[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Notices]
[Pages 61214-61215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information From Non-Federal Stakeholders on Progress 
and Accomplishments (2010-2015) Towards the Goals of the National 
Vaccine Plan

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY:  The development of a National Vaccine Plan was mandated by 
Congress as a mechanism for the Director of the National Vaccine 
Program (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 National Vaccine Plan, released in 2010, provides 
a comprehensive 10-year national strategy for enhancing all aspects of 
the National Vaccine Program including: Research and development, 
supply, financing, distribution, 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).
    In accordance with the 2010 National Vaccine Plan (NVP), the 
National Vaccine Program Office (NVPO) is conducting a mid-course 
review of the Plan following five years of its implementation. This 
review is intended to ensure that the priorities and activities 
outlined in the NVP are appropriately aligned towards the goals 
described therein given significant changes in the immunization 
landscape that have occurred since the NVP was released in 2010.
    The NVP is intended to be a national plan that includes 
contributions from both federal and non-federal stakeholders. In order 
to collect information from non-federal stakeholders in a uniform and 
systematic way, the NVPO is issuing a Request for Information (RFI) 
through a structured survey accessed on the NVPO Web site at http://www.hhs.gov/nvpo/vacc_plan/index.html#mid-course-review. The RFI will 
solicit specific information regarding the priorities, goals, and 
objectives within the NVP, significant accomplishments since 2010, 
remaining gaps, and stakeholder perspectives on priorities of the 
vaccine and immunization community for the remaining years of the NVP 
(2016-2020). Finally, stakeholders will also be provided the 
opportunity to briefly inform NVPO of the top contributions from their 
organization.

DATES: Survey responses on the National Vaccine Plan must be completed 
and submitted online by midnight, 12:00 a.m. EDT on November 9, 2015.

ADDRESSES: All those interested in participating in the survey to 
provide information on the National Vaccine Plan should do so by 
clicking on the survey link provided on the NVPO Web site at http://www.hhs.gov/nvpo/vacc_plan/index.html#mid-course-review.

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services; telephone (202) 690-5566; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The National Vaccine Program was established in compliance with 
Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec.  
2101) (42 U.S. Code 300aa-et seq (PDF--78 KB)) to achieve optimal 
prevention of human infectious diseases through immunization and to 
achieve optimal prevention against adverse reactions to vaccines. 
Development of a National Vaccine Plan has been mandated to the 
National Vaccine Program Office as a mechanism for the Director of the 
National Vaccine Program (the Assistant Secretary for

[[Page 61215]]

Health) to communicate priorities for both federal and non-federal 
stakeholders regarding vaccine research and the development, testing, 
licensing, production, procurement, distribution, and effective use of 
vaccines in order to carry out the Program's responsibilities.
    The immunization landscape has changed notably since the 
introduction of the NVP in 2010 and its subsequent implementation plan. 
New vaccines were developed. New vaccination related technologies were 
advanced and the passage of the Patient Protection and Affordable Care 
Act presented a unique opportunity for vaccination with its emphasis on 
preventive health.
    Increased access to immunizations has also changed the dynamic of 
immunization delivery. While increased demand for immunizations moves 
us toward the goal of better vaccine coverage and the reduction of 
vaccine preventable diseases, the costs of administering vaccines have 
risen over time and created additional stresses on the immunization 
infrastructure. These include costs for vaccine procurement, costs 
associated with proper vaccine storage and handling, insurance against 
loss, opportunity costs, and personnel costs such as managing 
inventory, vaccine counseling, administration, and entering data into 
medical records and immunization registries. Moreover, public health 
departments and local jurisdictions must navigate additional demands 
such as improving health information technology use, adherence to 
Meaningful Use requirements, outbreak detection and response, and 
public health preparedness and response efforts with limited (and 
oftentimes diminishing) resources. The use of social media and online 
communications to distribute vaccine information and misinformation has 
also expanded greatly in the past few years- bringing public trust in 
vaccines and the immunization system to the forefront of national 
conversations. Outbreaks of vaccine-preventable diseases such as 
measles and pertussis have highlighted the need for accessible and 
ongoing educational materials about the risks of vaccine preventable 
diseases and the risks and benefits of vaccinations.
    Finally, the momentum built from the 2010-2020 Decade of Vaccines 
Initiative, emerging global health crises such as the Ebola outbreaks 
in Western Africa, and imported cases of vaccine-preventable diseases 
such as measles have highlighted that U.S. efforts to support our 
national vaccine goals must also serve as building blocks for 
strengthening efforts towards the detection and prevention of 
infectious diseases world-wide.
    In accordance with the 2010 National Vaccine Plan (NVP), the 
National Vaccine Program Office (NVPO) is conducting a mid-course 
review of the NVP to ensure that the goals and objectives are 
appropriately aligned towards the goals described therein given 
significant changes in the immunization landscape that have occurred 
since the NVP was released in 2010. This analysis could include, but 
may not be limited to, evaluating the priority areas described in the 
Plan, identifying significant accomplishments and continued areas of 
opportunity towards the goals and objectives outlined in the 2010 NVP, 
and developing updated 2015-2020 priorities and indicators to optimize 
implementation efforts to better align with the current immunization 
landscape. This input will be used to inform Departmental priorities 
and activities going forward.

II. Request for Information

    In order to capture non-federal stakeholder input in a targeted and 
systematic way, NVPO is conducting a Request for Information using an 
on-line survey tool to compile information regarding the priorities, 
goals, and objectives within the NVP, significant accomplishments since 
2010, remaining gaps, and stakeholder perspectives on priorities of the 
vaccine and immunization community for the remaining years of the NVP 
(2016-2020). Finally, stakeholders will also be provided the 
opportunity to briefly inform NVPO of the top contributions from their 
organization. A link to the survey and instructions for completing the 
survey can be accessed via the NVPO Web site at http://www.hhs.gov/nvpo/vacc_plan/index.html#mid-course-review. All information collected 
will be aggregated and analyzed to help inform a high level summary of 
the overall progress towards the goals in the NVP.
    All responses to this Request for Information must be submitted by 
completing the online survey tool. Information collection sponsored by 
the NVPO required for the purposes of informing the National Vaccine 
Program and the National Vaccine Plan is not subject to Chapter 35 of 
title 44, United States Code [the Paperwork Reduction Act] as indicated 
in 42 U.S.C. 300aa-1 note (section 321 of Pub. L. 99-660).
    All survey submissions will become part of the public record and 
subject to public disclosure. While the survey tool does not solicit 
identifying information, submissions that contain this information will 
not be edited to remove any identifying.

III. Potential Responders

    HHS invites input from a broad range of stakeholders including 
individuals and organizations that have interests in vaccines and 
immunization efforts and goals outlined in the 2010 National Vaccine 
Plan.
    Examples of potential responders include, but are not limited to, 
the following:

--General public;
--advocacy groups, non-profit organizations, and public interest 
organizations;
--academics, professional societies, and healthcare organizations;
--public health officials and immunization program managers;
--physician and non-physician providers that administer immunization 
services, including pharmacists and community vaccinators
--representatives from the private sector.

    Dated: September 25, 2015.
Michelle Y. Blakely,
Senior Advisor and Acting Chief of Operations and Management, National 
Vaccine Program Office.
[FR Doc. 2015-25818 Filed 10-8-15; 8:45 am]
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