Meeting of the National Clinical Care Commission, 30966-30967 [2020-10925]
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30966
Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
III. Participating in the Public Web
Conference
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Registration: To register for the free
public web conference, complete the
registration form at https://www.ctticlinicaltrials.org/briefing-room/
meetings/ich-e6-guideline-good-clinicalpractice-stakeholder-engagement.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number.
Streaming Public Web Conference:
This live web conference will be
recorded and archived and will be
available after the event at the event
website. Persons interested in
participating in the live web conference
are encouraged to register in advance
(see Registration). The live web
conference will also be available at the
website above on the day of the event
without preregistration. Detailed
information is available at the following
website: https://www.ctticlinicaltrials.org/briefing-room/
meetings/ich-e6-guideline-good-clinicalpractice-stakeholder-engagement.
Registered web conference
participants will be sent technical
system requirements in advance of the
event. It is recommended that you
review these technical system
requirements prior to joining the
streaming web conference of the public
event.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the web conference
and will be publicly available at the
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briefing-room/meetings/ich-e6guideline-good-clinical-practicestakeholder-engagement.
Transcripts: Please be advised that
transcripts of the public web conference
will not be available.
Food and Drug Administration
Dated: May 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10975 Filed 5–20–20; 8:45 am]
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[Docket No. FDA–2018–N–1242]
Advisory Committee; Arthritis
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Arthritis Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Arthritis Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 5, 2022.
DATES: Authority for the Arthritis
Advisory Committee would have
expired on April 5, 2020, unless the
Commissioner had formally determined
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Yinghua Wang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, AAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 41
CFR 102–3, FDA is announcing the
renewal of the Arthritis Advisory
Committee. The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of arthritis,
rheumatism, and related diseases, and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
Under its Charter, the Committee
shall consist of a core of 11 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
SUMMARY:
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members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting representative member
who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
arthritis-advisory-committee or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the Committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
advisory-committees.
Dated: May 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10996 Filed 5–20–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Clinical Care
Commission
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The National Clinical Care
Commission (the Commission) will
conduct a virtual meeting on June 26,
2020. The Commission is charged to
evaluate and make recommendations to
the U.S. Department of Health and
Human Services (HHS) Secretary and
Congress regarding improvements to the
coordination and leveraging of federal
programs related to diabetes and its
complications.
DATES: The meeting will take place on
June 26, 2020, from 1 p.m. to
approximately 5 p.m. Eastern Daylight
time (EDT).
SUMMARY:
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Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
The meeting will be held
online via webinar. To register to attend
the meeting, please visit the registration
website at https://
kauffmaninc.adobeconnect.com/nccc_
june2020/event/event_info.html.
FOR FURTHER INFORMATION CONTACT:
Jennifer Anne Bishop, ScD, MPH,
Designated Federal Officer, National
Clinical Care Commission, U.S.
Department of Health and Human
Services, Office of the Assistant
Secretary for Health, Office of Disease
Prevention and Health Promotion, 1101
Wootton Parkway, Suite 420, Rockville,
MD 20852. Email: OHQ@hhs.gov.
SUPPLEMENTARY INFORMATION: The
National Clinical Care Commission Act
(Pub. L. 115–80) requires the HHS
Secretary to establish the National
Clinical Care Commission. The
Commission consists of representatives
of specific federal agencies and nonfederal individuals and entities who
represent diverse disciplines and views.
The Commission will evaluate and
make recommendations to the HHS
Secretary and Congress regarding
improvements to the coordination and
leveraging of federal programs related to
diabetes and its complications.
The seventh meeting will be held
virtually, and will consist of updates
from the Commission’s three
subcommittees and a discussion of
public comments and outreach to
stakeholder organizations. The final
meeting agenda will be available prior
to the meeting at https://health.gov/ourwork/health-care-quality/nationalclinical-care-commission/meetings.
Public Participation at Meeting: The
Commission invites public comment on
issues related to the Commission’s
charge. There will be an opportunity for
limited oral comments (each no more
than 3 minutes in length) at this virtual
meeting. Virtual attendees who plan to
provide oral comments at the
Commission meeting during a
designated time must register prior to
the meeting at https://
kauffmaninc.adobeconnect.com/nccc_
june2020/event/event_info.html.
Written comments are welcome
throughout the entire development
process of the Commission’s work and
may be emailed to OHQ@hhs.gov.
Written comments should not exceed
three pages in length.
Individuals who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should indicate the
special accommodation when
registering online or by notifying
Jennifer Gillissen at jennifer.gillissen@
kauffmaninc.com by June 12, 2020.
ADDRESSES:
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Authority: The National Clinical Care
Commission is required under the
National Clinical Care Commission Act
(Pub. L. 115–80). The Commission is
governed by provisions of the Federal
Advisory Committee Act (FACA), Public
Law 92–463, as amended (5 U.S.C.,
App.) which sets forth standards for the
formation and use of federal advisory
committees.
Dated: 05/15/2020.
Carter Blakey,
Acting Director, Office of Disease Prevention
and Health Promotion, Office of the Assistant
Secretary for Health.
[FR Doc. 2020–10925 Filed 5–20–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Purchased/Referred Care
Delivery Area Designation for the Little
Shell Tribe of Chippewa Indians of
Montana
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Indian Health Service (IHS) is
establishing the geographic boundaries
of the Purchased/Referred Care Delivery
Area (PRCDA) (formerly Contract Health
Service Delivery Area or CHSDA) for the
newly federally recognized Little Shell
Tribe of Chippewa Indians of Montana.
DATES: This notice is applicable as of
June 22, 2020.
ADDRESSES: This notice can be found at
https://www.federalregister.gov. Written
requests for information or comments
submitted by postal mail or delivery
should be addressed to Evonne Bennett,
Acting Director, Division of Regulatory
and Policy Coordination, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
09E70, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: CDR
John Rael, Director, Office of Resource
Access and Partnerships, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
10E85C, Rockville, Maryland 20857.
Telephone (301) 443–0969 (This is not
a toll free number).
SUPPLEMENTARY INFORMATION: The IHS
currently provides services under
regulations in effect on September 15,
1987, and republished at 42 CFR part
136, subparts A–C. When Tribes are
recognized under Federal law, either
Congress legislatively designates
counties to serve as PRCDAs, or the
Director, IHS, exercises reasonable
administrative discretion to designate
SUMMARY:
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30967
PRCDAs to effectuate the intent of
Congress for these Tribes. The Director,
IHS, publishes a notice in the Federal
Register (FR) when there are revisions
or updates to the list of PRCDAs,
including the designation of PRCDAs for
newly recognized or restored Tribes.
At 42 CFR part 136 Subpart C, a
PRCDA is defined as the geographic area
within which Purchased/Referred Care
(PRC) will be made available by the IHS
to members of an identified Indian
community who reside in the area. The
regulations provide that, unless
otherwise designated, a PRCDA shall
consist of a county which includes all
or part of a reservation and any county
or counties which have a common
boundary with the reservation (42 CFR
136.22(a)(6)). Residence within a
PRCDA by a person who is within the
scope of the Indian health program, as
set forth in 42 CFR 136.12, creates no
legal entitlement to PRC but only
potential eligibility for services.
Services needed but not available at an
IHS or Tribal facility are provided under
the PRC program depending on the
availability and accessibility of alternate
resources in accordance with the
regulations.
Under Public Law 116–92 (the ‘‘Act’’),
the Little Shell Tribe of Chippewa
Indians of Montana was officially
recognized as an Indian Tribe within the
meaning of Federal law. The Act sets
forth the service area for the newly
recognized Tribe for the purpose of the
delivery of Federal services and benefits
to Tribal members. The purpose of this
FR notice is to notify the public of the
establishment of the PRCDA for the
newly recognized Little Shell Tribe of
Chippewa Indians of Montana.
Consistent with the Act, IHS is
designating the counties of Blaine,
Cascade, Glacier, and Hill in the State
of Montana as the Tribe’s PRCDA.
Under 42 CFR 136.23, those otherwise
eligible Indians who do not reside on a
reservation but reside within a PRCDA
must be either members of the Little
Shell Tribe of Chippewa Indians of
Montana or maintain close economic
and social ties with the Tribe. The
financial resources required to meet the
immediate needs of the Little Shell
Tribe of Chippewa Indians of Montana
members residing in the PRCDA are
determined by the IHS, through
consultation with the Tribe and will be
placed in the Billings Area PRC budget.
This notice does not contain reporting
or recordkeeping requirements subject
to prior approval by the Office of
Management and Budget under the
Paperwork Reduction Act.
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Agencies
[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 30966-30967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the National Clinical Care Commission
AGENCY: Office of Disease Prevention and Health Promotion, Office of
the Assistant Secretary for Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Clinical Care Commission (the Commission) will
conduct a virtual meeting on June 26, 2020. The Commission is charged
to evaluate and make recommendations to the U.S. Department of Health
and Human Services (HHS) Secretary and Congress regarding improvements
to the coordination and leveraging of federal programs related to
diabetes and its complications.
DATES: The meeting will take place on June 26, 2020, from 1 p.m. to
approximately 5 p.m. Eastern Daylight time (EDT).
[[Page 30967]]
ADDRESSES: The meeting will be held online via webinar. To register to
attend the meeting, please visit the registration website at https://kauffmaninc.adobeconnect.com/nccc_june2020/event/event_info.html.
FOR FURTHER INFORMATION CONTACT: Jennifer Anne Bishop, ScD, MPH,
Designated Federal Officer, National Clinical Care Commission, U.S.
Department of Health and Human Services, Office of the Assistant
Secretary for Health, Office of Disease Prevention and Health
Promotion, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852. Email:
[email protected].
SUPPLEMENTARY INFORMATION: The National Clinical Care Commission Act
(Pub. L. 115-80) requires the HHS Secretary to establish the National
Clinical Care Commission. The Commission consists of representatives of
specific federal agencies and non-federal individuals and entities who
represent diverse disciplines and views. The Commission will evaluate
and make recommendations to the HHS Secretary and Congress regarding
improvements to the coordination and leveraging of federal programs
related to diabetes and its complications.
The seventh meeting will be held virtually, and will consist of
updates from the Commission's three subcommittees and a discussion of
public comments and outreach to stakeholder organizations. The final
meeting agenda will be available prior to the meeting at https://health.gov/our-work/health-care-quality/national-clinical-care-commission/meetings.
Public Participation at Meeting: The Commission invites public
comment on issues related to the Commission's charge. There will be an
opportunity for limited oral comments (each no more than 3 minutes in
length) at this virtual meeting. Virtual attendees who plan to provide
oral comments at the Commission meeting during a designated time must
register prior to the meeting at https://kauffmaninc.adobeconnect.com/nccc_june2020/event/event_info.html.
Written comments are welcome throughout the entire development
process of the Commission's work and may be emailed to [email protected].
Written comments should not exceed three pages in length.
Individuals who need special assistance, such as sign language
interpretation or other reasonable accommodations, should indicate the
special accommodation when registering online or by notifying Jennifer
Gillissen at [email protected] by June 12, 2020.
Authority: The National Clinical Care Commission is required under
the National Clinical Care Commission Act (Pub. L. 115-80). The
Commission is governed by provisions of the Federal Advisory Committee
Act (FACA), Public Law 92-463, as amended (5 U.S.C., App.) which sets
forth standards for the formation and use of federal advisory
committees.
Dated: 05/15/2020.
Carter Blakey,
Acting Director, Office of Disease Prevention and Health Promotion,
Office of the Assistant Secretary for Health.
[FR Doc. 2020-10925 Filed 5-20-20; 8:45 am]
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