Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

National Institute of Mental Health (NIMH)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Non-Human Primate Developmental Genotype-Tissue Expression (NHP dGTEx) Project (U24 Clinical Trials Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • June 21, 2021 - Notice of Pre-Application Webinar for Non-Human Primate Developmental Genotype-Tissue Expression Project (NHP dGTEx). See Notice NOT-HG-21-035.
Funding Opportunity Announcement (FOA) Number

RFA-HG-21-026

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.172 

 

Funding Opportunity Purpose

The purpose of this funding opportunity is to solicit applications for the Non-Human Primate Developmental Genotype-Tissue Expression (NHP dGTEx) Research Center. The NHP dGTEx Research Center will perform four major functions: 1) create a tissue resource of multiple reference tissues across developmental stages in non-human primates (NHPs); 2) perform transcriptome sequencing and other genomic analysis of single-cell and bulk tissues; 3) analyze gene expression patterns in NHPs and compare them to human gene expression patterns; and 4) make the tissue samples and data available and usable for the research community.

Key Dates
Posted Date

June 3, 2021

Open Date (Earliest Submission Date)

July 1, 2021

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

August 2, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
November 2021
Advisory Council Review

January 2022

Earliest Start Date
April 1, 2022
Expiration Date

August 3, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The purpose of this funding opportunity is to solicit applications for the Non-Human Primate Developmental Genotype-Tissue Expression (NHP dGTEx) Research Center. The NHP dGTEx Research Center will perform four major functions: 1) create a tissue resource of multiple reference tissues across developmental stages in non-human primates (NHPs); 2) perform transcriptome sequencing and other genomic analysis of single-cell and bulk tissues; 3) analyze gene expression patterns in NHPs and compare them to human gene expression patterns; and 4) make the tissue samples and data available and usable for the research community.

    Background

    Many of the factors that influence human health and disease throughout the lifespan are known to be initiated in prenatal and early childhood development. Studies of developmental genetics have demonstrated that gene expression patterns are not only tissue specific but also time dependent and controlled through coordinated regulation of complex networks and pathways. For this reason, it is valuable to study gene expression patterns at a tissue-specific level over several early development timepoints.

    NHGRI, NICHD, NINDS and NIMH recently launched Developmental Genotype-Tissue Expression (dGTEx) to characterize transcriptional profiles during human development. dGTEx is a follow-on to the Common Fund Genotype-Tissue Expression (GTEx) Project, which established gene expression profiles within and between human adults across multiple tissues, determining tissue-specific expression as well as correlating differences in expression with genetic variation. dGTEx will study gene expression patterns in multiple human tissues during postnatal and juvenile development, defining the role of gene expression in human development and providing insight into health- and disease-related processes that have their origins before adulthood. This initiative, NHP dGTEx, is designed to complement human dGTEx in translational NHP model species.  Specifically, to further our understanding of gene expression patterns across developmental timepoints, this FOA is requesting applications to extend these data to include comparable data from NHP.

    Evolutionary comparisons are vital to understanding the effect of genomic variation on biological processes and phenotypes, providing insights about the interplay of genomic variants and environmental pressures as well as the relevance of putative pathogenic variants identified in clinical studies. As emphasized in the NHGRI Strategic Vision, genomic data from multiple species have been instrumental in elucidating the consequences of natural genomic variation, the conservation of genomic elements, and the evolutionary changes in genomic regions associated with specific traits. Comparison across species at different evolutionary distances can help to identify functional constraints and facilitate correlation of genomic differences with specific traits and phenotypes.  In addition, use of laboratory animals can reduce variability and complexity, in this case allowing for studies at precise developmental stages while controlling for environmental factors. The use of NHPs will allow the inclusion of both pre-natal and post-natal developmental stages. Finally, work to advance an integrated comparative genomics resource for primate development would benefit research to develop new treatments for human diseases using translational NHP models.

     While many model organisms have been used in developmental biology studies, NHPs have developmental trajectories that are most similar to humans and therefore are particularly well suited as models to identify genomic contribution to traits and conditions that are highly developed in humans, such as higher-level cognition, complex social structures, and adaptive immunity. Having comparable data from two NHP species at different evolutionary distances from humans (i.e. representatives of both Old World and New World primates) can enable comparative genomic analyses of development. NHPs are experimentally tractable, providing the opportunity to validate observational findings with follow-up experiments. Unlike many other model systems, NHPs also have high levels of population genomic diversity even in captive populations, making them good models for studies of the impact of genetic variation on developmental processes. 

    Scope and Objectives

    The major goal of this FOA is to solicit the study of gene expression patterns in multiple reference tissues across developmental stages in NHPs and compare them to human gene expression patterns. This will be achieved through two objectives:

    Creation of a tissue resource and generation of gene expression data in developing non-human primates by: a) collecting and banking tissues from multiple animals at a minimum of 6 developmental stages spanning prenatal and postnatal development for at least two NHP species (at least one each of Old and New World species) used in biomedical research; and b) performing whole genome sequencing in blood on each animal and RNA sequencing on whole tissues and single-cell populations for at least 30 tissue types per animal. These data should be collected with design considerations that maximize their utility to validate and interpret the human data generated in dGTEx (e.g., assaying a combination of comparable and complementary tissues and developmental stages; coordinated sample collection and preservation procedures; standardized quality control/quality assessment, metadata and common data elements) as well as to provide reference data for follow-up functional experiments and experimental interventions in NHPs.  

    Making the NHP tissue resource and data available and useable for the community by: a) monitoring study progress and laboratory performance; b) performing quality control and basic analysis of expression data; c) identifying and implementing standards for data and metadata; and d) submitting datasets to appropriate repositories. To maximize impact, it will be important to leverage and integrate the data from this effort with existing developmental genomic data from humans and other species.

    Projects with the following properties will be considered non-responsive, and will not be reviewed:

    • Projects that do not have a plan to leverage evolutionary distance (e.g. by using Old and New World primates)
    • Projects that do not propose comparative genomics approaches that will help to validate and interpret the data generated in the human dGTEx project
    • Proposed work that does not have clear plans to make the NHP tissue resource and data available and usable to the community

    Consortium Formation and Responsibilities:

    This FOA uses the Cooperative Agreement mechanism. Successful applicants will interact with the dGTEx Consortium, composed of investigators who have been funded in response to either of the dGTEx FOAs (RFA-HD-21-008 and RFA-HG-20-039). Awardees are expected to work collaboratively with all members of the consortium towards meeting consortium goals, in addition to the research goals outlined in their individual applications.

    NHGRI strongly encourages all investigators with innovative ideas aligned with the goals of this FOA to submit applications.  NHGRI especially encourages applicants who are new investigators, experienced investigators who are new to genomic science, investigators that have not previously participated in a NHGRI consortium or program, and investigators from demographic groups or institutions that are generally underrepresented in genomic science.

    Informational Webinar

    All applicants are strongly encouraged to contact NHGRI Staff to discuss the responsiveness and alignment of their proposed work with the goals of this program. An informational webinar will be held for potential applicants. NIH staff will be available to answer questions related to this FOA. Time, date, and dial in information will be announced in an NIH Guide Notice and will be posted on the NHGRI website: http://www.genome.gov/ . During the webinar, NHGRI staff will present overviews of the FOAs and answer FOA-related questions from prospective applicants. The informational webinar is open to all prospective applicants, but participation is not a prerequisite for submission of an application.

    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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Issuing IC and partner components intend to commit an estimated total of $3.5M per year to fund 1-2 awards.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.

    Award Project Period

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • 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)

    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)
    • 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
    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 NOT 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.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • 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 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:

    Jennifer Troyer
    Email: troyerj@mail.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

    For this specific FOA, the Research Strategy section is limited to 30 pages.

    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.  

    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.

    For single PD/PI applications, the PD/PI is expected to devote at least 3 person months, based on a 12-month calendar. If multi-PDs/PIs are proposed, then each PD/PI is expected to commit sufficient time to serve his/her proposed role, with a minimum aggregate PD/PI effort of 3 person months.  The appropriateness of the effort of key personnel must be justified in the budget justification.

    Budgets should include support for a dedicated Project Manager who will devote a minimum of 3 person months, based on a 12-month calendar, to oversee the day-to-day activities of the center, coordinate metadata and data submissions, coordinate with related efforts, if applicable, and be responsible for promptly providing requested reporting information to NHGRI Program Staff. A PD/PI may serve as the Project Manager.

    Budgets should include funds for the PD(s)/PI(s) and key personnel to attend annual meetings.

    Budgets should include any funds required to support sharing of genomic data under this FOA.

    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: Describe the overall focus and goals of the entire proposed NHP dGTEx Project.

    Research Strategy: The research strategy section should provide a scientific vision for, and integrated overview of, how the proposed center would accomplish the objectives of this FOA toward Creation of a tissue resource and generation and analysis of gene expression data in developing non-human primates and how this resource will be made available and useable for the community. Applicants should discuss key decision points and trade-offs, including how they would prioritize scientific and practical choices (resource allocation among activities; how to balance number of tissues vs number of timepoints; which NHP species are chosen; etc.). Applicants are encouraged to propose creative and practical plans to attain the larger goals of this FOA as set out in the Funding Opportunity Description, particularly working towards the vision of an integrated comparative genomics resource for primate development. This section should also include:

    A high-level strategy for generating useful data for the community that complements and builds on human dGTEx and other developmental genomic resources in order to effectively investigate gene expression across developmental stages. The human dGTEx program was initiated a year ahead of NHP dGTEx. This means that decisions on human dGTEX awards and study design will not be finalized at the time that the NHP dGTEx applications are due but will be established by the time that the NHP dGTEx awards are made. Therefore, applicants should describe the approach they will take at the time of award to integrate and incorporate relevant information from the human dGTEx project into their final strategy. This section should also explain how this project will enable the research community to perform comparative genomics analyses that improve our understanding of general, primate-specific, and human-specific expression profiles throughout development, and how such studies can improve our understanding of human health and disease.

    A description of the overall structure of the project including management and reporting structuresGiven the complexity of the project and the number of different activities requested, each of which may require different areas of expertise, the application should describe how the project will operate as a cohesive whole.  Applicants should describe how they will standardize data collection, link animal information to tissue samples, monitor study progress and laboratory performance, and prepare general research results and other reports to the NIH Program Official. In addition, plans for handling logistics such as organizing working group calls and synthesizing and distributing meeting notes and action items should be outlined.  Plans should include coordination with the NHP center(s), the NHP resource community, the dGTEx program components, and with other related initiatives. It should also describe the approach that will be used for coordinating and harmonizing sampling protocols, data standards, and analyses with human dGTEx efforts once awards have been made for both projects.

    A description and justification of the overall study design. This should include the species chosen (at least one each of Old and New World Monkeys), the number and definition of developmental stages (at least 6 spanning prenatal and postnatal development), number and selection criteria for individuals at each developmental stage (at least 12 considering genetic diversity and sex balance), and number of tissues to be collected from each animal (at least 30 representing overlap with human GTEx). Applicants should demonstrate that they understand that final decisions about these priorities for developmental stages and tissue selection may need to change in conjunction with final decisions by the human dGTEx program. In addition to a clear plan for vertebrate animal use as required for all NIH projects, there should be a discussion about the animal welfare considerations and a strong scientific justification for this particular use of NHPs.  Applicants are encouraged to consider opportunistic sampling and/or banked samples when possible.  Clear decision-making processes for establishing trait, phenotype, and health data to collect for each animal should also be outlined.

    A plan for the provision of high-quality blood and tissue samples for DNA and RNA sequencing, as well as the maintenance of appropriate sample storage, tracking, and safeguards to preserve samples for future additional assays and analyses. Tissue-specific protocols that yield high quality nucleic acids (DNA and RNA) should be described for bulk tissue and single cell assays, building upon and facilitating comparability with GTEx protocols. Brain tissue processing must include single-cell sequencing of fresh frozen tissue (PMI < 8hrs), utilizing state-of-the-art techniques comparable with the Brain Cell Census Network (BICCN). Applicants should describe how tissues will be preserved so that duplicate experiments and/or experiments using different protocols or platforms can utilize the same starting material. Plans to ensure the preservation and storage of blood samples and extracted DNA and RNA samples to allow for downstream use by the research community should be included and a sustainable plan to provide sample aliquots to the research community is recommended. Applicants who are not using samples from an existing tissue bank should also describe other elements needed for establishing and maintaining a sustainable resource for these samples.

    A plan for genomic data generation. Applicants should describe their plans for generating whole genome sequencing on blood samples and transcriptome sequencing for tissues. Applicants may choose to propose additional plans for single-cell assays and analyses for a subset of samples/tissues and/or additional genomic approaches beyond DNA and transcriptome sequencing (e.g. histone modifications, DNA methylation, open chromatin) for ancillary analyses. Justification should be given for the specific genomic assays performed, and for the balance of single cell and bulk approaches. Information about the amount of material needed, the number of samples/tissues to be assayed (with a rationale), the proposed cost, and a cost/benefit analysis should be included.

    A plan for data analysis, data management and generation of data for the broader research community.  Applicants should describe their plans for analyses of genomic and expression data at the species, individual, tissue and single-cell level in order to achieve the objective of having data available and useable to the research community.  Applicants must include a detailed plan for public data releases, quality assurance/quality control (QA/QC), metadata harmonization, and the integration of NHP dGTEx data with GTEx and dGTEx datasets, as well as, to the extent possible, with comparable data from other organisms. They should also describe how single-cell data will be interoperable with data from the BICCN and Human Cell Atlas initiatives.  This plan needs to ensure that data and metadata are reported in standardized formats with respect to e.g., technology, QC, and cell location registration. Applicants should also outline a vision and proof of principle demonstration of how the data generated by NHP dGTEx can be used in integrative comparative genomics analysis to further elucidate developmental processes and how genomic variation impacts developmental regulation, networks, and pathways in ways that are important for function, health and disease.

    An overall view of how NHP dGTEx will be compatible with additional US and international efforts that provide developmental expression data to the community, as well as with other NHP genomic resources.  The application should convey how different parts fit together and will be coordinated, even if some are funded by other means. For example, NHP dGTEx will need access to computational resources to store, compute on/synthesize, and provide their data to the community. Applicants may propose to use grant funds for this, or may collaborate with existing informatics resources/facilities such as NCBI, the NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL), and the Alliance of Genomic Resources. NHGRI encourages these interactions because they represent a way to improve presentation and access to the resource, improve its sustainability, and leverage other funding. Applicants should demonstrate bioinformatics infrastructure and capabilities to transmit genomic data to the AnVIL and/or other appropriate data resources and for ensuring that data will be interoperable with human dGTEx and GTEx data and various resources for broader dissemination.  

    Plans for community outreach and engagement. Several of the objectives of this FOA require a high degree of community engagement, and the ability to productively lead collaborations with a wide range of consortium members and members of the research community, spanning interest areas (both basic and clinical researchers) and different levels of user expertise.  Therefore, a plan for engaging the user community early and throughout the production of the resource should be included. Applicants should also provide evidence of past successful experience in these areas.

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

    • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
    • A plan for sharing Project datasets (phenotypic, environmental, covariate, sequence data, gene expression, etc.) and associated genomic data should be provided. Awardees are required to comply with the NIH Genomic Data Sharing Policy (https://gds.nih.gov/). The plan should also describe broad data sharing of Project datasets for ‘General Research Use’ as defined by NIH at https://osp.od.nih.gov/wp-content/uploads/standard_data_use_limitations.pdf. Broad data sharing for general research use is required for NHP dGTEx datasets. A plan to share computerized resources such as study protocols, report templates, appropriate meta-data and bioinformatic tools must also be provided (see Notice Announcing the National Human Genome Research Institute’s Expectation for Sharing Quality Metadata and Phenotypic Data).
    • Data generated from NHP dGTEx samples are required to be available to the community and deposited into appropriate data bases for broad data sharing, such as the AnVIL. 
    • Rapid deposition of data into repositories is required. Depending on the type of data, the duration of data production, as well as the quantity of the samples assayed in a given period, the frequency of data deposition might vary. All data must be deposited once data generation is completed. Before this and other data deposits, a period of quality control of up to 3 months might be needed. Interim or periodic deposition might be expected if the data are produced over an extended period of time (e.g. >12 months) and are of sufficient size. For example, in a study generating results on a large number of samples over an 18-month period, data deposition may be expected at regular intervals.

    After initial review, NHGRI program staff will conduct an additional administrative review of the plans for sharing data, software, data analysis, and resources and may negotiate modifications of these plans with the prospective awardee. The final negotiated version of these plans will become a term and condition of the award of the cooperative agreement.

    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 NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at bettie_graham@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

     

    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.

    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? 

    Additionally, for this FOA, how will the scientific knowledge gained address research gaps in our understanding of development? Is the plan for providing a useful and useable community resource adequate? Will this project enable comparative genomics analyses that improve our understanding of primate-specific, and human-specific expression profiles throughout development?

    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?

    Additionally, for this FOA, does the PD(s)/PI(s) have prior experience working as part of a large collaborative research project that involves multiple investigators at different institutions, developing consensus approaches to address particular research-related topics, or other collaborative activities to meet individual study and collaborative goals? Will the PD(s)/PI(s) dedicate sufficient time to meet the needs of NHP dGTEx? 

    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?

    Additionally, for this FOA, are data sharing and analysis plans sufficiently innovative to meet the goals of the project? As new technologies become available, is the research team poised to leverage and implement them to do further research analyses? Are there effective and innovative plans for outreach to the community?

    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? 

    Additionally, for this FOA, will the conceptual design and overall operating plan effectively use comparative genomics approaches to investigate gene expression across developmental stages? Do applicants describe an adequate approach for incorporating relevant information from the human dGTEx project into their final strategy? Do the applicants describe an overall structure for the project to operate as a cohesive whole?  Are the proposed species, animals, developmental stages, tissue types, and assays well justified? Is there a plan to maximize the benefits of these samples, including establishing and maintaining a sustainable tissue resource for these samples?  Do the applicants have plans that will yield high quality nucleic acid (DNA and RNA) sequencing data? Are other genomic assays appropriate and well justified? Have investigators presented an adequate plan for QC and analysis that will enable the objective of having data available and useable to the research community? Does the data management plan include approaches that will facilitate the interoperability of the resultant datasets with data from other initiatives? Does the operating plan provide opportunity for collaboration, integration, and interaction with other appropriate resources?  Are there adequate plans for engaging the user community early and throughout the production of the resource?

    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? 

    Additionally, for this FOA, are the resources, equipment, and infrastructure available and in place (or readily obtainable) to allow for quick ramp-up? Are the bioinformatics infrastructure and capabilities and computational resources in place (or readily obtainable) and adequate to support the project?

    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.

    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

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: Sharing Model Organisms.

    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 NHGRI, 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:

    • 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.
    • Will receive a written critique.

    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 NHGRI National Advisory Council for Human Genome Research. 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.
    • Relevance of the proposed project to achieving programmatic balance.
    • Expansion of the community of genomic science to include new investigators, experienced investigators who are new to this field, and investigators from demographic groups or institutions that are generally underrepresented in genomic science
    • Inclusion of new investigators and experienced investigators that are new to NHGRI consortia
    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

    TERMS AND CONDITIONS

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this award will be managed as a 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 awardee. Specific tasks and activities may be shared with NHGRI staff as defined below.

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

    • Determining research approaches, designing protocols, setting project milestones and timelines, and conducting research.
    • Ensuring that the data, software, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan.
    • Preparing abstracts, presentations and publications in a timely manner.
    • Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH, NHGRI.
    • Not disclosing confidential information.
    • Interacting with other relevant NHGRI and NIH activities, as needed, to promote synergy and consistency among similar or related projects.
    • Submitting periodic progress reports in a standard format, including metrics of the use and impact on the community, agreed on with the NHGRI Project Scientist/Scientific Officer (PS/SO).
    • Providing reports, summary statistics, and data, as appropriate, in a timely fashion as agreed upon by the PS/SO.
    • Sharing research resources, tools, and data of interest with other grantees in the human dGTEx program, consistent with achieving the goals of the project.
    • Attending and participating in the human dGTEx Steering Committee and other working group meetings as appropriate and accepting and implementing decisions made by the human dGTEx SC or the PS/SO.
    • Interacting with other relevant NIH activities, as needed, to promote synergy and consistency among similar or related projects.

    Consistent with 45 C.F.R. 75.322, the awardee will own the data and software developed under this award and be able to continue to use these data and software upon expiration or termination of the award.  NIH will have unrestricted access to and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data.  NIH expects that the awardee will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements. 

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

    The Project Scientist/Scientific Officer (PS/SO) at NHGRI is a dual role held by an NHGRI Program Director. In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In the Scientific Officer role, the Program Director will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. The PS/SO will be named in the Notice of Award.

    The PS/SO will have the following substantial involvement:

    • Serving as a liaison, helping to coordinate activities among and for the awardees, including acting as a liaison to the NHGRI and as an information resource for the awardees about genome research activities. The PS/SO will also coordinate the efforts of the grantee(s) with other groups conducting similar studies.
    • Reporting periodically on the progress of the grantees to the NHGRI Director and to the National Advisory Council for Human Genome Research.
    • Assisting awardee(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
    • Providing advice on the management and technical performance of the award.
    • Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
    • Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the awardee has met any milestones required for each year of funding.  
    • Curtailing, withholding or reducing support for any awardee that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
    • Involving NIH or NHGRI staff who may assist the awardee(s) as designated by the PS/SO.
    • Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.

    External Scientific Panel (ESP): The NHGRI PS/SO may engage external scientists with relevant scientific and consortium experience, who are not funded as part of the project and who agree to a confidentiality policy, to provide input and advice to the NHGRI PS/SO about the project. The PS/PO will appoint scientists to the ESP and will determine the durations of service. 

    Activities of the ESP could include:

    • Participating, as appropriate, in grantees meetings, calls, and the annual grantees’ meetings; a subset of ESP members may also meet remotely at other times during the project period, as needed.
    • Reviewing and evaluating the progress of grantees (individually or as a group) in achieving the goals of the project.
    • Recommending changes in priorities based on scientific advances within and outside the project;
    • Providing individual recommendations regarding any changes in the project or grant(s) as necessary.

    The PS/SO will use these recommendations to make project changes, as appropriate.

    Areas of Joint Responsibility:

    If there are multiple awards working toward a common goal, close interaction between the participating grantee(s) and the PS/SO will be required, to manage, assess, and implement the award. This is accomplished by:

    • Meeting in person three times a year (2 in -person and 1 via webinar) to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.  These meetings may be held in conjunction with the human dGTEx steering committee meeting.
    • The human dGTEx SC may establish subcommittees to oversee the development and implementation of consortium policies including data [software] releases, publications and standards, etc. Subcommittees may be either permanent or time limited, may include additional experts, depending on the needs of the research.  Awardees and the PS/SO may participate in these subcommittees and working groups, as appropriate.
    • Establishing best practices for data integration and collaborative analyses as appropriate.
    • Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
    • Generating responses to ESP recommendations.

    The PS/SO will assist and facilitate the group process and not direct it.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel.  It will be composed of 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 disagreement for one award, the first member may be chosen by that 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)

    Jennifer Troyer, Ph.D
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-312-3276
    Email: troyerj@mail.nih.gov

    Peer Review Contact(s)

    Rudy Pozzatti, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-402-8739
    Email: pozzattr@exchange.nih.gov

    Financial/Grants Management Contact(s)

    Devon Bumbray-Quarles
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-451-7928
    Email: devon.bumbray-quarles@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.

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