and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
International Collaborations in Infectious Diseases Research (U19) |
Activity Code |
U19 Research Program Cooperative Agreements |
Announcement Type |
Reissue of RFA-AI-09-010 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AI-14-002 |
Companion Funding Opportunity |
RFA-AI-14-001, U01 Research Project Cooperative Agreements |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856 |
Funding Opportunity Purpose |
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from U.S. institutions and collaborating foreign (non-U.S.) institutions to study infectious diseases (excluding HIV/AIDS) of great public health significance in resource-constrained countries. The collaboration must include, at a minimum, one U.S. institution and one eligible foreign institution. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank. This work is expected to increase scientific knowledge on public health related issues, enhance relevant research experience for U.S. and foreign investigators, promote the development of research capacity, and encourage future collaborative relationships. |
Posted Date |
November 27, 2013 |
Open Date (Earliest Submission Date) |
February 7, 2014 |
Letter of Intent Due Date(s) |
February 7, 2014 |
Application Due Date(s) |
March 7, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
July 2014 |
Advisory Council Review |
October 2014 |
Earliest Start Date |
January 2015 |
Expiration Date |
March 8, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
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
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. The NIAID has a long-standing interest in and commitment to global health and international research on infectious diseases. A solid foundation of international research and collaborations enhances the U.S. capacity for infectious disease research and the ability to respond to newly emergent disease threats. Moreover, the availability of NIAID-sponsored overseas study sites for field research advances our global public health agenda and allows for research that might not be possible in the U.S.
The International Collaborations in Infectious Disease Research (ICIDR) Program, initiated in 1980, makes awards to institutions in the US and/or foreign countries to engage in substantial international collaborations in infectious disease research (excluding HIV/AIDS). The goals of the ICIDR program are to: support high-quality, collaborative research that will lead to or result in detection, prevention, amelioration, and/or improved treatment of infectious diseases; increase relevant and collaborative research experience for both U.S. and foreign investigators; and facilitate and enhance scientific linkages between U.S. and foreign investigators to enhance the independent research capacity of the collaborating foreign institutions and foster further international collaborative research projects.
This FOA invites applications from U.S. institutions or institutions in eligible, resource-limited foreign countries proposing collaborative research focused on infectious diseases that disproportionately affect the health of people living in resource-limited countries. The collaboration must include, at a minimum, one US institution and one eligible foreign institution. However, additional collaborations may be included with other developed countries, and/or with more than one eligible foreign country. Both the U.S. and eligible foreign institutions must have a lead investigator identified as key personnel; each lead investigator (U.S. and foreign) must have a primary appointment at the collaborating institution. Both the U.S. and foreign lead investigators must have a significant role in the design, implementation, monitoring, and administrative management of the research projects. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank. (See Section III.1 Eligible applicants). Applicants may choose to submit single project applications (U01 see companion RFA-AI-14-001) or multiple project applications (U19).
The ICIDR program supports research requiring access to populations of infected human and/or other mammalian hosts, parasites, and/or vectors limited or unavailable in the U.S. and other developed countries. Therefore, the majority of research supported under the ICIDR program must be conducted at one or more foreign sites with an emphasis on field and clinical studies of endemic diseases.
Characteristics of the proposed research should include the following:
Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded ICIDRs. Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award below.
NOTE: The following areas of research are not responsive to this FOA and will NOT be reviewed:
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
NIAID intends to commit $5 million in FY 2015 to fund 5 - 8 cooperative agreements. |
Award Budget |
Direct costs are limited to $500,000 per year excluding consortia F&A costs. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 5 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.
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Eligible countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS.
The application must include a collaborative arrangement between the U.S. and one or more established institutions (e.g. university, research institute, federal or state health department, hospital) located in one or more eligible foreign (non-U.S.) countries.
Non-domestic (non-U.S.) components of U.S. organizations are NOT eligible to apply as the foreign institution, but are eligible to apply as the U.S. institution.
However, organizational components (e.g., branches, posts) of institutions headquartered in the U.S. and other upper income economies that are physically located in an otherwise eligible country will not be eligible as the foreign country institution; they may apply as an additional collaborator.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with
his/her organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the
Senior/Key Person Profile (Expanded) Component of the SF424 (R&R)
Application Guide.
The PD(s)/PI(s) must hold a primary appointment at either a U.S. institution or at an institution in an eligible country.
Investigators at other U.S. or other high economy country institutions may be included as collaborators on the project(s). However, the majority of the research must be conducted in an eligible resource-limited country.
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.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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, 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:
The letter of intent should be sent to:
Annie Walker-Abbey, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3126, MSC-7616
6700B Rockledge Drive,
Bethesda, MD 20892-7616
Zip Code for express couriers: 20817-1821
Telephone: 301-451-2671
Fax: 301-480-2408
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core |
12 |
Core (use for Scientific/Service/Resource Core) |
6 |
Project (use for Research Projects) |
12 |
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
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Do not include Facilities & Other Resources or Equipment attachments to the Overall Component. Instead, load separate attachments containing only the information relevant to each individual research Project Component and Core Component within that component section of the application.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
Key personnel must be identified for both the U.S. and eligible foreign institution(s). If both U.S. and foreign PD(s)/PI(s) are not identified, then someone in key personnel must be identified as the major collaborator (MC). The MC must have a primary appointment at the collaborating U.S. or foreign institution. The MC must participate in the design, implementation, monitoring, and administrative management of the proposed research.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed program. Concisely and realistically describe the hypothesis or hypotheses to be tested.
Research Strategy: This section summarizes the overall research strategy 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. Summarize the special features in the environment and/or resources that make this application strong or unique.
Letters of Support: A letter of support, signed by the institutional official must be included for each collaborating institution.
Resource Sharing Plan: 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)) as provided in the SF424 (R&R) Application Guide, with the following modification:
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.
SF424 (R&R) Cover (Administrative Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Administrative Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Administrative 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.
Project /Performance Site Location(s) (Administrative 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 (Administrative 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.
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 ICIDR, and is responsible for creating within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the Research Projects and Core(s), and provides oversight and governance over fiscal and resource management.
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
Include the committed level of effort of the administrative and scientific staff.
Meetings: Applicants should request funds for the Annual Programmatic Meeting and Kick-Off Meeting in the budget. Annual Programmatic Meeting of all ICIDRs funded under this FOA are to start during the second year of award and should be attended by the PD(s)/PI(s), MC(s), and selected key personnel. These individuals should also budget and plan to attend the kick-off meeting to be held within three months of award.
Effort of ICIDR Personnel: It is expected that ICIDR scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations at the foreign site. It is anticipated that the U.S. PD(s)/PI(s) orMC will spend up to 2 months per year at the foreign site. Other U.S. ICIDR investigators may be expected to spend longer periods of time at the foreign site.
The U.S. PD(s)/PI(s) or MC must expend at least 2.4 person months effort on the ICIDR program. The foreign PD(s)/PI(s) or MC must commit at least 3.6 person months effort.
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 (Administrative Core)
Specific Aims: Briefly describe the specific aims of the Administrative Core.
Research Strategy: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to:
Management Plan: The Administrative Core should include a Management Plan that describes the organization of the proposed program and its management structure. The Management Plan should include:
The Management Plan should also include a Staffing Plan that describes:
Data Management: A data management system, managed at the foreign site must be maintained for the ICIDR project. Applicants must provide a description of the existing or planned data management system, including security features for controlled access to project data, tracking system for forms and activities, date and time stamps for all data records with electronic signatures, and audit trails to track all changes made to records. Training requirements for data managers and data entry personnel must be specified in the application. It is recommended that data management systems be developed using U.S. Food and Drug Administration (FDA) guidelines on electronic records issued in 21 CFR part 11 (http://www.biotechnicalservices.com/downloads/21CFRpart11.pdf).
Biostatistics: Biostatical support must be maintained for the ICIDR project. A description of how biostatistical support will be provided must be included in the application.
Consortium/Contractual Arrangements: If the ICIDR award is made to a U.S. institution, research activities conducted at the foreign affiliate must be supported under a consortium agreement made with the U.S. institution. If the ICIDR award is made to a foreign institution, research activities conducted at the U.S. institution must be supported under a consortium agreement made with the foreign institution.
Capacity Building: The applicant should include a strategic plan for strengthening research capacity at the foreign site(s) and for disseminating research findings to host country health leaders. This plan should include:
Letters of Support: The applicant must include a countersigned letter of commitment from the non-applicant collaborating institution(s) indicating acceptance of the proposed research and documenting both foreign/U.S. investigators and the foreign/U.S. site to be used as the collaborating institution(s).
Resource Sharing Plan: 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)) as provided in the SF424 (R&R) Application Guide, with the following modification:
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 (Administrative 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 (Administrative 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.
A minimum of two individual research Projects is required. Each of the two or more individual Research Projects must present a unified approach to the overall goals of the ICIDR.
SF424 (R&R) Cover (Research Projects)
Complete only the following fields:
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: For each research project, succinctly outline the specific research goals and the Center’s plan for attaining these goals.
Facilities & Other Resources: For each individual Research Project, include the attachment Facilities & Other Resources to provide information on resources available for that project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Equipment: For each individual Research Project, include the attachment Equipment to provide information on equipment available for that project. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment used for working with biohazards or other potentially dangerous substances.
Project /Performance Site Location(s) (Research Projects)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Research Projects)
Budget (Research Projects)
Budget forms appropriate for the specific component will be included in the application package.
Effort of ICIDR Personnel: It is expected that ICIDR scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations at the foreign site. It is anticipated that the U.S. PD(s)/PI(s) or MC will spend up to 2 months per year at the foreign site. Other U.S. ICIDR investigators may be expected to spend longer periods of time at the foreign site.
The U.S. PD(s)/PI(s) or MC must expend at least 2.4 person months effort on the ICIDR program. The foreign PD(s)/PI(s) or MC must commit at least 3.6 person months effort.
Each ICIDR must have a designated biostatistician and data manager. A data manager with minimum 3 person months effort is required at the major foreign site. The biostatistician must expend no less than 0.6 person months effort.
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: Identify and describe overall goals, objectives, and specific aims of each Research Project, and describe how the Project contributes to the ICIDR overall goals.
Research Strategy: Describe and explain the rationale for selecting the methods to accomplish the Specific Aims. State the biological significance of the research, indicate the potential importance of the proposed research to the health and well-being of the population in the disease endemic country, and the role of all consortium members.
Describe the research design, conceptual procedures, quality control, and analyses to be used to accomplish the Specific Aims of the project. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the project. Also discuss any technology transfer issues, infrastructure development or training associated with this research project.
If clinical studies are proposed, include the following:
A strong justification must be made in each application for the selection of the organisms/disease, especially if it is heavily funded by NIAID, the relevance of the disease/organism to the public health of the foreign country, the need to do studies using foreign populations or sites, as well as addressing a gap in the current understanding of the disease.
Letters of Support: Include Letters of Support, as applicable.
Resource Sharing Plan: 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)) as provided in the SF424 (R&R) Application Guide, with the following modification:
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.
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.
Applicants may propose no more than one additional Core integral to the success of the ICIDR and the proposed Research Projects; this additional Core is optional. The Core must be able to support at least two Research Projects. The Core must be well justified and clearly non-duplicative of other services or facilities available to ICIDR investigators. Examples of services provided by a shared scientific core are diagnostic platform production, peptide synthesis, or microbiology laboratory services. Shared microbiology cores could provide a source of patient specimens for clinical research. Applications proposing a Shared Resource Core must give a clear description of the facilities, techniques, and skills that the Core will provide to Research Projects.
SF424 (R&R) Cover (Scientific/Service/Resource Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Scientific/Service/Resource Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Scientific/Service/Resource 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.
Facilities & Other Resources: For the optional Core, include the attachment Facilities & Other Resources to provide information on resources available for that Core. 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. Include a description of how the scientific environment in which the core service or resource will be conducted contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport).
Equipment: For the Core, include the attachment Equipment to provide information on equipment available for the Core. 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) (Scientific/Service/Resource 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/Service/Resource Core)
Budget (Scientific/Service/Resource Core)
Budget forms appropriate for the specific component will be included in the application package.
The Core Component should have a separate budget that details the costs required to support the Core.
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/Service/Resource Core)
Specific Aims: 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 ICIDR s goals and how they relate to the individual Research Projects.
Research Strategy: Use this section to describe how the proposed Core activities will contribute to meeting the ICIDR's goals and objectives and explain the rationale for selecting 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 application. Provide justification for the Core to support the proposed Research Projects.
Experimental details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy.
Letters of Support: Include Letters of Support, as applicable.
Resource Sharing Plan: 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)) as provided in the SF424 (R&R) Application Guide, with the following modification:
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/Service/Resource 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/Service/Resource Core)
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.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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.
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 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.
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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Is the proposed research relevant and important to the foreign [non-U.S.] country or area? Is the work likely to influence on the public health or policy of the foreign country? Does the proposed research address a scientific problem that cannot be addressed in the U.S.?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the time and effort proposed by the Project Director(s)/Principal Investigator(s), Major Collaborator(s), Data Manager and Biostatistician adequate?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Are the research projects integrated into the overall goals of the ICIDR? Are plans for collaboration adequate? Is research capacity development well integrated into the research?
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?
Does the proposed research require access to populations or resources outside of the U.S.?
Are the field sites and/or clinical facilities appropriate for the research?
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 the Overall application:
For the Administrative Core:
For the Scientific/Service/Resource Core (if applicable):
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed 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 Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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.
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 Disease (NIAID), in accordance with NIH peer review policy and procedures,using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.
Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
SAM Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
The
PD(s)/PI(s) will have the primary responsibility for:
Intellectual Property
The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
The NIAID Project Scientist will provide overall coordination across all funded ICIDRs, and will coordinate with the PD(s)/PI(s) 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 the 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
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)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Polly R. Sager, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-1884
Email: [email protected]
Annie Walker-Abbey, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2671
Email: [email protected]
Leslie Boggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6450
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 Parts 74 and 92.
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