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 National Cancer Institute (NCI/NIH), (http://www.nci.nih.gov/) on behalf of the NIH.

Funding Opportunity Title
Nutrition for Precision Health, powered by the All of Us Research Program: Metabolomics and Clinical Assays Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

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-21-002
Companion Funding Opportunity
RFA-RM-21-001 , U54 Specialized Center (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-21-005 , UG1 Clinical Research Cooperative Agreements - Single Project
RFA-RM-21-006 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for a Metabolomics and Clinical Assays Center (MCAC) to join the Nutrition for Precision Health Consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). The focus of this center is to (1) generate targeted and non-targeted metabolite profiles and (2) perform or facilitate clinical assays from blood, urine and stool biospecimens.

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 Announcement (FOA) is to solicit applications for the Metabolomics and Clinical Assays Center (MCAC) to join the Nutrition for Precision Health Consortium. The focus of this center is to (1) generate targeted and non-targeted metabolite profiles and (2) perform or facilitate clinical assays from blood, urine and stool biospecimens.

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 MCAC 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-21-003: 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 conduct dietary assessment on participants and develop innovative approaches to address dietary assessment challenges.
  • RFA-RM-21-005: Nutrition for Precision Health, powered by the All of Us Research Program: Clinical Centers (UG1 Clinical Trial Required). Clinical Centers will engage, consent, and enroll participants from All of Us and conduct 3 diet modules (usual dietary assessment, a controlled feeding dietary intervention and a domiciled dietary intervention).
  • 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.

Key terms for this FOA

  • MCAC: Metabolomics and Clinical Assays Center
  • DRC: Data and Research Center
  • NPH: Nutrition for Precision Health
  • RCC: Research Coordinating Center

Background

Strategic plan for NIH Nutrition Research

The 2020-2030 Strategic Plan for NIH Nutrition Research was released in 2020 and will guide NIH-supported nutrition research over the next decade. The Plan was organized around a unifying vision of precision nutrition research.

Research is needed to provide more precise and dynamic nutritional recommendations than currently possible through population-wide guidance. This in turn will facilitate a deeper understanding of how human biological systems and molecular pathways interact with or mediate the relationships among dietary patterns, environmental, social, and behavioral factors to influence health status. Through advances in -omic technologies and mobile devices—combined with the large and diverse participant sample and existing infrastructure of 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 current All of Us participants through targeted enrollment. All of Us participants will not be required to participate in Nutrition for Precision Health, and a participant’s decision whether or not to enroll in Nutrition for Precision Health will not affect the participant’s status as an All of Us participant. Nutrition for Precision Health will use a separate enrollment process from the All of Us Research Program, and, in order for a participant to enroll in Nutrition for Precision Health, they must already be enrolled in All of Us.

Data Collection, Generation and Integration: All data from the Nutrition for Precision Health study will ultimately be deposited in the All of Us Researcher Workbench, where it will be integrated with All of Us-collected data and made available for use by the scientific community. Data will be generated and collected by the Clinical Centers, Dietary Assessment Center, Microbiome and Metagenomics Center, and Metabolomics and Clinical Assays Center. These Centers will send raw and processed data to the Research Coordinating Center for further curation and processing. The Research Coordinating Center will coordinate with the All of Us Data and Research Center to deposit the data into the Researcher Workbench. Nutrition for Precision Health investigators, including the 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 test meal challenges. 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 three 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

Awardees will collaborate with investigators from the All of Us Research Program Biobank, Data and Research Center, and Participant Technology Systems Center.

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.

The Nutrition for Precision Health projects will be embedded in the All of Us Research Program and will enroll existing All of Us participants. The All of Us Research Program is guided by a set of core values that will also guide the Nutrition for Precision Health consortium.

Research Objectives and Requirements of this FOA - Coordinating Center (MCAC)

Applicants responding to the MCAC FOA are expected to familiarize themselves with the companion FOAs and the structure and functioning of the Nutrition for Precision Health Consortium.

Timeline for the MCAC

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 a common set and any site-specific clinical assays that will be performed during the implementation phase.

Further, as the Clinical Centers initiate enrollment for their specific studies, the biospecimens should start to become available to MCAC during year 2, MCAC should plan on metabolite profiling and clinical assays on a rolling basis.

Profiling of Biospecimens

Biospecimen samples will be derived from the Biobank and/or Clinical Centers from individuals participating in controlled feeding studies. The exact number of biospecimen samples to be profiled/assayed will be determined by the study design, protocols and other factors proposed by the Clinical Centers. Clinical Centers are expected to collect approximately 144,000 blood, 16,000 urine, and 17,500 stool biospecimens during the five years of the Program, and these values should be used for planning purposes. The workflow involves receipt of the biospecimens from the Biobank/Clinical Center (if so warranted) and data delivery to the Research Coordination Center (RCC) which would serve as the central hub for the Nutrition for Precision Health Consortium and will be responsible for submitting data to the All of Us Data and Research Center (DRC). Data will ultimately be modeled by the Artificial Intelligence for Multimodal Data Modeling and Bioinformatics Center (explained in the background) to develop dietary response predictive algorithms.

Main Responsibilities of MCAC

  • MCAC should be able to provide broad coverage of the metabolome encompassing diverse metabolic pathways using appropriate platforms/technologies.
  • It is expected that the coverage would encompass host, microbiome and food/component metabolite pathways as appropriate.
  • The Program intends to return results of the clinical assays to the participants in the studies. Hence these assays should be performed/facilitated by MCAC using appropriate resources/approaches (CLIA certified labs or equivalent clinical laboratories) which enable the return of clinical assay results
  • Potential untargeted and targeted measures on collected biospecimens include a wide range of coverage. Therefore, it is essential that the MCAC must have the experience and flexibility to pivot to consortium prioritization. For those assays that are not prioritized, the biospecimens will be stored in the biorepository for potential use by the research community in subsequent ancillary studies
  • It is the responsibility of the MCAC to help develop best practices and standard operating procedures across the Clinical Sites for sample collection, handling and storage to optimize metabolite profiling and clinical assays
  • MCAC is also responsible for implementing data deposition pipelines for transfer of data to the RCC including relevant metadata as agreed upon by the Nutrition for Precision Health Steering Committee and in coordination with the Common Fund Data Ecosystem to ensure interoperability with other Common Fund datasets (e.g., those in the Metabolomics Workbench)
  • MCAC is also responsible for implementing data deposition pipelines for transfer of data to the RCC including relevant metadata as agreed upon by the Nutrition for Precision Health Steering Committee
  • MCAC personnel will serve as members of the Nutrition for Precision Health Steering Committee and participate in relevant sub-committee meetings to help develop and implement Nutrition for Precision Health Consortium processes and policies

Formation and Governance of the Nutrition for Precision Health Consortium

Steering Committee

Shortly after the award, the PDs/PIs and NIH program staff will form the Nutrition for Precision Health Steering Committee. One PD/PI per award and select NIH staff will be voting members of the Steering Committee. Consortium governance rests with the Steering Committee and is subject to oversight by 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 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 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
  • 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 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
  • 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 to streamline the protocol approval process and to standardize the monitoring of human subjects’ protection in Nutrition for Precision Health. The RCC will be responsible for developing and finalizing the Data and Safety Monitoring Plan and for managing DSMB and IRB logistics

Common Fund Data Ecosystem

The NIH Common Fund (CF) programs are intended to provide resources that accelerate discovery across many different biomedical research fields. These resources include large data sets and associated digital tools needed to mine and analyze the data. To maximize their impact, data sets and tools generated by the CF programs must be usable together. Towards achieving this goal, the Common Fund created the Common Fund Data Ecosystem (CFDE), a data management infrastructure where the interconnected ecosystem facilitates scientific advances by ensuring CF data and digital objects are usable and useful both within a program and in combination with data from other programs. Aims of the CFDE are to enhance the ability to ask scientific questions; enable the uptake, reuse, and addition of data sets generated by the future, current and ended CF programs and support their sustainability; and provide training that maximizes scientists’ ability to use the CF data sets and tools. The CFDE is composed of a CFDE Coordination Center (CFDE-CC) and the data coordinating centers (DCCs) of the participating CF Programs. CFDE teams will work towards standardizing the data deposition/structuring/handling to make data FAIR, adapting data and metadata standards to enable interoperability, and providing training about the available CF resources to the scientific community.

New CF programs (e.g., Nutrition for Precision Health) are expected to engage in the CFDE from the start. This can be achieved by designing the program components such that they: i) construct a data infrastructure which ensures FAIRness of the data, and ii) adapt the appropriate data and metadata standards to enable interoperability of the generated data with other data sets. The Nutrition for Precision Health Research Coordinating Center will be the primary point of contact with the CFDE. Applicants are expected to discuss their plans for ensuring compatibility with the CFDE and other Common Fund datasets and resources (e.g., via the CFDE portal, Metabolomics Workbench and the MoTrPAC Data Hub) in their proposal.

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

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit approximately $400,000 in FY2022, and $5,000,000 per year for FY2023 through FY2026. Approximately one award is anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

Award Budget

For all years, budget must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years

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

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.

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.

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

Applicants who anticipate requiring >$10,000 direct costs in commercial cloud services from either Google or AWS in any one year of the anticipated award are expected to request in-kind support via the Common Fund STRIDES partnerships rather than requesting direct cost support for these services. To request in-kind support for cloud services via STRIDES, applicants must outline the anticipated costs of commercial cloud services in the Budget Justification section, including, but not limited to, data storage, analysis, data movement/egress, professional services, training, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.

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: Outline the overall objectives of MCAC and the approach for achieving these goals, and how they will support the Nutrition for Precision Health consortium.

Research Strategy

While it is recognized that the exact numbers of biospecimens, the Clinical Centers from where these are derived, and the spectrum of clinical assays to be performed will not be known before award, the applicants should make reasonable assumptions on the proposed platforms in terms of rigor, capacity, throughput and ability to scale. This is especially important given data from the MCAC will contribute to the development of predictive algorithms that inform targeted dietary approaches.

  • Describe the leadership and membership encompassed in the Center and the ability to lead large efforts and the extent to which the team integrates the requisite technical and administrative expertise to run a successful metabolomics and clinical assays center involving large biospecimen sample volumes across biospecimen types. Also describe the Center's prior experience and demonstrable capabilities in leading large projects similar in scope and scale to MCAC.
  • Describe the Center’s approach to receiving of biospecimens, custody, and mapping data back to the respective samples including coordination with the RCC for data deposition. Detail the Laboratory Information Management System (LIMS) to be used including the ability to identify for real time tracking of any given biospecimen sample in the assay pipeline
  • Applicants should describe their capabilities and experience in untargeted and targeted metabolomics and clinical assays (e.g., clinical chemistries, special chemistries and hematology laboratory tests), without duplicating information in the biosketch. Describe the proposed metabolomics platforms, coverage, throughput, ability to scale, QA/QC approaches, and strategies for minimizing false discovery rates. Include plans for identifying unknowns as new information and tools become available. Also describe the plan for performing/facilitating clinical assays considering Nutrition for Precision Health Consortium's intent of returning these results to the participants
  • Propose a plan for pilot analyses across the biospecimen types in the planning phase to help allow for optimization of QA/QC measures to be employed during the subsequent scaleup implementation phase
  • The MCAC should provide a well delineated plan for quality assessment and quality control measures for the metabolite profiling and clinical assays proposed. This plan should include methodology to minimize drift due to platform, reagent, and batch effects. Metrics for failed sample recovery and statistics of how many biospecimens met or exceeded this metric should be detailed. Quality measures that minimize false discovery rates should be incorporated as well. In consultation with the Steering Committee. MCAC should make recommendations for common standards for each type of biospecimen including sample dependent and independent approaches

Examples of clinical assays

Examples of clinical assays that may be prioritized in the initial planning year related to diet, metabolism or nutrition include but are not limited to:

  • Plasma endocrines (e.g., insulin, cortisol, incretins, satiety factors, thyroid panels, GI peptides etc.)
  • Complete Blood Count
  • Vitamins (e.g., vitamin C), vitamin carrier proteins or conditionally essential micronutrients in plasma (e.g., choline)
  • Plasma microminerals (e.g., Zn, Cu), micromineral carrier proteins (e.g., ceruloplasmin) or macrominerals (ionized or total calcium, Na, K, Cl, Bicarbonate etc.)
  • Plasma lipids (total cholesterol, lipoprotein profiles, chylomicrons, triglycerides, NEFA etc.)
  • Urine Chemistries (microalbumin, creatinine, glucose, amino acids, urea nitrogen, osmolality, Na, K, pH, catecholamine metabolites, acylcarnitine profiles, etc.)
  • Plasma amino acids, BUN or creatine
  • Plasma biomarkers of oxidative, inflammatory or other stress (e.g., cortisol)
  • Markers of nutritional status (e.g., albumin, transferrin)

Data

It is expected that the Metabolomic profiling data should at a minimum consist of:

  • Raw data files including mzML or nmrML
  • Normalized data
  • Aggregated data

Data generated should be classified into the following levels (with consideration of the platform), based on the Metabolomics Standards Initiative: Metabolomics. 2007 Sep;3(3):211-221.

  • Level 1: Metabolites are verified by reference standards
  • Level 2: Metabolites are identified based on accurate mass data, retention time,
  • experimental MS/MS spectra, and library MS/MS spectra
  • Level 3: Metabolites are identified based on accurate mass data, retention time,
  • experimental MS/MS spectra, and knowledge of characteristic MS/MS ions
  • spectra
  • Level 4: Metabolites are speculated based on the similarity of accurate mass data, retention time, and biological relevance with known metabolites or pathways. It is envisioned that these would be validated in the future with the improvement of library spectra, availability of reference standards, and other relevant knowledge
  • Level 5: Metabolites are unknown based on lack of similarity for the data obtained to existing spectra, pathways or structural classes

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).
  • Research Resource Sharing Plan: NIH strives to ensure the dissemination of research resources developed with NIH Funds. It is expected that any tools developed through the support of this award will be broadly shared. Given the high profile of this study, the applicant’s tools could become an important resource that other investigators will want to utilize. The consortium is expected to substantively participate in this research project. If new tools are resources are developed through this project, the investigators must develop a resource sharing plan that explains how any developed resource will be made available to the investigator community in the future, including the timeline for that plan. The sharing plan may include fees for licensing or use of the tool or app, but may not have “reach through agreements,” for example that require the involvement of particular investigators in research grant applications, percent effort, future co-authorships, or other collaboration requirements. The plan should also minimize administrative impediments to academic sharing of this research resource.
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.

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.

For this particular announcement, note the following:

The common study protocol for Nutrition for Precision Health will be developed during the first year of the award and implemented by all Centers beginning in year 2.

The first year will serve as a planning year.

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?

Investigator(s)

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

Specific to this FOA: How well do the investigators describe their ability to lead a large highly coordinated center? To what extent does the investigator team bring together the necessary technical and administrative skills to make this center successful? To what extent does the application provide evidence of prior success in the context of collaborations within a large multidisciplinary program such as the Nutrition for Public Health consortium? How experienced is the team in obtaining, processing, analyzing, and sharing very large volumes of data as will be expected in this 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?

Specific to this FOA: Although not a significant component of this center, do the investigators propose novel approaches for handling the volume and breadth of analyses expected? Are there innovative suggestions for how to integrate the activities of this center with the other components of the Nutrition for Precision Health Consortium? To what extent does the application describe how this center will maximize opportunities for identifying unknown metabolites?

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?

Specific to this FOA: How sound are the proposed plans for maintaining the chain of custody of the biospecimens and resulting data? How well does the application describe a plan for harmonizing sample submission across multiple clinical centers? How rigorous are the methodologies for sample preparation? How effective are the approaches for minimizing false positives and false negatives? For targeted and untargeted metabolomics, to what extent will the sample preparation, acquisition and post-processing procedures yield high quality data with minimal artefacts? (data pipelines, tools, etc.) How clear and well thought out are the plans for identifying the metadata that will be included with every biospecimen? Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Resource Sharing Plan.

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?

Environment

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

Specific to this FOA: How well does the application describe the ability of this center to process the volume of samples and breadth of analyses expected from the Nutrition for Precision Health Consortium? How adequate is the infrastructure available to do this successfully? Considering the range of desired analyses is not entirely known at the time of application, how comprehensive are descriptions of the breadth of capabilities within the center? If there are plans to conduct any portion of the metabolomics or clinical assays through subawards, how well does the application describe coordination with, and oversight of, those activities?

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 use common protocols? Have the investigators agreed to uphold to the All of Us Research Program Core Values (https://allofus.nih.gov/about/core-values) and Privacy and Trust Principles (https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles)?

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).

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 the National Cancer Advisory Board. 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.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project

as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

1. Primary responsibilities of the PD(s)/PI(s)

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

  • 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 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 for 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 SC and the NIH WG, 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 WG 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 WG, 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.
  • 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 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. 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 by providing 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 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 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

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 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; 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
  • NIH staff and their respective Institutes and Centers will manage Conflicts of Interest and Management of Bias as detailed in the NIH Policy Manual. The Program Officer will not co-author publications with project investigators.
  • Progress Reviews. The annual evaluation by the Program Officer and Coordinators will be based on the non-competing application and progress report, , and assessments by the Project Scientist(s). 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.
  • 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 pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. EPCs will attend the annual in person meetings. Other government staff may also attend the annual investigators meetings.

The SC will serve as the main scientific body of the consortium, with the following roles:

  • The SC 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.

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)

Pothur Srinivas, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-7620
Email: srinivap@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Dawn Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dawn.mitchum@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.