[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Pages 50050-50051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20415]



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.


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

[[Page 50051]]

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 

    \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.

    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.

    \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.

    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 
    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]