Center for Scientific Review; Amended Notice of Meeting, 11682 [2015-04408]
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Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices
to learn about possible modifications
before coming to the meeting.
Agenda: On March 24, 2015, the
Pediatric Advisory Committee (PAC)
will meet to discuss pediatric-focused
safety reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act (Pub. L. 108–155). The PAC
will meet to discuss the following
products: CYMBALTA (duloxetine
hydrochloride), QUILLIVANT XR
(methylphenidate hydrochloride),
LUNESTA (eszopiclone), RISPERDAL
(risperidone), OXTELLAR XR
(oxcarbazepine), REVATIO (sildenafil),
ADVAIR HFA (fluticasone propionate/
salmeterol), DYMISTA (azelastine
hydrochloride/fluticasone proprionate),
QNASL (beclomethasone dipropionate),
VENOFER (iron sucrose), INVIRASE
(saquinavir), ALTABAX Ointment
(retapamulin), FluMist
QUADRIVALENT (influenza vaccine
live, intranasal), FLUARIX
QUADRIVALENT (influenza virus
vaccine), Medtronic ACTIVA
DYSTONIA THERAPY, and
LIPOSORBER LA–15 System. In
addition, there will be a short
presentation of the ethical issues
discussed by the Pediatric Ethics
Subcommittee of the PAC on March 23,
2015.
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 March 16, 2015.
Oral presentations from the public will
be scheduled on March 24, 2015,
between approximately 9 a.m. and 10
a.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 6, 2015. Time allotted
for each presentation may be limited. If
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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 9, 2015.
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 Walter
Ellenberg 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 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–04394 Filed 3–3–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, March
05, 2015, 11:00 a.m. to March 05, 2015,
05:00 p.m., National Institutes of Health,
6701 Rockledge Drive, Bethesda, MD,
20892 which was published in the
Federal Register on February 24, 2015,
80 FR 9738.
The meeting will be held on March
12, 2015. The meeting location and time
remain the same. The meeting is closed
to the public.
Dated: February 25, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–04408 Filed 3–3–15; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Neurological
Disorders and Stroke Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting 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 materials,
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: National Advisory
Neurological Disorders and Stroke Council.
Date: May 28–29, 2015.
Open: May 28, 2015, 8:00 a.m. to 3:00 p.m.
Agenda: Report by the Director, NINDS;
Report by the Associate Director for
Extramural Research; Administrative and
Program Developments; and an Overview of
the NINDS Intramural Program.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: May 28, 2015, 3:00 p.m. to 4:45
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: May 28, 2015, 4:45 p.m. to 5:15
p.m.
Agenda: To review and evaluate the
Division of Intramural Research Board of
Scientific Counselors’ Reports.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: May 29, 2015, 8:00 a.m. to 11:00
a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Robert Finkelstein, Ph.D.,
Associate Director for Extramural Research,
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[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Page 11682]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04408]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, March 05, 2015, 11:00 a.m. to
March 05, 2015, 05:00 p.m., National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal
Register on February 24, 2015, 80 FR 9738.
The meeting will be held on March 12, 2015. The meeting location
and time remain the same. The meeting is closed to the public.
Dated: February 25, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-04408 Filed 3-3-15; 8:45 am]
BILLING CODE 4140-01-P
