NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Although malaria has been eliminated from many parts of the globe, over 40% of the world’s population still lives in areas where they are at risk for contracting the disease. Control efforts have not been sustainable in many locations and have been associated with the emergence and spread of both parasite resistance to antimalarial drugs and vector resistance to insecticides. Currently, there are no point-of-care diagnostic tools available to monitor emerging drug resistance to malaria. A malaria vaccine has not yet been licensed, and although a number of promising candidates are in development, a highly effective malaria vaccine for all age groups may not be available for years to come. Although various efforts to curb malaria have been launched, it has become increasingly clear that sustainable and effective malaria control requires an improved understanding of the complex interactions among the parasite, the mosquito vector, and the human host in local clinical and field settings. Furthermore, novel drugs, diagnostics, and vaccines, as well as vector management strategies, will need to be developed, evaluated and ultimately utilized in malaria-endemic locations (http://www.who.int/malaria/publications/world_malaria_report_2014/report/en/). Thus, a multidisciplinary research approach is urgently needed to address these complex interactions at the molecular, cellular, organismic, population and field levels in malaria-endemic areas in order to provide the knowledge base necessary for improved clinical and field management of malaria, as well as to guide the development of new tools and interventions.

The objective of this Funding Opportunity Announcement (FOA) is to recompete the National Institute of Allergy and Infectious Diseases (NIAID) International Centers of Excellence for Malaria Research program comprised of a network of research centers in malaria endemic regions. In 2010 the NIAID established the International Centers of Excellence for Malaria Research (ICEMR) program to support multidisciplinary research in diverse epidemiologic settings spanning all representative malaria endemic regions of the world. Research projects were designed to capture and track changes in the complex interactions between the human host, malaria parasites and the mosquito vectors in different eco-epidemiologic settings. Unlike routine surveillance and intervention evaluation programs, the Centers are mandated both to adopt an integrated approach to malaria research, and to apply molecular epidemiology and genomics to study transmission and disease in the context of dynamic changes in disease prevalence and incidence. The research objective of each Center will focus on the design and conduct of multidisciplinary research on the epidemiology, transmission, and pathogenesis of malaria in endemic geographic regions, and the design and conduct of special projects to capitalize on new opportunities and emerging public health needs, and to assist in understanding, controlling and eliminating malaria. 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 majority of Center 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. and countries where malaria is not endemic. In addition, each Center must develop and maintain affiliations with local/regional government agencies and established institutions in the endemic countries to ensure necessary coordination of research activities with ongoing malaria control/intervention programs and to facilitate access to relevant study populations and treatment centers.

Location of Field Sites: Center research activities should include a minimum of three field sites which could be in the same or different countries at distances that provide for potential variability in the epidemiology and transmission across field sites. The application should describe the epidemiology of malaria at each of the sites to show that there is variability in transmission of malaria. Alternatively, Center research activities should include a minimum of three field sites in different malaria endemic regions but with similar malaria transmission characteristics. Examples of these include persistent low level transmission, seasonal transmission, and hyper-endemic perennial transmission. Applications with sites in malaria-endemic areas where there is a paucity of research and surveillance data are encouraged.

Each application in response to this FOA must include: (1) an Administrative Core; (2) a Data Management and Biostatistics Core; and (3) three or more Research Projects. In addition, the application may include optional Shared Resources Cores that support the work within the ICEMR.

Administrative Core

The ICEMR 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. The Administrative Core will also be responsible for the management and administration of the Special Projects Program which will be designed to capitalize on opportunities and needs resulting from (1) changing epidemiological conditions, (2) implementation of malaria control programs and resulting public health needs, and/or (3) emerging scientific developments and associated research needs.

Data Management and Biostatistics Core

All applications must include a Data Management and Biostatistics Core providing for the data management and statistical support of the overall center. The Data Management system must collect and manage data from all the participating study sites ensuring uniformity of procedures and high quality data. The Data Management Core will be responsible for the rapid release to the broader scientific community of datasets, analysis tools, reagents, and other resources generated under the grant in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) and the NIH Genomic Data Sharing (GDS) Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Shared Resource Cores

Shared Resource Cores are optional Cores that provide scientific and/or clinical services or resources to at least two research projects. Shared Resources Cores must be well justified and clearly non-duplicative of other services or facilities available to ICEMR investigators. Examples of services provided by a shared scientific core are laboratory support, monoclonal antibody production, peptide synthesis, microbiology laboratory services, insectary or vector biology laboratory, and immunology/molecular biology support. Shared clinical cores could provide a source of patients and healthy volunteers, clinical specimens or represent a facility for procedures that require health care personnel supervision.

Research Projects

The three research projects must address one question in Research Area A - Epidemiology, and two or more projects in Research Area B Transmission and/or Research Area C Pathogenesis and Diagnosis. Research Area A Epidemiology should be a multi-site project involving at least three of the field sites proposed by the Center. 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.

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

1. Research Area A Epidemiology

• 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, larviciding, 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;
• Immuno-epidemiology evaluating prevalence of antibodies, innate and adaptive responses associated with protection;
• Assessment of the degree of parasite population diversity and structure and its relevance to 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;
• Evaluation of novel diagnostics (until a new diagnostic receives regulatory approval, results should not impact clinical management of malaria cases);
• Factors, biomarkers, or combination of indicators associated with recurrent malaria infections and/or recrudescence.

2. Research Area B Transmission

• Research on vector biology and ecology;
• Impact of emerging resistance to current drugs and insecticides on transmission;
• 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;
• Assessment and evaluation of monitoring tools and surveillance methods when malaria transmission is at low levels or to detect onset of epidemics.

3. Research 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;
• Development and evaluation of:
  • rapid diagnostic tools that can evaluate the quality of antimalarial drugs;
  • 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.

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

• Research on malaria parasites that do not infect humans;
• Animal model research or the development of new/improved animal models;
• Research that does not require access to human subjects or specimens from malaria-endemic sites;
• Stand-alone basic research projects; stand-alone basic research not requiring access to malaria endemic field sites or samples from such field sites is funded through other mechanisms, including investigator-initiated research grants;
• Construction and major renovations other than minimal alterations of existing facilities to conform to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) guidelines; or adapted to an alternative use to meet a specific scientific requirement;
• Clinical trials, including interventional clinical trials of investigational products;
• Research on pathogens other than malaria except in the context of co-infections or non-malaria outcomes as a result of anti-malarial interventions;
• Research on vectors other than those that transmit malaria;
• Operations and Health Systems research, and outreach and care delivery that is not linked to one or more of the research areas (A, B, or C) identified above;
• Research on HIV and/or AIDS

Scientific Advisory Group (SAG)

Applicants, in collaboration with NIAID, will establish, plan and coordinate the activities of a Scientific Advisory Group (SAG) beginning in the second year. 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 proposed Special Projects. 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.

Applicants should not contact nor identify individuals who might be invited to serve on the SAG for their ICEMR program.

Annual Workshops

Each Center will be responsible for hosting one 2-3 day workshop during the life of the grant that will have the participation of all of 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.

For additional information about the ICEMR program and this FOA, see "Frequently Asked Questions for RFA-AI-15-056" at http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-15-056.aspx

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)
• 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities 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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Lianyong (Yong) Gao, Ph.D
Telephone: 240-669-5048
Fax: 240-627-3153
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	6
Core (Use for Data Management and Biostatistics Core and Shared Resources Cores)	6 pages each
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.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Data Management and Biostatistics Core: required
• Shared Resources Cores: optional, but each Core should support at least two research projects
• Research Projects: required (minimum of 3: one in Research Area A - Epidemiology, and two or more projects in Research Area B Transmission and/or Research Area C Pathogenesis and Diagnosis)

When preparing your application in ASSIST, 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.

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.

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 which 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, the significance of each project and core to the overall ICEMR design, along with the problems that are addressed, should be described in relation to the central theme. Summarize the special features in the environment and/or resources that make this application strong or unique. Include background data, experience, incidence and epidemiology at each site.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

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

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.
• For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Director. For institutions/organizations proposing multiple PD(s)/PI(s), one PD/PI must be selected to serve as the Administrative Core Director. Through the required Administrative Core functions indicated below, the Administrative Core Director provides leadership and guidance in fulfilling the stated objectives of his or her Center, and is responsible for creating within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the Research Projects and Cores, and provides oversight and governance over fiscal and resource management.

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

Include funding for:

• The overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here.
• Beginning in year three of the award, budget $50,000 in direct costs per year for Special Projects.
• Beginning in year two of the award request funds for travel of the SAG members to attend one annual group meeting.
• Estimate expenses for ICEMR Project Leaders, Core Leaders and key scientific staff to attend the Annual Workshops.
• Do not include costs associated with hosting the workshop, or travel and per diem costs of the selected experts. The mechanism of support to host the workshop will be determined at a later date when the awardee is expected to host the workshop.

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 an Administrative Core that provides 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 Research Project and Core Leaders with administrative aspects of their projects, such as gathering of progress reports and facilitating other communications with awardees and their collaborators;
• Promote collaboration and coordination 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 ensure 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 Cores;
• A plan on how research related travel will be organized and managed;
• 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 and within the scope of this FOA;
• Clear and explicit discussion on how resources will be prioritized, managed and allocated

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; and
• How the training of proposed staff will be completed including a description of the functions to be performed.

Special Projects Program: Describe the plans for establishing the Special Projects Program, including solicitation of projects, overseeing review, selection and management of awards for the Special Projects.

• Describe how the PD/PI will involve the SAG in the review and assessment of the special projects and will make recommendations to the Program Officer on the merit of the applications.
• Describe how progress or completion of the special projects will be evaluated.

Letters of Support: Include a letter from the PD/PI committing to the conduct of field site activities at the endemic site for a minimum of 90 days each year.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Data Management and Biostatistics Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Data Management and Biostatistics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Biostatistics Core)

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.

Facilities & Other Resources: All Centers and field sites should have computers, connectivity to the internet and communications capabilities. Redundancy, like having multiple power sources, uninterrupted power supply and multiple internet service providers is encouraged to ensure minimal downtime and greater reliability.

Project /Performance Site Location(s) (Data Management and Biostatistics Core)

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.

Research & Related Senior/Key Person Profile (Data Management and Biostatistics Core)

• 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.
• The Biographical Sketch should describe the expertise each Key person contributes to the Core.
• Each Core should be headed by a Core Leader whose expertise is appropriate to successfully manage all aspects of that particular Core.
• A full-time Data Manager must be present at the Center and/or each of the sites.

Budget (Data Management and Biostatistics Core)

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

If not in place, include funding for infrastructures like computers, connectivity to the internet and communications capabilities.

Include the apportionment of dollars or percentage of dollars that will be required to support each component of the core and how it applies to each of the proposed sites.

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.

PHS 398 Research Plan (Data Management and Biostatistics Core)

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

Research Strategy: The Data Management and Biostatistics Core is a resource to the multi-project grant as a whole and must support all the proposed research projects. All Centers should have access to dedicated statistical expertise that informs the research study design and provides the ability to conduct statistical data analysis. Support should provide for activities such as study design and protocol development and where appropriate, generating interim tables, preliminary statistical analyses for progress reports, and assisting with statistical issues related to laboratory testing and results.

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

• Indicate the different aspects of the projects that will be served by this core
• Present a clear picture of the facilities, techniques, and skills that the core will provide
• Describe the role of the Core Leader and each of the key participants

In addition, for the Data Management and Biostatistics core, describe plans and procedures for establishing a data management system that must be used to collect and manage data from the participating study sites to ensure uniformity of procedures and 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

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.

Applications must also address the time frame within which all design, development, testing, validation, and training activities will take place to achieve a fully operational data management system and appropriately trained staff. Plans and procedures must be in place to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.

The data management system should be tested and implemented before the end of the first year.

NIAID/DMID must be provided access to and may periodically review all data generated under this cooperative agreement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Data Management and Biostatistics Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Data Management and Biostatistics Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Shared Resources Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Shared Resources Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources Core)

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.

Project /Performance Site Location(s) (Shared Resources Core)

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.

Research & Related Senior/Key Person Profile (Shared Resources Core)

• 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.
• The Biographical Sketch should describe the expertise each Key person contributes to the Core.
• Each Core should be headed by a Core Leader whose expertise is appropriate to successfully manage all aspects of that particular Core.
• A full-time Data Manager must be present at the Center and/or each of the sites.

Budget (Shared Resources Core)

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

Include the apportionment of dollars or percentage of dollars that will be required to support each component of the core and how it applies to each of the proposed sites should also be presented.

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.

PHS 398 Research Plan (Shared Resources Core)

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

Research Strategy: A Shared Resources Core is a resource to the multi-project grant as a whole and must support at least two of the proposed research projects.

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

• Indicate the different aspects of the projects that will be served by this core
• Present a clear description of the quality and relevance of the facilities, techniques, and skills that the core will provide to the Research Projects
• Describe the role of the Core Leader and each of the key participants

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Shared Resources Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Shared Resources Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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.

Facilities & Other Resources: For each individual Research Project, provide information on resources available for that project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Equipment: For each individual Research Project, provide information on equipment available for that project. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment used for working with biohazards or other potentially dangerous substances.

Project /Performance Site Location(s) (Research Projects)

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.

Research & Related Senior/Key Person Profile (Research Projects)

• 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.
• The Biographical Sketch should describe the expertise each Key person contributes to the Project. Each Center should have a diverse set of expertise including basic science, vector research (and vector ecology), epidemiology and clinical studies.

Budget (Research Projects)

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.

PHS 398 Research Plan (Research Projects)

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.

Research Strategy: 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 site and the projects should be integrated and relate to the overarching thematic area. The project should identify critical barriers to the reduction of malaria morbidity and mortality. Applications need to include at least one basic science aim or translational science aim with the potential to inform product development, in each project involving human or vector samples. Field work that informs the research objectives for Research area A should take place in at least three field sites for 5 or more years.

Experimental details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new Research Projects must be included.

The research strategy should include the following:

• Discussion of relevant knowledge gaps with specific focus on the ones that will be addressed by the clinical and/or non-clinical study plan;
• A discussion of potential problems or obstacles to addressing these knowledge gaps and proposed strategies to overcome them;
• Discussion of how the research will advance malaria translational research and/or facilitate malaria elimination;
• Describe the research design, conceptual procedures, research questions to be addressed, and analyses to be used to accomplish the Specific Aims of the project;
• Describe any new methodology and its advantage over existing methodologies;
• Describe any novel concepts, approaches, tools, or technologies for the proposed studies;
• Discuss associations with clinical project(s);
• Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims;
• Provide a tentative sequence or timetable for the project (including obtaining clearances from in country human subject review boards, obtaining clearances from in-country use of research animal review boards, and analysis of final study data).

For clinical studies, include the following:

• A description of the study population, documentation of access to necessary patients and/or samples, and plans for the recruitment and retention of study participants.
• A brief concept proposal for each clinical study, detailing the following aspects of the proposed clinical research:
• Study title
• Hypothesis to be tested
• Study objectives
• Study population
• Clinical sites    
• Study design (not all parts may be relevant):

-Eligibility/exclusion criteria

-Sampling or Stratification plan

-Criteria for selection of comparison or control subjects/samples

-Number of subjects in each group

-Anticipated duration of recruitment phase

-Duration of follow-up for each subject

-Total study duration

-Study visit schedule and primary evaluations (including laboratory evaluations)

-Primary and secondary endpoints/outcomes with definitions

-Sample size justification

-Any proposed sub-studies

-Detailed description of the data analyses planned describing the specific outcome variable(s) and independent variables. Sample size justification should be based on planned primary data analysis

Milestones: Milestones and timelines should be placed at the end of the Research Strategy section.

Describe 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. Assigned NIAID staff, through the Cooperative Agreement grant mechanism, and the Scientific Advisory Group will monitor progress toward achieving milestones and work with the Center PD/PI to adjust or modify established milestones as needed to adapt to changes that are supported by strong scientific rationale.

Milestones should be presented 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. Demonstrate the integration of milestones with the overall goals of the proposed research project, and 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: Include a letter from the Project Leader committing to the conduct of field site activities at the endemic site for a minimum of 90 days each year.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

The PD/PI must have access to and visit each field site at least once a year.

The PD/PI and Project Leads must spend at least 90 days onsite at the malaria endemic sites each year.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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 components of participating organizations, 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 NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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 and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

• Is the program as a whole scientifically meritorious? Do the individual research projects and cores together relate to the common theme of the ICEMR, showing cohesiveness, multidisciplinary interactions, coordination, and synergy?
• Are the overall program goals significant and focused on studies that increase knowledge needed to inform strategies for the control and prevention of malaria?
• Does the PD/PI possess the leadership skills and scientific ability to develop a program of integrated research projects with a well-defined central research focus?
• Have the PD/PI and other Project/Core Leaders planned to devote adequate time and effort to the program and commit adequate time onsite?
• Does the PD/PI demonstrate a strong management approach in terms of staffing, organization, communication, leadership, lines of authority, as well as the ability to manage subcontracts and consultants?
• Does the PD/PI demonstrate the ability to coordinate, monitor and manage all activities, including appropriate research milestones?
• Are the proposed timelines for the initiation and completion of proposed studies appropriate and feasible?
• Is there adequate biostatistical and data management support?
• Will site administrative structure, scientific capacity, and training in site infrastructure enable all sites and subcontractors to perform future product testing and evaluation of public health interventions?
• Is there potential for the project to enhance the clinical research capacity at the sites, including strengthening of administrative, laboratory, or clinical infrastructure to function independently on this and other research projects?
• Is the proposed project important to public health in the endemic areas and likelihood that the results of the proposed project will have an impact on the health of those in the host countries?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the Project Lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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-Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Lead have experience leading a multidisciplinary team and demonstrate the ability to establish and manage administrative functions at the endemic sites? Is there substantial and appropriate integration of endemic country scientists into the research plan? Have the Project Leaders adequately demonstrated commitment to at least 90 days each year in country on site in the endemic region?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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 children, justified in terms of the scientific goals and research strategy proposed?

Are plans for collaboration adequate? Does the applicant (1) possess the capability to evaluate the changing landscape of malaria, (2) 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, (3) provide a process for assessing ongoing research projects and modifying, redirecting and/or curtailing ongoing research projects to reflect such changes/shifts?

How well do the research project milestones align with those of the overall Center? Are the milestones feasible based on the proposed time frames? Do they provide quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?

Environment

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?

Are the field sites and/or clinical facilities appropriate for the research? 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 each core 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 core proposed).

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.

• Is the administrative and organizational structure appropriate and sound to facilitate attainment of the objective(s) of the proposed program?
• 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?
• Is the management plan for management and accountability of funds and communication within the overall program appropriate?
• Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?
• Are the experience, level of commitment, and availability of the Administrative Core Leader and administrative staff adequate to manage the overall program?
• Does the Center have adequate capabilities to issue and manage subcontracts?
• Is the plan to solicit, review and manage the Special projects adequate, fair and transparent?

• Does the application adequately describe security features, a tracking system, reporting system, date and time stamping and audit trails?
• Does the application provide evidence of qualified staff to collaborate on the design development and testing of databases and data management software, validation, training, maintenance of systems, and documentation of changes and preparations of standard operating procedures?
• Is there a clear description of planning and implementation of the system, as well as the time frame to achieve a fully operational data management system with appropriately trained staff?
• Is there a detailed description of the data collection procedures, including specimen labeling, coding, tracking, archiving and quality assurance?
• Does the application provide evidence of adequate biostatistical support to provide assistance in protocol design, development and analysis?
• Is the data management sufficient to collect and manage data from the participating study sites, ensuring uniformity of procedures and high quality data?
• Does the plan adequately involve and train personnel at the endemic sites?

• Are the justification and usefulness of the core services and resources to the individual Research Projects appropriate and sound?
• Is the relationship of each core to the central focus of the overall Center strong and justified?
• Are the quality of the relevant facilities or services provided (including procedures, techniques, and quality control) and criteria for prioritization and usage acceptable and appropriate?
• Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?

As applicable for the 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 six 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 six 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 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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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 NIAID 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.
• Ability to obtain scientific achievement in appropriate endemic regions.
• Inclusion of holoendemic or hyperendemic sites/regions where there is a paucity of malaria data and research.

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. 

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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Overseeing, managing, and coordinating the overall Center;
• Ensuring that the individual projects and cores are synergized to advance the goals of the Center
• Retaining primary responsibility for the planning, directing, and executing the proposed scientific activities;
• Overseeing the Special Projects Program, to include:
• Coordinating and managing all funds for Special Research Projects and interfacing with NIH Grants Management offices and sponsored projects (grants) offices at awardees' institutions;
• Acting as the fiscal contact for their ICEMR investigators and providing fiscal oversight of the entire Special Projects program;
• 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;
• Reporting the number of monthly conference calls and the average number of participants in each call in the annual progress report;
• Maintaining a website or location where all ICEMR documentation is archived and accessible to all scientific staff (protocols, approvals, case report forms (CRF s), informed consents (IC s), standard operating procedures (SOP s), 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 Scientific Advisory Group (SAG) to include:
• Choosing up to five SAG members, in consultation with NIAID, representing the scientific areas of expertise relevant to the Center s research projects;
• Planning, organizing and conducting the annual SAG meetings 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;
• In addition to following the NIH Genomic Data Sharing Policy, following the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx). Project-generated data and software should be made available through a publicly accessible project website and other publicly accessible resources, including those at the NIAID funded Bioinformatics Resource Centers (http://www.niaid.nih.gov/dmid/genomes/brc/default.htm), at NCBI (http://www.ncbi.nlm.nih.gov/) and/or other repositories to be determined. Program-generated data and software include, for example:
  • all research data (both experimentally and computationally generated) and associated metadata;
  • database schema and specifications;
  • experimental protocols and Standard Operating Procedures (SOPs); and
  • data analysis tools, models and algorithms generated under this grant, including model parameters and source code, complete use documentation and tutorials.

Program-generated novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones), should be made available 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 Scientists 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 Scientists will select the SAG chair and will choose up to four additional Federal and non-Federal experts to participate in SAG activities in an advisory capacity when appropriate.
• 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/PI as needed.
• Additionally, a NIAID Project Scientist 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, beginning in the second year, at or near the host endemic site, or at another agreed-upon site following consultation with NIAID staff. The first year meeting will be a start-up meeting in the United States; all PD/PI/PL(s) and major foreign collaborators are expected to attend.

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 awardee. This special dispute resolution procedure does not alter the awardee'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.

When multiple years are involved, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

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

Lianyong (Yong) Gao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5048
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.