Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov) on behalf of the NIH.

Funding Opportunity Title
Nutrition for Precision Health, powered by the All of Us Research Program: Clinical Centers (UG1 Clinical Trial Required)
Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type
New
Related Notices
  • January 25, 2021 - Notice of Pre-Application Webinar for the Common Fund’s Nutrition for Precision Health Program RFAs. See Notice NOT-RM-21-013.
Funding Opportunity Announcement (FOA) Number
RFA-RM-21-005
Companion Funding Opportunity
RFA-RM-21-001 , U54 Specialized Center (Cooperative Agreements)
RFA-RM-21-002 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-RM-21-003 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-RM-21-004 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-RM-21-006 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

The purpose of this FOA is to invite applications for Clinical Centers (CC)s to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will support CCs to recruit participants and implement complex, modular protocols for dietary interventions studies. The CCs selected will work collaboratively with each other and other participating components of the Nutrition for Precision Health consortium to develop and implement study protocols. It is anticipated that all participants enrolled by the CCs into the Nutrition for Precision Health dietary studies will be part of the All of Us Research Program, and all Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. 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.

Key Dates

Posted Date
January 21, 2021
Open Date (Earliest Submission Date)
March 05, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
April 06, 2021 Not Applicable Not Applicable June 2021 October 2021 December 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.

Expiration Date
April 07, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to invite applications for Clinical Centers (CC)s to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will support CCs to enroll participants and implement complex, modular protocols for dietary interventions studies. The CCs selected will work collaboratively with each other and other participating components of the Nutrition for Precision Health consortium to develop and implement study protocols. It is anticipated that all participants enrolled by the CCs into the Nutrition for Precision Health dietary studies will be part of the All of Us Research Program, and all Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. 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.

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 CCs will be expected to communicate, coordinate, and collaborate with the awarded components of these FOAs.

Companion FOAs of the Nutrition for Precision Health Consortium

  • RFA-RM-21-001: Nutrition for Precision Health, powered by the All of Us Research Program: Artificial Intelligence for Multimodal Data Modeling and Bioinformatics Center (U54 Clinical Trial Not Allowed). An Artificial Intelligence, Multimodal Data Modeling, and Bioinformatics Center will develop comprehensive dietary intervention algorithms that can predict biological responses.
  • RFA-RM-21-002: Nutrition for Precision Health, powered by the All of Us Research Program: Metabolomics and Clinical Assay Center (U24 Clinical Trial Not Allowed). A Metabolomics and Clinical Assays Center will perform metabolomics analyses and other clinical assays on biospecimens.
  • RFA-RM-21-003: Nutrition for Precision Health, powered by the All of Us Research Program: Microbiome and Metagenomics Center (U24 Clinical Trial Not Allowed). A Microbiome and Metagenomics Center will perform microbiome, metagenomics and metatranscriptomics analyses on stool samples for all participants.
  • RFA-RM-21-004: Nutrition for Precision Health, powered by the All of Us Research Program: Dietary Assessment Center (U24 Clinical Trial Optional). A Dietary Assessment Center will support the application of innovative approaches to assess dietary intake.
  • RFA-RM-21-006: Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center (U24 Clinical Trial Not Allowed). The Overall study coordination and data management (this FOA) will be provided by a Research Coordinating Center (RCC).

The set of six companion FOAs and existing All of Us Research Program components will establish the Nutrition for Precision Health consortium.

Background

Strategic plan for NIH Nutrition Research

The 2020-2030 Strategic Plan for NIH Nutrition Research (https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/strategic-plan-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 the All of Us Research 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 - Primary Aims

Enrollment: Nutrition for Precision Health will enroll All of Us participants through targeted enrollment. Participation in Nutrition for Precision Health is voluntary, 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 consent 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. All All of Us participants are currently adults and therefore it is expected that all Nutrition for Precision Health participants will be adults.

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 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 transfer 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 Artificial Intelligence, Multimodal Data Modeling, and Bioinformatics Center, will access 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.

Module 1 will follow approximately 10,000 participants for up to 14 days to examine baseline diet and physiological responses to the test meal challenge. Module 1 is anticipated to consist of two clinic visits approximately two weeks apart, with remote data collection during the study period.

Module 2 is expected to be a free-living controlled feeding study that will examine responses to three short-term (~14 days) intervention diets in approximately 1,500-2,000 Module 1 participants. Additionally, after each intervention diet, physiological responses to the test meal will be assessed.

Module 3 is expected to be a domiciled controlled feeding study that will examine responses to the same three short-term (~14 days) intervention diets in approximately 500-1,000 participants from Module 1. Additionally, after each intervention diet, physiological responses to the test meal will be assessed.

In all 3 modules, investigators will collect dietary, microbiome, physiological, metabolic, behavioral, cognitive, environmental, 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.

Collaborative Aspect of the All of Us Research Program

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 All of Us participants. The All of Us Research Program is guided by a set of Core Values (https://allofus.nih.gov/about/core-values) that will also guide the Nutrition for Precision Health consortium.

Research Objectives and Requirements of this FOA: Clinical Centers (CC)s

Applicants responding to the CCs FOA are expected to familiarize themselves with the companion FOAs and the structure and functioning of the Nutrition for Precision Health Consortium outlined in the background section.

Timeline for the CCs: The first year of the Program represents an initial planning and coordination phase followed by a subsequent four-year implementation phase. During the planning phase, it is expected that the Program will reach consensus on plans for the implementation phase.

Functions of the CCs:

  • Implement modular dietary intervention protocols from the common study protocol, which will be developed during the first year. All CCs are expected to participate in Module 1 and at least one other module (see above). Participation in Module 2 will likely require access to a metabolic kitchen, and participation in Module 3 will additionally require access to a domiciled feeding center.
  • Participate in the development of the common study protocol(s) and manual of procedures agreed upon by the Nutrition for Precision Health consortium during the planning year including training study staff to enroll participants and implement the protocols. The CCs will implement a single mixed-meal test challenge that will be implemented in Modules 1, 2 and 3. Additionally, in Modules 2 and 3, CCs will implement three specific, isocaloric dietary interventions that are meaningfully different from each other and which would be expected to elicit different and measurable responses over an approximately two week intervention period. It is expected that the consortium, including the CCs, will make the final decision on which dietary interventions and measures will ultimately be deployed across the consortium.
  • Where geographically feasible, work with All of Us Health Care Provider Organizations (HPOs) to engage and enroll participants from the All of Us cohort to participate in the Nutrition for Precision Health study. If necessary, assist prospective participants with enrollment to All of Us prior to enrollment in Nutrition for Precision Health. CCs may propose collaborations with other institutions as needed to enhance research expertise, enrollment capacity, and diversity of participants to adhere to All of Us Research Program overall enrollment expectations (https://allofus.nih.gov/about/diversity-and-inclusion). Important to the Nutrition for Precision Health goals, participants in modules 1-3 should reflect the diversity of the United States population.
  • Where it is not geographically feasible to partner with an existing All of Us HPO, CCs will implement the All of Us enrollment protocol (https://allofus.nih.gov/about/all-us-research-program-protocol) for new All of Us participants, including collection of participant-provided information, physical measurements, and biospecimens, and linking electronic health records. This will require regulatory onboarding steps including executing a reliance agreement, AOU IRB approval, and an interconnection security agreement to share EHRs and implement the protocol.
  • Participate in a cooperative manner with other CCs, the Nutrition for Precision Health consortium, the All of Us Research Program, and NIH staff in all aspects of research, including but not limited to, protocol development, implementation, and data sharing. CCs should adequately support and oversee project management, personnel provision, space allocation, procurement, and equipment.
  • Collect data, biospecimens and other measures as agreed upon in the common study protocol. Sites will also be expected to process, temporarily store, and transfer biospecimens as determined by the Nutrition for Precision Health consortium. This will include facilitation of collection of dietary assessment measures and doubly labeled water protocols (Module 3) at the direction of the Dietary Assessment Center, aliquoting biospecimens at the direction of the consortium, and collecting additional measures (continuous glucose monitoring, mobile assessments, physical activity, behavioral and psychosocial measures, etc.). The CC’s will transfer data to the Nutrition for Precision Health Research Coordinating Center and will ultimately be accessible to the CCs and the scientific community via the All of Us Researcher Workbench. Biospecimens will be shipped to the All of Us Biobank by CCs.
  • Have infrastructure in place for communication and monitoring of adherence to the protocol(s) and ancillary health issues potentially impacted by protocol implementation.
  • Serve as members of the Nutrition for Precision Health Steering Committee, participate in Steering Committee and relevant sub-committee meetings, and attend annual in-person consortium meetings.
  • Enter into an agreement with the Nutrition for Precision Health Research Coordinating Center and to cooperate with the policy for capitation of participant compensation (e.g., incentives) via the Nutrition for Precision Health Research Coordinating Center. After the initial planning year, when the study begins, CCs can expect to receive per participant capitation of participant compensation from the Nutrition for Precision Health Research Coordinating Center per these agreements.
  • Comply with the NIH and All of Us Research Program Privacy and Trust Principles (https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles).
  • Uphold the All of Us Research Program Core Values (https://allofus.nih.gov/about/core-values).
     

Formation and Governance of the Nutrition for Precision Health Consortium

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. Consortium governance rests with the Steering Committee and is subject to oversight by a trans-NIH Nutrition for Precision Health 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 consortium, setting the policies and procedures for the governance of the consortium, assuring compliance with these consortium 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 awards are issued. The final plan, with a study timeline and milestones, will be submitted for the consideration by 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:
  • Developing consortium committees, policies, and procedures for the smooth governance of the SC;
  • Developing a detailed plan for enrollment of participants according to All of Us diversity goals;
  • Developing protocols and plans for the assessment of physiologic, metabolic, behavioral, environmental, contextual, dietary, and other phenotyping of participants;
  • Developing a plan to support study participants, clinical staff, and other study staff by facilitating and developing training materials and videos and providing staffing for help lines (staffed by dietitians) related to mobile technologies and dietary assessment;
  • Standardizing measures and surveys;
  • Refining inclusion/exclusion criteria and sample size;
  • Determining numbers and timing of biospecimen collection from participants;
  • Overseeing plans to address the various bio-ethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings) that are likely to arise during the conduct of the research;
  • Obtaining approvals as needed at the consortium Site institutions, such as Institutional Review Board (IRB) approval;
  • Preparing a Manual of Operations with primary responsibility residing with the RCC;
  • Developing a detailed plan for storage and shipping of all biospecimens;
  • Developing detailed plans for the thorough analysis of biospecimens collected in the Clinical Centers, including metagenomics, meta-transcriptomics, and metabolomics. This includes deciding which tissues will be analyzed by each method and adjusting these decisions as results and technologies become available;?
  • Planning for data standards, anonymization, assembly, curation, provenance, access, analysis, and storage;
  • Planning for deposition of data into the All of Us Researcher Workbench to ensure data access by the broader scientific community;
  • Planning for return of results to All of Us participants; and
  • Developing a detailed timeline with concrete milestones for the entire study.
     

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, per regulations at 45CFR 46.11, 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 educating the scientific community about available CF resources. 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 educational opportunities 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.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
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.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH Common Fund intends to commit approximately $7,000,000 in FY2022, and $9,500,000 per year for FY2023 through FY2026.

Approximately five-six awards are anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

Award Budget

Application budgets must reflect the actual needs of the proposed project. It is anticipated projects proposing to participate in all three study modules and/or with higher participant capacities may require higher budgets than other applications.

Award Project Period

The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

Eligible Agencies of the Federal Government, including the NIH Intramural Program

Foreign Institutions

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. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PI/PD(s) must possess a doctoral degree in a relevant field such as nutrition, medicine or physiology. The PD/PI(s) must have experience in leading large dietary intervention studies, multi-site clinical trials and recruiting diverse populations. Active participation of the PD/PI(s) is expected during all phases of a clinical research study.

One individual must be designated as an Alternate PD/PI(s), who is able to serve in the absence of the PD/PI(s). The alternate PD/PI(s) must also possess a doctoral degree in a relevant field such as nutrition, medicine, or physiology.

Together, the CC PD/PI(s) and staff should consist of a team of professionals with relevant expertise that may include (as appropriate), but is not limited to: nutritional scientists, biostatisticians, bioinformaticians, dietitians, physicians, as well as experts in study design and implementation. It is required than an All of Us Research Program Investigator (https://allofus.nih.gov/funding-and-program-partners/health-care-provider-organizations) and a Registered Dietitian be part of the research team, and applicants are encouraged to involve Early Stage Investigators as part of the research team, as appropriate. Together, the CC PD/PI(s) and staff should have the following minimum qualifications in terms of experience and expertise in:

  • Planning, developing, and executing dietary intervention studies
  • Functioning as part of large, multi-site clinical trials.
  • A broad range of clinical trial study design and statistical expertise, particularly with nutrition-related research.
  • Project management and knowledge of workflow and research team practices in implementation of clinical trials.
  • Enrollment and retention of a diverse population of participants.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:


Email: nutrprechealth@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources

The application must contain information on access to and capacity per week, month or year of any metabolic kitchen and/or domiciled feeding center, as appropriate to the study modules being proposed in the application.

Other Attachments: 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.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The budget for the first year will be for participation with the Steering Committee, in study planning activities, and preparation for the clinical study only. This should include minimal personnel costs and travel to one Steering Committee Meeting.

Applicants should budget based on their proposed protocols. However, it is understood that final budget numbers will reflect the common study protocol developed and approved by the Steering Committee that all Clinical Centers must implement.

Appropriate travel funds must be included in the proposed budget to support travel for at least one Clinical Center PD/PI to participate in an Annual Steering Committee Meeting.

Budgets should not include participant incentives (participant incentives will be provided via capitation from the Research Coordinating Center).

The CC’s F&A rates on the initial competitive awards will not be adjusted in future years due to changes in their negotiated rate agreements.

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, scientific education and outreach, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: The overall goal is to facilitate Nutrition for Precision Health, Powered by All of Us Research Program by enrolling All of Us Research Program participants and implementing Modules 1, 2 and/or 3 (described above). Applicant should describe how they will participate, or not, in each Module, and this will include capacity (participants per week, month or year). Applicants should describe how they plan to enroll participants and implement each module proposed. Applicants should also describe how the proposed CC will achieve the CC functions as described in Section I. Funding Opportunity Description.

Research Strategy: Applicants should describe how the proposed CC will fulfill the functions of the CC as described in Section I. Funding Opportunity Description, including enrollment of All of Us participants, the mixed-meal test challenge (Modules 1, 2 and 3) and three isocaloric dietary interventions proposed along with necessary washout periods (Modules 2 and 3), and collaboration with other components of the Nutrition for Precision Health consortium. Applicants should note that the applicant’s demonstrated capacity to perform the functions of a Clinical Center, the experience of applicants relevant to preforming the functions of the Clinical Center, and the proposed enrollment plan will be emphasized in review. The final common study protocol implemented by all CCs beginning in year two will be developed and decided upon by the Nutrition for Precision Health Steering Committee (SC), in which the CCs will have membership.

Applicants should address the following aspects of their proposed studies:

  • Participation, or not, in each module, and including capacity (participants per week, month or year) for each module in which they propose to participate.
  • Proposed dietary interventions (Note: Dietary interventions should be isocaloric, and should not be intended to cause weight change), including dietary composition, timing, wash-out period conditions and procedures for randomly assigning diets (forModules2, and 3);
  • Characteristics (demographics, sociocultural, environmental, etc.) of the CCs potential applicant pool and anticipated enrollment based on previous similar efforts. In particular, describe the CC’s ability ensure enrollment of a diverse sample representing the United States population.
  • Overview of proposed measures or outcomes, including assessments, biomarkers and clinical measures.
  • Overall design and structure of the CC including its management structure, integration of components, and any possible subcontracts.
  • Organizational chart of the tasks and milestones for what they will accomplish, identify the types of staff associated with each task, and describe their respective roles and responsibilities.
  • Relevant resources and expertise that are proposed for fulfilling the role of the CC, including access to metabolic kitchens and domiciled feeding centers.
  • How staff will interact with the All of Us Research Program to enroll participants from All of Us or how the Center will meet the requirements for enrolling new participants into All of Us according to the full All of Us protocol.
  • Prior experience with dietary intervention studies, domiciled feeding studies (if participation in Module 3 is proposed by the applicant) and large, multi-site clinical trials.
  • Any special strengths of the PD/PI or the Institution that would be relevant to the CC role in the Nutrition for Precision Health consortium(e.g., relevant expertise in coordinating large, complex clinical studies with data analytic, data science, and/or AI partners).

Letters of Support:

Include letters of support from partnering institutions, appropriate leaders of institutional component services, or outside collaborators with statement of roles/responsibilities. The application must include a statement from the applicant institution (senior institutional official) describing the commitment to the planned program, senior and junior investigators, research staff, and infrastructure needed.

A letter of assurance of cooperation with the policy for capitation of research costs as outlined below should be provided from the departmental and institutional offices of sponsored research programs.

To receive per participant capitation for participant incentive costs, a funded CC must set up an agreement with the Nutrition for Precision Health Research Coordinating Center.

The CC PD/PI or designee will be required to help the Research Coordinating Center manage protocol costs. The PD/PI or designee should propose estimates of enrollment efforts for each protocol to the Research Coordinating Center and update these at least annually.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • 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).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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,

with the following additional instructions:

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

A detailed explanation of how enrollment plans achieve All of Us Research Program diversity and inclusion goals (https://allofus.nih.gov/about/diversity-and-inclusion) and how the CC will interact with  of Us Research Program. Plans for participant retention and anticipated dropout rate should also be addressed.

Section 4 - Protocol Synopsis

4.3 Statistical Design and Power

The applicants should describe the study designs for Module 1, Module 2, and Module 3 (if proposed). This should include details on washout periods and randomization for Modules 2 and 3 which are both cross-over dietary intervention studies (if proposed). This should also include expected dropout rates at pivotal points for each Module, for example between Module 1 and each of 2 or 3, and during washout periods between dietary interventions in Modules 2 and 3. Further, applicants should describe plans to account for participant drop-out and other forms of missing data.

There are special considerations when addressing Statistical Design and Power for this FOA because Nutrition for Precision Health is a first of its kind, modular discovery science effort in precision nutrition. Applicants will have proposed baseline measures, dietary interventions, and outcomes which will include measures and physiological response to a test meal using scientific justification elsewhere in the application. Ultimately the exact baseline measures, dietary interventions, and outcomes measured will be decided upon by the SC and may vary from those proposed by the applicant. Further, the desired result of Nutrition for Precision Health is that there will be responders (defined as a change in some proposed measure) and non-responders (no change to a proposed measure) to each dietary intervention, that responders and non-responders will vary by baseline characteristics, dietary intervention and across outcome measures, and that this discovery data will be used to build an a yet-to-be-determined Artificial Intelligence-driven algorithm for predicting dietary response. Therefore, traditional power analysis approaches to determining a targeted sample size would not be appropriate in this context. The application should instead focus on quantifying detectable differences between intervention groups’ respective responders and non-responders, assuming a range of values for the variability in proposed measures supported in part by prior publications or data.

For Module 1 the applicants should describe important subgroups of participants (ex., those with low microbiome diversity, poor diets and poor diets or obesity at baseline) that are anticipated to have a differential response to the proposed mixed-meal test based on the expected distribution of these subgroups for participants enrolled at their CC. For the proposed primary outcomes, applicants should then provide power estimates for detecting differences between these important subgroups assuming a total sample size of 10,000 participants (Note: a CC will not be expected to enroll all 10,000 participants, this is just guidance for ease of calculating power; a CC will be expected to characterize their own enrolled cohort’s expected distribution of baseline subgroups). Expected minimally-detectable differences – and how such differences may vary by baseline subgroups–should be justified by the literature and/or historical data from an applicant’s experience, and sufficient detail should be included so that peer reviewers can confirm these calculations independently.

For Modules 2 and/or 3 (if proposed) the applicants should describe important subgroups of participants (ex., those with low microbiome diversity, poor diets or obesity at baseline) that are anticipated to have a differential response to the proposed three dietary interventions on the expected distribution of these subgroups for participants enrolled at their CC. For the proposed primary outcomes (which can include measures and measures of physiological response to the mixed-meal test), applicants should then provide power estimates for detecting differences between these important subgroups assuming a total sample size of 1,500 for Module 2 and 500 for Module 3 participants (Note: the specified total sample sizes should just serve as a guide for ease of calculating power, and how it may be impacted by an applicant’s expected distribution of baseline subgroups). Expected minimally-detectable differences per baseline subgroup should be justified by the literature and/or historical data from an applicant’s experience and sufficient detail should be included so that peer reviewers can confirm these calculations independently.

Applicants should also discuss using sets of outcomes (e.g., microbiome and physio-metabolic phenotyping measures) for which controlling a false-discovery rate might be appropriate, and be explicit on plans for handling incompletely-assessed sets of outcomes using principled missing-data methods. If applicants propose to elicit subgroups or latent classes (including latent transitions or growth curve / trajectory groupings) from post-baseline measures, some approach that considers false discovery rates and/or power to delineate subgroups should be specified AND supported by citation(s) from the peer-reviewed literature.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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) 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. See Section III of this FOA for information on registration requirements.

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. 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.

 

Applications Involving the NIH Intramural Research Program

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.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

For this particular announcement, note the following:

The Clinical Center will participate in a multi-center, dietary intervention study called “Nutrition for Precision Health, Powered by the All of Us Research Program” (NPH).

The common study protocol will be developed in coordination with the other Clinical Centers, the Research Coordinating Center, and other members of the NPH Steering Committee 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.

Every Clinical Center is expected to participate in Module 1. Applicants will also propose how they would participate and conduct Module 2 or Module 3 (or both). The proposed budgets should reflect the proposed studies.

Importantly, the capacity of applicants to perform the functions of a Clinical Center, the experience of applicants relevant to preforming the functions of the Clinical Center, and the proposed enrollment plan should be emphasized in review.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition:

Do PD(s)/PI(s), collaborators, and other researchers have appropriate time planned to execute their roles? Do they have demonstrated experience in conducting dietary intervention studies? Do they have demonstrated experience in being part of a multi-center, multi-component, collaborative study where a common protocol was developed and implemented? If domiciled feeding studies (Module 3) are proposed, do they have demonstrated experience in conducting domiciled feeding studies? Do they have experience enrolling diverse participants? Does the applicant demonstrate the ability to collaborate with the All of Us Research Program?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition:

Is the plan to enroll participants from the All of Us Research Program, including how applicants will interact with the All of Us Research Program to do so, adequate? Is the enrollment strategy feasible and aligned with the All of Us Research Program? Are plans for participant retention and anticipated dropout rates appropriate? Reviewers will comment on whether the Data Sharing Plan is reasonable.

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

In addition: Is the mixed-meal challenge for Modules 1, 2 and 3 appropriate? Does the applicant provide a strong rationale for the three isocaloric dietary interventions with washout periods for Modules 2 and 3 (as applicable), and proposed measures and outcomes? Applications that include animal models will be considered non-responsive.

 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

If proposing to conduct Modules 2 and/or 3, how appropriate are the food service resources, including metabolic kitchens? If proposing Module 3, how appropriate are the dedicated resources for domiciled feeding?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 implement common study 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)?

Study Timeline


Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by National Advisory Child Health and Human Development Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Compliance with data and resource/biospecimen sharing policies.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the \\"responsible party\\" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, 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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 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

Roles and Responsibilities & Management Strategy

1. PD(s)/PI(s) Responsibilities

The PD(s)/PI(s) will have the primary responsibility for:

  • All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, setting project milestones, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms.
  • Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by NIH staff and ensure that the data produced meets the quality standards agreed to by the consortium.
  • Awardee(s) will ensure that data are submitted in a timely fashion to the Nutrition for Precision Health Research Coordinating Center and the All of Us Researcher Workbench, that resources developed as part of this project are made publicly available according to consortium policies, and that results are disseminated in a timely manner. The PD/PI is responsible for the proper stewardship of the data, including accurate annotation, disclosure of any pre-processing, data use limitations, data provenance and other associated metadata as determined by any consortium and All of Us policies.
  • Ensuring that software and other tools and resources developed as part of this project are made publicly available according to Nutrition for Precision Health and All of Us policies, and that research products of the project are published in a timely manner. The PD/PI is expected to fully disclose data, algorithms, software source code, and experimental methods to the other members of the consortium or the External Program Consultants(EPCs)or the purpose of scientific evaluation and use by other consortium members in collaborative projects.
  • Awardee(s) will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
  • Agreeing to the governance of the consortium through the Steering Committee (SC)and the NIH Nutrition for Precision Health Working Group, including accepting approved recommendations from the EPCs.
  • Actively participating in the SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and subcommittees and ensuring timely completion of key SC tasks, such as finalization of the protocol, finalization of data sharing or other policies. At least one in-person SC meeting will be held per year, for which Nutrition for Precision Health awardees will pay the travel for their attending members. The PD/PI is expected to attend at least one consortium meeting in person each year.
  • Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH Nutrition for Precision Health Working Group and Project Scientists as appropriate.
  • Agreeing to abide by any policies and maintaining documentation of compliance -- including those regarding intellectual property, data and software sharing, publication of Nutrition for Precision Health consortium papers, reagent and protocol sharing, standards and calibration, metadata requirements, data use limitations and public copyright licensing -- that are recommended by the SC and approved by the NIH Nutrition for Precision Health Working Group, as well as applicable NIH policies, laws, and regulations.
  • Being prepared for annual administrative site visits or virtual site visits by NIH staff.
  • Agreeing to participate in the collaborative activities of the consortium and agreeing not to disclose confidential information obtained from other members of the consortium including, without limitation, unpublished data, informatics tools, protocols, data analysis, confidential exchanges between members of the consortium, as well as any confidential information received by third party collaborators.
  • Awardees will retain custody of and have primary rights to software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2. NIH Staff Involvement

Definitions

  • NIH Working Group (NIH WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH as well as the Office of the Director. This group will be primarily responsible for the stewardship of the Nutrition for Precision Health Program and will participate as non-voting members in the Consortium committees. The Nutrition for Precision Health WG is co-chaired by the Directors of the All of Us Research Program, NIDDK, NHLBI, NCI, and NICHD. It reports to the Directors of the Office of Strategic Coordination/Common Fund and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions.
  • Nutrition for Precision Health Coordinators: Two Coordinators are NIH extramural scientists who serve as Program Managers and are responsible for the overall and day-to-day management of the Consortium, progress towards the program’s goals and monitoring interactions between the Consortium and the external community. They will have substantial involvement in assessing progress and making recommendations about future funding. The Nutrition for Precision Health Coordinators will have substantial scientific programmatic involvement in the direction of all the Nutrition for Precision Health awards and may consult other NIH and non-NIH experts in making determinations. They will participate as members of all Consortium committees and will review and approve Consortium policies. The Nutrition for Precision Health Coordinators will not co-author publications with project investigators.
  • Steering Committee (SC): The purpose of the SC is to recommend direction for the Nutrition for Precision Health consortium consistent with the program goals, develop consortium policies and projects to build synergy and improve communication and collaboration between the projects, and to provide a forum for discussing progress, challenges and opportunities for the consortium. The SC will include PDs/PIs of each of the awards and NIH WG members. The SC will be chaired by two PD/PIs that are approved by the NIH WG. An Executive Committee (EC) composed of the co-chairs and the NIH Program Officers and Coordinators will meet to set the agenda for SC meetings. The SC will establish subcommittees to oversee the development and implementation of consortium policies including data release, publications and standards. It is expected that most of the decisions on the activities of the Nutrition for Precision Health Steering Committee will be reached by consensus. If a vote is needed, each project PD/PI (or Contact PI in the case of multi-PI projects) will have one vote. NIH staff will be non-voting members of the SC but will review and approve policies developed by the Steering Committee. When a vote is required, at least 60% of the votes will be required for approval. Steering Committee recommendations will go to the Nutrition for Precision Health Coordinators and the NIH Working Group for approval.
  • External Program Consultants (EPCs): As part of the Nutrition for Precision Health program, NIH staff will engage 4-6 External Program Consultants (EPCs) not funded as part of the program but with relevant scientific and consortium experience to provide input and advice to the NIH WG. This could include reviewing and evaluating the progress of the entire Nutrition for Precision Health Program or individual awardees as well as recommending changes in priorities for the Nutrition for Precision Health Program based on scientific advances within and outside of the consortium. The EPCs will be senior, scientific experts who are not directly involved in the activities of the Nutrition for Precision Health Program and who agree to a confidentiality policy, engaged on an as-needed basis to advise on specific issues. NIH is solely responsible for appointing EPCs for variable durations of service. EPCs are invited to participate in consortium meetings and Steering Committees calls and the annual investigators’ meeting. A subset of EPCs may also meet by phone or web at other times of the year, as needed. Annually, the EPCs will provide individual assessments to the NIH of the progress of the consortium and will present individual expert recommendations regarding any changes in the Nutrition for Precision Health Program as necessary. The assessments and recommendations will be provided through the NIH WG to the Director of the Office of Strategic Coordination, NIH
  • Nutrition for Precision Health Consortium: The Nutrition for Precision Health consortium is made up of Nutrition for Precision Health awardees, the NIH WG and other scientists and groups the SC agrees to include within the consortium. The consortium structure is meant to efficiently and effectively guide all the funded projects to meet the overall goals of the Nutrition for Precision Health Program.

For each individual award, NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • NIH Program Officer- A NIH Program Officer (PO) is responsible for the normal scientific and programmatic stewardship, including monitoring progress and compliance with general statutory, regulatory, or policy requirements; discussing and approving milestones and significant changes to the project; and technical assistance to correct performance and facilitate interactions. The PO must approve in advance and in writing annual milestones and any significant changes to the award. The PO also has the option to recommend to the Nutrition for Precision Health Coordinators, following consultation with the Project Scientist(s), EPCs or the NIH WG, restricting an award based on progress towards milestones, to incentivize rapid development and implementation of policies or collaboration between members of the consortium, or generation of data or resources for use by consortium members or the wider community. NIH also reserves the right to modify the budget or duration of funding or to curtail an award in the event of: (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the specific aims, (c) failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved consortium Policies, (d) failing to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues. The Program Officer will not co-author publications with project investigators.
  • NIH Project Scientist(s)- One or more NIH Program Staff will serve as Project Scientists (PSs), for each Nutrition for Precision Health award and, as appropriate, to oversee collaborative projects amongst awardees and/or other consortium members. The PSs will serve as the scientific representatives of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. If there is more than one PS, one of them will be designated as the Lead PS. The PSs will provide substantial NIH scientific programmatic involvement with the awardee that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones. PSs will work closely with the PD/PI, the Steering Committee, and the PIs of all projects/cores to maximize progress towards the goals of the project and the program.

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. NIH staff may have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • NIH staff (Nutrition for Precision Health Coordinators, Project Scientist(s) and Program Officer) have substantial programmatic involvement in oversight of project management.
  • The Program Officer is the NIH point-of-contact for the project, except for special circumstances designated by NIH. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer must approve in advance: (i) changes in the roster and effort of the PD(s)/PI(s) and key personnel, (ii) changes in the goals and milestones for the project, (iii) changes in the scientific scope of the project, (iv) changes to the frequency of business meetings, (v) changes in goals of collaborative projects, and (v) any exceptions to the consortium's policies. The Program Officer will not co-author publications with project investigators.
  • The Project Scientists(s) will provide advice and guidance to ensure that the project adheres to the objectives of the FOA, the Terms and Conditions of the award, and other agreements between the awardees and NIH. The Project Scientist(s) will keep the PD(s)/PI(s) informed of any issues and concerns involving the project and provide advice on how to address them. The Project Scientist may provide scientific and programmatic assistance to the PD/PI, including contributing to data analysis, key personnel selection, and promoting the availability of data and resources. The Project Scientist(s) will attend all official business meetings of the project's leadership and must be kept informed of all substantive deliberations and developments affecting the project. The Project Scientist(s) will not make decisions about the funding of this project and will not be involved in any special reviews of the project that make recommendations about funding.
  • The Nutrition for Precision Health Coordinators will work closely with the Program Officer and Project Scientist(s) to monitor progress of the project and coordinate collaborative projects, resource sharing and outreach as part of the consortium. The Coordinators will keep the PD(s)/PI(s) informed of consortium-wide activities, policies and issues. The Nutrition for Precision Health Coordinators will not co-author publications with project investigators.
  • NIH staff and their respective Institutes and Centers will manage Conflicts of Interest and Management of Bias as detailed in the NIH Policy Manual.
  • Progress Reviews. The annual evaluation by the Program Officer and Coordinators will be based on the non-competing application and progress report, center records, and assessments by the Project Scientist(s). The Program Officer and Coordinators will review the management, performance, and utilization of the project. If concerns are identified by the Program Officer or Coordinators, the Project Scientist(s) will work with the PD(s)/PI(s) to develop plans to address them in the next year of support and. In addition, NIH staff may conduct interim reviews of scientific progress beyond the normal yearly non-competing progress review to determine progress and use information from progress reviews to inform future funding for the project.
  • Special Reviews. In addition, if concerns are identified about the performance or the management of the project, the Program Officer may conduct special reviews of the project as he/she deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project. In the event of long-term incapacitation of resource facilities, NIH may reduce the budget or term of support to phase out the project. Though the Cooperative Agreement mechanism does provide options for restricting, reducing, or terminating awards, it also provides options for interacting supportively with awardees to help ensure program success. Before any modifications are made, NIH staff will engage with the awardees in a positive manner and as allowed by the Cooperative Agreement mechanism to resolve performance issues where possible in a timely manner.
  • Consortium Management. Funds may be restricted pending completion of key tasks, such as finalization of the protocol, finalization of data sharing or other policies, or transfer of data to the Research Coordinating Center and/or All of Us Researcher Workbench.

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 students and postdoctorates, including 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 will be responsible for coordinating the activities of the projects and is the committee through which the NIH WG formally interacts with the investigators. SC membership will include the PI(s) of each Project, (limited to one vote for a Project with multiple PIs) and NIH staff (non-voting members). The SC Chair(s) will be appointed by the Nutrition for Precision Health Coordinators and drawn from the individual project PIs. The SC may add additional, non-voting, members, as needed
  • All major scientific and policy decisions will be determined by voting policies as established by the Charter for the Steering Committee. Specific activities of the SC will include, but are not limited to: developing and reviewing consortium policies; identifying impediments to program goals and strategies to overcome them; approving and reviewing development of shared tools and collaborative projects; identifying opportunities for sharing techniques, materials, information and tools developed within each individual Nutrition for Precision Health project; facilitating communication and fostering collaboration across the consortium; reviewing progress of the consortium towards meeting the overall consortium goals; developing, adopting or updating data standards, metadata requirements, data quality standards, and submission and release policies; ensuring the consortium leverages existing resources and programs to accelerate progress; helping organize the scientific agenda for the annual Investigator Meeting.
  • The SC may choose to open consortium membership to collaborators not funded through the Nutrition for Precision Health Program, provided that such members agree to abide by policies enacted by the SC. The SC may generate additional conditions that apply to non-awardee members of the consortium.
  • 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.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. The panel will have three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Scientific/Research Contact(s)

Ashley Vargas, PhD, MPH, RDN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-6030
Email: ashley.vargas@nih.gov

Peer Review Contact(s)

Elaine Sierra-Rivera, Ph.D.
Center for Scientific Review (CSR)
301-435-1043
Email: riverase@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.