Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 11761-11762 [2018-05368]
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accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Yinghua Wang
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0757]
Pathways to Global Unity; Public
Workshop
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in collaboration
with the Association of Food and Drug
Officials (AFDO), is announcing the
following public workshop entitled
‘‘Pathways to Global Unity.’’ This 21⁄2day public workshop is intended to
provide information about FDA drug
and device regulation to the regulated
industries.
SUMMARY:
The public workshop will be
held on June 11–12, 2018, from 8 a.m.
to 5:30 p.m., and on June 13, 2018, from
8 a.m. to 12 p.m.
ADDRESSES: The public workshop will
be held at the Doubletree by Hilton
Hotel Burlington Vermont, 870
Williston Rd., Burlington, VT 05403,
802–865–6626. For directions to the
hotel and information on lodging, visit
https://burlington.afdo.org/hotel.html.
Attendees are responsible for their own
accommodations.
FOR FURTHER INFORMATION CONTACT:
Krystal Reed, Association of Food and
Drug Officials, 155 West Market St., 3rd
Floor, York, PA 17401, 717–757–2888,
Fax: 717–650–3650, email: kreed@
afdo.org.
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DATES:
SUPPLEMENTARY INFORMATION:
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FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The workshop helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
workshop also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
as outreach activities by government
agencies to small businesses.
II. Topics for Discussion at the Public
Workshop
[FR Doc. 2018–05386 Filed 3–15–18; 8:45 am]
AGENCY:
I. Background
The public workshop helps fulfill the
Department of Health and Human
Services and FDA’s mission to protect
the public health. The workshop will
provide FDA-regulated drug and device
entities with information on a number
of topics concerning FDA requirements
related to the production and marketing
of drugs and/or devices. The public
workshop’s agenda is available at https://
www.afdo.org/conference. Topics for
discussion include the following:
• FDA Associate Commissioner for
Regulatory Affairs Update
• Health Canada: Single Audit Program
• Enforcement Trends in Drug, Devices,
and Compounding Pharmacy
Inspections
• FDA Compliance Questions Panel
• International Compliance—Industry
Perspective
• Puerto Rico Emergency Response
Update
• Artificial Intelligence
• Supply Chain Control
• Dermal Abyss: Tattoos as Medical
Condition Monitors
• Design Controls for Combination
Products
• Benefit Risk—Using Benefit Risk in
Making Post-Market Decisions
III. Participating in the Public
Workshop
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Category
Cost of
registration
AFDO Members ....................
AFDO Non-Members ............
Additional Fee for Registration Postmarked After May
1, 2018 ..............................
$550
650
100
To register online, please visit https://
www.afdo.org/conference (FDA has
verified the website address, but is not
responsible for subsequent changes to
the website after this document
publishes in the Federal Register.) For
alternative registration, please complete
and submit an AFDO Conference
Registration Form, available at https://
burlington.afdo.org/registration.html,
along with a check or money order
payable to AFDO. Please mail your
completed registration form and
payment to: AFDO, 155 West Market St.,
3rd Floor, York, PA 17401. The registrar
will also accept payment through Visa,
MasterCard, and American Express
credit cards. For more information on
the public workshop, or for questions
about registration, please contact AFDO
at 717–757–2888, afdo@afdo.org, or
https://www.afdo.org/conference.
If you need special accommodations
due to a disability, please contact
Krystal Reed (see FOR FURTHER
INFORMATION CONTACT) at least 21 days in
advance of the workshop.
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05389 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
April meeting, the Clinical Care
Subcommittee will be taking charge of
the theme, focusing on advancing
consensus on dementia care elements to
SUMMARY:
Registration: You are encouraged to
register by May 1, 2018. Registration
fees cover the cost of facilities,
materials, and breaks. Seats are limited;
therefore, please submit your
registration as soon as possible. Course
space will be filled in order of receipt
of registration. Those accepted into the
course will receive confirmation.
Registration will close after the course is
filled. Registration at the site is not
guaranteed but may be possible on a
space-available basis on the day of the
PO 00000
public workshop beginning at 7:30 a.m.
The cost of registration is as follows:
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Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
guide new outcomes measurement. The
Council will hear speakers in two
sessions, one focuses on developing
consensus about dementia care
elements, and the second on models
that are informing outcomes
measurement. The meeting will also
include updates on work from the
previous meetings, a presentation on the
final report from the October 2017 Care
Summit, and federal workgroup
updates.
DATES: The meeting will be held on
April 27, 2018 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
napa@hhs.gov and put ‘‘April 27
Meeting Attendance’’ in the Subject line
by Tuesday, 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: During
the April meeting, the Clinical Care
Subcommittee will be taking charge of
the theme, focusing on advancing
consensus on dementia care elements to
guide new outcomes measurement. The
Council will hear speakers in two
sessions, one focuses on developing
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21:54 Mar 15, 2018
Jkt 244001
consensus about dementia care
elements, and the second on models
that are informing outcomes
measurement. The meeting will also
include updates on work from the
previous meetings, a presentation on the
final report from the October 2017 Care
Summit, and federal workgroup
updates.
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 12, 2018.
John R. Graham,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2018–05368 Filed 3–15–18; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Anti-Marinobufagenin
Antibodies and Methods for Diagnosis
and Treatment of Cardiovascular
Disease and Fibrotic Disease
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute on
Aging, an institute of the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an Exclusive
Patent License to practice the inventions
embodied in the U.S. and International
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to CTS Biopharma
LLC, located in Sunnyvale, CA.
DATES: Only written comments and/or
complete applications for a license
which are received by the National
Cancer Institute’s Technology Transfer
Center on or before April 2, 2018 will
be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Richard T. Girards, Jr., Esq.,
MBA, Senior Technology Transfer
Manager, NCI Technology Transfer
Center, 9609 Medical Center Drive, RM
SUMMARY:
PO 00000
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1E508 MSC 9702, Bethesda, MD 20892–
9702 (for business mail), Rockville, MD
20850–9702 (for overnight courier
services); Telephone: (240)-276–6825;
Facsimile: (240)-276–5504; Email:
richard.girards@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent
Application No. 60/694,733 [HHS Ref
No. E–092–2004/0–US–01], filed on
June 27, 2005 and entitled ‘‘Antimarinobufagenin antibodies and
methods for their use;’’ Patent
Cooperation Treaty Patent Application
No. PCT/US2006/024918 [HHS Ref No.
E–092–2004/0–PCT–02], filed on June
26, 2006 and entitled ‘‘Antimarinobufagenin antibodies and
methods for their use;’’ and U.S. and
foreign patents and/or patent
applications claiming priority to the
aforementioned applications, including
but not limited to United States Patent
No. 8,038,997 [HHS Ref No. E–092–
2004/0–US–03] entitled ‘‘Antimarinobufagenin antibodies and
methods for their use.’’
Certain rights in the patent and these
applications have been assigned to the
government of the United States of
America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the use
of the Licensed Patent Rights for the
following: (1) The use of antimarinobufagenin antibodies for one or
both of (a) the treatment of fibrotic
disease and (b) the treatment of
cardiovascular disease, including but
not limited to preeclampsia and (2)
companion diagnostics associated with
the aforementioned treatments.
The patents and applications
potentially to be licensed disclose
antibodies (mAbs) that specifically bind
marinobufagenin. They also disclose use
of these mAbs in the diagnosis and
treatment of cardiovascular disease such
as hypertension. Further, they disclose
use of these mAbs in the diagnosis and
treatment of fibrotic diseases. The
patents and applications potentially to
be licensed also disclose technologies
useful with respect to companion
diagnostics for both fibrotic and
cardiovascular diseases. The public
substantially will benefit from the
clinical and commercial development of
these mAbs for the treatment and of
cardiovascular as well as fibrotic
disorders. The public also will benefit
from the clinical and commercial
development of companion diagnostics
relative to these conditions.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
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[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11761-11762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05368]
-----------------------------------------------------------------------
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 Clinical Care Subcommittee
will be taking charge of the theme, focusing on advancing consensus on
dementia care elements to
[[Page 11762]]
guide new outcomes measurement. The Council will hear speakers in two
sessions, one focuses on developing consensus about dementia care
elements, and the second on models that are informing outcomes
measurement. The meeting will also include updates on work from the
previous meetings, a presentation on the final report from the October
2017 Care Summit, and federal workgroup updates.
DATES: The meeting will be held on April 27, 2018 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 [email protected]. Those submitting written 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 ``April
27 Meeting Attendance'' in the Subject line by Tuesday, 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: During the April meeting, the Clinical
Care Subcommittee will be taking charge of the theme, focusing on
advancing consensus on dementia care elements to guide new outcomes
measurement. The Council will hear speakers in two sessions, one
focuses on developing consensus about dementia care elements, and the
second on models that are informing outcomes measurement. The meeting
will also include updates on work from the previous meetings, a
presentation on the final report from the October 2017 Care Summit, and
federal workgroup updates.
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 12, 2018.
John R. Graham,
Acting Assistant Secretary for Planning and Evaluation.
[FR Doc. 2018-05368 Filed 3-15-18; 8:45 am]
BILLING CODE 4150-05-P
