83 FR 25020 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 105 (May 31, 2018)

Page Range		25020-25021
FR Document		2018-11745

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.

Federal Register, Volume 83 Issue 105 (Thursday, May 31, 2018)

[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25020-25021]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11745]


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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

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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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 http://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.'' 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]
 BILLING CODE 4150-44-P

25020 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices

This draft guidance is being issued among the various federal agencies This report provided recommendations
consistent with FDA’s good guidance involved in vaccine and immunization to the ASH on how to increase Human
practices regulation (21 CFR 10.115). activities. The NVPO also supports the Papillomavirus (HPV) vaccine uptake in
The draft guidance, when finalized, will National Vaccine Advisory Committee young adolescents by reviewing the
represent the current thinking of FDA (NVAC). The NVAC advises and makes current state of HPV immunization,
on ‘‘Q12 Technical and Regulatory recommendations to the ASH in his understanding the root cause(s) for the
Considerations for Pharmaceutical capacity as the Director of the National observed relatively low vaccine uptake
Product Lifecycle Management.’’ It does Vaccine Program on matters related to (both initiation and series completion),
not establish any rights for any person vaccine program responsibilities. and identifying existing best practices.
and is not binding on FDA or the public. The ASH charged the NVAC in Since the original NVAC HPV report,
You can use an alternative approach if February 2018 to establish a work group substantial progress led to policy and
it satisfies the requirements of the to produce a brief report by June 2018 program changes and advances in
applicable statutes and regulations. This on recommendations to strengthen the research. To build on the substantial
guidance is not subject to Executive effectiveness of national, state, and local progress made toward increasing HPV
Order 12866. efforts to improve Human vaccination coverage rates, the ASH
Papillomavirus (HPV) coverage rates. charged the NVAC in February 2018 to
II. Electronic Access
Through a series of conference calls, establish a work group to produce a
Persons with access to the internet electronic communication, and public brief report by June 2018 on
may obtain the document at https:// discussion at the May 3, 2018, NVAC recommendations to ‘‘strengthen the
www.regulations.gov, https:// public meeting, the work group effectiveness of national, state, and local
www.fda.gov/Drugs/Guidance identified a number of draft efforts to improve HPV coverage rates.’’
ComplianceRegulatoryInformation/ recommendations for consideration by The ASH specifically requested the
Guidances/default.htm, or https:// the NVAC. The work group’s draft NVAC to consider the following:
www.fda.gov/BiologicsBloodVaccines/ report and recommendations will (1) Many national organizations are
GuidanceComplianceRegulatory inform NVAC deliberations as it currently supporting HPV efforts. Are
Information/Guidances/default.htm. finalizes recommendations for there additional national organizations
Dated: May 24, 2018. transmittal to the ASH. that might contribute to increasing HPV
Leslie Kux, On behalf of NVAC, NVPO is vaccination coverage?
Associate Commissioner for Policy. soliciting public comment on the draft (2) At the state level, many states have
report and draft recommendations from formed coalitions to support HPV
[FR Doc. 2018–11641 Filed 5–30–18; 8:45 am]
a variety of stakeholders, including the vaccination efforts. Is there general
BILLING CODE 4164–01–P
general public, for consideration by the guidance for states that do not yet have
NVAC as they develop their final coalitions?
recommendations to the ASH. It is (3) Integrated health care delivery
DEPARTMENT OF HEALTH AND
anticipated that the draft report and networks can successfully integrate
HUMAN SERVICES
draft recommendations, as revised with comprehensive quality improvement
Solicitation of Written Comments on consideration given to public comment approaches to increase vaccination
the Human Papillomavirus Vaccination and stakeholder input, will be presented coverage rates. How can state
Implementation Work Group Draft to the NVAC for adoption in June 2018 immunization programs and coalitions
Report and Draft Recommendations at the quarterly NVAC meeting. engage with health systems to work
for Consideration by the National DATES: Comments for consideration by
together on improving HPV vaccination
Vaccine Advisory Committee the NVAC should be received no later coverage?
(4) Please specify recommendations
AGENCY: National Vaccine Program than 5:00 p.m. EDT on June 15, 2018.
on how to meet the needs of providers
Office, Office of the Assistant Secretary ADDRESSES:
in rural areas.
for Health, Office of the Secretary, (1) The draft report and draft The NVAC established the Human
Department of Health and Human recommendations are available on the Papillomavirus Vaccination
Services. web at http://www.hhs.gov/nvpo/nvac/ Implementation Work Group in
index.html. February 2018, a work group tasked to
ACTION: Notice.
(2) Electronic responses may be sent engage with a wide-range of
SUMMARY: The National Vaccine to: nvac@hhs.gov. implementation partners from across all
Advisory Committee (NVAC) was FOR FURTHER INFORMATION CONTACT: sectors (e.g., government, industry,
established in 1987 to comply with Title Captain Angela Shen, Designated health systems, associations, academia,
XXI of the Public Health Service Act. Its Federal Officer, National Vaccine and non-profit) to inform NVAC’s work
purpose is to advise and make Program Office, U.S. Department of and these recommendations.
recommendations to the Director of the Health and Human Services, Room The NVAC draft report highlights the
National Vaccine Program on matters 715H, Hubert H. Humphrey Building, progress made toward increasing HPV
related to program responsibilities. The 200 Independence Avenue SW, vaccination coverage rates, since the
Assistant Secretary for Health (ASH) has Washington, DC 20201. Phone: 202– 2015 NVAC report. The
been designated by the Secretary of 690–5566; email nvac@hhs.gov. recommendations detail how the ASH
Health and Human Services (HHS) as SUPPLEMENTARY INFORMATION: can support HHS activities to strengthen
the Director of the National Vaccine the effectiveness of national, state, and
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Program. The National Vaccine Program I. Background
local efforts to improve HPV coverage
Office (NVPO) is located within the On June 9, 2015, the National Vaccine rates.
Office of the Assistant Secretary for Advisory Committee (NVAC) issued a
Health (OASH), Office of the Secretary, report ‘‘Overcoming Barriers to Low II. Request for Comment
U.S. Department of Health and Human HPV Vaccine Uptake in the United NVPO, on behalf of the NVAC HPV
Services (HHS). NVPO provides States: Recommendations from the Vaccination Implementation Work
leadership and fosters collaboration National Vaccine Advisory Committee.’’ Group, requests input on the draft report

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Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25021

and draft recommendations. Please limit This meeting will be held online via individuals toward making informed
your comments to three (3) pages. webinar and is open to the public. The health decisions, and measure the
Committee will discuss the nation’s impact of our prevention and health
III. Potential Responders
health promotion and disease promotion activities. Healthy People
HHS invites input from a broad range prevention objectives and will provide 2030 health objectives will reflect
of stakeholders including individuals recommendations to improve health assessments of major risks to health and
and organizations that have interests status and reduce health risks for the wellness, changing public health
U.S. vaccine and immunization efforts nation by the year 2030. The Committee priorities, and emerging technologies
and the role of HHS in advancing those will further develop recommendations related to our nation’s health
efforts. regarding setting targets for the Healthy preparedness and prevention.
Examples of potential responders People 2030 objectives and Public Participation at Meeting:
include, but are not limited to, the recommendations regarding the role of Members of the public are invited to
following: law and policy, systems science, health join the online Committee meeting.
—General public; literacy, health promotion, health and There will be no opportunity for oral
—advocacy groups, non-profit well-being, summary measures, and public comments during this online
organizations, and public interest health equity in Healthy People 2030. Committee meeting. However, written
organizations; Pursuant to the Committee’s charter, the comments are welcome throughout the
—academics, professional societies, and Committee’s advice must assist the entire development process of the
healthcare organizations; Secretary in reducing the number of national health promotion and disease
—public health officials and objectives while ensuring that the prevention objectives for 2030 and may
immunization program managers; selection criteria identifies the most be emailed to HP2030@hhs.gov.
—physician and non-physician critical public health issues that are To join the Committee meeting,
providers that administer high-impact priorities supported by individuals must pre-register at the
immunization services, including current national data. Healthy People website at http://
pharmacists; and DATES: The Committee will meet on July www.healthypeople.gov. Participation in
—representatives from the private 10, 2018, from 1:00 p.m. to 4:00 p.m. the meeting is limited. Registrations will
sector. Eastern Time (ET). be accepted until maximum webinar
ADDRESSES: The meeting will be held capacity is reached, and must be
When responding, please self-identify completed by 9:00 a.m. ET on July 10,
online via webinar. To register to attend
with any of the above or other categories 2018. A waiting list will be maintained
the meeting, please visit the Healthy
(include all that apply) and your name. should registrations exceed capacity,
People website at http://
Anonymous submissions will not be and those individuals will be contacted
www.healthypeople.gov.
considered. Written submissions should as additional space for the meeting
not exceed three (3) pages. Please do not FOR FURTHER INFORMATION CONTACT:
Emmeline Ochiai, Designated Federal becomes available. Registration
send proprietary, commercial, financial, questions may be directed to
business, confidential, trade secret, or Official, Secretary’s Advisory
Committee on National Health HealthyPeople@norc.org.
personal information. Authority: 42 U.S.C. 300u and 42
Promotion and Disease Prevention
Dated: May 24, 2018. U.S.C. 217a. The Secretary’s Advisory
Objectives for 2030, U.S. Department of
Roula Sweis, Committee on National Health
Health and Human Services, Office of
Deputy Director, National Vaccine Program the Assistant Secretary for Health, Promotion and Disease Prevention
Office. Office of Disease Prevention and Health Objectives for 2030 is governed by
[FR Doc. 2018–11745 Filed 5–30–18; 8:45 am] Promotion, 1101 Wootton Parkway, provisions of the Federal Advisory
BILLING CODE 4150–44–P Room LL–100, Rockville, MD 20852, Committee Act (FACA), Public Law 92–
(240) 453–8255 (telephone), (240) 453– 463, as amended (5 U.S.C., App.) which
8281 (fax). Additional information is sets forth standards for the formation
DEPARTMENT OF HEALTH AND available on the Healthy People website and use of federal advisory committees.
HUMAN SERVICES at http://www.healthypeople.gov. Dated: May 24, 2018.
SUPPLEMENTARY INFORMATION: The Don Wright,
Meeting of the Secretary’s Advisory
Committee on National Health names and biographies of the Deputy Assistant Secretary for Health,
Committee members are available at (Disease Prevention and Health Promotion).
Promotion and Disease Prevention
Objectives for 2030 https://www.healthypeople.gov/2020/ [FR Doc. 2018–11600 Filed 5–30–18; 8:45 am]
about/history-development/healthy- BILLING CODE 4150–32–P
AGENCY: Office of Disease Prevention people-2030-advisory-committee.
and Health Promotion, Office of the Purpose of Meeting: Through the
Assistant Secretary for Health, Office of Healthy People initiative, HHS leverages DEPARTMENT OF HEALTH AND
the Secretary, Department of Health and scientific insights and lessons from the HUMAN SERVICES
Human Services. past decade, along with new knowledge
of current data, trends, and innovations, National Institutes of Health
ACTION: Notice.
to develop the next iteration of national
SUMMARY: The U.S. Department of health promotion and disease Center for Scientific Review; Notice of
Health and Human Services (HHS) prevention objectives. Healthy People Closed Meetings
amozie on DSK3GDR082PROD with NOTICES1

announces the next meeting of the provides science-based, 10-year national Pursuant to section 10(d) of the
Secretary’s Advisory Committee on objectives for promoting health and Federal Advisory Committee Act, as
National Health Promotion and Disease preventing disease. Since 1979, Healthy amended, notice is hereby given of the
Prevention Objectives for 2030 People has set and monitored national following meetings.
(Committee) regarding the development health objectives that meet a broad The meetings will be closed to the
of national health promotion and range of health needs, encourage public in accordance with the
disease prevention objectives for 2030. collaboration across sectors, guide provisions set forth in sections

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Document Created: 2018-05-31 00:48:46
Document Modified: 2018-05-31 00:48:46

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.
Dates		Comments for consideration by the NVAC should be received no later than 5:00 p.m. EDT on June 15, 2018.
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]
FR Citation		83 FR 25020