CDC-RFA-CK19-1904 FINAL.pdf

Centers for Disease Control

National Center for Emerging and Zoonotic Infectious Diseases

2019 Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC)

CDC-RFA-CK19-1904

Application Due Date: 05/17/2019

2019 Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC)

CDC-RFA-CK19-1904

TABLE OF CONTENTS

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

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

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-CK19-1904. 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) B. Notice of Funding Opportunity (NOFO) Title:

2019 Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

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

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK19-1904

E. Assistance Listings (CFDA) Number:

93.323 F. Dates:

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

Is a LOI:

N/A

2. Due Date for Applications:

3. Date for Informational Conference Call:

N/A Not Applicable

05/17/2019, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

N/A

An informational call will be held approximately two weeks after posting. The estimated date and time for this call is March 21, 2019 at 3:00 p.m.

G. Executive Summary:

1. Summary Paragraph:

The Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) Notice of Funding Opportunity (NOFO) builds upon the program that was initiated in 1995 as one of the key activities under CDC?s plan to address emerging infectious disease threats. The purpose of this NOFO is to protect the public health and safety of the American people by enhancing the capacity of public health agencies to effectively detect, respond, prevent and control known and emerging (or re-emerging) infectious diseases. This is accomplished by providing financial and technical resources to (1) strengthen epidemiologic capacity; (2) enhance laboratory capacity; (3) improve information systems; and (4) enhance collaboration among epidemiology, laboratory, and information systems components of public https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov health departments.

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 64

d. Total Period of Performance Funding: $1,500,000,000

e. Average One Year Award Amount: $3,125,000 Figure is estimate only

f. Number of Years of Award: 5

g. Estimated Award Date: 08/01/2019

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

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview The goal of the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) program is to reduce illness and related deaths caused by a wide range of infectious disease threats. The ELC Program provides annual funding, strategic direction and technical assistance to domestic jurisdictions for core capacities in epidemiology, laboratory, and health information technology activities. In addition to strengthening core infectious disease capacities nationwide, this cooperative agreement also supports a myriad of specific infectious disease programs.

In the last five years, NCEZID?s extramural funding has increased from $109 million in FY 2013 to $302 million in FY 2017. This increase coincides with increased responsibilities at the state and local level for emerging infectious disease control, notably for emergency responses to Ebola and Zika, and for expanded investment to curb antibiotic resistant (AR) infections and modernize public health laboratory capacity. Ebola and Zika funding began as one-time emergency funding, while AR funding is expected to reoccur annually, and base vector-borne disease funding is beginning to grow. Together with food- and water-borne disease program growth, these investments have moved from capacity building to program delivery. In other infectious disease areas, capacity building is still the focus of investments.

b. Statutory Authorities Public Health Service Act Sections 301(a) [42 U.S.C. 241(a)] and 317(k) (2) [42 U.S.C. 247b

(k) (2)], as amended and the Patient Protection and Affordable Care Act (PL 111-148), Title IV, Sections 4002 and 4304 (Prevention and Public Health Fund).

c. Healthy People 2020 The ELC supports the following activities aligned with Health People 2020 Topics and Objectives: Food Safety, Health Communication and Health Information Technology, Healthcare Associated Infections, Immunization and Infectious Diseases, Public Health Infrastructure, and Respiratory Diseases.

d. Other National Public Health Priorities and Strategies ELC supports CDC?s Agency priorities including Winnable Battles: Healthcare Associated Infections (HAI) and Food Safety. Other National Public Health Priorities and Strategies are defined in individual project attachments.

e. Relevant Work This ELC Competing Continuation builds upon the program that was initiated in 1995 as one of the first key activities under CDC?s plan to address emerging infectious disease threats. The program has grown to become one of CDC?s key nationwide cooperative agreements for supporting state and local infectious disease capacity for 1) cross-cutting epidemiology, laboratory and health information systems, and 2) specific infectious disease-area Programs and Projects. This also builds upon special funding allocations (e.g., Ebola, Zika, Hurricane funding, etc.) that helped to enhance epidemiology, laboratory, and health information systems to specific disease and health threats.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose The purpose of this NOFO is to protect the public health and safety of the American people by enhancing the capacity of public health agencies to effectively detect, respond, prevent and control known and emerging (or re-emerging) infectious diseases. ELC is CDC?s national funding strategy to support state, local, and territorial health departments to battle infectious disease threats in the U.S. This is accomplished by providing financial and technical resources to support the implementation of three core strategies; (1) surveillance, detection and response,

(2) prevention and intervention strategies, and (3) communications, coordination and partnerships. ELC resources may support each of these individually however, it is only through integration that these complementary core areas are optimized.

ii. Outcomes As reflected in the ELC Overall Roadmap, awardees are expected to show measurable progress made toward the outcomes for this five-year project period. Each of ELC?s Cross-Cutting, Program and disease-specific Projects focuses on one or more of these outcomes; these are specified in the ?Outcomes? section of each project attachment. As such, the specific outcomes awardees are expected to demonstrate progress for will depend on the Programs or Projects funded.

The mid-term outcomes will also be achieved during this project period: (1) Effective public health workforce better prepared to respond to infectious disease threats; (2) Improved understanding of the epidemiology and incidence of infectious diseases; (3) Improved surveillance: Improved completeness of data, Improved timeliness of reporting, Increased distribution and use of data to public health partners; (4) Improved efficiencies between laboratories and their networks/use of public health resources; (5) Infectious disease data is automated and efficient; (6) Electronic mechanisms for data exchange are in place; (7) Increased awareness of: Public regarding infectious disease risks and protective actions, Providers regarding appropriate public health actions.

Long term, ELC will contribute to: (1) More efficient and accurate public health reporting; (2) More rapid detection of cases and outbreaks; (3) More timely, complete and effective investigation efforts: Response to outbreaks, Investigation of outbreaks, and Implementation of control measures; (4) Improved use of data to: Inform public health response and control, Improve public health practice, Inform program and policy development, Develop and implement public health best practices and/or guidelines; (5) Public and healthcare providers adopt appropriate practices to protect themselves and the public from infectious diseases.

iii. Strategies and Activities Note that each project has a separate attachment (identified below) which details sub-activities and other key criteria. Furthermore, the planning and preparation of your response to this NOFO, and implementation and monitoring/evaluation of all ELC activities must be coordinated via your established ELC Governance Team.

The framework of this Cooperative Agreement is organized into three major sections of content:

Section I: Cross-cutting Emerging Infectious Disease Capacity, Systems and Leadership

A. Cross-Cutting Epidemiology and Laboratory Capacity B. ELC Leadership, Management and Administration C. Health Information Systems Capacity D. Impact and Evaluation E. Cross-Cutting Emerging Issues: Enhanced Surveillance, Investigation Response and

Reporting, Surge Efforts and Interventions

Section II: Emerging Infectious Disease Programs F. Foodborne, Waterborne, Enteric, and Environmentally Transmitted Diseases: Capacity Building for Surveillance, Detection, Response, Reporting, and Prevention G. Healthcare-associated Infections (HAI) and Antibiotic Resistance (AR) G1. Healthcare-associated Infections, Antibiotic Resistance, and Antibiotic Stewardship G2. Antibiotic Resistance Laboratory Network (AR Lab Network) H. Vector-borne Diseases: Building Comprehensive Programs to Identify, Diagnose, Report, Prevent, and Respond Section III: Disease-Specific Projects I. Mycotics: Detecting and Preventing Fungal Infections J. Binational Border Infectious Disease Surveillance (BIDS) Program K. Global Migration, Border Interventions and Migrant Health L. Prion Surveillance M. Rabies Surveillance N. Parasitic Diseases Surveillance O. Enhanced Vaccine-Preventable Disease (VPD) P. Legionnaires? Disease Prevention Q. Influenza Surveillance and Diagnostic Testing R. Non-Influenza Respiratory Diseases: Diagnostics, Reporting, and Surveillance S. Threat of Antibiotic-Resistant Gonorrhea: Rapid Detection and Response Capacity T. Gonococcal Isolate Surveillance Project (GISP) U. Syphilis and HIV Prevention Through Social, Sexual and Phylogenetic Networks V. Human Papillomavirus Surveillance Among Men W. Infants with Congenital Exposure: Surveillance and Monitoring to Emerging Infectious Diseases and Other Health Threats As described above, ELC is a complex Cooperative Agreement with cross-cutting and large infectious disease programs, as well as a myriad of disease-specific projects. Within each program or project section, the activities will be grouped by key strategies that link back to the mid- and long-term outcomes (see below and Roadmap in Section 2.a). Programs and Projects will vary in the number of strategies applied, and specific activities associated with these strategies are described in the program and project attachments within this NOFO.

A. Surveillance, Detection and Response 1a: Enhance workforce capacity

1b: Enhance investigation and outbreak response 1c: Improve surveillance and reporting 1d: Strengthen laboratory testing for response 1e: Enhance laboratory testing for surveillance and reporting 1f: Improve laboratory coordination and outreach to improve efficiency 1g: Enhance coordination between epi-lab 1h: Advance electronic information exchange implementation 1i: Sustain and/or enhance information systems

B. Prevention and Intervention Strategies 2a: Implement public health interventions and tools 2b: Develop/advance policies to improve public health capabilities 2c: Implement health promotion strategies

C. Coordination and Partnerships 3a: Coordinate and engage with partners 3b: Information dissemination

In this NOFO Programs and Projects have outlined a path to meet minimum expectations, expand or enhance these capacities, and even provide leadership amongst other jurisdictions.

Each Program or Project section will include an activities summary table, grouping the activities by three tiers:

Tier 1: Core required activities within the program Tier 2: Enhanced or expanded activities Tier 3: Advanced activities, Regional Activities, Centers of Excellence or similar

1. Collaborations Internal coordination for effective ELC portfolio management Since 2012, all ELC recipients were required to implement a governance structure for the management and oversight of the portfolio of ELC activities in their jurisdiction. All ELC recipients are required to maintain an active ELC Governance Team comprised of a Principal Investigator and representatives from epidemiology, laboratory, and health information systems (the PI may serve as a representative for one of these areas). Representatives on the Governance Team should be positioned within the organization such that they may make strategic recommendations and decisions about the activities supported with ELC resources. Members are expected to communicate with other staff regarding various aspects of ELC activities within the jurisdiction.

Building upon previous year?s successes and challenges, the role of this Team is to work together to assure sufficient and appropriate oversight and integration of the ELC Cooperative

Agreement planning and implementation. Funding to support the ELC program as a whole should complement and be closely coordinated, with other CDC programs related to improving surveillance for, and response to, infectious diseases, for example the Emerging Infections Program (EIP) and the Public Health Emergency Preparedness (PHEP) cooperative agreements. ELC recipients should also be aware of, and are strongly encouraged to use, resources designed as management tools that improve efficiency and promote sustainability of Public Health Labs (PHLs) and their services. Two of these resources have been developed in a collaborative fashion between CDC and the Association of Public Health Laboratories (APHL) under the Laboratories Efficiencies Initiative (LEI): (1) the LEI Informatics Self-Assessment Tool for Public Health Laboratories and (2) the online National PHL Test Service Directory.

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

Each Program or Project has its own description of required or suggested collaborations if applicable. This information may be found in each of the specific attachments.

b. With organizations not funded by CDC:

Each program or project that appears in Part II of this NOFO has its own program guidance that provides collaboration (if applicable) information specific to that CDC program.

2. Target Populations Each program or project that appears in Part II of this NOFO has its own program guidance that provides a target population (if applicable) information specific to that CDC program.

a. Health Disparities N/A

iv. Funding Strategy (for multi-component NOFOs only) Section I: Cross-cutting Emerging Infectious Disease Capacity, Systems and Leadership

A. Cross-Cutting Epidemiology and Laboratory Capacity $25,600,000; 64 awards B. ELC Leadership, Management and Administration $8,000,000 to $11,000,000; 40-50 awards C. Health Information Systems Capacity $32,000,000; 64 awards D. Impact and Evaluation $600,000; 5 awards E. Cross-Cutting Emerging Issues: Enhanced Surveillance, Investigation Response and

Reporting, Surge Efforts and Interventions (estimated) up to $500,000; up to 64 awards

Section II: Emerging Infectious Disease Programs F. Foodborne, Waterborne, Enteric, and Environmentally Transmitted Diseases: Capacity Building for Surveillance, Detection, Response, Reporting, and Prevention $33,000,000; 56-59 awards G. Healthcare-associated Infections (HAI) and Antibiotic Resistance (AR) G1. Healthcare-associated Infections, Antibiotic Resistance, and Antibiotic Stewardship

$28,000,000; 57 awards G2. Antibiotic Resistance Laboratory Network (AR Lab Network) $2,250,000; up to 56 awards H. Vector-borne Diseases: Detection, Response, Reporting and Prevention $16,000,000; 60 awards Section III: Disease-Specific Projects I. Mycotics: Detecting and Preventing Fungal Infections $600,000; 20 awards J. Binational Border Infectious Disease Surveillance (BIDS) Program $750,000; 1-4 awards K. Global Migration, Border Interventions and Migrant Health $230,000; 3-5 awards L. Prion Surveillance $500,000; 7 awards M. Rabies Surveillance $125,000; 2 awards N. Parasitic Diseases Surveillance $100,000; 10 awards O. Enhanced Vaccine-Preventable Disease (VPD) $6,400,000; 64 awards P. Legionnaires? Disease Prevention $3,000,000; 25 awards Q. Influenza Surveillance and Diagnostic Testing $8,100,000; 57 awards R. Non-Influenza Respiratory Diseases: Diagnostics, Reporting, and Surveillance $750,000;

10-15 awards S. Threat of Antibiotic-Resistant Gonorrhea: Rapid Detection and Response Capacity $5,164,038; 8 awards T. Gonococcal Isolate Surveillance Project (GISP) $915,000; 25 awards U. Syphilis and HIV Prevention Through Social, Sexual and Phylogenetic Networks $1,400,000; 2 awards V. Human Papillomavirus Surveillance Among Men $375,000; 3 awards W. Infants with Congenital Exposure: Surveillance and Monitoring to Emerging Infectious Diseases and Other Health Threats $3,000,000; 4-9 awards

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The purpose of evaluation and performance measurement is to help CDC and ELC awardees monitor the extent to which activities planned were successfully completed, demonstrate how capacity building activities contribute towards program outcomes, and inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance.

Each of the ELC Program or Projects require a detailed Evaluation and Performance Measurement Strategy described in their individual attachment (i.e., requirements for reporting of performance measures.).

In addition, funds provided under this cooperative agreement may be used to support activities that assure compliance with CDC?s Data Management Plan (DMP). A DMP is required if the NOFO involves the collection or generation of public health data. The goal of the policy is to ensure public access to federally funded public health data. This specifically requires the development of Data Management Plans (DMPs) for ELC activities that includes collection of public health data. One overall DMP is requested; however, if the information below differs by a specific ELC program or project, please describe those exceptions. DMPs should be as complete as possible but CDC can work jointly with ELC recipients within the first 6 months after award to finalize them. They can be updated as appropriate throughout the life cycle of the data. DMPs should include:

Descriptions of the data to be produced How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights) Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represents, and potential limitations for use Plans for archival and long-term preservation of the data, or explanation of why long-term preservation and access cannot be provided.

The DMP may be submitted as a checklist, paragraph, or other format, as currently, HHS/CDC does not have a standardized DMP template or checklist due to PRA requirements. However, below are DMP examples that applicants can refer to as they develop their DMP:

University of California: http://dmp.cdlib.org/ USGS: http://www.usgs.gov/datamanagement/plan/dmplans.php ICPSR: http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html

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

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

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

If needed, ELC will work with awardees during the first six months of the project period to finalize an evaluation and performance measurement plan to monitor the progress of the activities implemented and outcomes achieved. Each ELC program or project attachment illustrates its specific requirements for the NOFO.

c. Organizational Capacity of Recipients to Implement the Approach The successful ELC recipient must have a demonstrated core organizational capacity in order to effectively conduct the activities for which awards are made. This organizational capacity includes skill sets such as program planning and performance management, partnership development, evaluation, performance monitoring, financial reporting, budget management and administration, personnel management (including developing staffing plans, developing and training workforce and developing a sustainability plan). Applicants also must be fully capable of managing the required procurement efforts, including the ability to write and award contracts in accordance with 45 or 74 C.F.R.

d. Work Plan Each project the applicant is applying (see Part III) must include a work plan. Work plans should be detailed and should focus on the first year of the project period with only a high level plan for subsequent years. Work plans should demonstrate alignment among the outcomes, strategies, activities, timelines, and staffing/collaborations. Additional information on performance measures, data sources, and target population can also be included. (Note:

recipients will incorporate this Work Plan into their Approach for each ELC project they are applying for. See Program and Project Attachments).

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:

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

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.

REDCap may be utilized for the programmatic documentation of performance.

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

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC and recipients share responsibility for successfully implementing the award and meeting identified outcomes. The following are potential areas of substantial involvement, others may also be included:

1. Technical assistance in the following: evaluation, performance measurement, work plan development, program planning, and specific subject matter expertise for ELC Program or Projects.

2. National coordination of activities where appropriate.

3. Targeted Electronic Data Exchange (EDX) technical assistance to public health departments and public health labs.

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: U50 In cooperation with State or local government or other health-related organization, to perform special investigations of communicable diseases and other preventable health conditions, or to evaluate special methods of preventing disease or controlling health conditions.

3. Fiscal Year: 2019 Estimated Total Funding: $1,500,000,000

4. Approximate Total Fiscal Year Funding: $200,000,000 No funding floor or ceiling; numbers are approximate

This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding: $1,500,000,000 No funding floor or ceiling; numbers are approximate

6. Total Period of Performance Length: 5

7. Expected Number of Awards: 64

8. Approximate Average Award: $3,125,000 Per Budget Period Figure is estimate only

This amount is subject to the availability of funds.

9. Award Ceiling: $0 Per Budget Period None

10. Award Floor: $0 Per Budget Period None

11. Estimated Award Date: 08/01/2019

Throughout the period of performance, 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 (period of performance) 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).

12. Budget Period Length: 12 month(s)

13. Direct Assistance Direct Assistance (DA) is available through this NOFO.

Extremely limited opportunities for Direct Assistance (DA) may be available through this

FOA.

An official state, local or territorial government applicant may request that CDC provide Direct Assistance (DA) in the form of federal personnel as a part of the grant awarded through this

FOA. If your request for DA is approved as a part of your award, CDC will reduce the funding amount provided directly to you as a part of your award. The amount by which your award is reduced will be used to provide DA; the funding shall be deemed part of the award and as having been paid to you, the awardee.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

Government Organizations:

State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

2. Additional Information on Eligibility Specific ELC projects may have additional eligibility requirements associated with them. If so, these will be noted in the project-specific attachments.

Only current ELC recipients under CK14-1401 are eligible to apply for this announcement.

This includes the departments of health for all US states, 6 of the largest locals* (Chicago, District of Columbia, Houston, Los Angeles County, New York City, Philadelphia) and all of our US territories and affiliates in the Caribbean and Pacific (American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Puerto Rico, Republic of Palau, US Virgin Islands).

*Population based on last official publication, 2010

3. Justification for Less than Maximum Competition The Epidemiology and Laboratory Capacity for the Prevention and Control of Infectious Diseases (ELC) program has long been administering a cooperative agreement aimed at building public health capacity for our nation. The ELC program targets partnerships with states, and some of the nation’s largest local health departments, U.S. territories and affiliates because these governmental organizations are constitutionally empowered to have the responsibility for the protection of the health and welfare of their respective communities. Since 2012, the ELC has supported public health capacity building activities in all US states, 6 of the largest locals (Chicago, District of Columbia, Houston, Los Angeles County, New York City, Philadelphia) and all of our US territories and affiliates in the Caribbean and Pacific (American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Puerto Rico, Republic of Palau, US Virgin Islands).

Capacity built and sustained by the ELC helps prevent disease through better surveillance of known and emerging infectious diseases, leading to more rapid response to disease outbreaks and better development, implementation and evaluation of public health interventions. Future activities of the new 5-year cooperative agreement will directly build upon the existing capacity and infrastructure currently supported by ELC funding. Foundational capacity is essential for implementation of future work.

Current ELC recipients are uniquely qualified to ensure that the breadth of the work and significant financial resources provided through the ELC cooperative agreement are administered appropriately. The ELC program is very complex and currently has approximately 26 different partner programs at CDC in addition to a number of funding ‘types’. Upon becoming an ELC recipient, a jurisdiction must develop the local infrastructure for the coordination of all ELC-funded programs. Since 2012, existing ELC recipients have demonstrated efficacy in managing a broad portfolio of activities through the required ELC Governance Team structure. The existing infrastructure for these relationships within current ELC jurisdictions will continue to be a critical prerequisite to the achievement of program goals, to sound fiscal stewardship, and to maximize the benefit to public health.

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. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/ od/ pgo/ funding/ docs/ Financial ReferenceGuide.pdf.

1. Required Registrations http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf

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 www.SAM.gov.

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.

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 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 issues a new DUNS number check online at (http:// fedgov.dnb.

com/ webform) or call 1-866-705-

2 System for Award Management

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and

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-https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd%20-gov/home.do

(SAM)

formerly Central Contractor Registration

(CCR)

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) gov/home.do Calls: 866-606-

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 the 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 to 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.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488-2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

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) https://fsd.gov/fsd%20-gov/home.do https://www.grants.gov mailto:ogstims@cdc.gov

Due Date for Letter of Intent: N/A N/A

b. Application Deadline Due Date for Applications: 05/17/2019 , 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.

An informational call will be held approximately two weeks after posting. The estimated date and time for this call is March 21, 2019 at 3:00 p.m.

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.

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

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 Is a LOI: Not Applicable 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 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.

A Project Abstract is required as a part of this application.

10. Project Narrative Multi-component NOFOs may have a maximum of 15 pages for the “base” (subsections of the Project Description that the components share with each other, which may include target population, inclusion, collaboration, etc.); and up to 4 additional pages per component for Project Narrative subsections that are specific to each component.

Text should be single spaced, 12 point font, 1-inch margins, and number all pages.

Page limits include work plan; content beyond specified limits may not be reviewed.

Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity Announcement. 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.

The ELC application must be written according to the following outline. The entire application should contain a single, overarching ?Background & Overview? (see sections a. i-iv below, for more detail). Applications for each ELC program or project must contain a complete ?Project Approach? narrative that includes a problem statement, justification, and applicant capacity (see section b below, for more detail). Each Program/Project Narrative must be succinct, easily understood, and in the order outlined in this section (which will be reflected in the application templates applicants will use which the ELC Program will distribute). The narratives must address outcomes and activities to be conducted over the next budget period, but should also address the entire project period as identified in the CDC Project Description sections.

a. Background & Overview (Only one per application): Applicants must provide a description of relevant background information that includes the context of the problem. Specifically:

i. Jurisdictional Overview and Main Challenges: Provide information on the jurisdiction?s population size, demographic characteristics, and morbidity and mortality related to infectious diseases (e.g., priority infectious diseases in the jurisdiction).

ii. Structure and Organization: Provide an overview of the structure of jurisdiction?s health department (e.g. centralized, decentralized, hybrid) and where leadership involved in this ELC Cooperative Agreement reside https://www.grants.gov within the health department?s structure and describe the current process for supporting local public health concerns (including tribal governments within the jurisdiction, if applicable) and associated health departments.

Next, describe challenges or limitations expected across organizational (especially as it relates to the integration of epidemiology, laboratory and health IT), fiscal, administrative, and/or programmatic areas in the jurisdiction. Also include measures to overcome these challenges, to achieve full implementation of the activities proposed in this application.

This could include references to resources being requested through ELC?s new ?Leadership, Management and Administration? project.

Describe plans to ensure adequate planning and implementation of activities (e.g., hiring, contracting, procurement, collaborations, etc.) are quickly executed with rigorous tracking and oversight to avoid delays and reduce the potential for unobligated funds remaining at the end of the budget and project period.

iii. ELC Program Leadership, Governance, Integration, and Tracking and Reporting:

1. ELC Governance Team: Each grantee shall maintain an active ELC Governance Team that consists of three individuals who have leadership roles for the health department in epidemiology, laboratory, and health information systems (i.e., one person representing each area); plus the Principal Investigator (PI) if the PI is…