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

This funding opportunity announcement (FOA) solicits research applications focused on the causes, diagnosis, prevention, and treatment of select Neglected Tropical Diseases (NTDs) in endemic areas. The Tropical Medicine Research Centers (TMRCs) are intended to advance NIAID s global research effort by targeting research endeavors to: develop prevention and therapeutic strategies adapted for the unique needs of developing countries; create and sustain research capacity in-country; stimulate scientific collaboration and global partnerships; and work with in-country scientists to develop training, communications, and outreach programs.

Tropical diseases have been an integral part of the NIH mission since its inception. NTDs are caused by a wide range of organisms and can be transmitted by a variety of vectors and intermediate hosts (mosquitoes, sand flies, black flies, tsetse flies, triatomine insects, and snails) as well as by contaminated water, food and soil. NTDs are a major problem in developing countries where they contribute significantly to the overall burden of disease and it has become increasingly clear that NTDs contribute to poverty in countries where they are endemic. Thus, interventions targeting NTDs could have a substantial impact not only on the disease burden, but also on the overall economic capacity of the countries where these diseases predominate.

The TMRC Program was initiated in 1991 with the goal of building Tropical Medicine Research Centers on-site in the endemic countries to support clinical and field research. Funding will be made directly to foreign institutions who typically work with US collaborators. Currently, NIAID funds 8 Centers located in six countries. Historically, a major outcome of this research program is the ability of TMRC awardees to take advantage of the expertise and infrastructure gained through TMRC support and apply it to other research opportunities, such as the implementation of immunotherapeutic, immunoprophylactic, chemotherapeutic and chemoprophylactic methods, and vector control strategies.

The scope of the research to be supported under this FOA is limited to the following NTDs: schistosomiasis, hookworm infection, ascariasis, leishmaniasis, trypanosomiasis, Chagas Disease, trichuriasis, leprosy, lymphatic filariasis, trachoma, onchocerciasis, dracunculiasis, Buruli ulcer, echinococcosis, taeniasis and cysticercosis, and food-borne trematodiases. Each Center should design and conduct research on NTDs in endemic areas, and studies should address one or more of the following research areas: epidemiology, transmission, immunology, and pathogenesis. Research may be focused on a single pathogen or multiple pathogens. Multi-disciplinary research and/or research on more than one pathogen causing NTDs is encouraged. Research to be supported by the TMRC program will require clinical and field site development, as well as access to endemic populations including human subjects, vectors, or specimens from endemic area field sites. Projects may be in one or more countries where the disease is endemic. Research areas may include, but are not limited to, the following activities:

• Study of biomarkers;
• Development and/or evaluation of diagnostics;
• Vectors and transmission;
• Study of co-infections (excluding HIV).

NOTE: This FOA will NOT support the following types of research projects. Applications that propose research projects in these areas will be considered non-responsive and will not be reviewed.

• Clinical trials;
• Research that does not require access to human subjects or specimens from disease-endemic sites;
• Research on HIV and pathogens, other than the listed NTDs, except in the context of co-infections or non-NTD outcomes as a result of anti-NTD interventions.
• Research on Select Agents (see: http://www.selectagents.gov/SelectAgentsandToxinsList.html and accompanying regulations: http://www.selectagents.gov/regulations.html).

Each application submitted 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 Scientific Cores that support the work within the TMRC.

Administrative Core: The Administrative Core, headed by the PD/PI, will be responsible for managing, coordinating, and supervising the entire range of TMRC activities; monitoring progress; and ensuring that the overall project management plan is implemented effectively and within proposed timelines.

Data Management and Biostatistics Core: The Data Management and Biostatistics Core provides data management and statistical support for the overall TMRC. The Data Management system must collect and manage data from all participating study sites to ensure uniformity of procedures and high quality data. This Core will also be responsible for the rapid release of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the TMRC, to the broader scientific community 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.

Research Projects: Each TMRC must propose at least three research projects for the application to be considered complete. At least one of these research projects must be a clinical research study that involves enrollment of human subjects.

Scientific Core(s): The Scientific Cores are optional. A Scientific Core is a resource for the entire TMRC and must support at least two of the proposed research projects.. Common shared resources, e.g., laboratory or clinical service facilities, may be requested as Scientific Cores.

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

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

Applicant organizations must be headquartered in foreign (non-U.S.) resource-constrained countries (i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition).  To determine the eligibility status of a country, see the Income group column at http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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. An individual cannot be a PD/PI on more than one application submitted to this FOA..

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

The PD/PI must be located in a foreign (non-U.S.) resource-constrained country (i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition).  To determine the eligibility status of a country, see the Income group column at http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS .

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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:

Annie Walker-Abbey, Ph.D.
Telephone: 240-627-3390
Fax: 301-480-2408
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 Scientific Core)	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, 1
• Administrative Core: required, 1
• Data Management and Biostatistics Core: required, 1
• Scientific Core(s): optional, no minimum or maximum, but each Core should support at least two research projects
• Research Projects: required, minimum of 3, at least one of which is a clinical study which includes enrollment of Human Subjects

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.

Facilities and Other Resources: At the time of application submission, each site must demonstrate the existence of on-site administrative structure, scientific infrastructure and expert staff to enable the proposed field sites to perform the research activities proposed in the application.

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: 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, each project and core should be cited briefly as to its place in the overall scheme. Describe past research activities and achievements at these sites, if any. Summarize the special features in the environment and/or resources that make this application strong or unique. Describe the diverse group expertise of the Center as a whole including basic science, vector research (and vector ecology), epidemiology and clinical studies.

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 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.

Outline the budget required for the overall administrative efforts, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here.

Include expenses for travel of the PD/PI, Project and Core Leaders, key scientific staff and foreign collaborators to the start-up meeting to be held at or/near Bethesda, Maryland in the first year of the award.

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:

• Coordination, supervision, tracking and management of all Center activities, including sponsoring activities to advance the Center s integration, accelerate the pace of research, enable translation of basic research findings to clinical applications, and ensure a productive research effort;
• Provision of a supportive structure sufficient to ensure the accomplishment of all Center goals;
• Assistance to Research Project and Core Leaders with the administrative aspects of their projects, such as gathering of progress reports and facilitating other communications with awardees and their mentors;
• Promotion of collaboration and coordination among Research Project and Core Leaders
• Communication with other TMRCs 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;
• Fostering outreach activities to promote collaborations with the pertinent scientific communities;
• Communication and interaction with NIAID staff;
• Provision of 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:

• An outline of the organization of the TMRC and its management structure to form a cohesive, integrated and efficient Center that provides scientific and administrative oversight of all TMRC Research Projects and Cores; and
• A plan on how research related travel and training 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 fiscal and other resources will be prioritized, managed, allocated and accessed.

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

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

• The structure and roles of administrative and scientific staff; and
• The training and experience of proposed administrative and scientific staff who are not listed as Senior/Key Personnel and the functions to be performed.

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: Describe plans for current provision or establishment of computer access, connectivity to the internet and communications capabilities at all Centers and field sites before the end of the first year of the grant. Redundancy, (for example, 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.

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.

Describe access of all Centers to dedicated statistical expertise that will inform the research study design and provide the ability to conduct statistical data analysis. Describe how support will be provided 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 research 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

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. Each site should have complete access to all the data collected at that site. 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; and
• 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

Describe plans to ensure that the Data System resides at the endemic area, the cloud , or at a site where all key scientific staff will have access to the data collected. Describe plans to ensure/permit that the 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.

Describe how such a system will be planned and implemented, as well as 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.

Describe plans for testing and implementation of a large part of the computerized data management system 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 (Scientific 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 (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific 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) (Scientific 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 (Scientific 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 (Scientific Core)

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

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

PHS 398 Research Plan (Scientific Core)

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

Research Strategy: A Scientific Core is a resource to the Center and must support at least two of the proposed research projects.

Describe the specific projects to be served by the Scientific Core and provide a clear description of the quality and relevance of the facilities, techniques, skills and personnel that the Core will provide to Research Projects.

Describe plans and procedures for establishing and managing the Core to provide organizational capacity.

• 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

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 (Scientific 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 (Scientific 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: Succinctly outline the specific research goals and the Center’s plan for attaining these goals.

Facilities & Other Resources: Provide information on resources available for the 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: Provide information on equipment available for the 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.

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 and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project’s relationship to the TMRC’s goals and how they relate to other Research Projects or Cores in the application.

Research Strategy: Describe how the proposed project will contribute to meeting the TMRC’s goals and objectives and explain the rationale for selecting the methods to accomplish the Specific Aims. State the biological significance of the research, and indicate the project's relevance to the primary theme of the application.

Describe experimental details, using citations within the Bibliography and References Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new Research Projects must be included.

Include the following:

• A description of the research design, conceptual procedures, research questions to be addressed, and analyses to be used to accomplish the Specific Aims of the project;
• A description of any new methodology and its advantage over existing methodologies;
• A description of any novel concepts, approaches, tools, or technologies for the proposed studies;
• A discussion of the associations with clinical project(s);
• A discussion of the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims;
• 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 the 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):
  • Main 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
  • 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: Include milestones and timelines at the end of the Research Strategy section.

Provide well-described, quantifiable, and scientifically justified milestones for all study activities, 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.

Present milestones 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 NIAID.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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.

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 Center as a whole scientifically compelling?
• Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the proposed Center?
• Are the overall Center goals significant and focused on studies that meet the objectives of the FOA? Is the proposed Center research relevant and important to the foreign (non-U.S.) countries or region?
• Is the work of the Center likely to impact the public health practices of the foreign country?
• Does the Center PD/PI have experience leading a multidisciplinary team and does he/she demonstrate the ability to establish and manage administrative functions at the endemic sites?
• Does the Center PD/PI have the leadership and scientific ability to develop an integrated and focused research Center?
• Has the Center PD/PI adequately demonstrated commitment to at least 90 days each year in country on site in the endemic region?
• 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?
• Will the integration of the individual research projects into a single Center be more beneficial than pursuing each project independently?
• Are the administrative plans for the management of individual research projects and cores appropriate?  

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.

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? Is the proposed research relevant and important to the foreign [non-U.S.] countries or region?  Is the work likely to affect the public health or policy of the foreign country?

Are the project leads, 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 -has more than one project lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Will each individual research project leader devote adequate time and effort to the program?

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

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the field sites and/or clinical facilities appropriate for the research? Is there sufficient commitment of support from institutions in endemic areas to carry out the proposed research? Is there adequate evidence of sufficient institutional support for the Project Leader in terms of laboratory space, equipment and other resources?

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.

Administrative Core

• Is the administrative and organizational structure appropriate and sound to facilitate attainment of the objective(s) of the proposed program?
• 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?

Data Management and Biostatistics Core

• 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 application provide evidence of having statistical expertise qualified to assist with study design, protocol development and statistical analyses?

Scientific Core(s)

• Is provision of resources and Core services for the Individual Research Projects critical and justified?
• Is the relationship of a Scientific Core to the central focus of the overall Center strong?
• Is the quality of the relevant facilities or services provided and criteria for prioritization and usage 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

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

Not Applicable

As applicable for the 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.

Not Applicable

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 .

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

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

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.

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;
• Participating in teleconferences and other activities to be defined over the course of the award period;
• Extending invitations to the NIAID Program Official for specific Center meetings. This provides an opportunity for better communication and guidance among the specific researchers and the NIAID.
• Ensuring that in the first year of the grant, each center participates in a start-up workshop hosted in Bethesda, MD, to include the PD/PI/PL for each Center, key Center scientific staff, major foreign collaborators, the NIAID Program Officer, and other NIAID scientific staff.
• 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. Center-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.
• Center-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 TMRC member scientists to facilitate collaborations and to leverage the resources available to the Center.
• The NIAID Project Scientist will monitor the progress of the projects, help coordinate research approaches, and contribute to the shaping of research projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it.
• The NIAID Project Scientist will keep the Center informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The NIAID Project Scientist will coordinate access for the Center to other NIAID resources, as well as assist the research efforts of the Center by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• The NIAID Project Scientist will coordinate periodic telephone calls with PD/PI as needed.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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.

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 an Executive Committee 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 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
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, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3352
Email: [email protected]

Annie Walker-Abbey, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3390
Email: [email protected]

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
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.