[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74738-74739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information (RFI): Vaccines National Strategic Plan 
Available for Public Comment

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 Department of Health and Human Services (HHS) Office of 
Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the 
Assistant Secretary for Health (OASH) announces the draft Vaccines 
National Strategic Plan 2021-2025 (Vaccine Plan) available for public 
comment. The draft Vaccine Plan may be reviewed at www.hhs.gov/oidp.

DATES: All comments must be received by 5:00 p.m. ET on December 3, 
2020 to be considered.

ADDRESSES: All comments must be submitted electronically to 
[email protected] to be considered.

FOR FURTHER INFORMATION CONTACT: David Kim, OIDP, [email protected], 
202-795-7636.

SUPPLEMENTARY INFORMATION: The development of a National Vaccine Plan 
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 
Plan, 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). The 2010 Plan 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 Plan, there 
have been many changes in the vaccine landscape.
    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 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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[[Page 74739]]

    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.\2\ 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 P.J. 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 P.J. 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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    To respond to the public health challenges of VPDs, OIDP in 
collaboration with other federal partners is leading the development of 
the Vaccines National Strategic Plan (Vaccine Plan). This updated plan 
will recommend vaccine strategies across the lifespan and guide 
priority actions for the period 2021-2025. While COVID-19 and 
coronavirus vaccine development are currently changing the landscape of 
the vaccine enterprise, the Vaccine Plan has a broad focus on the 
entire vaccine enterprise and is not focused specifically on any one 
vaccine or the pandemic response. HHS, through OIDP, seeks input 
regarding the draft of the Vaccine Plan 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.
    The following are the Vaccine Plan's vision and goals. Vision: 
United States will be a place where vaccine-preventable diseases are 
eliminated through safe and effective vaccination over the lifespan. 
Goals:
    1. Foster innovation in vaccine development and related 
technologies.
    2. Maintain the highest possible levels of vaccine safety.
    3. Increase knowledge of and confidence in routinely recommended.
    4. Increase access to and use of all routinely recommended 
vaccines.
    5. Protect the health of the American public by supporting global 
immunization efforts.

Information Needs

    The draft Vaccine Plan may be reviewed at www.hhs.gov/oidp.
    OIDP seeks to obtain feedback from external stakeholders on the 
following:
    1. Do the draft Vaccine Plan's goals, objectives, and strategies 
appropriately address the vaccine landscape?
    2. Are there any critical gaps in the Vaccine Plan's goals, 
objectives, and strategies? If so, please specify the gaps.
    3. Do any of the Vaccine Plan's goals, objectives and strategies 
cause concern? If so, please specify the goal, objective or strategy, 
and describe the concern regarding it.
    Please be succinct and limit your comments to a maximum of seven 
pages.

    Authority: 42 U.S.C. Section 300aa-3.

    Dated: November 17, 2020.
B. Kaye Hayes,
Acting Director, Office of Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2020-25842 Filed 11-20-20; 8:45 am]
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