82 FR 4364 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 9 (January 13, 2017)
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4364-4365 | |
| FR Document | 2017-00606 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4364-4365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00606] ----------------------------------------------------------------------- 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. The theme of the February meeting will be clinical trials for Alzheimer's disease and related dementias and recruitment challenges. Additional presentations in the afternoon will include updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council's 2017 Recommendations, due in April 2017. DATES: The meeting will be held on Friday, February 3, 2017 from 9:00am to 5:00pm EDT. ADDRESSES: The meeting will be held in the Great Hall 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, 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 January 27, 2017. 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 ``February Meeting Attendance'' in the Subject line by Friday, January 20, 2017 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 theme of the February meeting will be clinical trials for Alzheimer's disease [[Page 4365]] and related dementias and recruitment challenges. Additional presentations in the afternoon will include updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council's 2017 Recommendations, due in April 2017. 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: January 5, 2017. Kathryn E. Martin, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2017-00606 Filed 1-12-17; 8:45 am] BILLING CODE P
![4364 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
Commissioner to authorize the permits Federal, State, and local Research, Care, and Services provides
emergency use of an unapproved governments to pre-position (e.g., advice on how to prevent or reduce the
medical product or an unapproved use stockpile, forward-deploy) MCMs in burden of Alzheimer’s disease and
of an approved medical product for anticipation of FDA approval or related dementias on people with the
certain emergency circumstances after clearance, authorization of an disease and their caregivers. The theme
the Department of Health and Human investigational use, or the issuance of an of the February meeting will be clinical
Services (HHS) Secretary has made a EUA. This authority is also discussed in trials for Alzheimer’s disease and
declaration of an emergency or threat this document. related dementias and recruitment
justifying emergency use. That challenges. Additional presentations in
II. Significance of Guidance the afternoon will include updates on
declaration by the HHS Secretary must
in turn be based on a determination of This guidance is being issued progress towards a Care and Services
an emergency or potential emergency or consistent with FDA’s good guidance Summit, federal workgroup updates,
material threat associated with the practices regulation (21 CFR 10.115). and preparation for the Advisory
CBRN agent by, respectively, the The guidance represents the current Council’s 2017 Recommendations, due
Secretary of Homeland Security, the thinking of FDA on emergency use in April 2017.
Secretary of Defense, or the HHS authorization of medical products and DATES: The meeting will be held on
Secretary. The Commissioner may issue related authorities. It does not establish Friday, February 3, 2017 from 9:00am to
an EUA to allow an MCM to be used in any rights for any person and is not 5:00pm EDT.
an emergency to diagnose, treat, or binding on FDA or the public. You can ADDRESSES: The meeting will be held in
prevent serious or life-threatening use an alternative approach if it satisfies the Great Hall in the Hubert H.
diseases or conditions caused by a the requirements of the applicable Humphrey Building, 200 Independence
CBRN agent, or by a product used to statutes and regulations. Avenue SW., Washington, DC 20201.
diagnose, treat, or prevent such diseases III. Electronic Access Comments: Time is allocated in the
or conditions, when available data meet afternoon on the agenda to hear public
specified criteria to support such uses Persons with access to the Internet comments. The time for oral comments
and there are no adequate, approved, may obtain the guidance at http:// will be limited to two (2) minutes per
and available alternatives. www.fda.gov/regulatoryinformation/ individual. In lieu of oral comments,
Section 564A, as added by PAHPRA, Guidances/default.htm, http:// formal written comments may be
establishes streamlined mechanisms to www.regulations.gov, or http://www.fda. submitted for the record to Rohini
facilitate preparedness and response gov/medicalcountermeasures. Khillan, ASPE, 200 Independence
activities involving certain FDA- IV. Paperwork Reduction Act of 1995 Avenue SW., Room 424E, Washington,
approved MCMs without FDA issuing DC 20201. All comments should be
This guidance contains information submitted to napa@hhs.gov for the
EUAs, which can be a resource-
collection provisions that are subject to record and to share with the Advisory
intensive process. These authorities,
review by the Office of Management and Council by January 27, 2017. Those
which apply only to eligible FDA-
Budget (OMB) under the Paperwork submitting comments should identify
approved medical products intended for
Reduction Act of 1995 (44 U.S.C. 3501– themselves and any relevant
use during a CBRN emergency, include
3520). This guidance refers to organizational affiliations.
provisions that:
previously approved collections of
• Empower FDA to extend the FOR FURTHER INFORMATION CONTACT:
information. These collections of
expiration date of an eligible FDA- Rohini Khillan (202) 690–5932,
information have been approved under
approved MCM stockpiled for use in a rohini.khillan@hhs.gov. Note: Seating
OMB control numbers 0910–0308,
CBRN emergency, and establish may be limited. Those wishing to attend
0910–0230, 0910–0471, 0910–0014,
appropriate conditions relating to such the meeting must send an email to
0910–0078 and 0910–0595. The
extensions, such as appropriate storage, napa@hhs.gov and put ‘‘February
collection of information in this
sampling, and labeling; Meeting Attendance’’ in the Subject line
guidance was approved under OMB
• Permit FDA to waive otherwise by Friday, January 20, 2017 so that their
control number 0910–0595.
applicable current good manufacturing names may be put on a list of expected
practice requirements (e.g., storage or Dated: January 10, 2017. attendees and forwarded to the security
handling) to accommodate emergency Leslie Kux, officers the Humphrey Building. Any
response needs; Associate Commissioner for Policy. interested member of the public who is
• Allow emergency dispensing of [FR Doc. 2017–00721 Filed 1–12–17; 8:45 am] a non-U.S. citizen should include this
MCMs during an actual CBRN BILLING CODE 4164–01–P information at the time of registration to
emergency event without requiring an ensure that the appropriate security
individual prescription, or all of the procedure to gain entry to the building
information otherwise required, for each DEPARTMENT OF HEALTH AND is carried out. Although the meeting is
recipient of the MCM; and HUMAN SERVICES open to the public, procedures
• Permit the Centers for Disease governing security and the entrance to
Control and Prevention to create and Advisory Council on Alzheimer’s federal buildings may change without
issue ‘‘emergency use instructions’’ Research, Care, and Services; Meeting notice. If you wish to make a public
concerning the FDA-approved comment, you must note that within
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Assistant Secretary for
conditions of use for eligible products. Planning and Evaluation, HHS. your email.
These authorities, and the definition of ACTION: Notice of meeting. SUPPLEMENTARY INFORMATION: Notice of
eligible products to which they apply, these meetings is given under the
are discussed in this guidance. SUMMARY: This notice announces the Federal Advisory Committee Act (5
To enable stakeholders to prepare for public meeting of the Advisory Council U.S.C. App. 2, section 10(a)(1) and
potential rapid deployment of MCMs on Alzheimer’s Research, Care, and (a)(2)). Topics of the Meeting: The
during an actual CBRN emergency, Services (Advisory Council). The theme of the February meeting will be
section 564B (also added by PAHPRA) Advisory Council on Alzheimer’s clinical trials for Alzheimer’s disease
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![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4365
and related dementias and recruitment Open: 1:00 p.m. to 2:00 p.m. Name of Committee: National Institute on
challenges. Additional presentations in Agenda: Program reports and Aging Special Emphasis Panel; Predictors
the afternoon will include updates on presentations; business of the Board. and Determinants of Age-Related Resiliencies
Closed: 2:00 p.m. to 3:00 p.m. to Physical Stressors, RFA–AG–014 (UH2).
progress towards a Care and Services Agenda: To review and evaluate grant Date: February 23, 2017.
Summit, federal workgroup updates, applications. Time: 2:30 p.m. to 4:30 p.m.
and preparation for the Advisory Place: National Cancer Institute Shady Agenda: To review and evaluate grant
Council’s 2017 Recommendations, due Grove 9609 Medical Center Drive, Room applications.
in April 2017. TE406 Rockville, MD 20850 (Virtual Place: National Institute on Aging,
Procedure and Agenda: This meeting Meeting). Gateway Building, Suite 2W200, 7201
is open to the public. Please allow 45 Contact Person: Paulette S. Gray, Ph.D., Wisconsin Avenue, Bethesda, MD 20892
minutes to go through security and walk Executive Secretary, Division of Extramural (Telephone Conference Call).
Activities, National Cancer Institute—Shady Contact Person: Carmen Moten, Ph.D.,
to the meeting room. The meeting will Grove National Institutes of Health, 9609
also be webcast at www.hhs.gov/live. MPH, National Institute on Aging, Gateway
Medical Center Drive, Room 7W444, Building, 7201 Wisconsin Avenue, Suite
Authority: 42 U.S.C. 11225; Section 2(e)(3) Bethesda, MD 20892, 240–276–6340, grayp@ 2C212, Bethesda, MD 20892, 301–402–7703,
of the National Alzheimer’s Project Act. The mail.nih.gov. cmoten@mail.nih.gov.
panel is governed by provisions of Public Any interested person may file written Name of Committee: National Institute on
Law 92–463, as amended (5 U.S.C. Appendix comments with the committee by forwarding Aging Special Emphasis Panel; Late Onset of
2), which sets forth standards for the the statement to the Contact Person listed on Alzheimer’s Disease (LOAD), PAR–16–205
formation and use of advisory committees. this notice. The statement should include the
(U24).
name, address, telephone number and when
Dated: January 5, 2017. Date: March 7, 2017.
applicable, the business or professional
Kathryn E. Martin, Time: 10:00 a.m. to 12:00 p.m.
affiliation of the interested person.
Agenda: To review and evaluate grant
Acting Assistant Secretary for Planning and Information is also available on the
applications.
Evaluation. Institute’s/Center’s home page: http://
Place: National Institute on Aging,
[FR Doc. 2017–00606 Filed 1–12–17; 8:45 am] deainfo.nci.nih.gov/advisory/ncab/ncab.htm,
Gateway Building, Suite 2W200, 7201
where an agenda and any additional
BILLING CODE P Wisconsin Avenue, Bethesda, MD 20892
information for the meeting will be posted
when available. (Telephone Conference Call).
Contact Person: Carmen Moten, Ph.D.,
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance MPH, National Institute on Aging, Gateway
Program Nos. 93.392, Cancer Construction; Building, 7201 Wisconsin Avenue, Suite
HUMAN SERVICES 93.393, Cancer Cause and Prevention 2C212, Bethesda, MD 20892, 301–402–7703,
Research; 93.394, Cancer Detection and cmoten@mail.nih.gov.
National Institutes of Health Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology (Catalogue of Federal Domestic Assistance
National Cancer Institute; Notice of Research; 93.397, Cancer Centers Support; Program Nos. 93.866, Aging Research,
Meeting 93.398, Cancer Research Manpower; 93.399, National Institutes of Health, HHS)
Pursuant to section 10(d) of the Cancer Control, National Institutes of Health, Dated: January 10, 2017.
HHS) Melanie J. Pantoja,
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Dated: January 9, 2017. Program Analyst, Office of Federal Advisory
hereby given of a meeting of the Melanie J. Pantoja, Committee Policy.
National Cancer Advisory Board. Program Analyst, Office of Federal Advisory [FR Doc. 2017–00733 Filed 1–12–17; 8:45 am]
The meeting will be open to the Committee Policy. BILLING CODE 4140–01–P
public as indicated below, with [FR Doc. 2017–00579 Filed 1–12–17; 8:45 am]
attendance limited to space available. BILLING CODE 4140–01–P
Individuals who plan to attend and DEPARTMENT OF HEALTH AND
need special assistance, such as sign HUMAN SERVICES
language interpretation or other DEPARTMENT OF HEALTH AND
reasonable accommodations, should HUMAN SERVICES National Institutes of Health
notify the Contact Person listed below
in advance of the meeting. The open National Institutes of Health Action Under the NIH Guidelines for
session will be videocast and can be Research Involving Recombinant or
accessed from the NIH Videocasting and National Institute on Aging; Notice of Synthetic Nucleic Acid Molecules (NIH
Podcasting Web site (http:// Closed Meetings Guidelines)
videocast.nih.gov). Pursuant to section 10(d) of the AGENCY: National Institutes of Health
The meeting will be closed to the Federal Advisory Committee Act, as (NIH), HHS.
public in accordance with the amended (5 U.S.C. App.), notice is ACTION: Notice of action under the NIH
provisions set forth in sections hereby given of the following meetings. Guidelines.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meetings will be closed to the
as amended. The grant applications and public in accordance with the SUMMARY: The National Institutes of
the discussions could disclose provisions set forth in sections Health (NIH) considered a proposal to
confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., conduct research involving the
property such as patentable material, as amended. The grant applications and deliberate transfer of a chloramphenicol
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and personal information concerning the discussions could disclose resistance trait to Rickettsia typhi,
individuals associated with the grant confidential trade secrets or commercial conorii, rickettsii, and felis. The
applications, the disclosure of which property such as patentable material, acquisition of this antibiotic resistance
would constitute a clearly unwarranted and personal information concerning trait could possibly compromise the use
invasion of personal privacy. individuals associated with the grant of a class of antibiotics for the treatment
Name of Committee: National Cancer applications, the disclosure of which of Rickettsia infections in humans.
Advisory Board. would constitute a clearly unwarranted Under the NIH Guidelines (http://
Date: February 15, 2017. invasion of personal privacy. www.osp.od.nih.gov/sites/default/files/
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Document Created: 2017-01-13 02:44:37
Document Modified: 2017-01-13 02:44:37
| 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 Friday, February 3, 2017 from 9:00am to 5:00pm 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 ``February Meeting Attendance'' in the Subject line by Friday, January 20, 2017 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 | 82 FR 4364 |
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