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 Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

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

Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Limited Competition: Knockout Mouse Phenotyping Project Data Coordination Center and Database (UM1)

Clinical Trial Not Allowed

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

Reissue, RFA-RM-15-016

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HG-21-037

Companion Funding Opportunity

RFA-HG-21-036 - Knockout Mouse Production and Phenotyping Project (UM1) Clinical Trial Not Allowed

Assistance Listing Number(s)

93.172; 93.213; 93.396; 93.867; 93.838; 93.837; 93.839; 93.840; 93.233; 93.866; 93.273; 93.855; 93.846; 93.865; 93.279; 93.173; 93.121; 93.847; 93.113; 93.853; 93.351; 93.313

Funding Opportunity Purpose

The purpose of the Knockout Mouse Phenotyping Project (KOMP2) is to produce a comprehensive resource of null-mutant mice, and associated phenotype data, for the purpose of elucidating functional information for each protein-coding gene in the mammalian genome. The goal of this FOA is to provide informatics support to NIH funded projects that are performing high-throughput broad-based phenotyping of mouse knock-out (KO) lines (see RFA-HG-21-036) and to coordinate with international efforts so as to integrate all data into a common database under the auspices of the International Mouse Phenotyping Consortium (IMPC). The Data Coordination Center and Database (DCCDB) will perform the validation, analysis, annotation, visualization, and dissemination of the phenotype data from the knockout lines. Curation will require integration with other data sources.

This is a limited competition RFA. Only recipient organizations funded under (RFA-RM-15-016) are eligible to apply.

Key Dates
Posted Date

August 31, 2021

Open Date (Earliest Submission Date)

October 1, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 1, 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

March 2022

Advisory Council Review

May 2022

Earliest Start Date

July 2022

Expiration Date

November 2, 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

    Background

    Defining the functional role of the complete set of protein-coding genes in the mammalian genome will have a transformative effect on biology and the understanding of human disease. The mouse has long been an important mammalian model system for the study of gene function in human health and disease, and the premiere embodiment of that is the ability to generate knockout (KO) mice. Mouse mutants with phenotypes mimicking human traits are critical research tools for understanding the genetics and physiological mechanisms underlying mammalian biology and disease.

    The original Knockout Mouse Program (KOMP) was launched in 2006 as a trans-NIH effort, stemming from discussions at a 2003 Cold Spring Harbor Laboratory Banbury Center meeting titled “Mouse Genome-wide Targeted Mutagenesis”. The KOMP project created 8,500 null alleles in embryonic stem cells derived from C57BL/6N. In 2011 the program was expanded as the Knockout Mouse Phenotyping Program (KOMP2), funded as a joint trans-NIH and Common Fund program, with the goal of generating and phenotyping mice strains. Since its launch, KOMP2 integrated operations with other members of the International Mouse Phenotyping Consortium (IMPC, http://www.mousephenotype.org/). IMPC scientists implemented uniform phenotyping protocols, data collection methods, and reporting standards, and made all data available via a data portal. Adoption of CRISPR technology in 2014 greatly increased the efficiency of this program. Presently, the KOMP2 research network has produced 5,500 strains and the IMPC has completed an additional 4,200 lines. To date, the KOMP Repository and Mutant Mouse Resource and Research Centers (MMRRC) have distributed over 39,000 products (vectors, Embryonic Stem (ES) cell lines, mice, and services) representing over 5,500 unique genes, which is a strong indication of the value and impact of the program. Importantly, these reagents have been used in 3,800 scientific publications by the research community (www.mousephenotype.org/data/publications).

    The current IMPC data release includes phenotype data for 7,590 genes, which are associated with 89,329 phenotype calls. There are now 599,052 images included (https://www.mousephenotype.org/news/data-release-14/). IMPC publications have described collections of genes with embryo lethal phenotypes, cardiovascular and metabolic phenotypes, deafness phenotypes, and ocular phenotypes (https://www.mousephenotype.org/understand/data-collections/). Statistical analysis has resulted in a plethora of novel gene-phenotype correlations in both well-studied and understudied genes. Because IMPC performs phenotype assays on male and female animals, the network has been able to describe wide-spread, significant effects of sex as a biological variable. Uptake of these data has been robust: web analytics indicate that between 2015 and 2020 about 100,000 unique users view nearly 1 million pages annually.

    Overall, this effort helps scientists explain the genetic basis of many different types of diseases in mice that also occur in humans, including rare diseases that have been under-studied as well as some common chronic diseases that affect much of the human population.

    Over the course of the program, the IMPC has increased its membership: the group currently comprises 22 centers across 6 continents. It is expected that the successful applicants to this FOA will coordinate with the other units of the KOMP2 research network and with the IMPC to identify knockout lines to be phenotyped, further harmonize phenotyping platforms, continue data integration and analysis, and make use of prior know-how and experience.

    Research Objective

    The purpose of this FOA is to solicit applications for a project to continue development and operation of the DCCDB component of the KOMP2 research network. The DCCDB will perform the validation, analysis, annotation, visualization, and dissemination of the phenotype data from the knockout lines. To accomplish this the DCCDB will work closely with the mouse production and phenotyping centers to help coordinate projects, track progress, and facilitate data upload. The DCCDB will maintain standard operating procedures (SOPs) and other associated metadata, and quality control (QC) uploaded data, with a goal to transfer only fully standardized and quality-controlled data into the core data archive (CDA). The CDA will be a robust data repository capable of handling multiple data types. The DCCDB will operate statistical analysis pipelines and perform annotation of the data, employing standard phenotype ontologies. The DCCDB will provide data via a web portal and an application programming interface (API) to external users. Multiple data types will need to be displayed and tools will need to be made available to allow ready access and the ability to visualize and query data. A key goal of this phase of the DCCDB is to expand the use of the web portal, data, and biologic resources by the broader scientific community, this should include integration of the data by building links to human disease databases and other relevant genomics datasets.

    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

    Renewal

    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

    Issuing IC and partner components intend to commit an estimated total of $7.5M total costs to fund 1 award.

    Award Budget

    Application budgets are not limited but need to 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)

    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
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are  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.
      • 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.

    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 or Modular Budget

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

    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: 

    Research Strategy: The Research Strategy should consist of the following subsections, uploaded as a single pdf attachment.

    A) Overall Goals

    B) Data Coordination Center

    C) Database, Web Portal, and Technology Development

    D) Management and Communication Plan

    A) Overall Goals

    Plans for the Continued Operation and Maintenance of the DCCDB: Provide a general overview of the proposed center. Describe the major objectives and aims for the DCCDB, the role it will play within the KOMP2 program and IMPC, and the vision for the DCCDB as a resource for the biomedical research community. Describe improvements and innovations that will enhance how the resources and data generated by the IMPC will be made available to the NIH-supported investigators and the broader biomedical research community. This section must include discussion of the management plan as well as the software and hardware resources that are required to fulfill its objectives. The application should include information on how efficient and unencumbered access to the data will be developed and maintained.

    B) Data Coordination Center (DCC)

    State concisely the goals of the proposed Data Coordination Center and summarize the expected outcomes.

    Progress Report: The applicant should include a detailed report describing activities related to high volume data upload and processing during the last 5 years. The applicant should describe the evolution of the processing methods and innovations that have been implemented.

    Data Exchange/Wrangling: Describe how the DCC will work with the mouse production and phenotyping centers to accomplish the tasks described below. For example, the applicant should describe a process to develop and track versions of SOPs. The data and metadata being uploaded by the DCC should include, but are not limited to, a variety of information types relating to the status and results of phenotyping projects (from gene selection through to phenotyping of mice) and the locations of mice in publicly funded repositories. The applicant should discuss processes to exchange these data with centers, repositories and processes to ensure data integrity. The applicant should describe requirements for, and processes to, transfer of these data into a core data archive.

    Project Tracking: Describe how the DCC will collect and compile data related to “phenotyping plans,” these plans being the gene-centric projects that encompass producing KO mice and phenotyping them. Describe how the DCC will collect and compile related data that may include availability and location of frozen embryos, sperm or mice, status in the mutation production and phenotyping pipelines, and derived data, such as calculations intended to identify incomplete projects. This functionality must allow complex queries of the project, not just gene-centric searches. Describe how the DCC will collect metadata, including a timestamp on all data sets, which will be vital to allow tracking of progress, identification of bottlenecks, incomplete steps, or languishing plans; and also allow for a retrospective analysis of the projects. Describe methods to handle multiple alleles generated by CRISPR/Cas9, as well as to collect and maintain data on genotyping and microinjection experiments.

    Phenotype Data: Describe how the DCC will collect and organize phenotype data and related metadata. The DCC operations should be able to accommodate not only the KOMP2 project, but also be able to continue the upload, QC and integration of data sets from other members of the IMPC to help reach the common international project goals. It is anticipated that multiple data types will be involved, including but not limited to numerical data, image data, graphical data representations and annotation of data. Describe how data will be quality controlled (QC’d), such as by using validation modules to prevent erroneous data from being uploaded to the CDA, and by automated quality control tests to identify questionable data for further investigation by data experts and the originating phenotyping center.

    C) Database (DB), Data Analysis, and Web Portal

    State concisely the goals of the proposed DB and Web Portal and summarize the expected outcomes.

    Progress Report: The applicant should include a detailed report describing activities related to high volume data analysis and annotation during the last 5 years. The applicant should describe the evolution of the processing methods and innovations that have been implemented.

    CDA: Describe software and hardware architecture of a CDA capable of storing and serving a large, complex dataset. The CDA should provide information about the mice and germplasm resources as well as facilitate the ability of researchers to obtain these materials. For phenotype data, it is anticipated that multiple data types will be involved, including but not limited to numerical data, image data, graphical data representations and annotation of data. It is anticipated that there could be the need for displays of Computed Tomography (CT) data, ultrasound, movies, histopathology images, Fluorescence-activated cell sorting data, and the flexibility to include additional data types and phenotype tests in the future. The structure of the CDA should accommodate complex queries. Describe plans and rationale for deposition of data in external databases, e.g., FlowRepository, Sequence Read Archive, or Metabolomics Workbench as appropriate.

    Data Access: Describe custom or adapted software tools for visualization and analysis that will be developed or are currently available, and the method for distribution. Describe API functionalities, and supporting documentation or training, that will be made available. A method of downloading large datasets from the DCCDB should be included so that users can directly query and download all or large parts of the data.

    Data Transfer: The DCCDB should describe the plan to transfer the contents of the database to a long-term, sustainably funded data warehouse, including but not limited to the National Center for Biotechnology Information. For example, it is anticipated that the DCCDB could work with NCBI to deliver data in formats appropriate for dbGaP (http://www.ncbi.nlm.nih.gov/gap).

    Data Analysis: Describe the statistical tools for analysis of the various data types described in the CDA section above. It will be important to automatically identify statistically significant phenotypes and annotate them for every procedure and parameter that is feasible.

    Data Annotation: The parameters measured in the phenotyping procedures will be described using controlled vocabularies and/or structured ontologies in order to make the data accessible and comparable from different centers. Describe tools to support annotation of 2-D and 3-D image data.

    Data Integration: The efforts of the DCCDB should not duplicate the informatics efforts of other projects (e.g., the Mouse Genome Database) funded to describe the characteristics or functions of mouse genes. However, certain useful external annotations should be presented on the IMPC web portal, such as synonyms and genome browser functions. Describe efficient and non-duplicative procedures to incorporate and make available this information. In addition, the applicant also should describe how information from the DCCDB will be transferred or linked to other informatics resources including, but not limited to, the UCSC Genome Browser, ENSEMBL, OMIM, and Mouse Genome Database. Describe plans for improving the utility of the resource to the broader scientific community by building links to human disease databases and other relevant genomics datasets

    Web Portal: The web portal (currently hosted at www.mousephenotype.org) will provide a single point of entry to access KOMP2 and IMPC data for the biomedical community. The application should describe the functionality of the interface that will allow searching by gene, phenotype, and disease terms. The applicant should describe plans to display results of statistical analysis on phenotyping assays using representations that are easily interpreted, with links to assay SOPs and related metadata. The applicant should describe innovative methods to summarize and display 2D and 3D image data including uCT, LacZ stains, X-ray, and ECHO for example.

    Visualization Tools: There is a strong need for improved and innovative visualization tools for various data types. The application should address plans to handle multiple data types and visualizations, including numerical data, image data, graphical data representations and annotation of data. Thus, the user interface and visualization tools must account for these data types and be adaptable for future improvements in data visualization and manipulation as suggested by KOMP2 members and the general scientific community. Describe a plan whereby viewing and manipulation of the data occurs for the most part with tools that are available freely.

    Other Features: The application should describe how the web portal will include tools to access the primary data, compare different KO datasets, and provide tools to search and analyze the KOMP2 data with a variety of third party data on gene function, pathway analysis, and systems analysis. Describe other data display and analysis tools that may be required. The ability to integrate KOMP2 data with other gene function data and to allow and encourage third parties with unique perspectives on human disease, data mining and complex data analysis to utilize the KOMP2/IMPC will be a critical means to accomplish the goals of KOMP2 and key metric for the DCCDB. The application should explain how it will be responsive to the requests of NIH staff, KOMP2/IMPC centers, and the external user community to continue improvement and refinement throughout the project. The web portal should support all major operating systems and browsers. The development of mobile apps is highly desirable.

    D) Management and Communication Plan

    Management: The application should describe a management plan commensurate with the complexity of this effort, including the integration of the separate components, key personnel, section leaders and internal reporting relationships and mechanisms for reporting progress to NHGRI and ORIP/DPCPSI. The proposed management plan should ensure appropriate prioritization of activities, including course corrections when needed; describe how problems will be identified and resolved; encourage and provide training for personnel; maintain visibility and evaluate effectiveness of the efforts. The management plan should discuss past experiences working in large collaborative data production projects of a degree of complexity similar to what is being requested.

    Coordination and Communication: The application must describe a plan to support, facilitate and coordinate communication and provide data to various meetings and sub-committees within the KOMP2 network and the IMPC. The DCCDB will have an important role in participating and contributing to the KOMP2 and IMPC focus groups and subcommittees. The application should describe how the DCCDB will support various working groups’ teleconferences to discuss data, SOPs, QC, and new developments. The center should actively participate in the KOMP2 and IMPC program evaluation activities including progress reports, site visits, and providing additional communication and materials to the NIH as needed.

    Marketing Plan: The DCCDB should present an effective marketing program, aimed at increasing the awareness of the scientific community regarding KOMP2, and generating a plan to identify and recruit additional entities who could potentially contribute to the created databases. The application should describe plans to assist the wider community to effectively access and use data created by KOMP2 resources, conduct additional analyses and apply for grants for secondary deep phenotyping, and where desirable, incorporate these additional datasets with the database. The DCCDB is highly encouraged to develop new marketing methods based upon evaluation of researcher interest via surveys, along with other methods to analyze interactions with the user interface. The applicant should describe methods for developing additional methods to raise visibility of resources available from the KOMP2, including social media and targeted publications. The implementation of a resource tagging system (e.g., RRID) is also encouraged.

    Community Outreach: The DCCDB will also develop a plan to provide community training to enhance the use and utility of the web portal by the user community. Seminars, presentations, posters and workshops should be an element of this effort. The DCCDB should implement mechanisms that solicit regular feedback and opinion from the user community, including comment boxes and online flash-surveys, and then regularly analyze the results.

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

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Awardees are expected to comply with the NIH Genomic Data Sharing (GDS) Policy. NHGRI supports the broadest appropriate genomic, phenotypic, and metadata data sharing with timely data release through widely accessible data repositories. Per NOT-HG-21-022, NHGRI expects applications awarded under this FOA to share comprehensive metadata and phenotypic data associated with the study, use standardized data collection protocols and survey instruments for capturing data, as appropriate, and use standardized notation for metadata (e.g., controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses. For more information on NHGRI’s genomic data sharing expectations, see the NHGRI’s Genomic Data Sharing Policy FAQs webpage. Therefore, responses to this FOA should propose a specific and comprehensive plan for the rapid release of data resulting from the knockout mouse production and phenotyping effort to the appropriate databases. Rapid release of the data to the scientific user community is a key component of the KOMP2 project because of the scope of this community resource project as described in this FOA and because of the national and scientific investment that the NIH will make in KOMP2. Accordingly, applicants should promote innovative methods for achieving the maximum use of the KOMP2 resource.

    Applicants should propose a data sharing plan consistent with this goal that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding principles (Findable, Accessible, Interoperable, Reusable), including:

    • Data and metadata assigned unique and persistent identifiers.
    • Data and metadata retrievable using standardized protocols/APIs.
    • Data pass strict quality metrics.
    • Data have clear provenance.
    • Rich metadata are collected with all data.
    • Wherever possible, community-standard formats, vocabularies, ontologies, quality metrics are used.
    • Plans for sharing protocols and methodologies should be included.

    Investigators responding to this funding opportunity should include a Plan for Sharing Research Resources addressing how unique research resources will be shared or explain why sharing is not possible. NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. Therefore, the applicant's data release plan should address how software or other resources developed under this funding will be publicly released. Applicants should not feel constrained to propose a standard plan for sharing materials, given the scope of KOMP2 as defined by the FOA and the NIH's investment in this project. Widespread dissemination and access to the materials generated through this program to the public and private research sectors are an aim of this FOA and will require innovative methods for achieving the maximum use of the resource to be produced under this project.

    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. 

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

    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.

    In order to expedite review, applicants are requested to notify the National Human Genome Research Institute Referral Office by email at {grahambj@exchange.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 proposed Data Coordination Center and Database (DCCDB) address the needs of the research consortium that it will coordinate and serve? Is the scope of activities proposed for the DCCDB appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?  ? Does the DCCDB serve the needs of investigators in a variety of research areas rather than in a single or few areas? Will the project resources be available to investigators on a local, regional, and national basis?

    Investigator(s)

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the DCCDB? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing genetics research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the DCCDB? Does the applicant have experience overseeing selection and management of subawards, if needed?  

    Innovation

    Does the application propose novel organizational concepts, management strategies, or information technology in coordinating the research consortium the DCCDB will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies or information technology proposed?   Does the application use innovative approaches to collect and provide data and resources generated by the project expeditiously to the biomedical community? 

    Approach

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the DCCDB will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

    Is the project well integrated with the broad based phenotyping activity of the KOMP2 research network? Are adequate approaches proposed for enhancing the capacity or research direction to use innovative technologies, and improve the efficiency of collecting, storing and analyzing the data?

    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 institutional environment in which the DCCDB will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the DCCDB proposed? Will the DCCDB benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

       Is there sufficient Institutional Support for the plans for continuity, as appropriate for the scientific field’s needs? Is the form of this commitment (space, resources) appropriate? Is there evidence of project participation in coordination and integration of its activity with other KOMP2 centers as well as other members of IMPC?

    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.

    Review Criteria for Data Coordination Center

    The DCC Section will receive an overall merit descriptor (outstanding, acceptable, unacceptable) based on consideration of the following items:

    • The quality of the plan to collect and QC mouse production data and metadata;
    • The quality of the plan to collect genotyping information on CRISPR/Cas9 knockout strains;
    • The quality of the plan to collect and QC phenotyping data in multiple formats and metadata;
    • The quality of the plan to track progress of the projects.

    Review Criteria for Core Data Archive

    The CDA Section will receive an overall merit descriptor (outstanding, acceptable, unacceptable) based on consideration of the following items:

    • The robustness of the hardware infrastructure and architecture;
    • The quality of the software platform;
    • The quality of the proposed API and documentation;
    • The quality of the plans for maintaining continued access to the dataset.

    Review Criteria for Data Analysis and Annotation

    The Data Analysis and Annotation Section will receive an overall merit descriptor (outstanding, acceptable, unacceptable) based on consideration of the following items:

    • The likelihood that proposed statistical approaches will yield valid annotations;
    • The accessibility and support provided for independent analyses of the dataset;
    • The utility of data integration strategies to the end-user.

    Review Criteria for Web Portal

    The Web Portal Section will receive an overall merit descriptor (outstanding, acceptable, unacceptable) based on consideration of the following items:

    • The quality and robustness of the data visualization tools;
    • The likelihood that end-users will be able to perform complex searches;
    • The quality of the plan to understand, respond to, and enhance the user experience.

    Review Criteria for Marketing Activity and Community Outreach

    The Marketing Activity and Community Outreach Section will receive an overall merit descriptor (outstanding, acceptable, unacceptable) based on consideration of the following items:

    • The likelihood that the marketing plan will increase awareness of IMPC in the biomedical research community;
    • The quality and value of the proposed training strategies.
    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

    For Renewals, the committee will consider the progress made in the last funding period.

    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

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Select Agent Research

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

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by{the National Human Genome Research Institute }, 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.

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

    Applications will be assigned on the basis of established PHS referral guidelines 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. 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 recipient 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) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipient. Specific tasks and activities may be shared within the consortium and with the 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, ORIP, and the Steering Committee (SC).
    • Not disclosing confidential information.
    • Interacting with other relevant NHGRI, ORIP, and NIH activities, as needed, to promote synergy and consistency among similar or related projects.
    • Collaborating with other members of the consortium. Recipient organizations that are part of a consortium will work collaboratively with a DCCDB that is tasked with a variety of roles, such as: ensuring that the products are the highest quality, developing standards; disseminating information; providing logistics, outreach and training, etc.
    • In order for the collaboration to be effective, PDs/PIs are responsible for:
      • Ensuring that the recipient organization receives the appropriate approvals for sharing data between the DCCDB and selected data repositories such as, MGD, DBGaP, and ClinGen and other appropriate public databases.
      • Transferring, in a timely manner, detailed (sequence, variant, phenotypic, etc.) and related data and metadata, as appropriate, to the DCCDB, using agreed-upon formats and processes, to facilitate dissemination of data more broadly through databases such as MGD, DBGaP, and ClinGen and other appropriate databases.
      • Collaborating with IMPC members to establish data formats and standards, to track and document collaborations and incoming samples, report findings, etc.
      • 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) or the SC.
      • Providing reports, summary statistics, and data, as appropriate, in a timely fashion as agreed upon by the SC.
      • Sharing research resources, tools, and data of interest with members of the consortium consistent with achieving the goals of the project.
      • Assessing and disseminating data, protocols, consent materials, and methods developed for or derived from the DCCDB within and outside the Consortium.
      • Abiding by common definitions, protocols, and procedures.
      • Attending and participating in SC and other working group meetings and accepting and implementing decisions made by the SC

    Consistent with 45 C.F.R. 75.322, the recipient 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 recipient 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 and ORIP 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 or ORIP is a dual role held by a 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 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 NIH and as an information resource for the awardees about genome research activities. The PS/SO will also coordinate the efforts of the recipient organization(s) with other groups conducting similar studies.
    • Reporting periodically on the progress of the recipient organizations to IC Directors.
    • Assisting recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action, including coordination with other NIH, national or international efforts.
    • 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 recipient has met any milestones required for each year of funding.  
    • Curtailing, withholding or reducing support for any recipient that fails to make satisfactory progress toward the approved work scope, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
    • Involving NIH staff who may assist the recipient(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/SO will appoint 4-6 scientists to the ESP and will determine the durations of service. Activities of the ESP could include:

    • Participating, as appropriate, in consortium meetings, Steering Committees calls, and the annual recipient organizations’ 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 recipient organizations (individually or as a group) in achieving the goals of the project.
    • Recommending changes in priorities based on scientific advances within and outside the consortium;
    • 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:

    Close interaction between the participating recipient organization(s) and the PS/SO will be required, to manage, assess, and implement the goals of the consortium. This is accomplished by:

    • Establishing a Steering Committee (SC): The SC will be the main governing body of the Consortium. The purpose of the SC will be to recommend directions for a consortium consistent with achieving the project goals, develop consortium policies to build synergy and improve communication and collaboration between the projects, and to provide a forum for discussing progress, challenges and opportunities for the consortium.
    • The SC will be composed of one representative from each of the grants awarded in consortium. Each PD/PI will decide who will be its representative. Multi-PI grants will have one representative. Each representative will have one vote; The PS/SO will be a voting member.

    Responsibilities of the SC will include:

    • Meeting monthly to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.
    • 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 by deadlines agreed upon by the SC and ESP members.
    • The SC may establish working groups to oversee the development and implementation of consortium policies and procedures. Working groups may be either permanent or time limited, may include additional experts, depending on the needs of the research.
    • The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate.
    • It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, at least 60% of the voting members most vote in favor of the proposal.
    • NIH staff will review and approve policies developed by the SC.
    • Awardees will be required to accept and implement policies approved by the SC.
    • 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 or ORIP 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. 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)

    Colin Fletcher
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-496-7531
    Email: fletcherc2@mail.nih.gov

    Oleg Mirochnitchenko
    Office of the Director, National Institutes of Health (NIH)
    Telephone: 301-435-0748
    Email: oleg.mirochnitchenko@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)

    Donna Morris
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-827-2745
    Email: donna.morris@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.

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