80 FR 61214 - Request for Information From Non-Federal Stakeholders on Progress and Accomplishments (2010-2015) Towards the Goals of the National Vaccine Plan
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 196 (October 9, 2015)
Federal Register Volume 80, Issue 196 (October 9, 2015)
| Page Range | 61214-61215 | |
| FR Document | 2015-25818 |
[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)] [Notices] [Pages 61214-61215] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25818] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4150-44-P
![61214 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Notices
Promenade SW., Washington, DC 20447, ‘‘All Atomic Weapons Employees who conducting a mid-course review of the
Attn: ACF Reports Clearance Officer. All worked at the Hooker Electrochemical Plan following five years of its
requests should be identified by the title Corporation in Niagara Falls, New York, implementation. This review is
during the operational period from July 1,
of the information collection. Email 1944, through December 31, 1948, for a
intended to ensure that the priorities
address: infocollection@acf.hhs.gov. number of work days aggregating at least 250 and activities outlined in the NVP are
work days, occurring either solely under this appropriately aligned towards the goals
OMB Comment
employment or in combination with work described therein given significant
OMB is required to make a decision days within the parameters established for changes in the immunization landscape
concerning the collection of information one or more other classes of employees in the that have occurred since the NVP was
between 30 and 60 days after Special Exposure Cohort.’’ released in 2010.
publication of this document in the This designation will become The NVP is intended to be a national
Federal Register. Therefore, a comment effective on October 22, 2015, unless plan that includes contributions from
is best assured of having its full effect Congress provides otherwise prior to the both federal and non-federal
if OMB receives it within 30 days of effective date. After this effective date, stakeholders. In order to collect
publication. Written comments and HHS will publish a notice in the information from non-federal
recommendations for the proposed Federal Register reporting the addition stakeholders in a uniform and
information collection should be sent of this class to the SEC or the result of systematic way, the NVPO is issuing a
directly to the following: Office of any provision by Congress regarding the Request for Information (RFI) through a
Management and Budget, Paperwork decision by HHS to add the class to the structured survey accessed on the NVPO
Reduction Project, Email: OIRA_ SEC. Web site at http://www.hhs.gov/nvpo/
SUBMISSION@OMB.EOP.GOV. Attn: vacc_plan/index.html#mid-course-
John Howard,
Desk Officer for the Administration for review. The RFI will solicit specific
Children and Families. Director, National Institute for Occupational
information regarding the priorities,
Safety and Health.
Robert Sargis,
goals, and objectives within the NVP,
[FR Doc. 2015–25757 Filed 10–8–15; 8:45 am]
significant accomplishments since 2010,
Reports Clearance Officer. BILLING CODE 4163–19–P
remaining gaps, and stakeholder
[FR Doc. 2015–25737 Filed 10–8–15; 8:45 am]
perspectives on priorities of the vaccine
BILLING CODE 4184–01–P and immunization community for the
DEPARTMENT OF HEALTH AND
HUMAN SERVICES remaining years of the NVP (2016–
2020). Finally, stakeholders will also be
DEPARTMENT OF HEALTH AND
Request for Information From Non- provided the opportunity to briefly
HUMAN SERVICES
Federal Stakeholders on Progress and inform NVPO of the top contributions
Designation of a Class of Employees Accomplishments (2010–2015) from their organization.
for Addition to the Special Exposure Towards the Goals of the National DATES: Survey responses on the
Cohort Vaccine Plan National Vaccine Plan must be
completed and submitted online by
AGENCY: National Institute for AGENCY: National Vaccine Program midnight, 12:00 a.m. EDT on November
Occupational Safety and Health Office, Office of the Assistant Secretary 9, 2015.
(NIOSH), Centers for Disease Control for Health, Office of the Secretary,
ADDRESSES: All those interested in
and Prevention, Department of Health Department of Health and Human
Services. participating in the survey to provide
and Human Services (HHS). information on the National Vaccine
ACTION: Notice. ACTION: Notice.
Plan should do so by clicking on the
SUMMARY: HHS gives notice of a SUMMARY: The development of a survey link provided on the NVPO Web
decision to designate a class of National Vaccine Plan was mandated by site at http://www.hhs.gov/nvpo/vacc_
employees from the Hooker Congress as a mechanism for the plan/index.html#mid-course-review.
Electrochemical Corporation in Niagara Director of the National Vaccine FOR FURTHER INFORMATION CONTACT:
Falls, New York, as an addition to the Program (the Assistant Secretary for National Vaccine Program Office, Office
Special Exposure Cohort (SEC) under Health) to communicate priorities for of the Assistant Secretary for Health,
the Energy Employees Occupational achieving the Program’s responsibilities Department of Health and Human
Illness Compensation Program Act of of ensuring adequate supply of and Services; telephone (202) 690–5566;
2000. access to vaccines and ensuring the email: nvpo@hhs.gov.
effective and optimal use of vaccines. SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT: The National Vaccine Plan, released in
Stuart L. Hinnefeld, Director, Division 2010, provides a comprehensive 10-year I. Background
of Compensation Analysis and Support, national strategy for enhancing all The National Vaccine Program was
NIOSH, 1090 Tusculum Avenue, MS C– aspects of the National Vaccine Program established in compliance with Title
46, Cincinnati, OH 45226–1938, including: Research and development, XXI of the Public Health Service Act
Telephone 1–877–222–7570. supply, financing, distribution, safety, (Pub. L. 99–660) (§ 2101) (42 U.S. Code
Information requests can also be informed decision making by consumers 300aa–et seq (PDF—78 KB)) to achieve
submitted by email to DCAS@CDC.GOV. and health care providers, vaccine optimal prevention of human infectious
SUPPLEMENTARY INFORMATION: preventable disease surveillance, diseases through immunization and to
tkelley on DSK3SPTVN1PROD with NOTICES
Authority: 42 U.S.C. 7384q(b). 42 U.S.C. vaccine effectiveness and use achieve optimal prevention against
7384l(14)(C). monitoring, and global cooperation adverse reactions to vaccines.
On September 22, 2015, as provided (http://www.hhs.gov/nvpo/vacc_plan/ Development of a National Vaccine Plan
for under 42 U.S.C. 7384l(14)(C),the index.html). has been mandated to the National
Secretary of HHS designated the In accordance with the 2010 National Vaccine Program Office as a mechanism
following class of employees as an Vaccine Plan (NVP), the National for the Director of the National Vaccine
addition to the SEC: Vaccine Program Office (NVPO) is Program (the Assistant Secretary for
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![Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Notices 61215
Health) to communicate priorities for detection and prevention of infectious information will not be edited to remove
both federal and non-federal diseases world-wide. any identifying.
stakeholders regarding vaccine research In accordance with the 2010 National
Vaccine Plan (NVP), the National III. Potential Responders
and the development, testing, licensing,
production, procurement, distribution, Vaccine Program Office (NVPO) is HHS invites input from a broad range
and effective use of vaccines in order to conducting a mid-course review of the of stakeholders including individuals
carry out the Program’s responsibilities. NVP to ensure that the goals and and organizations that have interests in
The immunization landscape has objectives are appropriately aligned vaccines and immunization efforts and
changed notably since the introduction towards the goals described therein goals outlined in the 2010 National
of the NVP in 2010 and its subsequent given significant changes in the Vaccine Plan.
implementation plan. New vaccines immunization landscape that have Examples of potential responders
were developed. New vaccination occurred since the NVP was released in include, but are not limited to, the
related technologies were advanced and 2010. This analysis could include, but following:
the passage of the Patient Protection and may not be limited to, evaluating the —General public;
Affordable Care Act presented a unique priority areas described in the Plan, —advocacy groups, non-profit
opportunity for vaccination with its identifying significant accomplishments organizations, and public interest
emphasis on preventive health. and continued areas of opportunity organizations;
Increased access to immunizations towards the goals and objectives —academics, professional societies, and
has also changed the dynamic of outlined in the 2010 NVP, and healthcare organizations;
immunization delivery. While increased developing updated 2015–2020 —public health officials and
demand for immunizations moves us priorities and indicators to optimize immunization program managers;
toward the goal of better vaccine implementation efforts to better align —physician and non-physician
coverage and the reduction of vaccine with the current immunization providers that administer
preventable diseases, the costs of landscape. This input will be used to immunization services, including
inform Departmental priorities and pharmacists and community
administering vaccines have risen over
activities going forward. vaccinators
time and created additional stresses on
the immunization infrastructure. These II. Request for Information —representatives from the private
include costs for vaccine procurement, sector.
In order to capture non-federal
costs associated with proper vaccine stakeholder input in a targeted and Dated: September 25, 2015.
storage and handling, insurance against systematic way, NVPO is conducting a Michelle Y. Blakely,
loss, opportunity costs, and personnel Request for Information using an on-line Senior Advisor and Acting Chief of
costs such as managing inventory, survey tool to compile information Operations and Management, National
vaccine counseling, administration, and regarding the priorities, goals, and Vaccine Program Office.
entering data into medical records and objectives within the NVP, significant [FR Doc. 2015–25818 Filed 10–8–15; 8:45 am]
immunization registries. Moreover, accomplishments since 2010, remaining BILLING CODE 4150–44–P
public health departments and local gaps, and stakeholder perspectives on
jurisdictions must navigate additional priorities of the vaccine and
demands such as improving health immunization community for the DEPARTMENT OF HEALTH AND
information technology use, adherence remaining years of the NVP (2016– HUMAN SERVICES
to Meaningful Use requirements, 2020). Finally, stakeholders will also be
outbreak detection and response, and provided the opportunity to briefly Indian Health Service
public health preparedness and inform NVPO of the top contributions
response efforts with limited (and Request for Public Comment: 60-Day
from their organization. A link to the Proposed Information Collection:
oftentimes diminishing) resources. The survey and instructions for completing
use of social media and online Indian Health Service (IHS) Sharing
the survey can be accessed via the What Works—Best Practice, Promising
communications to distribute vaccine NVPO Web site at http://www.hhs.gov/
information and misinformation has Practice, and Local Effort (BPPPLE)
nvpo/vacc_plan/index.html#mid- Form (OMB NO. 0917–0034)
also expanded greatly in the past few course-review. All information collected
years- bringing public trust in vaccines will be aggregated and analyzed to help AGENCY: Indian Health Service, HHS.
and the immunization system to the inform a high level summary of the ACTION:Notice and request for
forefront of national conversations. overall progress towards the goals in the comments. Request for extension of
Outbreaks of vaccine-preventable NVP. approval.
diseases such as measles and pertussis All responses to this Request for
have highlighted the need for accessible Information must be submitted by SUMMARY: In compliance with the
and ongoing educational materials about completing the online survey tool. Paperwork Reduction Act of 1995,
the risks of vaccine preventable diseases Information collection sponsored by the Public Law (Pub. L.) 104–13 [44 United
and the risks and benefits of NVPO required for the purposes of States Code (U.S.C.) § 3506(c)(2)(A)], the
vaccinations. informing the National Vaccine Program Indian Health Service (IHS) invites the
Finally, the momentum built from the and the National Vaccine Plan is not general public to take this opportunity
2010–2020 Decade of Vaccines subject to Chapter 35 of title 44, United to comment on the information
Initiative, emerging global health crises States Code [the Paperwork Reduction collection titled, ‘‘Indian Health Service
tkelley on DSK3SPTVN1PROD with NOTICES
such as the Ebola outbreaks in Western Act] as indicated in 42 U.S.C. 300aa–1 (IHS) Sharing What Works—Best
Africa, and imported cases of vaccine- note (section 321 of Pub. L. 99–660). Practice, Promising Practice, and Local
preventable diseases such as measles All survey submissions will become Effort (BPPPLE) Form,’’ Office of
have highlighted that U.S. efforts to part of the public record and subject to Management and Budget (OMB) Control
support our national vaccine goals must public disclosure. While the survey tool Number 0917–0034.
also serve as building blocks for does not solicit identifying information, This previously approved information
strengthening efforts towards the submissions that contain this collection project was last published in
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Document Created: 2015-12-15 08:34:28
Document Modified: 2015-12-15 08:34:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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] | |
| FR Citation | 80 FR 61214 |
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