RFA-CK-22-003 Amend 1.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Emerging Infections Sentinel Networks (EISN) Research

RFA-CK-22-003

11/01/2021

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Emerging and Zoonotic Infectious Diseases Notice of Funding Opportunity (NOFO) Title Emerging Infections Sentinel Networks (EISN) Research Activity Code U01 - Research Project - Cooperative Agreement

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

RFA-CK-22-003

Assistance Listings Number(s) 93.860 Category of Funding Activity HL - Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to provide a funding mechanism for Emerging Infections Sentinel Networks (EISN) research activities, specifically within a network of emergency departments (EDs). The EISN program assists awardees in operating ED provider-based sentinel networks. These networks will: 1) contribute to surveillance for emerging infectious diseases, such as those caused by drug-resistant, foodborne or waterborne microorganisms, and vaccine-preventable or potentially vaccine-preventable diseases (e.g., Clostridium difficile, carbapenem-resistant Enterobacteriaceae [CRE], viral hepatitis, tuberculosis, sexually transmitted diseases); 2) contribute to information for public health emergency preparedness and response through operational research on topics such as ED rapid triage, throughput, and surge capacity (e.g., assess the clinical characteristics, impacts and outcomes of new and emerging diseases); 3) help better understand and address the disproportionate impact of emerging infectious diseases (EIDs) on underserved and disadvantaged populations; and 4) enhance information exchange.

Key Dates Publication Date:

To receive notification of any changes to RFA-CK-22-003, 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:

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

Publication Date: 08/16/2021 Letter of Intent Due Date: 09/17/2021

Application Due Date:

11/01/2021 Application Due Date: 11/1/2021

On-time submission requires that electronic applications be error-free and made available to 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.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on 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 http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

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:

01/25/2022 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Secondary Review:

03/01/2022 Estimated Start Date:

05/01/2022 Expiration Date:

11/02/2021 Required Application Instructions 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 12 pages.

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

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

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

Executive Summary Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to provide a funding mechanism for Emerging Infections Sentinel Networks (EISN) research activities, specifically within a network of emergency departments (EDs). The EISN program assists awardees in operating provider-based sentinel networks. These networks will: 1) contribute to surveillance and development of strategies to mitigate the risk of emerging infectious diseases such as those caused by agents of bioterrorism, pathogens of pandemic potential, drug-resistant, foodborne or waterborne microorganisms, and vaccine-preventable, or potentially vaccine-preventable, diseases (e.g., Bacillus anthracis, Clostridium difficile, carbapenem-resistant Enterobacteriaceae [CRE], viral hepatitis and respiratory viruses of epidemic or pandemic potential, including SARS- CoV-2 and other related coronaviruses, tuberculosis, sexually transmitted diseases); 2) contribute to information for public health emergency preparedness and response, through operational research on topics such as ED rapid triage, throughput, and surge capacity (e.g., assess the clinical characteristics, impacts and outcomes of new and emerging diseases); 3) help better understand and address the disproportionate impact of emerging infectious diseases (EIDs) on underserved and disadvantaged populations; and

4) enhance information exchange.

Mechanism of Support: U01 – Research Project - Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funds available, including direct and indirect costs, for the entire five (5)-year project period is $1,300,000. The estimated number of awards will be one. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf 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 $300,000. The estimated total funding (direct and indirect) for the entire project period will be $1,300,000. The project period is anticipated to run from 05/01/2022 to 04/30/2027.

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. One.

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

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

SF424 (R&R) Form F is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority

Public Health Service Act, Section 301(a) [42 U.S.C. 241(a)], as amended.

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Public

Law 116-123.

Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136.

Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139.

American Rescue Plan Act of 2021, Public Law 117-2.

1. Background and Purpose The EISN program assists awardees in operating provider-based sentinel networks. These networks: 1) contribute to surveillance and development of strategies to mitigate the risk of emerging infectious diseases, including those caused by agents of bioterrorism, pathogens of pandemic potential, drug-resistant, foodborne or waterborne microorganisms, and vaccine-preventable, or potentially vaccine-preventable, diseases (e.g., Bacillus anthracis, Clostridium difficile, carbapenem-resistant Enterobacteriaceae [CRE], viral hepatitis and respiratory viruses of epidemic or pandemic potential, including SARS-CoV-2 and other related coronaviruses, tuberculosis, sexually transmitted diseases); 2) contribute to information for public health https://grants.nih.gov/grants/how-to-apply-application-guide.html emergency preparedness and response through operational research on topics such as ED rapid triage, throughput, and surge capacity (e.g., assess the clinical characteristics, impacts and outcomes of new and emerging diseases); 3) help better understand and address the disproportionate impact of EIDs on underserved and disadvantaged populations; and 4) enhance information exchange.

The purpose of this NOFO is to provide a funding mechanism for EISN research activities, specifically within a national network of geographically distributed emergency departments (EDs) in the United States, that can ensure a broad, representative sampling of the general US population as well as ensure an understanding of the unique risks EIDs may pose to underserved and disadvantaged populations.

Healthy People 2030 and other National Strategic Priorities The EISN program addresses HHS Infectious Disease - Healthy People 2030 | health.gov:

Reduce rates of infectious diseases and improve health for people with chronic infections, and the rate of health care-associated infections:

Reduce C. diff infections that people get in the hospital - HAI-01, and inappropriate antibiotic use in outpatient settings - HAI-Do1.

Reduce MRSA bloodstream infections that people get in the hospital — HAI-02.

Reduce the rate of hospital admissions for urinary tract infections among older adults –

OA-07.

This NOFO addresses CDC’s Core Capabilities and Strategic Priorities of eliminating disease and ending epidemics by responding to outbreaks at their source through surveillance and research of emerging infectious diseases.

Public Health Impact EISN networks contribute to public health by: a) ensuring public health recommendations are implementable in frontline clinical settings during routine and emergency settings; b) generating practical information for action; c) building capacity and clinical acumen to detect unusual events; d) helping clinicians determine when it is appropriate to activate the public health system; and e) providing information for public health emergency readiness and response through operational research on topics such as ED rapid triage, throughput, and surge capacity.

Health Equity CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in infectious diseases are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease https://www.cdc.gov/about/organization/strategic-framework/index.html

(https://www.cdc.gov/socialdeterminants/index.htm). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Relevant Work

1. Mohr, NM, Harland, KK, Krishnadasan, A, Ten Eyck, P, Mower, WR, Willey, J, Chisolm-Straker, M, Lim, SC, McDonald, LC, Kutty, PK, Hesse, E, Santibanez, S and Talan, DA. (2020). Diagnosed and undiagnosed COVID-19 in US emergency department health care personnel: a cross-sectional analysis. Ann Emerg Med. PMID: 33771413.

2. Talan DA, Takhar SS, Krishnadasan A, et al. Emergence of extended-spectrum β-lactamase urinary tract infections among hospitalized emergency department patients in the United States. Ann Emerg Med. 2020. https://www.annemergmed.com/article/S0196- 0644(20)30686-7/fulltext

3. Santibanez S, Fischer LS, Krishnadasan A, et al; EMERGEncy ID NET Study Group.

EMERGEncy ID NET: Review of a 20-Year multisite emergency department emerging infections research network. Open Forum Infect Dis 2017;4:ofx218.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5903406/

4. Albrecht V, Limbago B, Moran G, Krishnadasan A, Gorwitz R, McDougal L, and Talan DA; for the EMERGEncy ID NET Study Group. Staphylococcus aureus colonization and strain type at various body sites among patients with a closed abscess and uninfected controls at U.S. emergency departments. J Clin Microbiol. 2015 Aug. pii: JCM.01371-15.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609677/

5. Crisp JG, Takhar SS, Moran GJ, Krishnadasan A, Dowd SE, Finegold SM, Summanen PH, Talan DA; for the EMERGEncy ID Net Study Group. Inability of polymerase chain reaction, pyrosequencing, and culture of infected and uninfected site skin biopsy specimens to identify the cause of cellulitis. Clin Infect Dis. 2015 Aug. pii: civ655.

https://europepmc.org/article/med/26240200 https://www.cdc.gov/socialdeterminants/index.htm https://www.ncbi.nlm.nih.gov/pubmed/33771413/ https://www.annemergmed.com/article/S0196-0644(20)30686-7/fulltext https://www.annemergmed.com/article/S0196-0644(20)30686-7/fulltext https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5903406/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609677/ https://europepmc.org/article/med/26240200

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

CDC’s objectives for the provider-based sentinel network of EDs include the following:

To support linked groups of participating individuals or organizations in monitoring a variety of infectious disease problems and enhancing communication among participants and between participants and the public health community.

To serve as readily accessible mechanisms to address urgent public health infectious disease problems rapidly.

To improve understanding of specific public health issues and enhance readiness to meet new infectious disease threats.

To focus studies on the most important issues to be addressed by participating hospital EDs and CDC.

To estimate the community burden of diseases.

To contribute to information for public health emergency preparedness and response, through operational research on topics such as ED rapid triage, throughput, and surge capacity.

Objectives/Outcomes Research objectives for the provider-based sentinel network include investigations of various emerging infections and implementation of studies to examine risk factors, determine practice guidelines, and evaluate outcomes. This NOFO specifically aims to support the collection of infectious disease (ID) data from academically affiliated emergency departments. Emergency departments are considered an invaluable source of ID data for several reasons: a) EDs treat large numbers of persons, persons with acute and severe disease, persons with clinical syndromes, persons with community-acquired infections, and at-risk populations; b) EDs can collect prospective data in real time and usually have hospital laboratories available to them; and

c) EDs can also serve as the first line of detection and defense from public health threats and emerging infectious diseases.

Specific research objectives for a Network of Emergency Departments:

To provide descriptive epidemiology and/or assess risk factors of emerging infectious diseases, such as those caused by agents of bioterrorism, pathogens of pandemic potential, drug-resistant, foodborne or waterborne microorganisms, and vaccine-preventable, or potentially vaccine-preventable, diseases among patients presenting to emergency departments (potentially including specimen collection).

To provide descriptive epidemiology of infectious disease events occurring in metropolitan and/or rural areas nationwide (e.g., Bacillus anthracis, Clostridium difficile, carbapenem-resistant Enterobacteriaceae [CRE], viral hepatitis and respiratory viruses of epidemic or pandemic potential, including SARS-CoV-2 and other related coronaviruses, tuberculosis, sexually transmitted diseases).

To be a sentinel network for detection of, and rapid response to, naturally occurring and intentional outbreaks to help inform operational public health and healthcare decisions during public health emergencies (e.g., assessment of rapid screening and triage protocols during surge of infectious diseases cases presenting for clinical care).

To study the readiness of EDs and healthcare facilities to assess, manage, triage, and treat individuals suspected of carrying highly infectious diseases to contribute to information for public health emergency preparedness and response (e.g., assess the clinical characteristics, impacts and outcomes of new and emerging diseases).

To help better understand and address the disproportionate impact of EIDs on underserved and disadvantaged populations and enhance information exchange.

Target Population The target population is ED patients reached via a national network of geographically distributed emergency departments in the United States that can ensure a broad, representative sampling of the general US population as well as ensure an understanding of the unique risks EIDs may pose on underserved and disadvantaged populations.

Collaboration/Partnerships The application should include necessary and relevant collaborations and partnerships with academically affiliated emergency departments in the US.

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

The application should include an evaluation plan with performance measures applicable to each study, accounting for adequate sample size and enrollment, adherence to projected timelines, and abstract/manuscript acceptance. The plan should align with the stated purpose and outcomes of the NOFO.

Translation Plan The application should include a translation plan for submitting abstracts to relevant infectious disease conferences and manuscripts to appropriate peer-reviewed journals.

When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:

How will the scientific findings be translated into public health practice or inform public health policy?

How will the project improve or effect the translation of research findings into public health practice or inform policy?

How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

How will the findings advance or guide future research efforts or related activities?

3. Funding Strategy Awards issued under this NOFO may include general and special appropriations funding.

Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

Section II. Award Information Funding Instrument Type:

CA (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.

https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

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:

$ 1,300,000 Estimated Total Annual Budget Period Funding:

Year 1: $300,000 Year 2: $250,000 Year 3: $250,000 Year 4: $250,000 Year 5: $250,000

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $300,000

Estimated total funding available for the entire period of performance, including direct and indirect costs: $1,300,000

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

Award Ceiling:

$ 300,000 Per Budget Period

Award Floor:

$ 200,000 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 (https://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.

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

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)

Governments:

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

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.

Regional Organizations

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility Hospitals and Medical Centers may also apply

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If applications request a funding amount greater than the ceiling indicated in Section II. of this NOFO, HHS/CDC may consider the application non-responsive.

Applications submitted under this notice of funding opportunity must not include activities that overlap with simultaneously funded research supported by other awards.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

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://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal 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 an 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://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons 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 SAM.gov and the SAM.gov Knowledge Base.

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 NOFO 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 Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

To use ASSIST, applicants must visit https://public.era.nih.gov 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: http://grants.nih.gov/support/index.html

Email: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: 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.

Letters of Support from partners 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 using the forms and instructions for SF424(R&R) Form F:

Mandatory

1. SF424(R&R);

2. PHS 398 Cover Page Supplement;

3. Research and Related Other Project Information;

4. Project/Performance Site Location(s);

5. Research and Related Senior/Key Person Profile (Expanded);

6. Research and Related Budget;

7. PHS 398 Research Plan;

8. PHS Human Subjects and Clinical Trials Information.

https://public.era.nih.gov http://grants.nih.gov/support/index.html 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

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

Briefly describe how communication between institutions and the sIRB will be handled.

Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

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 09/17/2021

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

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 CDC 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 organization 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 notice of funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 Email: GAnderson@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 at https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional 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 mailto:GAnderson@cdc.gov https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf

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 at https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf 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 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).

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)

Other 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 partners or organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of 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 https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Support".

PLEASE NOTE: Follow the SF424R&R instructions for completing the PHS Human Subjects and Clinical Trials Information (Form F) found here:

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm

PHS Human Subjects and Clinical Trials Information

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

▪ Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

▪ Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

▪ Briefly describe how communication between institutions and the sIRB will be handled.

▪ Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

▪ Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

▪ Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

▪ Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the…