Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 50712-50713 [2016-18273]
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Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
• Confidential Submissions—To
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will not be disclosed except in
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applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
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received, go to https://
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Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Janet Donnelly, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5167, Silver Spring, MD 20993–
0002, 301–796–4187; or Irene StithColeman, Office for Human Research
Protections, 1101 Wootton Pkwy., Suite
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200, Rockville, MD 20852, 240–453–
6900.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP and FDA are announcing the
availability of a draft guidance
document entitled ‘‘Institutional Review
Board (IRB) Written Procedures:
Guidance for Institutions and IRBs.’’
This guidance is intended to assist IRB
administrators, IRB chairpersons, and
other institutional officials responsible
for preparing and maintaining written
procedures for IRBs.
OHRP and FDA frequently receive
requests for clarification regarding the
scope and content of IRB written
procedures. We recognize that
procedures may vary among institutions
and IRBs due to differences in the type
of research studies reviewed by the IRB,
institutional policy or administrative
practices, number of IRBs at the
institution, affiliation with an
institution, and local and State laws and
regulations. In order to provide
guidance on the appropriate content of
written procedures, while taking into
account these variations, we created an
IRB Written Procedures Checklist to
assist IRBs in preparing and maintaining
detailed written procedures suitable for
their institutions. The IRB Written
Procedures Checklist incorporates the
HHS and FDA regulatory requirements
for IRB written procedures and
additional topics that we recommend
including in written procedures. The
draft guidance, when finalized, will
supersede OHRP’s July 1, 2011,
‘‘Guidance on Written IRB Procedures’’
and FDA’s 1998 ‘‘Appendix H: A SelfEvaluation Checklist for IRBs,’’
(formerly part of FDA’s Information
Sheet Guidance for IRBs, Clinical
Investigators, and Sponsors).
To enhance human subject protection
and reduce regulatory burden, OHRP
and FDA have been actively working to
harmonize the Agencies’ regulatory
requirements and guidance for human
subject research. This guidance
document was developed as a part of
these efforts. OHRP and FDA believe
that it will be most helpful to the
regulated community to issue a joint
guidance document that will clearly
demonstrate the Agencies’ harmonized
approach to the topic of preparing and
maintaining IRB written procedures.
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 OHRP’s and FDA’s current
thinking on IRB written procedures. It
does not establish any rights for any
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person and is not binding on OHRP,
FDA, or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. 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 referenced in
this guidance that are related to IRB
recordkeeping requirements under 21
CFR 56.115, including the information
collection activities in the provisions in
21 CFR 56.108(a)(1) and (b), have been
approved under OMB control number
0910–0130. The collections of
information referenced in this guidance
that are related to IRB recordkeeping
requirements under 45 CFR 46.115,
including the information collection
activities in the provisions in 45 CFR
46.103(b)(4) and (5) have been approved
under OMB control number 0990–0260.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsandDraft
Guidances/default.htm, https://www.hhs.
gov/ohrp/regulations-and-policy/
requests-for-comments/, or
https://www.regulations.gov.
Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy, U.S. Food
and Drug Administration.
Dated: July 15, 2016.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, U.S.
Department of Health and Human Services.
[FR Doc. 2016–18191 Filed 8–1–16; 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
SUMMARY:
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The
Advisory Council will hear from a
number of CMS’s HCIA awardees about
their projects and their results.
Additional presentations in the
afternoon will include an overview of
the 2016 Update to the National Plan,
updates on progress towards a Care and
Services Summit, and Federal
workgroup updates.
DATES: The meeting will be held on
August 1, 2016 from 9 a.m. to 5 p.m.
EDT.
ADDRESSES: The meeting will be held in
Room 620/630, Building 35A (Porter
Building) of the National Institutes of
Health, 9000 Rockville Pike, Bethesda,
Maryland 20892.
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, ASPE, 200 Independence
Avenue SW., Room 424E, Washington,
DC 20201. All comments should be
submitted to napa@hhs.gov for the
record and to share with the Advisory
Council by April 20, 2016. Those
submitting 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
napa@hhs.gov and put ‘‘August 1
Meeting Attendance’’ in the Subject line
by Friday, July 22, 2016 so that their
names may be put on a list of expected
attendees and forwarded to the security
officers the Humphrey Building. 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 from a
number of CMS’s HCIA awardees about
their projects and their results.
Additional presentations in the
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afternoon will include an overview of
the 2016 Update to the National Plan,
updates on progress towards a Care and
Services Summit, and federal
workgroup updates.
Procedure and Agenda: This meeting
is open to the public. Please allow 45
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: July 8, 2016.
Kathryn E. Martin,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2016–18273 Filed 8–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Center for Advancing Translational
Sciences.
The meetings 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 meetings 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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cures Acceleration
Network Review Board.
Date: September 15, 2016.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director.
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Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: September 15, 2016.
Open: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: July 27, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–18291 Filed 8–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request; NCI’s Center for Cancer
Training Application Form for
Graduate Student Recruitment
Program (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
SUMMARY:
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[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50712-50713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18273]
-----------------------------------------------------------------------
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
[[Page 50713]]
burden of Alzheimer's disease and related dementias on people with the
disease and their caregivers. The Advisory Council will hear from a
number of CMS's HCIA awardees about their projects and their results.
Additional presentations in the afternoon will include an overview of
the 2016 Update to the National Plan, updates on progress towards a
Care and Services Summit, and Federal workgroup updates.
DATES: The meeting will be held on August 1, 2016 from 9 a.m. to 5 p.m.
EDT.
ADDRESSES: The meeting will be held in Room 620/630, Building 35A
(Porter Building) of the National Institutes of Health, 9000 Rockville
Pike, Bethesda, Maryland 20892.
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, ASPE, 200
Independence Avenue SW., Room 424E, Washington, DC 20201. All comments
should be submitted to napa@hhs.gov for the record and to share with
the Advisory Council by April 20, 2016. Those submitting 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 napa@hhs.gov and put ``August
1 Meeting Attendance'' in the Subject line by Friday, July 22, 2016 so
that their names may be put on a list of expected attendees and
forwarded to the security officers the Humphrey Building. 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 from a
number of CMS's HCIA awardees about their projects and their results.
Additional presentations in the afternoon will include an overview of
the 2016 Update to the National Plan, updates on progress towards a
Care and Services Summit, and federal workgroup updates.
Procedure and Agenda: This meeting is open to the public. Please
allow 45 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: July 8, 2016.
Kathryn E. Martin,
Acting Assistant Secretary for Planning and Evaluation.
[FR Doc. 2016-18273 Filed 8-1-16; 8:45 am]
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