CDC-RFA-IP21-2102 rev.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Surveillance and Response to Seasonal and Pandemic Influenza by Regional Offices of the World Health Organization

CDC-RFA-IP21-2102

06/21/2021

Table of Contents 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 Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- IP21-2102. 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:

Surveillance and Response to Seasonal and Pandemic Influenza by Regional Offices of the World Health Organization 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)).

New Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-IP21-2102

E. Assistance Listings Number:

93.318 F. Dates:

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

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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

N/A

2. Due Date for Applications:

06/21/2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph This Notice of Funding Opportunity (NOFO) will support the Regional Offices of the World Health Organization (WHO) to implement a coordinated plan to assist national governments and regional authorities to improve surveillance for influenza by enhancing capacity for laboratory and epidemiologic surveillance of seasonal and pandemic influenza; to assist in implementation of simple methods to determine burden of influenza disease in countries and regionally using surveillance data and other routinely collected information; to detect and respond to outbreaks of novel influenza viruses with pandemic potential, such as highly pathogenic avian influenza, swine viruses or other respiratory pathogens with similar pandemic potential; and, to assist countries to conduct activities that inform policies on introduction and increased use of influenza vaccines. Projects considered for this NOFO should build upon existing public health infrastructure focusing on country priorities, strengthen regional and national partnerships, public health capacity, leadership, and strategic collaboration and integrated health programming throughout the Region. Only one application per WHO Regional Office may be submitted. Activities identified should be complementary and not duplicative to the activities targeted through WHO’s Pandemic Influenza Preparedness Framework (PIP) or any other similar projects occurring within a region.

a. Eligible Applicants:

Single

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$ 41,000,000

e. Average One Year Award Amount:

$ 1,000,000

f. Total Period of Performance Length:

g. Estimated Award Date:

August 31, 2021

h. Cost Sharing and / or Matching Requirements:

No https://www.grants.gov/

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

1. Background

a. Overview An influenza pandemic has the potential to cause large and rapid global and domestic increases in deaths and serious illnesses. Preparedness is the key to substantially reducing the health, social, and economic impacts of an influenza pandemic and other public health emergencies.

Moreover, variants of seasonal influenza strains cause considerable mortality and morbidity every year in the US and abroad. CDC relies upon its international partnerships with the United Nations, international, and private, non-profit organizations to amplify CDC’s preparedness efforts and engage them on a multilateral and bilateral basis.

Past work by CDC with the World Health Organization for pandemic preparedness and response has led to substantial gains in preparing and responding to public health emergencies. The importance of routine surveillance systems was recently underscored with the SARS-coronavirus-2 pandemic in which components of influenza surveillance systems worldwide were utilized to detect, prevent, and respond to the outbreak. The ongoing capacity building efforts towards preparedness have paid off, but the response to the recent pandemic also revealed continued gaps in both surveillance and laboratory capacity, especially around sustainably sharing and characterizing viruses, and estimating and reporting disease impact. The rapid detection of pathogenic respiratory viruses with pandemic potential requires both a good routine surveillance system and pandemic preparedness. CDC will support routine influenza surveillance and the development of international capacity to detect and respond to public health threats.

Through ongoing partnerships with WHO Regional Offices, CDC will continue to support improvements in international capacity to prepare for, detect, and respond to an influenza pandemic with particular focus on ensuring sustainable capacity for both epidemiologic and diagnostic/laboratory-based surveillance, estimating the impact of influenza on countries, and working to establish policies for use and dissemination of seasonal vaccine in targeted countries.

The purpose of this notice of funding opportunity (NOFO) is to continue CDC’s relationships and continue efforts and support of influenza activities with current WHO Regional Offices. These activities include building and conducting epidemiologic and virologic surveillance for influenza and other respiratory diseases, improving pandemic preparedness including written plans and outbreak response and enhancing work at the animal-human interface to better understand zoonotic viruses and transmission to humans. Additionally, this NOFO will support improvements in estimating the impact of influenza on countries and work to establish policies for use and dissemination of seasonal vaccine in targeted countries.

This NOFO has two components: A Core Activities surveillance component to build and maintain a base level of surveillance and a Rapid Response to Infectious Disease Outbreaks or

Other Public Health Emergencies component to support responses to an identified public health emergency.

b. Statutory Authorities Section 307 of the Public Health Service Act, as amended (42 U.S.C. § 242l); Section 301(a) of the Public Health Service Act, as amended (42 U.S.C. § 241(a))

c. Healthy People 2030 This work contributes to accomplishing the following CDC Healthy People 2030 goals:

Improve health by preventing, detecting, and responding to public health events worldwide.

Healthy People 2030 focuses on increasing disease monitoring and prevention efforts and on improving global capacity to prevent, detect, and respond to public health threats including improvements in surveillance and laboratory systems.

Details can be found: https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health

d. Other National Public Health Priorities and Strategies Measurable outcomes of the program will be in alignment with the HHS Pandemic Influenza Operational Plan (http://www.flu.gov/planning-preparedness/federal/hhspandemicinfluenzaplan.pdf) and the President’s National Strategy for Pandemic Influenza (http://www.flu.gov/planning-preparedness/federal/pandemic-influenza.pdf) the principles of the International Partnership on Avian and Pandemic Influenza, and the following performance goal for the National Center for Immunization and Respiratory Diseases (NCIRD): Protect Americans from infectious diseases (https://www.cdc.gov/ncird/).

The strategies and activities outlined in this NOFO directly support the WHO’s Global Influenza Strategy (2019-2030).

e. Relevant Work This NOFO continues work initiated under previous announcements CDC-RFA-IP16-1606 as well as work in prior years. Cooperative agreements were developed to support and strengthen existing influenza surveillance systems, maintain capacity to detect, monitor and respond to changes in influenza viruses, and contain or mitigate transmission of novel influenza among humans. The proposed NOFO complements CDC’s global pandemic preparedness work and will strengthen the capacity of national health authorities to detect and respond to influenza outbreaks as well as other respiratory pathogen outbreaks such as SARS-coronavirus-2 utilizing systems developed to support the surveillance of influenza.

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

CDC-RFA-IP21-2102. Surveillance and Response to Seasonal and Pandemic Influenza Regional Offices of the World Health Organization Bold indicates period of performance outcome Component 1 – Core Activities

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health http://www.flu.gov/planning-preparedness/federal/hhspandemicinfluenzaplan.pdf http://www.flu.gov/planning-preparedness/federal/pandemic-influenza.pdf http://www.flu.gov/planning-preparedness/federal/pandemic-influenza.pdf https://www.cdc.gov/ncird/

Develop and maintain Regional Networks

Build/establish or maintain an integrated influenza surveillance system within the region

Enhance Regional Surveillance:

Build/establish or maintain current integrated national influenza surveillance system in countries within the region including connection with the Animal Human Interface/OneHealth platform

*Increased knowledge and awareness of ‘regional landscape’

*Improved understanding of data

*Improved number of countries with 90% indicator completion/year

*Improved awareness and knowledge in specimen collection and shipping

*Improved understanding of sustainability strategies

*Improved country awareness and knowledge of influenza related activity in the region

*Zoonotic surveillance platform enhanced

*Increased use of evidence-based ‘landscape’ to drive regional capacity

*Improved knowledge of participants

*Improved understanding of network role and purpose

*Data are used to inform changes in national clinical practice guidelines

*Improved data collection and management systems

*Improved reporting

*Improved quality of specimens received

*Increased number of countries that can respond rapidly

*Improved influenza related activity information

*Increased capacity to identify new and

*Improved epidemiologic and laboratory performance

*Increased implementation of key assessment recommendations

*Improved vaccine uptake

*Improved achievement of capacity objectives

*Increased ownership of surveillance system by country and region/network

*Increased number of countries sharing information about influenza related activity

*Improved awareness and response to zoonotic (novel) influenza human infections emerging influenza viruses

Component 2: Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies

Strategies Short-Term Outcomes Intermediate-Term Outcomes

Long-Term Outcomes

Emergency Response:

Respond to a declared public health emergency or identified highly infectious disease outbreak

*Rapid identification of and response to highly infectious disease outbreaks

*Strengthened coordination and robust emergency preparedness and response capacities

*Improved identification of cases and conducting appropriate outbreak investigations

*Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level

*Timelier and more accurate data for continuous situational analysis *Increased capacity for timely and accurate virus characterization

*Achieve timely outbreak response

*Reduced time to reinvigorate public health activities response

*Increased capacity of countries for early warning, risk reduction and management of national and global health risks

*Prevention of spread of the outbreak

i. Purpose This NOFO supports building routine influenza surveillance systems’ capacity to monitor, detect, respond and mitigate transmission of novel influenza viruses; enables national institutions to maintain their laboratory; supports full participation in WHO Global Influenza Surveillance and Response System (GISRS); enables influenza surveillance platforms to be expanded and utilized for response to outbreaks of other highly pathogenic respiratory viruses and provides support for utilization of collected data by Ministries of Health for healthcare policy decisions such as support for vaccination programs.

ii. Outcomes Component 1 – Core Activities Short-term Outcomes:

Increased knowledge and awareness of ‘regional landscape’ o Formal laboratory and surveillance assessments conducted within the region for targeted countries looking to establish National Influenza Center (NIC) designations, or with poor or low functioning systems o Updated assessments of current epidemiologic and laboratory reporting of Member States to WHO o Increased number of participants (e.g. surveillance, laboratory, rapid response, clinical, or veterinary) trained at a country/regional level o Improved number of influenza vaccine plans developed per country requests o Technical advice provided to country surveillance teams

Improved understanding of data Improved number of countries with 90% indicator completion/year o Improved understanding of sustainability strategies o Improved country awareness and knowledge of influenza related activity in the region

Improved awareness and knowledge of specimen collection and shipping o Improved awareness and knowledge among countries in standard practices and expectations for specimen collection and shipping

Zoonotic surveillance platform enhanced

Intermediate Outcomes:

Improved reporting o Improved timeliness and completeness of reporting to WHO/FluMart over year 1 baseline o Weekly reports of influenza activity at the WHO Regional level via FluNet or the designated regional platform feeding into FluNet o Improved reporting by partner countries o Improvement in the timing and quality of influenza related activity information shared with the region

Improved quality of specimens received o Improved performance and maintenance of equipment o Increased number of key recommendations are implemented o Knowledge of participants is improved for both process and technical recommendations o Data is used to inform changes in national clinical practice guidelines o Improvements are made to data collection and management systems o Improvement in the representativeness, timing and quality of specimens shared with WHO Collaborating Centers, and in non-human influenza viruses submitted for vaccine candidate consideration o Improved number of countries with proven ability to respond rapidly and effectively Measured through International Health Regulations (IHR) and Joint

External Evaluation (JEE) indicators

Increased number of countries that can respond rapidly Improved influenza related activity information

Long-term Outcomes:

Improved epidemiologic and laboratory performance o Improved laboratory performance in NICs in the region as measured by the

External Quality Assurance Program (EQAP) o Improved acquisition and exchange of human and avian disease surveillance and monitoring data Achievement of surveillance capacity objectives o Improved ability to estimate impact/burden estimates Increased number of countries conducting annual assessment of disease severity using the Pandemic Influenza Severity Assessment tools (PISA).

o Improved achievement of capacity objectives o Improved use of GISRS monitoring system to plan or take actions o Yearly assessment of surveillance trends in the region/network which is published or shared globally.

o Increased number of countries regularly submitting specimens per WHO guidelines

Increased implementation of key assessment recommendations o Outlined in formal assessments o Improved performance in identified training areas

Issues tracked and monitored for improvement

Improved vaccine uptake in risk groups targeted to receive vaccine.

o Use of regional plans supporting vaccine introduction

Increased ownership of surveillance system by country and region o Improved use and performance of rapid response teams in country and region

Increased number of countries sharing information about influenza related activity Improved awareness and response to zoonotic (novel) influenza human infections

Component 2: Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies Short-Term Outcomes

Rapid identification of and response to highly infectious respiratory disease outbreaks Strengthened coordination and robust emergency preparedness and response capacities Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level

Intermediate-Term Outcomes

Increased capacity for timely and accurate virus characterization

Long-Term Outcomes

Achieve timely outbreak and epidemic/pandemic control Increased capacity of countries for early warning, risk reduction and management of national and global health risks

iii. Strategies and Activities Component 1 – Core Activities Two strategies are covered within this Component: Develop and Maintain Regional Networks and Enhancement of Regional Surveillance.

Under these strategies, recipients will assist countries in each WHO Region to conduct the following activities:

Develop and Maintain Regional Networks

Develop or update current landscape analysis to better understand the surveillance and laboratory capabilities and capacities in the Region.

o Specifically, assess the following parameters: number and quality of active severe acute respiratory infections (SARI) sites; number and quality of active influenza-like illness (ILI) sites; frequency and comprehensiveness of reporting to WHO/FluMart; number of NICS including identification of activities performed within each NIC; and quarterly monitoring of shipments and sharing of influenza viruses and/or specimens with WHO Collaborating Centres.

Support acquisition and maintenance of equipment for laboratory activities in countries In collaboration with CDC, provide technical support for both surveillance and laboratory assessments and follow-up to recommendations made to countries using WHO or CDC developed standardized tools for an understanding of country’s surveillance and laboratory capabilities and capacities, with an emphasis on influenza viruses

Develop and conduct in country and regional trainings to enhance the national and regional/network surveillance and response for influenza.

o Specifically, develop and conduct trainings focused on surveillance, laboratory diagnostics, proper data management of data collected through surveillance and epidemiological analysis of data o Develop and conduct analogous trainings on avian influenza surveillance, where applicable

Develop regional vaccine policy workgroups to look at regional/network vaccine uptake, the level of evidence or impact data by country and develop regional vaccine plans for influenza based on country needs and intentions.

Support the development and enhancement of national networks of laboratories and surveillance sites for the rapid acquisition and exchange of disease surveillance and monitoring information.

Enhance Regional Surveillance

Provide technical assistance on the development of short- and long-range surveillance capacity plans within countries to support sustainability of the system

Support reporting of data to the Global Influenza Surveillance and Response System (GISRS) and FluMart/FluNet

Development of weekly reports of merged data using data provided by Ministries of Health and NICs of countries to highlight influenza weekly activity for the Region

Support the shipment of specimens/isolates to WHO Collaborating Centres for Influenza: develop quarterly reports highlighting the number of viruses shared with GISRS, the number of specimens/isolates submitted to WHO CC and CDC.

Support the development, training and exercising of in-country rapid-response team to assess and report quickly on respiratory outbreaks including influenza.

Component 2: Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies

Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation Intensify active surveillance, case finding, contact tracing, monitoring and other outbreak response measures at national and local levels Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation Intensify social mobilization, community and professional education and engagement Improve outbreak contact tracing management and infection control

Strengthen capabilities for preparedness and response to highly infectious diseases

1. Collaborations

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

To the extent possible align influenza surveillance efforts with current WHO guidance on influenza, Global Health Security Activities, WHO PIP program activities, CDC Country Office programs, other governmental and non-governmental partners, and coordinate work within the same geographic region. Recipient should identify plans to coordinate and support other initiatives in the region to ensure efficient use of resources and support a collaborative nonduplicative work environment.

b. With organizations not funded by CDC:

Collaborations with organizations not funded by CDC are not specifically required with this NOFO; however, Recipients are encouraged to work with other stakeholders in country and at the global level including but not limited to other government entities, non-governmental organizations, civil society, the private sector, and other USG agencies.

2. Target Populations Accomplishment of outcomes will benefit the global population and especially WHO-recommended high-risk target groups for influenza and other respiratory disease prevention.

a. Health Disparities Implementation of strategies and activities within this NOFO will support establishment of surveillance systems that provide a representative sample of country population, geographically, socio-demographically, including those populations identified as high-risk for morbidity from respiratory infections. Identification of the burden of disease, through use of surveillance data, will assist regions to plan and implement public health information campaigns and equitable vaccination programs.

iv. Funding Strategy

This NOFO is divided into two components. The applicant must apply for Component 1 (Core Activities) and may apply for Component 2 (Rapid Response to Infectious Disease Outbreaks or Public Health Emergencies). Applicants must apply for Component 2 during the Year 1 application in order to be eligible for funding in the event of a declared emergency.

Component 1 (Core Activities) within this NOFO is intended to be funded on an annual basis. Future year funding levels will be dependent on funding availability and successful completion of workplan activities and evaluation metrics.

Funds will be used to support WHO Regions through the WHO Regional Offices. The funds can augment an established and functioning surveillance system but should be a small portion of the overall cost of the influenza surveillance program.

The applicant is required to propose work with a clearly marked budget, and work plan for each component and strategy that they propose to conduct activities in. Components and strategies not outlined in this initial application cannot be added to work plans in subsequent years. The initial project application should contain a detailed Year 1 plan and a projection of strategies and activities to be accomplished in later years.

Component 2 – Rapid Response to Infectious Disease Outbreaks or Public Health Emergencies The ability to respond rapidly and effectively to public health emergencies is a key component of global health security. International public health emergencies including humanitarian crises are by nature unpredictable, requiring fulfilment of changing and often unpredictable needs that vary widely according to context. Consequently, funding for public health emergencies is also unpredictable and based on external factors. In recent years, there has been a sharp rise in the number of people living in regions of the world affected by public health emergencies, including humanitarian emergencies, which has often led to additional funding resources from the USG to respond to these threats. Given this unpredictability and the resulting need for rapid, flexible, and efficient process to award funding under an emergency situation, recipients that are selected for funding under this NOFO may be eligible to receive additional supplemental funding when a public health emergency occurs to scale up activities included within the scope of work of this

NOFO.

Definition of public health emergency:

1. When UN or WHO classifies the emergency as a Level 3 (L3)

2. When the US Congress appropriates funding for an international response related to humanitarian or public health crisis with the words containing “emergency” in the program title.

The appropriated funding could be for CDC directly or is transferred to CDC through an Interagency Agreement (IAA) by HHS or another USG agency

3. When the US government (Congress, White House, National Security Council etc.) declares a public health emergency as national security priority

4. When HHS Secretary declares an emergency

5. When the CDC Director activates Emergency Operation Center (EOC) in response to an international public health threat

6. When Department of State or U.S. Agency for International Development (USAID) transfer funds to CDC to respond to an international disaster or humanitarian assistance under 2 FAM 060 (International Disaster and Humanitarian Assistance)

If a public health emergency situation meets any one criterion listed above, then selected recipients under this NOFO may be eligible to receive supplemental emergency funding to scale up public health activities included in the scope of work of this NOFO on a single-source basis, i.e., without additional competition. There is no limit on the number of emergency supplemental funding that a recipient may receive within a budget period or period of performance, however, emergency funding requests cannot exceed a recipient’s budget period or period of performance.

In addition, all reporting requirements listed under this NOFO still apply to any emergency supplemental funding.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

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 the 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) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. 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, the applicant 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, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Applicant must be able to manage program performance, evaluation, performance monitoring, financial reporting, and must have capacity to manage the required funds in accordance with the HHS Grants Policy Statement.

Applicants should clearly document and demonstrate experience or institutional capacity (both technical and administrative) to achieve the outcomes outlined in the logic model including evidence of strong administration and information management systems to support he proposed activities and to manage the resources of the project, prepare reports, monitor and evaluate activities, audit expenditures and produce, collect, and analyze performance and surveillance data. Applications should: 1) clearly describe an approach that supports the strategies outlined in the NOFO; 2) describe strategies and activities that are achievable and appropriate to achieve the outcomes of the project, and evidence-based (to the degree practicable); 3) document current activities and status as well as identify activities that will address current gaps in the Region. Applicant should document and provide evidence that the proposed use of funds is an efficient and effective way to implement the strategies and activities and attain the period of performance outcomes. Priority countries should be identified as well as the process used to determine prioritization.

Applicants should document the ability to collect data on the process and outcome performance measures specified by CDC in the project description and presented by the applicant in their approach as well as describing clear monitoring and evaluation procedures and how performance measurement will be incorporated into planning, implementation and reporting of project activities. Information on staff, duties and clear activity timelines should be identified and how activities will be tracked for effectiveness. Applicants should include information on staff roles, responsibilities including percentage of time committed to project activities and a description of how these activities support long term value to the project. Finally, applicants must describe training received on USG fiscal management requirements and ability to meet all required deadlines for financial reporting, with description of standardized reporting of financial expenditures

Applicants should include a preliminary Data Management Plan (DMP), if applicable.

The applicant should provide as part of their appendix the following documents:

1) Curricula vitae (CVs)/Resumes for positions related to key staff related to program planning and implementation, finance, and monitoring and evaluation

2) Job descriptions (maximum 1 page per job description) for key positions related to program planning and implementation, finance, and monitoring and evaluation. Clearly identify percent (%) of time spent on activities supporting the proposed project

3) Organizational chart (maximum 1 page)

4) Capacity summary statement to be able to implement the activities proposed under this NOFO (maximum 1 page)

5) Financial management statement that demonstrates experience in managing USG or CDC funds that are similar in size and scope to this NOFO (maximum 1 page).

Details of required procurement process Details of internal monetary movement

The above referenced documents to be submitted in the appendix should demonstrate the organization's capacity to address the requirements of the NOFO.

Applicants must title these documents in their appendix as follows: "CVs/Resumes," "Job Descriptions," "Organizational Chart," "Capacity Summary," "Financial Statement" and upload as attachments to the application at www.grants.gov

d. Work Plan Applicants must include a work plan that demonstrates how the outcomes, strategies, timelines, and staffing will take place over the course of the award. Applicants must also submit a detailed work plan for the first year of the project and a high-level plan for the subsequent years.

Applicants should submit a work plan for each Component submitted within the application.

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.

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.

The following data sources will be utilized to monitor performance of Recipients:

Payment Management System (PMS) will be reviewed to ensure timely utilization of funds in support of project activities as well as timely reporting of fund use.

WHO FluNet and FluID will be used to monitor timely reporting of influenza virus identification and transmission.

Country shipments to a WHOCC (up to four shipments to a CC per year are recommended – 1 at season start, 1 to support annual Vaccine Strain Selection meeting (February or September), 1 mid-season and 1 at end of the season) will be used to monitor country participation in GISRs and Vaccine Composition.

Country participation in the WHO annual EQAP will be used to monitor capability to identify influenza viruses circulating. A sustained score of 80% or higher for established National Influenza Centres (NICs) will be used as minimally acceptable.

Federal Financial Reports (FFR) will be reviewed and tracked for timely and accurate reflection of the cooperative agreement funds. Annual FFRs are due 90 days following the end of the designated Budget Period. Reports are required to be submitted within

PMS.

Administrative accountability will be measured by use of and maintaining access to the Grant Solutions system and timely submissions of prior approval amendments and other requested information as required within the cooperative agreement.

The recipient(s) will be required to collaborate with CDC headquarters (HQ) for technical oversight of project activities to be implemented under this NOFO. In addition to the Project Officer, the recipient will collaborate with CDC in-country or HQ contacts, Subject Matter Experts (SMEs) and technical leads. The Project Officer for this award will provide relevant contacts of CDC staff and coordinate discussions with the award recipients.

Annual performance will be reviewed and may determine future funding decisions. Future funding for this cooperative agreement is based on satisfactory progress.

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U51 - Health Planning Strategies/National Academy of Sciences Activities

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$ 10,000,000

5. Total Period of Performance Funding:

$ 41,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$ 41,000,000

6. Total Period of Performance Length:

5 year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$ 1,000,000 Per Budget Period

9. Award Ceiling:

$ 0 Per Budget Period

This amount is subject to the availability of funds.

There is no award ceiling for this NOFO

10. Award Floor:

$ 0 Per Budget Period

There is no award floor for this NOFO

11. Estimated Award Date:

August 31, 2021

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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants Eligibility Category:

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

2. Additional Information on Eligibility Regional Offices of the World Health Organization

1. Regional Office for Africa – AFR, Brazzaville, Congo;

2. Regional Office for the Americas – PAHO, Washington, D.C.;

3. Regional Office for South-East Asia – SEAR, New Delhi, India;

4. Regional Office for Europe – EUR, Copenhagen, Denmark;

5. Regional Office for the Eastern Mediterranean – EMR, Cairo, Egypt; and

6. Regional Office for the Western Pacific – WPR, Manila, Philippines).

3. Justification for Less than Maximum Competition WHO Regional Offices because of their authority to work with targeted countries on health-related issues are uniquely positioned to provide support to build capacity for the identification, investigation and containment of a potential novel or pandemic strain of influenza and other pathogens. Further, they can lead regional surveillance and laboratory capacity building efforts;

develop and disseminate guidelines for surveillance and burden estimation; and they have extensive knowledge of country readiness to explore the development of vaccine policies within their identified networks.

WHO Regional Offices have a unique ability to work with countries to 1) provide leadership on matters critical to health and engage in partnerships where joint action is needed; 2) stimulate the generation, translation, and dissemination of valuable knowledge; 3) set norms and standards and promote and monitor their implementation; 4) articulate ethical and evidence-based policy options; 5) provide technical support, catalyst change, and build sustainable institutional capacity; 6) monitor the health situation and assess health trends; all of which are essential characteristics required for the successful completion of the announcement's requirements.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No 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.

5. Maintenance of Effort Maintenance of effort is not required for this program

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov/ usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

StepSystem Requirements Duration Follow Up

Data Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-

System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/SAM/ and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fs d.gov/ fsd-gov/ home.do Calls: 86 6-606-8220

3 Grants.gov

1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative

(AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

2. Request Application Package Applicants may access the application package at www.grants.gov.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/SAM/ https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by)

N/A

b. Application Deadline

06/21/2021 11:59 pm U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Due Date for Information Conference Call N/A

5. Pre-Award Assessments Risk Assessment Questionnaire Requirement

CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

https://www.grants.gov/ https://www.grants.gov/ https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts

Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e.