Pediatric Advisory Committee; Notice of Meeting, 11681-11682 [2015-04394]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
Contact Person: Philip Bautista,
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, EMDAC@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 the results of
the cardiovascular outcomes trial
(CVOT), Saxagliptin Assessment of
Vascular Outcomes Recorded in Patients
with Diabetes Mellitus, for new drug
application (NDA) 22350, Onglyza
(saxagliptin) and NDA 200678,
Kombiglyze XR (saxagliptin and
metformin HCl extended-release) tablets
manufactured/marketed by AstraZeneca
AB.
During the afternoon session, the
committee will discuss the results of the
CVOT, Examination of Cardiovascular
Outcomes with Alogliptin versus
Standard of Care, for NDA 22271,
Nesina (ALOGLIPTIN); NDA 022426,
Oseni (ALOGLIPTIN and
PIOGLITAZONE); and NDA 203414,
Kazano (ALOGLIPTIN and
METFORMIN) tablets marketed by
Takeda Pharmaceutical U.S.A., Inc.
Saxagliptin and ALOGLIPTIN are
dipeptidyl peptidase-4 inhibitors, both
indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
Both CVOTs were submitted in
accordance with the 2008 FDA Draft
Guidance, ‘‘Diabetes Mellitus—
Evaluating Cardiovascular Risk in New
Antidiabetic Therapies to Treat Type 2
Diabetes,’’ to demonstrate that a new
antidiabetic therapy to treat type 2
VerDate Sep<11>2014
18:11 Mar 03, 2015
Jkt 235001
diabetes is not associated with an
unacceptable increase in cardiovascular
risk.
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 31, 2015.
Oral presentations from the public will
be scheduled between approximately
10:10 a.m. to 10:40 a.m., and 3:30 p.m.
to 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 March 23, 2015. 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 24, 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 Philip
Bautista 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.
PO 00000
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11681
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. 2015–04395 Filed 3–3–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pediatric 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: Pediatric
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 24, 2015, from 8 a.m. to
5:30 p.m.
Location: Double Tree by Hilton, 8727
Colesville Rd., Silver Spring, MD 20910,
301–589–5200. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301–796–
0885, email: walter.ellenberg@
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
E:\FR\FM\04MRN1.SGM
04MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
11682
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
VerDate Sep<11>2014
18:11 Mar 03, 2015
Jkt 235001
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]
BILLING CODE 4164–01–P
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
PO 00000
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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,
E:\FR\FM\04MRN1.SGM
04MRN1
Agencies
[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11681-11682]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Pediatric 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: Pediatric 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 24, 2015, from 8
a.m. to 5:30 p.m.
Location: Double Tree by Hilton, 8727 Colesville Rd., Silver
Spring, MD 20910, 301-589-5200. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301-796-0885, email:
walter.ellenberg@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
[[Page 11682]]
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
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/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 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-04394 Filed 3-3-15; 8:45 am]
BILLING CODE 4164-01-P