Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 17440-17441 [2015-07374]
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17440
Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
general circumstances in which CDRH
consults with a panel of the Medical
Devices Advisory Committee, the
process for exchange of information
between CDRH, the members of the
panel, industry, and the public, and the
conduct of panel meetings. The Medical
Devices Advisory Committee includes
17 panels other than the DRP (Ref. 1).
The panels, according to their specialty
area and authorization, advise the
Commissioner of Food and Drugs in
discharging responsibilities as they
relate to assuring the safety and
effectiveness of medical devices, and as
required, any other product for which
FDA has regulatory responsibility.
This draft guidance is intended to
provide more comprehensive
information for industry and for CDRH
staff on the processes associated with a
panel meeting held for any of the
reasons identified in the guidance. Once
final, this guidance will replace the
‘‘Guidance on Amended Procedures for
Advisory Panel Meetings’’ (Ref. 2) and
the guidance document entitled ‘‘Panel
Review of Premarket Approval
Applications #P91–2 blue book memo’’
(Ref. 3). This guidance supplements
existing FDA Agency-wide guidance on
the conduct of Advisory Committee
meetings.
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II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the panel meeting process for
medical devices. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Procedures for Meetings of the
Medical Devices Advisory Committee’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 413 to
identify the guidance you are
requesting.
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IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 860 have
been approved under OMB control
number 0910–0138; the collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231; and the collections
of information in 21 CFR part 814,
subpart H have been approved under
OMB control number 0910–0332.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VI. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. CDRH’s Medical Devices Advisory
Committee, available at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
MedicalDevices/
MedicalDevicesAdvisoryCommittee/
default.htm.
2. ‘‘Guidance for Industry and FDA Staff:
Guidance on Amended Procedures for
Advisory Panel Meetings,’’ July 2000,
available at https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm073726.pdf.
3. ‘‘Panel Review of Premarket Approval
Applications #P91–2 (blue book memo),’’
May 1991, available at https://www.fda.gov/
MedicalDevices/
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DeviceRegulationandGuidance/
GuidanceDocuments/ucm081363.htm.
Dated: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07438 Filed 3–31–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
April meeting, the Advisory Council
will build on the goals of White House
Conference on Aging (WHCOA) through
a half-day session with dementiafocused panels on each WHCOA topic
area: Healthy aging, long-term services
and supports, retirement security, and
elder justice. Following this session, the
Advisory Council will also hold a brief
discussion on the 2015 Update to the
National Plan to Address Alzheimer’s,
as well as a discussion of international
events on dementia.
DATES: The meeting will be held on
April 28th, 2015 from 9:00 a.m. to 5:00
p.m. EDT.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW., Washington, DC 20201.
Comments: Time is allocated in the
afternoon on the agenda to hear public
comments. The time for oral comments
will be limited to two (2) minutes per
individual. In lieu of oral comments,
formal written comments may be
submitted for the record to Rohini
Khillan, OASPE, 200 Independence
Avenue SW., Room 424E, Washington,
DC 20201. Comments may also be sent
to napa@hhs.gov. Those submitting
written comments should identify
themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Rohini Khillan (202) 690–5932,
rohini.khillan@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
SUMMARY:
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Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
napa@hhs.gov and put ‘‘April 28
Meeting Attendance’’ in the Subject line
by Friday, April 17, so that their names
may be put on a list of expected
attendees and forwarded to the security
officers at the Department of Health and
Human Services. Any interested
member of the public who is a non-U.S.
citizen should include this information
at the time of registration to ensure that
the appropriate security procedure to
gain entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The
Advisory Council will hear
presentations on the basics of long-term
care, including presentations on
programs, settings, and payers. The
Council will use a portion of the
meeting to review the work it has
accomplished thus far towards the 2025
goals, and then discuss the process for
developing recommendations for the
2015 update to the National Plan. The
Council will also hear presentations
from the three subcommittees (Research,
Clinical Care, Long-Term Services and
Supports, and Ethics).
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Vitamin D External Quality Assessment
Scheme (DEQAS), announce that as part
of the Vitamin D Standardization
Program (VDSP), they are recruiting
laboratories to participate in a study of
the commutability of pooled serum
samples used in assays to measure total
25-hydroxyvitamin D [25(OH)D].
DATES: The expected start date for the
study is June 2015.
ADDRESSES: For more information about
the study and to let us know if you are
interested in participating, please
contact us at: vdsp@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT: Drs.
Johanna Camara, NIST, and Christopher
Sempos, ODS, Director and Co-Director,
respectively, for the VDSP
Commutability Study 2. Email: VDSP@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
objective of the study is to promote the
standardized measurement of total
25(OH)D by evaluating the
commutability of NIST Standard
Reference Materials® (SRM) used as
‘‘trueness’’ controls and the materials
used in the major Performance Testing/
External Quality (PT/EQA) programs
administered by CAP and DEQAS. Who
Can Participate: (1) All commercial
manufacturers of 25(OH)D assays
(requests from manufacturers with
assays in development will be
considered); (2) Clinical and research
laboratories using a commercial assay
platform; (3) Laboratories for national/
subnational nutrition surveys; and (4)
Laboratories using in-house developed
assays.
For details about the study design and
time lines, see the recently published
paper in the February 2015 edition of
Clinical Laboratory News, (https://
www.aacc.org/publications/cln/articles/
2015/february/vitamin-dcommutability-study).
Dated: March 25, 2015.
Richard G. Frank,
Assistant Secretary for Planning and
Evaluation.
Dated: March 24, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–07374 Filed 3–31–15; 8:45 am]
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[FR Doc. 2015–07326 Filed 3–31–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Office of Dietary Supplements VDSP
Commutability Study 2
NIH Office of Dietary
Supplements (ODS) and the National
Institute of Standards and Technology
(NIST), in collaboration with the College
of American Pathologists (CAP) and
SUMMARY:
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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 meeting.
The meeting will be closed to the
public in accordance with the
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17441
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: National Institute on
Aging Special Emphasis Panel; Fibroblast
Growth Factor And Aging.
Date: May 1, 2015.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alicja L. Markowska,
Ph.D., DSC., Scientific Review Branch,
National Institute On Aging, 7201 Wisconsin
Avenue, Suite 2c212, Bethesda, MD 20892,
301–496–9666, markowsa@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 26, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07338 Filed 3–31–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 Board
of Scientific Counselors, NIA.
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 as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE ON AGING,
including consideration of personnel
qualifications and performance, and the
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]]>Agencies
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17440-17441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07374]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Council on Alzheimer's Research, Care, and Services;
Meeting
AGENCY: Assistant Secretary for Planning and Evaluation, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the public meeting of the Advisory
Council on Alzheimer's Research, Care, and Services (Advisory Council).
The Advisory Council on Alzheimer's Research, Care, and Services
provides advice on how to prevent or reduce the burden of Alzheimer's
disease and related dementias on people with the disease and their
caregivers. During the April meeting, the Advisory Council will build
on the goals of White House Conference on Aging (WHCOA) through a half-
day session with dementia-focused panels on each WHCOA topic area:
Healthy aging, long-term services and supports, retirement security,
and elder justice. Following this session, the Advisory Council will
also hold a brief discussion on the 2015 Update to the National Plan to
Address Alzheimer's, as well as a discussion of international events on
dementia.
DATES: The meeting will be held on April 28th, 2015 from 9:00 a.m. to
5:00 p.m. EDT.
ADDRESSES: The meeting will be held in Room 800 in the Hubert H.
Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Comments: Time is allocated in the afternoon on the agenda to hear
public comments. The time for oral comments will be limited to two (2)
minutes per individual. In lieu of oral comments, formal written
comments may be submitted for the record to Rohini Khillan, OASPE, 200
Independence Avenue SW., Room 424E, Washington, DC 20201. Comments may
also be sent to napa@hhs.gov. Those submitting written comments should
identify themselves and any relevant organizational affiliations.
FOR FURTHER INFORMATION CONTACT: Rohini Khillan (202) 690-5932,
rohini.khillan@hhs.gov. Note: Seating may be limited. Those wishing to
attend the meeting must send an email to
[[Page 17441]]
napa@hhs.gov and put ``April 28 Meeting Attendance'' in the Subject
line by Friday, April 17, so that their names may be put on a list of
expected attendees and forwarded to the security officers at the
Department of Health and Human Services. Any interested member of the
public who is a non-U.S. citizen should include this information at the
time of registration to ensure that the appropriate security procedure
to gain entry to the building is carried out. Although the meeting is
open to the public, procedures governing security and the entrance to
Federal buildings may change without notice. If you wish to make a
public comment, you must note that within your email.
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The Advisory Council will hear
presentations on the basics of long-term care, including presentations
on programs, settings, and payers. The Council will use a portion of
the meeting to review the work it has accomplished thus far towards the
2025 goals, and then discuss the process for developing recommendations
for the 2015 update to the National Plan. The Council will also hear
presentations from the three subcommittees (Research, Clinical Care,
Long-Term Services and Supports, and Ethics).
Procedure and Agenda: This meeting is open to the public. Please
allow 30 minutes to go through security and walk to the meeting room.
The meeting will also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National
Alzheimer's Project Act. The panel is governed by provisions of
Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
Dated: March 25, 2015.
Richard G. Frank,
Assistant Secretary for Planning and Evaluation.
[FR Doc. 2015-07374 Filed 3-31-15; 8:45 am]
BILLING CODE 4150-05-P
