Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/)  through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Cancer Institute (NCI), (http://www.cancer.gov/) on behalf of the NIH Office of Strategic Coordination (Common Fund).  

Funding Opportunity Title

Development of a Knowledge Management Center for Illuminating the Druggable Genome (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • October 21, 2013 - See Notice NOT-RM-13-026. Technical Assistance Webinar for this RFA.

Funding Opportunity Announcement (FOA) Number

RFA-RM-13-011

Companion Funding Opportunity

RFA-RM-13-010, U01 Research Project--Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.310

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is a part of the new NIH Common Fund program, “Illuminating the Druggable Genome” (IDG). The goal of this program is to increase the understanding of the properties and functions of poorly characterized and/or un-annotated proteins within four of the most commonly drug-targeted protein families. The IDG will include two components, the Knowledge Management Center (KMC, to be supported under this FOA) and the Technology Development Initiative (to be supported under a companion FOA, RFA-RM-13-010).

Applications for KMC under this FOA must be focused on expanding the knowledge about (i.e., “illuminating”) four major families of the Druggable Genome (DG): G-protein-coupled receptors; nuclear receptors; ion channels; and kinases.

The proposed KMC must be organized around two functional units: a Data Organizing Core (DOC) and a User Interface Portal (UIP). The DOC of the KMC will focus on accruing and abstracting primary data and information gathered from analysis of such data on the Druggable Genome through deployment of tools (possibly automatic) for data retrieval of any member of the aforementioned gene families, followed by human-driven curation. The UIP will focus on development of tools to interrogate and display the data obtained by the DOC and facilitate the public dissemination of the data. The KMC awardees will be expected to interact and collaborate with the future awardees of the IDG Technology Development initiative.

Key Dates
Posted Date

September 16, 2013

Letter of Intent Due Date(s)

November 11, 2013

Application Due Date(s)

December 11, 2013  

AIDS Application Due Date(s)

December 11, 2013

Scientific Merit Review

March 2014  

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

December 12, 2013,

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Purpose

This Funding Opportunity Announcement (FOA) is a part of the new NIH Common Fund program, “Illuminating the Druggable Genome” (IDG). NIH Common Fund programs (htp://commonfund.nih.gov/) are intended to support development of cross-cutting transformative programs to fill fundamental knowledge gaps to make rapid progress in solving complex biomedical problems.

The overarching goal of the IDG program is to increase the understanding of the properties and functions of uncharacterized and/or poorly annotated proteins within four of the most commonly drug-targeted protein families, the G-protein coupled receptors (GPCRs), nuclear receptors (NRs), ion channel proteins, and protein kinases. To achieve this goal, the IDG will begin with the establishment of a Knowledge Management Center (KMC) that will rapidly assess the current landscape for further exploration and identification of gaps in knowledge of the DG.

The proposed KMC must consist of three components:

the Data Organizing Core (DOC);

a User Interface Portal (UIP); and

an Administrative Core (AC).

The DOC will be focused on developing an integrated informatics solution that will encompass data accrual, analysis, data-driven prioritizations, and abstraction/summarization. The UIP will serve as a community interface to display, query, and access the data and information gathered by the DOC from multiple data-sources in an integrated manner to facilitate the exploration of the poorly characterized space in the DG by the broader research community.

The immediate aim is to enable a science- and data-driven prioritization of the DG in the four protein families (similar, but not identical, to the results obtained by Edwards et al, Nature. 2011; 470 (7333):163-5; expanded on the website http://baderlab.org/Data/RoadsNotTaken) so that the least well-known proteins can be targeted by the scientific community at-large for subsequent projects, focusing on deeper characterization of function and disease relevance.

The DOC is intended to collect, integrate, and collate information in an automatic fashion for all members of the targeted gene families, followed by extensive human-based curation to ensure data quality. Data sources for the DOC include publications, data available in multiple repositories or with the biopharmaceutical industry, catalogs of reagents, knowledge about biological function or disease relevance, and other relevant resources that are available to the entire biomedical community. The previous list is not extensive and applicants can expand on the number and type of data sources to be queried.

In addition to KMC awardees, the IDG will also include the awardees of the companion initiative for Technology Development under RFA-RM-13-010. This companion FOA is designed to promote the development of transformative technologies that will enable swift, scalable, cost-effective, and robust interrogation of protein families. Outcomes of both IDG initiatives will facilitate the exploration of these proteins by the scientific community at-large.

Background

The human genome has revealed a great deal about the human proteome, though significant portions remain uncharacterized and/or poorly annotated. This absence of annotation has resulted in reduced priority given to exploring the biological space of various portions of the genome. Of the known human genome, only a small subset of expressed proteins has been sufficiently well characterized, and has the requisite properties to have served as targets for the development of therapeutics. Termed the Druggable Genome (DG), it has been described as “…the subset of the ~30,000 genes in the human genome that express proteins potentially able to bind drug-like molecules.” The burning question in this area is how to organize the existing data around the uncharacterized and/or poorly annotated portions of the DG in a manner to identify key gaps in knowledge for empirical follow-up. The demonstrated druggability of proteins in these families and their relationship to diseases suggest that many more of the as yet unannotated members of the DG have the potential to serve as drug targets for diseases and conditions important to human health. The IDG has the possibility to transform research by revealing a number of new activities and potential drug targets. Moreover, it has the potential to transform our understanding of on- and off-target effects by establishing functional relationships among uncharacterized members of the commonly targeted gene families.

The DG is operationally being defined in this FOA as a subset of the human genome coding for proteins that can be modified by small, drug-like, compounds. The term "drug-like" refers to the physical, biochemical, and pharmacological attributes of small molecule compounds that are generally recognized to be required for efficacious clinical drugs in humans. These proteins have served as targets whose activity is modulated by drug-like compounds with resulting effects on various diseases and conditions important to public health. A large number of these targets belong to a few protein families, including GPCRs, ion channels, NRs and protein kinases. Each of these families has many more members than those that have been annotated to date suggesting that with increased knowledge the DG can be expanded, resulting in the addition of many more putative disease targets.

General Objectives of this FOA

This FOA is focused on development of a Knowledge Management Center (KMC) with a Data Organizing Core (DOC), a User Interface Portal (UIP), and an Administrative Core (AC) to provide data aggregation and tool generation to facilitate experimental prioritization of these less-studied members of the DG.

The NIH wants the KMC to develop a comprehensive knowledge-base for the DG that would allow for rapid data querying revealing information about the uncharacterized and/or poorly annotated portion of the DG drawn from existing but disparate data sources, potentially including information from the pharmaceutical industry through strategic partnerships. Data retrieval from existing publicly accessible (and, if possible, voluntarily-shared, privately-held, e.g., pharmaceutical) databases will allow investigators and the NIH to appreciate what is known and what needs to yet be done to uncover function for the 'dark matter' of the DG. The DOC will focus on rapid development and demonstration of an initial informatics platform for accruing data and information on the DG, while the UIP will provide an interface incorporating tools to interrogate and display the data obtained by the DOC. The focus is to create a useful community resource for specific proteins of interest to the IDG, that, in principle, can be applied to any protein target and at the same time to enable multi-faceted sorting and filtering of the list of proteins based on multiple criteria, e.g., to identify the most experimentally accessible proteins with a close connection to a human disease, among others.

The Required KMC Structure and Scientific Objectives

The structure of the proposed KMC must cover three major and well-integrated components:

A) Data Organizing Core (DOC) that will extract, compile in an automated manner, and subsequently manually abstract and curate the most pertinent information stored in public databases (and accessible private databases);

B) User Interface Portal (UIP) that will facilitate user-friendly querying, retrieval, and reporting of the data gathered by the DOC; and

C) Administrative Core (AC) to enable the smooth functioning of the DOC and IUP components as a unified Center as well as to coordinate the interactions of KMC with the awardees of the complementary IDG initiative, Technologies Development FOA (RFA-RM-13-010).

The different KMC units must have a complementary set of capabilities in order to meet the objectives and milestones delineated in this FOA. For details on these milestones refer to Section IV, under each separate component.

Specific scientific objectives for each KMC unit are described below.

A. Data Organizing Core

The staff members of the DOC must have expertise and capabilities suitable for efficient gathering, abstracting, and organizing molecular and functional data on the genes and proteins identified as part of the uncharacterized or poorly annotated space of the DG. As such, the DOC will have to identify the data sources (databases both public and accessible private, the existing literature, patent applications, etc.) that could be used to gather the required data for such protein annotation. The proposed DOC may use various methodologies for the data parsing, abstracting, curation, and annotation, providing details on capabilities to be used and scientific justification on all the choices (i.e., data sources, methodologies proposed, etc.). Ideally, the data gathering should be done in an automatic manner, preserving the manpower for the detailed curation and abstraction of the information.

Some examples of the desirable capabilities and activities for a DOC are detailed below.

1. Data accrual, abstraction, and integration: The proposed DOC is expected to accrue and abstract data available in publicly accessible databases that allow for characterization of proteins in the uncharacterized and/or poorly annotated space of the four protein families aforementioned. It is expected that no data containing personally identifiable information will be acquired by the DOC. Examples of data types that could be collected and abstracted include, but are not limited to:

2. Analysis and modeling methodologies: The proposed DOC must be able to use approaches to demonstrate the utility of modeling, or analysis to produce useful biomedical information that must be easily accessed by the UIP and allow for decision-making on the IDG proteins that are most worthy of further investigation.  Examples of approaches include, but are not limited to:

B. User Interface Portal

The UIP is expected to be a central resource and provide all of the data gathered by the DOC to the research community at-large in an easily navigable and comprehensible format. The key feature of the UIP is to support the querying, visualization, navigation (e.g., via faceted browsing) and reporting of the data gathered by the DOC.

For example, a query may ask for the set of all genes that have complete information on a number of characteristic features, and allow for immediate linking to all publicly available web sites related to the appropriate data sets, such that one may understand whether the gene in question has applicable key reagents, assays, GWAS hits or other coding Single Nucleotide Polymorphisms (SNPs) of interest, related molecular interactions or pathways, cell-specificity, disease-related information, or proof-of-concept studies required for further “functionation.”

The UIP will be responsible for providing access to and sharing of databases, information about reagents and assays, a user-driven interface for knowledge management, such as search tools and display formats for interpretation.

The database specifications should be available to the community and should be supported by a well-defined application programming interface (API). If a formal ontology/taxonomy is needed to develop the portal, one or more widely used schemes should be employed (e.g., Medical Subject Headings (MeSH), Unified Medical Language System (UMLS), or the National Center for Biomedical Ontology). The applicant must propose methods to promote the use of the UIP by the broader research community, gathering feedback on the usability of the portal, and providing technical support for the tools on the UIP.

The UIP is expected to perform a wide variety of functions to support the objectives stated above. Examples include, but are not limited to:

C.  Administrative Core

The Administrative Core (AC) of the KMC will be responsible for integrating the DOC and UIP investigators to coalesce around the overall goals of the KMC. The AC will be expected to manage budget allocations for the two other KMC units, arrange for Steering Committee and Investigator meetings of the IDG, External Scientific Panel (ESP) interactions, and reports to the NIH. The AC will also be responsible for facilitating cross-communication and trans-IDG interactions. The AC will collate and share milestones and metrics with the NIH staff. The AC will also be responsible for defining the terms of hand-off to the Technology Development investigators minimal administrative details for IDG once the formal project period for the KMC ends.

IDG Integration and Governance

IDG is expected to operate as an integrated network with a joint Steering Committee involving all IDG awardees as its governing body. IDG will also have an External Scientific Panel (ESP). For details see Section VI.2. Cooperative Agreement Terms and Conditions of Award

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 staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The Common Fund intends to fund one award, corresponding to a total of $3,000,000, for fiscal year 2014.

Award Budget

The budget limit for this FOA is $3,000,000 in Total Costs, though the budget should reflect the actual needs of the proposed project.

Award Project Period

Project period of 2 years must be requested.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

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 PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 PHS 398 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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:

The letter of intent should be sent to:

Jean C. Zenklusen, Ph.D.
National Cancer Institute (NCI)
Email: zenklusj@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five  signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide the total budget for the initial budget period for the entire Center application by summing the individual budgets of each of the components (Data Organization, User Interface Portal, and Administration, including sub-contracts); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire KMC.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide the total budget for the entire proposed budget period for the entire Center application, by summing the individual budgets of each of the components (Data Organization, User Interface Portal, and Administration Component, including sub-contracts); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire KMC.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims for the entire KMC.

Research Strategy:  Provide a concise description of the vision and proposed plan for the Center.  What DOC and UIP issues of relevance to the DG are being addressed, what approaches, methods, software, and tools will be generated, who are the prospective users, and how will the Center be useful?  This section should also include a concise description of the structure of the Center, including a brief management plan and organization chart with the role of the Administrative Core defined.

Explain how the KMC units, including key personnel, will interact, how their activities will contribute to the accomplishment of the overall Center goals, and how the organization of the components into a Center will create an entity that will result in a community resource useful and important for the greater biomedical research community.

Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Specific Plan for Sharing Software:  Consistent with the goals of this FOA, a software dissemination plan, with appropriate timelines, is expected to be included in the application.  There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:

Data Organizing Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide a budget that includes funds for Data Organizing activities. Travel for scientific meetings and conferences, as well as Data Organizing Core-specific travel should be requested in this section.

Note: KMC applicants are expected to allocate to the DOC approximately 60% of Center's budget for the first year of funding. In the second year of funding, some of the funds are expected to be shifted to the UIP to accommodate the need to focus on the UIP unit.

Budget for Entire Proposed Period of Support (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide a budget that includes funds for Data Organizing activities. Travel for scientific meetings and conferences, as well as Data Organizing Component-specific travel should be requested in this section.

Biographical Sketch (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Include the biographical sketches for the Data Organizing Component lead(s) as well as others involved in the Data Organizing activities.

Resources (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Describe all resources available for the Data Organizing activities.

Research Plan (Data Organizing Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: This section should include the Data Organizing Core Specific Aims.

Research Strategy: Given the compressed timeframe for completion, applicants will need to be immediately ready to achieve progress upon issuance of the award.

A Data Organizing Core is one of the two major KMC functional units. This section should focus on innovative and high-impact computational and informatics approaches to bring together relevant information about the four protein families of central importance to the IDG program (GPCRs, NRs, ion channels, and kinases), as discussed in the Scientific Objectives section above.  The applicant should identify the research questions s/he proposes to address, and how these questions are related to important problems faced by both translational and basic researchers in understanding the role of the majority of proteins involved in the part of the DG that is not well studied. 

Note: Although this FOA is not prescriptive regarding technologies and approaches, applicants must address all the stated objectives and expectations. Applications that do not address how each of those objectives will be met shall be deemed non-responsive. Non-responsive applications will not be reviewed.

The applicants must demonstrate their proficiency in collecting, synthesizing and presenting information relevant to IDG goals. Familiarity of the team with the wide variety of publically available web portals used in other scientific fields is also expected.

Applications must specify which databases will be used and justify their selection.

It is essential that the applicant propose approaches that have already been established for assessing individual data types and the research aim in this application is to creatively undertake integrative analysis to efficiently accomplish the objectives in the 1-year time frame to beta testing, and 2-year timeframe of this award.  An important element of the specific aims in the application is the balance between algorithmic integration of multiple datasets to extract and weight evidence versus human curation. It is important for applicants to articulate how a useful balance will be achieved between algorithmic analysis and human curation, how they propose to validate the methodologies proposed, e.g., by highlighting how the methodologies replicate the importance and relevance of known targets.

Each application should contain a plan for validation of the scientific methods, approaches, software, tools, and related resources.  This plan should provide the organizing principles by which scientific validation will be conducted. Each application should describe the different kinds of interfaces and functionalities that apply to different stakeholder and user communities.

The products of the Center are expected to be generalizable beyond the specific subset of the proteins described in this FOA and, ideally, can be applied to any subset of the human proteome.  Thus, the applicant should discuss the generalizability of the proposed products of the Center.

The DOC is expected to include streamlined and efficient ways for keeping this resource current with biomedical science advances, including approaches such as: automating as many processes as possible, using human curation creatively, using well-established approaches to data integration from the community and implementing these algorithms and tools within the context of the IDG.

A major product of the Center will be the software that it develops.  The software and tools should be freely available and developed in such a way that they can be turned into professional-grade software and tools.  The Center should: (i) provide tools and resources to users; and (ii) as appropriate, provide software environments where users/developers can contribute their own software, ontologies, and standards.  As appropriate, applicants should also describe data and software management and provenance, software development and testing practices, software toolkit development and deployment, application programming interfaces (APIs), and human subject data privacy and security protections.

Data Sources: Development of comprehensive central databases for particular data types is not within the scope of this FOA, although an applicant may propose the development of one or more limited databases for research and validation of the approaches, methods, software, tools, or related resources being developed in the project.  Putting existing databases in a newly proposed knowledge/research commons, or extending existing knowledge/research commons to data types beyond currently supported databases would be within scope.

Databases and Software: The use of data and metadata standards is critical for achieving the goal of the IDG KM Center. The application should include a plan for how the proposed Center will manage data and metadata standards and formats.  The Center should: (i) engage with community-based standard and format development activities; and (ii) if appropriate, apply community-based standards and formats to the data and metadata that the Center is using for its research. Some amount of data curation will be necessary and such efforts must be described and adequate resources should be devoted to such activities.

Milestones for the Proposed DOC: The applicants must address the Milestones listed below and provide realistic plans substantiating their capabilities to meet these Milestones.

The DOC unit could include an appropriate database for efficient programmatic access and any attendant human curation efforts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:  Applicants are instructed to place the Resource Sharing Plan only in the Overall Component and follow the modified instructions described under that section.

User Interface Portal

All instructions in the PHS398 Application Guide must be followed.

Face Page (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Travel for scientific meetings and conferences, as well as User Interface Portal-specific travel should be requested in this section.

Note: KMC applicants are expected to allocate to UIP approximately 30% of the entire budget in the first year of funding. Appropriate ramping up on the second year may be proposed to allow for full deployment of the UIP.

Budget for Entire Proposed Period of Support (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Travel for scientific meetings and conferences, as well as UIP component-specific travel should be requested in this section.

Biographical Sketch (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed.

Resources (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: describe all resources available for the UIP.

Research Plan (User Interface Portal)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: This section should include the User Interface Portal related Specific Aims.

Research Strategy: This is the second major unit of the IDG KMC. This section should focus on innovative and high-impact software and visualization approaches to bring together relevant information about the four protein families of major interest to the IDG program (GPCRs, NRs, ion channels and kinases), gathered by the DOC and as discussed in the Required KMC Structure and Scientific Objectives section above. The applicant should identify the principles to be used for the design of the UIP, the relevant research questions to address, and how these questions are related to assimilating multiple pieces of evidence so that both translational and basic researchers will be able to use the resource to design appropriate follow-up experiments in understanding the role of the majority of proteins involved in the part of the DG that is not well studied. The UIP must be tailored to: 1) data scientists (including informaticians and computational and quantitative scientists) who wish to access the resources generated by of the DOC; and 2) biomedical scientists who wish to browse, query and perform integrated queries and view the resources generated by the DOC.

The application should explain the plans for outreach to the community, as well as dissemination of the approaches, methods, software, tools, related resources, and associated documentation.

Milestones for UIP:  The applicants must address the Milestones listed below and provide realistic plans substantiating their capabilities to meet these Milestones.

By the end of the first year of project period -- The data curated by the DOC must be available in a usable form for beta-release internally to the IDG program and NIH Staff. This version of the portal must support the interactive and iterative creation of prioritized lists of genes according to a set of criteria that can be manipulated to create different reports. Reports must be printable in a well-formatted manner with listings of criteria used for the generation of such lists.

By the end of the second year of project period -- A publicly available beta version of the UIP must be launched.  A package for deployment of the UIP at another location must be created. While adoption is not required, potential NIH-supported portals that might be willing to deploy/host the portal will have been identified.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: Applicants are instructed to place the Resource Sharing Plan only in the Overall Component and follow the modified instructions described under that section.

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide a budget that includes funds for Administration activities. Travel for IDG-wide community workshops, as well as annual IDG Constorium meetings should be requested in this section. Travel for the ESP members to the annual Consortium meeting should also be included.

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide a budget that includes funds for Administration activities. Travel for an annual IDG Consortium meeting should be requested in this section. Travel for the ESP members to the annual Consortium meetings should also be included.

Center Director’s effort: The scientific and managerial complexity of an IDG KMC will require a substantial amount of the PD/PI's effort to be successful. The KMC PD/PI must commit a minimum effort of 1.2 person-months per year to the Administrative Core activities.

Biographical Sketch (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Include the biographical sketches for the Administration lead(s) as well as others involved in the Administration activities.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Describe all resources available for Administration activities. A strong institutional commitment is encouraged, and should be described if provided. The commitment may include faculty appointments, partial salary support for investigators, purchase of research equipment, and assignment of research space to support the research and facilitate collaboration and interdisciplinary interaction.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: This section should include Administrative Core Specific Aims and an Administrative Core Strategy to achieve them. This third arm of the KMC should constitute approximately 10% of the overall effort.

Research Strategy: The Research Strategy of the Administrative Core should include the following information.

Administrative Plan: The application should describe the management and integration of activities of the two major components in the Center, namely the DOC and UIP. Applicants should specify appropriate administrative/business management staff, as well as the oversight mechanisms that will be used by the Center Director (PD/PI), any Center Co-Directors, and any other relevant key personnel. If multiple geographic sites are involved in the proposed Center, the Administrative Plan should describe the leadership and communication plans to manage the multiple sites. The applicant should describe the proposed Center structure and the application may include an organizational chart. An important function of the Administrative Core is identifying investigators, companies, and other agencies willing to share expertise, data and resources in return for early access. Counting "Hits" to the UIP, user surveys, and reaching out to the user community are all expected. Included in the plan should be hosting of Steering Committee, Investigator and ESP meetings.

Assessment of Progress: The Administrative Plan should describe a set of milestones or defined objectives that the PD/PI and NIH staff can use for semi-annual assessments of whether the proposed research and other activities of the Center are progressing appropriately toward the goals of the Center. NIH recognizes that some basic research accomplishments may not be easily quantifiable; thus, the PI/PD should propose appropriate criteria to measure the progress of the research. The proposed milestones or objectives for the second-year may be less detailed than those for the first year of the project. Since the award uses the Cooperative Agreement mechanism, a set of Center milestones or objectives will be negotiated with program staff prior to the award. Progress toward the milestones or objectives should be reported semi-annually, and the milestones will be reconsidered, and renegotiated if necessary, as part of the annual non-competing renewal process. The list of Center milestones or objectives should be limited to two pages.

Evaluation: The Administrative Plan should include a plan for evaluating the quality and utility of the Center products from the DOC and the UIP. Criteria for evaluation of Center products may include adequacy, trustworthiness, authenticity, integrity, availability, documentation, and transparency.  Specific examples of evaluative information could include tracking the number of users, background/training of the users, requests for services, successful use of the Center products. The research community being served will have expectations that could be documented through mechanisms such as user feedback, letters of support, etc. Methods for assessment, such as user registration, should not be so onerous that they compromise the use of the Center resources.

Infrastructure: Setting up the DOC resource and the UIP requires appropriate computer, data storage, and networking infrastructure resources. The application should describe the infrastructure resources that are available, to be obtained, or will be developed during the award, and justify how these resources will be used to support the research at the host institution as well as the biomedical research community. 

Sustained distribution of Center products: The application should describe a plan for the continued maintenance and distribution of the software, database and tools beyond the funding period.

External scientific panel: The applicant may request funds to support an external advisory panel that will advise the PD/PI about the Center’s activities and monitor progress.  If included, the Administrative Plan should describe the types of expertise that would be on this committee, although the application should not name specific individuals.  The application should describe how the committee would function, and how its advice would be implemented.

Milestones for the Administrative Core: The applicants must address the Milestones listed below and provide realistic plans substantiating their capabilities to meet these Milestones.

By the end of the first year of project period – The DOC and UIP will be fully integrated with adherence to the individual milestones and timelines defined by the investigators with input from the NIH. The KMC will be integrated with the Technology Development awardees to form the IDG Consortium. Regular Steering Committee meetings will be held and an annual in person IDG Consortium meeting will be held.

By the end of the second year of the project period – The AC will have managed any change in balance between the DOC and UIP consistent with stated objectives of the KMC. The AC will have defined mechanisms for exchange of information between and among the Technology Development projects and the KMC. The AC will have defined a minimal set of administrative operating procedures for hand-off to the Technology Development consortium.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification: Applicants are instructed to place the Resource Sharing Plan only in the Overall Component and follow the modified instructions described under that section.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Applicant Information Webinar

An Applicant Information Webinar will be held to provide information about the FOA to prospective applicants. NIH staff will provide an overview of the FOA and answer questions.  The webinar is open to all prospective applicants. Participation in the webinar is not a prerequisite for applying.  Information about how to participate in the webinar will be posted at http://commonfund.nih.gov/IDG/. Potential applicants are encouraged to submit their questions or comments prior to the meeting, as indicated on the website. Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site. NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. 

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in

NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the KMC 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 KMC proposed).

Scored Review Criteria - Overall

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 KMC address an important problem or a critical barrier to progress in the field? If the aims of the KMC are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

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

Specific to this FOA: Is there expertise in handling and displaying integrated, high-dimensional data sets for a variety of uses and users? Are the leadership plans, experience, and levels of effort appropriate for managing a project of this magnitude and duration? 

Innovation

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

Specific to this FOA: Are the approaches proposed applicable to other target classes?    

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

Environment

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

Specific to this FOA: Will the proposed Center benefit from unique features of the scientific environment, specific datasets, or collaborative arrangements? Are the institutional support, equipment, bandwidth, and other physical resources available to the investigators adequate for both the DOC and UIP?

How is the applicant organization concentrating on its core competencies in order to maximize its chances of success?

Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of and added value to the research goals? Does the project take advantage of the best available tools and resources available to the scientific community to-date? Do the letters of collaboration and institutional support show strong commitment to the project?  

Additional Review Criteria - Overall

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 Organizing Core
Review Criteria for User Interface Portal

How well does the management structure support achievement of the proposed goals and milestones? Is the proposed UIP data release plan appropriate for a community resource project?

Review Criteria for Administrative Core
Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 - Overall

As applicable for the KMC 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: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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)the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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 grantee’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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2 "Award Administration Information".

The IDG Program: 

This is the Illuminating the Druggable Genome Program developed through the NIH Common Fund to address the special opportunities related to uncovering new information about the Druggable Genome.  The opportunities are defined by the companion Knowledge Management Center (KMC) and Technology Development initiatives (RFA-RM-13-011 and -010, respectively) for cooperative agreement awards.  The IDG Program is described in the portal: https://commonfund.nih.gov/IDG/.

The IDG Consortium:

This includes the PIs of the set of funded KMC and Technology Development projects and the NIH IDG Working Group.

IDG Steering Committee:

This is the primary forum of the IDG Consortium. The PI(s)/PD(s) of the awards from both KMC and Technology Development projects and the NIH Lead Project Scientist serve on the Steering Committee. See further details about the Steering Committee under Terms and Conditions Section VI.2, Areas of Joint Responsibility.

NIH IDG Working Group:

The IDG Working Group of trans-NIH staff will provide coordination for and management and oversight of the IDG Program. The Working Group membership will include representatives from NIH Institute and Center program staff. The Working Group will receive recommendations from the Steering Committee and the External Scientific Panel. Working Group approval will be required for adoption of Steering Committee recommendations and for the initiation of collaborative projects within the Consortium. The Working Group will report to the NIH Institute and Center Director (ICD) co-chairs from the sponsoring NIH Institutes.

The IDG Consortium will rely on collegial and cooperative interactions among its members. 

External Scientific Panel (ESP):

This will be composed of senior scientists with relevant expertise who are not PI(s)/PD(s) or supported by an award in the IDG Initiative. NIH will appoint the members. The ESP will be responsible for evaluating the progress of the IDG Program, including the IDG KMC and Technology Development projects.

Each year there will be an IDG Consortium Meeting in the DC Metro area. The Consortium Meeting will be held back-to-back with a meeting of the External Scientific Panel. Each project will present its research findings at this meeting. 

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

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

In addition, the NIH Program Officer will:

Other NIH Program Staff:

Areas of Joint Responsibility include:

The Steering Committee is responsible for coordinating the activities of the IDG Projects and is the committee through which the IDG Working Group formally interacts with the IDG Investigators.  Steering Committee membership will include the PI of each Project (limited to one person for a Project with multiple PIs) and the NIH Lead Project Scientist, each of whom will have one vote in IDG Steering Committee actions. The Steering Committee Chair will be appointed by the NIH and drawn from individual project PIs. The IDG Steering Committee may add additional, nonvoting members, as needed. Other government staff may attend the IDG Steering Committee meetings, if their expertise is required for specific discussions. The IDG Steering Committee may set up subcommittees, including KMC or Technology Development staff, NIH Program Staff, and other appropriate experts as needed.

There will be periodic teleconferences at an agreed upon schedule to coordinate activities of the IDG Steering Committee.

There will be one annual in-person Consortium meeting which will involve the ESP.  PIs for each project will include travel to attend such meetings in their budgets. The Administrative Core of the KMC will be responsible for convening IDG Steering Committee and Consortium meetings.

Together, the members of the IDG Steering Committee will:

The External Scientific Panel (ESP):

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Jean C. Zenklusen, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-451-2144
Email: zenklusj@mail.nih.gov.nih.gov

Peer Review Contact(s)

Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: jacobsonrh@csr.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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