PKG00264465-instructions.pdf

Centers for Disease Control and Prevention

Center for Global Health

Support of Global Polio Eradication Initiative (GPEI) using Integrated Modeling

CDC-RFA-GH21-2101

Application Due Date: 02/11/2021

Support of Global Polio Eradication Initiative (GPEI) using Integrated Modeling

CDC-RFA-GH21-2101

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 "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH21-2101. 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:

Support of Global Polio Eradication Initiative (GPEI) using Integrated Modeling 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.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52. 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-GH21-2101

E. Assistance Listings (CFDA) Number:

93.185 F. Dates:

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

2. Due Date for Applications: 02/11/2021, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

Under this Cooperative Agreement, the recipient will build upon previous work with CDC on complex issues for the Global Polio Eradication Initiative using a differential equation-based proprietary model to estimate the disease and economic impact of policies regarding aspects of various polio vaccine formulations, polio surveillance, immunization campaigns and outbreak response strategies on the achievement of global polio eradication. These outcomes will be used to guide the development of efficient and adaptable polio eradication and vaccine policies and understand their economic implications, covering the final wild poliovirus elimination phase, the monitoring and containment phase, and the endgame vaccine options required for certifying the final eradication of polio. This NOFO may also support modeling related to control and elimination of other vaccine preventable diseases (VPDs).

a. Eligible Applicants: Single https://www.grants.gov https://www.grants.gov https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $3,750,000

e. Average One Year Award Amount: $750,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 04/15/2021

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview The Global Polio Eradication Initiative (GPEI) began in 1988 with the objective of wild poliovirus (WPV) eradication and ultimate full poliovirus eradication. Centers for Disease Control and Prevention (CDC) was one of the founding partners of the GPEI, and polio eradication remains an agency-wide priority; CDC's Emergency Operations Center (EOC) has been activated since December 2011 for global polio response activities. CDC is currently one of six partners in GPEI, providing technical and financial support for polio eradication and childhood immunization activities along with the World Health Organization (WHO), Rotary International, United Nations Children?s Fund (UNICEF), the Bill and Melinda Gates Foundation (BMGF), and Gavi, the Vaccine Alliance.

The GPEI has made tremendous progress toward global eradication with WPV circulating in only 2 countries in 2020, Afghanistan and Pakistan, down from 125 countries in 1988. WPV type 2 and 3 have been successfully certified as eradicated with only type 1 WPV remaining. With the certification of WHO?s African Region as free of WPV on August 25, 2020, five of WHO?s six Regions are now declared WPV free. Only the Eastern Mediterranean Region has yet to achieve this goal. The GPEI now faces two major challenges: 1) continued transmission of WPV1 in Pakistan and Afghanistan and 2) an increasing number of outbreaks of circulating Vaccine Derived Polioviruses (cVDPVs) which result from prolonged circulation in under-immunized communities of the live weakened virus from the oral poliovirus vaccine (OPV).

The applicant and CDC have collaboratively addressed complex polio eradication issues for almost 20 years to inform policymaking by CDC and GPEI. The work completed under the most recent cooperative agreement (NU2RGH001913) included updates to the global integrated economic, risk and dynamic disease model to reflect the current GPEI strategic planning and implementation efforts to characterize poliovirus transmission and assess the health and economic trade-offs associated with different policy options. The applicant's expanded and updated poliovirus transmission model accounts for differences in serotype and transmission routes, routine childhood immunization schedules, Sabin OPV evolution in transmission and the emergence of cVDPVs, particularly type 2 (cVDPV2). During 2019, the applicant focused on characterizing WPV transmission in Borno and Yobe states of northeast Nigeria and the confidence in the available evidence of no transmission of WPV, to inform the Africa Region Certification Commission?s evaluation of certifying the region WPV-free. In addition, in 2020, they have modeled the changing cVDPV2 epidemiology and risk of different response strategies that may result in restarting Sabin type 2 in routine immunization schedules, and what potential outcomes are possible with wide scale use of a novel, stabilized type 2 OPV. Numerous key questions about the polio eradication endgame remain, particularly the best vaccine strategies to address cVDPV2 outbreaks and ultimately withdraw all use of Sabin OPV. At this stage of the GPEI, modeling of new strategies is required, particularly with respect to use of a stabilized, novel OPV type 2 and other outbreak strategies to stop and prevent VDPV2 outbreaks, as well as how to achieve WPV eradication in Pakistan and Afghanistan.

This announcement expands upon previous GPEI support work conducted under the agreement noted above, as well as expanding modeling work for control and elimination of other VPDs in addition to polio.

b. Statutory Authorities Section 317(k)(2) of the Public Health Service Act [42 USC § 247b(k)(2)], as amended. Section 307 of the Public Health Service Act [42 USC § 242l].

c. Healthy People 2030 This announcement addresses the Healthy People 2030 focus area(s) of Immunization and infectious Diseases.

https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination; https://health .gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/maintain-eliminatio n-measles-rubella-congenital-rubella-syndrome-and-polio-iid-01;

d. Other National Public Health Priorities and Strategies CDC has a major role in the Global Health Security Agenda (GHSA, http://www.cdc.gov/globa health/security/cdc.htm) based on concepts in the agency?s mission to protect public health worldwide: Prevent, Detect, Respond. The Global Health Initiative (GHI, http://www.ghi.gov /about/howWeWork /index.html) strategically combines the capacities of U.S. Government agencies to address global health challenges that threaten lives at home and abroad. By supporting all U.S. Government agencies to function with common goals across >70 countries governed by GHI principles, the United States is maximizing investments to protect the American people and advancing our global mission to save more lives.

https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/maintain-elimination-measles-rubella-congenital-rubella-syndrome-and-polio-iid-01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/maintain-elimination-measles-rubella-congenital-rubella-syndrome-and-polio-iid-01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/maintain-elimination-measles-rubella-congenital-rubella-syndrome-and-polio-iid-01 http://www.cdc.gov/globahealth/security/cdc.htm http://www.cdc.gov/globahealth/security/cdc.htm http://www.ghi.gov/about/howWeWork%20/index.html http://www.ghi.gov/about/howWeWork%20/index.html

e. Relevant Work Work completed under cooperative agreement (NU2RGH001913) relates to this NOFO including: 1) updating the global integrated dynamic disease model to assess the health and economic trade-offs associated with different risk management and policy options; 2) modeling WPV transmission in northeast Nigeria that indicated very low likelihood of transmission supporting the Africa Regional Certification Commission?s evaluations [the WHO African Region was certified WPV-free in August 2020]; 3) modeling changes in cVDPV2 epidemiology and risks of different response strategies; and 4) highlighting the high likelihood of OPV2 reintroduction into routine immunization. https://www.kidrisk.org

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-GH21-2101

Logic Model: Support of Global Polio Eradication Initiative (GPEI) using Integrated Modeling

Strategies and Activities

Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Model population immunity in remaining polio endemic countries and newly affected areas Characterize the risk associated with cVDPV outbreaks and the use of different vaccine strategies Evaluate the cost effectiveness and policy implications of the use of new OPV strains (nOPV) Evaluate and summarize poliovirus surveillance information Analyze phased withdrawal of OPVs

Increased understanding about Afghanistan and Pakistan polio epidemiology, program performance and estimation of global susceptibility to imported WPVs Improved understanding by GPEI on strategies to combat cVDPV2 outbreaks Increased understanding by GPEI on thresholds for restarting tOPV and cessation of bOPV and or introduction of nOPV1, 2, 3 in supplementary or routine immunization Structured decision analysis of choices related to growing and maintaining the environmental surveillance network Informed decisions at Technical Advisory Group

Expand informed, updated decisions at TAG discussions and similar meetings about poliovirus vaccine choice for routine and supplementary immunization activities Improve decisions by GPEI on the size and replenishment of the poliovirus vaccine stockpiles during transition to OPV cessation Improved supportive policy development and implementation in key countries toward WPV and cVDPV elimination and eventual eradication Improved understanding among Ministries of Health (MOHs) and

Polio elimination lessons/information used by MOHs and other key stakeholders to develop the most efficient and effective programmatic operations to improve control of other VPDs Improve incorporation of lessons learned and policy implications by post-certification partners Improve decision making by GPEI on additional sites for consideration in the global environmental surveillance network Improved decisions among USG players for planning documents about managing US risks of potential https://www.kidrisk.org/ and the need to restart with various options Evaluate laboratory containment condition and aspects critical to preventing re-introduction of live polioviruses Extend models to support control and elimination of other VPDs Characterize risks for the US associated with importations of poliovirus and VPDs Provide technical feedback to GPEI partners about policy implementation and lessons learned

(TAG) discussions and similar meetings about poliovirus vaccine choice for routine and supplementary immunization activities Improved understanding among USG about managing US risks of importations of poliovirus or other VPDs Improved understanding by GPEI partners of lessons learned regarding Sabin OPV cessation stakeholders of lessons learned by GPEI and available decision support Improved decisions on laboratory containment requirements and evaluation Informed elimination goals and targets for other VPDs Improved understanding by post-certification partners of lessons learned and policy implications release of poliovirus Improved understanding among USG about managing US risks of VPDs for which there are newly developed vaccines

i. Purpose The purpose of this NOFO is to provide critical disease modeling for decision making to the GPEI to help guide the development of policies and strategies for polio eradication. Outcomes will be used to guide the development of efficient and adaptable polio eradication and vaccine policies and understand their economic implications, covering the final wild poliovirus elimination phase, the monitoring and containment phase, and the endgame vaccine options required for certifying the final eradication of polio. This NOFO may also support similar modeling for other VPDs.

ii. Outcomes Short term outcomes:

Improved understanding by GPEI on strategies to combat cVDPV2 outbreaks including vaccine choice, response size, and coverage needed.

Increased understanding by GPEI on thresholds for restarting tOPV and cessation of bOPV and/or introduction of nOPV1, 2, 3 in supplementary and routine immunization

Informed decisions at TAG discussions and similar meetings by GPEI about poliovirus vaccine choice for routine and supplementary immunization activities

Improved understanding by GPEI partners of lessons learned regarding Sabin OPV cessation

Intermediate outcomes:

Expand informed, updated decisions at TAG discussions and similar meetings by GPEI about poliovirus vaccine choice for routine and supplementary immunization activities

Improve decisions by GPEI on the size and replenishment of the poliovirus vaccine stockpiles during transition to OPV cessation

Improved supportive policy development and implementation in key countries toward WPV and cVDPV elimination and eventual eradication

Improved understanding by post-certification partners of lessons learned and policy implications

Long term outcomes:

Improve incorporation of lessons learned and policy implications by post-certification partners

Improve decision making by GPEI on the additional sites for consideration in the global environmental surveillance network

Improved decisions among USG players for planning documents about managing US risks of potential release of poliovirus

iii. Strategies and Activities The activities supported by this NOFO will help with decision making in the development of strategies, policies and plans for implementation of activities of GPEI, of which routine immunization strengthening is a part. More specifically, activities to be conducted as part of this NOFO will include, but are not limited to:

Model population immunity to transmission in remaining polio-endemic, recently outbreak-affected, and other high-risk countries/areas currently and into the future.

Strategy: potential for sustainability beyond the period of performance

Characterize the risk associated with circulating vaccine-derived poliovirus outbreaks and the use of different vaccine strategies. Strategy: potential for sustainability beyond the period of performance

Evaluate the cost-effectiveness and policy implications of the use of novel poliovirus vaccine strains (nOPV). Strategy: providing strong evidence of effectiveness

Evaluate and summarize poliovirus surveillance information Analyze phased withdrawal of OPVs, including consideration of vaccine formulation and content options. Strategy: potential for sustainability beyond the period of performance Evaluate laboratory containment conditions and aspects critical to preventing re-introduction of live polioviruses. Strategy: potential for sustainability beyond the period of performance

Extend models developed to support control and elimination of other VPDs. Strategy:

providing strong evidence of effectiveness

Characterize risks for the US associated with importations or accidental release from containment of poliovirus (and other VPDs) Strategy: potential for sustainability beyond the period of performance Provide ongoing technical feedback to GPEI partners about policy options, implications and lessons learned

1. Collaborations

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

Recipient is required to collaborate closely with Centers for Disease Control and Prevention/National Center for Immunization and Respiratory Diseases (CDC/NCIRD) Division of Viral Diseases

b. With organizations not funded by CDC:

Recipient is required to collaborate with other modeling groups working on polio or other VPDs.

The recipient may also collaborate with other external organizations such as academic institutions, USAID, UNICEF, Gavi, Rotary International, and/or other organizations. Recipient is requested to submit Letters of Support, MOUs or MOAs to verify collaborations. Applicants must file the MOU or MOA, as appropriate, name the file "MOUs/MOAs", and upload it as a PDF file at www.grants.gov.

2. Target Populations Populations under-immunized against childhood VPDs; with respect to polio, populations in countries experiencing poliovirus outbreaks or at high risk for polio transmission

a. Health Disparities Recipients are encouraged to describe how populations at greatest risk for VPDs will be served through activities supported by this NOFO, including description of targeted approaches.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Throughout the 5-year NOFO period, CDC will work with recipient to assess whether funded activities are leading to intended short and intermediate outcomes, and what contribution these are making to long-term outcomes.

The CDC evaluation and performance measurement strategy requires that the recipient provide data that address the questions listed below. This strategy will help the CDC assess the recipient's progress on (1) implementation of activities in the logic model and (2) the extent to which period of performance outcomes have been achieved. The key question below will determine this. These questions, and subsequent performance measures including potential data sources and frequency of reporting, are listed below. The recipient should, at a minimum, report on all of these measures as per the relevant frequency.

Type: Outcomes Link to logic model:

Short term outcomes:

Improved understanding by GPEI on strategies to combat cVDPV2 outbreaks including vaccine choice, response size, and coverage needed.

Increased understanding by GPEI on thresholds for restarting tOPV and cessation of bOPV and/or introduction of nOPV1, 2, 3 in supplementary and routine immunization

Informed decisions at TAG discussions and similar meetings by GPEI about poliovirus vaccine choice for routine and supplementary immunization activities

Improved understanding by GPEI partners of lessons learned regarding Sabin OPV cessation

Intermediate outcomes:

Expand informed, updated decisions at TAG discussions and similar meetings by GPEI about poliovirus vaccine choice for routine and supplementary immunization activities

Improve decisions by GPEI on the size and replenishment of the poliovirus vaccine stockpiles during transition to OPV cessation

Improved supportive policy development and implementation in key countries toward WPV and cVDPV elimination and eventual eradication

Improved understanding by post-certification partners of lessons learned and policy implications

Long term outcomes:

Improve incorporation of lessons learned and policy implications by post-certification partners

Improve decision making by GPEI on the additional sites for consideration in the global environmental surveillance network

Improved decisions among USG players for planning documents about managing US risks of potential release of poliovirus

Performance Measures that will demonstrate the use of information generated through this NOFO by the GPEI include:

Number, frequency and type of TAG meetings or similar meetings that draw on model-based recommendations

Number, frequency and type of US Government reports or meetings that reference model-based recommendations

Number and status of countries' implementation of model-based recommendations

Frequency: Bi-annual

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/additional-requirements/ar-25.html.

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

DMP is not requested

c. Organizational Capacity of Recipients to Implement the Approach Eligible applicant must demonstrate:

Technical expertise in applying the applicant's polio model, adjusting the model as needed, interpreting and presenting results, and publishing research articles in biomedical journals

Project management, staffing and administration capacity and experience, documented by the project organizational chart, staff roles, and CVs/Resumes for key staff.

The ability to manage grants and contracts with a financial management system that will allow proper funds management and segregation of funds by program, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and https://www.cdc.gov/grants/additional-requirements/ar-25.html

Audit Requirements for HHS Awards: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1 .75#se45.1.75_1302"45 CFR 75.302 The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award.

Applicant must upload all additional documentation in Grants.gov under Other Attachment Forms. Document should be labeled: "CVs/Resumes, and Organizational Charts.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

d. Work Plan The work plan allows the CDC project officer to monitor implementation of activities and progress on period of performance outcomes. Applicants should provide a high-level work plan that covers the duration of the project, with more detail for the first year of the project. The work plan must include, at minimum:

Activities and timelines to support achievement of NOFO outcomes. These activities must be in alignment with the NOFO logic model and have appropriate performance measures or milestones for accomplishing tasks.

Staff and administrative roles and functions to support implementation of the award.

Monitoring and evaluation plan to determine quality and effectiveness of program activities within each country (as per previous section).

A suggested work plan format is provided below. If using this format, the table should be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Applicant may use a different work plan format as long as it is clear how the components 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.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance

Measurement section]

Strategies and Process Measure Responsible Completion Date https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75%23se45.1.75_1302%2245%20CFR%2075.302 https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75%23se45.1.75_1302%2245%20CFR%2075.302

Activities [from Evaluation and Performance

Measurement section]

Position /Party

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.

Throughout the five-year period of performance, 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

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, and other VPD control or elimination 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 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: U2R

3. Fiscal Year: 2021

4. Approximate Total Fiscal Year Funding: $750,000

5. Approximate Period of Performance Funding: $3,750,000

This amount is subject to the availability of funds.

Estimated Total Funding: $3,750,000

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

7. Expected Number of Awards: 1

8. Approximate Average Award: $750,000 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

11. Estimated Award Date: 04/15/2021

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.

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 Eligibility – KidRisk Inc. Eligibility is limited to:

KidRisk Inc.

7512 Dr. Phillip Blvd.

Ste. 50-523 Orlando, Florida 32819

3. Justification for Less than Maximum Competition The applicant has developed the only available integrated, dynamic, global model of poliovirus infection and the effects of interventions such as using one vaccine versus another with attendant risks and costs. Their process has involved over a decade of continuing extensive literature review, data-gathering and iterative model development, through close collaboration with CDC and other international polio experts. Through this process, the applicant's staff have developed extensive knowledge and expertise concerning poliovirus vaccines, infections, outbreaks, policies, risks and costs. This collaboration successfully modeled all previous outbreaks and the endemic disease situations to allow evaluation of multiple policy decisions and tactical operations. Furthermore, the programming for this model is copyrighted and represents the intellectual property of the applicant, making them the solely qualified collaborator for the complexities of polio eradication. No other groups have conducted the extensive data gathering, literature review, and complex model development incorporating economic decision-making. The applicant, is the only organization that can provide an integrated economic dynamic disease, risk and decision analytic model of global and domestic policy issues to meet all the GPEI program requirements -- including cost and time constraints.

Their performance under past CDC cooperative agreements and contracts has established a track record for timely completion of tasks. Guidance provided by the outputs of the applicant's global model is urgently needed to address new policy questions that have arisen and others that will arise over the next five years. Policy questions to be addressed include: addressing the remaining challenges and barriers to polio eradication; assessment and mitigation of new risks of VDPVs; introduction of a stabilized, novel OPV; use of antivirals; and the implications of various policy decisions related to changes in immunization policy.

The impact of disapproval of a sole source justification is that without a continuing collaboration, there would be additional years needed to derive a similar comprehensive model with another recipient (modeling group) and to develop the needed expertise in interpretation of the literature for all the assumptions and variables included in such models. Given the delays and threats to the goal of polio eradication, working with a different recipient to develop another global model to provide the information necessary to create an expensive multi-year delay in critical tools for decision making. This would negatively impact GPEI effectiveness in meeting polio eradication goals resulting in increased morbidity and mortality from polio.

For this project, a new NOFO, no same or similar deviation has been previously requested.

However, the previous NOFO, CDC-RFA-GH16-1602 was approved as a single source eligibility NOFO also to Kid Risk Inc.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No

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/index.html.

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 usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/index.html https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/

Step System Requirements Duration Follow Up 1 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 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/index.

html 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://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

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 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/index.html%20 https://www.sam.gov/index.html%20 https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

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

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) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 02/11/2021 , 11:59 p.m. 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.

Date for Information Conference Call N/A

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

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.

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. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

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

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent LOI is not requested or required as part of the application for this NOFO.

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

https://www.grants.gov

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description.

Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period.

See the Strategies and Activities section of the CDC Project Description.

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. 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: