[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Notices]
[Pages 2076-2078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-495]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments on Draft Strategic National
Vaccine Plan
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
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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
NVPComments@hhs.gov. 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.
FOR FURTHER INFORMATION CONTACT: CAPT Raymond A. Strikas, M.D.,
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 nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION:
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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
nvpo@hhs.gov, 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
agencies.
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
organization.
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]
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