Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Limited Competition: Revision Applications for International Centers of Excellence for Malaria Research (U19 Clinical Trial Optional)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-17-044  

Companion Funding Opportunity

None  

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit revision applications from currently funded International Centers of Excellence for Malaria Research (ICEMR) investigators. These awards will support the conduct and oversight of observational studies or implementation studies to evaluate the impact of in-country, approved vector control and malaria prevention interventions on the incidence, prevalence, and transmission of malaria. This program will leverage the baseline data, infrastructure, and capacity established by the ICEMRs. The studies will augment or use the established malaria surveillance systems to study the impact of the vector control and malaria prevention interventions on human health outcomes. This FOA solicits three distinct types of studies: Study Type 1 is a Controlled Environment study, Study Type 2 is an Observational study, and Study Type 3 is an Implementation study. For Study Type 3 (Implementation study) this FOA supports a "Go/No-Go" approach to funding, which is significantly different from most U19 projects. Continued funding for the full award duration is dependent upon achieving negotiated “Go/No-Go” criteria by the end of Year 2 of the revision award. Applications may propose only one project for each Study Type.  

Key Dates
Posted Date

December 22, 2017

Open Date (Earliest Submission Date)

April 30, 2018

Letter of Intent Due Date(s)

April 30, 2018

Application Due Date(s)

May 30, 2018 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

October 2018

Advisory Council Review

January 2019

Earliest Start Date

April 2019

Expiration Date

May 31, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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 using ASSIST or an institutional system-to-system solution; 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 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) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    The purpose of this funding opportunity announcement (FOA) is to solicit revision applications from currently funded International Centers of Excellence for Malaria Research (ICEMR) investigators. The ICEMR Program was recently re-competed, with 11 Centers awarded in FY 2017. These awards will support the conduct and oversight of observational studies or implementation studies to evaluate the impact of country-approved malaria and vector control interventions on the incidence, prevalence, and transmission of malaria. This new competitive revision will leverage the baseline data, infrastructure, and capacity established by the ICEMRs. The studies will augment or use the established malaria surveillance systems to study the impact of malaria and vector interventions on human health outcomes. It is anticipated that the systems for disease surveillance in humans, data management, and vector surveillance at the field sites will be established within the first two years of the ICEMR awards, prior to the award of these competitive revisions/supplements. The proposed competitive revisions will build off these established systems and customize them to the scientific needs of their new proposed projects. This FOA describes three distinct types of studies that may be proposed: Study Type 1 is a Controlled Environment study, Study Type 2 is an Observational study, and Study Type 3 is an Implementation study.

    Background

    Vector-borne emerging diseases pose a continuing threat in the US and globally.  In recent years, malaria, dengue, West Nile Virus, Chikungunya and now Zika, have challenged public health systems.  Developing a clinical framework to study the impact of interventions with epidemiologic and clinical outcomes will enable the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) to better support and guide investigators pursuing this area of research, which is critical to NIAID’s global health mandate.

    Currently, there are many innovative vector control developments in the laboratory that could impede pathogen transmission and are now ready for field evaluation, including: genetically modified mosquitoes; mosquitoes infected with microbial symbionts that are vertically transmitted; new chemical odorants and repellents for topical use in humans; insecticide-impregnated fabric and repellent patches; improved baited traps and nets; and improved long-lasting, slow release larvicides. To assess the feasibility and environmental risks of field release of genetically modified mosquitos, closed endemic-specific biospheres may be used to evaluate vector behavior and survival in the endemic setting. In addition, recent experiences within and outside the U.S. suggest that there is a need to conduct community-based, socio-behavioral studies to determine the acceptability of such research in the target communities, and how to engage these communities before, during and after and intervention has been deployed.

    Research studies suggest that vectors are adapting to the current field-deployed interventions, thus reducing their impact. Widespread use of insecticides in agriculture and disease control has selected for insecticide resistance and thus has reduced the effectiveness of control measures, such as insecticide-treated bed nets and indoor residual spraying with insecticides. Furthermore, while Anopheline mosquitoes that spread malaria primarily exhibit indoor nocturnal biting behavior, recent studies from the ICEMR Program suggest that these mosquitoes have altered their behavior and are now biting outdoors and earlier in the evening. Such adaptive changes exemplify the need to study the epidemiologic and clinical impact of government-approved vector control or malaria prevention interventions to inform decision makers on which malaria control interventions to choose for deployment as public health control measures. 

    In recent years vector-targeted interventions that repel, kill, reduce, replace or alter the vectorial capability of populations of arthropods, especially mosquitoes, which transmit diseases to humans, have been developed and/or tested.  Entomologic outcomes for some of these interventions have been measured, but the impact of these interventions on clinical outcomes has not yet been evaluated (except in the case of insecticide and bed net use for malaria).  Nevertheless, public health agencies are increasingly requesting demonstration of linkages between entomologic and epidemiologic outcomes, as exemplified in recent recommendations from the Vector Control Advisory Group at the World Health Organization.

    In addition to vector-targeted interventions, several treatment and prevention interventions are now being implemented in different transmission settings. These include mass drug administration, focal screen and treat approaches, school-based treatment, and seasonal malaria chemoprophylaxis approaches. While these interventions have been implemented as public health programs, few studies have systematically evaluated the impact of these interventions using rigorous effectiveness study designs with the goal of determining the incremental benefit of these approaches and their impact on reduction of disease risk, transmission, and emergence of drug resistant parasites.

    Research Objectives

    This FOA describes three distinct types of studies to which eligible applicants may respond. Applications may address up to one of each of the following types of studies:

    Study Type 1: Controlled Environment studies

    This type of study will involve outdoor contained/controlled environments, such as studies in contained bio-spheres within the ICEMR endemic sites, to evaluate the impact of novel EPA-approved or non-EPA-approved chemicals insecticides, new vector control products, genetically modified mosquitoes or microbial symbiont-infected mosquitoes. These studies will not involve human subjects as research participants, and all products must be approved for testing or further evaluation by appropriate in-country government or regulatory authorities. Controlled Environment studies may include, but are not limited to:

    • Data collection necessary for the preparation and implementation of environmental interventions, such as studies in contained and controlled bio-spheres, which will inform future field studies;
    • Evaluation of novel chemical attractant or repellents in a controlled setting.

    Note: For Study Type 1 (Controlled Environment studies) all applicants will be required to serve as the regulatory sponsor in-country (if required by the local authorities).  

    Study Type 2: Observational studies

    This type of study involves the collection of preliminary background data from the community and stakeholders to inform the design of future, larger implementation studies, and will not include interventions or an evaluation of the effect of a prospective intervention on participants. Examples of observational studies may include, but are not limited to:

    • Small, socio-behavioral studies that will assess community acceptability, concerns, and factors which influence the conduct of future large-scale implementation studies; these studies can include surveys, questionnaires, focus group discussions, and interviews, but may not include collection of biological specimens or samples;
    • Community-based, socio-behavioral surveys to inform and plan future clinical trials or implementation studies that introduce interventions such as:
    • Drug prophylaxis or treatment approaches;
    • Diverse vaccination strategies, including novel routes of delivery;
    • Strategies to target special populations for treatment or prevention;
    • Field release of new mosquito strains (e.g., strains with reduced transmission competence); or
    • Field release of genetically modified mosquitoes.

    Study Type 3: Implementation studies

    This type of study will assess the impact or effectiveness of country-approved public health interventions on malaria incidence or transmission in an endemic setting.  Such studies must include in country-approved products provided by the local Ministry of Health (MOH); however, in country-approved products that are not utilized as a part of current routine public health practice in the country due to cost or supply considerations may be included. Implementation studies may include controlled, cluster-randomized studies in which participants are given combinations of interventions, each of which is approved by in-country MOHs (such as bed nets, larvicides, indoor residual spraying, prevention, and treatment). Implementation studies should be designed to determine the most cost-effective treatment combinations and strategy that will reduce the burden of disease due to malaria.  The Center will design the study in cooperation with the relevant government agencies or MOH to determine where, when and how to administer the available intervention(s).  The government agency, MOH or organizations working with the MOH routinely implementing malaria control activities, will fund, manage and administer all aspects of the actual intervention. Interventions or personal protectants may also be purchased by participants. The ICEMR may provide advice and direction to the MOH, but should not be involved in the actual field operations related to the administration or implementation of control activities. The Center will be engaged in the study oversight, data collection and outcome measurement of the intervention.

    Implementation studies may include, but are not limited to:

    • Acceptability, compatibility and effectiveness of in-country-approved outdoor personal protection measures against mosquitoes, e.g., topical repellents containing DEET, topical creams with citronella, bracelets with repellents, insecticide impregnated fabric;
    • Integrated vector management with different combinations of existing vector control tools and assessment of their combined impact on risk, disease transmission, and clinical outcomes;
    • Studies to evaluate effectiveness of in country-approved insecticides and products, such as traps, attractants, repellents and larvicides, and their impact on risk, disease transmission, and clinical outcomes;
    • Studies evaluating impact of different drug treatment strategies, such as mass drug administration, focal treatment strategies, school-based prevention and treatment interventions, or seasonal malaria prophylaxis, in conjunction with other routine malaria control activities;
    • Studies evaluating in country-approved drugs targeting gametocytes;
    • Studies evaluating the effectiveness of the RTS,S (Mosquirix®) vaccine in conjunction with other malaria control strategies.

    Go/No-Go Criteria

    For Study Type 3 (Implementation studies): this FOA requires projects to include Go/No-Go criteria to be met by the end of the second year of the award. This is a significant requirement beyond the conventional U19 application. Initially, support will be provided for up to two years; if the Go/No-Go criteria are met, funding may be continued for an additional three years, for a total of five years of support. The stated Go/No-Go criteria will be included in the Notice of Award. Although applicants will submit an application including five years of research, at the end of Year 2, the progress of research towards the stated Go/No-Go criteria will be evaluated by NIH Program staff. Three additional years of funding may be available for those who successfully meet their criteria; for applicants not meeting their Go/No-Go criteria the revision award will close out at the end of year 2.

    The following types of studies will be considered non-responsive to this FOA; applications including such studies will not be reviewed:

    • Applications proposing more than one Research Project for each Study Type.
    • For Study Type 1 (Controlled Environment studies): applications including any human subjects research;
    • For Study Type 1 (Controlled Environment studies) & Study Type 2 (Observational studies): applications proposing Clinical Trials;
    • For Study Type 1 (Controlled Environment studies) & Study Type 3 (Implementation studies): Uncontrolled release into the environment of genetically modified mosquitoes, or mosquitoes carrying Wolbachia bacteria or other microorganisms intended to alter vector-borne transmission of Plasmodium spp.;
    • For Study Types 1 (Controlled Environment studies), 2 (Observational studies) and 3 (Implementation studies): projects conducted in foreign sites other than those listed in the parent grant;
    • For Study Type 3 (Implementation studies):
    • use of products not approved for use in the country in which the trial will be conducted;
    • studies that would require a U.S. FDA IND submission, as determined by the NIAID, DMID;
    • studies that would expose human beings to two or more chemically active interventions;
    • applications that do not include a Research Strategy encompassing 5 years of proposed research;
    • interventions exclusively targeting pregnant women;
    • field studies of new topical creams, aerosols, chemicals or insecticides that are not U.S. FDA or U.S. EPA approved for use in humans or in the environment;
    • Applications proposing studies on HIV, AIDS or SIV.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    Revision

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIAID intends to commit $4 million in FY 2019 to fund up to 12 awards as follows:

    • For Study Type 1 (Controlled Environment studies) & Study Type 2 (Observational studies): up to 6 awards may be funded for no more than two years for each Study Type. 
    • For Study Type 3 (Implementation studies) awards will be made as follows:
    • Up to 6 awards may be funded for no more than two years.
    • Upon NIAID review/approval after two years, up to 4 of these awards may be funded for no more than three additional years - for a total of up to five years of funding.
    Award Budget

    Application budgets for Study Types 1 and 2 should not exceed $200,000 per year in direct costs for years 1-2. 

    Application budgets for Study Type 3 should not exceed $400,000 per year in direct costs for years 1-2 and $900,000 per year in direct costs for years 3-5.

    Award Project Period

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Applications may be submitted only from current International Centers of Excellence for Malaria Research (ICEMR) awardees, funded under RFA AI-15-056. The parent grant must be active when the application is submitted.

    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.

    Required Registrations

    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.

    Eligible Individuals (Program Director/Principal Investigator)

    The PD/PI (or Contact PD/PI for multi-PD/PI awards) on the parent award must remain the same on the revision application.  

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Only one application per institution/ICEMR (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).
    •  Research Projects must be conducted only in the countries listed in the original ICEMR application.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    A button to access the online ASSIST system 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.

    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.

    2. Content and Form of Application Submission

    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.

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

    Letter of Intent

    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:

    Ann-Marie Cruz, Ph.D.
    Telephone: 301-761-3100
    Email: ann-marie.cruz@nih.gov

    Page Limitations

    Component Types Available in ASSIST

    Research Strategy/Program Plan Page Limits

    Overall

    6 pages

    Project (use for Research Projects)

    12 pages

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

    Instructions for the Submission of Multi-Component Applications

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

    Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

    The application should consist of the following components:

    • Overall: required
    • Project(s): required; minimum of 1, maximum of 3 (applications may propose a maximum of 1 project on each Study Type)
    Overall Component

    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.

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    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.

    Research & Related Senior/Key Person Profile (Overall)

    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.

    Budget (Overall)

    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.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Revision applications, an Introduction to Application is required in the Overall component. Provide an overview of the structure of the awarded parent grant. Describe the progress made with respect to site development, initiation of field studies, enrollment and accrual rates of human subjects at each of the sites since April 2017. Provide a description of the data management system, its implementation, the amount of clinical data that has been entered in its final form, and the amount and types of clinical data that were uploaded into PlasmoDB to enable data sharing. 

    Specific Aims: List the Specific Aims of the parent award and explain how the proposed new project(s) will extend the aims of the Center.  

    Research Strategy:  State the public health significance of the research and discuss how the studies will advance the field of antimalarial interventions and how it will address critical issues relevant to clinical research and disease control. Provide a description of how the proposed project(s) leverage the baseline data, infrastructure, and capacity established by the ICEMRs to support the proposed studies. Include a discussion of how the project(s) address critical issues relevant to clinical research and disease control.

    Provide the rationale and justification for adding the proposed new project(s). State how the previous achievements have prepared the site for the proposed research. Indicate the project's/projects' relevance to the primary goal of the ICEMR. Describe the country's control programs and the participating agencies that implement or fund the control efforts and their respective roles (e.g., NGOs, President's Malaria Initiative, The Global Fund, etc.). Describe the recent gains or setbacks experienced by the control programs and the potential contributing factors. Describe how the proposed research enhances the ICEMR site's capacity for contributing to strategies supporting current interventions and the development of future interventions.

    Provide a description of how the data management system will be enhanced and scaled up. Provide a plan on how and when future data uploading to PlasmoDB will be piloted and tested.   

    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:

    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)

    Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or 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

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

    PHS Assignment Request Form (Overall)

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

    Research Project(s)

    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 Project(s)

    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 Project(s)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Project(s)

    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) (Research Project(s)

    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 Project(s)
    • 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.
    • Investigators other than the PD/PI may be included as the Research Project Lead.
    • For Study Type 2 (Observational studies): participation of a social scientist (e.g., with a background in sociology, anthropology or psychology in a relevant field) is required. 
    Budget (Research Project(s)

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

    At least 80% of the annual direct costs must be committed for field work and related research activities at the endemic sites. 

    ICEMR funds may not be used to procure the malaria control interventions, or to fund the logistics and staff associated with the implementation of the malaria control activities.

    Submit separate budget pages for each Study Type (Study Type 1, Study Type 2, and/or Study Type 3). Budgets should reflect the Study Type for which they are requested.

    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 Project(s)

    Introduction to Application: For Revision applications, an Introduction to Application is allowed for each component.

    Specific Aims: List the specific objectives of the proposed research.   

    Research Strategy:  

    For Study Type 1 (Controlled Environment studies) and Study Type 2 (Observational studies): Include the following in the Research Strategy:

    • An explanation of the rationale for selecting the strategy, methodology and analytical strategies proposed to accomplish the specific aims, including relevant preliminary data. State the public health significance of the research and discuss how the studies will advance the field of antimalarial interventions and how it will address critical issues relevant to clinical research and disease control.
    • A description of how the proposed project(s) leverage the baseline data, infrastructure, and capacity established by the ICEMRs to support the proposed studies.
    • A discussion of how the project(s) address critical issues relevant to clinical research and disease control?
    • A discussion of major barriers to the future conduct of the studies.
    • Project Management Plan: include a detailed description of how the study will be organized and managed, including the plans to identify and select additional collaborators, if applicable. Include a description of the planning activities prior to the start of the study, Go/no-go decision points, and contingency plans.
    • Timelines: include a timeline for completion of the proposed study.

    For Study Type 1 (Controlled Environment studies):

    In addition, include the following in the Research Strategy:

    • A description of the data collection activities necessary for the preparation and implementation of malaria control interventions or preliminary laboratory and environmental data for studies in controlled bio-spheres in the endemic settings.
    • Include a statement from the PD/PI indicating willingness to serve as the regulatory sponsor in-country (if required by local authorities).

    For Study Type 2 (Observational studies):

    In addition, include the following in the Research Strategy:

    • A detailed description of the roles and responsibilities specific to the responsible Government Agency or Ministry of Health (MOH), local government(s) where applicable, agencies working with MOH, collaborator(s), residents and community stakeholders as they relate to the intervention to be studied.
    • A description of the target population for the observational study, the sample selection, the underlying theory or approach for any social-behavioral studies and the study design. Describe in detail the qualitative and quantitative analytical approaches that will be used.

    For Study Type 3 (Implementation studies):

    Include the following in the Research Strategy:

    • An explanation of the rationale for selecting the strategy, methodology and analytical strategies proposed to accomplish the specific aims, including relevant preliminary data.
    • A description of how the proposed project(s) leverage the baseline data, infrastructure, and capacity established by the ICEMRs to support the proposed studies.
    • A description of the roles and responsibilities specific to the responsible Government Agency or Ministry of Health (MOH), local government(s) where applicable, agencies working with MOH, collaborator(s), and ICEMR investigators and staff. Details for each participating institution, where applicable, should include:
    • Participation and inputs into the experimental study design and protocol development,
    • Funding, acquisition and administration of the interventions,
    • Data collection to quantify the interventions, participation, and coverage,
    • Measurement of process indicators and data validation methods,
    • Ground truthing to validate the satellite or remote sensing data with observations or field measurements,
    • Supervision and quality control methods at every level (field, laboratory and data management),
    • A description of the data management system and whether it follows the CDISC guidelines,
    • A discussion of major barriers to the conduct of the studies.
    • Project Management Plan: include a detailed description of how the study will be organized and managed, including the plans to identify and select additional collaborators, if applicable. Include a description of the planning activities prior to the start of the study, Go/no-go decision points, and a discussion of potential problems with contingency plans.
    • Timelines: in a clearly labeled section, describe timelines for the overall project, distinguishing the work to be completed in years 1-2 versus years 3-5. For clinical trials, applicants will provide specific clinical trials timelines under the PHS Human Subjects and Clinical Trials Information and these must not be duplicated under the Research Strategy.

    Go/No-Go Decision Criteria: in a clearly labeled section, state the Go/No-Go criteria for completion of the first 2 years of research. Include a description of the population that was enrolled in the first 2 years of study, which must be at least 2000 individuals, divided into 2 or more clusters. Describe the surveillance that has been set up to track the 2000 individuals and additional surveillance sites for the subsequent years. Include a discussion of the suitability of the proposed milestones for assessing success of the first 2 years of research, and a discussion of the implications of successful completion of these milestones for the proposed final 3 years of work. Include a discussion of the field readiness to scale up during years 3-5, and status of the data management system level of conformance to CDISC standards, and sharing of data from years 1-2. Go/No-Go decision criteria should be specific, quantifiable and scientifically justified; they should not simply be a restatement of the specific aims.  

    Letters of Support: Applicants must provide letters of support from each applicable site Director, local government/responsible Government or MOH collaborator, and/or significant research contributor indicating agreement for continued utilization of collaborative resources (e.g., a Network, CTSA, or Consortium).

    For the Controlled Environment study (Study Type 1): Include letters of support from the concerned in-country regulatory authorities or MOH permitting the use of in-country approved experimental products to be studied in a contained controlled environment. The letter should specify the exact site/location(s) where the evaluation will be permitted.

    For the Observational study (Study Type 2): Include letters of support from the concerned in-country regulatory authorities or MOH, which endorse the conduct of the survey. The letter should state that the types of interventions contained in the survey are of relevance to the treatment and/or prevention of malarial disease within that country.

    For the Implementation study (Study Type 3): For situations in which a Government Agency or MOH is the sole implementer of malaria control activities, provide a letter(s) of agreement from the Government Agency to fund and administer all aspects of the actual intervention.  In countries where other agencies also support and implement malaria control activities, include letters of support from other agencies expressing willingness to work with the ICEMR and the responsible Government Agency or MOH to adopt the study design outlined in the application. The letter should state that the agency will be responsible for all costs associated with the procurement and implementation of the interventions.

    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:

    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 (Core or Project Name)

    Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or 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.

    Section 2 Study Population Characteristics

    Section 2.6 Recruitment and Retention Plan

    For Study Type 3 (Implementation studies): Include a plan to conduct studies in multiple clusters (villages) with a total population of at least 2000 individuals in the first 2 years, divided into at least study two groups, with at least two clusters in each group. Outline plans for all study groups to receive interventions, to be administered by the local MOH in the final 3 years. The first 2 years may include expanded surveillance for baseline information from additional study sites, to inform the future expanded study design and implementation in years 3-5.  The sample size for the initial 2 years of research is not expected to be statistically powered to detect statistically significant differences.

    Delayed Onset Study

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

    Foreign Institutions

    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.

    3. Unique Entity Identifier and System for Award Management (SAM)

    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.

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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.

    7. Other Submission Requirements and Information

    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. 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 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.

    Prior Consultation with NIAID

    Consultation with NIAID staff at least 10 weeks prior to the application due date is strongly encouraged for submission of any NIAID U19 revision application. If requested, NIAID staff will consider whether the proposed resource project meets the goals and mission of the Institute, and whether it addresses one or more high priority research areas. NIAID staff will not evaluate the technical and scientific merit of the proposed grant; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    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.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact - Overall

    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).

    • How likely is it that the proposed project(s) will significantly build or advance the field of antimalarial interventions?
    •  How does/do the project(s) described in the application leverage the baseline data, infrastructure, and capacity established by the ICEMRs to support the proposed studies?
    •  To what extent does/do the project(s) address critical issues relevant to clinical research and disease control?
    Overall Impact - Research Projects

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

    Scored Review Criteria - Research Project(s)

    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? Is there a strong scientific premise for the project? 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 there sufficient preliminary data and justified rationale to support the proposed studies?

    For Study Type 2 (Observational studies) and Study Type 3 (Implementation studies): Are the plans for the involvement of the governing Ministry of Health officials, residents and community stakeholders adequate as they relate to the design of future malaria control interventions on human health outcomes?

    In addition, for applications proposing clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    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?

    In addition, for applications proposing clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    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? 

    In addition, for applications proposing clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? 

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project(s)? 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(s) involve 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 the activities proposed for planning the studies appropriate and adequately described for timely and successful implementation of the study? Do the proposed planning activities address all major barriers to the future conduct of the studies? Are there adequate plans for the development of an effective organizational structure for carrying out the proposed studies? 

    For Study Type 1 (Controlled Environment studies): Does the project described in the application include data collection activities necessary for the preparation and implementation of malaria control interventions or preliminary laboratory and environmental data for studies in controlled bio-spheres in the endemic settings? 

    For Study Type 1 (Controlled Environment studies) and Study Type 2 (Observational studies): Are the proposed timelines appropriate and feasible?

    In addition, for applications proposing clinical trials

    Does the application adequately address the following, if applicable:

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    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?

    Has adequate documentation been provided to indicate the level of commitment/support from the MOH, or other agencies working with the MOH that are performing malaria control activities?

    In addition, for applications proposing clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Overall, Research Projects

    As applicable for the Center 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.

    Study Timeline

    Specific to applications proposing clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    For Study Type 3 (Implementation studies):

    Go/No-Go Decision Criteria

    Are the proposed Go/No-Go decision criteria well-defined with quantifiable and measurable outcomes appropriate for assessing the success of the first 2 years of the application? Does the project adequately describe how the successful completion of these milestones will enable a smooth transition to the final 3 years of study? Does the project adequately describe the field readiness to scale-up to the final 3 years of study, the status of the data management system, level of conformance to CDISC standards and sharing of data from years 1-2?

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Children 

    When the proposed Center 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 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.

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    Not Applicable  

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations - Overall, Research Projects  

    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.

    Applications from Foreign Organizations

    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.

    Select Agent Research

    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).

    Resource Sharing Plans

    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 .

    Authentication of Key Biological and/or Chemical Resources

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    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:

    • 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.  
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.   

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/   

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).    

    2. Administrative and National Policy Requirements

    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.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 “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

    • Each revision made under this FOA will be subject to the same terms and conditions specified for the parent award (RFA-AI-15-056).
    • For Study Type 1 (Controlled Environment studies) all applicants will be required to serve as the regulatory sponsor in-country (if required by the local authorities).
    • The Go/No-Go criteria will be included in the Notice of Award.
    3. Reporting

    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 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.

    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. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, 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
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Malla R. Rao, Dr.P.H.
    National Institute of Allergy and Infectious Diseases (NIAID) 
    Telephone: 240-627-3352
    Email: mrao@mail.nih.gov

    Peer Review Contact(s)

    Ann-Marie Cruz, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-3100
    Email: ann-marie.cruz@nih.gov

    Financial/Grants Management Contact(s)

    Tina Carlisle 
    National Institute of Allergy and Infectious Diseases (NIAID) 
    Telephone: 240-669-2947 
    Email: tc48k@nih.gov 

    Section VIII. Other Information

    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.

    Authority and Regulations

    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.

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