81 FR 50712 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 148 (August 2, 2016)
Federal Register Volume 81, Issue 148 (August 2, 2016)
| Page Range | 50712-50713 | |
| FR Document | 2016-18273 |
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)] [Notices] [Pages 50712-50713] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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, [email protected]. Note: Seating may be limited. Those wishing to attend the meeting must send an email to [email protected] 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] BILLING CODE P
![50712 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
• Confidential Submissions—To 200, Rockville, MD 20852, 240–453– person and is not binding on OHRP,
submit a comment with confidential 6900. FDA, or the public. You can use an
information that you do not wish to be SUPPLEMENTARY INFORMATION:
alternative approach if it satisfies the
made publicly available, submit your requirements of the applicable statutes
comments only as a written/paper I. Background and regulations.
submission. You should submit two OHRP and FDA are announcing the II. Paperwork Reduction Act of 1995
copies total. One copy will include the availability of a draft guidance
information you claim to be confidential This draft guidance refers to
document entitled ‘‘Institutional Review
with a heading or cover note that states previously approved collections of
Board (IRB) Written Procedures:
‘‘THIS DOCUMENT CONTAINS information. These collections of
Guidance for Institutions and IRBs.’’
CONFIDENTIAL INFORMATION.’’ The information are subject to review by the
This guidance is intended to assist IRB
Agency will review this copy, including Office of Management and Budget
administrators, IRB chairpersons, and
the claimed confidential information, in (OMB) under the Paperwork Reduction
other institutional officials responsible
its consideration of comments. The Act of 1995 (44 U.S.C. 3501–3520). The
for preparing and maintaining written
second copy, which will have the collections of information referenced in
procedures for IRBs.
claimed confidential information OHRP and FDA frequently receive this guidance that are related to IRB
redacted/blacked out, will be available requests for clarification regarding the recordkeeping requirements under 21
for public viewing and posted on http:// scope and content of IRB written CFR 56.115, including the information
www.regulations.gov. Submit both procedures. We recognize that collection activities in the provisions in
copies to the Division of Dockets procedures may vary among institutions 21 CFR 56.108(a)(1) and (b), have been
Management. If you do not wish your and IRBs due to differences in the type approved under OMB control number
name and contact information to be of research studies reviewed by the IRB, 0910–0130. The collections of
made publicly available, you can institutional policy or administrative information referenced in this guidance
provide this information on the cover practices, number of IRBs at the that are related to IRB recordkeeping
sheet and not in the body of your institution, affiliation with an requirements under 45 CFR 46.115,
comments and you must identify this institution, and local and State laws and including the information collection
information as ‘‘confidential.’’ Any regulations. In order to provide activities in the provisions in 45 CFR
information marked as ‘‘confidential’’ guidance on the appropriate content of 46.103(b)(4) and (5) have been approved
will not be disclosed except in written procedures, while taking into under OMB control number 0990–0260.
accordance with 21 CFR 10.20 and other account these variations, we created an III. Electronic Access
applicable disclosure law. For more IRB Written Procedures Checklist to
information about FDA’s posting of Persons with access to the Internet
assist IRBs in preparing and maintaining may obtain the draft guidance at either
comments to public dockets, see 80 FR detailed written procedures suitable for
56469, September 18, 2015, or access http://www.fda.gov/ScienceResearch/
their institutions. The IRB Written SpecialTopics/RunningClinicalTrials/
the information at: http://www.fda.gov/ Procedures Checklist incorporates the
regulatoryinformation/dockets/ ProposedRegulationsandDraft
HHS and FDA regulatory requirements Guidances/default.htm, http://www.hhs.
default.htm. for IRB written procedures and
Docket: For access to the docket to gov/ohrp/regulations-and-policy/
additional topics that we recommend requests-for-comments/index.html, or
read background documents or the including in written procedures. The
electronic and written/paper comments http://www.regulations.gov.
draft guidance, when finalized, will
received, go to http:// supersede OHRP’s July 1, 2011, Dated: July 27, 2016.
www.regulations.gov and insert the ‘‘Guidance on Written IRB Procedures’’ Leslie Kux,
docket number, found in brackets in the and FDA’s 1998 ‘‘Appendix H: A Self- Associate Commissioner for Policy, U.S. Food
heading of this document, into the Evaluation Checklist for IRBs,’’ and Drug Administration.
‘‘Search’’ box and follow the prompts (formerly part of FDA’s Information Dated: July 15, 2016.
and/or go to the Division of Dockets Sheet Guidance for IRBs, Clinical Karen B. DeSalvo,
Management, 5630 Fishers Lane, Rm. Investigators, and Sponsors). Acting Assistant Secretary for Health, U.S.
1061, Rockville, MD 20852. To enhance human subject protection Department of Health and Human Services.
Submit written requests for single and reduce regulatory burden, OHRP [FR Doc. 2016–18191 Filed 8–1–16; 8:45 am]
copies of the draft guidance to the and FDA have been actively working to BILLING CODE 4164–01–P
Division of Drug Information, Center for harmonize the Agencies’ regulatory
Drug Evaluation and Research, Food requirements and guidance for human
and Drug Administration, 10001 New subject research. This guidance DEPARTMENT OF HEALTH AND
Hampshire Ave., Hillandale Building, document was developed as a part of HUMAN SERVICES
4th Floor, Silver Spring, MD 20993– these efforts. OHRP and FDA believe
0002. Send one self-addressed adhesive that it will be most helpful to the Advisory Council on Alzheimer’s
label to assist that office in processing regulated community to issue a joint Research, Care, and Services; Meeting
your requests. See the SUPPLEMENTARY guidance document that will clearly AGENCY: Assistant Secretary for
INFORMATION section for electronic demonstrate the Agencies’ harmonized Planning and Evaluation, HHS.
access to the draft guidance document. approach to the topic of preparing and ACTION: Notice of meeting.
FOR FURTHER INFORMATION CONTACT: maintaining IRB written procedures.
mstockstill on DSK3G9T082PROD with NOTICES
Janet Donnelly, Office of Good Clinical This draft guidance is being issued SUMMARY: This notice announces the
Practice, Food and Drug Administration, consistent with FDA’s good guidance public meeting of the Advisory Council
10903 New Hampshire Ave., Bldg. 32, practices regulation (21 CFR 10.115). on Alzheimer’s Research, Care, and
Rm. 5167, Silver Spring, MD 20993– The draft guidance, when finalized, will Services (Advisory Council). The
0002, 301–796–4187; or Irene Stith- represent OHRP’s and FDA’s current Advisory Council on Alzheimer’s
Coleman, Office for Human Research thinking on IRB written procedures. It Research, Care, and Services provides
Protections, 1101 Wootton Pkwy., Suite does not establish any rights for any advice on how to prevent or reduce the
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![Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices 50713
burden of Alzheimer’s disease and afternoon will include an overview of Place: National Institutes of Health,
related dementias on people with the the 2016 Update to the National Plan, Building 31, Conference Room 6, 31 Center
disease and their caregivers. The updates on progress towards a Care and Drive, Bethesda, MD 20892.
Advisory Council will hear from a Services Summit, and federal Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
number of CMS’s HCIA awardees about workgroup updates. for Advancing Translational Sciences, 1
their projects and their results. Procedure and Agenda: This meeting Democracy Plaza, Room 1072, Bethesda, MD
Additional presentations in the is open to the public. Please allow 45 20892, 301–435–0809, anna.ramseyewing@
afternoon will include an overview of minutes to go through security and walk nih.gov.
the 2016 Update to the National Plan, to the meeting room. The meeting will Name of Committee: National Center for
updates on progress towards a Care and also be webcast at www.hhs.gov/live. Advancing Translational Sciences Advisory
Services Summit, and Federal Council.
workgroup updates. Authority: 42 U.S.C. 11225; Section 2(e)(3) Date: September 15, 2016.
of the National Alzheimer’s Project Act. The Open: 8:30 a.m. to 2:30 p.m.
DATES: The meeting will be held on panel is governed by provisions of Public
August 1, 2016 from 9 a.m. to 5 p.m. Agenda: Report from the Institute Director
Law 92–463, as amended (5 U.S.C. Appendix and other staff.
EDT. 2), which sets forth standards for the Place: National Institutes of Health,
ADDRESSES: The meeting will be held in formation and use of advisory committees. Building 31, Conference Room 6, 31 Center
Room 620/630, Building 35A (Porter Dated: July 8, 2016. Drive, Bethesda, MD 20892.
Building) of the National Institutes of Kathryn E. Martin, Closed: 3:00 p.m. to 4:30 p.m.
Health, 9000 Rockville Pike, Bethesda, Agenda: To review and evaluate grant
Acting Assistant Secretary for Planning and
Maryland 20892. applications.
Evaluation.
Comments: Time is allocated in the Place: National Institutes of Health,
[FR Doc. 2016–18273 Filed 8–1–16; 8:45 am] Building 31, Conference Room 6, 31 Center
afternoon on the agenda to hear public BILLING CODE P Drive, Bethesda, MD 20892.
comments. The time for oral comments Contact Person: Anna L. Ramsey-Ewing,
will be limited to two (2) minutes per Ph.D., Executive Secretary, National Center
individual. In lieu of oral comments, DEPARTMENT OF HEALTH AND for Advancing Translational Sciences, 1
formal written comments may be HUMAN SERVICES Democracy Plaza, Room 1072, Bethesda, MD
submitted for the record to Rohini 20892, 301–435–0809, anna.ramseyewing@
Khillan, ASPE, 200 Independence National Institutes of Health nih.gov.
Avenue SW., Room 424E, Washington, (Catalogue of Federal Domestic Assistance
DC 20201. All comments should be National Center for Advancing Program Nos. 93.859, Pharmacology,
submitted to napa@hhs.gov for the Translational Sciences; Notice of Physiology, and Biological Chemistry
record and to share with the Advisory Meetings Research; 93.350, B—Cooperative
Council by April 20, 2016. Those Agreements; 93.859, Biomedical Research
submitting comments should identify Pursuant to section 10(d) of the and Research Training, National Institutes of
Federal Advisory Committee Act, as Health, HHS)
themselves and any relevant
organizational affiliations. amended (5 U.S.C. App.), notice is Dated: July 27, 2016.
FOR FURTHER INFORMATION CONTACT: hereby given of meetings of the National David Clary,
Rohini Khillan (202) 690–5932, Center for Advancing Translational Program Analyst, Office of Federal Advisory
rohini.khillan@hhs.gov. Note: Seating Sciences. Committee Policy.
may be limited. Those wishing to attend The meetings will be open to the [FR Doc. 2016–18291 Filed 8–1–16; 8:45 am]
the meeting must send an email to public as indicated below, with BILLING CODE 4140–01–P
napa@hhs.gov and put ‘‘August 1 attendance limited to space available.
Meeting Attendance’’ in the Subject line Individuals who plan to attend and
by Friday, July 22, 2016 so that their need special assistance, such as sign DEPARTMENT OF HEALTH AND
names may be put on a list of expected language interpretation or other HUMAN SERVICES
attendees and forwarded to the security reasonable accommodations, should
officers the Humphrey Building. Any notify the Contact Person listed below National Institutes of Health
interested member of the public who is in advance of the meeting.
a non-U.S. citizen should include this Proposed Collection; 60-day Comment
The meetings will be closed to the Request; NCI’s Center for Cancer
information at the time of registration to public in accordance with the
ensure that the appropriate security Training Application Form for
provisions set forth in sections Graduate Student Recruitment
procedure to gain entry to the building 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
is carried out. Although the meeting is Program (NCI)
as amended. The grant applications
open to the public, procedures and/or contract proposals and the SUMMARY: In compliance with the
governing security and the entrance to discussions could disclose confidential requirement of Section 3506(c)(2)(A) of
federal buildings may change without trade secrets or commercial property the Paperwork Reduction Act of 1995,
notice. If you wish to make a public such as patentable material, and for opportunity for public comment on
comment, you must note that within personal information concerning proposed data collection projects, the
your email. individuals associated with the grant National Cancer Institute, the National
SUPPLEMENTARY INFORMATION: Notice of applications and/or contract proposals, Institutes of Health (NIH) will publish
these meetings is given under the periodic summaries of proposed
mstockstill on DSK3G9T082PROD with NOTICES
the disclosure of which would
Federal Advisory Committee Act (5 constitute a clearly unwarranted projects to be submitted to the Office of
U.S.C. App. 2, section 10(a)(1) and invasion of personal privacy. Management and Budget (OMB) for
(a)(2)). Topics of the Meeting: The Name of Committee: Cures Acceleration review and approval.
Advisory Council will hear from a Network Review Board. Written comments and/or suggestions
number of CMS’s HCIA awardees about Date: September 15, 2016. from the public and affected agencies
their projects and their results. Time: 8:30 a.m. to 2:30 p.m. are invited to address one or more of the
Additional presentations in the Agenda: Report from the Institute Director. following points: (1) Whether the
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Document Created: 2016-08-02 01:47:54
Document Modified: 2016-08-02 01:47:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| Dates | The meeting will be held on August 1, 2016 from 9 a.m. to 5 p.m. EDT. | |
| Contact | Rohini 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 ``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. | |
| FR Citation | 81 FR 50712 |
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