EXPIRED
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
U19 Research Program Cooperative Agreements
NOT-OD-22-189 -Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-195 -New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for a Genomic Centers for Infectious Disease (GCID) Program. This renewal initiative will support GCIDs to advance the development and use of innovative genomic and bioinformatics tools with an emphasis on human pathogens and their interactions with the host and microbiome, and to rapidly respond to emerging needs, especially during disease outbreaks. The Program will address basic, translational, and clinically relevant questions in host-pathogen interactions and support the development of genomics-based tools to diagnose, prevent, and treat infectious diseases. In the event of an infectious disease outbreak, the GCIDs will be poised to leverage the expertise and resources within the network to assist in a coordinated research response.
30 days prior to the application due date
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
June 02, 2023 | June 02, 2023 | Not Applicable | November 2023 | January 2024 | April 2024 |
All applications are due 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.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for a Genomic Centers for Infectious Disease (GCID) Program. This renewal initiative will support GCIDs to advance the development and use of innovative genomic and bioinformatics tools with an emphasis on human pathogens and their interactions with the host and microbiome, and to rapidly respond to emerging needs, especially during disease outbreaks. The GCID Program will address basic, translational, and clinically relevant questions in host-pathogen interactions and support the development of genomics-based tools to diagnose, prevent, and treat infectious diseases. In the event of an infectious disease outbreak, the GCIDs will be poised to leverage the expertise and resources within the network to assist in a coordinated research response.
High-throughput genomic and transcriptomic sequencing is frequently used to answer infectious disease questions. For example, genomic sequencing enabled SARS-CoV-2 diagnosis and viral variant detection, and millions of viral genome sequences have been generated and shared publicly during the pandemic. Sequencing was instrumental to advancing our knowledge about SARS-CoV-2 evolution, the development of drug resistance, antibody evasion, and viral transmission during localized outbreaks. Sequencing is also critical for the diagnosis and management of infections, including those caused by antimicrobial-resistant bacteria, fungi, and parasites. It further advances our understanding of pathogen biology, pathogenesis, and interactions with the host, including the microbiome.
The NIAID GCID Program was established in 2004 to apply and promote genomics to address important scientific questions and knowledge gaps in infectious diseases, to increase the number of pathogen genome sequences and gold standards in public databases, and to develop and advance the necessary tools for genomic data analysis. Since then, the GCID Program has made key contributions to technological advances, including the development of improved laboratory protocols, tools, and platforms to effectively process challenging samples. The GCIDs have also been developers and early adopters of novel and emerging approaches, including synthetic biology, microbiome analyses, metagenomics, CRISPR-based approaches, and cloud computing. In addition to technology development, the GCID Program has a long history of supporting NIAID's priority pathogen research and emergency responses, including those to anthrax, influenza, Zika and Ebola virus, and SARS-CoV-2, among others. The GCID are arranged into scientific projects that focus on different pathogens groups (i.e., viruses, bacteria, fungi, and parasites, with the inclusion of their vectors, as applicable) that are supported by a technology and data core to drive innovation in genomics across domains and to ensure rapid sharing of high-quality data. Current projects supported by the GCID Program are listed at https://www.niaid.nih.gov/research/genomic-centers-infectious-diseases.
Although substantial progress in sequencing technologies has resulted in routine use of sequencing in many research, clinical, and public health settings, significant obstacles in both clinical and research settings continue to hinder the broad use of large scale genomics for all infectious diseases, including in the areas of diagnostics, therapeutics, microbial-host interactions, and functional genomics. These obstacles include but are not limited to (1) the still relatively high cost of end-to-end workflows from sample isolation to receiving actionable results, (2) the requirement of expert personnel to perform multi-step laboratory and data analysis workflows, and (3) technological and bioinformatic challenges that limit fast and high-throughput sample processing, data analysis and integration, and the sharing of the large amounts of generated and complex data.
This renewal builds on the GCID Program’s rich history and will continue to apply innovative and large-scale genomics technologies and bioinformatics analysis tools to address these challenges. Such efforts will provide state-of-the art technologies and advance our understanding of key areas in infectious diseases, including for epidemic and pandemic threats and emerging pathogens. The renewed Program will also continue to support NIAID's efforts to understand and respond to high-priority, emerging and continuing infectious disease threats.
Research Objectives and Scope
The purpose of the GCID Program is to devise genome-scale methods to develop cutting-edge technologies and critical computational tools; develop methods and protocols to successfully use high-throughput sequencing and genomic technologies to study infectious diseases including host-pathogen-microbiome interactions; and advance genomics in clinical and basic research for different pathogens, including those with more complex genomes, and emerging pathogens during epidemic and pandemic disease outbreaks.
It is expected that embedded in an overall theme, GCID research approaches will develop, use, and improve high-throughput sequencing and related genomic technologies such as transcriptomics and metagenomics of microorganisms, vectors and hosts, and host microbiomes to address knowledge gaps. The approaches should be innovative and provide rapid and cost-efficient production of high-quality sequences. It is further expected that projects will incorporate emerging genomic technologies into all areas of the program. The scope of the research is both basic and translational, and the use of clinical samples already at hand or retrieved through collaborations is encouraged.
Overall themes and research areas could include, but are not limited to:
Applications including the following types of studies will be considered non-responsive and will not be reviewed:
Pathogens: Scientific projects can address a wide variety of pathogens and are encouraged to include microorganisms from NIAID’s List of Emerging Infectious Diseases and NIAID’s recently identified Prototype Pathogens. Projects should propose sequencing of multiple strains and/or isolates of specific species, populations, and/or communities rather than sequencing of individual microorganisms or vectors.
Pandemics, Epidemics, and Outbreak Responses: It is expected that the GCIDs will continue to support epidemic and pandemic infectious disease outbreak responses and emerging infectious diseases by leveraging available expertise and resources. This can be accomplished through Emergency Response or Collaborative Pilot Projects, as outlined under the Administrative Core and Research Projects.
Data and Resource Sharing: A primary objective of the GCID Program is to stimulate rapid progress in infectious disease genomics, with data and resource sharing being an essential part of this process. NIAID expects that all products and data of the GCID Program will become available to the community throughout the duration of the award to enhance reproducibility of research results and secondary use, as appropriate and consistent with achieving the goals of the GCID Program.
Scientific and Fiscal Flexibility (for Emergency Responses only): For Emergency Responses, a GCID has the authority to re-prioritize and re-allocate some resources/funds according to GCID operating policies and procedures proposed in the application and in consultation with NIAID, as long as these changes are within the scope of the award's scientific priorities and the structure and minimum number of components of the GCID are maintained.
The Program shall consist of an Administrative Core; 4 Research Projects each addressing a different pathogen group (viruses, bacteria, fungi, and parasites, including their vectors, as applicable); one Technology and Data Core, and up to 1 Optional Scientific Core. The Technology and Data Core shall support all Research Projects. Applications that do not have the required components are considered incomplete and will be withdrawn.
Administrative Core: Each GCID must include an Administrative Core, headed by the Contact PD/PI, that will be responsible for Center activities, including but not limited to: supervising, managing, coordinating, and monitoring Center progress, activities, milestones and timelines; overseeing the Project Management and Staffing Plan, including scientific and fiscal flexibility considerations; overseeing the Data Management and Sharing Plan; administering and overseeing Collaborative Pilot and Emergency Response Projects and the implementation of the Plan for Enhancing Diverse Perspectives; and communicating with NIAID staff.
Collaborative Pilot Projects (CPPs): This FOA supports Collaborative Pilot Projects for small-scale studies in areas of shared scientific or technological interest between the funded GCIDs, and of benefit to the broader scientific community. The projects will be identified by the Administrative Core with input from the Administrative Core Leader and with NIAID consultation.
Emergency Response Projects (ERPs): This FOA supports Emergency Response Projects to develop critical genomics-based technological tools, methods, and studies that advance our understanding of pathogens during pandemic and epidemic outbreaks. Similar to the CPPs, the projects will be identified by the Administrative Core and its leaders, with NIAID consultation.
Plan for Enhancing Diverse Perspectives (PEDP): This initiative requires a Plan for Enhancing Diverse Perspectives submitted as attachment (see Section IV). The Administrative Core will oversee and ensure implementation of the Center's PEDP.
Technology and Data Core: Each GCID must include a single Technology and Data Core. The Core will support research and development to offer innovative genomic and data technologies as a shared resource to all research projects. The Core synergizes with the Research Projects to 1) develop innovative genome and related sequencing technologies and approaches, including large-scale high-throughput sequencing, transcriptomics and metagenomics; 2) provide data analysis and management capabilities and support, including innovative bioinformatics, computational and data visualization and integration approaches; and 3) efficiently and rapidly disseminate generated data, analysis tools, reagents, and other resources generated to the broader scientific community via open-domain repositories and knowledgebases in adherence to the requirements and timelines described in the NIH Guidelines (https://sharing.nih.gov/).
Optional Scientific Core: Each GCID may include a maximum of 1 Optional Scientific Core to support resources and/or facilities that are essential for the activities of two or more Research Projects, but inclusion of Scientific Cores is not required. Optional Cores must be well justified and provide support to at least 2 Research Projects.
Research Projects: Each application must propose 4 Research Projects, each addressing a different human pathogen group centered around the theme of viruses, bacteria, fungi, and parasites and vectors. Applicants are encouraged to incorporate pathogens in the NIAID priority pathogens list and Prototype Pathogens, as well as microbiome analysis where appropriate and relevant. Research Projects are expected to incorporate state-of-the-art technologies and approaches and use a combination of genomic sequencing, functional genomics, and bioinformatics analyses to understand infectious diseases. It is further expected that during pathogen outbreaks, the relevant research project is prepared to undertake Emergency Response Projects to support NIAID's infectious disease response and to advance knowledge about emerging pathogens.
Programmatic Meetings and Annual Site Visits
An initial Program kick-off and annual programmatic meetings will be held to establish the major roles and function of the Program and to facilitate communication and collaboration among funded GCIDs. The annual meetings will report progress, seek new research directions and ideas, provide opportunity for collaboration, and update NIAID on issues of need. The meetings will be virtual (in years 2, 4, and 5) and in-person (in year 3 in Rockville, MD), and the meeting organization is expected to rotate between each of the GCIDs. NIAID will organize the kick-off and year 3 meetings.
Annual site visits will be used by NIAID program staff to review and discuss progress; problems and obstacles and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans.
Plan for Enhancing Diverse Perspectives (PEDP)
This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.
The GCID Program aims to continue to contribute to the training and development of the next generation of scientists and future leaders in the areas of pathogen genomics, technological development, and bioinformatics to enhance infectious disease and host-pathogen research. As such, the PEDP should also extend to any proposed training goals of the GCID.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIAID intends to commit $9.24 million in 2024 to fund 2-3 awards.
Application budgets are not expected to exceed $2.85 million in direct costs per year, which includes up to $50,000 in direct costs for one Collaborative Pilot Project per year. Application budgets need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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
Local Governments
Federal Governments
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.
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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
Maryam Feili-Hariri, Ph.D.
Telephone: 240-669-5026
Email: haririmf@niaid.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
---|---|---|---|---|---|
Overall | Overall | 12 | Required | 1 | 1 |
Admin Core | Admin Core | 12 | Required | 1 | 1 |
Technology and Data Core | Core | 12 | Required | 1 | 1 |
Scientific Core | FOA Specific | 6 | Optional | 0 | 1 |
Project | Project | 12 | Required | 4 | 4 |
Instructions for the Submission of Multi-Component Applications
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
Overall Component
When preparing your application, 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.
Follow standard instructions, with the following additional instructions:
Other Attachments:
Plan for Enhancing Diverse Perspectives (PEDP)
In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.
Project/Performance Site Locations (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 and Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
PEDP implementation costs:
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed Program. Describe the hypothesis or hypotheses to be tested.
Research Strategy:
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Overall)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form (Overall)
All instructions in the SF424 (R&R) Application Guide must be followed.
When preparing your application, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
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 for the following:
Management and Staffing Plan
The Management and Staffing plan should include:
Collaborative Pilot Project Plan
The Collaborative Pilot Project Plans should include:
Emergency Response Project Plan
The Emergency Response Project Plan would be executed only in the case of a Public Health Emergency that requires a rapid research response. The plan should include:
Note: The CPP and ERP sections should only include information about the establishment and management of the projects and should not include any CPP or ERP proposed research projects.
Milestones and Timelines
A section of the Administrative Core entitled Milestones and Timelines should be provided. The section should include milestones and timelines and a plan describing how they will be met, addressing all Research Project and Core activities.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Appendix:
Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Informationform or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
When preparing your application, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Note: Investigators can request funds toward data management and sharing in the budget and budget justification sections of their applications as part of the Data Sharing and Management Plan.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Describe the broad, long-range objectives and goals of the proposed Technology and Data Core.
Research Strategy: Describe plans and procedures for establishing and effectively managing a Technology and Data Core, including the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed
When preparing your application, use Component Type FOA Specific.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Scientific Core.
Research Strategy: Provide details of the services or resources provided by the scientific core to support at least two Research Projects, and how the core is relevant to the primary theme of the application.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed
When preparing your application, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Note: Do not budget for costs associated with prospective human sample collection. If samples for the proposed studies are to be provided from an independently funded clinical research project, you may include the following costs: costs for preparation and shipping.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Describe the broad objectives and goals of the proposed Research Project. Concisely and realistically describe the hypothesis or hypotheses to be tested. State the Projects relationship to the Center’s goals and how they relate to the other Research Projects and the Cores.
Research Strategy: Preliminary studies for projects should be included as part of the Approach section, and include the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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 Genomic Center for Infectious Disease 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 Genomic Center proposed)
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Center 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?
Specific to this FOA:
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
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?
Specific to this FOA:
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the Center 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
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?
Specific to this FOA:
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the research project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below, as appropriate for the individual project, in the determination of merit and will give an overall impact score for each project but will not give separate scores for each criterion.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core activities to meet the needs of individual Research Projects or other Cores, and to contribute to Center goals and objectives, in consideration of the following points (as applicable to the Core proposed).
Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score but will not give separate scores for these items.
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 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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:
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Collaborative pilot and emergency response projects require prior approval by NIH prior to initiation.
For any Collaborative Pilot or Emergency Response Project, the recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH Human Subjects Research policies.
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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Part 75 and 2 CFR Part 200, and other DHHS, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Program Generated Data, Software and Other Resources
Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
Program-generated data and software include, for example:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Additionally, a NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
The NIAID Project Scientist will provide overall coordination across all funded GCIDs, will coordinate with the PD(s)/PI(s), and will hold regular GCID Program-wide discussions to facilitate the achievement of GCID Program goals. In the event that some members of the GCID Program develop common research interests working groups may be formed to pursue collaborative activities.
In addition, PD(s)/PI(s), Research Project and Core Leaders and the NIAID Project Scientist will discuss potential projects to be funded through the Collaborative Pilot and Emergency Response Project Program.
Bimonthly Teleconferences
These teleconferences will be held to discuss progress, problems, proposed solutions and any matter that is relevant to the scientific and financial administration of the Center and future activities. The schedule for those meetings will be established by the PD(s)/PI(s) and the NIAID Project Scientist.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between 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 Steering 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 recipient. This special dispute resolution procedure does not alter the recipient'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.
3. Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Inka Sastalla, Ph.D.
National Institute for Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6431
Email: inka.sastalla@nih.gov
Maryam Feili-Hariri, Ph.D.
National Institute for Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5026
Email: haririmf@niaid.nih.gov
Annie Grimes
National Institute for Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7315
Email: Annie.grimes@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.