It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

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

Despite remarkable progress in malaria control since 2000, the rate of decline in malaria morbidity and mortality has slowed in recent years. Alarmingly, the World Health Organization (WHO) reported 14 million additional malaria cases and 69,000 additional deaths in 2020 compared to 2019 in the World Malaria Report 2021. Malaria control efforts face evolving threats, including: the emergence and spread of antimalarial drug and insecticide resistance; emergence and spread of mutated parasites that evade detection by current rapid diagnostic tests (RDTs); spread of an invasive mosquito vector capable of supporting malaria transmission in urban settings; changing vector behavior and ecology; humanitarian crises and population migration; and the effects of climate change. These threats require investments in research to understand, predict, and control malaria if progress towards its elimination and eventual eradication is to be restored and sustained.

Research to support and accelerate control, elimination, and eradication of malaria is an integral part of the National Institute of Allergy and Infectious Diseases (NIAID) Strategic Plan for Malaria Research and Development. To that end, NIAID established the International Centers of Excellence for Malaria Research (ICEMR) Program in 2010 to support multidisciplinary research in diverse epidemiologic settings spanning all malaria-endemic regions of the world. The ICEMR program provides a multidisciplinary and integrated framework to assess the dynamic epidemiology and global landscape of malaria, and support evaluation of the impact of current interventions and control programs. It provides critical data to inform the design and evaluation of new tools and future interventions to reduce the burden and interrupt transmission of malaria.

The objective of this Funding Opportunity Announcement (FOA) is to solicit applications for the NIAID ICEMR program. The research objectives of the Program are to 1) improve our understanding of malaria pathogenesis, epidemiology, and transmission; and 2) evaluate, optimize, and inform development of interventions to understand, control, eliminate, and eventually eradicate malaria. The Centers in the Program will achieve these objectives through the design and conduct of multidisciplinary studies in malaria-endemic settings in close coordination with local ministries of health and other malaria control counterparts. The Program will also strengthen malaria research capabilities in endemic-country institutions and provide research opportunities for early-stage investigators.

All field Research Projects must be conducted within malaria-endemic geographic regions and must provide for significant involvement of local/regional researchers in study design, development, and execution. It is important to note that the ICEMR program is not intended to support research that can be conducted primarily in the U.S. or other countries where malaria is not endemic; however laboratory and in silico studies conducted in non-endemic settings are allowed. In addition, each Center must develop and maintain affiliations with local/regional government agencies and established institutions in the endemic sites to ensure necessary coordination of research activities with ongoing malaria control/intervention programs and to facilitate access to relevant study populations and treatment centers. Integral to accomplishing the goals of each Center is the inclusion of milestones, which will be used to measure the progress of the individual projects and Cores as well as the Center as a whole.

The proposed research should not be limited to malaria surveillance, surveys and/or measurement of impact of control programs. The application should address a central theme characteristic of the proposed endemic sites, and the projects should be integrated and relate to the overarching thematic area. The projects should identify critical barriers to the reduction of malaria morbidity and mortality. Hypotheses should be developed based on observations and data from the field. Applications must include at least one basic science aim or translational science aim, with the potential to inform product development, within at least one Research Project. The basic science or translational science aim must utilize human or vector samples. Field work that informs the research objectives should take place in at least three field sites for four years or more with field activities lasting at least eight months each year at each field site. Field activities include human subject studies, disease surveillance, and studies of vectors in the field.

Location and Number of Field Sites: Area A Epidemiology (below) research activities must include a minimum of three field sites which could be in the same or different countries, at distances that provide for significant variability in the epidemiology and transmission across field sites. Examples of these include persistent low-level transmission, seasonal transmission, and high perennial transmission. Applications that include sites in malaria-endemic areas where there is a high burden of disease and a paucity of research and surveillance data, are encouraged. There are no requirements for minimum numbers of field sites for Area B Transmission and Area C Pathogenesis and Diagnosis.

ICEMR Program Components

Each application in response to this FOA must include one Administrative Core, one Data Management Core and two or more Research Projects.

Administrative Core

The Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that the project milestones are being met and are being implemented effectively within the proposed timelines. Travel policies permitting, the PD(s)/PI(s) and Project Leaders must visit all the field sites proposed in the application at least three times annually to address administrative issues and monitor scientific progress.

Data Management Core

The Data Management Core will provide data management support for the overall Center and establish a data management system to collect data from all participating study sites, to ensure uniformity of procedures and high-quality data. The Data System should reside at the endemic area, the cloud , or at a site where all key scientific staff will have access to the data collected. Each site should have complete access to all the data collected at their site. Data management staff from the endemic sites will collaborate on the design, development and testing of databases and data management software, validation of the data system, training of data management and field personnel on data collection procedures and activities, maintenance of the database and software systems, documentation of changes, and preparation of data dictionaries and standard operating procedures for all aspects of data management. The data management system should be tested and implemented before the end of the first year.

The ICEMR should have access to dedicated statistical expertise that informs the research study design and provides the ability to conduct statistical data analysis. The Core will be responsible for the rapid release of datasets, analysis tools, reagents, and other resources generated, to the broader scientific community, in adherence to the requirements and timelines described in the NIAID Data Management and Sharing Guidelines (https://www.niaid.nih.gov/research/data-sharing-guidelines) and the NIH Genomic Data Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Research Projects

The Research Projects must address one question in Area A - Epidemiology, and one or more aims in Area B Transmission and/or Area C Pathogenesis and Diagnosis. Area A Epidemiology must be a multi-site project involving at least three of the field sites proposed by the Center. There are no requirements for minimum numbers of field sites for Areas B and C. The Research Projects may propose specific aims addressing each Area alone, or specific aims covering Areas A, B, and/or C in combination. The design of the Research Projects should reflect a multidisciplinary approach that integrates clinical and field aspects with laboratory, molecular and genomic methods, and be capable of adapting to a changing landscape based on epidemiological malaria research. Research Projects should be designed to test novel hypotheses or address important research questions that inform and accelerate product development and new interventions.

Examples of research activities that are responsive to this FOA include, but are not limited to, the following:

Area A Epidemiology

• Causes for the intransigence of malaria burden to routine control measures implemented.
• Causes for the persistence of low levels of malaria.
• Research and impact analysis (e.g., cost-effectiveness analysis) to assess the optimal combination of standard public health interventions in an integrated manner to reduce the burden of disease due to malaria. Examples of such interventions include use of rapid diagnostics, larvicides, bed-net use, indoor residual spraying, and treatment or prevention of malaria which are in routine public health use in accordance with the country’s Ministry of Health (MOH) guidelines.
• Research to inform sub-national strategies on tailoring interventions to the local context.
• Assessment of parasite population diversity and structure and their relevance to design of new products and interventions.
• Multidisciplinary research approaches to discover, identify, validate, evaluate, and optimize interventional tools and strategies.
• Studies that encourage the merging of laboratory research and field research, such as use of molecular tools and/or immune responses to explain linkage between epidemiologic, pathologic, and ecologic phenomena.
• Development of mathematical models based on emerging field data that will help guide product development and optimize the combinations of interventions.
• Studies on the impact of climate change, environmental modifications, and extreme weather events on risk and transmission of malaria.
• Studies on urban malaria.
• Evaluation of novel diagnostics (until a new diagnostic receives regulatory approval, results should not impact clinical management of malaria cases). Diagnostics should be in the final form and field ready to be deployed and may not be in the early stages of development or prototype devices.
• Factors, biomarkers, or combination of indicators associated with recurrent malaria infections and/or recrudescence.

Area B Transmission

• Research on vector biology and ecology.
• Study of residual transmission and outdoor biting behavior of anopheline mosquitoes.
• Evaluation of impact of emerging resistance to current drugs and insecticides on transmission.
• Assessment of impact of vector management or control strategies on disease transmission.
• Evaluation of novel transmission reduction strategies, e.g., combination of existing vector control methods.
• Study of asymptomatic carriers and their contribution to disease transmission.
• Study of factors affecting gametocytogenesis in symptomatic and asymptomatic disease and their contributions to transmission.
• Assessment and evaluation of monitoring tools and surveillance methods when malaria transmission is at low levels or to detect onset of epidemics.

Area C Pathogenesis and Diagnosis

• Identification and characterization of:
  • host susceptibility and parasite virulence factors contributing to changes in the spectrum of disease severity, changes in pathological manifestation(s), evasion of protective host responses, or increased transmissibility.
  • host factors and immune responses that are associated with resistance to infection and/or disease, or with reduced transmission.
  • host factors associated with carriage of hypnozoites.
  • serological markers and diagnostic tools for identification of carriers of hypnozoites
  • factors associated with persistence or clearance of gametocytes.
• Identification, development and testing of diagnostics for human and mosquito infections, as well as drug and insecticide resistance.
• Discovery and validation of novel antigens or biomarkers to inform development of new rapid diagnostics to detect malaria at point of care settings.
• Development and evaluation of field deployable genomic surveillance tools for parasites and vectors.
• Development or adaptation of robust genomic tools for analysis of field derived host, parasite, and vector specimens.

Scientific Advisory Group (SAG)

Applicants, in collaboration with NIAID, will establish, plan, and coordinate the activities of a Scientific Advisory Group (SAG). The SAG will review Center progress and provide scientific advice with respect to the scientific direction of the Center, progress and performance of ongoing Research Projects, and suggest new directions for the Center in response to the changing epidemiology or new technologies. The SAG will also make recommendations regarding the continuation or re-direction of projects on an ongoing basis and in consultation with the NIAID staff. The SAG will meet annually in person and might have additional ad hoc meetings based on needs identified by the SAG and NIAID.

The NIAID Project Scientist will select members of the SAG. Applicants should not contact nor identify individuals in their application who might be invited to serve on the SAG for their ICEMR program.

Annual Workshops

Each Center will be responsible for hosting one 3-day workshop during the life of the grant that will have the participation of all the ICEMR program Centers. The workshops are intended to identify areas of collaboration among the Centers, including methods to share expertise, facilities, and other resources of the Centers and identifying opportunities for clinical research involving participating sites from more than one ICEMR.

Applications proposing the following studies will be considered non-responsive and will not be reviewed:

• Applications that do not address one question in Area A Epidemiology, and one or more aims in Area B Transmission and/or Area C Pathogenesis and Diagnostics;
• Research on malaria parasites that do not infect humans;
• Vertebrate animal model research or the development of new/improved animal models;
• Applications in which all Research Projects solely utilize archived human samples, which are not collected prospectively from malaria-endemic sites (though archived human samples may be used as part of a Research Project or as a complete aim);
• Applications in which all of the research is conducted entirely in the U.S. or other countries where malaria is not endemic;
• Stand-alone basic Research Projects that do not require access to malaria endemic field sites;
• Stand-alone Research Projects enrolling only special populations, such as severely malnourished children, pregnant women, refugees, migrants;
• Clinical trials, including interventional clinical trials of investigational products;
• Research on pathogens other than malaria except in the context of co-infections;
• Research on vectors other than those that transmit malaria, except in the context of co-infections;
• Research involving release of genetically modified mosquitoes;
• Research using drones without in-country aviation permits or licenses;
• Operations and Health Systems research, and outreach and care delivery that is not linked to one or more of the Areas (A, B, or C) identified above;
• Research on HIV and/or AIDS except in the context of co-infections;
• Centers that do not develop and maintain affiliations with local/regional government agencies and established institutions in endemic sites;
• Centers that do not include a minimum of three field sites for Area A - Epidemiology.
• Centers that do not demonstrate any field activities for eight months of each year, for four years, at each site;
• Applications that do not include at least one basic science aim or translational science aim utilizing human or vector samples;
• Applications that do not propose one Administrative Core, one Data Management Core and two or more Research Projects;
• Applications that do not include Timelines and Milestones in the Overall component.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) must have a current full-time regular faculty appointment at the applicant institution to be eligible to apply for this FOA. The following individuals are not eligible to apply as the PD(s)/PI(s): Emeritus or distinguished/retired investigators/professors, postdoctoral fellows, research or teaching instructors, research assistant professors, research scientists, and adjunct faculty who currently have appointments contingent on the individual securing his/her salary from grants.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application.". This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Caitlin Brennan, Ph.D.
Telephone: 301-761-7792
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	30 pages
Admin Core	6 pages
Core (Use for Data Management Core)	6 pages
Project (Use for Research Projects)	12 pages each

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

The application should consist of the following components:

Overall: required, 1

Administrative Core: required, 1

Data Management Core: required, 1

Research Projects: required, minimum of 2

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

In the biosketches, highlight the PD(s) /PI(s) experience in leading multi-disciplinary teams, managing multi-site projects (including milestones) and administrative functions in less developed settings/endemic sites, and experience working with the local ministries of health and/or stakeholders involved in malaria research and disease control. Outline his/her experience and scientific ability to develop a program of integrated Research Projects with a well-defined central research focus. Outline the PD(s) /PI(s) experience in coordinating and managing all activities to complete the proposed milestones, as well as managing subcontracts and consultants.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Subcontracts to institutions in endemic countries must constitute at least 65% of direct costs.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed program. Concisely describe the hypothesis or hypotheses to be tested.

Research Strategy: The application should be built around a central theme that impacts malaria transmission and epidemiology that is characteristic of the proposed endemic areas. Summarize the overall research plan for the multi-component application. The multi-component application should be viewed as a confederation of interrelated Research Projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, describe the significance of the Cores and each project to the overall ICEMR design, along with the problems that are addressed, in relation to the central theme.

Discuss overall goals and how these studies will increase knowledge needed to inform strategies for the control and prevention of malaria. Discuss the importance of the project to public health in the endemic areas and likelihood that the results will impact the burden of diseases due to malaria in the host countries. Discuss how the endemic country scientists will be integrated into the research plan. Discuss how the basic and translational science aspects will contribute to the development of future malaria control interventions. Provide the process for periodically evaluating the changing landscape of malaria and modifying, redirecting and/or curtailing ongoing research projects to respond to the changes and shifts. Outline the rationale, criteria, or conditions for expanding field sites and/or adding new field sites based on the emerging needs and/or changing epidemiological conditions within the geographic region.

Heterogenous field sites: Describe the 3 field sites (minimum) that are sufficiently different from each other in terms of malaria risk and transmission to support the generalizability and external validity of research findings. Describe the proposed sites and provide a rationale for their inclusion, including background historical data, experience, and incidence to corroborate the heterogeneity of the sites. Describe the process to identify, evaluate the capabilities of, and add new field sites in the future, based on the emerging needs and/or changing epidemiological conditions within the geographic region.

Multidisciplinary research: Describe the various disciplines (e.g., clinical, vector biology, immunology, genomics etc.) represented to provide a multidisciplinary approach in the Research Projects, and how they will be coordinated and synergized to address the overarching study goal.

Local collaborations: Describe how the ICEMR will develop and maintain affiliations with local/regional government agencies and established institutions, such as local ministries of health, malaria control programs, and/or other in-country stakeholders in the endemic sites, to ensure coordination of research activities with existing malaria control efforts and facilitate access to relevant study populations. Study designs may involve stakeholders implementing control interventions and the ICEMR’s measuring the response to the interventions and their impact.

Capacity Building: Describe how the ICEMR will support clinical and/or field research capacity building of local institutions, including strengthening of administrative, laboratory or clinical infrastructure to function independently on this and other Research Projects. Describe how the site administrative structure, scientific capacity and educational activities will enable all sites and subcontractors to perform future product testing and evaluation of public health interventions. Describe how the ICEMR will provide opportunities for early-stage investigators in the context of the proposed Research Projects.

Timelines & Milestones: Provide detailed overall project timelines and milestones along with contingency plans. Describe feasible, quantifiable, and scientifically justified milestones, including protocol development, development of Standard Operating Procedures, goals for collection and analysis of field samples, parasite isolates, obtaining clearances from in-country human subject review boards, obtaining clearances from in-country use of research animal review boards, study completion, and analysis of final study data. Describe how the timelines and milestones of the individual Research Projects align with the goals of the overall Center.

Milestones should be present via a Gantt chart or equivalent, with associated timelines and identified outcomes. Milestones must specify the outcome(s) for each activity. It is recognized that milestones associated with more basic science-oriented projects may be difficult to quantify; however, in those cases, applicants should develop quantifiable outcomes. Provide a schedule and method for evaluating progress and modifying milestones based on need, and in consultation with the SAG and NIAID.

Letters of Support: Provide letters of support from each applicable site Director, local government/responsible Government or MOH collaborator, and/or significant research contributor indicating agreement for access to and use of facilities, resources, staff, and data records and willingness to collaborate on the proposed research.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin Core .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• It is strongly recommended that the PD(s)/PI(s) be the Core lead for the Administrative Core.

Budget forms appropriate for the specific component will be included in the application package.

Include funding for:

• Request funds for travel of the SAG members to attend one annual two-day in-person group meeting, between the key personnel of the individual ICEMRs and the SAG.
• Estimated expenses for ICEMR Project Leaders, Core Leaders, and key scientific staff to attend a three-day Annual Workshop in one of the malaria endemic countries of the ICEMRs, in which all ICEMRs meet to exchange ideas and foster collaborations.
• Budget for the travel of the Program Director(s) to make at least three annual visits to each of field sites proposed in the application.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core.

Research Strategy: Describe plans and procedures for establishing and managing the Administrative Core to provide the organizational capacity to ensure the following:

• Coordinate, supervise, track, and manage all Center activities, including sponsoring activities to advance the Center’s integration;
• Provide a supportive structure sufficient to ensure the accomplishment of all Center goals;
• Assist the ICEMR with administrative aspects such as gathering of progress reports and facilitating other communications with awardees and their collaborators;
• Promote collaboration, coordination, problem identification and resolution among Research Project and Core Leaders;
• Communicate with other ICEMRs regarding collaboration and coordination of activities and projects and explain how communications, such as periodic meetings and conference calls with minutes, will be scheduled and managed;
• Foster outreach activities to promote collaborations with the pertinent scientific communities;
• Communicate and interact with NIAID staff;
• Provide daily administration, fiscal management, and management of subcontracts.

Management Plan: Include a Management Plan that describes the organization of the proposed Center and its management structure. The Management Plan should include:

• The organization of the ICEMR and its management structure to form a cohesive, integrated, and efficient Center that provides scientific and administrative oversight of all ICEMR Research Projects and the Core;
• An overview of how the multiple Research Projects will be coordinated, integrated, and scientifically and technically managed to answer the scientific questions and hypotheses proposed within the application;
• Clear and explicit discussion on how resources will be prioritized, managed, allocated and communicated to the ICEMR sites;
• Plans for management and accountability of funds and communication within the overall program;
• Plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program;

The Management Plan should also include a Staffing Plan that describes:

• How the structure and roles of administrative and scientific staff add to the application;
• How the personnel at the endemic sites will be involved in the organization and planning of the research, and
• How the education of proposed staff will be completed with respect to operations and quality control of activities in the field, data management centers, and laboratories.

Letters of Support: Include a letter from the PD(s)/PI(s) committing to make site visits to each of the field sites at least three times each year (travel policies permitting) to oversee the administration of the ICEMR and monitor the scientific progress of the projects.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• It is strongly recommended that an onsite data manager be included for this Core.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Data Management Core.

Research Strategy: Without duplicating information in the biosketches, highlight the capabilities of the team to collaborate on the design, development and testing of databases and data management software, validation, maintenance of systems, and documentation of changes and preparations of standard operating procedures. Also highlight the capabilities of the team to provide biostatistical support, and to provide assistance in protocol design, development and analysis.

Data Management System: Describe plans and procedures for establishing a data management system that will be used to collect and manage data from the participating study sites to ensure uniformity of procedures, high-quality data and serve the diverse needs of all sites. The data management system should ideally include:

• Security features for controlled access to all project data;
• A tracking system for data forms, activities, and study samples;
• Date and time stamping of all data records with electronic signatures;
• Audit trails to track all changes made to data records;
• A reporting system that generates error reports and summary information reports;
• A plan and system for uploading individual level data for public access per NIH guidelines
• A description of planning and implementation of the system, as well as the time frame to achieve a fully operational data management system. Address the time frame within which all design, development, testing, validation, and educational activities will take place to achieve a fully operational data management system and appropriately trained staff;
• A detailed description of the data collection procedures, including specimen labeling, coding, tracking, archiving and quality assurance;
• A plan to collect and manage data from the participating study sites, while ensuring uniformity of procedures and high-quality data.
• Include plans and procedures to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed Research Project. Concisely describe the hypothesis or hypotheses to be tested. Applications must include at least one basic science aim or translational science aim (in at least one Research Project), with the potential to inform product development. The basic science or translational science aim(s) must utilize at least some of the human or vector samples collected in the ICEMR.

Research Strategy: There is no need to repeat background information described in the Overall Section.

Research Projects must address one question in Area A - Epidemiology, and one or more projects in Area B Transmission and/or Area C Pathogenesis and Diagnosis. Area A Epidemiology must be a multi-site project involving at least three of the field sites proposed by the Center. There are no requirements for minimum numbers of field sites for Areas B and C. The Research Projects may propose specific aims addressing each Area alone, or specific aims covering Areas A, B, and/or C in combination. The design of the Research Projects should reflect a multidisciplinary approach that integrates clinical and field aspects with laboratory, molecular and genomic methods, and be capable of adapting to a changing landscape based on epidemiological malaria research. Research Projects should be designed to test novel hypotheses or address important research questions that inform and accelerate product development and new interventions. All field Research Projects must be conducted within malaria-endemic geographic regions; however, some of the laboratory and in silico studies may be conducted in non-endemic settings.

For all studies (clinical and non-clinical), the Research Strategy should include the following:

• Discussion of relevant knowledge gaps with specific focus on the ones that will be addressed by the project;
• Discussion of how the research will advance malaria translational research and/or facilitate malaria elimination;
• The rationale for the study designs that require field-activities (for at least 8 months of the year) to address the research questions.
• For modeling and cost-effectiveness studies, clearly describe what parameters will be measured vs. estimated. Describe the data sources, sensitivity analyses, and validation methods that will be used.

Letters of Support: Include a letter from the Project Leader committing to the conduct of field site activities at the endemic site and visiting (travel policies permitting) each of the endemic sites at least three times each year.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Are the overall program goals focused on studies that increase knowledge needed to inform strategies for the control and prevention of malaria? How effective will the proposed project be to improving public health in the endemic areas, and will the results of the proposed project reduce the burden of disease due to malaria in the host countries?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center ? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the Center?

Specific to this FOA: How relevant is the experience of the PD(s)/PI(s) in leading a multidisciplinary team and managing the scientific and administrative functions at the endemic sites? "Is there evidence that the PD(s)/PI(s) possess(es) the leadership skills and scientific ability to develop a Center comprised of integrated Research Projects, with a well-defined central research focus? Has/Have the PD(s)/PI(s) demonstrated their ability(ies) to coordinate, monitor, and manage all activities, including research milestones?"

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center ? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Are plans for collaboration with all stakeholders adequate? Does the research approach for the ICEMR (1) provide the flexibility necessary to respond to changes in the parasite population, mosquito vectors, epidemiologic shifts, and the availability of new or improved control interventions, (2) provide a process for assessing ongoing Research Projects and modifying, redirecting and/or curtailing ongoing Research Projects to reflect such changes/shifts?

Do the individual Research Projects and Cores together relate to the common theme of the ICEMR, showing cohesiveness, multidisciplinary interactions, coordination, and synergy? Will the integration of the individual Research Projects into a single Center be more beneficial than pursuing each project independently? Is there substantial and appropriate integration of endemic country scientists into the research plan? Have the investigators adequately demonstrated the potential for the ICEMR to enhance the field and/or clinical research capacity at the sites, including strengthening of administrative, laboratory, or clinical infrastructure to function independently on this and other Research Projects? Will site administrative structure, scientific capacity, and educational activities enable all sites and subcontractors to perform future product testing and evaluation of public health interventions? How well do the Research Project milestones align with those of the overall Center? How feasible are the milestones based on the proposed time frames? Do the milestones provide quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: How appropriate are the field sites and/or clinical facilities for the research? Are the three field sites sufficiently different from each other in terms of malaria risk and transmission? Is there a process to identify, evaluate the capabilities of, and add new field sites based on the emerging needs and/or changing epidemiological conditions within the geographic region?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved.

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score for each core but will not give separate scores for these items.

Administrative Core

• Does/do the PD(s)/PI(s) possess the ability to manage subcontracts and consultants?
• Is the organization and administrative structure conducive for ensuring collaborative efforts, interaction among ICEMR sites, and appropriate integration of endemic country scientists into the Research Projects?
• How appropriate is the management plan for management and accountability of funds and communication within the overall program?
• How appropriate are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program?
• Does the Management Plan adequately involve personnel at the endemic sites in the organization and planning of the research?

Data Management Core

• Does the application provide evidence of qualified staff to collaborate on the design, development, and testing of databases and data management software, validation, maintenance of systems, and documentation of changes and preparations of standard operating procedures?
• How clear and appropriate is the description of planning and implementation of the data management system, as well as the time frame to achieve a fully operational data management system with appropriately qualified staff?
• How adequate is the description of the data collection procedures, including specimen labeling, coding, tracking, archiving and quality assurance?
• How adequate is the evidence presented to show biostatistical support to provide assistance in protocol design, development, and analysis?
• Is the proposed data management system sufficient to collect and manage data from the participating study sites, ensuring uniformity of procedures and high-quality data?

As applicable for the Core or project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed Core or project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the Core or project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Conducting site visits (travel policies permitting) and reporting details of trips to each of the endemic sites at least three times each year.
• Organizing monthly conference calls or meetings with all participating sites to discuss progress, problems, and corrective actions. Minutes of these calls, including action items to be tracked, should be circulated, and approved by all key scientific staff of the ICEMR;
• Maintaining a website or location where all ICEMR documentation is archived and accessible to all scientific staff (protocols, approvals, case report forms (CRFs), informed consents (ICs), standard operating procedures (SOPs), meeting or conference call minutes, reports, presentations, etc.);
• Organizing and participating in Scientific Advisory Group (SAG) meetings, Annual Workshops, teleconferences, and other activities to be defined over the course of the award period;
• Organizing, planning, and coordinating the activities of a SAG and preparing reports of the meeting content, relevant discussions, and SAG recommendations;
• Reporting of data released for public access (per NIH policy) after a manuscript has been accepted for publication to the SAG; reasons for not releasing such data must also be reported;
• Making available novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones) upon request or through NIAID-supported repositories, such as the NIAID BEI Resources (http://www.beiresources.org/) or in other repositories to be determined.

NIAID staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).
• The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other ICEMR member scientists to facilitate collaborations and to leverage the resources available to the Center.
• The NIAID Project Scientist will monitor the progress of the projects, help coordinate research approaches, and contribute to the shaping of Research Projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it.
• The NIAID Project Scientist will keep the Center informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The NIAID Project Scientist will coordinate access for the Center to other NIAID resources, as well as assist the research efforts of the Center by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• The NIAID Project Scientist will serve as a non-voting member of the ICEMR SAG and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
• The NIAID Project Scientist will select the SAG chair and will choose up to eight additional Federal and non-Federal experts to participate in SAG activities in an advisory capacity when appropriate.
• NIAID staff and the SAG will monitor progress toward achieving milestones and work with the Center PD(s)/PI(s) to adjust or modify established milestones as needed to adapt to changes that are supported by strong scientific rationale.
• The NIAID Project Scientist will assist with the determination of the site for the Annual Workshop and SAG meetings.
• The NIAID Project Scientist will coordinate the conference calls with PD(s)/PI(s) as needed.
• NIAID/DMID must be provided access to and may periodically review all data generated under this cooperative agreement.
• Additionally, a NIAID Program Officer will be responsible for the normal scientific and programmatic stewardship of the award.

Areas of Joint Responsibility include:

• The NIAID Project Scientist and the PD(s)/PI(s) will coordinate the scientific objectives and progress at the annual workshop to facilitate the achievement of program goals.
• Workshop: The workshop participants will include the PD(s)/PI(s) for each Center, key Center scientific staff for each Center, the NIAID Project Scientist, and other NIAID scientific staff. Up to ten additional Federal, and non-Federal experts, selected by the NIAID Project Scientist, may participate in an advisory capacity, when appropriate. The workshops shall be held annually, at or near the host endemic site, or at another agreed-upon site following consultation with NIAID staff.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the SAG chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://grants.nih.gov/support/index.html(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Malla Rao, DrPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3352
Email: [email protected]

Marci Scidmore, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3255
Email: [email protected]

Tina M. Carlisle
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2947
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.