CDC-RFA-OE15-15010501SUPP20.pdf

Centers for Disease Control and Prevention

Center for Surveillance, Epidemiology and Laboratory Services

CDC Partnership: Strengthening Public Health Laboratories

CDC-RFA-OE15-15010501SUPP20

Application Due Date: 04/17/2020

CDC Partnership: Strengthening Public Health Laboratories

CDC-RFA-OE15-15010501SUPP20

TABLE OF CONTENTS

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

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

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- OE15-15010501SUPP20. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

CDC Partnership: Strengthening Public Health Laboratories 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-OE15-15010501SUPP20

E. Assistance Listings (CFDA) Number:

93.322 F. Dates:

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

2. Due Date for Applications: 04/17/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

This is single source cooperative agreement only one applicant is eligible to apply, hence a letter of intent is not applicable.

3. Date for Informational Conference Call:

Thursday April 9, 2020

G. Executive Summary:

1. Summary Paragraph:

This notice of funding opportunity announces the availability of emergency supplemental funding to support the Association of Public Health Laboratories (APHL) efforts that will enhance the capabilities and increase the capacities of Public Health Laboratories (PHLs). This APHL will do by strengthening the effectiveness and functionality of PHLs individually and as components of the national laboratory system to improve public health and prevent, prepare for, and respond to COVID-19 threats. In 2015 APHL was the recipient of a single source umbrella cooperative agreement (CoAg) to strengthen the capacity of PHLs. APHL is therefore uniquely qualified to implement the activities of this supplemental CoAg during this national emergency.

a. Eligible Applicants:

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

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $25,000,000

e. Average One Year Award Amount: $25,000,000

f. Total Period of Performance Length: 1

g. Estimated Award Date: 04/30/2020

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview On January 20, 2020, CDC activated its Emergency Operations Center. On January 31, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the emerging outbreak of coronavirus a “public health emergency of international concern” (PHEIC). On February 11, 2020, the World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease: COVID-19.

On Friday, March 6, the President signed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The supplemental contains more than $8 billion, of which $950 million is specifically directed for grants or cooperative agreements to include:

states, localities, territories, etc. to carry out surveillance, epidemiology, laboratory capacity, infection control, mitigation, communications, and other preparedness and response activities.

Consistent with the supplemental appropriation, funds were to be allocated to support public health laboratories within the United States and its territories. The Centers for Disease Control and Prevention (CDC) is taking a multipronged approach to provide at least $10 million in COVID-19 funding to PHLs. CDC’s approach aims to get public health resources out quickly during the COVID-19 declared emergency and enable broad access and opportunity to COVID- 19 resources.

State, local, and territorial public health laboratories (PHLs) play an indispensable role in protecting the health of Americans from new, emerging, and existing health threats by conducting laboratory testing and providing other science-based services. The work of public health laboratory systems is interdigitated with other aspects of public health work, including epidemiology. Public health professionals and policy makers use actionable information from PHLs daily to identify and prioritize these population health threats, and to develop and implement effective interventions. In order to fulfill their critical public health mission, PHLs must be capable of and effective at detecting and responding to a myriad of threats across a broad and expanding spectrum of health domains, including infectious diseases, such as

COVID-19.

Consistent with the supplemental appropriation, this NOFO aims to support efforts that will enhance the capabilities and increase the capacities of PHLs by: 1) promoting national, state and local PHL systems that collaborate with clinical laboratories; 2) promoting and supporting health systems-oriented laboratory informatics and information sharing practices; 3) using new data exchange technologies and standards-based interoperability; 4) conducting preparedness assessments and facilitating evaluations of new technologies and methods; 5) analyzing biosafety and biosecurity guidelines and regulations and developing best practices and policies to enhance biosafety and biosecurity in PHLs; and 6) developing resources and providing technical assistance to state and local PHLs to ensure capability and capacity to respond to all public health threats.

b. Statutory Authorities Under section 317(k)(2) of the Public Health Service Act [42 USC 247b(k)(2), as amended] and the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116- 123).

c. Healthy People 2030 This NOFO supports the following Healthy People 2020 (http://www.healthypeople.gov) topic areas and objectives:

Global Health Healthcare -Associated Infections Health Communication / Health Information Technology Immunization and Infectious Diseases Preparedness Public Health Infrastructure Respiratory Diseases

d. Other National Public Health Priorities and Strategies This cooperative agreement aligns with, and supports, other relevant national strategies including:

The National Health Security Strategy: https://www.phe.gov/Preparedness/planning/authority /nhss/Pages/default.aspx National Biodefense Strategy: https://www.phe.gov/Preparedness/biodefense-strategy/Pages /default.aspx The HHS Strategic Plan, FY 2018-2022: https://www.hhs.gov/about/strategic-plan/index.html CDC Surveillance Strategy: https://www.cdc.gov/surveillance/index.html http://www.healthypeople.gov/ https://www.healthypeople.gov/2020/topics-objectives/topic/global-health/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-technology/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/preparedness/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/public-health-infrastructure https://www.healthypeople.gov/2020/topics-objectives/topic/respiratory-diseases/objectives https://www.phe.gov/Preparedness/planning/authority/nhss/Pages/default.aspx https://www.phe.gov/Preparedness/planning/authority/nhss/Pages/default.aspx https://www.phe.gov/Preparedness/biodefense-strategy/Pages/default.aspx https://www.phe.gov/Preparedness/biodefense-strategy/Pages/default.aspx https://www.hhs.gov/about/strategic-plan/index.html https://www.cdc.gov/surveillance/index.html

e. Relevant Work This NOFO (CDC-RFA-OE15-15010501SUPP20) builds upon previous and currently funded cooperative agreements that have enhanced the capacity and capabilities of local, state, and national public health laboratories. The currently funded cooperative agreement is described in

CDC-RFA-OE15-1501

https://wwwn.cdc.gov/fundingprofiles/Report_Docs/PDFDocs/Rpt2015/Projects-Funded-through-Prevention-And-Public-Health-Fund-Report-2015.pdf.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose The purpose of this NOFO is to announce the availability of emergency supplemental funding to enable APHL to provide resources and technical assistance to enhance the infrastructure, and strengthen the capacity and capabilities of the nation’s public health laboratories to adequately respond to the demands of the COVID-19 testing, quality and safety, reporting, data management, surveillance, and epidemiology.

ii. Outcomes This NOFO is expected to demonstrate measurable progress toward addressing the following outcomes Intermediate Outcomes

More effectively prepared laboratories to respond to public health needs, including emergencies

Improved protection of the public from public health threats More prepared network of public and private laboratories Improved informatics capacity More competent, collaborative, and practice ready PHL workforce Improved laboratory methods, systems, standards, and safety in PHLs Increased laboratory effectiveness in response to public health needs, including emergencies Improved public health laboratory detection and response programs

Long-Term Outcomes

Improve the effectiveness, capabilities, and sustainability of PHLs to prepare for, respond to, and recover from COVID-19

Reduced incidence and prevalence of preventable diseases and public health threats Reduced morbidity and mortality equitably delivered throughout the United States and the world More sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs

iii. Strategies and Activities This NOFO is expected to employ the following overarching strategies listed below:

Conduct preparedness assessments and facilitate evaluations of new technologies and methods, develop resources and provide technical assistance to state and local PHLs to ensure capability and capacity to respond to all public health threats

Analyze biosafety and biosecurity guidelines and regulations and develop best practices and policies to enhance biosafety and biosecurity in PHLs

Promote national, state and local PHL systems that collaborate with clinical laboratories Promote and support health systems-oriented laboratory informatics and information sharing practices, use of new data exchange technologies and standards-based interoperability

Address gaps within state, local, tribal and territorial jurisdictions related to preparedness and COVID-19 response activities, which may include addressing gaps in public health laboratory (PHL) capacity and human surveillance and outreach to at-risk population

Provide guidance to state and local health departments with implementing and scaling-up laboratory testing and data collection to enable identification and tracking of COVID- 19 cases in the communities and implementing of real-time reporting to CDC

The recipient is expected to conduct the following activities:

Conduct regular assessments of laboratory capability and capacity including equipment availability, reagent shortages, assay implementation changes and other pressing issues.

Establish mechanisms that provide interim solutions to temporary supply chain challenges.

Work with CDC and a network of public health laboratories to conduct validation studies and adjust existing tests.

Conduct educational activities in person and online for public health laboratories as travel restrictions require. These will also encompass developing and sharing information on biosafety, including risk assessments, with public health and private clinical laboratories.

Maintain COVID-19 Taskforce to inform laboratory aspects of the response.

Work with public health laboratories to convene at least four forums, which engages private clinical laboratories including academic laboratories to discuss response needs.

Place two APHL Bioinformatics Fellows in relevant laboratories to address COVID-19 needs including direct device reporting and next generation sequencing.

Develop tools and resources to educate partners and the public on laboratory testing processes, test performance and the role of the public health laboratory system in emerging infectious disease response.

Provide technical assistance to public health laboratories to ensure continued availability of PHLIP data accommodating vocabulary and assay changes.

Establish systems for direct device reporting through AIMS to facilitate transfer of COVID-19 data from systems similar to Cepheid GeneExpert and bioMerieux BioFire.

Establish systems to aid public health laboratories in test ordering and reporting of test results

Work with laboratory partners to ensure labs receive updated guidance on appropriate testing algorithms and sample types as additional information is acquired

Provide guidance to state and local health department to ensure data management systems are in place and meet the needs of the jurisdiction

Provide direct coordination and support to CDC’s State Coordination Task Force (SCTF). Activities could include:

o Assign dedicated resources to SCTF and other CDC working groups as needed;

o Activate and scale up organizational emergency response structure;

o Facilitate, support, or attend in person/virtual CDC and partner meetings;

o Provide input and feedback on CDC guidance as requested;

o Track evaluate and report to CDC organizational and external (CDC and health department/laboratories) successes and barrier impacting COVID-19 response operations.

o Provide guidance to state and local health department to ensure data management systems are in place and meet the needs of the jurisdiction

Work with PHLs and other partners to sustain, strengthen and continually improve infectious disease detection and surveillance activities in the US. Activities could include:

o Coordinating the evaluation of new technologies, test methods and practices;

provide and assure access to highly- specialized or low-volume testing services through a network of Reference Centers or shared-service models;

o Develop guidelines and recommendations on laboratory policy and practice;

o Provide training to PHLs, clinical laboratories and other partners;

o Provide technical assistance to PHLs to promote the adoption of more advanced test methods or practices;

o Promote the role of PHLs in infectious disease testing and response activities to public health partners and the public Improve the effectiveness, capabilities and sustainability of PHLs to prepare for, respond to and recover from COVID-19. Activities could include:

o Provide guidance, tools and training;

o Promote information and technology transfer from CDC and other agencies to member laboratories;

o Expand and enhance relationships between member laboratories and other stakeholders;

o Provide support for the Laboratory Response Network;

o Shape and promote policies that support laboratory preparedness and response;

o Enhance laboratory surge capacity plans;

o Ensure clear guidance is communicated to clinical labs and physicians on how to obtain appropriate lab testing; and o Assess commercial and public health capacity for lab testing.

1. Collaborations

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

The recipient is expected to collaborate across the various CDC Centers, Divisions, and Offices that fund this supplemental NOFO. That approach will support the accomplishment of strategies and activities of that project and lead to desired outcomes.

b. With organizations not funded by CDC:

The recipient is expected to continue to build strategic partnerships and collaborations with organizations that have a role in empowering the recipient to achieve the activities and outcomes of the supplemental NOFO.

2. Target Populations Public Health Laboratories.

a. Health Disparities N/A

iv. Funding Strategy This NOFO is directly funded by the COVID-19 response appropriation from CDC centers to include but not limited: the National Center for Immunization and Respiratory Diseases (NCIRD) and the Center for Preparedness Response (CPR).

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Outcomes provided above do not need to be final, CDC and the recipient will have 6 months after award to discuss outcomes and finalize activities, process measures, outcomes, and outcome measures.

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.

c. Organizational Capacity of Recipients to Implement the Approach Describe the applicant’s Organizational Capacity needed to implement the award:

Require applicants to demonstrate relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes, experience and capacity to implement:

o the evaluation plan to achieve the project outcomes o a staffing plan and project management structure with clearly defined staff roles o and specify the number of years of experience needed, or other quantifiable characteristics Applicant should ensure that the information presented in this section aligns with the eligibility requirements for this NOFO Applicant should demonstrate that they have a financial management system that will allow proper funds management and segregation of funds by program.

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

Due to the urgency and the significant work load related to COVID-19 emergency response, the response to this NOFO only requires initial submission of a brief, high-level work plan, using the following template. in addition, the recipient will have 45 days from the award date to submit revised work plans for all projects.

Period of Performance Outcome:

Outcome Measure:

Strategies and Activities

Process Measure

Responsible Position /

Party

Completion Date

1.

2.

3.

4.

5.

6.

The submitted work plan should indicate how performance measures are linked to the selected program outcomes.

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.

In addition the recipient must evaluate and update organization specific response plans based on lessons learned during COVID-19 response activities. Activities could include:

Develop an after-action report that identifies strengths and gaps and update processes as appropriate

Revise ConOps Create and revise standard operating procedures per the gaps identified in after-action reports.

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

COOPERATIVE AGREEMENTS)

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: U60

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $25,000,000

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

This amount is subject to the availability of funds.

Estimated Total Funding: $50,000,000

6. Approximate Period of Performance Length: 1 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $25,000,000 Per Project Period

9. Award Ceiling: $100,000,000 Per Project Period

This amount is subject to the availability of funds.

10. Award Floor: $10,000,000 Per Budget Period

11. Estimated Award Date: 04/30/2020

12. Budget Period Length: 12 month(s)

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

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

C. Eligibility Information

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

Information on Eligibility" for clarification)

Additional Eligibility Category:

Government Organizations:

Local governments or their bona fide agents

2. Additional Information on Eligibility This Funding Opportunity Announcement is a single-source eligibility. The only applicant eligible to apply is the APHL because of the specialized skills and abilities to enhance the capacity of PHLs.

3. Justification for Less than Maximum Competition The APHL is the only national organization that represents the public health laboratories (PHLs) in all 50 states, territories, and local jurisdictions. No other organization serves as the national representative of governmental public health laboratories (PHLs) in the United States.

As a result, the APHL is a unique resource for CDC to directly engage the extensive public health laboratory community to efficiently and effectively provide resources and technical assistance during this COVID-19 public health emergency.

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

5. Maintenance of Effort

D. Application and Submission Information

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

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

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

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

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

b. System for Award Management (SAM):

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

c. Grants.gov:

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

All applicant organizations must register at www.grants.gov. The one-time registration process 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 1. Click on http:// 1-2 To confirm that https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform

Universal Number System

(DUNS)

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

Business Days you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

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

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

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

Applicants may access the application package at www.grants.gov.

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

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

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 04/17/2020 , 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.

This is single source cooperative agreement only one applicant is eligible to apply, hence a letter of intent is not applicable.

Date for Information Conference Call Thursday April 9, 2020

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

Applicants may follow either of the following processes:

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

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

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

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

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

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

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

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

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

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

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

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

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

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

7. Letter of Intent LOI is not required.

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

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

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

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

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

https://www.grants.gov

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

b. Approach

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

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

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

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

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

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

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

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

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

Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see https://www.cdc.gov/od/science/integrity/reducePublicBurden/.

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, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

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 the DMP elements) within the first 6 months of award, as described in the Reporting Section of this NOFO.

d. Organizational Capacity of Applicants to Implement the Approach Applicants must address the organizational capacity requirements as described in the CDC Project Description.

11. Work Plan (Included in the Project Narrative’s page limit) Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative Applicants must submit an itemized budget narrative. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

https://www.cdc.gov/od/science/integrity/reducePublicBurden/

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs could include the cost of collecting, managing, sharing and preserving data.

Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this NOFO to meet national standards or seek health department accreditation through the Public Health Accreditation Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, 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), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the NOFO. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed.

Vital records data, including births and deaths, are used to inform public health program and policy decisions. If applicable and consistent with the cited statutory authority for this NOFO, applicant entities are encouraged to collaborate with and support their jurisdiction’s vital records office (VRO) to improve vital records data timeliness, quality and access, and to advance public health goals. Recipients may, for example, use funds to support efforts to build VRO capacity through partnerships; provide technical and/or financial assistance to improve vital records timeliness, quality or access; or support vital records improvement efforts, as approved by CDC.

Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current http://www.phaboard.org negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Recipients under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds.

Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards.

Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Recipients will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide recipients and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

Records that identify adequately the source and application of funds for federally-funded activities.

Effective control over, and accountability for, all funds, property, and other assets.

Comparison of expenditures with budget amounts for each Federal award.

Written procedures to implement payment requirements.

Written procedures for determining cost allowability.

Written procedures for financial reporting and monitoring.

14. Intergovernmental Review Executive Order 12372 does not apply to this program.

15. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition that applies the terms of 48 Code of Federal Regulations (CFR) section 3.908 to the award and requires that recipients inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

16. Copyright Interests Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible.