[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Pages 2076-2078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-495]



Solicitation of Written Comments on Draft Strategic National 
Vaccine Plan

AGENCY: Department of Health and Human Services, Office of the 

ACTION: Notice.


SUMMARY: On behalf of the National Vaccine Advisory Committee (NVAC), 
the National Vaccine Program Office (NVPO) is soliciting public comment 
on the draft strategic National Vaccine Plan.

DATES: All comments on the draft strategic National Vaccine Plan should 
be received no later than 5 p.m. on January 30, 2009.

ADDRESSES: Electronic responses are preferred and may be addressed to 
[email protected]. Written responses should be addressed to National 
Vaccine Program Office, Department of Health and Human Services, 200 
Independence Avenue, SW., Room 443-H, Washington, DC 20201, Attention: 
National Vaccine Plan RFI.

National Vaccine Program Office, Department of Health and Human 
Services, 200 Independence Avenue, SW., Room 443-H, Washington, DC 
20201; (202) 690-5566; fax 202-260-1165; e-mail [email protected].


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I. Background

    The National Vaccine Program was established in 1986 to achieve 
optimal prevention of infectious diseases through immunization and 
optimal prevention of adverse reactions to vaccines. NVPO is located 
within the Office of Public Health and Science within the Office of the 
Secretary, HHS, and has responsibility for coordinating and ensuring 
collaboration among the many Federal agencies involved in vaccine and 
immunization activities as part of the National Vaccine Program. NVAC 
is a statutory Federal advisory committee that provides advice and 
makes recommendations to the Director of the National Vaccine Program 
on matters related to the Program. The purpose of the National Vaccine 
Plan is to promote achievement of the National Vaccine Program mission 
by providing strategic direction and promoting coordinated action by 
vaccine and immunization enterprise stakeholders.
    Federal involvement in civilian and military vaccination programs 
is longstanding, including in research and development, regulation, 
vaccine delivery and the evaluation of the impacts of immunizations. 
This draft strategic National Vaccine Plan builds on the many 
achievements of the vaccine and immunization enterprise prior to and 
since the establishment of the National Vaccine Program in 1986 and the 
completion of the first National Vaccine Plan in 1994. Both the draft 
strategic National Vaccine Plan and the 1994 National Vaccine Plan are 
available at http://www.hhs.gov/nvpo/vacc_plan/. New vaccines have 
been developed and licensed; many of these new vaccines are now 
recommended for children, adolescents and adults. These new vaccines 
have expanded the number of infections that can be prevented, and more 
effectively and safely prevent some diseases for which earlier 
generation vaccines already existed. Opportunities exist to improve 
protection against vaccine-preventable diseases by (1) developing 
improved vaccines based on new adjuvants and better understanding of 
the immune system, and (2) developing a variety of delivery systems for 
vaccines, such as intradermal, oral, and immunostimulant patches. In 
addition, federal immunization financing programs have reduced or 
eliminated many financial barriers to immunizations, particularly for 
children. The number of infections prevented by vaccination has 
decreased significantly while coverage for many vaccines has reached 
record levels. More robust systems have been developed to identify 
adverse events following immunization and to assess potential 
associations of those events with vaccination. Globally, the United 
States has worked with multilateral and bilateral partners and non-
governmental organizations in contributing to improvements in child 
health status and the prevention of hundreds of thousands of child 
deaths each year through improved vaccine coverage and introduction of 
new vaccines. Of the fourteen anticipated outcomes included in the 1994 
National Vaccine Plan, most were substantially or fully realized.
    Despite these successes, however, many of the challenges that 
stimulated establishment of the National Vaccine Program and the 
development of the 1994 National Vaccine Plan remain relevant today. 
Vaccine shortages have frequently been experienced for many routinely 
recommended vaccines. Despite improved vaccination coverage among 
children, the occurrence of several recent vaccine preventable disease 
outbreaks serves as a reminder that these diseases still occur. Among 
older adults both vaccination coverage and the effectiveness of some 
routinely recommended vaccines remain sub-optimal. As the number of 
vaccines has increased and vaccine preventable diseases have declined, 
vaccine safety concerns are expressed more prominently today and may be 
more widely shared. Enhancing the current vaccine safety system is 
important to keep pace with several factors influencing it: an 
increasing number of vaccines and vaccine combinations, expanding 
target populations, and a better understanding of human biology, 
especially the human immune system. As the cost of vaccination has 
increased, financial barriers to vaccination have emerged for health 
departments, health care providers, and the public. Significant 
scientific challenges remain in the development of safe and effective 
vaccines against existing global health threats, such as HIV, TB, 
malaria, and influenza (developing vaccines with broader protection). 
Vaccines that have been developed and are in use in industrialized 
countries have the potential to make major contributions to health in 
developing countries, but are underutilized. Additionally, emerging and 
pandemic infections and bioterrorist threats pose new challenges for 
vaccine development and manufacturing, vaccine delivery, regulation, 
and access in the U.S. and abroad.
    The Plan is built around the achievement of five broad goals:
    Goal 1: Develop new and improved vaccines.
    Goal 2: Enhance the safety of vaccines and vaccination practices.
    Goal 3: Support informed vaccine decision-making by the public, 
providers, and policy-makers.
    Goal 4: Ensure a stable supply of recommended vaccines and achieve 
better use of existing vaccines to prevent disease, disability and 
death in the United States.
    Goal 5: Increase global prevention of death and disease through 
safe and effective vaccination.
    These goals will be achieved by pursuing objectives and strategies 
that address each of the key determinants of those outcomes. Success in 
achieving these goals will be assessed by tracking progress in 
achieving measurable outcomes (``indicators'') associated with each 
goal. Final definition of the indicators and the development of 
specific numeric targets will occur through further consultation with 
stakeholders and the IOM Committee.
    The current draft strategic National Vaccine Plan is based largely 
on input received from Federal Departments and agencies. Recognizing 
that success can best be achieved through a national plan that includes 
coordinated action by public and private sector stakeholders in pursuit 
of the Plan's goals, extensive outreach and consultation will be 
implemented as the Plan is finalized. A committee empanelled by the 
National Academy of Sciences' Institute of Medicine (IOM) reviewed the 
1994 National Vaccine Plan and provided guidance on the development of 
the updated Plan (see http://www.iom.edu/CMS/3793/55143.aspx). The IOM 
committee is also holding a series of national meetings focused around 
each of the goals in which perspectives from many of the stakeholders 
will be obtained. Following these meetings, the IOM committee will 
prepare a report that includes conclusions and recommendations about 
priority actions within major components of the Plan. The National 
Vaccine Advisory Committee (NVAC), a Federal advisory committee that 
includes representatives from many of the key vaccine and immunization 
enterprise stakeholders, is also implementing a process to obtain input 
from a wide range of stakeholder groups. This input will include 
comments on this draft Plan and additional strategies that they can 
contribute to achieve Plan goals. The NVAC will devote its meeting on 
February 6, 2009 to stakeholder and public comments on the draft Plan. 
In addition, input from the public will also be solicited to identify 
priority areas from their perspective in a series of meetings planned 
for later in 2009,

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locations to be determined. This draft Plan will serve as the basis for 
the development of the updated National Vaccine Plan and based on this 
range of input, indicators of measurable outcomes will be determined 
and priorities will be presented. In addition, an implementation plan 
will be drafted that identifies specific actions that will be 
undertaken by government and other vaccine and immunization enterprise 
stakeholders to achieve the objectives and strategies in the plan and 
milestones will be established that will allow progress to be measured. 
The draft Plan has a ten-year horizon, and thereby balances a strategic 
vision, which requires development and implementation of new 
initiatives, with the recognition that changing circumstances and new 
opportunities and challenges will occur over the next decade. The ten-
year horizon also allows incorporation of the HealthyPeople 2020 
objectives once those are established by the Department of Health and 
Human Services (see http://www.healthypeople.gov). Annual monitoring of 
progress and a mid-course review will promote both accountability and 
flexibility. The updated National Vaccine Plan is expected to be 
completed by early 2010.
    Through this Request for Information, HHS is seeking broad comment 
from stakeholders and the general public. Comments received will be 
available for public viewing and will be summarized in an open meeting 
on February 6, 2009, to the NVAC in Washington, DC. If you wish to 
attend the meeting in person or by audioconference, please reply to 
[email protected], or to 202-690-5566.

II. Information Request

    NVPO, on behalf of the NVAC requests information in four broad 
areas. Responders may address one or more of the areas below.
    (1) Comments on priorities for the National Vaccine Plan for a ten-
year period: What do you recommend be the top priorities for vaccines 
and the immunization enterprise in the United States and globally? Why 
are those priorities most important to you? [Provide up to 3 pages for 
an answer to these questions].
    (2) Comments on the goals, objectives, and strategies for the 
National Vaccine Plan for a ten-year period: Please comment on the 
existing goals, objectives, and strategies in the draft Plan, and 
suggest specific goals, objectives, or strategies to be added to it, if 
the existing ones do not address your concerns. Are there any goals, 
objectives or strategies in the draft strategic Plan that should be 
discarded or revised? Which ones, and why? [Provide up to 3 pages for 
an answer to these questions].
    (3) Comments on the indicators for the National Vaccine Plan for a 
ten-year period: Please comment on the existing indicators in the draft 
Plan, and suggest target estimates for them. Please suggest new 
indicators to be added to it, if the existing ones do not address your 
concerns. Are there any indicators in the draft strategic Plan that 
should be discarded or revised? Which ones, and why? [Provide up to 3 
pages for an answer to these questions].
    (4) Comments on stakeholders' roles in the National Vaccine Plan: 
Please identify which stakeholders you believe should have 
responsibility for enacting the objectives and strategies listed in the 
draft Plan, as well as for any new objectives and strategies you 
suggest. Specifically identify roles your organization can play in the 
Plan. [Provide up to 3 pages for an answer to these questions].

III. Potential Responders

    HHS invites input from a broad range of individuals and 
organizations that have interests in vaccines and the immunization 
enterprise. Some examples of these organizations include, but are not 
limited to, the following:
     General public.
     Advocacy groups and public interest organizations.
     State, local, and tribal governments and public health 
     State and local public health departments.
     Vaccine manufacturing industry, distributors, investors, 
and other businesses.
     Health care professional societies and organizations.
     Academic researchers and groups.
     Health care payers and plans.
     International organizations.
     Non-governmental organizations.
     Philanthropic organizations.
     Travel industry.
    The submission of written materials in response to the RFI should 
not exceed 12 pages (3 pages for each of the four broad topics), not 
including appendices and supplemental documents. Responders may submit 
other forms of electronic materials to demonstrate or exhibit concepts 
of their written responses. Any information you submit will be made 
public. Consequently, do not send proprietary, commercial, financial, 
business confidential, trade secret, or personal information that you 
do not wish to be made public. Information and comments will not be 
considered nor made publicly available, if it is not signed by, or 
attributed to, an individual, or an individual representing an 
    Public Access: Responses to this RFI will be available to the 
public on the NVPO Web site at http://www.hhs.gov/nvpo/vacc_plan/. You 
may access public comments received from this RFI by going to the above 
Web site.

    Dated: January 7, 2009.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, U.S. Department of Health and Human Services.
[FR Doc. E9-495 Filed 1-13-09; 8:45 am]