PKG00264044-instructions.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Research to Inform Pandemic Response and Recovery of Emergency-Affected

Populations by Determining Public Health Needs, Improving Methods, and Integrating Services to Mitigate Morbidity and Mortality

RFA-GH-21-004

Application Due Date: 02/18/2021

Conducting Research to Inform Pandemic Response and Recovery of Emergency-Affected

Populations by Determining Public Health Needs, Improving Methods, and Integrating Services to Mitigate Morbidity and Mortality

RFA-GH-21-004

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health Notice of Funding Opportunity (NOFO) Title Conducting Research to Inform Pandemic Response and Recovery of Emergency-Affected Populations by Determining Public Health Needs, Improving Methods, and Integrating Services to Mitigate Morbidity and Mortality Activity Code U01

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-GH-21-004

Assistance Listings (CFDA) Number(s) 93.269 Category of Funding Activity:

Health NOFO Purpose The purpose of this NOFO is to understand the needs of emergency-affected and displaced populations and estimate morbidity and mortality in the context of the COVID-19 pandemic.

The overall goals of this operational research are to a) improve mortality and cause of death estimation during the acute emergency phase, b) understand COVID-19 disease transmission, contributing factors and secondary health consequences, c) study the effects of various hand hygiene interventions on mitigating the spread of COVID-19 and d) understand the mental health impact of COVID-19 to reduce associated morbidity and mortality among displaced populations and in emergency settings.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-21-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/18/2021

Application Due Date: 02/18/2021

On-time submission requires that electronic applications be error-free and made available to https://www.grants.gov

CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/16/2021

Secondary Review: 06/16/2021

Estimated Start Date: 09/01/2021

Expiration Date: 02/19/2021 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 16 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this NOFO is to understand the needs of emergency-affected and displaced populations and estimate morbidity and mortality in the context of the COVID-19 pandemic. In order to achieve these overarching goals, the following objectives are proposed among displaced populations affected by humanitarian emergencies:

To develop more accurate and refined systems based on evidence-based implementation generated by comparing various mortality surveillance, mortality surveys and cause of death methods specific for humanitarian settings.

To compare surveillance and mitigation strategies to better understand disease transmission among emergency-affected populations and develop evidence-based guidelines for the effectiveness and impact of various interventions in humanitarian settings.

To leverage a prospective research design to further our understanding of disease transmission, trajectory, secondary and longer-term outcomes of the COVID-19 pandemic among displaced persons.

To study hand hygiene activities and evaluate how types of hardware (handwashing stations, soaps, hand gels) and behavior change interventions effect COVID-19 transmission and document the health impact of handwashing interventions on COVID- 19, and enteric or respiratory diseases.

To conduct innovative research including randomized controlled trials on the effectiveness and impact of various mental health interventions, programs and services, and develop evidence-based guidelines in humanitarian settings.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year project period is $75,000,000.

The number of awards will be up to 5.

Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $15,000,000 with individual awards ranging from $0 to $3,000,000 for the first year.

The estimated total funding (direct and indirect) for the entire project period will be $75,000,000. The project period is anticipated to run from 09/01/2021 to 08/31/2026.

Awards including funds made available under the Coronavirus Preparedness and Response

Supplemental Appropriations Act, 2020 (P.L. 116-123) or the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136) will be required to submit financial and performance progress reports on a quarterly basis to the named Grants Management Specialist and Scientific Program Officer.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs: There will only be one PD/PI for each application. Applications may include more than one PI; however, the first PI listed on the application will be the contact PI for all correspondence. Any additional PIs should be listed as Co-PIs.

Number of Applications: Only one application per institution (normally identified by having a unique DUNS number) is allowed. Each application should include one research proposal and budget for the first year of funding. Applications must include the objectives and outcomes they plan to address. Applicants may propose research projects addressing one or more of the objectives of this funding opportunity.

Application Type: New Special Date(s): Letter of Intent Due Date: January 18, 2021; Application Due Date: February 18, 2021. Applicants must submit their questions by e-mail to cgherpo@cdc.gov, within 15 days after the publication date of this NOFO in www.grants.gov. The NOFO number and Principal Investigator name should be included in the e-mail subject line of all questions related to this NOFO. Questions received after this time will not be considered for response. All changes, updates including the Q/A will be added as an amendment to the NOFO and will be posted on grants.gov within a reasonable time.

Application Materials: See Section IV.1 for application materials. Please note that Form F is to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 301(a) of the Public Health Service Act [42 USC § 241(a)], as amended and Section 307 of the Public Health Service Act [42 USC §242l], as amended and the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136).

1. Background and Purpose Conflict and displaced populations are at increased risk for communicable disease outbreaks http://www.grants.gov/ due to poor living conditions, access to health care and safe water, sanitation and hygiene (WASH). The inability to practice common mitigation measures such as physical distancing in dense refugee and internally displaced persons (IDPs) settlements adds to the concern of rapid spread communicable diseases including COVID-19 among these vulnerable populations.

However, to date, there have been relatively low numbers of reported COVID-19 cases in these settings. In order to investigate COVID-19 in displaced and emergency-affected populations, CDC proposes operational research order to investigate COVID-19 in displaced and emergency-affected populations, CDC proposes operational research targeting humanitarian populations by studying surveillance systems, disease transmission, mitigation measures, and mental health.

Mortality data are often underreported or unavailable in many humanitarian settings due to access, security and socio-cultural practices. Mortality surveillance is often set up too late in the emergency after data gaps are evident. There have been many different applications of mortality surveillance at the community level. However, there is no standardized approach that is rapid and simple, which can be quickly implemented during the early phase of an emergency to inform response efforts in humanitarian settings. Additional research is needed to compare various mortality surveillance methods with other data collection methods such as surveys to better understand mortality patterns, including societal factors (barriers/motivators) that contribute to mortality early in the acute phase. Comparing various mortality methods and cause of death at the community level, as early as possible in the acute phase, will fill a recurring gap in emergency settings. Simple systems and tools will contribute to early and more effective response efforts specifically focusing on humanitarian emergency settings.

It is unclear whether national surveillance guidelines and mitigation measures which have been adapted to settings such as refugee and IDP settlements have helped to avert the expected large number of cases of COVID-19 or whether there are additional factors such as low testing capacity, fear and misconceptions surrounding COVID-19 or other protective measures. Field reports on compliance and adherence mitigation strategies currently in place have been conflicting and inconclusive.

In addition, data gaps on mortality and COVID-19 surveillance are exacerbated by declines in care seeking. COVID-19 has limited the ability to capture routine facility-based surveillance for monitoring incidence of suspect COVID-19 cases and other priority conditions. Establishment of cohorts is proposed as an alternative method of surveillance to enable monitoring of displaced children and their households. Such design, which enables prospective longitudinal monitoring, will enable characterization of incidence and clinical progression of COVID-19 and other impacted health conditions among these populations. There is a need to identify gaps in case detection through traditional surveillance data to inform improved case detection and isolation, and to provide real time data on barriers to care seeking to strengthen interventions aimed at maintaining access to essential health services. Such designs may also allow for identification of modifiable risk factors for morbidity from COVID-19 and other priority conditions impacted by the pandemic to inform a response.

Hand hygiene is one of the many mitigation efforts employed as a prevention measure to limit the spread of COVID-19. Hand hygiene interventions may also lead to reduced transmission of other pathogens that cause diarrheal diseases or respiratory infections. Yet, access to handwashing facilities remains limited in some settings. Programs to increase hand hygiene may include improvements in hand hygiene hardware such as handwashing stations or behavior change interventions to increase hand hygiene practices. There is a need to investigate strategies to increase handwashing practices among emergency affected populations and identify strategies that are successful in leading to sustained behavior change. The current types of hardware used in many hand washing interventions (handwashing stations, soaps, hand gels) are commonly provided in emergency settings, but more research is needed to understand whether these interventions have successfully reduced SARS-CoV-2 transmission. Similarly, behavioral interventions promoting hand washing have largely been used but research must be conducted in order to fully understand its effectiveness on COVID-19 and other enteric and respiratory disease.

Although there is ongoing research into addressing the public health needs of displaced populations, mental health needs often go unaddressed (Prince M, et al., The Lancet 2007).

Emergency-affected populations worldwide are at particularly high risk for developing mental health problems. Based on previous experiences during the Ebola and SARS epidemics, we can expect an increase in mental illness related to the COVID-19 pandemic among people already affected by humanitarian emergencies. Surveys of emergency-affected populations have demonstrated prevalence of posttraumatic stress disorder symptoms (PTSD) from 5% to almost 40% and of depressive symptoms from 30% to almost 70%. (Mollica RF, et al., The Lancet 2004; Lopes Cardozo B, et al., JAMA, 2004; Lopes Cardozo, et al., JAMA, 2000; Husain F, et al., JAMA 2011; Mollica RF, et al., JAMA. 1993). In a systematic review in 2019, the World Health Organization (WHO) estimated the prevalence of mental disorders (depression, anxiety, post-traumatic stress disorder, bipolar disorder, and schizophrenia) was 22·1% (95% UI 18·8– 25·7) at any point in time in the conflict-affected populations assessed (Charlson F, et al., The Lancet 2019).

More research is needed to evaluate the effectiveness and impact of various mental health interventions and services in emergency-affected populations and establish guidance and tools for evidence-based mental health interventions in humanitarian emergency settings (Jordans MJ, Tol WA, Int Health. 2013).

Given the stress on surveillance systems and hypothesized secondary health effects on displaced populations and populations in humanitarian emergency settings, this NOFO requests applicants to submit applications proposing research studies among populations in humanitarian settings (such as refugee camps and internally displaced populations) in order to do at least one of the following:

1. Improve mortality estimation and cause of death methods in the acute emergency phase.

2. Understand SARS-CoV-2 transmission among displaced populations by comparing surveillance strategies and develop an understanding of risk factors, and motivators and barriers for certain mitigation measures.

3. Study the effects of hand hygiene interventions on mitigating the spread of COVID-19.

4. Understand COVID-19 secondary health impacts among displaced persons.

5. Understand the impact of COVID-19 on mental health.

Healthy People 2030 and other National Strategic Priorities This NOFO supports multiple priorities of Healthy People 2030, including:

The global health priority to improve public health and strengthen U.S. national security through global disease detection, response, prevention, and control strategies, The burden of non-communicable diseases in emergency settings.

The development of public health infrastructure, ensuring humanitarian organizations have a capable workforce that can respond to public health needs in emergencies and disease outbreaks.

The improvement of the nation’s ability to prevent, prepare for, respond to, and recover from PHEICs.

For additional information:

This NOFO supports CDC’s Global Health Strategy, which focuses on: 1) improving the health and well-being of people around the world; 2) improving capabilities to prepare for and respond to infectious diseases, other emerging health threats and public health emergencies; and, 3) maximizing the potential of CDC’s global programs to achieve public health impact. Additional information can be found at https://www.cdc.gov/globa lhealth/security/index.htm.

https://www.healthypeople.gov/2020/topics-objectives/topic/global-health

Public Health Impact This NOFO will support impactful research activities that are not adequately addressed in refugee and internally displaced populations. In humanitarian settings, surveillance systems are usually late to be instituted and data to detect outbreaks, such as COVID-19 may not accurately reflect true incidence within the population. This operational research will improve our understanding of the most effective surveillance systems to implement in humanitarian contexts.

The research will also fill gaps in our knowledge of the secondary effects of pandemics, such as the COVID-19 pandemic on other health and mental health outcomes in humanitarian settings.

Relevant Work The Emergency Response and Recovery Branch (ERRB) applies public health and epidemiologic science to reduce the public health impact of disasters and humanitarian emergencies, and strengthen the recovery of health systems in these settings. Working in partnership with other U.S. government agencies, United Nations (UN) agencies, such as the UN High Commissioner for Refugees (UNHCR), UN Children’s Fund (UNICEF) and non-governmental organizations (NGOs), ERRB coordinates, supervises and monitors CDC’s work in international emergency settings and among refugee or displaced populations. ERRB also provides assistance during emergencies focusing on the following:

Rapid assessments on, water, sanitation and hygiene (WASH), health, and nutrition Public health surveillance and epidemic investigations Operational research in emergency and post-emergency settings Program development and evaluation Post-emergency health systems reconstruction Partner capacity building This NOFO intends to build upon current activities and non-research cooperative agreements by supporting operational research to understand SARS-CoV-2 https://www.cdc.gov/globalhealth/security/index.htm https://www.cdc.gov/globalhealth/security/index.htm https://www.healthypeople.gov/2020/topics-objectives/topic/global-health transmission, best practices for surveillance and collection of mortality data, and the secondary health impacts and mental health impact of the COVID-19 pandemic in humanitarian settings.

2. Approach In order to achieve the overarching objectives, the applicant should specify how they plan to achieve these outcomes through at least one of the following methods:

Compare various mortality surveillance systems, mortality surveys and cause of death methods specific for humanitarian settings to develop accurate and refined systems.

Compare surveillance and mitigation strategies to better understand disease transmission among emergency-affected populations, in order to develop evidence-based guidelines for the implementation of effective interventions in humanitarian settings.

Leverage prospective research designs to understand SARS-CoV-2 transmission, and the trajectory, longer-term outcomes, and secondary health effects of COVID-19 disease among displaced persons

Research hand hygiene efforts in emergency settings and evaluate the effects of hand hygiene interventions on SARS-CoV-2 transmission and other enteric and respiratory diseases in the acute emergency phase and post recovery phase

Conduct innovative research, including randomized controlled trials, on the effectiveness and impact of various mental health interventions, programs and services, and develop evidence-based guidelines for humanitarian settings.

Each application should include one research proposal and budget for the first year of funding.

Applications must include the objectives and outcomes they plan to address. Applicants may propose research projects addressing one or more of the objectives of this funding opportunity.

Research proposals should reflect the capacity of the organization to conduct methodologically sound health research in humanitarian settings. Proof of strong local support through local organizations is highly desired, for example through inclusion of a letter of support from collaborating organizations, as well as a demonstrated experience conducting research in resource-limited settings.

Objectives/Outcomes This NOFO requests applicants to submit applications describing research seeking to accomplish at least one of the following:

1. Improve mortality estimation and cause of death methods in the acute emergency phase

2. Understand SARS-CoV-2 transmission among displaced populations

3. Understand the secondary impacts of COVID-19 among displaced populations

4. Understand hand hygiene effects on mitigating disease transmission

5. Understand the impact of COVID-19 on mental health in humanitarian emergency settings

The following outcomes and obectives are anticipated from the applicant’s proposed research:

Evidence to support the development of more accurate and refined systems for mortality surveillance, mortality surveys and cause of death methods specifically for humanitarian settings.

o and/or

A better understanding of disease transmission among emergency-affected populations and the development of evidence-based guidelines for the implementation of interventions, programs and services in humanitarian settings, including those affected by the COVID-19 pandemic.

o and/or An understanding of SARS-CoV-2 transmission, COVID-19 disease trajectory, longer-term outcomes, and secondary health effects (e.g., changes in incidence of other health conditions, changes in care seeking behaviors, changes in care practices, linear growth, and/or mortality) among displaced persons.

o and/or An evaluation of the effects of hand hygiene interventions on SARS-CoV-2 transmission and other enteric and respiratory diseases during the acute emergency phase and post recovery phase.

o and/or An improved understanding on how to reduce morbidity and mortality associated with mental health problems among people affected by humanitarian emergencies and the COVID-19 pandemic.

Target Population The target population includes those groups affected by humanitarian crises or disease outbreak in a variety of locations; urban, peri-urban or rural. These populations can include displaced groups such as refugees and internally displaced persons (IDPs).

The target population may also include those groups at high risk of being impacted by future public health emergencies, such as populations living in politically fragile states (https://www .acaps.org/methodology/severity) and countries or regions with a history of civil conflict.

Collaboration/Partnerships Given that this is a cooperative agreement, substantial involvement from CDC is expected from both scientific or program staff to assist, guide, coordinate, or participate in project activities.

Additionally, partnership involves collaboration with local governments and humanitarian organizations in the methods to implement scientific measurement of needs and outcomes;

operational research related to program implementation, integration, and evaluation. Letters of support from partnership collaborations are requested.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 5-year research project period. The grantee will establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and https://www.acaps.org/methodology/severity https://www.acaps.org/methodology/severity describe the development and implementation of project performance measures based on specific programmatic objectives.

Applicants should include their performance measures for ongoing monitoring of the recipients’ progress (process indicators) and the long-term deliverables/outcomes (outcome indicators).

Recipients are expected to provide regularly updates through monthly virtual meetings and/or through email communications. Recipients are also expected to submit a report on their progress towards these indicators annually. Applicants must include a timeline of how they plan to achieve each of these indicators as well as including planned activities and sub-activities. Plans for ensuring data quality, human subjects protection and regulatory compliance must be indicated in each application.

Translation Plan Applicants must also include plans for research dissemination which can include peer-reviewed journals, presentations at conferences, reports, and meetings. Each application must include a plan for disseminating findings to various types of audiences including researchers, stakeholders, government institutions, international organizations, NGOs, public health programs, professional organizations, practitioners and policy makers.

CDC will provide technical assistance in the analysis and dissemination of information, data and findings from the project, facilitating dissemination of results. In collaboration with CDC, awardee may present at national or international meetings and publish research findings in peer-reviewed scientific journals.

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $75,000,000 Estimated Total Annual Budget Period Funding:

Year 1: $15,000,000 Year 2: $15,000,000 Year 3: $15,000,000

Year 4: $15,000,000 Year 5: $15,000,000

Anticipated Number of Awards: 5 Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, 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.

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $3,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities

(HBCUs) Tribally Controlled Colleges and Universities

(TCCUs) Alaska Native and Native Hawaiian Serving

Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher

Education)

Other:

Faith-based or Community-based

Organizations Regional Organizations Foreign Organizations: a Foreign

Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility N/A N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness

Applications submitted without a LOI submission will be deemed non-responsive.

If an applicant requests a funding amount greater than the ceiling of $3,000,000 in any year as indicated in Section II. of this NOFO, under Executive Summary and under Application and Submission Instructions, HHS/CDC will consider the application non-responsive and it will not enter the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

If the application is incomplete, meaning required components of the application package are missing. The applicant will be notified that the application did not meet submission requirements.

Late submissions will be considered non-responsive. See Section IV.9. Submission Dates and Time for more information on deadlines.

Total amount of appendices should not include more than 50 pages. For this purpose, all appendices must have page numbers and must be clearly identified in the Table of https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

Contents.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://cage.dla.mil/

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/index.html .

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms.

Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review Letters of Support from partner companies or organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

3. Letter of Intent Due Date for Letter of Intent: 01/18/2021 http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf

The LOI allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity announcement Anticipated WHO region(s) in which research proposal will be conducted NOFO objectives anticipated to be addressed (applicants may propose research projects addressing one or more objectives)

The letter of intent should be sent by email to:

Lata Kumar Extramural Research Program Office Office of the Associate Director of Science Center for Global Health Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS D-69 Atlanta, GA 30333 Email: lkumar@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm for additional https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf rights -this section should address access to identifiable and de-identified data);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use;

and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

Letters of Support from partner companies or organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please note: According to the Additional Requirement-25 (AR-25) (https://www.cdc.gov/grants /additionalrequirements/ar-25.html), investigators who plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS…