Notice of Funding Opportunity

Application due Monday, June 22, 2026

Global Health Center/Office of Director

Enhancing Understanding of and Preparedness for Public Health Threats Through Research in Kenya Opportunity number: RFA-JG-26-034

Contents

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Agency priorities 10

Program description 13

Step 2: Get Ready to Apply 25

Find the application package 26

Get registered 26

Help applying 27

Step 3: Build Your Application 28

Application checklist 29

Application contents and format 31

Step 4: Understand Review, Selection, and Award 36

Application review 37

Award notices 43

Step 5: Submit Your Application 44

Submission requirements and deadlines 45

Step 6: Learn What Happens After Award 47

Post-award requirements and administration 48

Contacts and Support 53

Before you begin 3

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on Monday, June 22, 2026.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Agency priorities 10

Program description 13

Basic information Centers for Disease Control and Prevention

Global Health Center/Office of Director

Advancing research on public health threats in Kenya to inform U.S. and global preparedness and strengthen Kenya’s local capacity to respond to infectious diseases.

Have questions? See Contacts and Support.

Key facts

Opportunity name:

Enhancing Understanding of and Preparedness for Public Health Threats Through Research in Kenya

Opportunity number:

RFA-JG-26-034

Assistance listing: 93.326

NOFO version: Original

Key dates

Application submission deadline: Monday, June 22, 2026

Optional letter of intent deadline: May 23, 2026

Expected scientific review dates: July 2026

Expected secondary review dates: July 2026

Expected award date:

September 1, 2026

Expected start date:

September 30, 2026

Expiration date:

June 23, 2026

See Submit your application for other submission requirements and deadlines that may apply to this NOFO.

Summary This notice of funding opportunity (NOFO) supports research, implementation science, and public health evaluations to inform best practices for preventing and responding to infectious disease threats in Kenya, while strengthening local research capacity.

The award recipient will conduct research, implementation science, and public health evaluations through the Kenya Medical Research Institute (KEMRI) and focus on four required priority areas:

• Influenza and other respiratory pathogens: Activities include surveilling high-risk groups; monitoring for human and avian influenza and other pathogens; and evaluating efficacy and use of vaccines and other treatments. Outcomes include increasing understanding of disease burden and improving vaccination strategies.

• Vaccine-preventable diseases: Research will assess disease burden, vaccine effectiveness, and sociocultural factors influencing immunization.

Outcomes include increasing vaccine uptake and strengthening immunization systems.

• Drug-resistant infections: Activities include monitoring antimicrobial resistance (AMR) trends, applying novel diagnostics, and identifying drivers of resistance. Outcomes include improving mitigation strategies and global AMR preparedness.

• Global and emerging health threats: Research will address malaria, HIV, tuberculosis, schistosomiasis, and emerging infections. Outcomes include improving understanding of disease dynamics, intervention effectiveness, and cross-border risks.

Step 1: Review the Opportunity 5

The recipient will also conduct research coordination and administration activities to manage and oversee U.S. government–funded public health research, ensure compliance with financial and ethical standards, and enhance organizational infrastructure. Outcomes include improved management and compliance with federal funding regulations.

The proposed activities under this NOFO will generate evidence to guide U.S.

and global preparedness, reduce disease burden and health threats in Kenya, and prevent the spread of health threats across borders.

Funding details Funding type: Cooperative agreement

Expected awards: 1

The number of awards is subject to available funds and program priorities.

Period of performance: 5 years in 12-month budget periods.

Application type: New

Expected total program funding over the performance period: $30 million

Expected total program funding per budget period: $3 to 6 million

Expected funding per applicant per budget period: $3 to 6 million

Maximum award amount per budget period: $6 million

Minimum award amount per budget period: $0

For budget year 1, we will budget the following amounts for each priority. We will only fund applications that include all four priorities. We will not fund any priority individually.

• Influenza and other respiratory pathogens: $2 to 3 million

• Vaccine-preventable diseases: $75,000 to $100,000

• Drug-resistant infections: $400,000

• Global and emerging health threats: $100,000

Step 1: Review the Opportunity 6

Eligibility Eligible applicants Only these types of organizations may apply.

• Public and state-controlled institutions of higher education.

• Nonprofits with a 501(c)(3) status, other than institutions of higher education.

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Foreign organizations. A foreign organization is a public or private organization, whether nonprofit or for-profit, located in a country other than the United States 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.

Applications from consortia are allowed.

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet all eligibility criteria. See requirements in Eligibility.

• Is submitted after the application deadline.

• Does not demonstrate evidence of an established institutional presence in Kenya, such as an office, personnel, or other infrastructure.

• Does not demonstrate access to relevant research infrastructure (such as facilities and equipment) and document a history of technical collaboration or ongoing work with the Kenya Medical Research Institute (KEMRI) and/or the Kenya Ministry of Health (MoH). See the responsiveness criteria documentation section of the application requirements for information on how to meet this requirement.

• Does not describe all core categories, priority areas, and research coordination and administration functions.

Step 1: Review the Opportunity 7

◦ Your application must respond to all the priority areas described in the summary of this NOFO. You will submit a separate research plan for each priority area. See the research plan section of this NOFO.

If your application does not address all responsiveness criteria, it will be deemed nonresponsive and will not be forwarded for review. In addition, if you request a funding amount greater than the total ceiling, HHS/CDC will consider the application nonresponsive, it will not enter the review process, and you will be notified that the submission did not meet the requirements.

See the application checklist to understand which elements of your application are part of the responsiveness criteria.

Application limits You must follow these limits on the number of applications your organization can submit.

You may submit more than one application if each application is scientifically distinct. All applications submitted by an eligible institution must name the same, single lead principal investigator/principal director (PI/PD).

Qualifications for principal investigator or project director We invite anyone who has the skills, knowledge, and resources needed to carry out the proposed research as a project director or principal investigator (PD/PI) to work with their organization or institution to apply.

Step 1: Review the Opportunity 8

Cost sharing and matching funds This program has no cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

If you choose to include cost-sharing funds, we won’t consider it during review. If you receive an award, we will include your voluntary commitment in the award, and you must report on the funds.

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Step 1: Review the Opportunity 9

Agency priorities Required alignment with CDC priorities The recipient of this award must implement any funds awarded under this NOFO to effectuate program goals or agency priorities in accordance with the Centers for Disease Control and Prevention (CDC) Priorities when authorized (for a full description of the CDC Priorities, please follow the provided hyperlink).

Funded activities must:

• Align with CDC’s core priorities by demonstrating a commitment to gold-standard science, transparency, and evidence-based practices.

• Support CDC’s mission to protect Americans from infectious and chronic diseases, strengthen public health systems, and advance innovation in health data and infrastructure.

• Contribute to rapid, science-driven responses to health threats, promote global health leadership, and adhere to principles of integrity, accountability, and compliance with applicable laws and federal priorities.

Consistent with CDC’s values, in carrying out any project funded under this NOFO, the recipient must adhere to the following principles where consistent with the authority and scope of the award and its activities:

• A commitment to gold-standard science and ensuring trust, transparency, and credibility: To build trust and improve CDC’s ability to lead during health crises, CDC will increase transparency, be more accountable, and follow strict, gold-standard scientific practices that are open, unbiased, and based on clear evidence.

• A commitment to global leadership: With staff in 63 countries and supporting 20 more, CDC’s Global Health Center:

◦ Works to prevent disease and advance emergency response.

◦ Detects health threats early, sends response teams, trains health workers, and provides personal protective equipment, vaccines, and medicines.

◦ Tests disease samples from around the world to prepare for flu and other serious outbreaks.

◦ Has strengthened systems to better protect people at home and abroad after the COVID-19 outbreak.

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Step 1: Review the Opportunity 10 https://www.cdc.gov/about/cdc/index.html

• A commitment to ensuring rapid, evidence-based responses to crises:

During public health emergencies, ensuring rapid, science-driven responses is critical to minimizing harm, maintaining public trust, and restoring stability. To meet this goal, CDC must continue to strengthen its emergency response systems by:

◦ Streamlining internal processes.

◦ Improving risk communication strategies.

◦ Ensuring that laboratory capacity is fully equipped and tested—capable of rapidly developing and deploying scalable diagnostics during crises.

◦ Embedding structures for real-time learning, independent after-action reviews, and the application of lessons learned will ensure that each crisis response is smarter, faster, and more effective than the last.

• A commitment to vaccine safety and efficacy research: CDC will apply “gold-standard” science to all of its vaccine safety and effectiveness research. It will make vaccine data, research methods, and related datasets publicly available through simple data use agreements to improve transparency, accountability, and trust.

• A commitment to advancing our understanding of the causes of autism spectrum disorder (ASD), neurodevelopmental disorders (NDDs), and chronic disease: CDC conducts research and works with partners to better understand the causes of autism spectrum disorder, neurodevelopmental disorders, and chronic diseases. It will use new and existing data to study the rise in these conditions, including the increase in autism diagnoses from 1 in 150 to nearly 1 in 31 over the past 25 years.

• A commitment to modernizing public health infrastructure and enhancing our approach to health data: CDC will modernize public health infrastructure to create a faster, more efficient health system that can detect and respond to outbreaks in real time. This effort includes:

◦ Replacing data silos with integrated systems.

◦ Using advanced technology.

◦ Strengthening partnerships with states to ensure shared responsibility and strong local health data systems.

◦ Emphasizing collaboration across federal and state partners, resilient and adaptable systems, and accountability for funded programs to ensure they align with these priorities and federal requirements.

Step 1: Review the Opportunity 11

• Conflicts of interest: CDC will not support funding programs with conflicts of interest and ensure its work is based on transparent, unbiased science.

• Immigration: CDC funds will not be used to support or encourage illegal immigration, consistent with federal law.

• Protecting life and the family: CDC funds will not be used to support elective abortions, consistent with the Hyde Amendment, and will promote maternal health, the dignity of life, and strong families.

• Ending disorder on America’s streets: CDC will prioritize evidence-based programs that reduce homelessness, drug use, and public disorder. It will support comprehensive services for people with serious mental illness and substance use disorder. CDC will not support housing first strategies, harm-reduction or safe consumption sites, or related activities. To the extent allowable by federal law, CDC intends to give priority to grantees in States and municipalities that have laws and policies that support and enforce CDC’s priorities.

• Gender ideology and protecting children: CDC will not fund medical interventions for minors seeking gender transition and will define sex based on biological criteria.

• DEI: CDC will not support DEI initiatives based on group identity and focus on merit-based, evidence-driven approaches to improve health outcomes.

• Parental rights: CDC will support policies that protect parental authority, promote transparency, and give parents greater control over their children’s education.

The recipient must demonstrate ongoing compliance with the full description and listing of CDC values and priorities, in all programs that are authorized to advance them, through program design, implementation, reporting, and evaluation.

Failure to meaningfully align funded activities with the applicable requirements may result in corrective action, additional reporting requirements, or other enforcement actions consistent with federal grant regulations found at 2 CFR Part 200 and the terms and conditions of this award. The full CDC Priorities Statement can be found here: Centers for Disease Control and Prevention (CDC) Priorities.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 12 https://opa.hhs.gov/sites/default/files/2025-11/gender-dysphoria-report.pdf

Program description Background The Centers for Disease Control and Prevention (CDC) advances its mission to protect the United States from health, safety, and security threats by supporting research and capacity-building in regions with high burdens of infectious disease. Kenya, as a major trade and travel hub with frequent outbreaks of endemic, emerging, and reemerging diseases, presents unique risks for cross-border spread of infectious threats to the U.S., the region, and the world.

CDC has a long-running collaboration with Kenyan government institutions conducting scientific research that address major public health threats. This includes research into strategies to control and reduce the spread of malaria, HIV/AIDS, tuberculosis, vaccine-preventable diseases, emerging infectious diseases, drug-resistant infections, and infectious disease outbreaks. CDC supports research, implementation science, and public health evaluations to inform best practices for countering infectious disease health threats. This contributes to CDC’s mission to save lives and protect American people from health threats, while also contributing to a safer world.

National strategic priorities This project aligns with the HHS Strategic Plan (2022–2026) [PDF], including Goal 2, Safeguard and Improve National and Global Health Conditions, and Objective 4.3, Strengthen Surveillance, Epidemiology, and Laboratory Capacity. The project advances the National Health Security Strategy (2023–2026) by supporting infectious disease research and surveillance in Kenya, which helps detect and contain emerging threats at their source, strengthen laboratory and data systems, and apply a One Health approach.

The project also aligns with the Administration’s Biothreat Radar initiative, These activities protect Americans by reducing the risk of cross-border spread of high-priority pathogens and ensuring that the U.S. public health system has timely, actionable information for response.

Related work For over 40 years, CDC has partnered with the Kenya Medical Research Institute (KEMRI) to advance research on the epidemiology, prevention, and control of infectious diseases. This collaboration has built population-based surveillance platforms, internationally accredited laboratories, and clinical

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Step 1: Review the Opportunity 13 https://stratml.us/pdfs/HHS2022.pdf https://stratml.us/pdfs/HHS2022.pdf https://stratml.us/pdfs/HHS2022.pdf https://www.cdc.gov/budget/documents/fy2026/fy-2026-cdc-cj.pdf research centers that generate evidence informing international and Kenyan Ministry of Health policies. These efforts strengthen global health security by enabling early detection of pathogens, advancing vaccines and diagnostics, and reducing cross-border transmission risks.

Population-based surveillance and pathogen discovery The Population-Based Infectious Disease Surveillance (PBIDS) in Siaya and Nairobi counties, expanded to Isiolo county in 2024, comprises household, community, environmental, and health facility surveillance. It has been critical for outbreak preparedness and research. Research has defined causes of pneumonia and diarrheal and febrile illnesses; identified zoonotic threats;

and provided evidence of the effectiveness of vaccines such as rotavirus, pneumococcal conjugate vaccine (PCV10), typhoid, respiratory syncytial virus (RSV), and COVID-19.

Laboratory science and innovation CDC-supported KEMRI laboratories serve as accredited reference centers for HIV viral load, HIV and TB drug resistance, and TB diagnostics. The Diagnostic Laboratory Systems Program (DLSP) lab, located at Kisumu and Nairobi KEMRI campuses, strengthens outbreak detection, diagnostic innovation, and research. The lab conducted genomic sequencing of SARS-CoV-2 to track variants and support trials, implementation research, and surveillance. DLSP also supports the CHAMPS study, which generates high-quality child mortality data for global health policy. Laboratory-based studies have validated improved TB diagnostics such as Xpert Ultra and pediatric-friendly sampling methods.

Clinical and translational research CDC helped establish two research centers that are operated by KEMRI and are available for collaboration on CDC-funded projects.

• The Siaya Clinical Research Center is central to CDC-supported malaria studies including prevention (chemoprevention, monoclonal antibodies), treatment, and vaccines (RTS,S/AS01). These studies have informed malaria guidelines in Kenya and globally.

• The Kisumu Clinical Research Center supported several studies led or supported by CDC on HIV prevention, including demonstrating efficacy of antiretroviral therapy (ART) in pregnancy, validating oral pre-exposure prophylaxis (PrEP), and establishing long-acting injectable PrEP as superior to daily oral dosing.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://pbids.kemri.go.ke/ https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-6770-9 https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-6770-9 https://archive.cdc.gov/www_cdc_gov/globalhealth/countries/kenya/blog/child-deaths-in-western-kenya.html

Purpose The purpose of this NOFO is for CDC to support or facilitate research, implementation science, and public health evaluations to inform best practices for preventing infectious diseases and countering health threats that both affect Americans and have a high burden or risk in Kenya and outside the U.S. Findings from supported research will benefit preparedness in the U.S., Kenya, and globally. To promote long-term capacity to conduct relevant research, CDC plans to support Kenya’s local capacity to research public health threats. The goal is to strengthen local response and reduce the spread of infectious disease threats.

The NOFO recipient will support surveillance, epidemiological studies, laboratory research, and dissemination of scientific results. They will also support KEMRI’s administration and business systems to facilitate research.

Approach This NOFO will support various CDC projects on public health threats in Kenya to be conducted at KEMRI, institutions collaborating with KEMRI, or KEMRI affiliates.

The NOFO also aims to support KEMRI to enable CDC-supported research on public health threats while Kenya consolidates its public health functions under the Kenya National Public Health Institute (KNPHI).

This NOFO builds on a previous NOFO, “Advancing Public Health Research in Kenya” (RFA-GH-21-003).

Objectives and outcomes This section includes the outcomes we expect you to report progress on and achieve within the period of performance if you receive funding.

This notice of funding opportunity includes two main areas:

• Research, implementation science, and public health evaluations.

• Research infrastructure coordination and administration.

Step 1: Review the Opportunity 15

1. Research, implementation science, and public health evaluations Priority area 1A: Influenza and other respiratory pathogens

Outcome 1A: To better understand the disease burden of influenza and other respiratory pathogens nationally and among groups at increased risk of influenza complications to guide targeted public health interventions

Objectives—you must address all five in your research plan:

1. To conduct surveillance of influenza and other respiratory infections in populations at high risk to guide targeted public health interventions.

2. Prioritize innovation with new technologies such as AI, use of targeted and untargeted sequencing and metagenomics capacity, and systems that can support both pathogen-specific and pathogen-agnostic surveillance.

3. To monitor human respiratory pathogens including avian and human influenza, respiratory syncytial virus (RSV), and other respiratory pathogens, and to archive samples for related public health research.

4. To assess efficacy, effectiveness, cost-effectiveness, immunogenicity, and impact of recommended vaccines, treatments, and nonpharmaceutical interventions (NPIs) and other control measures to reduce the burden of influenza disease and other respiratory pathogens among high-risk populations.

5. To evaluate strategies to optimize routine use of licensed vaccines for influenza or other respiratory pathogens in Kenya.

Priority area 1B: Vaccine-preventable diseases

Outcome 1B: Improved understanding of the burden of other vaccine-preventable diseases (VPDs) and opportunities to increase vaccination to reduce threat of VPDs.

Objectives—choose and describe one:

1. To estimate the disease burden of groups at increased risk of VPDs to guide targeted public health interventions, including vaccination.

2. To assess efficacy, effectiveness, immunogenicity, and impact of vaccines, coverage, schedules, product switches, treatments, and other interventions to reduce burden of VPDs.

3. To conduct sociocultural and behavioral research on knowledge, attitudes, and practices related to VPDs.

Step 1: Review the Opportunity 16

4. To research immunization information systems, social mobilization, communications, coverage, and quality of immunization service delivery, including identifying barriers to vaccination in high-risk groups.

Priority area 1C: Drug-resistant infections

Outcome 1C: Improved understanding of drivers of antimicrobial resistance and identification of effective mitigation strategies.

Objectives—choose and describe at least two:

1. To assess the burden and trends in antimicrobial resistance among community and hospitalized populations at both epidemiologic and molecular levels.

2. To better detect and characterize antimicrobial-resistant pathogens, including by using new technologies and rapid diagnostics.

3. To identify factors and pathways contributing to the spread of antimicrobial resistance.

4. To evaluate and implement novel strategies to surveil antimicrobial resistance.

5. To identify and evaluate the impact of interventions on mitigating antimicrobial resistance across different populations.

Priority area 1D: Global and emerging public health threats

Outcome 1D: Enhance understanding of infectious disease epidemiology, risk groups, and intervention outcomes in Kenya to generate insights to help protect U.S. and local populations from global diseases (such as malaria, HIV, tuberculosis, and schistosomiasis) and emerging health threats.

Objectives—choose and describe one:

1. Conduct research and surveillance using program, survey, and national/ subnational data to assess epidemiology and intervention effectiveness for global and emerging health threats.

2. Evaluate new interventions, diagnostics, and technologies for their effectiveness, acceptability, and potential applicability for preparedness for global and emerging health threats.

3. Study the dynamics of infectious diseases, including co-infections and cross-border threats, to inform strategies for risk mitigation in the U.S., locally, and globally for global and emerging health threats. This could include collaborations on surveillance for communicable disease for international travelers at ports of entry.

Step 1: Review the Opportunity 17

2. Research coordination and administration Outcome 2: Strengthen KEMRI’s research coordination and administration, evidenced by full compliance with U.S. government financial and ethical standards, timely reporting on all funded projects, and improved institutional capacity to deliver high-quality research that informs local, U.S., and global responses to emerging and reemerging health threats.

Objectives—you must address all five:

1. Collaborate with KEMRI to provide administrative, financial management, and oversight support for U.S. government–funded research projects that generate critical data for addressing health threats.

2. Ensure fiduciary oversight of CDC subawards by reviewing, monitoring, and confirming cost allocations to safeguard U.S. assistance and ensure responsible use of research funds.

3. Guarantee compliance with research ethics procedures and internal review board (IRB) requirements, ensuring the integrity of research that will underpin local, U.S., and global public health policy and preparedness.

4. Strengthen KEMRI’s organizational capacity, including infrastructure and human resources, to conduct collaborative research that informs local, U.S., and global health responses.

5. Help the research laboratory maintain international standards to generate reliable scientific evidence that advances local, U.S., and global health security and disease prevention.

Collaborations

• You are required to collaborate with the Kenya Ministry of Health (MoH) and the Kenya Medical Research Institute (KEMRI). You must submit information and supporting documents on how you will establish and maintain these collaborations and have established similar collaborative work in the past. Please see the responsiveness criteria documentation section of the application requirements for submission requirements.

• You are required to collaborate with other recipients of CDC assistance on activities that are complementary to this NOFO, such as those supporting surveillance and laboratory platforms.

Step 1: Review the Opportunity 18

Evaluation and performance measurement CDC will monitor performance of recipient during the life of the award, with quarterly meetings held between you and CDC. You will work with CDC and other partners as appropriate to develop and implement an evaluation plan and performance measures after the award begins. Some examples of potential performance measures are:

• Research, implementation science, and public health evaluations:

◦ Number of protocols launched on planned timeline.

◦ Proportion of studies done in compliance with protocol.

◦ Proportion of participants recruited on time.

◦ Proportion of studies completed on time.

• Research coordination and administration:

◦ Implementation of necessary administrative standard operating procedures.

◦ Number of routine meetings with key stakeholders scheduled and completed.

◦ Timely submission of quarterly financial plan with clear cost allocation breakdown.

◦ Timely submission of progress reports and dissemination to key stakeholders.

◦ Implementation of cost allocation plans for KEMRI campus management and laboratory services.

Step 1: Review the Opportunity 19

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require the Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget.

To determine if a proposed activity requires PRA approval, contact your scientific and research contact. Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

For more information about CDC’s requirements under PRA see CDC Paperwork Reduction Act Compliance.

Translation plan You should describe plans for how you will report and disseminate research and scientific findings, such as through peer-reviewed journals, scientific presentations, reports, meetings, or conferences. Specify how you will integrate these activities into the project plan. Your translation of findings should be understandable to a variety of audiences, including policymakers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, the public, and researchers. The aim of translation is to make the evidence from the research findings and data accessible to policymakers to inform policies, guidelines, or interventions.

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Step 1: Review the Opportunity 20 https://www.cdc.gov/scientific-integrity/php/public-information-collection/ https://www.cdc.gov/scientific-integrity/php/public-information-collection/

Funding policies and limitations Changes in HHS regulations As of October 1, 2025, HHS adopted 2 CFR 200, with some exceptions included in 2 CFR 300. These regulations replace those in 45 CFR 75. You can find details in HHS Summary of Regulatory Changes, which is posted in the Grants.gov Related Documents tab for this opportunity.

General guidance All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate;

racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. If you have questions about these purposes, ask the grants management specialist.

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, travel, equipment, supplies, contractual, other (includes consultant costs), and indirect costs.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

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Step 1: Review the Opportunity 21 https://www.ecfr.gov/current/title-2/part-200 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-300 https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html

• If we receive more funding for this program, we will consider:

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

Unallowable costs You may not use funds for:

• Clinical care, except as allowed by law.

• Pre-award costs. Any costs incurred prior to the Notice of Award will not be reimbursed.

• Other than for normal and recognized executive-legislative relationships:

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

See Anti-Lobbying Restrictions for CDC Recipients [PDF].

For guidance on some types of costs that we restrict or do not allow, see 2 CFR 200.420, Considerations for Selected Items of Cost.

Indirect costs Indirect costs are those shared across multiple projects and not easily separated. Learn more at CDC Budget Preparation Guidelines [PDF].

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. If you currently have an indirect cost rate approved by your cognizant federal agency, you may use that rate.

Enclose a copy of the current approved rate agreement in your Other Attachments Form.

Method 2 — De minimis rate. If you do not have a current negotiated indirect cost rate, you may elect to charge a de minimis rate (see 2 CFR 200.414(f)). This rate is 15% of modified total direct costs (MTDC). See the definition of MTDC (2 CFR 200.1). You can use this rate indefinitely.

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Step 1: Review the Opportunity 22 https://www.cdc.gov/grants/documents/Anti-Lobbying-Restrictions.pdf https://www.ecfr.gov/current/title-2/section-200.420 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

Recipients may charge indirect costs on awards to foreign organizations and foreign public entities performed fully outside of the U.S. and its territories to support the costs of complying with federal requirements. This rate is fixed at 8% of MTDC, excluding tuition and related fees, direct expenditures for equipment, and subawards over $25,000.

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

Other indirect cost policies As described in 2 CFR 200.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

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

Salary rate limitation The salary rate limitation in the current appropriations act applies to this program. As of January 2026, the salary rate limitation is $228,000. We update this limitation when it changes.

Program income If you earn any money from your award-supported project activities (known as program income), you must use it for the purposes and under the conditions of the award. Find more about program income at 2 CFR 200.307.

Expanded authority For more information on expanded authority, see the HHS Grants Policy Statement and speak to the grants management contact.

Public health data We require that awards include the needed costs and methods to share public health data. You may include the reasonable cost of sharing or archiving public health data as part of your requested budget for first-time or continuation awards. For more information, see Data Management and Access.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 23 https://www.ecfr.gov/current/title-2/part-200#p-200.403(d) https://www.ecfr.gov/current/title-2/section-200.307 https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

Human subjects We will restrict funds related to conducting research involving human subjects until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. To lift the restrictions, we require copies of all current local IRB approval letters, local IRB-approved protocols, and CDC IRB approval letters, when applicable.

If the proposed research project involves more than one institution and will be conducted in the United States, we expect you to:

• Use a single Institutional Review Board (sIRB) to conduct the required ethical review.

• Include a single IRB plan in your research plan and PHS Human Subjects and Clinical Trials Information form, unless either of the following is true:

◦ Review by an sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.

◦ You provide a compelling justification based on ethical or human subject protection issues or other well-justified reasons.

Do not duplicate information in the research plan form and the PHS Human Subjects and Clinical Trials Information form.

In your research plan, discuss the overall strategy, methodology, and analyses of your proposed research. Use the PHS Human Subjects and Clinical Trials Information form to provide detailed information for human subjects studies and clinical trials.

We will review and approve exceptions in accordance with 45 CFR part 46 and, as applicable, 21 CFR part 50 and 21 CFR part 56, or we may place a restriction on the award.

Note: The sIRB requirement applies to participating sites in the United States.

Foreign sites participating in CDC-funded, cooperative research studies do not need to follow the requirement for sIRB.

For more information, please consult the scientific and research contact listed for this NOFO.

Statutory authority Public Health Service Act, Section 301(a) [42 USC 241(a), as amended], Section 307 [42 USC 242l, as amended].

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 24 https://www.ecfr.gov/current/title-45/part-46 https://www.ecfr.gov/current/title-21/part-50 https://www.ecfr.gov/current/title-21/part-56

Step 2:

Get Ready to Apply

In this step

Find the application package 26

Get registered 26

Help applying 27

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov or eRA ASSIST and search for opportunity number RFA-JG-26-034. After opening the opportunity, select the “package” tab to see the forms.

We recommend that you select the Subscribe button from the View Grant Opportunity page for this NOFO to get updates.

If you can’t use Grants.gov to download application materials or have other technical difficulties, including issues with application submission, contact Grants.gov for help.

Get registered You must be registered in both SAM.gov and Grants.gov to apply. You can review the requirements and get started on developing your application before your registrations are complete.

SAM.gov You must have an active account with SAM.gov to apply. SAM.gov registration can take several weeks. Begin that process today.

To register:

• Go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

• You must agree to the financial assistance general certifications and representations specifically. Those for contracts are different.

When you register, you will also receive your required Unique Entity Identifier

(UEI).

Once you register:

• You will have to maintain your registration throughout the life of any award.

• If your organization has multiple UEIs, use the one associated with your physical location.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 26 https://grants.gov/search-grants https://public.era.nih.gov/assist/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fassist%2F https://www.grants.gov/support https://www.grants.gov/support https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

eRA Commons You must register in eRA Commons. Your senior and key personnel must also register and affiliate their accounts with your organization’s account.

Register at least four weeks before the application deadline.

Need help? See Contacts and Support.

Help applying For help with the application process and tips for preparing your application, see How to Apply on our website and the Research Instructions for NIH and Other PHS Agencies [PDF].

If any instructions differ from those in this NOFO, follow the instructions in this NOFO.

For other questions, see Contacts and Support.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 27 https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://public.era.nih.gov/commonsplus/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons https://www.cdc.gov/grants/applying/index.html https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf

Step 3:

Build Your Application

In this step

Application checklist 29

Application contents and format 31

Application checklist You must follow the research instructions [PDF] to complete your application.

In this section, we also provide NOFO-specific guidance for some forms.

Make sure that you have everything you need to apply:

Form Required for

PHS 398 Research Plan form All applications.

SF424 (R&R) All applications.

PHS 398 Cover Page Supplement Form All applications.

SF424(R&R) Other Project Information All applications.

SF424(R&R) Project/Performance Site Locations All applications.

SF424(R&R) Senior/Key Person Profile All applications.

R&R Budget Form or HS 398 Modular Budget Form

All applications.

• Include only one of these forms, not both, in your application.

• The modular form is typically used by domestic organizations requesting $250,000 or less per budget period in direct costs.

R&R Subaward Budget Attachments Form If your application proposes subawards.

PHS Human Subjects and Clinical Trials Information All applications.

PHS Assignment Request Form Optional.

Other Attachments Form All applications.

Report on overlap If applicable.

Bona fide agents documentation If applicable.

Indirect cost agreement If applicable.

Overall management plan All applications.

Responsiveness criteria All applications.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 29

See submission requirements and deadlines to see if there are other requirements beyond the application itself.

Important: Public information

When filling out your SF-424 form, pay attention to Box 15: Descriptive Title of Applicant’s Project.

We share what you put there with USAspending. This is where the public goes to learn how the federal government spends their money.

Instead of just a title, insert a short description of your project and what it will do.

See instructions and examples [PDF].

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 30 https://www.usaspending.gov/ https://www.hhs.gov/sites/default/files/hhs-writing-award-descriptions.pdf

Application contents and format You must follow the research instructions [PDF] in the How to Apply:

Application Guide unless this NOFO says otherwise. We strictly enforce these requirements. If you do not follow them, we may delay or not accept your application for review.

See responsiveness criteria to make sure you meet all requirements.

As you build your application, keep the review criteria in mind.

PHS 398 Research Plan form You will use the PHS 398 Research Plan form to complete your research plan.

You will upload each of the following parts of the form as a separate attachment.

Some parts may not be required for your application. We provide guidance here and in the Application Guide.

Follow all instructions beginning on page 80 of the research instructions [PDF]. We note additional instructions in this NOFO.

Introduction This section only applies to resubmission or revision applications. Do not include this section if you are submitting a new or renewal application.

Research plan section To complete this section use the instructions beginning on page 82 of the research instructions [PDF]. The parts for this section include:

Parts Required for Page limit

Specific aims All applications. 1 page

Research strategy All applications. 15 pages

Your application package must include all the components of the SF-424 package. Each application must include an SF-424 R&R with a separate research plan, budget, and strategy to address each priority area. (Note that you must also include a separate budget narrative that does not exceed

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 31 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=80 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=80 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/research-forms-i.pdf#page=82 the provided funding levels for each priority area. The budget narrative is not included in the page limit. See the budget form section.)

All research plans submitted by an eligible institution must name the same, single lead Principal Investigator/Principal Director (PI/PD, along with all key staff responsible for programmatic oversight.

If your application is submitted by a consortium, you must provide details on the consortium agreement, including the management structure. The lead entity of the consortium has overall responsibility for the management plan.

Applicants are expected to apply for the entire project period, with specific focus on required objectives in Year 1.

You must follow all page limits described in this NOFO. Pages that exceed the limits will be removed and not forwarded for peer review, potentially affecting your score.

To complete this section use the instructions beginning on page 86 of the research instructions [PDF]. The parts for this section include:

Parts Required for Page limit

Vertebrate animals If you answer “Yes” to the question “Are Vertebrate Animals Used?” on the R.220 - R&R Other Project Information Form.

None

Select agent research If your proposed activities involve the use of select agents at any time during the proposed period of performance.

None

Multiple PI/PD leadership plan If you designate multiple PD/PIs (on the R.240 - R&R…