80_FR_17502 80 FR 17440 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting

80 FR 17440 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 62 (April 1, 2015)

Page Range17440-17441
FR Document2015-07374

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.

Federal Register, Volume 80 Issue 62 (Wednesday, April 1, 2015)
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17440-17441]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07374]


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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]
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                                                  17440                         Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices

                                                  general circumstances in which CDRH                     IV. Paperwork Reduction Act of 1995                   DeviceRegulationandGuidance/
                                                  consults with a panel of the Medical                                                                          GuidanceDocuments/ucm081363.htm.
                                                  Devices Advisory Committee, the                           This guidance refers to previously
                                                                                                                                                                  Dated: March 26, 2015.
                                                  process for exchange of information                     approved collections of information
                                                                                                          found in FDA regulations. These                       Leslie Kux,
                                                  between CDRH, the members of the                                                                              Associate Commissioner for Policy.
                                                  panel, industry, and the public, and the                collections of information are subject to
                                                  conduct of panel meetings. The Medical                  review by the Office of Management and                [FR Doc. 2015–07438 Filed 3–31–15; 8:45 am]

                                                  Devices Advisory Committee includes                     Budget (OMB) under the Paperwork                      BILLING CODE 4164–01–P

                                                  17 panels other than the DRP (Ref. 1).                  Reduction Act of 1995 (44 U.S.C. 3501–
                                                  The panels, according to their specialty                3520). The collections of information in
                                                                                                          21 CFR part 807, subpart E have been                  DEPARTMENT OF HEALTH AND
                                                  area and authorization, advise the                                                                            HUMAN SERVICES
                                                  Commissioner of Food and Drugs in                       approved under OMB control number
                                                  discharging responsibilities as they                    0910–0120; the collections of
                                                                                                          information in 21 CFR part 860 have                   Advisory Council on Alzheimer’s
                                                  relate to assuring the safety and                                                                             Research, Care, and Services; Meeting
                                                  effectiveness of medical devices, and as                been approved under OMB control
                                                  required, any other product for which                   number 0910–0138; the collections of                  AGENCY: Assistant Secretary for
                                                  FDA has regulatory responsibility.                      information in 21 CFR part 814 have                   Planning and Evaluation, HHS.
                                                     This draft guidance is intended to                   been approved under OMB control                       ACTION: Notice of meeting.
                                                  provide more comprehensive                              number 0910–0231; and the collections
                                                  information for industry and for CDRH                   of information in 21 CFR part 814,                    SUMMARY:   This notice announces the
                                                  staff on the processes associated with a                subpart H have been approved under                    public meeting of the Advisory Council
                                                  panel meeting held for any of the                       OMB control number 0910–0332.                         on Alzheimer’s Research, Care, and
                                                  reasons identified in the guidance. Once                V. Comments                                           Services (Advisory Council). The
                                                  final, this guidance will replace the                                                                         Advisory Council on Alzheimer’s
                                                  ‘‘Guidance on Amended Procedures for                       Interested persons may submit either               Research, Care, and Services provides
                                                  Advisory Panel Meetings’’ (Ref. 2) and                  electronic comments regarding this                    advice on how to prevent or reduce the
                                                  the guidance document entitled ‘‘Panel                  document to http://www.regulations.gov                burden of Alzheimer’s disease and
                                                  Review of Premarket Approval                            or written comments to the Division of                related dementias on people with the
                                                  Applications #P91–2 blue book memo’’                    Dockets Management (see ADDRESSES). It                disease and their caregivers. During the
                                                  (Ref. 3). This guidance supplements                     is only necessary to send one set of                  April meeting, the Advisory Council
                                                  existing FDA Agency-wide guidance on                    comments. Identify comments with the                  will build on the goals of White House
                                                  the conduct of Advisory Committee                       docket number found in brackets in the                Conference on Aging (WHCOA) through
                                                  meetings.                                               heading of this document. Received                    a half-day session with dementia-
                                                                                                          comments may be seen in the Division                  focused panels on each WHCOA topic
                                                  II. Significance of Guidance
                                                                                                          of Dockets Management between 9 a.m.                  area: Healthy aging, long-term services
                                                     This draft guidance is being issued                  and 4 p.m., Monday through Friday, and                and supports, retirement security, and
                                                  consistent with FDA’s good guidance                     will be posted to the docket at http://               elder justice. Following this session, the
                                                  practices regulation (21 CFR 10.115).                   www.regulations.gov.                                  Advisory Council will also hold a brief
                                                  The draft guidance, when finalized, will                                                                      discussion on the 2015 Update to the
                                                  represent the Agency’s current thinking                 VI. References
                                                                                                                                                                National Plan to Address Alzheimer’s,
                                                  on the panel meeting process for                          The following references have been                  as well as a discussion of international
                                                  medical devices. It does not create or                  placed on display in the Division of                  events on dementia.
                                                  confer any rights for or on any person                  Dockets Management (see ADDRESSES),                   DATES: The meeting will be held on
                                                  and does not operate to bind FDA or the                 and may be seen by interested persons                 April 28th, 2015 from 9:00 a.m. to 5:00
                                                  public. An alternative approach may be                  between 9 a.m. and 4 p.m., Monday                     p.m. EDT.
                                                  used if such approach satisfies the                     through Friday, and are available                     ADDRESSES: The meeting will be held in
                                                  requirements of the applicable statute                  electronically at http://
                                                  and regulations.                                                                                              Room 800 in the Hubert H. Humphrey
                                                                                                          www.regulations.gov. (FDA has verified                Building, 200 Independence Avenue
                                                  III. Electronic Access                                  the Web site addresses, but we are not                SW., Washington, DC 20201.
                                                                                                          responsible for any subsequent changes                   Comments: Time is allocated in the
                                                     Persons interested in obtaining a copy               to the Web sites after this document
                                                  of the draft guidance may do so by                                                                            afternoon on the agenda to hear public
                                                                                                          publishes in the Federal Register.)                   comments. The time for oral comments
                                                  downloading an electronic copy from
                                                  the Internet. A search capability for all                 1. CDRH’s Medical Devices Advisory                  will be limited to two (2) minutes per
                                                  CDRH guidance documents is available                    Committee, available at http://www.fda.gov/           individual. In lieu of oral comments,
                                                                                                          AdvisoryCommittees/                                   formal written comments may be
                                                  at http://www.fda.gov/MedicalDevices/                   CommitteesMeetingMaterials/
                                                  DeviceRegulationandGuidance/                                                                                  submitted for the record to Rohini
                                                                                                          MedicalDevices/
                                                  GuidanceDocuments/default.htm.                          MedicalDevicesAdvisoryCommittee/
                                                                                                                                                                Khillan, OASPE, 200 Independence
                                                  Guidance documents are also available                   default.htm.                                          Avenue SW., Room 424E, Washington,
                                                  at http://www.regulations.gov. Persons                    2. ‘‘Guidance for Industry and FDA Staff:           DC 20201. Comments may also be sent
                                                  unable to download an electronic copy                   Guidance on Amended Procedures for                    to napa@hhs.gov. Those submitting
                                                                                                          Advisory Panel Meetings,’’ July 2000,                 written comments should identify
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                                                  of ‘‘Procedures for Meetings of the
                                                  Medical Devices Advisory Committee’’                    available at http://www.fda.gov/downloads/            themselves and any relevant
                                                  may send an email request to CDRH-                      MedicalDevices/                                       organizational affiliations.
                                                                                                          DeviceRegulationandGuidance/
                                                  Guidance@fda.hhs.gov to receive an                      GuidanceDocuments/ucm073726.pdf.                      FOR FURTHER INFORMATION CONTACT:
                                                  electronic copy of the document. Please                   3. ‘‘Panel Review of Premarket Approval             Rohini Khillan (202) 690–5932,
                                                  use the document number 413 to                          Applications #P91–2 (blue book memo),’’               rohini.khillan@hhs.gov. Note: Seating
                                                  identify the guidance you are                           May 1991, available at http://www.fda.gov/            may be limited. Those wishing to attend
                                                  requesting.                                             MedicalDevices/                                       the meeting must send an email to


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                                                                                Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices                                                 17441

                                                  napa@hhs.gov and put ‘‘April 28                         Vitamin D External Quality Assessment                 provisions set forth in sections
                                                  Meeting Attendance’’ in the Subject line                Scheme (DEQAS), announce that as part                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  by Friday, April 17, so that their names                of the Vitamin D Standardization                      as amended. The grant applications and
                                                  may be put on a list of expected                        Program (VDSP), they are recruiting                   the discussions could disclose
                                                  attendees and forwarded to the security                 laboratories to participate in a study of             confidential trade secrets or commercial
                                                  officers at the Department of Health and                the commutability of pooled serum                     property such as patentable material,
                                                  Human Services. Any interested                          samples used in assays to measure total               and personal information concerning
                                                  member of the public who is a non-U.S.                  25-hydroxyvitamin D [25(OH)D].                        individuals associated with the grant
                                                  citizen should include this information                 DATES: The expected start date for the                applications, the disclosure of which
                                                  at the time of registration to ensure that              study is June 2015.                                   would constitute a clearly unwarranted
                                                  the appropriate security procedure to                   ADDRESSES: For more information about                 invasion of personal privacy.
                                                  gain entry to the building is carried out.              the study and to let us know if you are                 Name of Committee: National Institute on
                                                  Although the meeting is open to the                     interested in participating, please                   Aging Special Emphasis Panel; Fibroblast
                                                  public, procedures governing security                   contact us at: vdsp@mail.nih.gov.                     Growth Factor And Aging.
                                                  and the entrance to Federal buildings                                                                           Date: May 1, 2015.
                                                                                                          FOR FURTHER INFORMATION CONTACT: Drs.
                                                  may change without notice. If you wish                                                                          Time: 1:00 p.m. to 5:00 p.m.
                                                                                                          Johanna Camara, NIST, and Christopher                   Agenda: To review and evaluate grant
                                                  to make a public comment, you must
                                                                                                          Sempos, ODS, Director and Co-Director,                applications.
                                                  note that within your email.
                                                                                                          respectively, for the VDSP                              Place: National Institute on Aging,
                                                  SUPPLEMENTARY INFORMATION: Notice of                    Commutability Study 2. Email: VDSP@                   Gateway Building, Suite 2C212, 7201
                                                  these meetings is given under the                       mail.nih.gov.                                         Wisconsin Avenue, Bethesda, MD 20892,
                                                  Federal Advisory Committee Act (5                                                                             (Telephone Conference Call).
                                                                                                          SUPPLEMENTARY INFORMATION: The
                                                  U.S.C. App. 2, section 10(a)(1) and                                                                             Contact Person: Alicja L. Markowska,
                                                                                                          objective of the study is to promote the              Ph.D., DSC., Scientific Review Branch,
                                                  (a)(2)). Topics of the Meeting: The
                                                                                                          standardized measurement of total                     National Institute On Aging, 7201 Wisconsin
                                                  Advisory Council will hear
                                                                                                          25(OH)D by evaluating the                             Avenue, Suite 2c212, Bethesda, MD 20892,
                                                  presentations on the basics of long-term
                                                                                                          commutability of NIST Standard                        301–496–9666, markowsa@nia.nih.gov.
                                                  care, including presentations on
                                                                                                          Reference Materials® (SRM) used as                    (Catalogue of Federal Domestic Assistance
                                                  programs, settings, and payers. The
                                                                                                          ‘‘trueness’’ controls and the materials               Program Nos. 93.866, Aging Research,
                                                  Council will use a portion of the
                                                                                                          used in the major Performance Testing/                National Institutes of Health, HHS)
                                                  meeting to review the work it has
                                                                                                          External Quality (PT/EQA) programs
                                                  accomplished thus far towards the 2025                                                                          Dated: March 26, 2015.
                                                                                                          administered by CAP and DEQAS. Who
                                                  goals, and then discuss the process for                                                                       Melanie J. Gray,
                                                                                                          Can Participate: (1) All commercial
                                                  developing recommendations for the                                                                            Program Analyst, Office of Federal Advisory
                                                                                                          manufacturers of 25(OH)D assays
                                                  2015 update to the National Plan. The                                                                         Committee Policy.
                                                                                                          (requests from manufacturers with
                                                  Council will also hear presentations                                                                          [FR Doc. 2015–07338 Filed 3–31–15; 8:45 am]
                                                                                                          assays in development will be
                                                  from the three subcommittees (Research,
                                                                                                          considered); (2) Clinical and research                BILLING CODE 4140–01–P
                                                  Clinical Care, Long-Term Services and
                                                                                                          laboratories using a commercial assay
                                                  Supports, and Ethics).
                                                     Procedure and Agenda: This meeting                   platform; (3) Laboratories for national/
                                                                                                          subnational nutrition surveys; and (4)                DEPARTMENT OF HEALTH AND
                                                  is open to the public. Please allow 30                                                                        HUMAN SERVICES
                                                  minutes to go through security and walk                 Laboratories using in-house developed
                                                  to the meeting room. The meeting will                   assays.                                               National Institutes of Health
                                                                                                             For details about the study design and
                                                  also be webcast at www.hhs.gov/live.
                                                                                                          time lines, see the recently published                National Institute on Aging; Notice of
                                                    Authority: 42 U.S.C. 11225; Section 2(e)(3)           paper in the February 2015 edition of
                                                  of the National Alzheimer’s Project Act. The                                                                  Meeting
                                                                                                          Clinical Laboratory News, (https://
                                                  panel is governed by provisions of Public                                                                        Pursuant to section 10(d) of the
                                                  Law 92–463, as amended (5 U.S.C. Appendix
                                                                                                          www.aacc.org/publications/cln/articles/
                                                                                                          2015/february/vitamin-d-                              Federal Advisory Committee Act, as
                                                  2), which sets forth standards for the
                                                  formation and use of advisory committees.               commutability-study).                                 amended (5 U.S.C. App.), notice is
                                                                                                                                                                hereby given of a meeting of the Board
                                                    Dated: March 25, 2015.                                  Dated: March 24, 2015.
                                                                                                                                                                of Scientific Counselors, NIA.
                                                  Richard G. Frank,                                       Lawrence A. Tabak,                                       The meeting will be open to the
                                                  Assistant Secretary for Planning and                    Deputy Director, National Institutes of Health.       public as indicated below, with
                                                  Evaluation.                                             [FR Doc. 2015–07326 Filed 3–31–15; 8:45 am]           attendance limited to space available.
                                                  [FR Doc. 2015–07374 Filed 3–31–15; 8:45 am]             BILLING CODE 4140–01–P                                Individuals who plan to attend and
                                                  BILLING CODE 4150–05–P                                                                                        need special assistance, such as sign
                                                                                                                                                                language interpretation or other
                                                                                                          DEPARTMENT OF HEALTH AND                              reasonable accommodations, should
                                                  DEPARTMENT OF HEALTH AND                                HUMAN SERVICES                                        notify the Contact Person listed below
                                                  HUMAN SERVICES                                                                                                in advance of the meeting.
                                                                                                          National Institutes of Health                            The meeting will be closed to the
                                                  National Institutes of Health                                                                                 public as indicated below in accordance
                                                                                                          National Institute on Aging; Notice of
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                                                                                                                                                                with the provisions set forth in section
                                                  Office of Dietary Supplements VDSP                      Closed Meeting
                                                                                                                                                                552b(c)(6), Title 5 U.S.C., as amended
                                                  Commutability Study 2
                                                                                                            Pursuant to section 10(d) of the                    for the review, discussion, and
                                                  SUMMARY:   NIH Office of Dietary                        Federal Advisory Committee Act, as                    evaluation of individual intramural
                                                  Supplements (ODS) and the National                      amended (5 U.S.C. App.), notice is                    programs and projects conducted by the
                                                  Institute of Standards and Technology                   hereby given of the following meeting.                NATIONAL INSTITUTE ON AGING,
                                                  (NIST), in collaboration with the College                 The meeting will be closed to the                   including consideration of personnel
                                                  of American Pathologists (CAP) and                      public in accordance with the                         qualifications and performance, and the


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Document Created: 2015-12-18 11:04:04
Document Modified: 2015-12-18 11:04:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of meeting.
DatesThe meeting will be held on April 28th, 2015 from 9:00 a.m. to 5:00 p.m. EDT.
ContactRohini Khillan (202) 690-5932, [email protected] Note: Seating may be limited. Those wishing to attend the meeting must send an email to [email protected] 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.
FR Citation80 FR 17440 

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