CDC-RFA-CK19-1904_NOFO_Combined_2019_03_27_revised.pdf

2019 Epidemiology and Laboratory Capacity for Prevention and Control of Emerging

Infectious Diseases (ELC)

CDC-RFA-CK19-1904

National Center for Emerging and Zoonotic Infectious Diseases

(NCEZID)

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Estimated Publication Date: March 1, 2019

Contents Part I. Overview

A. Federal Agency Name:

B. Funding Opportunity Title:

C. Announcement Type: New - Type 1

D. Agency Funding Opportunity Number:

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

F. Dates

G. Executive Summary

Part II. Full Text

A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part III. Program and Project Attachments

A. Program and Project Summaries with Tiered Activities

B. Program and Project Detailed Guidance Attachments

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, Outbreak Investigation Response and Reporting, Surge Efforts and Interventions

Section II: Emerging Infectious Disease Programs

F: Foodborne, Waterborne, Enteric, and Environmentally Transmitted Diseases: Surveillance, Detection, Response, Reporting, and Prevention

G: Healthcare-associated Infections and Antibiotic Resistance Program

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

Part I. Overview 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) / Agency for Toxic Substance and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

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 http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-CK19-1904

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

93.323

F. Dates

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

N/A

2. Due Date for Applications:

Applications are due on May 10, 2019, 11:59 p.m. Eastern Standard Time, on www.grants.gov

3. Date for Informational Conference Call:

An informational call will be held approximately two weeks after posting. The date and time for this call is March 14, 2019 at 3:00 p.m. ET.

Dial-in number: (773) 756-0169 (toll) or (800) 857-4945 (toll free) Passcode: 3092790 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 health departments.

a. Eligible Applicants:

Limited competition

b. NOFO Type:

Cooperative Agreement

c. Approximate Number of Awards:

d. Total Period of Performance Funding:

$1,000,000,000

Approximately $200M awarded annually

e. Average One Year Award Amount:

$3,125,000

f. Total Period of Performance Length:

g. Estimated Award Date:

08/01/2019

h. Cost Sharing and / or Matching Requirements:

N/A

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, CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) 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 infections and modernize public health laboratory capacity. Ebola and Zika funding began as one-time emergency funding, while antibiotic resistance 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 Agency priorities, including 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 NOFO 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. Previous ELC cooperative agreement announcement numbers include CI04-040, CI07-701, CI07-702, CI10-1012, CK12-1201, and CK14- 1401. The program has grown to become one of CDC’s key nationwide cooperative agreements for supporting state and local infectious disease control capacity for 1) cross-cutting epidemiology, laboratory and health information systems, 2) infectious disease programs (Food and Water, Healthcare Associated Infections/Antimicrobial Resistance, and Vector-borne), and 3) disease-specific projects.

This also builds upon special funding allocations in the previous NOFO that helped to enhance epidemiology, laboratory, and health information systems to specific disease and health threats.

2. CDC Project Description

a. Approach

CDC-RFA-CK19-1904

OVERALL ROADMAP FOR THE EPIDEMIOLOGY AND LABORATORY CAPACITY FOR

PREVENTION AND CONTROL OF EMERGING INFECTIOUS DISEASES (ELC)

The ultimate goal of the ELC is to prevent the transmission of future outbreaks of known and emerging (or re-emerging) infectious diseases while reducing the exposure to current infectious disease threats. We achieve this by enhancing the capacity of public health agencies to effectively detect, respond to, control, and prevent known and emerging (or re-emerging) infectious diseases threats.

Core Areas/Strategies

ELC provides funding to recipients to implement these strategies.

Short-term

ELC recipients produce these outputs as a result of implementing the strategies.

Mid-term

As a result of the outputs, ELC recipients will achieve these outcomes.

Long-term

As a result of achieving the mid-term outcomes, these longer term outcomes will be achieved.

1. 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-HIT

• 1h: Advance electronic information exchange implementation

• 1i: Sustain and/or enhance information systems

Effective public health workforce prepared to respond to infectious disease threats

Investigations conducted

Best practices for outbreak management in place

Surveillance of infectious disease conducted

Best fit and/or modern laboratory diagnostic techniques and capabilities in place

Laboratory operations are maintained and improved

Coordination between laboratories within the state and/or within laboratory networks are

Improved understanding of the epidemiology and incidence of infectious diseases

Improved surveillance

• Improved completeness of data

• Improved timeliness of reporting

• Increased distribution and use of data to public health partners

Improved efficiencies between laboratories and their networks, use of public health resources

Infectious disease data is automated and efficiently transmitted Electronic mechanisms for data exchange are in place

More efficient and accurate public health reporting

More rapid detection of cases and outbreaks

More timely, complete and effective investigation efforts:

• Response to outbreaks

• Investigation of outbreaks

• Implementation of control measures

Improved use of data to:

• Inform response and control

• Improve public health practice

• Inform program and policy development

• Develop and implement public health best practices and/or guidelines

Public and healthcare providers adopt appropriate practices to

2. Prevention and Intervention

• 2a: Implement public health interventions and tools

• 2b: Develop/advance policies to improve public health capabilities

• 2c: Implement health promotion strategies improved

Increased interoperability between information systems and entities

Integrated surveillance systems

Development, implementation and evaluation of strong public health interventions

Partnerships and collaborations formed

Increased awareness among:

• Public regarding infectious disease risks and protective actions

• Providers regarding appropriate public health actions

Enhanced coordination on prevention and control of infectious diseases between partners protect themselves and the public from infectious diseases

3. Communications, Coordination and Partnerships

• 3a: Coordinate and engage with partners

• 3b: Information dissemination

i. Purpose The purpose of the activities supported through 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 areas; (1) surveillance, detection and response, (2) prevention and intervention, and (3) communications, coordination and partnerships. Any surveillance data collection efforts should leverage existing tools and systems and should adhere to national data and technology standards to support interoperability of system- to-system data exchange.

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, recipients are expected to show measurable progress made toward the outcomes for this five-year period of performance. Each of ELC’s Cross-Cutting, Program and disease-specific Projects focus on achieving one or more of the outcomes from the ELC Overall Roadmap (see 2. CDC Project Description, a. Approach section above). Each program and project have specified this information in the ‘Outcomes’ section of each project attachment. As such, the specific outcomes recipients are expected to demonstrate progress for will depend on the Programs or Projects funded.

The mid-term outcomes will also be achieved during this period of performance: (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 Applicants should apply for programs and projects that will support identified infectious disease detection, prevention, and control needs in their jurisdictions. Note that each program and project has a separate attachment (in Part III, Section B. Program and Project Detailed Guidance Attachments) which details sub-activities, funding strategies other key criteria. Applicants may apply to any program or project, depending on jurisdiction-specific needs. 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.

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: Surveillance, Detection, Response, Reporting, and Prevention

G. Healthcare-associated Infections and Antibiotic Resistance Program

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.

1. 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

2. 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

3. 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

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

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. Recipients should have a coordinated understanding and approach to all health information systems strengthening and enhancements occurring across the ELC portfolio. 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.

Each Program or Project has its own description of required or suggested collaborations if applicable.

This information may be found in Part III, Section B. Program and Project Detailed Guidance Attachments.

b. 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.

c. With organizations not funded by CDC:

Each program or project that appears in Part III of this NOFO has its own program guidance that provides collaboration (if applicable) information specific to that CDC program. This information may be found in Part III, Section B. Program and Project Detailed Guidance Attachments.

2. Target Populations Each program or project that appears in Part III of this NOFO has its own program guidance that provides a target population (if applicable) information specific to that CDC program. This information may be found in Part III, Section B. Program and Project Detailed Guidance Attachments.

a. Health Disparities Recipients are encouraged to consider underserved populations (e.g., rural, tribal, and ESOL populations, people with disabilities) throughout their ELC portfolio of activities, especially where infectious disease health disparities and high health burdens exist. Each program or project that appears in Part III of this NOFO has its own program guidance that provides additional information about Health Disparities (if applicable) to that CDC program. This information may be found in Part III, Section B.

Program and Project Detailed Guidance Attachments.

iv. Funding Strategy The dollar amounts listed below are the estimated total annual funding, and number of awards expected for each program or project. More detail on each program or project’s funding strategy may be found in Part III. Section B. Program and Project Detailed Guidance Attachments.

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 and Antibiotic Resistance Program 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: Building Comprehensive Programs to Identify, Diagnose, Report, Prevent, and Respond $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) $660,000; 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 recipients 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, an overall Data Management Plan (DMP) is required for each recipient. Funds provided under this cooperative agreement may be used to support activities that assure compliance with CDC’s 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. 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. Additional details and resources for developing a DMP can be found in Part II, D. 18. Data Management Plan in this NOFO.

ii. Applicant Evaluation and Performance Measurement Plan If needed, ELC will work with recipients during the first six months of the period of performance 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). Specific expectations around capacity may be found in Part III, Section B. Program and Project Detailed Guidance Attachments. Applicants also must be fully capable of managing the required procurement efforts, including the ability to write and award contracts in accordance with 45

CFR §75.

d. Work Plan Each project the applicant is applying for (see Part III, Section B. Program and Project Detailed Guidance Attachment) must include a work plan. Work plans should be detailed and should focus on the first year of the period of performance 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. Specific expectations for the Work Plans may be found in Part II, Section D10. Project Narrative, and Part III, Section B. Program and Project Detailed Guidance 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:

• 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 to assist with programmatic documentation of performance.

f. CDC Program Support to Recipients 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

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$200,000,000

5. Approximate Period of Performance Funding:

$1,000,000,000, subject to the availability of funds.

6. Total Period of Performance Length:

Five years

7. Expected Number of Awards:

8. Approximate Average Award:

$3,125,000, subject to availability of funds.

9. Award Ceiling:

None

10. Award Floor:

None

11. Estimated Award Date:

August 1, 2019

12. Budget Period Length:

12 months

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

Extremely limited opportunities for DA may be available through this NOFO.

An official state, local or territorial government applicant may request that CDC provide DA as a part of the grant awarded through this NOFO. Recipients may request that CDC provide DA to support assignment of federal staff through CDC fellowships (e.g., Epidemic Intelligence Officers, Laboratory Leadership Service Fellows). 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 recipient. Additional information about available DA may be found in Part III, Section B. Program and Project Detailed Guidance Attachments.

C. Eligibility Information

1. Eligible Applicants 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).

2. Additional Information on Eligibility Specific ELC Programs and Projects may have additional eligibility requirements associated with them.

If so, these will be noted in the project-specific attachments.

3. Justification for Less than Maximum Competition The Epidemiology and Laboratory Capacity for the Prevention and Control of Infectious Diseases (ELC) is a cooperative agreement to build the governmental public health system capacity to address emerging infectious disease prevention, detection, and response of our nation. Capacity built and sustained in health departments with jurisdictional authority for public health helps prevent disease through better surveillance of known and emerging infectious diseases, which leads to more rapid response to disease outbreaks and better development, implementation and evaluation of public health interventions.

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 and are responsible for the protection of the health and welfare of their respective communities. Governmental public health agencies execute this responsibility through their unique access to health information, laboratory samples, and their legal powers to investigate diseases through interactions with patients, the health care system, other governmental agencies (e.g., environmental agencies, emergency response agencies), and the law enforcement abilities of state and local government. In addition to these legal authorities, eligible applicants must have functional infectious disease detection, prevention, and control programs; and already existing public health outbreak response infrastructure and capacity. Established capacity and infrastructure to detect, prevent and control infectious disease outbreaks are critical requirements, to enable recipients to act expeditiously to implement the activities in this cooperative agreement.

Since 2012, under CK12-1201 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 the Marshall Islands, Republic of Palau, US Virgin Islands). State recipients are required to document their partnerships and support for local health departments that are not receiving federal funds directly, and award amounts to states take into account the needs of the local jurisdictions within the state. For local jurisdictions, these health departments represent the largest population centers and align with related public health programs, including the Public Health Emergency Preparedness (PHEP) program and the Public Health Crisis Response cooperative agreement. By aligning these three programs, local jurisdictions can best leverage existing capacities and coordinate efforts both for public health emergencies and for ongoing infectious disease response efforts. These governmental entities continue to be critical partners to respond to infectious disease threats across the nation. Under CK12- 1201, ELC recipients were required to build local infrastructure for the coordination of all future ELC-funded programs. The infrastructure and relationships built in funded jurisdictions through ELC since 2012 are a critical prerequisite to the achievement of program goals, to sound fiscal stewardship, and to maximize the benefit to the Nation's public health in 2019-2024.

The ELC is approved to limit eligibility for CK19-1904 to only those governmental public health agencies previously funded to ensure successful progress in meeting ELC program outcomes. There are significant programmatic needs, which only the prior-funded 64 jurisdictions have the legal authorities, intergovernmental relationships, and capacity for adequately addressing. Should this request to limit eligibility not be approved, the intended outcomes under the ELC Cooperative Agreement, CK19-1904, are at significant risk of not being completed due to entrance of additional site that lack the responsibilities, authorities, and technical capability necessary to be successful. Such an outcome would jeopardize the nation's system for responding to infectious disease threats.

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

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

D. Application and Submission Information

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

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements. The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http://fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge.

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

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an 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 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/webf orm) 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 www.sam.gov 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

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) N/A

b. Application Deadline Applications are due on May 10, 2019, 11:59 p.m. Eastern Standard Time, on www.grants.gov

An informational call will be held approximately two weeks after posting. The date and time for this call is March 14, 2019 at 3:00 p.m.

Dial-in number: (773) 756-0169 (toll) or (800) 857-4945 (toll free) Passcode: 3092790

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 (ELC or others) 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 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 CDC Risk Questionnaire, OMB Control Number 0920-1132 annually. The 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.”

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.

9. Project Abstract Summary (Maximum 1 page)

A Project Abstract is required for submission of the application.

10. Project Narrative

2019 ELC Project Narrative Guidance:

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 in this section below, for more detail). Applications must include a Project Approach for each ELC program and project applied for that includes a problem statement, justification, and applicant capacity (see section b in this section below, for more detail). Each Project Approach must be succinct, easily understood, and in the order outlined in this section, which will be reflected in the application template tools distributed by ELC. The Project Approaches must address outcomes and activities to be conducted over the next budget period, but should also address the entire period of performance as identified in Part III, Section B. Program and Project Detailed Guidance Attachments.

ELC highly recommends recipients use the application template tools provided by ELC for NOFO submission. These tools will capture all required information for each ELC program and project and will be distributed to applicants at the time this NOFO is published.

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…