and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Novel, Alternative Model Systems for Enteric Diseases (U19) |
Activity Code |
U19 Research Program Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AI-14-011 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) will support the development of novel model systems that permit integrated approaches to advance understanding of enteric disease at the level of basic science and, ultimately, to facilitate product development. A team of investigators from disparate scientific fields will leverage advances in biomedical and tissue engineering (e.g., the generation of complex human tissue constructs) and/or the gastrointestinal microbiome to develop models that mimic pathophysiology and host response to provide relevant predictive outcomes for human disease, such as distinct clinical outcomes or potentially lethal sequelae. |
Posted Date |
January 27, 2014 |
Open Date (Earliest Submission Date) |
April 29, 2014 |
Letter of Intent Due Date(s) |
April 29, 2014 |
Application Due Date(s) |
May 29, 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 |
September 2014 |
Advisory Council Review |
January 2015 |
Earliest Start Date |
May 2015 |
Expiration Date |
May 30, 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
Diarrheal diseases remain one of the top five causes of morbidity globally with 3-5 billion cases annually; it is the second leading cause of death in children during their first year of life. In addition to causing acute illness, some enteric pathogens are associated with serious sequelae, such as: preterm delivery, stillbirth, malabsorption, stunting, organ inflammation, peptic ulcers, gastric carcinoma, Guillain-Barr syndrome, hemolytic-uremic syndrome, or reactive arthritis. Post-infectious chronic conditions might include long-term alteration of intestinal barrier function, irritable bowel syndrome or inflammatory bowel disease. Moreover, the overall burden of diarrheal disease syndromes is underestimated due to the involvement of multiple pathogens, repeated episodes of diarrhea, and the frequent failure to identify the etiologic agent.
Significant advances have occurred in the fields of Tissue Engineering, Regenerative Medicine, and the Human Microbiome. With the accumulation of vital knowledge and the advent of sophisticated technologies, the current state of understanding in these fields is scientifically poised to capture and combine disparate disciplines (infectious diseases and tissue engineering and/or studies of the human gut microbiome) into synergistic approaches to address complex, unresolved problems in enteric diseases research.
To initiate an alliance between the tissue engineering and infectious diseases scientific communities, NIAID/DMID held an In vitro Tissue Models for Infectious Diseases workshop in the Spring of 2013 at which experts in these fields shared the current state of knowledge in their respective scientific areas, available research techniques, and obstacles toward advancing basic and applied research. Working groups were assembled around human physiological systems and asked to address questions relevant to specific infectious agents or diseases according to tissue engineering principles, methodologies, and resources.
The GI Organ System working group identified key gaps, cell types and requirements for engineered GI systems, and defined markers needed to validate organ systems as accurate, relevant replicates for human disease studies.
This program will support multidisciplinary, collaborative, and synergistic research approaches to enteric diseases research that are designed to bridge the gap between basic and clinical research for a translational outcome. This program is intended to advance understanding of enteric diseases through overcoming obstacles that inhibit basic science and product development.
This FOA solicits research applications that adapt state-of-the-art bioengineering, especially tissue engineering, methodologies to the field of infectious disease research. The long term goal is to develop in vitro models that mimic biological structures, recapitulate human physiology and disease pathology, and incorporate components critical to disease and human host response. These models should facilitate studies that span the pipeline from basic research (pathogenesis) to product development.
Models of interest might range from 1) the incorporation of gut microbiota and immune cells in a system that simulates the human GI tract to 2) complex nephron-like structures that permit identification of the mechanism of kidney failure post-infection with enterohemorrhagic Escherichia coli, i.e., the development of hemolytic uremic syndrome. For enteric pathogens that have no relevant animal model, one long term goal is to have model systems that can be used in IND-enabling studies.
Thus, responsive applications would include development of the model system (e.g., GI organ-like structures or biomechanical devices that incorporate key aspects of pathophysiology), implementation to demonstrate feasibility, and application of the model to address key questions for infectious diseases that range from basic science to preclinical, perhaps even IND-enabling, studies. The use of clinical samples (e.g., bacterial isolates, human tissues, human blood, immune components, stem cells and fecal samples) in these studies will reinforce the pertinence to human disease. Importantly, technologies must be developed with the end use in mind, i.e., sufficiently simple for routine use in infectious disease laboratories or adequately robust for use in preclinical or IND-enabling studies.
Research is limited to the following enteric agents:
Bacteria
Viruses
Examples of research gaps or model characteristics to be addressed under this program include:
This FOA will NOT support:
Applications proposing projects focused on the areas above will be deemed non-responsive and will not be reviewed.
Each NAMSED CRC should be composed of a multidisciplinary research team with expertise spanning the fields of infectious disease and bioengineering. The NAMSED Centers must establish and manage multi-disciplinary, synergistic research and technology teams that incorporate collaborative Research Projects with a focus on the development of novel models for enteric diseases. Development of these model systems will require extensive collaboration between the infectious disease scientists and developers of model systems; for the purposes of this FOA, the central focus is infectious enteric disease. Each NAMSED CRC is expected to include researchers with unique expertise that will enhance the overall quality of the Center. Expertise crucial for the development, validation, and utilization of newly developed models also might include, but is not limited to, the areas of host immunity, biomedical imaging, pathology, and/or assay development and validation.
Each NAMSED CRC must carry out at least two thematic Research Projects and support scientific service and/or resource Cores as necessary to ensure the success of the supported Research Projects and overall goal of the Center. A Center Director will coordinate the Projects and Cores within each NAMSEC CRC. The Center Director will be the (or one of the) PD/PI(s) of the application, and must be the contact PD/PI. In addition, each NAMSED CRC must include an Administrative Core responsible for guiding the overall activities of the Center.
Administrative Core activities to include:
Pilot Developmental Research Projects
Each NAMSED CRC should identify and support pilot Developmental Research Projects (DRPs) that take advantage of novel technologies and new opportunities in enteric research. These projects may provide an opportunity to expand on basic science hypotheses, enable testing of novel ideas, develop new technologies, or provide further training in certain areas under investigation by the Center.
Each NAMSED CRC is limited to supporting no more than two pilot DRPs per year, although the total number of pilot DRPs that a NAMSED CRC can support during the entire award project period is left to the discretion of each NAMSED CRC.
DRPs are not intended for pre-doctoral candidates, but may include researchers new to the scientific focus of the Center. This program is designed to provide research opportunities within the approaches, methodologies and resources generated under the Center that can enhance or transition into Research Projects as needed. The NAMSED CRC Executive Committee will review each NAMSED CRC’s pilot DRPs and will provide recommendations to the PD(s)/PI(s) regarding their probability for success.
However, applications must not include descriptions of projects that would be supported by DRP funds in the application; DRPs will be proposed, selected and approved after award.
Annual Programmatic Meetings
Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded NAMSED CRCs. Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award.
NAMSED CRC Executive Committee (EC)
A NAMSED CRC Executive Committee (EC) will be established to participate in the review and recommendation of the pilot DRPs from each NAMSED CRC. In addition, the EC will facilitate interaction, collaboration, and communication among the NAMSED CRCs and NIH Program staff. The composition, responsibilities, and meeting/logistical requirements of the EC, whose membership includes the PD(s)/PI(s) from each NAMSED CRC, are detailed in the cooperative agreement terms and conditions of award.
Intellectual Property
The awardee shall be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed to perform the research projects. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the grantee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the research projects.
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 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The NIAID intends to commit $4.5 million in FY 2015 to fund up to 4 awards. Future year amounts may vary depending on annual appropriations. |
Award Budget |
The budget for each NAMSED CRC cannot exceed $1.5 million in total costs per year. Application budgets need to reflect the actual needs of the proposed project. |
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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
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:
L.-Yong Gao, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
6700B Rockledge Dr, Rm 3127
Bethesda, MD 20817
Telephone: 301-443-8115
Fax: 301-480-2408
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core |
12 |
Core |
6 |
Project |
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:
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 and core 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. The PD(s)/PI(s) will oversee, manage and coordinate the research of the NAMSED CRC; ensure that the individual projects and cores are synergized to advance the goals of the Center; be responsible for overseeing the Pilot Developmental Research Projects; and serve as the principal point(s) of contact for the NAMSED CRC.
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: Summarize the overall research plan for the multi-component application. The multi-component application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.
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)
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
Pilot Developmental Research Projects (DRP): Applicants should request funds for pilot DRPs in the Administrative Core budget. Individual DRP awards may not exceed $75,000 direct costs per year and are limited to no more than two years duration, without prior approval from the EC. NAMSED CRCs are limited to no more than two new DRPs per year and the total number of pilot DRPs to be supported during the duration of the award is at the discretion of each NAMSED CRC site. NAMSED CRCs should initiate pilot DRPs within the first year of the award.
Meetings: Applicants should request funds for the Kick-Off Meeting and Annual Programmatic Meeting in the Administrative Core budget. Annual Programmatic Meetings of all NAMSED CRCs funded under this FOA are to start during the second year of award and should be attended by the PD(s)/PI(s), Research Project Leaders, and Core Leaders. These individuals should also budget and plan to attend the kick-off meeting to be held within six months of award. Assume these meetings are held at a location at/near Bethesda, Maryland.
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: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core.
Research Strategy: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:
Management Plan: Include a Management Plan that describes the organization of the proposed Center and its management structure. The Management Plan should include:
The Management Plan should also include a Staffing Plan that describes:
Pilot Developmental Research Project Plan: Describe a DRP Plan that describes procedures for: requesting pilot DRPs; selecting the most promising pilot DRPs; and monitoring success/productivity of the pilot DRPs. However, do not include descriptions of projects that would be supported by DRP funds; these will be proposed, selected and approved after award.
Include the internal institutional plans and procedures to ensure that all pilot DRPs supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines for research involving vertebrate animals and human subjects, including for human subjects the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects.
Human Subject approval dates for pilot DRPs (if applicable) should NOT be submitted with the application, but should be provided to the NIAID for approval with Just-in-Time information (for pilot DRPs that are to start at the time of award), or prior to the start of the pilot DRP, and with annual progress reports.
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 Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Applicants may propose any number of Cores integral to the success of the NAMSED CRC and the proposed Research Projects. However, each Core must be able to support at least two Research Projects. Cores must be well justified and clearly non-duplicative of other services or facilities available to NAMSED CRC investigators. Examples of services that might be provided by a shared scientific core include tissue construct resources and fabrication, microbiota resources, clinical specimen acquisition, and statistical support. Shared microbiology cores could provide a source of patient specimens for clinical research.
SF424 (R&R) Cover (Core (Scientific/Service/Resources))
Complete only the following fields:
PHS 398 Cover Page Supplement (Core (Scientific/Service/Resources))
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Core (Scientific/Service/Resources))
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.
Bibliography & References Cited: Cite experimental details for the Core. These should not be detailed in the Research Strategy.
Facilities & Other Resources: Provide information on resources available for the 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. Describe 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: 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) (Core (Scientific/Service/Resources))
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 (Core (Scientific/Service/Resources))
Budget (Core (Scientific/Service/Resources))
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Core (Scientific/Service/Resources))
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 NAMSED CRC’s goals and how they relate to the individual Research Projects or to other Cores in the application.
Research Strategy: Describe how the proposed Core activities will contribute to meeting the NAMSED CRC's goals and objectives and explain the rationale for selecting the general methods and approaches proposed to accomplish the Specific Aims. Indicate the relevance of the Core to the primary theme of the application. Provide justification for the Core to support at least two of the proposed three or more Research Projects. Applications proposing Shared Resource Cores must give a clear description of the facilities, techniques, and skills that the Core will provide to Research Projects.
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 (Core (Scientific/Service/Resources))
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 (Core (Scientific/Service/Resources))
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Research Projects)
Complete only the following fields:
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.
Bibliography & References Cited: Cite experimental details for the Project. These should not be detailed in the Research Strategy.
Facilities & Other Resources: Provide information on resources available for the project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Equipment: Provide information on equipment available for the project. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment used for working with biohazards or other potentially dangerous substances.
Project /Performance Site Location(s) (Research Projects)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Research Projects)
Budget (Research Projects)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Research Projects)
Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed Research Project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project’s relationship to the NAMSED CRC’s goals and how they relate to other Research Projects or Cores in the application.
Research Strategy: Describe how the proposed project will contribute to meeting the NAMSED CRC’s goals and objectives and explain the rationale for selecting the methods to accomplish the Specific Aims. State the biological significance of the research, and indicate the project's relevance to the primary theme of the application.
Experimental details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new Research Projects must be included.
Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the project.
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.
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.
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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 proposed NAMSED CRC to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).
As applicable for the project proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
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 or core that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), Project Leaders, 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? Does the Project Leader have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct a Research Project? Does he/she have time commitment as well as demonstrated ability to manage this project and establish collaborations? Does the Project Leader have a successful record of collaborations within his/her scientific community and appropriate track record for collaborative activities? Are the proposed key personnel /staff for the project appropriate and do they have the expertise to carry out the work?
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?
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?
Overall Impact Individual Cores
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed).
Review Criteria Individual Cores
Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.
Administrative Core
Scientific Cores
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.
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 human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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
Not Applicable
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
Not Applicable
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 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.
Awardee-selected pilot Developmental Research Projects (DRPs) require prior approval by NIH prior to initiation.
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:
Pilot Developmental Research Projects (DRPs). This will include coordinating the management of all funds to Pilot Developmental Research Projects and interfacing with NIH Grants Management offices and sponsored projects (grants) offices at awardees' institutions. In addition, he/she will provide fiscal oversight of the entire DRP program, and will be the fiscal contact to their NAMSED CRC’s DRP investigators.
Annual Programmatic Meetings. Each Center will assume responsibility for organizing at least one 1 to 2 day Annual Programmatic Meeting of all Centers during the award period. These meetings are to be held at a location at/near Bethesda, Maryland or at another agreed-upon site following consultation with NIAID staff. Each Center should fund travel and attendance at yearly meetings by the PD(s)/PI(s), the Project Leaders and Cores leaders, and other key personnel, who are expected to attend. Costs associated with organizing the Annual Programmatic Meeting are not allowable expenses. Travel and per diem costs to attend the Annual Programmatic Meeting must be included in the budget.
NIAID staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The role of the NIAID Project Scientist (PS) in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).
Additionally, an NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
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]
Melody Mills, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-2876
Email: [email protected]
L.-Yong Gao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-443-8115
Email: [email protected]
Regina Kitsoulis
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-402-6245
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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