oppCDC-RFA-GH18-1803-cfda93.099-cidCDC-RFA-GH18-1803-instructions.pdf

Centers for Disease Control

Center for Global Health

Cooperative Agreement on Immunization with the World Health Organization (WHO)

CDC-RFA-GH18-1803

Application Due Date: 05/09/2018

Cooperative Agreement on Immunization with the World Health Organization (WHO)

CDC-RFA-GH18-1803

TABLE OF CONTENTS

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

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information 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 "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-GH18-1803. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Cooperative Agreement on Immunization with the World Health Organization (WHO) C. Announcement Type: New - Type 1 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH18-1803

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.099 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 05/09/2018, 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 agreement provides resources to the WHO to support polio eradication, measles mortality reduction and regional measles and rubella elimination, and other VPD surveillance; global laboratory networks for polio and measles/rubella; planning and implementation of supplemental immunization campaigns; and strengthening of immunization delivery systems and capacities in high priority countries. These functions are critical to achieving globally and regionally agreed goals for VPD elimination and reduction. This agreement also may be used to support activities to address other global health priorities in line with CDC goals.

Results and measurable outcomes must align with Government Performance Results Act (GPRA): Long Term Objective 10.B.1: Help domestic and international partners achieve WHO's goal of global polio eradication; or Long Term Objective 10.B.2: Work with global partners to reduce the cumulative global measles-related mortality by 90% compared with 2000 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 estimates (baseline 777,000 deaths) and to maintain elimination of endemic measles and rubella transmission in the Americas.

This announcement is for non-research activities. If research is proposed, the application will not be reviewed. For the definition of research, please see the website: http://www.cdc.gov/od /science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $0 There is no project period ceiling; however, estimated funding is $400M

e. Average One Year Award Amount: $80,000,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 07/01/2018

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

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview The World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) have a long-standing collaboration to support and implement global health priorities. The U.S. Government supported resolutions to include the creation of the Global Polio Eradication Initiative (WHA 41.28), the adoption of ambitious measles mortality reduction goals (WHA 56.20), the adoption of the Global Vaccine Action Plan (GVAP) (WHA 65.17). As the lead scientific public health agency for the United States, CDC works with WHO and other global partners on these efforts.

CDC’s efforts as part of the Global Polio Eradication Initiative (GPEI) helped reduce polio cases to a record low of 12 in 2017, down from ~350,000 in 1988. Yet, to achieve and maintain worldwide polio eradication, CDC must minimize the risk of poliovirus reintroduction to areas declared polio-free. Only three countries have never interrupted wild polio circulation.

However, four out of six WHO regions, covering 80% of the world’s population, have already achieved certification of being free of wild poliovirus. CDC will collaborate with partners to address the country-specific challenges to achieve global polio eradication. CDC will also continue polio transition planning devised to ensure that functions essential for maintaining a http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf polio-free world remain in place.

Measles elimination, mortality reduction, rubella/congenital rubella syndrome (CRS) elimination are also of vital importance to the U.S. Nearly all measles cases in the U.S. are caused by international importation of the measles virus as measles has been eliminated from the US since 2000. Progress has been made toward both measles and rubella elimination since 2001 with measles-related deaths down 84 percent from 2000 (as of data available in 2016), preventing 20.4 million measles-related deaths, and rubella/CRS having been eliminated from the Americas. Despite these advances, neither measles nor rubella elimination targets in the GVAP are on track worldwide, putting Americans at risk for these diseases. Improving case-based, fever/rash surveillance enabling early outbreak detection and response, on-time delivery of the first and second doses of measles/rubella combined vaccine, and reducing missed opportunities for vaccination is required to ensure that gains in measles and rubella control can be sustained.

Vaccines are cost effective and lifesaving public health interventions. While the U.S. has reduced the domestic vaccine preventable disease (VPD) burden, the nation remains at risk from importation of other VPDs. CDC's global immunization activities focus on people in developing countries who are at the highest risk for illness and death from VPDs to stop these diseases before they reach our borders, which saves lives of Americans. CDC’s global immunization program is essential in identifying where VPDs emerge and teaches other nations the basic skills needed to control disease outbreaks at the source.

b. Statutory Authorities Sections 301 (c), 307, and 317 of the Public Health Service Act (42 U.S.C. sections 241 (c), 242l, and 247b); and section 104 of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b)

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Disease (https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases), and Maternal, Infant and Child Health (https://www.healthypeople.gov /2020/leading-health-indicators/2020-lhi-topics/Maternal-Infant-and-Child-Health)

d. Other National Public Health Priorities and Strategies This NOFO will support the US Government endorsed Global Polio Eradication Initiative (GPEI) and the Global Vaccine Action Plan (GVAP). In addition, this NOFO will support CDC’s Global Health Strategy, which focuses on: 1) improving the health and well-being of people around the world; 2) improving capabilities to prepare for and respond to infectious diseases, other emerging health threats and public health emergencies; and, 3) maximizing the potential of CDC’s global programs to achieve public health impact. By working closely with WHO to support this Global Health Strategy, CDC enhances the technical capabilities of WHO and ensures that the interests of Americans are well represented.

e. Relevant Work Agency Funding Opportunity Number: CDC-RFA-GH13-1301, Cooperative Agreement on Immunization with the World Health Organization (WHO), is the previous NOFO between https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/leading-health-indicators/2020-lhi-topics/Maternal-Infant-and-Child-Health https://www.healthypeople.gov/2020/leading-health-indicators/2020-lhi-topics/Maternal-Infant-and-Child-Health

CDC and WHO. This NOFO builds on the activities and goals of GH13-1301 by continuing the progress in polio eradication, measles elimination and enhancing other life-saving VPD activities.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose The NOFO is to sustain support for the US Government-endorsed Global Polio Eradication Initiative (GPEI), Measles and Rubella Initiative (M&RI), Global Vaccine Action Plan (GVAP) and the CDC’s Global Immunization Strategic Framework, 2015-2020. This agreement provides resources to strengthen immunization systems, enhance global laboratory networks for polio and measles/rubella, and conduct supplemental immunization campaigns in priority countries. All are critical to achieving globally agreed goals for disease elimination and reduction.

ii. Outcomes The recipient is expected to achieve the short, intermediate, and long-term outcomes below and also bolded in the logic model.

Short Term Outcomes

Increased synergy between efforts to eradicate polio, eliminate measles and rubella, achieve targets for control of other VPD and strengthen immunization systems

Policies, guidelines, norms, standards and tools reflect best available evidence and meet needs of countries and global immunization community

Improved performance of immunization systems Broader understanding of barriers to vaccination and effect of strategies to address these Countries are able to identify the need for and prioritize the introduction of new vaccines relevant to their country context More countries meet global, regional and national surveillance targets for polio, measles/rubella and tetanus compared to 2017 Improvement in detection and response to VPD outbreaks Polio transition strategies implemented as planned in the GPEI Transition Planning

Framework Improved workforce development strategies implemented and evaluated Increased availability and use of relevant immunization related economic and financial data by countries for planning and decision-making

Intermediate Term Outcomes

Improved national and district-level coverage for vaccines in the national immunization schedule

Increased country ownership and financing of national immunization programs Reduced reliance on SIAs and increased reliance on a strong routine immunization system Countries fully implement post-interruption, certification, and post certification activities for polio Improved quality, real-time availability, and use of vaccination and VPD surveillance data Demonstrated improvements in performance of national surveillance systems for polio, measles/rubella, CRS and MNT All countries have introduced MCV2 and established CRS surveillance Demonstrated progress in reaching elimination targets for measles, rubella/CRS and

MNT

Demonstrated progress toward reaching hepatitis B control goals Demonstrated progress in improving technical and management capacity, performance and accountability of the immunization workforce

Long Term Outcomes

Reduced mortality and morbidity from VPDs in children under 5 years of age, compared to 2017 estimates

iii. Strategies and Activities

1. Provide logistical, vaccine, technical and material support to countries to achieve and sustain Global, Regional and National goals for polio eradication and transition; measles, rubella/CRS, maternal and neonatal tetanus (MNT) elimination; control of other VPDs;

immunization coverage and equity; and new vaccine introduction.

I. Strengthening of immunization systems

i. Support countries to adapt and implement immunization guidelines and multi-year plans for immunization program strengthening.

ii. Foster timely, effective and safe delivery of vaccines through supporting implementation and evaluation of strategies to improve immunization program delivery, such as

a. Integration of immunization with other health interventions

b. Identification of RI-SIA synergies

c. Reducing missed opportunities for vaccination

d. Safe immunization practices and reducing barriers to safe delivery of vaccines

e. Responding to AEFI clusters and mitigating effects of real or suspected AEFIs on public confidence in immunization programs

f. Improving timeliness and validity of doses (reminder systems)

g. Addressing challenges associated with co-administration of multiple injectable vaccines

h. Identifying, evaluating and promoting best practices for supply chain and vaccine management systems

i. Promoting in-country adoption and scale-up of innovative delivery technologies and strategies that improve vaccine supply chain efficiency (e.g., compact-pre-filled auto- disable injection devices for TT in difficult settings)

j. Identifying hard-to-reach groups and special populations (e.g., refugees) and tailoring delivery of routine immunization services to reach them

k. Identifying and addressing individual, community and health-sector barriers to equitable access and optimal utilization of immunization systems

l. Increasing demand for vaccines and addressing barriers which reduce demand

m. Identifying characteristics of unvaccinated persons

n. Regular evaluation of the skill level of trained healthcare workers and implementation and evaluation of strategies to enhance knowledge, skills and retention of staff involved in management and delivery of immunization programs

And any other elements as programmatically relevant.

iii. Support countries to develop/maintain national immunization information systems which are sustainable and link appropriately with broader health information systems.

a. Support countries to routinely monitor the quality (accuracy, timeliness,completeness) of administrative vaccination data and data on adverse events following immunization (AEFI) at national and sub-national levels.

b. Support countries to routinely analyze and use administrative vaccination data and data on AEFI at national and sub-national levels.

iv. Support countries to routinely monitor performance of immunization program and conduct periodic evaluations of identified strategies and sub-national risk-assessments, as needed. Foster sharing of results from these.

v. Support workforce development strategies, e.g., training to implement Global Routine Immunization Strategies and Practices (GRISP) strategies in targeted countries and disseminate lessons learned.

vi. Support countries to evaluate their needs and preferences for new and emerging vaccines, formulations, presentations, dosing and scheduling and support countries to introduce and evaluate these.

a. Support countries to implement and evaluate introduction of new opportunities for vaccination throughout the life course (e.g., second year of life, primary school-age children, adolescence, women of childbearing age, adults, elderly).

vii. Provide technical assistance to countries transitioning from Gavi Alliance support to plan for, and establish sustainable immunization financing II. Optimizing planning and performance of supplemental immunization activities (SIA)

i. Support countries to plan, implement and evaluate SIAs and immunization campaigns

ii. Improve SIA quality, especially in polio-endemic and high risk countries

iii. Identify, implement and evaluate strategies to reach underserved and hard to reach populations

iv. Implement and evaluate approaches to delivery of SIAs and immunization campaigns in security-compromised areas

v. Implement and evaluate strategies to improve cross border collaboration in planning and implementation of SIAs and campaigns

vi. Integrate delivery of tetanus vaccine in polio and MR SIAs especially in challenging settings III. Strengthening surveillance of VPDs and vaccine safety

i. Assist countries to develop and/or update country-level guidelines and standard operating procedures for VPD surveillance.

ii. Assist countries to establish and/or maintain relevant and high performing systems for VPD surveillance across all relevant levels of the health systems.

iii. Establish and/or strengthen and evaluate surveillance for VPDs

iv. Assist countries to conduct serosurveys to document prevalence of VPDs in the population, impact of vaccination, and verify achievement of global/regional eradication, elimination and/or control goals.

v. Support countries to establish and/or maintain high-performing acute flaccid paralysis and environmental surveillance for poliovirus.

vi. Establish and/or strengthen, and evaluate surveillance for AEFI.

vii. Support development or maintenance of high-performing laboratory networks to support polio, measles/rubella and other VPD surveillance and outbreak preparedness and response

viii. Facilitate linkage between national laboratories and VPD surveillance systems

ix. Support the development of innovative technologies for the rapid detection of VPDs (including polio, measles and rubella) from specimens and the environment

x. Support and strengthen surveillance data quality, management, analysis, visualization, dissemination and use

xi. Support countries to develop/maintain national surveillance information systems which are sustainable and link appropriately with broader health information systems

xii. Identify, implement and evaluate strategies to enhance the knowledge, skills and retention of staff managing and implementing VPD surveillance and staff from Global Polio Laboratory Network and VPD-supporting laboratories

xiii. Support the integration of VPD surveillance training into the curricula of institutions that train peripheral level healthcare workers IV. Strengthen VPD outbreak response and evaluation

i. Support countries to implement poliovirus containment activities outlined in Global Action Plan for Poliovirus Containment (GAPIII), including deployment of consultants to provide technical assistance.

ii. Support development and updating of national plans for VPD outbreak preparedness and response.

iii. Strengthen countries’ human and material resource capacity to detect and respond to any possible event/outbreak independently, promptly and adequately

iv. Support rapid deployment of logistics and personnel to support the response to outbreaks of polio, other VPDs and emergencies where vaccination is an appropriate response strategy.

v. Assist countries to conduct thorough analyses of the risk factors and underlying causes of recent VPD outbreaks or ongoing endemic transmission of polio, measles and rubella and use results to define corrective measures.

vi. Strengthen countries’ human and material resource capacity to plan, implement and monitor vaccination campaigns as part of a targeted response to VPD outbreaks.

V. Support polio transition and certification of VPD eradication and/or elimination

i. Support countries to develop written plans for polio transition, to include inventory of country specific polio program assets, infrastructure and economic and financial data.

ii. Develop guidelines and recommendations and provide technical assistance to countries in to support the transition of polio program assets and infrastructure

iii. Support planning for, coordination and evaluation of the eventual withdrawal of type 1 and type 3 oral polio vaccines (OPV)

iv. Support countries to collect evidence required for certification of eradication/elimination of VPDs.

v. Support countries to plan for and gather evidence to support certification of the elimination of measles and rubella

vi. Support countries to prepare and submit complete documentation for certification of polio eradication and/or measles/rubella elimination to the Regional Certification Commissions and the Global Certification Commission (RCC and GCC).

vii. Support the establishment and functioning of regional verification committees to track progress of countries in achieving regional and global targets for control of other VPDs including hepatitis B and neonatal tetanus VI. Strengthen financial management and evaluation

i. Enhance national planning and financial management in order increase efficient use of existing financial resources

a. Provide technical support for tracking domestic expenditures for national immunization programs to facilitate accurate reporting of indicators on sustainable immunization financing.

2. Lead development of guidelines, norms and standards for routine and supplementary immunization activities, VPD surveillance, outbreak response and laboratory networks which support testing for VPDs.

I. Support partner coordination mechanisms to foster exchange of technical information and data between partners in global immunization and country governments.

i. through regional and national structures, support the exchange of technical information and data between partners and country governments at regional, national, district and local levels

ii. provide programmatic advice to donors to help inform introduction of new vaccines II. Support the SAGE secretariat, SAGE working groups and other regional and/or technical working groups.

III. Develop or update WHO policy and/or position papers for identified priority technical areas which may evolve over time. Currently these may include, but are not limited to:

i. measles, rubella and tetanus

ii. neonatal and non-neonatal tetanus surveillance indicators including serosurveillance

iii. delivery of fractional doses

iv. catch-up vaccination for IPV

v. appropriate surveillance performance indicators for measles/rubella, congenital rubella syndrome, and non-neonatal tetanus

vi. vaccine safety including AEFI IV. Develop and/or update guidance documents for identified priority technical areas, which may evolve over time. Currently these may include, but are not limited to:

i. national introduction of human papillomavirus vaccine including target populations

ii. harmonized vaccination recommendations/schedules

iii. coverage survey methods

iv. budgeting and financial management

v. missed opportunities for vaccination

vi. vaccine safety and AEFI (including response to AEFI clusters)

vii. delivery of immunization in outbreak or humanitarian emergency settings

viii. norms and standards for collection and use of VPD surveillance and immunization data

ix. planning, implementation and evaluation of SIAs

x. response strategies to measles and rubella that are specific to the endemic and post-elimination settings

xi. global policy for infection prevention and control

xii. reviews: national EPI, vaccine introduction, joint external evaluations (JEE) V. Strengthen approaches to policy development at global, regional and national levels

i. create enabling environments for evidence-based decision making

ii. support NITAG development

iii. encourage inter-ministerial coordination and collaboration to develop and implement policy VI. Develop, evaluate and/or support workforce development initiatives that are timely, appropriately delivered and meet the performance needs of the workforce.

i. Define, test and disseminate standards and best practices for immunization competencies,

ii. Analyze worker performance needs and strategies using organization objectives and factors influencing performance outcomes

iii. Incorporate performance improvement and support strategies including training based on analysis

iv. Support emerging technologies and strategies, e.g., distance learning, to enhance learning and performance

v. Evaluate workforce development interventions

vi. Provide and use evidence of planning and implementation quality, outcomes and apply lessons to ensure continuous quality improvement.

VII. Develop/refine strategies/communication materials to reduce vaccination hesitancy & increase demand for vaccines (e.g., global version of EURO TIP guide).

3. Generate evidence to inform decision making for immunization programs, including the design and delivery of routine and supplementary activities, VPD surveillance and outbreak response.

I. Support planning, implementation and use of findings from reviews of national immunization and VPD surveillance programs. Promote integration and synergy of these reviews.

i. Collect, analyze, interpret/visualize and disseminate immunization and VPD surveillance data to monitor progress toward global, regional and national vaccination coverage targets and disease elimination, eradication and control goals.

ii. Continue to review and refine approaches to this.

II. Monitor and/or evaluate strategies to strengthen immunization service delivery across the lifespan and in special populations and identify the un-vaccinated. This could include:

i. Public/private partnerships

ii. introduction of immunization at new ages (at birth, in the 2nd year of life)

iii. Catch-up vaccination

iv. School-based delivery of vaccines

v. Screening of vaccination status at school/childcare entry

vi. Delivery of immunization services in peri/post humanitarian emergencies and in highly mobile and/or underserved populations

vii. Defaulter tracking systems (e.g., SMS)

viii. Electronic immunization registers and strategies to improve quality of administrative vaccination data

ix. Supply chain and vaccine management systems

x. Best practices for safe delivery of vaccines and response to AEFIs III. Monitor and/or evaluate the introduction of new vaccines, presentations, formulations, dosing, scheduling and delivery technologies, and facilitate use of these findings. This could include, but is not limited to;

i. dosing (e.g., fractional dose)

ii. vial size (e.g., 5 vs 10 dose vials)

iii. need for, and frequency of, vaccine booster doses

iv. post-vaccine introduction evaluations

v. financial and economic evaluations prior to and after changes to immunization programs

vi. analysis of bottlenecks inhibiting the introduction of new vaccines

vii. emerging devices and delivery technologies (e.g., vaccine patch, controlled temperature chain) IV. Generate evidence to inform the development and/or scale up of strategies to reduce vaccination hesitancy and increase demand.

This could include, but is not limited to:

i. measure and monitor demand for vaccination in the population and/or sub-groups

ii. identify strategies that effectively increase demand for vaccination among the general population and specific subgroups experiencing rates of vaccine uptake below national targets

iii. evaluation of responses to adverse events following immunization (AEFI) and other vaccine related events across a range of platforms including mass media, social media, community engagement and social mobilization

iv. optimising use of social media strategies V. Monitor and/or evaluate policies, strategies to improve planning, and delivery of VPD surveillance and outbreak response.

i. conduct case studies of VPD surveillance systems at the national and regional levels.

VI. Generate economic and financial evidence to support sustainable immunization financing, program planning, budgeting and decision-making.

i. Assess the global cost of disease elimination/eradication and implementation of standard surveillance systems

ii. Increase availability of data on supply, demand, and vaccine pricing and procurement strategies.

iii. Develop and evaluate systems, strategies and policies to improve and strengthen financial accountability.

1. Collaborations

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

Recipient is expected to collaborate with other immunization partners including CDC programs and CDC-funded organizations:

CDC’s Global Immunization Division (GID);

National Center for Immunization and Respiratory Diseases (NCIRD);

WHO regional and country teams;

UNICEF country teams;

CDC subject matter experts in other Centers and Offices (required when applicable);

CDC staff in affected countries (required when applicable);

CDC Incident Command leadership and staff (required when applicable) International Federation of Red Cross (IFRC) African Field Epidemiology Network (AFENET) Training Programs in Epidemiology and Public Health Interventions Network

(TEPHINET)

Eastern Mediterranean Public Health Network (EMPHNET) National Stop Transmission of Polio Program (NSTOP) Field Epidemiology Training Program (FETP)

b. With organizations not funded by CDC:

Recipient may collaborate with other organizations external to CDC as deemed necessary to achieve project outcomes. Organizations include Bill and Melinda Gates Foundation, US Agency for International Development, GAVI Alliance, Rotary International, Ministries of Health, non-state actors and/or other organizations.

2. Target Populations The target population will be children under the age of 5 years old but may include other populations that need vaccination (e.g., teenagers, women of childbearing age).

a. Health Disparities The NOFO requires recipient to collaborate with WHO Country offices who will work with Ministries of Health and local health volunteers to conduct outreach to underserved communities in low-performing districts. The teams will develop and maintain registers of children in these communities to track their vaccination status and ensure they are adequately immunized against polio. The use of volunteers from within the underserved community will assure language does not impede inclusion.

Federal disability rights laws apply to foreign assistance programs. Funded programs consider including people with disabilities in all aspects of the program (e.g., advisory boards, planning committees, project staff, consultants), and ensure to best of their ability that persons with disabilities are not discriminated against in hiring processes, and that facilities and communications are accessible.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The purpose of evaluation and performance measurement is to help CDC recipients: (1) Monitor the extent to which activities were successfully completed; (2) Demonstrate progress toward achieving program outcomes (e.g., Were outcomes of interest achieved?); and (3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g.,What and how could performance be improved?).

An Evaluation and Performance Measurement Plan (EPMP) is required as part of this NOFO to measure NOFO accomplishments. The primary objective of the EPMP implementation is to determine the progress of activities under this NOFO and indicate how they relate to the desired outcomes. The results will be used for program improvement, accountability and reporting, and for sharing with partners and other stakeholders. The EPMP framework describes the desired activities, outcomes and performance measures and how CDC will work with the recipient to support achievement of these.

Activity/strategy Performance measure (process) Potential data sources*

1. Provide logistical, vaccine, technical and material support to countries to achieve and sustain Global, Regional and National goals for polio eradication and transition;

measles, rubella/CRS, maternal and neonatal tetanus (MNT) elimination; control of other VPDs; immunization coverage and equity; and new vaccine introduction

· Describe type and frequency of assistance provided to countries during the reporting period to achieve Global, Regional and National immunization goals including polio eradication.

· Number of WHO-supported human resources providing support to member countries globally in the reporting period.

· Minutes and reports from the SAGE and other technical working groups are disseminated to all partners in a timely manner

Reports WHO consultant and staff databases

2. Lead development of guidelines, norms and standards for routine and supplementary immunization activities, VPD surveillance, outbreak response and laboratory networks which support testing for VPDs.

· Topic/title and number of a) position statements, b) guidelines, c) tools and d) other norms, standards, communication materials either newly developed or updated in the reporting period.

· Describe process used to ensure best available evidence is used as basis for development or revision of guidelines, norms and standards and provide examples.

3. Generate evidence to inform decision making for immunization programs, including the design and delivery of routine and supplementary immunization activities, and VPD surveillance and outbreak response.

· Describe outputs from activities to generate evidence during the reporting period.

· Describe most significant change that this evidence is meant to inform.

· Describe type and importance of new economic and financial evidence generated during the reporting period.

· Provide examples of use of this evidence.

SHORT TERM OUTCOMES (outcome evaluation)

Outcome Performance measure (outcome measure)

Potential data sources*

1. Increased synergy between efforts to eradicate polio, eliminate measles/rubella, achieve targets for control of other VPD and strengthen routine immunization systems

· Describe the nature and type of new partnerships created to facilitate activities under the GPEI, M&RI and control of other VPDs

· Describe most significant change/s which have resulted from synergies between polio eradication, measles and rubella elimination and strengthening of routine immunization globally, in the reporting period

2. Policies, guidelines, norms, standards and tools reflect best available evidence and meet needs of countries and global immunization community

· Determination of best available evidence of how existing policies, guidelines, standards and tools are being used by, and/or meet needs of countries

· Gaps in policies, guidelines, standards and tools identified, and solutions developed to address the gaps

· Number of countries aware of new position statements, guidelines, standards/norms or tools released in the reporting period.

· Describe changes in global, regional or national level policy or practice resulting from WHO policies, guidelines, norms/standards or tools released during the reporting period.

· Describe results from any monitoring and/or evaluation of position statements, guidelines, norms/standards or tools completed in the reporting period

Monitoring and/or evaluation of position statements, guidelines, policies, norms/standards or tools

3. Improved performance of immunization systems

· Number/% of countries reaching national coverage targets for DTP3 in reporting period

· Change (n/%) in the number of unvaccinated children globally compared to 2017 WUENIC estimates

· Number/% of SIA for polio that reach > 90% coverage

· Number/% of SIAs for measles-containing vaccines which reach > 95% coverage

WUENIC

estimates SIA reports

· Describe improvements in response to, and monitoring of, AEFI globally and any changes that have directly resulted from these

4. Broader understanding of barriers to vaccination and effect of strategies to address these at all levels

· Describe (including examples) of newly generated/updated evidence about barriers to vaccination and/or effect of strategies to address these.

· Provide an example of how understanding barriers to immunization has been used to improve routine immunization systems, VPD surveillance and/or outbreak response during the reporting period.

· Provide one or more examples effective strategies that are being implemented during the reporting period.

5. Countries are able to identify the need for and prioritize the introduction of new vaccines relevant to their country context

· Number/% change in the number of countries which have introduced new or under-utilized vaccines compared to 2017

· Number/% of countries which have applied for/identified funding for introduction of new vaccines in the reporting period

JRF data

6. More countries meet global, regional and national surveillance targets for polio, measles/rubella and tetanus compared to 2017

· Number of countries who meet national surveillance targets for a) polio, b) measles/rubella during the reporting period.

· Number of regions where neonatal and non-neonatal surveillance guidelines with established surveillance performance indicators are available

· Most significant change in surveillance targets observed at global, regional and national level during the reporting period.

JRF data

7. Improvement in detection and response to VPD outbreaks.

· Number of VPD outbreaks in the reporting period & number/% of these detected within required timeframe/s

· Describe change/s (including policy or practice) which resulted in improved detection and/or response to VPD

Outbreak investigation reports outbreaks in the reporting period.

8. Polio transition strategies implemented as planned in the GPEI Transition Planning Framework.

· Number of transition strategies from the 16 high priority countries that have been implemented as planned during the reporting period

9. Improved workforce development strategies implemented and evaluated

· Number/% of workforce improvement strategies implemented with worker performance needs, learning objectives and outcomes assessed and evaluation of process and outcome indicators.

· Number/% of workforce improvement strategies developed based on analyzed performance and/or competency needs and cause analysis

Reports, Evaluation results

10. Increased availability and use of economic and financial data by countries for planning and decision-making

· Number of priority countries with completed assessment of economic and financial data needs to support sustainable immunization financing

INTERMEDIATE OUTCOMES (outcome evaluation)

Activity/strategy Performance measure Potential data sources*

1. Improved national and district-level coverage for vaccines in the national immunization schedule

· Number/% of countries reaching each of the following targets:

a) 90% national coverage for 3-doses of DTP-containing vaccines

b) 80% coverage in 80% of districts or equivalent administrative area

· For a-b above, number/% of countries which have improved, compared to 2017 WUENIC estimates

WUENIC data

2. Increased country ownership and financing of immunization programs

· Change (number/%) in number of countries that have a functioning NITAG.

· Number of countries which increase % of total expenditure on vaccines financed by government, compared to

JRF data

3. Reduced reliance on SIAs · Change in the frequency of SIAs for and increased reliance on a strong routine immunization system

a) measles and b) polio, globally, compared to 2017

· Number of countries reaching 95% national coverage for two doses MCV

· Describe factors contributing to successful reduction in SIA frequency, in one or more countries.

4. Countries fully implement post-interruption, certification, and post-certification activities for polio

· Number of countries that have transitioned identified polio resources to support other VPD-related activities

· Number of countries that provide at least one dose of IPV into their EPI schedule

· Describe successful strategies to implement post-certification activities, from one or more countries.

· Polio surveillance in countries is sufficiently robust to successfully document the absence of poliovirus to regional and global certification committees

5. Improved quality, real-time availability, and use of vaccination and surveillance data

· Correlation between % districts with DTP3 coverage ≥ 80% compared to national coverage estimate for DTP3

· Describe factors affecting accuracy of numerator data globally, and any changes in these.

· Number/% of low- and middle income countries with functioning real-time data (e.g., dashboard) for a) VPD surveillance and b) immunization coverage data.

JRF data

6. Demonstrated improvements in performance of national surveillance systems for polio, measles/rubella, CRS and

MNT.

· Number/% of countries where case-based surveillance for neonatal tetanus is integrated with AFP and MR surveillance

7. All countries have introduced MCV2 and established CRS surveillance

· Number of countries routinely delivering MCV2 in the EPI program

· Number of countries with CRS surveillance included in the national surveillance system

8. Demonstrated progress in reaching elimination targets for measles, rubella/CRS and MNT

· Number of countries reaching surveillance targets for; a) measles/rubella, b) CRS

· Number/% of countries which achieve high coverage (national coverage >80%) with tetanus toxoid containing vaccine among women of childbearing age

· Describe most significant changes in the reporting period which directly effect the elimination of a) measles, b) rubella/CRS and c) MNT globally.

JRF data Coverage surveys

9. Demonstrated progress toward reaching hepatitis B control goals

· Number/% change of countries with universal hepatitis B vaccine birth dose in their immunization schedule

· Number/% of countries that have reached the regional hepatitis B control goal

· Describe most significant change in the reporting period that contributes to hepatitis B control globally.

JRF data Serological survey data

10. Demonstrated progress towards improved technical and management capacity, performance and accountability of the immunization workforce

· Number of strategies implemented with specific performance outcomes and learning objectives met

· Number/percent of staff receiving intervention and performing adequately based on identified workforce performance priorities by demographics e.g., number of staff trained, local, sub-national, national level staff, etc.)

Monitoring and evaluation reports.

Workforce analysis

LONG TERM OUTCOMES (outcome evaluation)

Activity/strategy Performance measure Potential data sources*

1. Reduced mortality and morbidity from vaccine preventable diseases in children under 5 years of age, compared

· Change in global under-five mortality rate (per 1000 live births) from vaccine preventable diseases, since 2017

· Change in global under-five

Global burden of disease data to 2017 estimates morbidity from vaccine preventable diseases, since 2017

*Sources of data for performance measures may include existing data sources, such as administrative immunization coverage data provided through existing channels like the WHO/UNICEF Joint Reporting Form, or may include new data sources, such as quarterly update reports to CDC. Relevant data sources from the sub-national, national, regional or global level should be specified, as appropriate, in the Evaluation and Performance Measurement Plan (EPMP). As such, reporting frequency of measures will vary. Recipients should specify reporting frequency as quarterly or annually in the EPMP.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Throughout the five-year NOFO period, CDC will work with the recipient to measure https://www.cdc.gov/grants/additionalrequirements/ar-25.html performance. Note that:

- CDC will use results of performance measures to continuously determine whether NOFO activities and outcomes were achieved as planned.

- CDC will review the reported results and provide feedback, noting any necessary corrective and/or improvement actions and discuss these with the recipient

- Annually, CDC, in partnership with the recipient, will hold Implementation Reviews in order to review financial information, status of activities and key successes and challenges to achieve outcomes. This will include site monitoring in order to (1) demonstrate accountability of the NOFO investments, and (2) prioritize actions needed to achieve the desired outcomes as planned.

c. Organizational Capacity of Recipients to Implement the Approach The eligible applicant must clearly describe their demonstrated experience and collaboration in the following areas:

Collaboration in public health programs with priority country national governments;

Collaboration with multiple polio eradication and measles/rubella elimination partners including BMGF, USAID, UNICEF, Rotary, Gavi and others;

Demonstrated accomplishments in designing and implementing public health action and programs in complex settings;

Demonstrated capacity to mobilize sufficient culturally competent personnel to achieve outcomes;

Ability to manage financial reporting, budget management and administration, personnel, as well as management of grants and contracts.

d. Work Plan Project Period Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

CDC Grant Monitoring Activities Throughout the five-year NOFO period, CDC will engage in the following monitoring activities:

Monthly calls to review program progress, determine needs for technical assistance, and review administrative actions

Annual site visits to review programmatic progress and to plan for the following budget period; site visits will include a review of recipient program and financial reporting systems

Technical review of annual workplans and budgets, with written feedback provided to the recipient

Review of financial and programmatic reports submitted by the recipient

CDC Approaches for NOFO Evaluations:

Throughout the five-year NOFO period, CDC will partner with the recipient to conduct program monitoring and evaluation of activities as needed. This includes:

- To conduct process and outcome evaluations of the funded activities.

o Process Evaluation: Process evaluation will assess the extent to…