Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, 36609-36610 [2018-16238]
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Christian Hussong, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3283, Silver Spring,
MD 20993–0002, 240–402–2246, or ELP
Management, ELP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
CDRH is responsible for ensuring the
safety and effectiveness of medical
devices marketed in the United States.
Additionally, CDRH assures patients
and providers have timely and
continued access to high-quality, safe
and effective medical devices.
Continuing our 2016 and 2017 priorities
of Partnering with Patients and
Promoting a Culture of Quality and
Organizational Excellence, adding our
2018–2020 Strategic Priorities of
Simplicity, Collaborative Communities
and Employee Engagement,
Opportunity, and Success, overlaid by
our constant strive for patient safety and
innovation highlights our need to
understand the perspective of our
stakeholders. The Center encourages
applicants to consider including
opportunities to discuss innovation,
patient perspective, patient safety,
incorporating quality system design and
management, simplification principles,
and utilization of collaborative
communities in their proposal(s) as they
contribute to the success of the device
development life cycle.
CDRH is committed to advancing
regulatory science, providing industry
with predictable, consistent,
transparent, and efficient regulatory
pathways, and helping to ensure
consumer confidence in medical
devices marketed in the United States
and throughout the world. The ELP is
intended to provide CDRH and other
FDA staff with an opportunity to
understand the laboratory and
manufacturing practices, quality system
management, patient perspective/input,
simplification principles, and other
challenges and how they impact the
medical device development life cycle.
ELP is a collaborative effort to enhance
communication with our stakeholders to
facilitate medical device reviews. The
Center is committed to understanding
current industry practices, innovative
technologies, regulatory impacts and
needs, and how patient perspective/
input, safety and quality systems
management advance the development
and evaluation of medical devices, and
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20:33 Jul 27, 2018
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monitoring the performance of marketed
devices.
These formal training visits are not
intended for FDA to inspect, assess,
judge, or perform a regulatory function
(e.g., compliance inspection), but rather,
they are an opportunity to provide
CDRH and other FDA staff a better
understanding of the products they
review, and how they are developed.
Additionally, it is to understand
challenges related to quality systems
development and management and
simplification in processes, patient
preferences and safety, in the product
life cycle, and how medical devices fit
into the larger health care system. CDRH
is formally requesting participation from
industry, academia, and clinical
facilities, medical device incubators and
accelerators, health technology
assessment groups, and those that have
previously participated in the ELP or
other FDA site visit programs.
Additional information regarding the
CDRH ELP, including current areas of
interest, submission dates, a sample site
visit request, and an example of a site
visit agenda, is available on CDRH’s
website at: https://www.fda.gov/
scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
II. CDRH ELP
A. Areas of Interest
In the ELP training program, groups of
CDRH and other FDA staff will observe
operations in the areas of research,
device development, Digital Health,
incorporating patient information and
reimbursement, manufacturing, quality
management principles, and health care
facilities. The areas of interest for visits
include various topics identified by
managers at CDRH and other areas
within FDA. These areas of interest are
listed on the ELP website and are
intended to be updated quarterly.
To submit a proposal addressing one
of the Center’s areas of interest, visit the
link for the table of areas of interest at:
https://www.fda.gov/ScienceResearch/
ScienceCareerOpportunities/
UCM380676.htm.
Once you have determined an area of
interest to address in your ELP proposal,
follow the instructions in section III to
complete the site visit request template
and agenda provided at: https://
www.fda.gov/downloads/
ScienceResearch/ScienceCareer
Opportunities/UCM392988.pdf and at:
https://www.fda.gov/downloads/
ScienceResearch/ScienceCareer
Opportunities/UCM487190.pdf.
Submit all proposals at ELP@
fda.hhs.gov within the dates provided at
PO 00000
Frm 00097
Fmt 4703
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36609
the ELP website at: https://www.fda.gov/
scienceresearch/sciencecareer
opportunities/ucm380676.htm.
B. Site Selection
CDRH and FDA will be responsible
for its own staff travel expenses
associated with the site visits. CDRH
and FDA will not provide funds to
support the training provided by the site
to the ELP. Selection of potential
facilities will be based on CDRH and
FDA’s priorities for staff training and
resources available to fund this
program. In addition to logistical and
other resource factors, all sites must
have a successful compliance record
with FDA or another Agency with
which FDA has a memorandum of
understanding (if applicable). If a site
visit involves a visit to a separate
physical location of another firm under
contract with the site, that firm must
agree to participate in the ELP and must
also have a satisfactory compliance
history, and must be listed in the
proposal along with a Facility
Establishment Identifier number, if
applicable.
III. Request To Participate
Information regarding the CDRH ELP,
including a sample request and an
example of a site visit agenda, and
submission dates is available on CDRH’s
website at: https://www.fda.gov/
scienceresearch/sciencecareer
opportunities/ucm380676.htm.
Proposals to participate should be
submitted at ELP@fda.hhs.gov, within
the dates provided at the ELP website at:
https://www.fda.gov/scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16177 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Meeting of the
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030
Office of the Secretary, Office
of the Assistant Secretary for Health,
Office of Disease Prevention and Health
Promotion, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The U.S. Department of
Health and Human Services (HHS)
announces the next meeting of the
SUMMARY:
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36610
Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030
(Committee). The meeting is open to the
public and will be held in the
Washington, DC metropolitan area. The
Committee is working to accomplish its
mission to provide independent advice
to the Secretary of the U.S. Department
of Health and Human Services or a
designated representative for the
implementation of Healthy People 2030.
DATES: The Committee will meet on
September 6, 2018, from 8:30 a.m. to
5:00 p.m. Eastern Time (ET), and
September 7, 2018, from 8:30 a.m. to
3:00 p.m. ET.
ADDRESSES: The meeting will be held at
the 20 F Street Conference Center,
located at 20th F Street NW,
Washington, DC 20001. To register to
attend the meeting, please visit the
Healthy People website at https://
www.healthypeople.gov.
FOR FURTHER INFORMATION CONTACT:
Emmeline Ochiai, Designated Federal
Officer, Secretary’s Advisory Committee
on National Health Promotion and
Disease Prevention Objectives for 2030,
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, Room LL–100,
Rockville, MD 20852, (240) 453–8255
(telephone), (240) 453–8281 (fax).
Additional information is available on
the Healthy People website at https://
www.healthypeople.gov.
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Appointed Committee Members: The
names and biographies of the appointed
Committee members are available at
https://www.healthypeople.gov/2020/
about/history-development/healthypeople-2030-advisory-committee.
Purpose of Meeting: In accordance
with Federal Advisory Committee Act
and to promote transparency of the
process, deliberations of the Committee
will occur in a public forum. At this
meeting, the Committee will continue
its deliberations from the last public
meeting.
Background: The Committee, a federal
advisory committee, is charged with
issuing recommendations for the
Secretary regarding the implementation
of national health promotion and
disease prevention objectives for 2030.
The Committee will discuss the nation’s
health promotion and disease
prevention objectives and will provide
recommendations to improve health
status and reduce health risks for the
nation by the year 2030. The Committee
will develop recommendations for
VerDate Sep<11>2014
20:33 Jul 27, 2018
Jkt 244001
implementing Healthy People 2030,
including recommendations for
engaging stakeholders in the
implementation and achievement of the
objectives. Through the Healthy People
initiative, HHS leverages scientific
insights and lessons from the past
decade and new knowledge of current
data, trends, and innovations to develop
the next iteration of national health
promotion and disease prevention
objectives to improve the health of the
nation. Healthy People provides
science-based, 10-year national
objectives for promoting health and
preventing disease. Since 1979, Healthy
People has set and monitored national
health objectives that meet a broad
range of health needs, encourage
collaboration across sectors, guide
individuals toward making informed
health decisions, and measure the
impact of our prevention and health
promotion activities.
Meeting Agenda: The meeting agenda
is available at the Healthy People
website at https://
www.healthypeople.gov. The Committee
will develop further its
recommendations regarding:
Stakeholder engagement; the roles of
health equity, complex systems science
and modeling, and summary measures
in Healthy People 2030; and activities
for implementing Healthy People 2030.
Public Participation at Meeting:
Members of the public are invited to
attend the Committee meeting. There
will be no opportunity for oral public
comments during the Committee
meeting. However, written comments
are welcome throughout the entire
development process of the national
health promotion and disease
prevention objectives for 2030 and may
be emailed to HP2030@hhs.gov. To
attend the Committee meeting,
individuals must pre-register at the
Healthy People website at https://
www.healthypeople.gov. Registrations
must be completed by 5:00 p.m. E.T., on
August 31, 2018. Space for the meeting
is limited and registration will be
accepted until maximum room capacity
is reached. A waiting list will be
maintained should registrations exceed
room capacity. Individuals on the
waiting list will be contacted as
additional space for the meeting
becomes available. Registration
questions may be directed to
HealthyPeople@norc.org.
Authority: 42 U.S.C. 217a. The
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030 is
governed by provisions of the Federal
Advisory Committee Act (FACA), Public
Law 92–463, as amended (5 U.S.C.,
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
App.) which sets forth standards for the
formation and use of federal advisory
committees.
Dated: July 25, 2018.
Donald Wright,
Deputy Assistant Secretary for Health,
(Disease Prevention and Health Promotion).
[FR Doc. 2018–16238 Filed 7–27–18; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7006–N–13]
60-Day Notice of Proposed Information
Collection: Voucher Management
System (VMS), Section 8 Budget and
Financial Forms
Office of the Assistant
Secretary for Public and Indian
Housing, PIH, HUD.
ACTION: Notice.
AGENCY:
HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
parties on the proposed collection of
information. The purpose of this notice
is to allow for 60 days of public
comment.
SUMMARY:
Comments Due Date: September
28, 2018.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
Colette Pollard, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 7th Street
SW, Room 4176, Washington, DC
20410–5000; telephone 202–402–3400
(this is not a toll-free number) or email
at Colette.Pollard@hud.gov for a copy of
the proposed forms or other available
information. Persons with hearing or
speech impairments may access this
number through TTY by calling the tollfree Federal Relay Service at (800) 877–
8339.
FOR FURTHER INFORMATION CONTACT:
Arlette Mussington, Office of Policy,
Programs and Legislative Initiatives,
PIH, Department of Housing and Urban
Development, 451 7th Street SW,
(L’Enfant Plaza, Room 2206),
Washington, DC 20410; telephone 202–
402–4109, (this is not a toll-free
number). Persons with hearing or
speech impairments may access this
number via TTY by calling the Federal
Information Relay Service at (800) 877–
DATES:
E:\FR\FM\30JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36609-36610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Meeting of the Secretary's Advisory Committee on
National Health Promotion and Disease Prevention Objectives for 2030
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Office of Disease Prevention and Health Promotion, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Health and Human Services (HHS)
announces the next meeting of the
[[Page 36610]]
Secretary's Advisory Committee on National Health Promotion and Disease
Prevention Objectives for 2030 (Committee). The meeting is open to the
public and will be held in the Washington, DC metropolitan area. The
Committee is working to accomplish its mission to provide independent
advice to the Secretary of the U.S. Department of Health and Human
Services or a designated representative for the implementation of
Healthy People 2030.
DATES: The Committee will meet on September 6, 2018, from 8:30 a.m. to
5:00 p.m. Eastern Time (ET), and September 7, 2018, from 8:30 a.m. to
3:00 p.m. ET.
ADDRESSES: The meeting will be held at the 20 F Street Conference
Center, located at 20th F Street NW, Washington, DC 20001. To register
to attend the meeting, please visit the Healthy People website at
https://www.healthypeople.gov.
FOR FURTHER INFORMATION CONTACT: Emmeline Ochiai, Designated Federal
Officer, Secretary's Advisory Committee on National Health Promotion
and Disease Prevention Objectives for 2030, 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, Room LL-100, Rockville, MD 20852, (240) 453-8255 (telephone),
(240) 453-8281 (fax). Additional information is available on the
Healthy People website at https://www.healthypeople.gov.
SUPPLEMENTARY INFORMATION:
Appointed Committee Members: The names and biographies of the
appointed Committee members are available at https://www.healthypeople.gov/2020/about/history-development/healthy-people-2030-advisory-committee.
Purpose of Meeting: In accordance with Federal Advisory Committee
Act and to promote transparency of the process, deliberations of the
Committee will occur in a public forum. At this meeting, the Committee
will continue its deliberations from the last public meeting.
Background: The Committee, a federal advisory committee, is charged
with issuing recommendations for the Secretary regarding the
implementation of national health promotion and disease prevention
objectives for 2030. The Committee will discuss the nation's health
promotion and disease prevention objectives and will provide
recommendations to improve health status and reduce health risks for
the nation by the year 2030. The Committee will develop recommendations
for implementing Healthy People 2030, including recommendations for
engaging stakeholders in the implementation and achievement of the
objectives. Through the Healthy People initiative, HHS leverages
scientific insights and lessons from the past decade and new knowledge
of current data, trends, and innovations to develop the next iteration
of national health promotion and disease prevention objectives to
improve the health of the nation. Healthy People provides science-
based, 10-year national objectives for promoting health and preventing
disease. Since 1979, Healthy People has set and monitored national
health objectives that meet a broad range of health needs, encourage
collaboration across sectors, guide individuals toward making informed
health decisions, and measure the impact of our prevention and health
promotion activities.
Meeting Agenda: The meeting agenda is available at the Healthy
People website at https://www.healthypeople.gov. The Committee will
develop further its recommendations regarding: Stakeholder engagement;
the roles of health equity, complex systems science and modeling, and
summary measures in Healthy People 2030; and activities for
implementing Healthy People 2030.
Public Participation at Meeting: Members of the public are invited
to attend the Committee meeting. There will be no opportunity for oral
public comments during the Committee meeting. However, written comments
are welcome throughout the entire development process of the national
health promotion and disease prevention objectives for 2030 and may be
emailed to [email protected]. To attend the Committee meeting, individuals
must pre-register at the Healthy People website at https://www.healthypeople.gov. Registrations must be completed by 5:00 p.m.
E.T., on August 31, 2018. Space for the meeting is limited and
registration will be accepted until maximum room capacity is reached. A
waiting list will be maintained should registrations exceed room
capacity. Individuals on the waiting list will be contacted as
additional space for the meeting becomes available. Registration
questions may be directed to [email protected].
Authority: 42 U.S.C. 217a. The Secretary's Advisory Committee on
National Health Promotion and Disease Prevention Objectives for 2030 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: July 25, 2018.
Donald Wright,
Deputy Assistant Secretary for Health, (Disease Prevention and Health
Promotion).
[FR Doc. 2018-16238 Filed 7-27-18; 8:45 am]
BILLING CODE 4150-32-P
