[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50050-50051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20415]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information (RFI) From Non-Federal Stakeholders:
Developing the 2020 National Vaccine Plan
AGENCY: Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office
of the Assistant Secretary for Health, Office of the Secretary,
Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The development of a National Vaccine Plan (NVP) was mandated
by Congress as a mechanism for the Director of the National Vaccine
Program (as delegated by the Assistant Secretary for Health) to
communicate priorities for achieving the Program's responsibilities of
ensuring adequate supply of and access to vaccines and ensuring the
effective and optimal use of vaccines. The most recent NVP, released in
2010, provided a comprehensive 10-year national strategy for enhancing
all aspects of the plan, including vaccine research and development,
supply, financing, distribution, and safety; informed decision-making
by consumers and health care providers; vaccine-preventable disease
surveillance; vaccine effectiveness and use monitoring; and global
cooperation (http://www.hhs.gov/nvpo/vacc_plan/index.html). To help
inform the development of the National Vaccine Plan 2020, HHS is
issuing a Request for Information (RFI). The RFI will solicit specific
information regarding the priorities, goals, and objectives in the next
iteration of the NVP, remaining gaps, and stakeholder perspectives for
the 2020-2025 timeframe.
DATES: To be considered, comments must be received electronically at
the email address provided below, no later than 5:00 p.m. ET on October
24, 2019.
ADDRESSES: Responses must be submitted electronically, and should be
addressed to [email protected]. Mailed paper submissions and submissions
received after the deadline will not be reviewed.
SUPPLEMENTARY INFORMATION: With U.S. vaccination rates above 90% for
many childhood vaccines, most individuals have not witnessed firsthand
the devastating illnesses against which vaccines offer protection, such
as polio or diphtheria. According to a recent study, routine childhood
immunizations among U.S. children born in 2009 will prevent 20 million
cases of disease and 42,000 premature deaths, with a net savings of
$13.5 billion in direct costs
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and $68.8 billion in total societal costs.\1\ In contrast, adult
vaccination coverage rates have remained persistently low, with only
modest gains for certain populations in the past few years.\2\ As a
result, the standards for adult immunization practice were updated in
2014 to promote integration of vaccines into routine clinical care for
adults.\3\
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\1\ Zhou F et al. Economic evaluation of the routine childhood
immunization program in the United States, 2009. Pediatrics. 2014;
133: 1-9.
\2\ https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2017.html.
\3\ National Vaccine Advisory Committee. Recommendations from
the National Vaccine Advisory Committee: standards for adult
immunization practice. Public Health Rep. 2014;129:115-23.
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Despite the widespread availability of effective vaccines, vaccine-
preventable diseases (VPDs) remain a significant public health
challenge. In particular, rates of non-medical exemptions for childhood
vaccines are increasing,\4\ and there have been recent measles
outbreaks in the U.S.\5\ and globally, due to growing vaccine hesitancy
and coverage levels below the threshold needed for herd immunity. With
an estimated cost of $20,000 per case of measles to the public sector
in 2016,\6\ the economic consequences of this and other VPDs, as well
as the health consequences, are significant. Furthermore, few adults in
any age group are fully vaccinated as recommended by the Advisory
Committee on Immunization Practices. Large disparities in vaccine
coverage by race/ethnicity persist, with African Americans, Hispanics,
and Asian Americans lagging behind whites in nearly all vaccination
coverage rates.\7\ VPDs such as pertussis and hepatitis B continue to
take a heavy toll on public health,\8\ with 18,975 cases of pertussis
and 3,409 (22,000 estimated) cases of hepatitis B infections reported
in the United States in 2017.9 10 In light of these
challenges, strengthening the vaccine and immunization enterprise is a
priority for HHS.
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\4\ Omer, S. et al. Nonmedical exemptions to school immunization
requirements: secular trends and association of state policies with
pertussis incidence. JAMA. 2006;296(14):1757-1763.
\5\ https://www.cdc.gov/measles/cases-outbreaks.html.
\6\ Lo NC, Hotez PJ. Public Health and Economic Consequences of
Vaccine Hesitancy for Measles in the United States. JAMA Pediatr.
2017;171(9):887-892. doi:10.1001/jamapediatrics.2017.1695.
\7\ Lu PJ et al. Racial and Ethnic Disparities in Vaccination
Coverage Among Adult Populations in the U.S. Am J Prev Med.
2015;49(6 Suppl 4):S412-S425. doi:10.1016/j.amepre.2015.03.005.
\8\ https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/e/reported-cases.pdf.
\9\ https://www.chop.edu/centers-programs/vaccine-education-center/global-immunization/diseases-and-vaccines-world-view.
\10\ Schillie et al. Prevention of Hepatitis B Virus Infection
in the United States: Recommendations of the Advisory Committee on
Immunization Practices. MMWR. 2018;67(1):1-31.
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The 2010 National Vaccine Plan (https://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-Plan/nationalvaccineplan.pdf) and the
associated implementation plan (https://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-2015-Plan/implementationplan.pdf) have played
an important role in guiding strategies and allocations of resources
with respect to vaccines and vaccination. However, since the
publication of the 2010 National Vaccine Plan, there have been many
changes in the vaccine landscape.
To respond to the public health challenges of VPDs, OIDP in
collaboration with other federal partners is leading the development of
the 2020 National Vaccine Plan. This updated plan will recommend
vaccine strategies across the lifespan and guide priority actions for
the period 2020-2025. To develop this plan, HHS, through OIDP, seeks
input from subject matter experts and nonfederal partners and
stakeholders such as health care providers, national professional
organizations, health departments, school administrators, community-
based and faith-based organizations, manufacturers, researchers,
advocates, and persons affected by VPDs.
This request for information seeks public input on strengthening
and improving the nation's response to VPDs and strategies to address
infectious diseases through vaccination. The 2020 National Vaccine
Program requests information in five broad areas. Responders may
address one or more of the areas below:
1. Priorities for the 2020 National Vaccine Plan during 2020-2025.
What do you recommend as the top priorities for vaccines and
immunizations in the United States? Why are these priorities most
important to you? [Provide up to 2 pages to answer these questions]
2. What changes should be made to the 2010 National Vaccine Plan to
make it more current and useful? This could include changes to the
goals, objectives, strategies, activities, indicators, and other areas
of the plan. Which components of the 2010 National Vaccine Plan worked
well and should be maintained? [Provide up to 2 pages to answer these
questions]
3. What are the goals, objectives, and strategies for each of your
top priority areas? Are there any goals in the current strategy that
should be discarded or revised? Which ones and why? [Provide up to 2
pages to answer these questions]
4. What indicators can be used to measure your top priorities and
goals? Are there any indicators in the 2010 National Vaccine Plan or
the National Adult Immunization Plan (https://www.hhs.gov/sites/default/files/nvpo/national-adult-immunization-plan/naip.pdf) that
should continue to be used? If so, which ones, and why? [Provide up to
2 pages to answer these questions]
5. Identify which stakeholders you believe should have
responsibility for enacting the objectives and strategies listed in the
2020 National Vaccine Plan, as well as for any new objectives and
strategies you suggest. Specifically identify roles that you or your
organization might have in the 2020 National Vaccine Plan. [Provide up
to 2 pages to answer these questions].
The information received will inform the development of the 2020
National Vaccine Plan.
Dated: September 9, 2019.
Tammy R. Beckham,
Director, Office of Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2019-20415 Filed 9-23-19; 8:45 am]
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