The committee will discuss
the report of the intramural research
programs and make recommendations
regarding personnel staffing decisions.
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 Prabha
Atreya or Denise Royster 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.
VerDate Mar<15>2010
17:59 Feb 11, 2014
Jkt 232001
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–02943 Filed 2–11–14; 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
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; PAR13–259
Program Project: Behavioral and
Neurobiological Effects of Drug Use.
Date: March 3, 2014.
Time: 12:00 p.m. to 4:00 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: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Radiation Therapy and Biology.
Date: March 4–5, 2014.
Time: 9:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Bo Hong, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD
20892, 301–435–5879, hongb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–12–
186: Macroeconomic Aspects of Population
Aging.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Date: March 4, 2014.
Time: 1:00 p.m. to 3:00 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: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Development of Appropriate Pediatric
Formulations and Pediatric Drug Delivery
System.
Date: March 4, 2014.
Time: 12:00 p.m. to 3:00 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: Robert C. Elliott, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3130,
MSC 7850, Bethesda, MD 20892, 301–435–
3009, elliotro@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Brain Disorders, Language,
Communication and Related Neurosciences.
Date: March 6–7, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Residence Inn Bethesda,
7335 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Vilen A. Movsesyan,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892, 301–402–
7278, movsesyanv@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Emerging Technologies in
Neuroscience.
Date: March 7, 2014.
Time: 10:00 a.m. to 12:00 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: Sharon S. Low, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5104, MSC 5104, Bethesda, MD
20892–5104, 301–237–1487, lowss@
csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS).
E:\FR\FM\12FEN1.SGM
12FEN1
Agencies
[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8463-8464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02943]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Vaccines and Related Biological Products 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: Vaccines and Related Biological Products
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 March 20, 2014, from
11:30 a.m. to approximately 3:20 p.m.
Location: Rockwall II, Conference Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is welcome to attend the meeting at the
specified location where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room.
Contact Person: Prabha Atreya or Denise Royster, 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). 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 March 20, 2014, the committee will meet in open session
to hear updates of the research programs in the Laboratory of
Respiratory and Special Pathogens, Division of Bacterial, Parasitic and
Allergenic Products, and in the Laboratory of Hepatitis Viruses,
Division of Viral Products, Center for Biologics Evaluation and
Research, FDA.
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/
[[Page 8464]]
default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: On March 20, 2014, from 11:30 a.m. to approximately 2:10
p.m., the meeting is open to the public. 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 March 13, 2014. Oral presentations from the public
will be scheduled between approximately 1:10 p.m. and 2:10 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
March 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 by March 5, 2014.
Closed Committee Deliberations: On March 20, 2014, from
approximately 2:10 p.m. to approximately 3:20 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)). The
committee will discuss the report of the intramural research programs
and make recommendations regarding personnel staffing decisions.
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 Prabha Atreya or
Denise Royster 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: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-02943 Filed 2-11-14; 8:45 am]
BILLING CODE 4160-01-P