EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Cancer Institute(NCI/NIH), (https://www.cancer.gov/) on behalf of the NIH.
U54 Specialized Center- Cooperative Agreements
New
RFA-RM-21-001
RFA-RM-21-002 - U24, Resource Related Research Projects Cooperative Agreements
RFA-RM-21-003 - U24, Resource Related Research Projects Cooperative Agreements
RFA-RM-21-004 - U24, Resource Related Research Projects Cooperative Agreements
RFA-RM-21-005 - UG1, Clinical Research Cooperative Agreements Single Project
RFA-RM-21-006 - U24, Resource Related Research Projects Cooperative Agreements
93.310
The purpose of this FOA is to invite applications for the Artificial Intelligence for Multimodal Data Modeling and Bioinformatics (AIMDMB) Center to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will generate actively learning algorithms to predict human response to different foods, nutrients, food components, and dietary patterns as well as advance understanding, from the individual and population level, of longitudinal dynamics from multimodal data with advanced computer modeling tools (e.g., with in silico human dietary response replicates or user-tailored, high-fidelity models that incorporate demographic, environmental, behavioral, multi-omic, social, cultural, clinical or other data to predict health trajectories).The Center will support the development of robust and artificially intelligent informatics platforms of multimodal, metadata-complete, human data sets from the Nutrition for Precision Health consortium. The proposed Center projects will develop a suite of computational tools to perform data integration, harmonization, analysis and visualization of the multi-modal and multi-fidelity data as well as incorporate an adaptive design for future data incorporation. The proposed Center will be a hub in communicating state of the art for AI-ready' biomedical data to the Nutrition for Precision Health consortium. All Nutrition for Precision Health awardees must work collaboratively to plan and execute a large dietary intervention study to catalyze precision nutrition research in transforming the application of targeted dietary approaches to improve health and reduce chronic diseases. The end products of the Nutrition for Precision Health consortium will be a rich data resource for research use and algorithms to improve the precision of nutrition advice for individuals. The consortium projects will be directly connected with the All of Us Research Program and will enroll existing All of Us participants. All Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. The All of Us Research Program is guided by a set of core values that will also guide the Nutrition for Precision Health consortium.
January 21, 2021
March 5, 2021
30 days prior to the application due date
April 6, 2021
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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
October 2021
December 2021
April 7, 2021
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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of this FOA is to invite applications for the Artificial Intelligence for Multimodal Data Modeling and Bioinformatics (AIMDMB) Center as part of the Nutrition for Precision Health consortium. The overall goals of the AIMDMB Center are to develop comprehensive dietary intervention algorithms that can predict biological responses to a myriad of input data, and to enable adaptive visualization and interrogation of multimodal data with advanced mathematical and computer modeling tools, Examples of such advanced tools and techniques include, but are not limited to in silico human dietary response replicates or digital twins (e.g., user-tailored, high-fidelity models that incorporate environmental, behavioral, multi-omic, social, clinical or other data to predict health trajectories). These tools would be utilized by researchers to understand nutritional perturbations at the individual to population level as well longitudinal dynamics of human health, and subsequent transition to disease, by way of nutritional patterns.
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
Applicants responding to this FOA are expected to familiarize themselves with the five other companion FOAs listed below since the AIMDMB will be expected to communicate, coordinate, and collaborate with the awarded components of these FOAs.
Companion FOAs of the Nutrition for Precision Health Consortium
The set of six companion FOAs and existing All of Us Research Program components will establish the Nutrition for Precision Health consortium.
AIMDMB Center: Artificial Intelligence for Multimodal Data Modeling and Bioinformatics Center
DAC: Dietary Assessment Center
DRC: Data Research Center
NPH: Nutrition for Precision Health
RCC: Research Coordinating Center
Background
Strategic plan for NIH Nutrition Research
The 2020-2030 Strategic Plan for NIH Nutrition Research was released in 2020 and will guide NIH-supported nutrition research over the next decade. The Plan was organized around a unifying vision of precision nutrition research.
Research is needed to provide more precise and dynamic nutritional recommendations than currently possible through population-wide guidance. This in turn will facilitate a deeper understanding of how human biological systems and molecular pathways interact with or mediate the relationships among dietary patterns, environmental, social, and behavioral factors to influence health status. Through advances in -omic technologies and mobile devices combined with the large and diverse participant sample and existing infrastructure of theAll of UsResearch Program, innovations in artificial intelligence, machine learning, computational and mathematical modeling of complex biological systems an unprecedented opportunity exists currently to predict dietary responses and to design targeted dietary interventions aimed at improving health and quality of life.
The goal of the Nutrition for Precision Health, powered by the All of Us Research Program consortium (referred to as Nutrition for Precision Health in this document) is to develop algorithms that predict individual responses to foods and dietary patterns.
Nutrition for Precision Health, powered by the All of Us Research Program
Enrollment: Nutrition for Precision Health will enroll current All of Us participants through targeted enrollment. All of Us participants will not be required to participate in Nutrition for Precision Health, and a participant s decision whether or not to enroll in Nutrition for Precision Health will not affect the participant’s status as an All of Us participant. Nutrition for Precision Health will use a separate enrollment process from the All of Us Research Program, and, in order for a participant to enroll in Nutrition for Precision Health, they must already be enrolled in All of Us.
Data Collection, Generation and Integration: All data from the Nutrition for Precision Health study will ultimately be deposited in the All of Us Researcher Workbench, where it will be integrated with All of Us-collected data, analyzed by Nutrition for Precision Health researchers, and made available for use by the scientific community. Data will be generated and collected by the Clinical Centers, Dietary Assessment Center, Microbiome and Metagenomics Center, and Metabolomics and Clinical Assays Center. These Centers will send raw and processed data to the Research Coordinating Center for further curation and processing. The Research Coordinating Center will coordinate with the All of Us Data and Research Center to deposit the data into the Researcher Workbench. Nutrition for Precision Health investigators, including the AIMDMB Center, will access and work with Nutrition for Precision Health data in the Researcher Workbench. By leveraging existing data collection approaches, metadata standards, APIs, and other tools compatible with the Common Fund Data Ecosystem (CFDE; https://commonfund.nih.gov/dataecosystem), the Nutrition for Precision Health consortium will facilitate interoperability of Nutrition for Precision Health data with other large NIH datasets and interrogation across datasets (e.g., by using the CFDE workspaces), as allowed by data protection status.
Modular Discovery Science: Nutrition for Precision Health is a modular discovery science study.
In all 3 modules, investigators will collect dietary, microbiome, physiological, metabolic, behavioral, cognitive, environmental, social, demographic, cultural, and contextual data, and leverage standard All of Us-collected genomic, electronic health, and survey data to model the impact of diet and dietary patterns on physiological responses.
All Nutrition for Precision Health awardees must work collaboratively to plan and execute a large precision nutrition study that will catalyze precision nutrition research in transforming the application of targeted dietary approaches to improve health and reduce chronic diseases. The product will be predictive algorithms that inform targeted dietary approaches.
This project will be embedded in the All of Us Research Program and will enroll existing All of Us participants. The All of Us Research Program is guided by a set of Core Values that will also guide the Nutrition for Precision Health consortium.
The goal for the field of precision nutrition, a subset of precision medicine, is to provide more precise and dynamic nutritional recommendations than currently possible through population-wide guidance. To advance this field, research is needed to achieve a deeper understanding of the interplay of human biological systems with the wide variety of factors known to underlie interindividual differences in dietary responses. Individual differences in genetics, epigenetics, microbiome ecologies, biology, nutritional status, behaviors, environments, and socioeconomic influences and disparities may influence these interrelationships. Progress in development of new large data sets and advanced methods for mining them offer an opportunity for precision nutrition to advance its goal.
New advances in data science, including approaches to the description, collection, storage, integration, and analysis of large, heterogeneous, structured and unstructured data sets, as well as new computational methods utilized for analysis and prediction probability (e.g., machine learning, deep learning, and artificial intelligence - AI) are expected to transform biomedical and behavioral research and lead to improved health for individuals to populations. These advances offer biomedical research the ability to computationally make predictions based on data (e.g., probability projections of multiple outcome trajectories). For example, AI can be applied to -omic data, imaging data, traditional data collection systems (e.g., electronic medical records, national health systems, surveillance, surveys) and/or other contextual metadata for machine-assisted learning and prediction from diverse, high-content data. AI can be used for both the prerequisite integration of multimodal data as well as for the modeling and predictive output. Most recent progress in AI for biomedical applications has been restricted to well-defined tasks not requiring integration of data across multiple modalities. For example, clinical successes have been achieved for digital pathology and radiomics. Although, the impact of AI for the biomedical sciences has been constrained by the availability of appropriate training and benchmarking datasets (e.g., bias, noise, sample size, sharing/acquisition policies, data complexity, and protected health information/personal identifiable information protection) as the predictive value of the AI-generated models are only as valuable as the input data. This presents a challenge to realizing the primary benefit of AI in the biomedical sciences (e.g., predictive analytics from the totality of medical evidence) as human health, and subsequent transition to disease, occuras a longitudinal set of perturbations over the course of life, requiring context (e.g., diet, past medical history, -omics, laboratory results, health disparities, social and behavioral determinants).
Nutrition for Precision Health aims to overcome past nutrition barriers in order to acquire signatures of human health with respect to nutrition. This begins with the generation of multimodal, metadata-complete, human data sets that exemplify adherence to specific rubrics from a large sub-population of All of Us Research Program participants. Thus, offering appropriate sample size as well as consistent data provenance and quality from both data collection and measurement, these data sets will enable AI-based informatics tools to be trained and ultimately utilized for understanding human health with respect to nutrition, and other elements that play a role, in the transition to disease. Furthermore, a prospective analysis of signatures of health and nutritional intake will enable tools that facilitate more effective decision making by individuals and their nutritional intake.
This FOA invites researchers to submit applications as to the development of robust and artificially intelligent informatics platforms to model and interrogate multimodal, metadata-complete, human data sets from the Nutrition for Precision Health consortium. With the ultimate goal of producing algorithms that predict individual responses to foods and dietary patterns, the proposed AIMDMB Center projects will develop a suite of computational tools to perform data integration, harmonization, analysis and visualization of the multi-modal and multi-fidelity data as well as incorporate an adaptive design for future data incorporation, while within the All of Us Researcher Workbench. The AIMDMB Center will generate actively learning algorithms to predict human biological response to different foods, nutrients, food components, and dietary patterns as well as advance understanding, from the individual and population level, of longitudinal dynamics from multimodal data with advanced mathematical and computer modeling tools (e.g., with in silico human dietary response replicates or user-tailored, high-fidelity models that incorporate environmental, behavioral, multi-omic, social, clinical or other data to predict health trajectories). The proposed AIMDMB Center will be a hub in communicating state of the art for AI-ready' biomedical data (e.g., well-annotated metadata, requisite sample size and data granularity, data provenance, multimodal data dynamics and curation needs) to Nutrition for Precision Health and be a hub of discovery from artificial intelligence for biomedical research excellence.
Research Objectives and Scope
The objective of this FOA is to enable AI-assisted learning, visualization and, ultimately, prediction from diverse, longitudinal data acquired from both non-targeted -omic data (e.g., genomics, epigenomics, proteomics, metabolomics, transcriptomics, metagenomics) as well as other targeted inputs (e.g., continuous or discontinuous metabolic, endocrinologic, physiological, wearable device data, cognitive and behavioral measures, surveys, questionnaires, electronic health records, data from social media apps and, and community/environmental data). Although diversity of data types will be broad, the measurement methods and provenance will be consistent, furthermore, will be acquired from a large sample size representative of the U.S. population. A goal for the Center will be to leverage multidisciplinary approaches and technologies, including advanced computing, predictive computational modeling and AI, to derive new knowledge and generate hypotheses through active learning for precision nutrition.
The scope of this FOA covers data integration, informatics technology, and software development for multimodal data from the Nutrition for Precision Health consortium in the All of Us Researcher Workbench, as well as AI-guided data integration, modeling and prediction. As such, the AIMDMB Center should consist of a set of projects and cores that can synergistically work in tandem and with the Nutrition for Precision Health consortium to deliver both platform technologies as well as scientific discovery from biomedical data. Applicants are required to develop multidisciplinary (e.g., biomedical data science, bioinformatics, clinical/health informatics, biostatistics, machine learning, artificial intelligence, nutrition, -omics, or other biological and physical sciences) expertise and encouraged to have multisector (e.g., public, private, non-profit, or government collaborations) teams to lead and perform the AIMDMB Center research and development efforts. While innovative new solutions are encouraged, so is building upon existing open-source community tools or projects. It is also critical, to maintain flexibility and innovation both in the types of data science research undertaken during the course of this project as well as software engineering approaches that will be adopted. A key consideration is that Nutrition for Precision Health data will be deposited and shared in the All of Us Research Program s Researcher Workbench (https://www.researchallofus.org/workbench/); it is important to pursue technological and computational strategies that enable acceptable and facile data flow with the Researcher Workbench.
Potential Areas of Research
While the specific area(s) the AIMDMB Center application proposes to address will be determined by the applicant, potential topics, especially in the context of the needs for the broader Nutrition for Precision Health consortium, that should be considered include, but are not limited to:
Team Expertise
To address the goals of this FOA, the team of the proposed AIMDMB Center could include, although not limited to, the following group / types of experts:
Expertise in biomedical data science, bioinformatics, clinical / health informatics, and/or machine learning / artificial intelligence;
Expertise in nutrition science, intermediary metabolism, and / or physiology;
Expertise in advanced computational and data analysis approaches (or biostatistics necessary to support data efforts), and software platform development.
AIMDMB Center Structure
Each Artificial Intelligence for Multimodal Data Modeling and Bioinformatics (AIMDMB) Center should contain several interconnected structural/functional units:
Administration and Coordination Core: Given the need for integration of multidisciplinary efforts in the AIMDMB Center, the scientific leadership and other senior members of the team are expected to have considerable experience in collaborative, multidisciplinary research and development relevant to the goals of the AIMDMB. The Center must organize an Administrative and Coordination Core to facilitate effort coordination and support the operation of the Center. This core leads the projects/cores, maintains the organization of the Center (and its external collaborations), and ensures that the projects and cores are being supported to achieve the AIMDMB Center goals. The Administrative Core facilitates and coordinates communication of results, accomplishments, and implications of the AIMDMB Center research to stakeholders, including appropriate NIH staff, the Nutrition for Precision Health consortium's Research Coordinating Center (RCC), Nutrition for Precision Health consortium's Steering Committee, and other stakeholders in a context that makes the research applicable to the target audiences. The Administrative Core has the critical role in assisting project/core leaders in translating their research outcomes and activities to appropriate audiences (including industry partners for applicable commercialization of AIMDMB Center-related innovations); ensuring the accurate and timely use of products and sharing of findings; and advancing appropriate ethical, legal, and social implications of research tied to research projects. This core also has the primary role of initiating partnerships, arranging appropriate subawards, determining and distributing award funds, etc. as partnerships expand over the course of the award. It is anticipated that an iterative cycle of both technological and intellectual development flowing between the AIMDMB and other components of the Nutrition for Precision Health consortium (including components of the All of Us Research Program) will be coordinated by the Administration and Coordination Core of the AIMDMB Center to ensure a continued engagement by all parties and that this will escalate in sophistication over the project period.
Additionally, a key component of the Administrative and Coordination Core must involve a mechanism to provide sub-award support for pilot projects that have significant potential to address developing needs and opportunities while being shorter term and varying throughout the period of award. These pilot projects will allow the AIMDMB Center and the broader Nutrition for Precision Health consortium to take advantage of new directions stimulated by the evolving needs and science. Further, to form new partnerships, provide support to early-stage investigators to undertake data science-related research and innovation in or related to nutritional science, and support relevant cross-consortium projects. For example, these projects could include: optimization of data platforms developed by other Nutrition for Precision Health consortium components, AI grand challenges or 'hackathons' to drive algorithm development, focus on elements that were not originally proposed by AIMDMB Center yet are needed from the evolving nature of the broader consortium, etc. The pilot projects will be initiated by way of the collective decision, as to their focus and needs, from the Nutrition for Precision Health consortium's Steering Committee. It is expected that the AIMDMB Administrative and Coordination Core will establish and manage a solicitation, review, and selection process for collaborative sub-award pilot projects, including the distribution of yearly sub-award funds. AIMDMB Centers are required to fund a minimum of one sub-award project per year and allocate a minimum of $250K per year direct costs, beginning in Year 2 of the research funding cycle.
AIMDMB Research Projects: A set of two to four individual Research Projects are required for each AIMDMB Center. These projects should be synergistic to represent an integrated research program and support the overarching goals for both the Center and the Nutrition for Precision Health consortium. One research project must be solution-oriented through the development or adaptation of a product (software or hardware) or new technology that is needed for the collection of new data within the consortium. Other research projects proposed will be up to the applicants to define relative to the needs outlined above and the investigator-initiated ideas as to how to build the Center for delivering the needs for the Nutrition for Precision Health consortium. Projects should primarily focus on use of data that will be obtained during the Nutrition for Precision Health study and with respect to the Consortium Data Workflow (see below). Research Projects may be supported by optional Shared Resources Core(s).
AIMDMB Data Management and Analysis Core: Data represent important research products and attention is needed to provide for its stewardship and to treat it as an asset. To promote best practices and support NIH data sharing policies (https://grants.nih.gov/policy/sharing.htm), the AIMDMB Center must have one Data Management and Analysis Core (DMAC). The primary purpose of the DMAC is to support the management, integration, and interoperability (as appropriate) of data assets across the Center, including research projects and all pilot projects, and ensuring interoperability and compatibility of APIs and other tools with the Common Fund Data Ecosystem. The DMAC will support management and analysis of both pre-existing data used by the Center and new data produced through the Nutrition for Precision Health consortium, as well as the development of tools for data assessment. Developing creative approaches that foster the development or strengthening of artificial intelligence ready data sets (AI-Ready) is desired. The DMAC should also establish, coordinate, and monitor processes for data analysis and work closely with project (and core) leaders to ensure high data quality throughout the entire lifecycle of the data. The DMAC also has a coordinating role to work with project/core leaders to identify opportunities for integrating Nutrition for Precision Health consortium data with other existing datasets, as appropriate. Importantly, the AIMDMB DMAC will ensure that algorithms are developed and trained from ethical and unbiased data sets (e.g., inclusive of racial and ethnic minorities, geographic area, and other health disparities). It is anticipated that data from the Nutrition for Precision Health consortium study will be collected across a broad cohort that is representative of the U.S. population.
Consortium Data Workflow
It is expected that the platforms, tools, algorithms or other to be developed by an AIMDMB Center will include a distinctive and integrated combination of them, as appropriate to the above objectives and scope. These are anticipated to be built within the framework of the AIMDMB Center with respect to the Nutrition for Precision Health consortium's data workflow.
Nutrition for Precision Health Consortium Formation and Governance
The award(s) funded under this FOA will be a cooperative agreement (s). Close interactions amongst the awardee, awardees from the companion FOAs, awardees from existing All of Us components (Biobank, Data and Research Center, and Participant Technology Systems Center), and NIH staff will be required. Shortly after the award, the PDs/PIs and NIH program staff will form the Nutrition for Precision Health Steering Committee. One PD/PI per award and select NIH staff will be voting members of the Steering Committee. Consortium governance rests with the Steering Committee and is subject to oversight by an NIH Nutrition for Precision Working Group of the NIH Common Fund, which will include NIH representatives from the All of Us Research Program.
The NIH will appoint co-chairs of the Steering Committee from among the Nutrition for Precision Health PDs/PIs. The Steering Committee Co-Chairs will preside at all Steering Committee meetings and serve on an Executive Committee. The Executive Committee will assist as necessary with annual progress reports and appoint and charge members of subcommittees. These subcommittees will facilitate development, implementation, and monitoring of specific Nutrition for Precision Health functions/activities as needed, such as recruitment and retention, participant engagement, biospecimen quality control, and publications and presentations. Representatives from various components of Nutrition for Precision Health consortium will be expected to serve on subcommittees as appropriate according to their expertise.
The Steering Committee will meet in person in Bethesda, Maryland twice during the first year and at least annually thereafter. Monthly teleconferences will be held for the Steering Committee and its subcommittees, and these may be more frequent at times to facilitate planning, etc. The RCC will be responsible for organizing and facilitating the meetings and teleconferences. Applicants should plan to attend an initial planning meeting of the Steering Committee in Bethesda, Maryland, to be held within 4 months of the initial award.
The Steering Committee will have responsibility for developing the overall scientific direction of the program, setting the policies and procedures for the governance of the program, assuring compliance with these program policies and procedures, designing study protocols, implementing studies, ensuring data quality and completeness, planning for analysis and interpretation of data, developing data sharing policies and reporting results in presentations and publications. The Steering Committee must work cooperatively and interactively during the first year to develop the final protocols and the materials necessary to begin the study twelve months after award. The final plan, with a study timeline and milestones, will be submitted for the consideration of the NIH Nutrition for Precision Health Working Group and the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) before the second year of funds will be awarded.
First year planning activities for all consortium components include, but are not limited to:
As the Nutrition for Precision Health study data will begin to be available by the second year, additional planning activities specific to the AIMDMB Center could include:
External Study Monitoring
Four to six External Program Consultants will provide input based on their individual areas of expertise as needed over the course of the program. They will assist the NIH Nutrition for Precision Health Working Group regarding processes and substantive issues that arise during the project and will help ensure that the resources to be delivered by the program are as useful as possible for the end users.
An independent Data and Safety Monitoring Board (DSMB) will be established to monitor and provide recommendations to the NIH regarding participant engagement/enrollment, safety, data quality, and other issues, as appropriate. The DSMB will also review the Steering Committee-approved common protocol, informed consent templates, milestones, and monitoring plans prior to the start of enrollment. A single central Institutional Review Board (IRB) should be used to streamline the protocol approval process and to standardize the monitoring of human subjects protection in Nutrition for Precision Health. The RCC will be responsible for developing and finalizing the Data and Safety Monitoring Plan and for managing DSMB and IRB logistics.
Common Fund Data Ecosystem
The NIH Common Fund (CF) programs are intended to provide resources that accelerate discovery across many different biomedical research fields. These resources include large data sets and associated digital tools needed to mine and analyze the data. To maximize their impact, data sets and tools generated by the CF programs must be usable together. Towards achieving this goal, the Common Fund created the Common Fund Data Ecosystem (CFDE), a data management infrastructure where the interconnected ecosystem facilitates scientific advances by ensuring CF data and digital objects are usable and useful both within a program and in combination with data from other programs. Aims of the CFDE are to enhance the ability to ask scientific questions; enable the uptake, reuse, and addition of data sets generated by the future, current and ended CF programs and support their sustainability; and provide training that maximizes scientists ability to use the CF data sets and tools. The CFDE is composed of a CFDE Coordination Center (CFDE-CC) and the data coordinating centers (DCCs) of the participating CF Programs. CFDE teams will work towards standardizing the data deposition/structuring/handling to make data FAIR, adapting data and metadata standards to enable interoperability, and providing training about the available CF resources to the scientific community.
New CF programs (e.g., Nutrition for Precision Health) are expected to engage in the CFDE from the start. This can be achieved by designing the program components such that they: i) construct a data infrastructure which ensures FAIRness of the data, and ii) adapt the appropriate data and metadata standards to enable interoperability of the generated data with other data sets. The Nutrition for Precision Health Research Coordinating Center will be the primary point of contact with the CFDE. Applicants are expected to discuss their plans for ensuring compatibility with the CFDE and other Common Fund datasets and resources (e.g., via the CFDE portal, Metabolomics Workbench and the MoTrPAC Data Hub) in their application.
Leveraging STRIDES for Cloud Computing Activities
The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and .Sustainability (STRIDES) initiative has established partnerships with commercial cloud service providers (CSPs) Google and Amazon Web Services (AWS) to provide favorable pricing for cloud-based costs. The NIH Common Fund, managed by the Office of Strategic Coordination, is using the STRIDES partnerships to provide in-kind support for CSP costs. For more details, please see NOT-RM-20-009.
IMPORTANT NOTE: Researchers uncertain as to whether their intended framework for a AIMDMBC Center meets the requirements of this FOA are encouraged to contact NCI scientific staff listed in Section VII. Agency Contacts.
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.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials
Need help determining whether you are doing a clinical trial?
The NIH Common Fund intends to commit approximately $2,000,000 in FY2022 and FY2023, and $3,000,000 per year for FY2024 through FY2026. Approximately one award is anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.
For all years, budget must reflect the actual needs of the proposed projects.
A project period of 5 years must be requested.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
In view of the goals for this FOA, applicants should assemble a multi-disciplinary team with expertise in biomedical data science, systems biology, artificial intelligence, and nutrition as well as other biological and physical science expertise, if viewed as necessary to facilitating a successful outcome when preparing the application and as outlined in Section I.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Any individual designated as a PD/PI must not be designated as a PD/PI on another AIMDMB Center application.
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.
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:
Email: nutrprechealth@nih.gov
Available Component Types |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core (use for "Administration and Coordination Core) |
6 |
Core (use for AIMDMB Data Management and Analysis Core and, if any, Shared Resource Core(s)) |
6 |
Project (use for AIMDMB Research 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, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions. with the following modifications:
Project Summary/Abstract: For the Overall Component, applicants must provide overall goals/abstract/summary for the entire AIMDMB Center application. The Project Summary should provide an overall indication of the proposed methods and science as to what is proposed to accomplish. For example, the summary should describe research approaches, data science methodologies, available infrastructure, new data required to answer research questions, technology development, etc. In addition, the summary should highlight aspects of the application that are particularly innovative or paradigm-shifting. The primary activities of the cores should be integrated into the summary. The benefits of the AIMDMB Center (in terms of improving healthcare or public health through data science and innovation) should also be included. Note: the project summary should be written in plain language for a diverse set of reviewers while providing a depth of understanding of the science and activities of the AIMDMB Center application.
Project Narrative: In the "Project Narrative", the relevance of the AIMDMB Center research and platform development to the Nutrition for Precision Health consortium in terms of: nutrition research, biomedical data science, and public health should be stated in lay language.
Facilities & Other Resources: In addition to standard items, describe existing facilities and/or other resources (such as existing institutional shared resource cores) available to the proposed AIMDMB Center. As applicable and pertinent to the proposed research, describe partnerships (e.g., U.S. government agency, private sector, non-profit, or academic shared resource collaborations) that will provide relevant capabilities (e.g., technology development, computational expertise, data access to All of Us Research Program's Researcher Workbench, federated database systems, high performance computing, other clinical study data that would be of relevance to the Nutrition for Precision Health study).
Other Attachments: Include attachment named " Previous Platform or Tools Experience." In the attachment, provide a summary documentation for all members of the Center team (preferably in tabular format) to document:
a) Previously developed or used informatics, AI, and biomedical data modeling platforms, tools or software relevant to nutrition research and/or biomedical data science; and
b) any non-nutrition or biomedical data science related informatics, AI, and biomedical data modeling platforms, tools or software previously developed that will be relevant to, and used by, the proposed Center.
Note: This attachment should be formatted as a cumulative summary of informatics, AI, and biomedical data modeling platforms, tools or software for the entire team arranged by aspects a-b listed above. Indicate the institution of technology originators or users as appropriate (e.g., by a column in a table). Justification of the use or need within the project / Center for these items should be saved for the research plan section.
The following item should be included as attachments under Other Attachments.
Consortium Assurance: The filename "Consortium Assurance.pdf" should be used.
The PD/PI should provide a letter stating his/her willingness to participate in Consortium activities, including sharing the scientific portion of the application, participating in meetings at the NIH and regular conference calls and abiding by approved Consortium policies, following all common elements in the protocol agreed to during the planning phase, providing clinical data to the Research Coordinating Center (RCC) in approved formats, and submitting biospecimens for storage at the All of Us Biobank throughout the study. In the letter, the PD/PI may discuss past experiences participating in multi-center studies.
In addition, the PD/PI and an authorized Institutional Official must provide evidence that the Institution is willing to sign a standard reliance agreement and use the single IRB proposed by the RCC, if required, as part of its application, in accordance with NIH policy on the use of a single Institutional Review Board for multi-site research, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
Biographical Sketch:
List in sub-section D (Research Support) of biosketches for all key personnel any relevant experiences in operating large multidisciplinary research centers, program projects or other large-scale research endeavors.
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.
Applicants who anticipate requiring >$10,000 direct costs in commercial cloud services from either Google or AWS in any one year of the anticipated award are expected to request in-kind support via the Common Fund STRIDES partnerships rather than requesting direct cost support for these services. To request in-kind support for cloud services via STRIDES, applicants must outline the anticipated costs of commercial cloud services in the Budget Justification section, including, but not limited to, data storage, analysis, data movement/egress, professional services, training, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.
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: State concisely the overall vision of the proposed Center. This should not be specific aims of the projects, but should be overarching and at a high level aims / goals / deliverables for the Center. This should highlight the project (and cores or other) and how all components of the Center will work in tandem towards the ultimate goals of both the Center as well as goals of the Nutrition for Precision Health consortium in developing algorithms to predict individual responses to dietary patterns and foods. This should highlight structure and synergy of the Center as well as collaborations to drive both scientific discovery and platform development. This should also highlight any resources that would be leveraged by the Center to amplify the Center impact for the Nutrition for Precision Health consortium beyond the funds awarded.
Research Strategy: The Research Strategy for the Overall component must consist of sub-sections outlined below.
The proposed Center is expected to demonstrate a high level of scientific competence and strong capability for innovation and collaboration. Present the overall vision for the Center, including descriptions of the following:
Center Overview
Significance and Relevance to the Nutrition for Precision Health consortium
Leadership and Center Organization.
Describe how the components of the Center, including key personnel, will interact within the AIMDMB Center, why each is essential for accomplishing the overall Center goals, and how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating results that will be important for the Nutrition for Precision Health consortium as well the broader biomedical data science and biomedical research communities.
Letters of Support: Include letters of support as appropriate.
Resource
Sharing Plan: Individuals are required to comply with the instructions
for the Resource Sharing Plans as provided in the SF424 (R&R) Application
Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan. NIH strives to ensure the dissemination
of research resources developed with NIH Funds. Detailed Resource Sharing Plans
for sharing of intellectual and technological resources is a fundamental aspect
of the Nutrition for Precision Health consortium. Resource Sharing Plans should
be described here and should be presented as summary of data sharing, management
and analysis to be shared. Any proposed sharing plan needs to be consistent
with the All of Us Research Program’s data sharing policies
(https://allofus.nih.gov/about/core-values).
Further, as it is expected that the algorithms, platform technologies, and / or software the Center has developed, will be further validated and improved through the Nutrition for Precision Health consortium's research. Given the high profile of this study, the PD/PI’s tools could become an important resource that other investigators will want to utilize. While the investigators are expected to substantively participate in this research project, the applicants must develop a resource sharing plan inclusive to all Center projects and cores that explains how the developed resource will be made available to the investigator community in the future including the time course for that plan. The sharing plan may include fees for licensing or use of the tools, but may NOT have reach through agreements , for example that require the involvement of particular investigators in research grant applications, percent effort, future co-authorships or other collaboration requirements. The plan should also minimize administrative impediments to academic sharing of research resources.
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
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 Summary/Abstract: Provide overall goals/abstract/summary for the Administrative Core.
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.
Personnel: The budget should include a detailed justification for key personnel. The PD/PI or each of the component leads is expected to devote at least 3 person months of his/her efforts to the U54 Center. Salaries for support positions in the U54 Center are permitted. No overlap of time and effort between the U54 Center and other funded projects is permitted.
Supplies: Consumable supplies related to the operation of the U54 Center such as office materials are permitted.
Service Contracts: Service Contracts for major equipment items are allowed.
Consultants: Consultants and any associated costs are permitted.
Pilot program: Budget for the Administration and Coordination Core is required to fund a minimum of one sub-award project per year and allocate a minimum of $250K per year direct costs, beginning in Year 2 of the research funding cycle.
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: Succinctly describe the list of specific objectives and goals of the Administrative Coordination Core.
Vision Statement of Center Outcomes: This section of the application should entail forward-looking statements about the AIMDMB Center's potential impact beyond the initial award period, addressing all the aspects identified below.
Organizational Structure and Staff Responsibilities:
Plans for Pilot Program Structure and Governance:
Letters of Support: Include letters of support as appropriate.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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 Summary/Abstract: Provide overall goals/abstract/summary for the AIMDMB Research Project.
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: Describe the specific objectives and goals of the AIMDMB Research Project in similar manner as traditional NIH single project applications. The specific aims section should also contain a brief statement about how the project relates with the overall goals of the AIMDMB Center and, as applicable, integration across projects and cores with respect to shared specific aims.
Research Strategy:
This section of the application should address the background and salient approaches and methods in the AIMDMB Research Project with enough detail for critical evaluation of both the quality of the research activities and how they contribute to the AIMDMB Center.
Applicants should highlight the significance of the research project, the expertise of the research team without duplicating information in the biosketches, the innovation of the science, the details of the experimental approach (including a rationale for the methodology), the strengths of the research environment, as well as a description of how the project contributes to the AIMDMB Center. The following subsections are recommended: Significance and Relevance to the Nutrition for Precision Health consortium; Investigators; Innovation; Approach; Environment; and AIMDMB Center Integration. Within the sub-sections, address the following additional aspects of the AIMDMB Research Project:
Research project milestones must be included for each project, defining how the applicants propose to achieve major goals of the project. An associated timeline should be included to provide further information regarding the timeframe of each element associated with each project milestone. These milestones and the timeline should be distinct from the overall AIMDMB Center milestones, albeit aligned, and more granular to address how applicants propose to achieve the specific goals of each research project.
Letters of Support: Include letters of support as appropriate.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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 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 Summary/Abstract: Provide overall goals/abstract/summary for the AIMDMB Data Management and Analysis Core.
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: Describe the specific objectives and goals of the AIMDMB Data Management and Analysis Core (DMAC). The specific aims section should contain brief statement about how the Core integrates with each of the research projects and cores as well as how it helps to achieve the Center's goals.
Research Strategy: This section of the application should address the resource functions of the AIMDMB Data Management and Analysis Core with enough detail for critical evaluation in the context of the AIMDMB Center.
Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach). Additionally, a comprehensive data management plan that describes the specific objectives and goals of the DMAC to support efficient data management and analysis should include plans for coordination with projects and cores, fostering data sharing and interoperability, as well as data quality assurance and quality control plans. It should also outline methods for measures to mitigate bias in datasets as well as the ethical use of them.
Within these sub-sections, address the following additional aspects of the AIMDMB Data Management and Analysis Core:
Letters of Support: Include letters of support as appropriate. This is recommended for all resources to be leveraged by the DMAC.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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 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 Summary/Abstract: Provide overall goals/abstract/summary for the RTB.
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: Describe the specific objectives and goals of the AIMDMB Shared Resource Core. Further, specific aims section should contain a brief statement about how the Core integrates with the rest of the AIMDMB Center.
Research Strategy: This section of the application should address the resource functions of the optional AIMDMB Shared Resource Core with enough detail for critical evaluation in the context of the AIMDMB Center. Applicants must include the description of the Core, services to be rendered, methodological approaches to be used, and plans for prioritizing the use of the Core by AIMDMB Center members. This section must clearly present the facilities, techniques, and professional skills that the core will provide. Innovation, if not overtly inherent, can be addressed by focusing on the mission critical role that the Core plays for the AIMDMB Center and / or the Nutrition for Precision Health consortium. It should also describe how the AIMDMB Center will be more efficient than if the research projects themselves were to provide the functionality or how the Core provides added value beyond that which would be provided by acquisition through fee for service or commercial access agreements.
Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach).
Within these sub-sections, address the following additional aspects of the optional AIMDMB Shared Resource Core:
Explain how the Core's focus / function presents an opportunity to demonstrate and optimize AIMDMB Center development or other;
Describe plans for Core's personnel to work with the AIMDMB Center projects and cores and engage in iterative experimentation and feedback;
Explain the Core's process for evaluating success versus potential failures at different stages of the award period and the role of the Core in addressing, as appropriate, such aspects as the availability of new technologies, software, data infrastructures, or other under development;
Detail the process by which the Core will turn over activities, if applicable to its primary function, to the AIMDMB Center or Nutrition for Precision Health consortium in the iterative cycle between technology development and inquiry; and
Describe plans to coordinate with project/core leaders to identify opportunities for integrating Nutrition for Precision Health consortium data with other existing datasets, as appropriate.
Letters of Support: Include letters of support as appropriate. This is recommended for all resources to be leveraged by the Shared Resource Core.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above and as described in the NIH Intramural Source Book.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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.
For this particular announcement, note the following:
A meritorious AIMDMB Center application is expected to be well-balanced in multidisciplinary science that spans expertise in both biomedical data science technology development, computer modeling, and nutrition research (or corollary expertise across those general fields to drive goals of the AIMDMB Center with impact to the needs of Nutrition for Precision Health consortium). The overarching goal for Nutrition for Precision Health is to overcome past nutrition barriers in health outcomes. This will be implemented by way of a consortium with national impact that is at the forefront of developing the data, processes, and technology to acquire signatures of human health with respect to nutrition. Meritorious applications are anticipated to articulate how the iteration between the AIMDMB Center (and its projects and cores) as well as the broader Nutrition for Precision Health consortium will produce uniquely enabling resources that advance our fundamental understanding of human health with respect to nutrition.
The common study protocol for Nutrition for Precision Health will be developed during the first year of the award and implemented by all Centers beginning in year 2.
The first year will serve as a planning year.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the AIMDMB Center as a whole to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a AIMDMB Center that by its nature is not innovative may be essential to advance a field.
Does the AIMDMB 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 AIMDMB 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: Are the platform technologies, software and computational approaches proposed for development by the AIMDMB Center likely to become an important resource for the Nutrition for Precision Health consortium researchers? In a broad sense, will the work proposed further our understanding of the field of precision nutrition? What is the potential for wider adoption of technical or conceptual innovation developed by the AIMDMB Center in the long-term by the broader biomedical and data science research fields?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the AIMDMB Center? 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: How well does the proposed AIMDMB Center utilize combined expertise in artificial intelligence / computer modeling, bioinformatics platform development and nutrition research? Are the applicant PD(s)/PI(s) recognized as leaders in their respective fields with experience in managing multidisciplinary teams? Are collaborators likely to work together synergistically and enhance the potential impact of the research and activities proposed? Are the applicant PD(s)/PI(s) dedicating sufficient level(s) of effort to the AIMDMB Center?
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: Do the proposed data science-driven approaches lead toward novel solutions for nutritional health barriers or advance understanding of nutrition with respect to Precision Health? Does the application uniquely combine platform technologies, biomedical data science, and nutrition or -omics research in a manner that is 1) enabling for the Nutrition for Precision Health consortium and development of multimodal signatures of health with respect to nutrition, 2)toward novel solutions for nutritional health barriers or advance understanding of nutrition with respect to Precision Health and subsequent disease, and 3) for the broader biomedical research and data science communities?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the AIMDMB Center? Have 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: How well does the application justify the rationale and motivation for selection of the theoretical concepts, technologies, approaches or methodologies, data sets and infrastructure, to address the research challenge(s) that defines the Nutrition for Precision Health consortium? Does the approach have the requisite synergy and structure of projects and cores to have overall additive value versus simply a collection of individual projects to achieve impact, in terms of the Nutrition for Precision Health consortium? Does the approach enable an iterative methodology to amplify new research findings or discoveries from the Center, Nutrition for Precision Health consortium, or external research community further, faster?
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: Does the applicant institution(s) have existing technology development infrastructure, resources, or cores that can be leveraged to complement the proposed AIMDMB Center? Willexisting or proposed external partnerships through foundations or industry extend the resources for the AIMDMB Center? How well does the environment facilitate multidisciplinary relationships and the iterative flow between the AIMDMB Research Projects as well as between DMAC Core and AIMDMB Shared Resource Core(s), if any?
As applicable for the AIMDMB Center 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.
Integration
Will the proposed AIMDMB Center be a truly integrated entity, rather than a collection of unrelated research projects and support services? Does the proposed AIMDMB Center address the need and the methodology to deliver a suite of computational tools to perform data integration, harmonization, analysis and visualization of the multi-modal and multi-fidelity data as well as incorporate an adaptive design for future data incorporation? Does the proposed AIMDMB Center address the need and the methodology to deliver comprehensive dietary intervention algorithms that can predict biological responses, available energy, and individual health trajectories from multiple types of input data by way of Nutrition for Precision Health study and / or other available data sets? Does the proposed AIMDMB Center address the need and the methodology to deliver adaptive, predictive algorithms and visualization software / tools for interrogation of Nutrition for Precision Health study, retrospective, or future prospective data for the broader biomedical research community? How well does the AIMDMB Center organization promote scientific, technical, and administrative integration, synergy and a cohesive research program? Does the application include overall Center performance-based milestones addressing how the key goals of the AIMDMB Center will be achieved as well as timeline for interactions of project and core milestones across the center? Does the applicant adequately describe plans to collaborate and share models, software, and other resources within the AIMDMB Center and across the Nutrition for Precision Health consortium? Do the proposed components require a Center-based research structure for success?
Consortium Activities
Have the investigators stated their willingness to collaborate with NIH scientists and staff, and with investigators and staff from other components of the Nutrition for Precision Health consortium, including the All of Us Research Program? Have the investigators stated a willingness to participate in planning the study and to use common protocols? Have the investigators agreed to uphold to the All of Us Research Program Core Values (https://allofus.nih.gov/about/core-values) and Privacy and Trust Principles (https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles)?
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. The AIMDMB Research Project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a AIMDMB Research Project that by its nature is not innovative may be essential to advance a field.
Impact Score
Significance
Investigator(s)
Innovation
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the AIMDMB Research Project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the AIMDMB Research 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? Is a process to pursue alternative approaches to solving technological problems in development of the methods or technologies, if the main conceptual thrust should prove unfeasible within the AIMDMB Center reasonable? 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?
Environment
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.
When the proposed unit 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the AIMDMB Center 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.
Not Applicable
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIH Center for Scientific Review, 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 Cancer Advisory Board. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 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.
1. Primary responsibilities of the PD(s)/PI(s)
The PD(s)/PI(s) will have the primary responsibility for:
2. NIH Staff Involvement
Definitions
For each individual award, NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH will designate program staff, including a Program Officer and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer and Grants Management Specialist will be named in the Notice of Grant Award.
3. Areas of Joint Responsibility
Close interaction among the participating investigators will be required, as well as significant involvement from the NIH during each phase of the program. The awardees, the PSs, and other designated NIH Staff will participate in the annual in-person investigator meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. EPCs will attend the annual in person meetings. Other government staff may also attend the annual investigators meetings.
The SC will serve as the main scientific body of the consortium, with the following roles:
The SC may set up subcommittees as needed to address particular issues. These subcommittees will include representatives from the Nutrition for Precision Health projects, NIH staff and possibly other experts. The SC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees. The SC is responsible for recording and archiving decisions made, and for assessing the advice of subcommittees in a methodical manner. It is anticipated that multiple subcommittees may need to be formed to address important topics, including but not limited to policies, communications and engagement, recruitment and retention, publications and presentations, and data quality and completeness.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final 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.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions 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: http://grants.nih.gov/support/ (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: 301-945-7573
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Christopher M Hartshorn, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3315
Email: hartshorncm@mail.nih.gov
Jacinta Bronte-Tinkew, Ph.D.
Center for Scientific Review (CSR)
301-806-0009
brontetinkewjm@mail.nih.gov
Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: Dawn.Mitchum@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.