CDC-RFA-19-1901 UPDATE (4.20.2020) A FINAL (002).pdf

Centers for Disease Control and Prevention

Amendment I.

The amendment is for informational purposes only. CDC is not accepting new applications for award

The purpose of this amendment is to include language regarding COVID-19 response and future VPD public health threats

Amended language in Section G. 1, page 1; Section A.1., pages 5 and 7

National Center for Immunization and Respiratory Diseases

Immunization and Vaccines for Children

CDC-RFA-IP19-1901

Application Due Date: 05/05/2020

Immunization and Vaccines for Children

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Required Registrations E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- IP19-1901. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

Centers for Disease Control and Prevention (CDC)

Immunization and Vaccines for Children

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

This announcement is only for non-research activities support by CDC.

93.268 F. Dates:

1. Due Date for Letter of Intent (LOI): 03/01/2019

Is a LOI: Recommended but not Required Letter of Intent is recommended but not required.

2. Due Date for Applications: 04/08/2019, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

This opportunity supports public health systems to ensure high vaccination coverage, low incidence of vaccine preventable diseases (VPD), and the ability to respond to VPD threats. The Vaccines for Children (VFC) program allows increased access to vaccines for eligible children by supplying government-purchased vaccines to enrolled health care providers. Section 317 of the Public Health Service Act authorizes awards to States, political subdivision of States, and to other public entities to help meet the costs of prevention health services. Priorities for Section 317 immunization programs are to preserve public health immunization infrastructure; maintain adequate vaccine supply as a safety net for uninsured adults, and other urgent vaccine needs;

and to respond to VPD outbreaks. Also, to rapidly identify and investigate current and future VPD cases/outbreaks, including COVID-19 or other emerging public health emergencies, conduct surveillance and laboratory testing, implement vaccination and other measures to

B. Notice of Funding Opportunity (NOFO) Title:

E. Assistance Listings (CFDA) Number:

A. Federal Agency Name:

C. Announcement Type: New - Type 1

D. Agency Notice of Funding Opportunity Number:

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov/ control the spread of VPD and prevent future outbreaks. Award recipients are responsible for VFC and Section 317 vaccine program implementation.

Project activities include provider and public education, vaccine distribution and inventory management, supporting immunization outreach, Immunization Information System (IIS) maintenance and enhancement, and VPD surveillance. Recipients must be positioned to transition into the changing health care environment and make use of quality improvement to reduce or eliminate vaccination coverage disparities and protect vulnerable populations.

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 64 All 64 applicants will be awarded Component 1 for the core cooperative agreement.

Optional program area components will be awarded to a subset of core award recipients.

Program components applications will be reviewed and scored by an objective panel. Award selection for the optional program area components will be determined by the availability of funding and the strength of the application.

• Project AA1: Expected number of awards: 25

• Project BB1: Expected number of awards: 25

• Project CC1: Expected number of awards: 5

• Project CC2: Expected number of awards: 20

• Project CC3: Expected number of awards: 12

• Project CC4: Expected number of awards: 25

d. Total Period of Performance Funding: $1,978,608,755

e. Average One Year Award Amount: $5,364,491 Annual average funding amount is based on the estimated annual funding for Component 1 core cooperative agreement. Applicants that successfully compete for the optional program area components in this NOFO will receive additional funding to implement required activities for those program components.

Optional program area components will be awarded to a subset of core award recipients.

Program components applications will be reviewed and scored by an objective panel. Award

• Project AA1: Approximate average award: $250,000

• Project BB1: Approximate average award: $250,000

• Project CC1: Approximate average award: $1,000,000

• Project CC2: Approximate average award: $300,000

• Project CC3: Approximate average award: $300,000

• Project CC4: Approximate average award: $100,000

f. Number of Years of Award: 5

g. Estimated Award Date: 06/01/2019

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirements for this NOFO exists, leveraging resources and related ongoing effort to promote sustainability is strongly encouraged.

Applicants must use the Immunization Program Operation Manual (IPOM) that further explains available resources. The IPOM is available through the NCIRD Partner SharePoint Portal.

https://partner.cdc.gov/Sites/NCIRD/PAP/SitePages/Home.aspx Component 1: Immunization and VFC cooperative agreement core award with required activities will be available to applicants as described in the eligible applicants section.

The program area components are optional for applicants and will be available to a subset of the core award recipients. Applicants may submit application requests for any program component project for their jurisdiction. The application for each program area component project must be in separate documents for application review process. Applicant must provide a separate project narrative, work plan, and budget for each project requested. Program component applications will be reviewed and scored by an objective review panel. Award selection for program components will be determined based on availability of funding and the strength of the application. Program components for this opportunity in Year 1 are:

Program Area AA: Enhanced immunization projects such as quality improvement, vaccine specific outreach, or targeting distinct populations for vaccine coverage improvement.

• Project AA1: Improving vaccination coverage among under vaccinated populations.

This project opportunity is intended to operationalize enhanced activities related to strategies listed in Program Effectiveness of the funding opportunity. This project will support programmatic activities to understand, reach, and improve vaccination of under vaccinated populations specified by the applicant.

Program Area BB: Emerging vaccine preventable disease (VPD), project evaluation or VPD outbreak response.

• Project BB1: VPD outbreak response to provide enhanced capacity support for non-vaccine needs. This project opportunity is intended to provide additional non-vaccine infrastructure support to immunization programs at the time of VPD outbreak response to strengthen capacity necessary for an effective and timely response to a VPD outbreak.

Program Area CC: Enhancement of Immunization Information Systems (IIS) that expand IIS functionality and data use.

• Project CC1: Improving performance of underperforming IIS. This project will allow for competitive funding for underperforming or unsustainable IISs to invest in improving their systems. Underperforming IIS lack the functionalities and high data quality data needed to improve and sustain immunization coverage for children and adolescents. Eligible applicants are indicated by the applicant's most recent Immunization Information Systems Annual Report (IISAR) responses reflecting a >20 percentage points difference between IIS coverage estimates for children aged 19-35 month who received the 7-vaccine series and the respective NIS Child coverage estimate, or a >20 percentage points difference between IIS coverage estimates for adolescents aged 13-17 who received Td/Tdap and the respective NIS Teen coverage estimate. Unsustainable IIS may be built on costly, outdated, or difficult to maintain platforms.

• Project CC2: Improving IIS data completeness and quality for childhood data in select

IISs. This project will allow for competitive funding for applicants whose IIS are close to having complete enough data to use for state or local coverage assessment and who need funding to invest in improving IIS data completeness and quality. Eligible applicants are indicated by the applicants with a 10 to 20 percentage points difference between IIS coverage estimates for children aged 19-35 month who received the 7-vaccine series and the corresponding NIS Child coverage estimate or a 10 to 20 percentage points difference between IIS coverage estimates for adolescents aged 13-17 who received Td/Tdap and the corresponding NIS Teen coverage estimate. Eligible applicants also include those few applicants whose jurisdictions were not assessed by the most recent NIS Child survey.

• Project CC3: IIS Learning Laboratories supporting development of best practices for IIS for coverage assessment and other programmatic functions. The funding opportunity aims to identify approaches for assessing coverage and identifying under vaccination in the applicant's jurisdiction, as well as developing best practices for monitoring vaccine coverage in the IIS community. This project will allow for competitive funding for eligible applicants with IIS that meet or exceed the following criteria:

2017 Immunization Information Systems Annual Report (IISAR) responses for IIS childhood (aged 19-35 months) 7-series vaccination coverage estimate is no more than 10 percentage points lower than the corresponding NIS Child coverage estimate, and 2017 IISAR responses for IIS Td/Tdap vaccination coverage estimate for adolescents is no more than 10 percentage points lower than the corresponding NIS Teen coverage estimate.

• Project CC4: Vaccine Coverage Assessment using IIS. This funding opportunity aims to advance the use of IIS data for monitoring vaccination coverage and vaccine use.

Accurate vaccination data is critical for measuring vaccine uptake, evaluating usage, monitoring trends during vaccine shortages, assessing compliance with vaccine recommendations and informing decision makers. IIS data can be used to complement and improve national surveys and fill critical knowledge gaps. This project allows for competitive funding for applicants that meet or exceed the following eligibility criteria:

Immunization Information Systems Annual Report (IISAR) responses for IIS childhood (aged 19-35 months) 7-series vaccination coverage estimate is no more than 10 percentage points lower than the corresponding NIS Child coverage estimate, and most recent IISAR responses for IIS Td/Tdap vaccination coverage estimate for adolescents is no more than 10 percentage points lower than the corresponding NIS Teen coverage estimate, and at least 90% of reported vaccine doses administered to persons <19 years of age,during the most recent year, have been submitted to and processed by the IIS within 30 days of vaccine administration.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview The National Center for Immunization and Respiratory Diseases (NCIRD) is committed to the prevention of disease, disability, and death through immunization and by the control of vaccine preventable respiratory and related diseases. The Immunization Services Division (ISD) protects individuals and communities from vaccine preventable diseases through provision of federal funds and contracts to purchase and distribute vaccine, provision of technical and financial support of immunization programs, vaccine preventable disease (VPD) surveillance, provider and public education, and evaluation.

The goals for this funding opportunity are to improve and sustain vaccination coverage among children, adolescents, and adults; reduce vaccination disparities across pediatric, adolescent and adult populations; improve readiness to respond to current and future vaccine preventable disease (VPD) outbreaks and other related public health emergencies, including COVID-19; reduce incidence of VPDs; and reduce VPD-related morbidity and mortality. This funding opportunity will support recipients with their development, implementation, assessment, and promotion of immunization related activities with the goal of achieving and sustaining high immunization coverage, reducing vaccination disparities and incidents of vaccine preventable disease, and improving readiness to respond to vaccine preventable disease threats. This project also assists recipients to implement, develop, and/or enhance their Immunization Information Systems (IIS) to support public health objectives. Project required activities include the implementation of the Vaccines for Children (VFC) and Section 317 vaccine programs for eligible individuals in the recipient's jurisdiction.

Award recipients are expected to use a collaborative approach to improve vaccination coverage and access to vaccine for the jurisdiction's population. This collaboration builds upon the efforts of the previous funding opportunity CDC-RFA-IP13-1301.

Immunization and VFC cooperative agreement core award, Component 1, will be available to applicants as described in the eligible applicants section. Program area components are optional projects available to a subset of the core award recipients;

program component applications will be reviewed and scored by an objective review panel. Award selection for program components will be determined based on strength of the application and availability of funding. Program area components included in this NOFO offer applicants the opportunity to participate in program area components to address specific needs or enhance capacity in their jurisdiction.

b. Statutory Authorities The program is authorized under Section 317 of the Public Health Service Act [42 U.S.C. section 247b], as amended.

The Vaccines for Children (VFC) Program is authorized under Section 1928 of the Social Security Act. [42 U.S.C. section 1396s].

c. Healthy People 2030 This funding opportunity addresses the Healthy People 2020 focus area of Immunization and Infectious disease https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-disea ses/objectives Immunization Objectives may include:

IID-1 Reduce, eliminate, or maintain elimination of cases of vaccine-preventable diseases IID-7 Achieve and maintain effective vaccination coverage levels for universally recommended vaccines among young children IID-8 Increase percentage of children aged 19-35 months who receive the recommended doses of DTaP, polio, MMR, Hib, hepatitis B, varicella and pneumococcal conjugate vaccine (PCV) (7-series) IID-9 Decrease the percentage of children in the United States who receive 0 doses of recommended vaccines by age 19 to 35 months IID-10 Maintain vaccine coverage levels for children in kindergarten IID-11 Increase routine vaccination coverage levels for adolescents

IID-12 Increase the percentage of children and adults who are annually vaccinated against seasonal influenza IID-13 Increase the percentage of adults who are vaccinated against pneumococcal disease IID-14 Increase the percentage of adults who are vaccinated against zoster (shingles)

IID-15 Increase hepatitis B vaccine coverage among high-risk populations IID-16 Increase the scientific knowledge on vaccine safety and adverse events

IID-17 Increase the percentage of providers who have had vaccination coverage levels among children in their practice population measured within the last year IID- 18 Increase the percentage of children under age 6 years of age whose immunization records are in a fully operational, population-based immunization information system (IIS) IID-19 Increase the number of States collecting kindergarten vaccination coverage data according to CDC minimum standards IID-20 Increase the number of States, the District of Columbia, and other reporting areas that have 80 percent of adolescents with 2 or more age- appropriate immunization recorded in an immunization information system (IIS) among adolescents aged 11 to 18 years IID-24 Reduce chronic hepatitis B infections in infants and young children (perinatal infections)

d. Other National Public Health Priorities and Strategies This funding opportunity supports the strategies to increase vaccination coverage, decrease vaccination coverage disparities, reduce the incidence of VPD, and reduce VPD mortality and morbidity. The following national guidance documents support these activities:

https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives

Recommendations of the Advisory Committee on Immunization Practices https://www.cdc.gov /vaccines/hcp/acip-recs/index.html CDC's Infectious Disease Framework https://www.cdc.gov/oid/framework.html HHS National Vaccine Program Office, Nation Vaccine Plan https://www.hhs.gov/nvpo/national-vaccine-plan/index.html Program evaluation framework to improve and account for public health actions https://www.cdc .gov/eval/framework/index.htm The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology(ONC) https://www.healthit.go implement activities to incentivize the adoption of "Meaningful Use" of Electronic Health Records (EHR) systems in medical offices and hospitals. IIS program area components will enhance public health capacity to support Meaningful Use.

e. Relevant Work This funding opportunity builds upon previous work of the Immunization and Vaccines for Children (VFC) cooperative agreement (CDC-RFA-IP13-1301) which focused on supporting infrastructure and capacity to assure high vaccination coverage, low incidence of vaccine-preventable disease, and maintain or improve response to current and future VPD public health threats, including COVID-19. NCIRD works closely with immunization award recipients to enhance immunization systems as part of the ongoing immunization and VFC cooperative agreement and other related projects. For more information see https://www.cdc.gov/ncird/index .html

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

https://www.cdc.gov/vaccines/hcp/acip-recs/index.html https://www.cdc.gov/vaccines/hcp/acip-recs/index.html https://www.cdc.gov/oid/framework.html https://www.hhs.gov/nvpo/national-vaccine-plan/index.html https://www.hhs.gov/nvpo/national-vaccine-plan/index.html https://www.cdc.gov/eval/framework/index.htm https://www.cdc.gov/eval/framework/index.htm https://www.healthit.gov/ https://www.cdc.gov/ncird/index.html https://www.cdc.gov/ncird/index.html

i. Purpose This NOFO will support public health programs to carry out the fundamental work of immunization to improve and sustain high immunization coverage, reduce vaccination disparities and incidents of VPD, and improve readiness to respond to VPD threats. These actions will help to reduce or eliminate morbidity and mortality due to VPDs. Core areas of the NOFO include program management and sustainability, program effectiveness, vaccine access and management, IIS systems and technology, communication, partnerships, and education, provider quality improvement, surveillance and outbreak response, perinatal hepatitis B prevention, pandemic influenza preparedness, school vaccination coverage, adolescent and adult immunization.

ii. Outcomes Applicants should elaborate on these expected outcomes to address specific processes within their jurisdiction.

Component 1: Immunization and Vaccines for Children core cooperative agreement Short-term outcomes

• Immunization activities are implemented regionally and/or locally

• Activities implemented to improve vaccination coverage

• Providers adhere to public vaccine ordering and administering policies

• Providers receive sufficient quantities of public vaccine

• Vaccine is stored/handled to maintain viability and reduce wastage

• Increased number of HBV-exposed newborns receive PEP

• Increased number of newborns receive hepatitis B vaccine series

• Increased number of infants receive post vaccination serologic testing (PVST)

• Vaccination coverage students for required vaccines are increased

• Increased adolescent vaccination coverage

• Increase adult vaccination coverage

Long-term outcomes

• Improved and sustained vaccination coverage among children, adolescents, and adults

• Reduced vaccination coverage disparities across pediatric, adolescent and adult populations

• Improved readiness to respond to VPD outbreaks and other public health emergencies

• Reduced incidences of VPDs

• Reduced VPD-related morbidity and mortality

Project AA1: Improving vaccination in under vaccinated populations. Applicants should choose additional outcomes that relate specifically to their population focus area chosen.

Short-term outcomes

• Activities implemented to improve vaccination coverage

• Immunization activities are implemented regionally and/or locally

Long-term outcomes

• Reduced vaccination coverage disparities across pediatric, adolescent and/or adult populations

• Reduced incidences of VPDs

Project BB1: VPD Outbreak response to provide strengthen capacity support for non-vaccine needs.

• Immunization activities are implemented regionally and/or locally

Long-term outcomes

• Improved readiness to respond to VPD outbreaks and other public health emergencies

• Reduced incidences of VPDs

• Reduced VPD-related morbidity and mortality

Project CC1: Improving Performance of Underperforming IIS Short-term outcomes

• Stakeholders are better informed to support immunization work

Long-term outcomes

• Improved and sustained vaccination coverage among children, adolescents, and adults

Project CC2: Improving Data Completeness and Quality for Childhood Data in select IISs Short-term outcomes

• Stakeholders are better informed to support immunization work

Long-term outcomes

• Improved and sustained vaccination coverage among children, adolescents, and adults

Project CC3: Immunization Information Systems Learning Laboratory Short-term outcomes

• Activities implemented to improve vaccination coverage

Long-term outcomes

• Improved and sustained vaccination coverage among children, adolescents, and adults

Project CC4: Immunization Information Systems coverage assessment

• Stakeholders are better informed to support immunization work

Long-term outcomes

• Improved and sustained vaccination coverage among children, adolescents, and adults

iii. Strategies and Activities The funding opportunity activities reflect core program activities and structure as well as individual programmatic activities. Program required activities include the implementation of the Vaccines for Children (VFC) and Section 317 vaccine programs for eligible individuals in the recipient's jurisdiction. These activities are required. Award recipients will be held accountable for the requirements as detailed in the funding opportunity and Immunization Program Operations Manual (IPOM). Applicants must create activities specific to their jurisdiction that explain how they will implement the CDC requirements and measure progress and success of their activities.

Component 1: Immunization and Vaccines for Children Cooperative Agreement - core Program Management and Sustainability: Ensure program infrastructure to support organizational capacity, program operations, funding stability and fiscal accountability.

Program Effectiveness: Identify geographic areas or population subgroups with low vaccination coverage. Perform activities to improve vaccination coverage with population subgroups.

Participation in the integration of IIS data with CDC National Immunization Survey (NIS).

Vaccine Access and Management: Maintain a network of immunization providers and ensure they administer vaccine appropriately. Perform quality assurance measures to ensure Vaccines for Children (VFC) and Section 317 programs are properly implemented. Adhere to CDC guidance specific to each federal vaccine funding type. Use CDC-provided mechanisms for vaccine planning, ordering, and distribution in accordance with CDC guidance/requirements.

Ensure that providers store and handle publicly purchased vaccines in a manner that maintains vaccine viability and reduces vaccine wastage.

Immunization Information Systems (IIS) and Technology: Advance IIS capabilities to support Immunization Program by implementing the CDC IIS Functional Standards (https://www.cdc.gov/vaccines/programs/iis/func-stds.html) and evaluating performance.

Communication, Partnership and Education: Engage networks of health care providers and other key partners and stakeholders to support efforts for improvement of vaccination coverage.

Engage American Indian/ Alaska Native (AI/AN) communities and other tribal stakeholders to improve vaccination coverage within the jurisdiction's AI/AN population. Utilize effective communication methods to address current immunization issues. Promote and provide educational opportunities for health care providers and the general public.

Provider Quality Improvement: Work with eligible VFC providers to implement quality improvement and monitor the impact on vaccination coverage. Use IIS data to inform and manage Immunization Quality Improvement for Providers (IQIP) assessment activities.

Surveillance and Outbreak Response: Conduct surveillance and support capacity to identify, control, and prevent VPD cases and/or outbreaks. Ensure VPD cases and/or outbreaks are reported to local/state public health officials and case notifications are provided to CDC.

Encourage health care provider Vaccine Adverse Event Reporting System (VAERS) reporting http://www.cdc.gov/vaccines/programs/iis/func-stds.html) and monitor VAERS and vaccine safety data.

Perinatal Hepatitis B Prevention: Identify HBsAg-positive pregnant women and births to HBsAg-positive women. Ensure hepatitis B virus (HBV)-exposed newborns receive post-exposure prophylaxis (PEP) per ACIP recommendations. Ensure HBV-exposed infants complete the hepatitis B vaccine series and receive post-vaccination serologic testing (PVST) per ACIP recommendations.

Pandemic Influenza Preparedness: In collaboration with preparedness program staff and other stakeholders, prepare for and implement a vaccine response to an influenza pandemic for adult and pediatric populations, including potentially targeted critical workforce.

School Vaccination Coverage: Assess students in child care, kindergarten through high school, and technical school/college/university for compliance with state and local school vaccination requirements. Communicate relevant school vaccination coverage and exemption estimates to schools, state/local departments of education, and other stakeholders to ensure individuals in child care and school settings are protected against VPDs.

Adolescent Immunization: Work with partners to promote continuous quality improvement and implement methods to increase vaccination coverage among adolescents.

Adult Immunization: Work with partners to promote continuous quality improvement and implement methods to increase vaccination coverage among adults.

Component 1 Immunization and VFC core cooperative agreement must include the required strategies and activities. Applications must include include performance measures both process and outcome that will help the award recipient and CDC measure the progress or success of activities to address NOFO long-term outcomes.

Program area component funded activities are available through competitive application. This funding opportunity offers optional program area component projects to enhance core program activities. Applicants may submit application requests for any program component project for their jurisdiction. The application for each program area component project must be in separate documents for application review process. Applicant must provide a separate project narrative, work plan, and budget for each project requested. Award recipients will be accountable for only those project activities that are approved and funded.

Funding for optional program area activities will be determined annually, at CDC's discretion and subject to the availability of funding. The Year 1 program area components are:

Project AA1: Improving vaccination coverage among under vaccinated populations.

• Perform activities to improve vaccination coverage with population subgroups o Identify specific under vaccination populations in the jurisdiction

• Engage networks of health care providers and other key partners and stakeholders to support efforts for improvement of vaccination coverage o Work with stakeholders to determine education or vaccination needs in the identified population

• Promote and provide educational opportunities for health care providers and the general public

Project BB1: VPD outbreak response to provide strengthen capacity support for non-vaccine needs.

• Conduct surveillance and support capacity to identify, control, and prevent VPD cases and/or outbreaks

• Ensure VPD cases and/or outbreaks are reported to local/state public health officials and case notifications are provided to CDC

• In collaboration with preparedness program and other stakeholders, prepare for and implement a vaccine response o Work with stakeholders to identify and implement an effective and timely response

Project CC1: Improving performance of underperforming IIS.

• Advance IIS capabilities to support Immunization Program by implementing the CDC IIS

Functional Standards and evaluating performance.

o Conduct analysis (e.g.,cost benefit analysis) informing the applicants approach to achieving a high performing and sustainable IIS.

o Applicants' choice of activities will depend on the current state of their IIS and their sustainability goals. Example activities include: Conduct an independent technical assessment to document the IIS's current technical state, risks and issues associated with the system and supporting processes, gaps in functionality, and recommendations for achieving a sustainable IIS solution that meets or exceeds CDC IIS Functional Standards; Use IIS Functional Standards and best practices, (e.g., HL7 Implementation Guide, Modeling of Immunization Registry Operations Work group) to implement new functionality and improve existing functionality;

Gather, analyze, and document IIS requirements necessary to meet CDC IIS Functional Standards and support immunization program operations and information needs; or Plan for and transition to a new IIS platform.

o Funded recipients will be required to participate in post-award meeting to share information, clarify expectations, and establish routine conference calls to discuss issues and report progress.

o Funded recipients will be expected to participate in regularly scheduled conference calls to review progress, planned activities and exchange ideas for future activities.

Project CC2: Improving IIS completeness and data quality for childhood data in select IISs.

o Applicants' choice of activities will depend on the current state of their IIS and root causes for their data completeness and quality issues. Example activities include: Implementing specific IIS functions or improvements to facilitate improved data completeness and quality (e.g., bidirectional data exchange);

Implementing specific activities to facilitate data completeness or quality (e.g.

improved deduplication processes); or Conduct outreach, educate, enroll and maintain provider participation for bidirectional data exchange with the IIS.

Project CC3: IIS Learning Laboratories supporting development of best practices for IIS for coverage assessment and other programmatic functions.

• Identify areas with low vaccination coverage o Conduct evaluation projects using innovative IIS analytic methods for assessing vaccination coverage; Example of activities included but are not limited to developing and evaluating methods for small area vaccination coverage estimation; Developing and evaluating IIS analytic methods for identifying under-immunized populations; Developing and evaluating methods for reducing bias in IIS-based coverage assessments; or Developing and evaluating methods for validating the accuracy of coverage estimates within a jurisdiction.

• Advance IIS capabilities to support Immunization Program by implementing the CDC IIS Functional Standards and evaluating performance.

o Conduct an evaluation project to assess IIS-based strategies for supporting VFC program accountability. This is an optional activity. Examples of optional activities may include, but not limited to assessing quality improvement, dose-level accountability, and vaccine ordering impact.

• Engage stakeholders to support efforts for improvement of vaccination coverage.

o Maintain childhood 7-series vaccination coverage assessment (calculated from the applicant's IIS) that is no more than 10 percentage points lower than the corresponding NIS Child estimate.

o Maintain Td/Tdap vaccination coverage assessment for adolescents (calculated from the applicant's IIS) that is no more than 10 percentage points lower than the corresponding NIS Teen estimate.

o Identify at least one IIS Learning Laboratory project staff to participate in annual face-to-face meeting with CDC IISSB Evaluation Team and subject staff for intensive discussion on strategically identifying topics for the betterment of the overall project.

o Identify at least one IIS Learning Laboratory project staff to participate in regularly scheduled conference calls with CDC IISSB Evaluation Team as part of ongoing communication for the betterment of the overall project. Call schedule shall be determined in agreement with the awarded projects.

• Funded recipients will be required to complete a minimum of four evaluation projects during the 5-year period of performance. At least one of the evaluation projects must be a collaborative evaluation with another IIS Learning Laboratory or NOFO funded IIS program. At least three of the evaluation projects must be submitted to peer-review journals or MMWR. Other proposals for non-peer review publications (e.g.white paper, technical journal) must be at least 2000 words and must be approved by IISSB staff. All publications for IIS Learning Laboratories must meet the International Committee of Medical Journal Editors Guidelines for authorship.

(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1416675/pdf/bmjcrde00465-0038.pdf)

Project CC4: Vaccine Coverage Assessment using IIS.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1416675/pdf/bmjcrde00465-0038.pdf) o Improve measurement in vaccination coverage and uptake Annually, submit de-identified record-level child and adolescent IIS data to CDC. Applicants shall authorize CDC to use the submitted data to develop methods to estimate national vaccination coverage, and calculate jurisdictional vaccination coverage for all routinely recommended childhood vaccines (e.g., vaccination coverage estimates that are annually published for the NIS Child and Teen). Submitted values will not include names or addresses, but will include county (zip code) of residence, race, and other demographic and vaccination fields. Applicants shall have the opportunity to review, approve, or reject manuscripts, conference abstracts, and other summaries findings prior to dissemination external to CDC.

Submit monthly influenza vaccination aggregate data to CDC. CDC will work collaboratively with awarded sites to determine quality and acceptability of submitted data for analysis, recognizing that completeness will vary between age groups. Applicants shall authorize CDC to use the submitted data to monitor influenza vaccination coverage. Applicants shall have the opportunity to review, approve, or rejects manuscripts, conference abstracts, and summaries of findings prior to dissemination external to

CDC.

In the event of an influenza pandemic during this period of performance, submit weekly influenza vaccination aggregate data to CDC. CDC will work collaboratively with awarded sites to determine quality and acceptability of submitted data for analysis, recognizing that completeness will vary between age groups. Applicants shall authorize CDC to use these aggregate data submissions to monitor pandemic influenza vaccination. Applicants shall have the opportunity to review, approve, or reject manuscripts, conference abstracts, and other summaries of findings prior to dissemination external to CDC.

Submit aggregate IIS data to CDC as requested for ad hoc vaccination analyses. Approximately three to seven ad hoc aggregate data request are anticipated annually. CDC will provide table shells and instructions to award recipients to describe each query. Applicants shall authorize CDC to use the submitted data for analysis and dissemination within CDC.

Applicants shall have the opportunity to review, approve, or rejects manuscripts, conference abstracts, and summaries of findings prior to dissemination external to CDC.

Optional activity: Submit de-identified data to CDC from the award recipient's IIS, or data source external to the IIS (such as de-identified medical claims data and de-identified vital statistics data). Applicants shall have the opportunity to review, approve, or rejects manuscripts, conference abstracts, and summaries of findings prior to dissemination external to CDC. Available datasets, as well as processes and policies required to assess each data source will be identified in collaboration with CDC. This activity is listed as optional to allow sites to opt-out of request if legal, policy, or technical barriers prevent sharing of requested data.

Develop a data use agreement (DUA) with legal advisement to allow sharing of required data submissions for the award recipient to CDC. If the development of a DUA is hindered by legal or policy constraints, program staff will report to CDC the specific legal or policy barrier.

• Engage stakeholders to support efforts for improvement of vaccination coverage.

o Maintain childhood 7-series vaccination coverage assessment (calculated from the applicant's IIS) that is no more than 10 percentage points lower than the corresponding NIS Child estimate.

o Maintain Td/Tdap vaccination coverage assessment for adolescents (calculated from the applicant's IIS) that is no more than 10 percentage points lower than the corresponding NIS Teen estimate.

o Maintain at least 90% of reported vaccine doses administered to persons aged <19 years are submitted and processed by the IIS within 30 days of vaccine administration.

o Identify at least one coverage assessment project staff to participate in regularly scheduled conference calls to discuss analyses of submitted data. Call schedule shall be determined in agreement with the awarded projects.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Collaboration is a vital part of this immunization and vaccines for children opportunity.

Recipients are expected to collaborate with CDC programs involved in immunization/vaccination activities and other CDC immunization award recipients. Cooperation within awarding agency and with partners and stakeholder in their jurisdiction is essential to the successful implementation of program activities.

Project CC1: Improving Performance of Underperforming IIS and Project CC2: Improving Data Completeness and Quality projects are expected to participate in efforts by the American Immunization Registry Association (AIRA) related to interoperability and provider onboarding.

Project CC3: IIS Learning Laboratory projects must collaborate with other funded IIS Learning Laboratory award recipients and CDC IISSB Evaluation Team and subject staff on proposed evaluations conducted. Award recipients are expected to conduct at least one collaborative evaluation project focused on pediatric and/or adolescent coverage with another IIS funded award recipient.

b. With organizations not funded by CDC:

Applicants must collaborate with programs, stakeholders, and organizations internal and external to CDC. Collaboration with organizations that support the achievement of the NOFO strategies and outcomes is essential. Examples of collaborations include working with the business community, non-governmental organizations, non-profit agencies, community coalitions, tribal organizations, healthcare providers, hospitals and healthcare systems.

2. Target Populations Component 1: Immunization and VFC cooperative agreement (core)

The target populations are child, adolescent and adult populations in the applicant's jurisdiction, with specific emphasis on underserved VFC-eligible children and adolescents, and underinsured adults.

VFC-eligible target population are children that meet at least one of the following criteria:

• Medicaid-eligible

• Uninsured

• American Indian/Alaskan Native

• Underinsured with respect to vaccines, served by a Federally Qualified Health Center

(FQHC) or Rural Health Center (RHC) or enrolled VFC provider deputized by a FQHC or RHC.

Children are defined as newborns through 18 years of age.

Project AA1: Improving vaccination in under vaccinated populations.

Target population is under vaccinated populations in the applicant's jurisdiction when compared to the general population. Applicant must describe the specific target population(s) served through this project and explain the effects of the project on the population(s).

Project BB1: VPD outbreak response to provide strengthened capacity support for non-vaccine needs.

Target population is all residents in the applicant's jurisdiction. Target population may vary and must be identified by applicant. Applicant must describe the specific target population(s) served through this project and explain the effects of the project on the population(s).

Project CC1: Improving performance of underperforming IIS.

Target population includes children and adolescents <19 years of age served by the IIS within the applicant's jurisdiction. Applicants may target provider populations, as part of this component, such as onboarding new providers to the IIS or initiating bidirectional data exchange for providers serving children and adolescents <19 years of age. Applicant must describe the specific target population(s) served through this project and explain the effects of the project on the population(s).

Project CC2: Improving IIS completeness and data quality in select IISs.

Target population includes children and adolescents <19 years of age served by the IIS within the applicant's jurisdiction. Applicants may target provider populations, as part of this component, such as onboarding new providers to the IIS or initiating bidirectional data exchange for providers serving children and adolescents <19 years of age. Applicant must describe the specific target population(s) served through this project and explain the effects of the project on the population(s).

Project CC3: Immunization Information Systems Learning Laboratories.

Target population includes all population served by the IIS within the applicant's jurisdiction.

Applicant must describe the specific target population(s) served through this project and explain the effects of the project on the population(s).

Project CC4: Vaccine Coverage Assessment using IIS.

Target population includes all population served by the IIS within the applicant's jurisdiction.

Applicant must describe the specific target population(s) in the jurisdiction (including special populations such as underserved, geographic clusters with lower vaccination coverage, racial/ethnic groups or geographic disparities, etc.), and explain how submitted data from these and other populations will support achieving the goals of the project.

a. Health Disparities The VFC and Section 317 vaccine programs are designed to provide vaccination services to vulnerable populations, include persons living in poverty, American Indian/Alaskan Natives, and persons using RHC for their health care. Applicants must describe specific underserved or under immunized target population(s) in their jurisdiction; that is identify communities or geographic clusters with lower vaccination coverage rates and/or higher incidence of VPDs.

iv. Funding Strategy (for multi-component NOFOs only) The Immunization and VFC cooperative agreement is a complex program with many funding streams and program activities.

Component 1: Immunization and VFC core cooperative agreement. Eligible award recipients will be funded for the core activities using the funding methodology based on factors such as total population size, birth cohort, proportion under-immunized, vaccination coverage levels, rurality, poverty rate, proportion of non-English speakers, health care provider population, principal personnel costs and cost of living estimates. Funding methodology for this opportunity is further explained in the IPOM Unit I Immunization Cooperative Agreement Essentials. IPOM is available through the ISD Awardee SharePoint portal. https://partner.cdc.gov/Sites/NCIRD/PAP /SitePages/Home.aspx Final decisions concerning funding and allocations rest with NCIRD. The Immunization and VFC core cooperative agreement is a five-year project with non-competing applications due before the end of each budget year.

Program area component opportunities are optional and funding for these opportunities to enhance immunization program activities will be determined annually, at CDC's discretion and based on availability of funding. Each of the program area components has separate optional projects available. Applicants may submit application requests for any program component project for their jurisdiction. The application for each program area component project must be in separate documents for application review process. Applicant must provide a separate project narrative, work plan, and budget for each project requested. The immunization program area components for Year 1 are:

Program Area AA: Enhanced immunization projects such as quality improvement, vaccine specific outreach, or targeting distinct populations for vaccine improvement.

Project AA1: Improving vaccination coverage among under vaccinated populations. Funds may be awarded up to 25 applicants per year. Funding range: $200,000-$500,000 per year, Average award $250,000. 12-month projects with opportunity to compete in a future budget year within the period of performance.

Program Area BB: Emerging VPDs, project evaluation or VPD outbreak response.

Project BB1: VPD outbreak response to provide strengthen capacity support for non-vaccine needs. Funds may be awarded up to 25 applicants per year. Funding range: $100,000-$500,000 https://partner.cdc.gov/Sites/NCIRD/PAP/SitePages/Home.aspx https://partner.cdc.gov/Sites/NCIRD/PAP/SitePages/Home.aspx per year, Average award $250,000. 12-month projects with opportunity to compete in a future budget year within the period of performance.

Program Area CC: Enhancement of IIS that expand IIS functionality and data use.

Project CC1: Improving performance of under performing IIS. Funds may be awarded to up to 5 applicants each year. Funding range: $500,000 to $1,500,000 per year, Average award $1,000,000. Approximately $5 million per year is available.12-month projects with opportunity to compete in a future budget year within the period of performance.

Project CC2: Improving IIS data completeness and quality for childhood data in select IISs. Funding will be awarded to up to 20 applicants each year. Funding range: $200,000 to $400,000 per year, Average award $300,000. Approximately $6 million per year is available. 12-month projects with opportunity to compete in a future budget year within the period of performance.

Project CC3: IIS Learning Laboratories supporting development of best practices for IIS for coverage assessment and other programmatic functions. Funds will be awarded to up to 12 applicants. Funding range: $300,000 per year, Average award $300,000. Approximately $3.6 million per year is available. Five-year project with five 12-month budget years with non-competing application due each year. Five years of funding.

Project CC4: Vaccine Coverage Assessment using IIS. Funds will be awarded to up to 25 applicants in Year 1. Funding range: $80,000 to $120,000 per year, Average award $100,000. Two-year projects. One additional non-competing application for 12-month budget will be due before the end of Year 1.