Solicitation of Written Comments on Draft Strategic National Vaccine Plan, 2076-2078 [E9-495]
Download as PDF
<![CDATA[
sroberts on PROD1PC70 with NOTICES
2076
Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
Audio conferencing will be available for
the second day of the meeting.
DATES: The meeting will be held on
February 5, 2009, from 8:30 a.m. to 6:30
p.m. and on February 6, 2009, from 8
a.m. to 3:30 p.m.
ADDRESSES: Department of Health and
Human Services; Hubert H. Humphrey
Building, Room 800; 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Andrea Krull, National Vaccine Program
Office, Department of Health and
Human Services, Room 443-H, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201. Phone: (202)
690–5566; Fax: (202) 260–1165; e-mail:
nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. Section 300aa-1),
the Secretary of Health and Human
Services was mandated to establish the
National Vaccine Program to achieve
optimal prevention of human infectious
diseases through immunization and to
achieve optimal prevention against
adverse reactions to vaccines. The
National Vaccine Advisory Committee
was established to provide advice and
make recommendations to the Director
of the National Vaccine Program, on
matters related to the Program’s
responsibilities. The Assistant Secretary
for Health serves as Director of the
National Vaccine Program.
Topics to be discussed at the meeting
on Thursday, February 5, 2009 include
vaccine financing, vaccine safety,
vaccine stockpile, seasonal influenza
and related issues, vaccine
development, and the National Vaccine
Plan. Updates will be given by the
NVAC Financing, Adult Immunization,
and Safety working groups. The meeting
on Friday, February 6, 2009 is a full day
stakeholders’ meeting to discuss the
draft strategic National Vaccine Plan.
The draft plan can be viewed at the
following Web site: https://www.hhs.gov/
nvpo/vacc_plan/. The meeting will
begin with a plenary session to provide
an overview of the day’s agenda
followed by break-out sessions for each
of the five draft strategic National
Vaccine Plan goals. Audio-conferencing
will be available for the stakeholders’
meeting on February 6, 2009 for the
plenary as well as break-out sessions.
Call-in numbers for the meeting are as
follows: plenary sessions on February 6:
(888) 390–3413 (passcode: 60302); goal
1: research (888) 469–1340 (passcode
27271); goal 2: safety (888) 989–4406
(passcode 41520); goal 3:
communication (800) 779–6844
(passcode 19562); goal 4: supply (888)
VerDate Nov<24>2008
21:01 Jan 13, 2009
Jkt 217001
994–8791 (passcode 37886); and goal 5:
global health (888) 989–4717 (passcode
12377). Agendas for each day of the
meeting will be posted on the NVAC
Web site: www.hhs.gov/nvpo/nvac by
January 21, 2009.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person at least one
week prior to the meeting. Members of
the public will have the opportunity to
provide comments at the meeting.
Public comment will be limited to five
minutes per speaker. Individuals who
would like to submit written statements
should e-mail or fax their comments to
the National Vaccine Program Office at
least five business days prior to the
meeting. A separate Federal Register
Notice will be issued with detailed
instructions for submitting comments
about the draft strategic National
Vaccine Plan. Any members of the
public who wish to have printed
material distributed to NVAC members
should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business January 30, 2009.
Dated: January 5, 2009.
Bruce Gellin,
Deputy Assistant Secretary for Health,
Director, National Vaccine Program Office.
[FR Doc. E9–498 Filed 1–13–09; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health; Decision To
Evaluate a Petition To Designate a
Class of Employees for the Piqua
Organic Moderated Reactor Site,
Piqua, Ohio, To Be Included in the
Special Exposure Cohort
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
SUMMARY: HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
of employees for the Piqua Organic
Moderated Reactor site, Piqua, Ohio, to
be included in the Special Exposure
Cohort under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
warranted by the evaluation, is as
follows:
Facility: Piqua Organic Moderated
Reactor site.
Location: Piqua, Ohio.
Job Titles and/or Job Duties: All
employees associated with reactor
activities who worked within and
around the Reactor Dome.
Period of Employment: January 1,
1963 through December 31, 1966.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Dated: January 6, 2009.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–571 Filed 1–13–09; 8:45 am]
BILLING CODE 4163–19–P
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.
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:
E:\FR\FM\14JAN1.SGM
14JAN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
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 https://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
VerDate Nov<24>2008
21:01 Jan 13, 2009
Jkt 217001
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 suboptimal. 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.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
2077
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 https://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,
E:\FR\FM\14JAN1.SGM
14JAN1
2078
Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
sroberts on PROD1PC70 with NOTICES
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
https://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
VerDate Nov<24>2008
21:01 Jan 13, 2009
Jkt 217001
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 https://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]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10161, CMS–
1882, CMS–437A and B, CMS–1557 and
CMS–10036]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: New Freedom
Initiative—Web-based Reporting System
for Grantees; Use: CMS currently awards
competitive grants to States and other
eligible entities for the purpose of
designing and implementing effective
and enduring improvements in
community-based long-term services
E:\FR\FM\14JAN1.SGM
14JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[[Page 2077]]
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 https://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 https://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,
[[Page 2078]]
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 https://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 https://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]
BILLING CODE 4150-44-P
