PKG00245773-instructions.pdf

Centers for Disease Control

Center for Global Health

Cooperative Agreement with The Pan American Health Organization (PAHO): Protecting and

Strengthening Immunization Programs in The Americas

CDC-RFA-GH19-1901

Application Due Date: 01/07/2019

Cooperative Agreement with The Pan American Health Organization (PAHO): Protecting and

Strengthening Immunization Programs in The Americas

CDC-RFA-GH19-1901

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. 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-GH19-1901. 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 with The Pan American Health Organization (PAHO): Protecting and Strengthening Immunization Programs in The Americas 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-GH19-1901

E. Assistance Listings (CFDA) Number:

93.185 F. Dates:

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

2. Due Date for Applications: 01/07/2019, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

01/07/2019

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

The current Notice of Funding Opportunity (NOFO) represents the fifth five-year cooperative agreement between the recipient and the Centers for Disease Control and Prevention (CDC).

This NOFO aims to build upon the achievements of past agreements, while forging new collaborations to strengthen the Expanded Program on Immunization in the Americas as a whole. To this end, this NOFO is aligned with CDCs Strategic Framework for Global Immunization 2016-2020 and the recipient's Regional Immunization Action Plan (RIAP) 2015- 2020 while also harmonizing current pertinent global and regional immunization strategic frameworks, including: the Global Vaccine Action Plan 2011-2020; the Polio Eradication and Endgame Strategic Plan 2013-2018; and the recipient's Strategic Plan of 2014-2019. The current partnership with the recipient includes development of standards for national immunization 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 programs, development of national immunization program capacity to prevent, detect and respond to vaccine preventable diseases (VPDs), and maintain the status of polio eradication;

rubella, measles and neonatal tetanus elimination; and support the elimination of Hepatitis B.

To achieve these strategies, the recipient will provide direct technical cooperation to Member States through both its regional headquarters and country offices. The CDC looks forward to the close and active technical collaboration with the recipient.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $25,000,000 There is no award or period of performance ceiling; however, the above are estimates.

e. Average One Year Award Amount: $5,000,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 05/01/2019

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

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview The recipient and CDC have a successful cooperative agreement history spanning over 25 years.

The Pan American region was the first region in the world to eliminate polio in 1991, measles in 2002, rubella and congenital rubella syndrome (CRS) in 2009, and maternal and neonatal tetanus (MNT) in 2017.

The region continues to provide leadership for new vaccine introduction in low and middle income countries, and is the earliest Gavi-eligible adopter for pneumococcal conjugate, rotavirus and human papillomavirus vaccines (HPV). The recipient is working toward elimination of viral hepatitis. Over 50% of PAHO countries include a Hepatitis B birth dose in their immunization schedules. Yellow fever outbreaks and subsequent lack of surveillance raise the risk of yellow fever throughout the Americas, including the US, in spite of high vaccination coverage. Additionally, the recipient made notable progress strengthening routine immunization and surveillance systems for polio, influenza, measles and rubella; maintaining the revolving fund for the bulk purchase of vaccines for member countries; and developing a strong platform to strengthen surveillance of other VPDs.

The world is on the verge of eradication of poliovirus. The Pan American region was certified as polio free in 1996, and must maintain this status as we move toward global eradication and post eradication. Based on the achievements in the Americas following the regional polio elimination goal to be polio free by 1990, and the Global Polio Eradication Initiative (GPEI) started in 1998, the world has seen a reduction of about 99.9% of incident cases. Five of the seven WHO regions were certified as polio free. Intense, sustained, evidence-based efforts by GPEI partners and staff around the world for 30 years led to stellar results in the reduction of polio morbidity and mortality. As we approach eliminating the last 0.1% of cases globally, it is imperative that all polio-free regions maintain their status, especially given that a case of wild poliovirus anywhere in the world is a risk to all children not fully vaccinated and to global eradication. The approach ensures continued high vaccination coverage, maintaining high levels of population immunity to polio, meeting performance standards of core acute flaccid paralysis (AFP) surveillance indicators, and compliance with polio lab containment standards.

The United States eliminated measles and rubella in 2000, 2001, respectively. All PAHO member countries verified rubella/CRS and measles elimination in 2015, 2016, respectively.

Although the measles and rubella viruses no longer occur naturally in the Americas, imported cases from other regions are a constant threat, with seven million people worldwide infected with measles annually. Unvaccinated people can spread this highly contagious disease from imported cases which can lead to disease outbreaks and ultimate loss of regional elimination achievements.

Polio, measles, and rubella initiatives demonstrate the impact of immunizations on averting disease, disability and death. Immunization currently averts an estimated 2 to 3 million deaths every year. While polio, measles and rubella were successfully eliminated from the Western Hemisphere, experience demonstrates that if population immunity is not maintained, regional achievements will be forfeited. American children remain at risk for these diseases due to importations from countries where these diseases are endemic. The US government is compelled to ensure that American children and children across the globe are protected from VPDs.

b. Statutory Authorities Sections 307 and 317(k)(1) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)(1))

c. Healthy People 2020 This NOFO supports multiple priorities of Healthy People 2020, including:

Immunization and Infectious Diseases Global Health

d. Other National Public Health Priorities and Strategies This NOFO will support the US Government endorsed Global Polio Eradication Initiative (GPEI) , the Global Vaccine Action Plan (GVAP), 2011-2020., and CDCs Strategic Framework for Global Immunization 2016-2020. 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;

https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/topics-objectives/topic/global-health http://polioeradication.org/ http://polioeradication.org/ http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/ https://www.cdc.gov/globalhealth/immunization/framework.html https://www.cdc.gov/globalhealth/immunization/framework.html https://www.cdc.gov/globalhealth/security/index.htm https://www.cdc.gov/globalhealth/security/index.htm

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.

e. Relevant Work Agency Funding Opportunity Number: CDC-RFA-GH14-1401, COOPERATIVE

AGREEMENT WITH THE PAN AMERICAN HEALTH ORGANIZATION (PAHO):

Protecting the Advances in Polio, Rubella and Measles Elimination: Strengthening Immunization Programs in the Americas; is the current NOFO between CDC and the recipient.

CDC-RFA-GH19-1901 builds on the activities and goals of the current agreement by continuing and sustaining the progress in polio eradication; measles, rubella and neonatal tetanus elimination; and enhancing other life-saving VPD activities and is in alignment with CDCs Strat egic Framework for Global Immunization 2016-2020.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-GH19-1901 Logic Model: Protecting and Strengthening Immunization Programs in the Americas Bold indicates period of performance outcome

Strategies and Activities Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Lead development of guidelines, norms and standards for national immunization programs

Develop national immunization program capacity to achieve regional polio recertification;

maintain polio free status;

sustain Global, Regional and National Goals for measles, rubella/CRS, Regional Certification Commission affirms polio-free status annually

International Expert Committee/working group affirms continued measles and rubella elimination status annually

Improved quality, real-time availability and use of immunization and VPD surveillance data

Regional immunization

Demonstrated progress in reaching VPD control and elimination targets

Increased evidence-base for national immunization program decision making

Maintaining high levels of population immunity

Achieving and/or maintaining VPD control, elimination and eradication targets

Decreased VPD morbidity and mortality https://www.cdc.gov/globalhealth/immunization/framework.html https://www.cdc.gov/globalhealth/immunization/framework.html maternal and neonatal tetanus

(MNT)

elimination;

achieve elimination of hepatitis B and control of other VPDs;

Improve immunization coverage and equity;

new vaccine introduction

Identify and disseminate lessons learned/best practices for high quality national immunization programs to/from other regions program policies, guidelines, and tools reflect best evidence

Updated regional guidelines on AEFI surveillance in PAHO region

Improved capacity for VPD serosurveillance to detect immunity gaps

Increased vaccination coverage

AFP surveillance performance indicators met

Documented transfer of lessons learned to/from other regions against VPDs

Increased equity of vaccination coverage

Improved capacity to prevent, detect and respond to VPDs

Increased technical collaboration among PAHO and WHO regions

i. Purpose This NOFO will support efforts to sustain and strengthen global, regional, and national immunization program capacity needed to:

Maintain regional polio-free status by ensuring: continued vaccination; meeting GPEI AFP surveillance indicators; compliance with global containment standards

Achieve/maintain GVAP goals (elimination targets for select VPDs; polio eradication/containment; coverage and equity targets)

Achieve 2030 Sustainable Development Goal: End VPD deaths in children under age 5;

Reduce chronic disease and cancer deaths from VPDs

Prevent, detect, and respond to VPD outbreaks

ii. Outcomes Short-Term Outcomes

1. Regional Certification Commission affirms polio-free status annually at the AMR RCC, documentation to show polio-free status of PAHO Member States will be presented and Commissioners will affirm status

2. International Expert Committee/working group affirms continued measles and rubella elimination status annually

3. Improved quality, real-time availability and use of immunization and VPD surveillance data o Improved quality of country-collected immunization and VPD surveillance data from identified areas for review o Polio environmental surveillance conducted using best practices o Polio environmental surveillance results are used to inform polio response

4. Regional immunization program policies, guidelines, and tools reflect best evidence

5. Updated regional guidelines on AEFI surveillance in PAHO region

6. Improved capacity for VPD serosurveillance to detect immunity gaps

7. Increased vaccination coverage o High hepatitis B vaccination coverage including birth dose

8. AFP surveillance performance indicators met o Meeting performance standards on two core surveillance indicators (AFP detection rate and stool adequacy) has been demonstrated to be the hallmark of a strong polio surveillance system, and has been used for decades. It is critical to achieve and maintain high performance standards of these indicators. Integrated VPD surveillance is to be progressively strengthened

9. Documented transfer of lessons learned to/from other regions

Intermediate Outcomes

1. Demonstrated progress in reaching and maintaining VPD control and elimination targets o Measles and rubella elimination targets achieved and maintained o Neonatal tetanus elimination targets achieved and maintained o Member states receive guidance for assessing progress towards hepatitis B elimination should be developed and a process for verification of elimination established.

o Region and member states have evidence from serosurveys or other appropriate methods to assess progress towards and achievement of hepatitis B elimination.

o Elimination target achieved for hepatitis B through high levels of hepatitis B vaccination including the birth doses

2. Increased evidence-base for national immunization program decision making o Lessons learned disseminated to improve regional and global guidance on use of school platform for vaccination coverage screening.

3. Maintaining evidence of high levels of population immunity against VPDs o Children protected from polio through high levels of population immunity according to regional goals o Control of tetanus is achieved through inclusion of tetanus booster dose in national immunization programs of all member states o Increased evidence of population immunity to VPDs

4. Increased equity of vaccination coverage o Progress made to achieve high vaccination coverage in all districts o All PAHO countries meeting regional standards for AEFI surveillance and reporting o Rapid response systems in place to investigate, characterize and communicate emerging vaccine safety data and to appropriately adapt vaccination policy

5. Improved capacity to prevent, detect and respond to VPDs o High quality country VPD surveillance data including from electronic immunization information systems o Improved coverage of cholera vaccination where indicated, and integration of WASH activities with cholera vaccination response o Successful implementation of yellow fever vaccination catch-up campaigns in high-risk countries o AFP surveillance performance indicators maintained o Successful containment of all Type 2 poliovirus o Successful implementation of strategies to respond to and mitigate VPD outbreaks when they occur

6. Increased technical collaboration among PAHO and WHO regions

Long-Term Outcomes

1. Achieving and/or maintaining VPD control, elimination and eradication targets o Regional measles and rubella/CRS elimination target maintained o Regional maternal and neonatal tetanus elimination target maintained o Demonstrated progress in reaching VPD elimination targets for hepatitis B o Demonstrated progress in reaching and maintaining of control of other VPDs o Poliovirus contained after global polio eradication is achieved

2. Decreased VPD morbidity and mortality o Decreased morbidity and mortality due to yellow fever o Decreased morbidity and mortality due to cholera

iii. Strategies and Activities Strategies and Activities

1. Lead development of guidelines, norms and standards for national immunization programs

2. Develop national immunization program capacity to achieve regional polio recertification; maintain polio free status; achieve and sustain Global, Regional and National Goals for measles, rubella/CRS, maternal and neonatal tetanus (MNT) elimination; achieve elimination of hepatitis B and control of other VPDs; immunization coverage and equity; and new vaccine introduction o Reconvene International Expert Committee/Regional Verification Committee for measles and rubella to establish ongoing process for affirming elimination status o optimize keep-up and catch-up vaccination for children seen in health care settings and extend vaccination through the life course Characterize and strengthen school screening policies and practices, and assess impact on immunization coverage.

Ensure strong safety systems to rapidly detect and respond to adverse events following immunization Develop and appropriately scale strategies to respond rapidly and effectively to threats to vaccine acceptance o reach chronically unreached children for vaccination

Support the development and appropriate scaling of strategies to address vaccine hesitance and bring other behavioral insights to generate self-sustaining demand for vaccines and vaccination services o Support member states in achieving hepatitis B elimination Develop and disseminate guidance to member states for assessing progress toward hepatitis B elimination and verification Collect or provide technical assistance to collect evidence from serosurveys or other appropriate methods to assess progress toward hepatitis elimination o expand yellow fever vaccination to endemic areas o develop high quality VPD surveillance and response, including laboratory networks supporting VPD testing Develop and refine methodologies for conducting polio environmental surveillance within GID priority countries including comparing of genetic sequences from polioviruses isolated with environmental surveillance with those isolated from clinical cases and using results to inform response conduct systematic and ad-hoc environmental surveillance for polioviruses in GID priority countries o provide evidence-based decision making for program management and policy development by strengthening:

collection and use of strategic immunization information

1. Implementation of Immunization Information Systems Assessment (IISA) and evaluation of Immunization Registries in targeted countries as requested. Outputs include 1.) A report with data quality and data use indicators; 2.) An evaluation of the strengths and weaknesses of the electronic immunization registry system; 3.) Elaboration of a data quality improvement (DQI) plan;

and 4.) Monitor implementation of DQI plan.

2. Data quality evaluation and/or improvement in a high needs PAHO country, as requested by PAHO

3. Collaboration on standards and guidelines for methods and systems to improve vaccination and VPD surveillance data quality in the Americas region, including electronic immunization registries.

4. Innovative approaches to evaluate data quality in the Americas region, possibly including a refinement of the methodology to evaluate data quality in electronic immunization registries.

immunization workforce capacity to monitor, evaluate and improve program performance

1. Assess need for EPI workforce capacity building interventions in target countries in the region.

development of evidence-based recommendations for improved immunization policies and practices by National Immunization Technical Advisory Groups

1. Pilot testing of NITAG evaluation tool.

2. Support for training of NITAGs and shared training missions within the region for NITAGs evidence-base for sustainable immunization financing

1. Provide technical support on improving financial ownership of immunization programs for GID priority countries in PAHO region

2. Provide technical guidance on improving affordability of vaccines and development of frameworks for vaccine procurement mechanisms for countries without Gavi support public health institution functionality for evidence-based decision making development and use of technically accurate materials and guidance for strategic communications

3. Identify and disseminate lessons learned/best practices for high quality national immunization programs to/from other regions o Identify and disseminate lessons learned and best practices for high quality immunization program financial planning and management such as (but not limited to) expenditure tracking and economic evaluations tools and guidance documents

1. Collaborations

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

Recipient is expected to collaborate with the following groups and to explain how each of these collaborations might assist the recipient in achieving the NOFO outcomes:

CDC's Global Immunization Division (GID);

CDC’s National Center for Immunization and Respiratory Diseases UNICEF country teams;

WHO regional and 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)

b. With organizations not funded by CDC:

Recipient may collaborate with other organizations external to CDC as deemed necessary to achieve project outcomes. The recipient should explain how each of these collaborations might assist the recipient in achieving the NOFO outcomes. Organizations include: Ministries of Health (and Finance when needed), Bill and Melinda Gates Foundation (BMGF), USAID, Gavi, Lions Clubs International, Medicines Sans Frontier (MSF), Rotary International, National Red Cross/Crescent Societies; National polio programs including Emergency Operations Centers where applicable 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). Vaccinating children in hard to reach areas is also paramount. If a wild poliovirus were to be imported, older children and adults could be affected.

a. Health Disparities 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, etc.), 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. Below are suggested measures.

Activity/Strategy Performance measure (process)

Potential data source

Activity #2 Optimize keep-up and catch-up vaccination for children seen in health care settings and extend vaccination through the life course

Number of school screening policies and practices updated.

Number of countries with surveillance systems that are able to detect AEFI increased.

Number of countries that have risk communication plans in place Number of countries who have trained their communications staff in the last year

Reports from the countries

Activity #2 Reach unreached children for chronically vaccination

Number of countries that have developed strategies to address vaccine hesitance Number of countries that have a demand module included in the most recent national EPI review Number of countries that have community engagement activities incorporated into Red/REC strategy.

Number of lowest performing areas that have user-perspective data incorporated into annual planning.

Country reports

Activity #2 Expand yellow fever vaccination to endemic areas

Number of countries, with endemic yellow fever disease, that include yellow fever vaccine in their routine immunization system

Country reports

Activity #2 Collection and use of strategic immunization information

Implementation of Immunization Information Systems Assessment (IISA) and evaluation of Electronic Immunization

Concept Note/Proposal; Final Report; Data Quality Improvement Plan (Done for every IISA)

Registry in targeted countries IISA plan and budget developed Development of indicators and analysis themes Development of Data Quality Improvement plan and implementation within timeframe

Activity #2 Development of evidence-based recommendations for improved immunization policies and practices by National Immunization Technical Advisory Groups

Number of countries that have piloted the NITAG evaluation tool Number of trainings for NITAG implemented and NITAG missions completed

Country reports

Activity #2 Provide technical support on improving financial ownership of immunization programs for GID priority countries in PAHO region

Number of consultations with PAHO countries on financial planning and management

Reports, Meeting minutes

Activity #2 Provide technical guidance on improving affordability of vaccines and development of frameworks for vaccine procurement mechanisms for countries without Gavi support

Number of technical consultations, trainings, and workshops conducted by the recipient on vaccine affordability

Technical consultation reports, Meeting minutes

Activity #2 Identify and disseminate lessons learned and best practices for high quality immunization program financial planning and management such as (but not limited to) expenditure tracking and economic evaluations tools and guidance documents

Number of publications materials and/or peer reviewed disseminations Number of financial planning/ management tools and guidance documents made accessible in public domain

Peer reviewed literature databases, PAHO online repository

Outcomes Performance measure (outcome)

Potential data sources

Short Term #1 Regional Certification Commission affirms polio-free status annually

Frequency and nature of engagement with Member States Clear presentation and rationale of which countries are selected to present documentation at

AMR RCC.

Countries required to present documentation actually present documentation at AMR RCC

PAHO RCC Reports, meeting minutes/partner communications; ad hoc and frequency TBD

Short Term #3 Improved quality, real- time availability and use of immunization and VPD surveillance data

Monitor implementation of any DQI plans developed from IISAs Development and utilization of standards, Standard Operating Procedures (SOPs), and/or guidelines for methods and approaches to implement adequate immunization service provision, EPI data management and overall improvement of VPD surveillance data quality in the Americas region, including electronic immunization registries Number of countries meeting regional standards for AEFI surveillance and reporting 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

Reports, Technical Working Group meetings, Technical Assistance Reports (Done for every DQI; report on quarterly basis); JRF data functioning real-time data (e.g., dashboard) for a) VPD surveillance and b) immunization coverage data.

Short Term #4 Regional immunization program policies, guidelines, and tools reflect best evidence

Regional guidelines for AEFI surveillance updated and disseminated throughout the region

Regional report

Short Term #6 Improved capacity for VPD serosurveillance to detect immunity gaps

Countries conducting serosurveillance studies Countries using Multiplex bead assays (MBA) technology Lab trainings on MBA

Serological survey data

Short Term #7 High hepatitis B vaccination coverage, including birth dose

Number/% of countries reaching national coverage targets for penta3 in reporting period Number/% of countries reaching national coverage targets for hepatitis B birth dose

WUENIC estimates

Short Term #9 Documented transfer of lessons learned to/from other regions

Improved access to tools and technical guidance on program financial budgeting/planning cMYP, Annual Plans

Intermediate #3 Maintaining high levels of population immunity against VPDs

Increased # of countries conducting serosurveillance studies Increased # of countries using Multiplex bead assays (MBA) technology

Serological survey data RI program plans

Intermediate #5 Improved capacity to prevent, detect and respond to VPDs

Number of health workers deploying to or working in hard to reach areas Proportion of children vaccinated within a given administrative unit in hard to reach areas Demonstration of immunization coverage in hard to reach areas (using VTS, coverage surveys, PAHO RCC Reports, meeting minutes/partner communications; interim reports including task team sitreps, etc; ad hoc and frequency TBD

LQAS, IM, or any other methods as appropriate for region) Optional: demonstration of poliovirus immunity via serosurveys

Intermediate #5 Achieve and maintain post-eradication poliovirus containment

Validated national surveys for all poliovirus infectious and potentially infectious materials Validated attestations of destruction, inactivation, or transfer Established National Authority for Containment in every country retaining poliovirus materials All poliovirus materials retained in a certified polio essential facility Demonstrated national compliance with all elements of GAP III and all relevant global poliovirus containment standards

PAHO RCC and GCC reports;

adhoc and frequency TBD

Intermediate #5 AFP surveillance performance indicators met and maintained

Reverse cold chain assessment Demonstration of efforts made to maintain and strengthen AFP surveillance;

Documentation of NPAFP rate of ≥2 cases per 100,000 children aged <15 years, and ≥80% stool specimen adequacy.

PAHO RCC Reports, partner communications; ad hoc and frequency TBD

Intermediate #5 Successful containment of Type 2 poliovirus

Validated national surveys for all Type 2 poliovirus infectious and potentially infectious materials Validated attestations of destruction, inactivation, or transfer

PAHO RCC and GCC Reports

Established National Authority for Containment in every country retaining Poliovirus materials All Poliovirus materials retained in a certified polio essential facility Demonstrated national compliance with all elements of GAP III and all relevant global poliovirus containment standards

Intermediate #6 Increased technical collaboration among PAHO and WHO regions

Increased adoption of evidence based program planning and management

Long Term #1 Maintaining VPD control, elimination targets for polio, measles, rubella/CRS, and maternal and neonatal tetanus

Number/% of countries that meet DPT3/penta3 immunization targets Number/% of countries that include tetanus booster doses in national immunization program IEC/workgroup for Measles and Rubella reconvenes to establish an ongoing process for affirming (or denying) continued measles and rubella elimination

WUENIC,

JRF data RVC reports

Long Term #1 Demonstrated progress in reaching VPD coverage, control and elimination targets for Hepatitis B

Regional guidance/guidelines for monitoring progress towards and verification of hepatitis B control and elimination goal are developed Process for reviewing & verifying achievement of

Guidelines/guidance JRF data Serological survey data Coverage surveys hepatitis B control and elimination is established Number of countries that have evidence from serologic surveys or other appropriate methods to verify progress towards/achievement of hepatitis B elimination goal.

*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).

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, 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 performance.

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:

1. Collaboration in public health programs with priority country national governments;

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

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

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

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

d. Work Plan Applicants should provide a detailed work plan for the first year of the project period and a high level work plan for subsequent years.

No specific work plan format is required, as long as it is clear how the contents in the work plan crosswalk to the strategies and activities, outcomes and evaluation and performance measures presented in the logic model and the narrative sections of the NOFO.

A sample work plan format is presented below to show how a traditional work plan aligns with the logic model and narrative.

In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Period of Performance 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.

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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:

Conducting process and outcome evaluations of the funded activities.

Process Evaluation: Process evaluation will assess the extent to which the agreed NOFO activities have been implemented as planned. Limitations, barriers, and key success factors of the implementation will be explored. It is expected that this evaluation will be conducted during Years 2-3.

Outcome Evaluation: Outcome evaluation will be conducted to determine whether the funded activities are leading to the expected outcomes. It is expected that this evaluation will be conducted during Years 3-4.

Finalizing the evaluation protocols and plan for implementation at the designated timeframe, a system for collecting data over time to answer evaluation questions should be established during program implementation.

Ensuring that all evaluations are consistent with established frameworks and program specific requirements. Submission of Non-research Determination (NRD) CDC-ADS for ethical clearance is required. CDC will assist the submission process.

Reporting the evaluation findings to relevant stakeholders and will make these publically available in order to enhance the utilization of the findings to improve program effectiveness, and continued program improvement upon completion of the award.

CDC Roles & Responsibilities:

CDC will provide technical assistance to the recipients to ensure that the following practices are consistent with the established evaluation standards and are integrated with all evaluation activities:

Engage stakeholders Clearly state evaluation questions, purpose, and objectives Use appropriate evaluation design, methods, and analytical techniques Address ethical considerations and assurances Identify resources and articulate budget Construct data collection and management plans

Ensure appropriate evaluator qualifications and evaluation independence Monitor the planning and implementation of an evaluation Produce quality evaluation reports Disseminate results Use findings for program improvement and sustainability

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

CDC Staff will be substantially involved in the program activities outlined in this NOFO to include

Providing technical assistance to recipient in support of the activities implemented under this agreement

Collaborating with recipient to provide programmatic support to national governments for planning, implementing, and evaluating polio eradication, measles mortality reduction, rubella control/elimination and other globally agreed VPD control activities.

Assisting in providing technical training, support, and consultation to expert staff hired by recipient to assist in the polio eradication, measles mortality reduction, rubella control/elimination and GVAP strategies.

Providing expertise for the maintenance and development of disease surveillance structures, including assessment, strategy design, evaluation and assistance in priority countries.

Providing laboratory expertise to recipient for the strengthening and expansion of laboratory-based surveillance systems.

Collaborating with and providing technical assistance to recipient to determine appropriate strategies to address other mutually agreed global health priorities that may be addressed through this agreement, if and when required.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U66

3. Fiscal Year: 2019

4. Approximate Total Fiscal Year Funding: $5,000,000

5. Approximate Period of Performance Funding: $25,000,000

This amount is subject to the availability of funds.

There is no award or period of performance ceiling; however, the above are estimates.

Estimated Total Funding: $25,000,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $5,000,000 Per Budget Period

9. Award Ceiling: $0 Per Budget Period

This amount is subject to the availability of funds.

There is no award ceiling; however, the estimated amount is $5,000,000

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 05/01/2019

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Additional Information on Eligibility Single - Pan American Health Organization (PAHO)

3. Justification for Less than Maximum Competition PAHO is the lead public health agency with more than 100 years of experience in the countries of the Americas. PAHO wears two institutional hats: 1) it is the specialized health agency of the

Inter-American System and 2) serves as Regional Office for the Americas of the World Health Organization (WHO), the specialized health agency of the United Nations.

PAHO is the only organization with a mandate for the control and prevention of vaccine-preventable diseases (VPDs) in the region of the Americas. PAHO has the lead responsibility among the United Nations organizations for implementing activities to achieve the Pan American Sanitary Conference resolution of 1994 calling for the regional elimination of measles, and the year 2003 resolution calling for the elimination of rubella and Congenital Rubella Syndrome (CRS) by year 2010.

PAHO is the only trans-national health organization in the hemisphere with a presence in each of the member countries. Under the leadership of its 35 member countries and territories, PAHO sets the region of the Americas' health priorities and mobilizes action to address health problems that respect no borders and that, in many cases, jeopardize the sustainability of health systems. Through their presence in the member countries, PAHO promotes technical cooperation between countries and works in partnership with ministries of health and other government agencies, civil society organizations, other international agencies, universities, social security agencies, community groups, and other partners.

PAHO has demonstrated the capacity and leadership in setting the standard for public health and immunizations both regionally and globally which makes PAHO uniquely qualified to implement the regional immunization vision and strategy. The region of the Americas, with PAHO leadership and technical assistance, was the first to eliminate polio in 1991, eliminate measles in 2002 (and verified in 2016) and eliminate rubella and Congenital Rubella Syndrome (CRS) in 2009 (verified in 2015). PAHO continues to provide leadership in new vaccine introduction for low and middle-income countries, with the earliest Gavi-eligible adopters for pneumococcal conjugate, rotavirus and human papillomavirus vaccines.

PAHO has demonstrated success in its partnership with CDC through a cooperative agreement history spanning more than 25 years. During this time, PAHO has made outstanding progress towards strengthening routine immunization and surveillance systems for polio, measles and rubella; including maintaining the revolving fund for the bulk purchase of vaccines for member countries and developing a strong platform for strengthening surveillance of other VPDs.

During the current cooperative agreement, CDC-RFA-GH14-1401, PAHO has continued to maintain its polio-free certification since 1994, as well as verification of regional rubella and CRS elimination since 2015 and regional measles elimination since 2016. The Americas are the first global region to achieve these milestones due to PAHO’s efforts and collaboration with

CDC.

Because of the qualifications, mandates and accomplishments listed above, as well as their positioning throughout the…