RFA-CK-25-035_20241125.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Monitoring, Operations Research, Evaluation of Tools for Malaria Control and Prevention in Kenya

RFA-CK-25-035

02/12/2025

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 Monitoring, Operations Research, Evaluation of Tools for Malaria Control and Prevention in Kenya Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-CK-25-035

Assistance Listings Number(s) 93.326 Category of Funding Activity HL - Health NOFO Purpose

The purpose of this notice of funding opportunity (NOFO) is to support research to assist with the design and implementation of malaria focused operations research, surveillance, and monitoring and evaluation activities in Kenya. Through this NOFO, CDC seeks to fund critical operations research and evaluation activities with the potential to yield high impact public health findings and to improve strategies and interventions that will decrease the overall burden of malaria and increase the health and well-being of affected populations in Kenya.

Specifically, the research project supported by this NOFO is expected to: (1) Conduct research to inform malaria control and elimination activities in Kenya as well as global malaria control policy; (2) Advance epidemiologic methods to monitor and measure impact of malaria prevention, detection, control, and response efforts, including those supported by President’s Malaria Initiative (PMI); and (3) Advance laboratory methods and strengthen the capacity of local laboratories to identify infection, monitor for parasite and vector resistance, and measure impact of malaria prevention, detection, control, and response efforts in Kenya.

Key Dates Publication Date:

To receive notification of any changes to RFA-CK-25-035, 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:

01/13/2025

Application Due Date:

02/12/2025

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 11:59 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:

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

04/15/2025 Secondary Review:

05/15/2025 Estimated Start Date:

09/01/2025 Expiration Date:

03/14/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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

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.

Executive Summary

• Purpose: The purpose of this notice of funding opportunity (NOFO) is to support research to assist with the design and implementation of malaria focused operations research, surveillance, and monitoring and evaluation activities in Kenya. Through this NOFO, CDC seeks to fund critical operations research and evaluation activities with the potential to yield high impact public health findings and to improve strategies and interventions that will decrease the overall burden of malaria and increase the health and well-being of affected populations in Kenya. Specifically, the research project supported by this NOFO is expected to: (1) Conduct research to inform malaria control and elimination activities in Kenya as well as global malaria control policy; (2) Advance epidemiologic methods to monitor and measure impact of malaria prevention, detection, control, and response efforts, including those supported by President’s Malaria Initiative (PMI); and (3) Advance laboratory methods and strengthen the capacity of local laboratories to identify infection, monitor for parasite and vector resistance, and measure impact of malaria prevention, detection, control, and response efforts in Kenya.

• Mechanism of Support: U01 - Research - Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year period of https://grants.nih.gov/grants/how-to-apply-application-guide.html performance is $13,000,000. The number of awards will be one (1). 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 Period of Performance: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $3,000,000 for the first year. The estimated total funding (direct and indirect) for the entire period of performance will be $13,000,000. The period of performance is anticipated to run from 09/01/2025 to 08/31/2030.

• 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. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities 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.

• Number of Applications. Only one application per institution (normally identified by having a unique entity identifier or UEI number) is allowed.

• Application Type. New

• Application Materials. See Section IV.1 for application materials.

Section I. Funding Opportunity Description

Statutory Authority 301(a) and 317(k) (2) of the Public Health Service Act, [42 U.S.C. Sections 241(a) and 247b (k) (2), as amended

1. Background and Purpose CDC supports the Global Malaria Programme of the World Health Organization (as a WHO Collaborating Centre) and the Roll Back Malaria (RBM) Partnership to coordinate global malaria scale-up and evaluation efforts under the framework of the Global Technical Strategy (GTS) for Malaria, 2016—2030. As a partner, CDC has been building and working with numerous international networks, consortia, and partnerships to achieve the GTS targets. This cooperative agreement is intended to support research to inform global malaria policy and provide technical assistance to targeted malaria-endemic countries in sub-Saharan Africa, with a focus on Kenya.

Activities funded through this mechanism will focus on evaluation of novel interventions, surveillance of threats to malaria case management, and operational research aimed at controlling and ultimately eliminating malaria.

While unprecedented gains in the fight against malaria were seen from 2000 to 2015, during which time malaria deaths in Africa were cut by more than half, progress has stalled in the past five years, impeded by the COVID-19 pandemic. From 2000 to 2019, malaria case incidence declined from 81 to 57 per 1000 population at risk, however, rates have remained stable since, and in 2022, malaria case incidence was 58 per 1000 population at risk. In 2015, there were an estimated 231 million malaria cases globally, while in 2022 there were 249 million. Globally, malaria deaths declined steadily from 864,000 in 2000 to 576,000 in 2019 but were at 608,000 in 2022. In addition, the percentage of total malaria deaths in children under 5 years of age, which dropped from 87% in 2000 to 76% in 2015, remains unchanged since 2015. It is thus imperative that we identify ways to optimize existing interventions and identify new interventions to achieve global malaria control and elimination targets.

The purpose of this NOFO is to: (1) Conduct research to inform malaria control and elimination activities in Kenya as well as global malaria control policy; (2) Advance epidemiologic methods to monitor and measure impact of malaria prevention, detection, control, and response efforts, including those supported by President’s Malaria Initiative (PMI); and (3) Advance laboratory methods and strengthen the capacity of local laboratories to identify infection, monitor for parasite and vector resistance, and measure impact of malaria prevention, detection, control, and response efforts in Kenya.

Healthy People 2030 and other National Strategic Priorities N/A

Public Health Impact The Public Health Impact of this proposed work will be two-fold: (1) these evaluations and laboratory and field studies will provide critical scientific knowledge to inform and guide malaria program implementation and global policy in malaria-endemic countries, especially in Kenya and other sub-Saharan Africa countries. And (2) the ultimate outcome of these activities will be reduced morbidity and mortality due to malaria through the identification and scale-up of evidence-based intervention strategies and ongoing evaluations of these strategies.

Relevant Work For more than 75 years, CDC has been a leader in the fight against malaria since its successful elimination in the United States. Building on that success, CDC experts continue to develop and evaluate malaria control interventions to reduce malaria illness and death with the ultimate goal of eliminating malaria globally. CDC’s strategic research helped develop and evaluate critical effective tools now used throughout the world to prevent and control malaria including:

• Insecticide-treated bed nets (ITNs)

• Intermittent preventive treatment for pregnant women (IPTp) and infants (IPTi)

• Improved management of malaria illness with rapid diagnostic tests (RDTs) and artemisinin-containing combination therapies (ACTs)

• Indoor residual spraying (IRS)

• RTS,S/AS01 malaria vaccine

While unprecedented gains in the fight against malaria were seen from 2000 to 2019, progress has stalled in the past five years, impeded by the COVID-19 pandemic. It is imperative to build on recent work to scale up novel interventions to gain lost ground in the fight against malaria.

NOFO history in the past:

RFA-GH-20-002: Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya.

2. Approach Through this NOFO, CDC seeks to fund critical operations research and evaluation activities with the potential to yield high impact public health findings and to improve strategies and interventions that will reduce malaria morbidity and mortality in Kenya and other high transmission settings in sub-Saharan Africa.

Objectives/Outcomes An application should address at least one (1) activity under each of the three (3) objectives below.

Objective 1. With the Kenya Medical Research Institute (KEMRI) and with buy-in from the Kenyan National Malaria Control Program (NMCP), conduct (1) operations applied research and

(2) monitoring and evaluation activities, to improve the efficacy/effectiveness of currently deployed malaria control tools and optimize intervention packages, including existing and novel interventions, to inform malaria control and elimination activities in Kenya.

Example activities may include but are not limited to the following:

• Assess novel preventative and therapeutic interventions such as monoclonal antibodies, antimalarial drugs, vaccines, and novel vector control strategies (for example, housing modification, spatial repellents, larval source management, etc.) to prevent malaria morbidity and mortality in various populations.

• Evaluate approaches to improve the uptake/ effectiveness of existing interventions for malaria prevention and control.

• Evaluate the effectiveness of all aspects of the case management pathway, including appropriate referral, diagnosis, correct prescribing and appropriate messaging at all levels of the health systems.

• Evaluate the therapeutic efficacy of antimalarials to treat uncomplicated and severe malaria.

Outcomes:

• Increased information about the efficacy of currently deployed malaria control interventions in Kenya (and sub-Saharan Africa), especially those threatened by the development of resistance to insecticides by disease vectors and resistance to drugs by parasites.

• Increased evidence related to innovative interventions addressing key challenges in: vector control interventions (including insecticide resistance and outdoor transmission); malaria chemoprevention and vaccination; strategies to improve malaria case management at the health facility and community levels; access to hard-to-reach populations; and reduced transmission through targeting the parasite reservoir.

Objective 2. Advance epidemiologic methods to monitor and measure impact of malaria prevention, detection, control, and response efforts, including those supported by President’s Malaria Initiative (PMI).

Example activities may include but are not limited to the following:

• Strengthen surveillance systems that can more accurately estimate the burden of malaria and monitor artemisinin resistance and are both timely and inclusive of all malaria cases presenting to all sectors (i.e. community level, private sector, and non-governmental organizations).

• Evaluate enhanced surveillance systems in the collection of real-time case information and data use in identifying populations at increased risk of malaria infection.

• Contribute to the evidence base for transforming surveillance into a core malaria intervention, as recommended in the Global Technical Strategy for Malaria, 2016-2030.

• Improve monitoring of the entomological impact of current vector control interventions and surveillance for new vectors, in particular An. stephensi, and insecticide resistance among malaria vectors.

• Assess whether there is an epidemiologic link between An. stephensi and malaria incidence.

• Improve surveillance, monitoring and evaluation tools for low transmission and pre-elimination settings.

• Develop new tools to improve surveillance, monitoring, and evaluation.

Outcomes:

• Increased information about the efficacy of currently deployed malaria prevention and control interventions in Kenya (and sub-Saharan Africa), especially those threatened by the development of resistance to insecticides among disease vectors and resistance to antimalarial drugs among malaria parasites.

• Increased evidence related to effective new tools to improve surveillance, monitoring, and evaluation.

• Improved information about feasibility and impact of transforming surveillance into a key malaria intervention.

• Identification and assessment of improved and cost-effective approaches to monitoring changes in malaria burden.

Objective 3. Advance laboratory methods and strengthen the capacity of local laboratories to identify infection, monitor for parasite and vector resistance, and measure impact of malaria prevention, detection, control, and response efforts.

Example activities may include but are not limited to the following:

• Assess quality of routine malaria microscopy.

• Implement malaria and mosquito salivary antigen testing and malaria antibody testing using a Multiplex Bead-based Assay (MBA) to measure current and historical malaria burden, and immunological responses to malaria vaccine.

• Improve laboratory methods to perform molecular testing for malaria diagnosis, confirmation of HRP2/3 deletions, identification of molecular markers of anti-malarial resistance, determination of recrudescence vs reinfection, and evaluation of markers of malaria vaccine escape.

Outcomes:

• Identification and assessment of improved and cost-effective approaches to monitoring changes in malaria burden and vector biting.

• Assist the KEMRI lab to develop and maintain the capacity to conduct and analyze relevant serologic and molecular assays.

Population of Focus Target populations should include people living or working in epidemiological defined areas of malaria transmission in Kenya, or in areas predicted to be at high risk for re-introduction of endemic malaria, due to importation of new malaria vectors (i.e., An. stephensi). Subpopulation target groups within these malaria transmission zones should include those most at-risk, such as children under five years of age, school children, pregnant women, children admitted with severe malaria/severe anemia.

Collaboration/Partnerships An applicant should ensure collaboration with the Kenya Medical Research Institute (KEMRI) and buy-in from the Kenyan National Malaria Control Program (NMCP), as well as County Ministers of Health in formulating their activity priority lists. In addition, an application is expected to demonstrate a strong history of collaboration with malaria research partners at

KEMRI.

Evaluation/Performance Measurement An application should include measurable goals and aims based on a five (5) year research period of performance. An 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.

Translation Plan The recipient should plan for adequate resources to disseminate findings with local research and malaria control partners as well as communities that contribute to the research program. The recipient should use appropriate scientific journals to disseminate research findings to the broader scientific community in conjunction with CDC scientists. The recipient should present important evaluation and research findings at relevant international scientific meetings and conferences.

3. Funding Strategy N/A

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.

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:

$13,000,000 Year 1: $3,000,000

Year 2: $2,500,000

Year 3: $2,500,000

Year 4: $2,500,000

Year 5: $2,500,000

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $3,000,000

Estimated total funding available for the entire period of performance, including direct and indirect costs: $13,000,000

Throughout the period of performance, 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:

$3,000,000 Per Budget Period

Award Floor:

$1,500,000 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.

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)

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

Additional Eligibility Category:

Other:

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.

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

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 UEI by viewing the organizational registration on SAM.gov. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

Foreign components of U.S. Organizations are not 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 Foreign Organizations/Institutions are eligible to apply. To be considered eligible, the application should have a demonstrated presence in Western Kenya, including evidence of prior malaria research conducted in collaboration with the KEMRI Center for Global Health Research and a letter of support and collaboration from the KEMRI Center for Global Health Research Malaria Program director stating their intention to collaborate on this project.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an application requests a funding amount greater than the ceiling of $3,000,000 for the first budget period as indicated in Section II. of this NOFO, HHS/CDC may consider the application non-responsive.

This NOFO requires institutional presence and research infrastructure in Western Kenya. An applicant must have existing institutional presence (e.g., office location, staff role, financial systems) in Western Kenya and present such info in the application cover page and the mandatory Project/Performance Site Location form.

An application must include a Letter of Support (as indicated in Section IV of this NOFO) from the Kenya Medical Research Institute (KEMRI) Center for Global Health Research Malaria Program.

An application will be deemed non-responsive if: (1) the application does not demonstrate having existing institutional presence in Western Kenya; OR (2) there is no Letter of Support as requested here.

Non-responsive applications will not enter into the review process. HHS/CDC will notify the applicants that their application did not meet the submission requirements.

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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

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 Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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 https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM.gov 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 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 UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

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 entity identifier (UEI) 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

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 Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide 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 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.

Please note: If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

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

Please note: Follow the instructions in this NOFO for including a Data Management Plan in the Resource Sharing Plan section of the PHS 398 Research Plan Component of your application.

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

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 https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

7. PHS 398 Research Plan

8. 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 delayed onset study justification.

• Note: The sIRB requirement applies to participating sites in the United States. Foreign sites participating in CDC-funded, cooperative research studies are not expected to follow the requirement for sIRB.

3. Letter of Intent Due Date for Letter Of Intent 01/13/2025

A Letter of Intent is requested as the information that it contains allows CDC staff to better plan and line up proper review panels for applications.

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 NOFO

The letter of intent should be emailed 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 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 How to Apply

- Application Guide 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 timeline.

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. Other Plan(s) mailto:GAnderson@cdc.gov

12. Authentication of Key Biological and/or Chemical Resources

13. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide 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 Other Plan(s) 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 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);

• A statement (required) of any limitations you may encounter with sharing data collected or generated under this award with CDC (such as legal, regulatory, policy, or technical concerns);

• 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).

The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

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

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.docx

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

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

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".

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publicly https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.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 available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PLEASE NOTE: If applications go beyond the page limit designated for a given section, excess pages will be removed from the application prior to peer review and may negatively affect the application’s scoring.

7. Page Limitations All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 12 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide at .How to Apply - Application Guide.

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications.

ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission. If ASSIST detects errors, then the applicant must correct errors before their application can be submitted. Applicants should view their applications in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application must be resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.

https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://era.nih.gov/files/ASSIST_user_guide.pdf

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant 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).

Applicants who encounter problems when submitting their applications must attempt to resolve them by contacting the NIH eRA Service desk at:

Toll-free: 1-866-504-9552; Phone: 301-402-7469 http://grants.nih.gov/support/index.html Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on Federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726 https://www.grants.gov/support support@grants.gov Hours: 24 hours a day, 7 days a week; closed on Federal holidays

It is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track submission and verify the submission…