Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 11680-11681 [2015-04395]
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11680
ACTION:
Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices
Notice.
The Administration on Aging
(AoA) is announcing that the proposed
collection of information listed below
has been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written or electronic
comments on the collection of
information by May 4, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: louise.ryan@acl.gov.
Submit written comments on the
collection of information to Louise
Ryan, U.S. Administration for
Community Living, 1 Massachusetts
Avenue, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Louise Ryan, telephone: (202) 357–3503;
email: louise.ryan@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, AoA
has submitted the following proposed
collection of information to OMB for
review and clearance.
States provide the following data and
narrative information in the report:
1. Numbers and descriptions of cases
filed and complaints made on behalf of
long-term care facility residents to the
statewide ombudsman program;
2. Major issues identified impacting
on the quality of care and life of longterm care facility residents;
3. Statewide program operations; and
4. Ombudsman activities in addition
to complaint investigation.
The report form and instructions have
been in continuous use, with minor
modifications, since they were first
approved by OMB for the FY 1995
reporting period. This request is for
approval to extend use of the current
form and instructions, with no
modifications, for three years, covering
the FY 2015–2017 reporting periods.
The data collected on complaints filed
with Ombudsman programs and
narrative on long-term care issues
provide information to Centers for
Medicare and Medicaid Services and
others on patterns of concerns and
major long-term care issues affecting
residents of long-term care facilities.
Both the complaint and program data
collected assist the states and local
Ombudsman programs in planning
strategies and activities, providing
training and technical assistance and
developing performance measures.
A reporting form and instructions
may be viewed in the ombudsman
section of the AoA Web site, https://
www.aoa.acl.gov/AoA_Programs/Elder_
Rights/Ombudsman/NORS.aspx. AoA
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SUMMARY:
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estimates the burden of this collection
and entering the report information as
follows: Approximately 7,702.3 hours,
with 52 State Long-Term Care
Ombudsman programs responding
annually.
Dated: February 26, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–04470 Filed 3–3–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Intent To Award a Single
Source Non-Competing Continuation
Cooperative Agreement to Amputee
Coalition
Administration for Community
Living, HHS.
SUMMARY: The Administration for
Community Living (ACL) is proud to
announce the Center for Improved
Health of Persons with Limb Loss (Limb
Loss Program) is moving to ACL as a
result of the 2015 budget recently signed
by President Obama.
The Limb Loss Program supports a
national resource center and related
activities that provides comprehensive
information and resources to assist
individuals and families dealing with
Limb Loss. The Limb Loss Program
currently operates through a cooperative
agreement between the Amputee
Coalition and the U.S. Department of
Health and Human Services (HHS)
Centers for Disease Control and
Prevention (CDC). ACL will be working
with the CDC on transitioning the
program to ACL.
Program Name: Limb Loss Program
Award Amount: $2,730,000
Project Period: 4/1/2015 to 3/31/2016
Award Type: Cooperative Agreement
AGENCY:
Statutory Authority: This program is
authorized under Section 317 of the Public
Health Service Act (42 U.S.C. 247(b–4));
Consolidated and Further Continuing
Appropriations Act, 2015, Public Law 113–
235 (Dec. 16, 2014).
Catalog of Federal Domestic Assistance
(CFDA) Number: 93.325 Discretionary
Projects
DATES: Estimated Project Period—April
1, 2015 through March 31, 2016.
I. Program Description
The purpose of this cooperative
agreement is to continue existing
activities to promote health, wellness
and the adoption of healthy behaviors
with the objective of preventing and/or
reducing chronic conditions associated
with limb loss. The grantee will
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continue to use both traditional and
innovative approaches that will educate
and inform people with disabilities,
their family members, health care
providers, policy makers, community
members, and the general public.
Justification: The Limb Loss Program
currently operates through a cooperative
agreement between the Amputee
Coalition and the U.S. Department of
Health and Human Services (HHS)
Centers for Disease Control and
Prevention (CDC). ACL will be working
with the CDC on transitioning the
program to ACL. To ensure
uninterrupted continuation of the grant
goals and objectives, ACL plans to issue
a one year non-competing award to the
incumbent Limb Loss Program grantee,
Amputee Coalition.
II. Agency Contact
For further information or comments
regarding this action, contact Ophelia
M. McLain, U.S. Department of Health
and Human Services, Administration for
Community Living, Administration on
Intellectual and Developmental
Disabilities, Office of Innovation, One
Massachusetts Avenue NW.,
Washington, DC 20001; telephone (202)
690–7025; fax (202) 357–3560; email
Ophelia.McLain@acl.hhs.gov.
Dated: February 26, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–04460 Filed 3–3–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Endocrinologic and Metabolic Drugs
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: Endocrinologic
and Metabolic 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 April 14, 2015, from 7:30 a.m.
to 5:15 p.m.
E:\FR\FM\04MRN1.SGM
04MRN1
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
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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.
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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
]]>Agencies
[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11680-11681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04395]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Endocrinologic and Metabolic Drugs 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: Endocrinologic and Metabolic 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 April 14, 2015, from
7:30 a.m. to 5:15 p.m.
[[Page 11681]]
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/AboutAdvisoryCommittees/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 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/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. 2015-04395 Filed 3-3-15; 8:45 am]
BILLING CODE 4164-01-P
