Solicitation of Written Comments on the Human Papillomavirus Vaccination Implementation Work Group Draft Report and Draft Recommendations for Consideration by the National Vaccine Advisory Committee, 25020-25021 [2018-11745]
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Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
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Considerations for Pharmaceutical
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You can use an alternative approach if
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guidance is not subject to Executive
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II. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.regulations.gov, https://
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ComplianceRegulatoryInformation/
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GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11641 Filed 5–30–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Written Comments on
the Human Papillomavirus Vaccination
Implementation Work Group Draft
Report and Draft Recommendations
for Consideration by the National
Vaccine Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Vaccine
Advisory Committee (NVAC) was
established in 1987 to comply with Title
XXI of the Public Health Service Act. Its
purpose is to advise and make
recommendations to the Director of the
National Vaccine Program on matters
related to program responsibilities. The
Assistant Secretary for Health (ASH) has
been designated by the Secretary of
Health and Human Services (HHS) as
the Director of the National Vaccine
Program. The National Vaccine Program
Office (NVPO) is located within the
Office of the Assistant Secretary for
Health (OASH), Office of the Secretary,
U.S. Department of Health and Human
Services (HHS). NVPO provides
leadership and fosters collaboration
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SUMMARY:
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Jkt 241001
among the various federal agencies
involved in vaccine and immunization
activities. The NVPO also supports the
National Vaccine Advisory Committee
(NVAC). The NVAC advises and makes
recommendations to the ASH in his
capacity as the Director of the National
Vaccine Program on matters related to
vaccine program responsibilities.
The ASH charged the NVAC in
February 2018 to establish a work group
to produce a brief report by June 2018
on recommendations to strengthen the
effectiveness of national, state, and local
efforts to improve Human
Papillomavirus (HPV) coverage rates.
Through a series of conference calls,
electronic communication, and public
discussion at the May 3, 2018, NVAC
public meeting, the work group
identified a number of draft
recommendations for consideration by
the NVAC. The work group’s draft
report and recommendations will
inform NVAC deliberations as it
finalizes recommendations for
transmittal to the ASH.
On behalf of NVAC, NVPO is
soliciting public comment on the draft
report and draft recommendations from
a variety of stakeholders, including the
general public, for consideration by the
NVAC as they develop their final
recommendations to the ASH. It is
anticipated that the draft report and
draft recommendations, as revised with
consideration given to public comment
and stakeholder input, will be presented
to the NVAC for adoption in June 2018
at the quarterly NVAC meeting.
DATES: Comments for consideration by
the NVAC should be received no later
than 5:00 p.m. EDT on June 15, 2018.
ADDRESSES:
(1) The draft report and draft
recommendations are available on the
web at https://www.hhs.gov/nvpo/nvac/
index.html.
(2) Electronic responses may be sent
to: nvac@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Captain Angela Shen, Designated
Federal Officer, National Vaccine
Program Office, U.S. Department of
Health and Human Services, Room
715H, Hubert H. Humphrey Building,
200 Independence Avenue SW,
Washington, DC 20201. Phone: 202–
690–5566; email nvac@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 9, 2015, the National Vaccine
Advisory Committee (NVAC) issued a
report ‘‘Overcoming Barriers to Low
HPV Vaccine Uptake in the United
States: Recommendations from the
National Vaccine Advisory Committee.’’
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Fmt 4703
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This report provided recommendations
to the ASH on how to increase Human
Papillomavirus (HPV) vaccine uptake in
young adolescents by reviewing the
current state of HPV immunization,
understanding the root cause(s) for the
observed relatively low vaccine uptake
(both initiation and series completion),
and identifying existing best practices.
Since the original NVAC HPV report,
substantial progress led to policy and
program changes and advances in
research. To build on the substantial
progress made toward increasing HPV
vaccination coverage rates, the ASH
charged the NVAC in February 2018 to
establish a work group to produce a
brief report by June 2018 on
recommendations to ‘‘strengthen the
effectiveness of national, state, and local
efforts to improve HPV coverage rates.’’
The ASH specifically requested the
NVAC to consider the following:
(1) Many national organizations are
currently supporting HPV efforts. Are
there additional national organizations
that might contribute to increasing HPV
vaccination coverage?
(2) At the state level, many states have
formed coalitions to support HPV
vaccination efforts. Is there general
guidance for states that do not yet have
coalitions?
(3) Integrated health care delivery
networks can successfully integrate
comprehensive quality improvement
approaches to increase vaccination
coverage rates. How can state
immunization programs and coalitions
engage with health systems to work
together on improving HPV vaccination
coverage?
(4) Please specify recommendations
on how to meet the needs of providers
in rural areas.
The NVAC established the Human
Papillomavirus Vaccination
Implementation Work Group in
February 2018, a work group tasked to
engage with a wide-range of
implementation partners from across all
sectors (e.g., government, industry,
health systems, associations, academia,
and non-profit) to inform NVAC’s work
and these recommendations.
The NVAC draft report highlights the
progress made toward increasing HPV
vaccination coverage rates, since the
2015 NVAC report. The
recommendations detail how the ASH
can support HHS activities to strengthen
the effectiveness of national, state, and
local efforts to improve HPV coverage
rates.
II. Request for Comment
NVPO, on behalf of the NVAC HPV
Vaccination Implementation Work
Group, requests input on the draft report
E:\FR\FM\31MYN1.SGM
31MYN1
Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
and draft recommendations. Please limit
your comments to three (3) pages.
III. Potential Responders
HHS invites input from a broad range
of stakeholders including individuals
and organizations that have interests
U.S. vaccine and immunization efforts
and the role of HHS in advancing those
efforts.
Examples of potential responders
include, but are not limited to, the
following:
—General public;
—advocacy groups, non-profit
organizations, and public interest
organizations;
—academics, professional societies, and
healthcare organizations;
—public health officials and
immunization program managers;
—physician and non-physician
providers that administer
immunization services, including
pharmacists; and
—representatives from the private
sector.
When responding, please self-identify
with any of the above or other categories
(include all that apply) and your name.
Anonymous submissions will not be
considered. Written submissions should
not exceed three (3) pages. Please do not
send proprietary, commercial, financial,
business, confidential, trade secret, or
personal information.
Dated: May 24, 2018.
Roula Sweis,
Deputy Director, National Vaccine Program
Office.
[FR Doc. 2018–11745 Filed 5–30–18; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on National Health
Promotion and Disease Prevention
Objectives for 2030
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 U.S. Department of
Health and Human Services (HHS)
announces the next meeting of the
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030
(Committee) regarding the development
of national health promotion and
disease prevention objectives for 2030.
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17:46 May 30, 2018
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This meeting will be held online via
webinar and is open to the public. 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 further develop recommendations
regarding setting targets for the Healthy
People 2030 objectives and
recommendations regarding the role of
law and policy, systems science, health
literacy, health promotion, health and
well-being, summary measures, and
health equity in Healthy People 2030.
Pursuant to the Committee’s charter, the
Committee’s advice must assist the
Secretary in reducing the number of
objectives while ensuring that the
selection criteria identifies the most
critical public health issues that are
high-impact priorities supported by
current national data.
DATES: The Committee will meet on July
10, 2018, from 1:00 p.m. to 4:00 p.m.
Eastern Time (ET).
ADDRESSES: The meeting will be held
online via webinar. 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
Official, 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: The
names and biographies of the
Committee members are available at
https://www.healthypeople.gov/2020/
about/history-development/healthypeople-2030-advisory-committee.
Purpose of Meeting: Through the
Healthy People initiative, HHS leverages
scientific insights and lessons from the
past decade, along with new knowledge
of current data, trends, and innovations,
to develop the next iteration of national
health promotion and disease
prevention objectives. 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
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25021
individuals toward making informed
health decisions, and measure the
impact of our prevention and health
promotion activities. Healthy People
2030 health objectives will reflect
assessments of major risks to health and
wellness, changing public health
priorities, and emerging technologies
related to our nation’s health
preparedness and prevention.
Public Participation at Meeting:
Members of the public are invited to
join the online Committee meeting.
There will be no opportunity for oral
public comments during this online
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 join the Committee meeting,
individuals must pre-register at the
Healthy People website at https://
www.healthypeople.gov. Participation in
the meeting is limited. Registrations will
be accepted until maximum webinar
capacity is reached, and must be
completed by 9:00 a.m. ET on July 10,
2018. A waiting list will be maintained
should registrations exceed capacity,
and those individuals 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. 300u and 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: May 24, 2018.
Don Wright,
Deputy Assistant Secretary for Health,
(Disease Prevention and Health Promotion).
[FR Doc. 2018–11600 Filed 5–30–18; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
E:\FR\FM\31MYN1.SGM
31MYN1
Agencies
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25020-25021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments on the Human Papillomavirus
Vaccination Implementation Work Group Draft Report and Draft
Recommendations for Consideration by the National Vaccine Advisory
Committee
AGENCY: National Vaccine Program Office, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Vaccine Advisory Committee (NVAC) was established
in 1987 to comply with Title XXI of the Public Health Service Act. Its
purpose is to advise and make recommendations to the Director of the
National Vaccine Program on matters related to program
responsibilities. The Assistant Secretary for Health (ASH) has been
designated by the Secretary of Health and Human Services (HHS) as the
Director of the National Vaccine Program. The National Vaccine Program
Office (NVPO) is located within the Office of the Assistant Secretary
for Health (OASH), Office of the Secretary, U.S. Department of Health
and Human Services (HHS). NVPO provides leadership and fosters
collaboration among the various federal agencies involved in vaccine
and immunization activities. The NVPO also supports the National
Vaccine Advisory Committee (NVAC). The NVAC advises and makes
recommendations to the ASH in his capacity as the Director of the
National Vaccine Program on matters related to vaccine program
responsibilities.
The ASH charged the NVAC in February 2018 to establish a work group
to produce a brief report by June 2018 on recommendations to strengthen
the effectiveness of national, state, and local efforts to improve
Human Papillomavirus (HPV) coverage rates. Through a series of
conference calls, electronic communication, and public discussion at
the May 3, 2018, NVAC public meeting, the work group identified a
number of draft recommendations for consideration by the NVAC. The work
group's draft report and recommendations will inform NVAC deliberations
as it finalizes recommendations for transmittal to the ASH.
On behalf of NVAC, NVPO is soliciting public comment on the draft
report and draft recommendations from a variety of stakeholders,
including the general public, for consideration by the NVAC as they
develop their final recommendations to the ASH. It is anticipated that
the draft report and draft recommendations, as revised with
consideration given to public comment and stakeholder input, will be
presented to the NVAC for adoption in June 2018 at the quarterly NVAC
meeting.
DATES: Comments for consideration by the NVAC should be received no
later than 5:00 p.m. EDT on June 15, 2018.
ADDRESSES:
(1) The draft report and draft recommendations are available on the
web at https://www.hhs.gov/nvpo/nvac/.
(2) Electronic responses may be sent to: [email protected].
FOR FURTHER INFORMATION CONTACT: Captain Angela Shen, Designated
Federal Officer, National Vaccine Program Office, U.S. Department of
Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200
Independence Avenue SW, Washington, DC 20201. Phone: 202-690-5566;
email [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On June 9, 2015, the National Vaccine Advisory Committee (NVAC)
issued a report ``Overcoming Barriers to Low HPV Vaccine Uptake in the
United States: Recommendations from the National Vaccine Advisory
Committee.'' This report provided recommendations to the ASH on how to
increase Human Papillomavirus (HPV) vaccine uptake in young adolescents
by reviewing the current state of HPV immunization, understanding the
root cause(s) for the observed relatively low vaccine uptake (both
initiation and series completion), and identifying existing best
practices. Since the original NVAC HPV report, substantial progress led
to policy and program changes and advances in research. To build on the
substantial progress made toward increasing HPV vaccination coverage
rates, the ASH charged the NVAC in February 2018 to establish a work
group to produce a brief report by June 2018 on recommendations to
``strengthen the effectiveness of national, state, and local efforts to
improve HPV coverage rates.'' The ASH specifically requested the NVAC
to consider the following:
(1) Many national organizations are currently supporting HPV
efforts. Are there additional national organizations that might
contribute to increasing HPV vaccination coverage?
(2) At the state level, many states have formed coalitions to
support HPV vaccination efforts. Is there general guidance for states
that do not yet have coalitions?
(3) Integrated health care delivery networks can successfully
integrate comprehensive quality improvement approaches to increase
vaccination coverage rates. How can state immunization programs and
coalitions engage with health systems to work together on improving HPV
vaccination coverage?
(4) Please specify recommendations on how to meet the needs of
providers in rural areas.
The NVAC established the Human Papillomavirus Vaccination
Implementation Work Group in February 2018, a work group tasked to
engage with a wide-range of implementation partners from across all
sectors (e.g., government, industry, health systems, associations,
academia, and non-profit) to inform NVAC's work and these
recommendations.
The NVAC draft report highlights the progress made toward
increasing HPV vaccination coverage rates, since the 2015 NVAC report.
The recommendations detail how the ASH can support HHS activities to
strengthen the effectiveness of national, state, and local efforts to
improve HPV coverage rates.
II. Request for Comment
NVPO, on behalf of the NVAC HPV Vaccination Implementation Work
Group, requests input on the draft report
[[Page 25021]]
and draft recommendations. Please limit your comments to three (3)
pages.
III. Potential Responders
HHS invites input from a broad range of stakeholders including
individuals and organizations that have interests U.S. vaccine and
immunization efforts and the role of HHS in advancing those efforts.
Examples of potential responders include, but are not limited to,
the following:
--General public;
--advocacy groups, non-profit organizations, and public interest
organizations;
--academics, professional societies, and healthcare organizations;
--public health officials and immunization program managers;
--physician and non-physician providers that administer immunization
services, including pharmacists; and
--representatives from the private sector.
When responding, please self-identify with any of the above or
other categories (include all that apply) and your name. Anonymous
submissions will not be considered. Written submissions should not
exceed three (3) pages. Please do not send proprietary, commercial,
financial, business, confidential, trade secret, or personal
information.
Dated: May 24, 2018.
Roula Sweis,
Deputy Director, National Vaccine Program Office.
[FR Doc. 2018-11745 Filed 5-30-18; 8:45 am]
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