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

Tropical Medicine Research Centers (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-AI-06-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-11-001

Companion FOA

none

Number of Applications

Applicants may submit only one application, See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856  

FOA Purpose

This FOA, issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, encourages applications from institutions/ organizations that propose to conduct research on the causes, diagnosis, prevention, and treatment of tropical diseases in endemic areas, including creating and sustaining research capacity in-country. The scope of the research to be supported is limited to Neglected Tropical Diseases (NTDs) and their corresponding vectors. Research may be focused on a single pathogen or more than one pathogen causing NTDs. Multi-disciplinary research and/or study of multiple pathogens are encouraged.

Key Dates
Posted Date
Letter of Intent Due Date

April 12, 2011

Application Due Date(s)

May 12, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

September, 2011

Advisory Council Review

January, 2012

Earliest Start Date(s)

June, 2012

Expiration Date

May 13, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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 National Institutes of Allergy and Infectious Diseases (NIAID) invites research applications focused on the causes, diagnosis, prevention, and treatment of Neglected Tropical Diseases (NTDs) in endemic areas, including creating and sustaining research capacity in-country. Funds are awarded directly to foreign institutions located in endemic areas. The Tropical Medicine Research Centers (TMRCs) are intended to facilitate the NIAID global research agenda by targeting research efforts 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.

Background

Tropical diseases have been an integral part of the NIH mission since its inception, and the Director of NIH has recently made Global Health a priority area for the NIH. The President's Initiative on Global Health calls specifically for support to fight NTDs http://www.neglecteddiseases.gov/newsroom/speeches_and_testimony/ghana_visit.html. 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. 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.

Research Scope and Objectives

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, trichuriaisis, 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. The TMRC program will support research requiring access to endemic populations, and supports clinical and field site development. Research should require access to human subjects, vectors, or specimens from endemic area field sites.  Projects may be in one or more countries where the disease is endemic. A major outcome of this research program is to ensure that TMRCs with demonstrated success in their research projects and infrastructure are capable of positioning themselves to conduct future clinical trials, implement immunotherapeutic, immunoprophylactic, chemotherapeutic and chemoprophylactic methods, and implement vector control strategies. Research areas may include, but are not limited to the following activities:

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

At the time of submission, each site must have an existing on-site administrative structure, scientific capacity and training available to enable the proposed field sites to perform the research activities proposed in the application.

Components of the TMRCs

Applications must propose at least three individual research projects, an administrative core and a data and biostatistics core. Applications without these will be considered non-responsive and will not be reviewed.

Individual Research Projects: The multiproject P50 application must propose at least three research projects for the application to be considered responsive. At least one of these research projects should be a clinical study involving enrollment of human subjects.

Administrative Core: Required. Each application must include an administrative core headed by the PD/PI. An administrative core is a resource to the multi-project application, providing for the overall management, coordination and supervision of the Program.  A well-developed administrative plan is integral to the success of the Program and must include: a clear and explicit discussion of the structure and roles of administrative staff, including the training and experience of proposed staff, the leadership plan and the functions to be performed; how access to fiscal and other resources will be prioritized, and how such resources will be allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted. All travel should follow NIH travel guidelines. The TMRC administrative core 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. Each TMRC must have a well-delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of basic research findings to clinical applications, and ensure a productive research effort.

In the proposed budget, applicants must include funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications, and communication expenses.

Data and Biostatistics Core: Required. Each application must include a Data and Biostatistics Core. The Data and Biostatistics Core is a resource to the multi-project application, providing for the data management and statistical support of the overall Center and individual research projects.  The Data and Biostatistics Core has several components: an electronic data management system, a data management implementation plan, and biostatistics support. A full-time Data Manager must be present onsite at the Center or at the place where the electronic data management system is hosted and statistical expert(s) should be available as needed.

Applications must provide a detailed description of the existing or planned data management system.  The data management system must be capable of collecting and managing data from the participating study sites in order to ensure uniformity of procedures and high quality data.  The data management system should reside at the endemic area site(s) and data management staff will be responsible for 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. Each TMRC and related field sites should have computers, connectivity to the internet and communications capabilities.  For sites without such capabilities, funding for such infrastructure should be budgeted in this core and the infrastructure should be in place before the end of the first year of the grant.

The data management system should include, but is not limited to:

If applicants do not have the capability for the data management system at the time of application submission, the applicant should describe a plan for designing and implementing a fully operational data management system based on the system requirements, including provisions for the time frame for design, development, testing, validation, and training activities. Plans and procedures must be in place to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.

Each TMRC should have staff with data management (Data Manager) expertise at each site.  The Center should have access to dedicated statistical expertise that informs the research study design and provides the ability to conduct statistical data analysis. They should provide for activities such as study design and protocol development and where appropriate, generating interim tables, preliminary statistical analyses for progress reports, and assisting with statistical issues related to laboratory testing and results. 

Scientific Core(s): Optional.  A scientific core is a resource to the multi-project grant as a whole and must support at least two of the proposed individual research projects.  The application must indicate the specific individual research projects to be served by the Scientific Core(s).  Common shared resources, e.g., laboratory or clinical service facilities may be requested as Scientific Cores. This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants.  The apportionment of dollars or percentage of dollars that will be required to support each individual research project utilizing a scientific core should also be presented.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAID intends to commit an estimated total of $2.9M for 4-6 awards

Award Budget

Direct costs are limited to $540,000 for the first year of the award.  In subsequent years of the award, applicants may request recommended levels limited to 3% escalation costs. A maximum of 15% of the requested budget may be used to fund institutions in, and consultants from, high-economy countries. .

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed five years.

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

NOTE:  Only foreign organizations may apply; U.S. organizations are not eligible.

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Institutions or organizations 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). Organizational components (e.g., branches, posts) of institutions headquartered in the U.S. or other upper and upper-middle income economies are not eligible. See the Income group column at http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS to determine if your institution is in an eligible country.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

Only one PD/PI may be designated on the 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

Applicants may submit only one application.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Annie Walker-Abbey 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Room 3126, MSC 7616
Bethesda, MD 20892-7616 (Express courier zip: 20817)
Telephone: (301) 451-2671
FAX: 301-480-2408
Email: aabbey@niaid.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Dr. Annie Walker-Abbey 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Room 3126, MSC 7616
Bethesda, MD 20892-7616 (Express courier zip: 20817)
Telephone: (301) 451-2671
FAX: 301-480-2408
Email: aabbey@niaid.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) Sharing Plan) as provided in the PHS 398 Application Guide.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instructions for the Preparation of Multi-Project Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme. 

The supplemental instructions for multi-project applications below are divided as follows:

A. General Instructions – addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Research Projects – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Project.

C. Specific Instructions for Cores – Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Core.

A. General Instructions

All applications must be submitted on Form PHS 398.  The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.


2. Form Page 2

Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD/PI of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core.  A page reference should be included for the budget for each project and each core.  Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader.  The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4. Composite Budget

Do not use Form Page 4 of PHS Form 398.  Instead, using the suggested format presented below, prepare a Composite Budget For All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

 

 

 

 

 

 

5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).  If the FOA allows for budget requests beyond 5 years, use a second Form Page 5 to reflect the additional budget years requested. 

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PI/PD first, followed by those of other key personnel in alphabetical order.

7. Resources Format Page

Do not complete.  Essential information is to be presented in the individual research project and core sections of the application.

8. Center Program Overview (Research Objectives and Strategic Plan)

Specific Aims (Limited to 1 page.)

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

Research Objectives and Strategic Plan (Limited to 12 pages)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 12 pages.  The multi-project 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 Center – 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 individual research project and core should be cited briefly as to its place in the overall scheme.  Summarize the special features in the environment and/or resources that make this application strong or unique.  If the application is a renewal, the Center Program Overview (Research Objectives and Strategic Plan) section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions.  Preliminary studies and/or progress reports must be contained within the page limits of the Research Strategy section.

9 Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

10. Appendix Materials

Refer to section titled "Appendix" below for instructions on submitting appendix materials.

For each project or core in the multi-project application, 3 publications plus other approved material are allowed. 

B. Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.

For each individual Research Project, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Plan

Resources

1. Cover Page

The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application.  Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project.  This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

2. Form Page 2

Provide a Description (abstract) of the research proposed in the individual research project according to the instructions on Form Page 2 of PHS Form 398.  In addition, the abstract should contain a brief description of how the individual research project will contribute towards attainment of the multi-project Center objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

5. Individual Research Project Research Plan (a minimum of three individual research projects are required for the TMRC)

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the Center goals and how it relates to other projects or cores.

Research Strategy (Limited to 12 pages.)

Use this section to describe how the proposed research will contribute to meeting the Center’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the Center application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new projects and progress reports for renewal projects as part of a renewal application must be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.

6. Resources

Provide information on resources available for the project.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  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.

7. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents). 

C. Specific Instructions for Core(s)

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

For each individual Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Plan

Resources Format Page

1. Cover Page.  The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application.  Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core.  This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual.  For all other items in the core application, follow the usual PHS 398 instructions.

2. Form Page 2.  Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the Center objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3.  Prepare a Table of Contents for the core using page 3 of Form PHS 398. 

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

5. Core Research Plan (required cores: Administrative Core, Data and Biostatistics Core)

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed core. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the core’s relationship to the Center goals and how it relates to the individual research projects or other cores in the application.

Research Strategy (Limited to 6 pages.)

Use this section to describe how the proposed core activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the primary theme of the Center application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new cores and progress reports for renewal cores in a renewal application must be included as part of the approach section and must be contained within the page limits of the Research Strategy section.

6. Resources

Provide information on resources available for the core.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  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.

7. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

Human Subjects Research

A description of plans for 1) protection of human subjects from research risks, 2) potential benefits to the subjects and others, 3) importance of the knowledge to be gained, and 4) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, and whether it is justified in terms of the scientific goals and research strategy, must be contained within the Human Subjects section of each individual research project where human subjects research is proposed.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Overall Center Program: Is the Center proposal 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 on the public health or policy of the foreign country?

Individual Research Projects: 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?

Investigator(s)

Are the PD/PIs, 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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Will the individual research project leader (PL) devote adequate time and effort to the program? 

Overall Center Program: Does the Center PD/PI have experience leading a multidisciplinary team and 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?  Will the Center PD/PI devote adequate time and effort to the program?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Overall Center Program: 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, including plans for resolving conflicts, appropriate?  

Environment

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

Administrative Core.

Is the administrative and organizational structure appropriate and adequate to attain the objective(s) of the proposed Center?   Is the management plan for fiscal accountability and communication within the proposed Center appropriate?  Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the Center appropriate?  Are the experience, level of commitment, and availability of the Administrative Core Leader (CL) and administrative staff adequate to manage the program? 

Data 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 a data manager, data management staff and software experts, to collaborate on the design, development and testing of databases and data management software, validation, training, maintenance of systems, 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? 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 Cores (if applicable).

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?    

Additional Review Criteria - Overall

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/priority score, but will not give separate scores for these items.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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

Revisions

Not Applicable.

Additional Review Considerations - Overall

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/priority 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) Genome Wide Association Studies (GWAS).

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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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:

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

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 business official.

Awarde0es 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.      

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Dr. Malla Rao
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-3749
Email:mrao@niaid.nih.gov

Peer Review Contact(s)

Dr. Annie Walker-Abbey 
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 451-2671
Email: aabbey@niaid.nih.gov.

Financial/Grants Management Contact(s)

Leslie Boggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6450
Email: boggsl@mail.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 Parts 74 and 92.


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