Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Introduction

This FOA is a part of the Implementation Phase of the NIH Common Fund program, Illuminating the Druggable Genome (IDG). All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Background

The human genome has revealed a great deal about the human proteome, though significant portions remain understudied. Only a subset of expressed proteins demonstrates the requisite properties to serve as targets for the development of therapeutics. Many bona fide drug targets likely remain to be discovered in the Druggable Genome (DG), which can be defined as a subset of the ~20,000 genes in the human genome encoding proteins that have the potential to bind drug-like molecules. 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. While the number of proteins in the DG is upwards of 3,000, the existing clinical pharmacopeia is represented by only a few hundred targets, leaving a huge swath of biology that remains unexploited.

The discovery of a disease association or the development of a useful tool reagent can accelerate research into a previous understudied protein, such as was the case for BRAF. Thus, while many interesting and critical biological processes and potential therapeutic avenues remain unexplored because an initial, catalyzing event has not yet occurred, the IDG Program will address this bottleneck by systematically querying these understudied proteins to find phenotypic associations and develop useful research tools.

While at the informatics level, genome- and proteome-wide tools can collate information and query all proteins, technical feasibility necessitates a narrower focus of experimental efforts into protein families for which there are definable understudied members along with existing technologies that can be readily adapted at the scale necessary for wholesale elucidation of their function and generation of tools. During the Pilot Phase of the IDG, it was determined that the experimental focus of the IDG will be on the understudied members in the families of non-olfactory GPCRs, ion channels, and protein kinases, as these families contain adequate numbers of understudied members and are well-established druggable families with high potential to impact human health once disease associations are made. It is expected that experimental priorities among the proteins within these three families will change over the period of the project.

The IDG Consortium is expected to transform research by revealing a number of new activities and potential drug targets amongst these understudied proteins. Moreover, it is anticipated that the IDG Consortium will enhance our understanding of on- and off-target effects by establishing functional relationships among understudied members of the commonly targeted gene families.

Thus, the overall long-term goals of the IDG Program are two-fold:

• To advance research through the development, broad dissemination, and use of community scientific resources to study human proteins for which publicly available information or active research is lacking in order to catalyze the discovery of entirely novel biology, with a particular focus on understudied members of the protein kinase, ion channel, and non-olfactory GPCR families.
• To demonstrate the feasibility and benefits of illuminating the roles of understudied proteins, permitting the expansion of such approaches to a broader array of protein families beyond the three families of proteins in the IDG Program.

To accomplish these goals, awardees of this FOA will be working closely with the existing awardees in the IDG program. Awardees from all IDG FOAs will form the nucleus of the IDG Consortium that will pursue the overall goals of the program. Additional non-IDG-funded members could be included in the IDG Consortium in the future.

The current IDG Consortium is made up of awardees from the following FOAs:

• The Knowledge Management Center (KMC; RFA-RM-16-024) aggregates knowledge from a protein-centric viewpoint across the entire human proteome, with an emphasis on the understudied non-olfactory GPCRs, protein kinases, and ion channels that are the focus of the experimental initiative. The KMC also develops a knowledge portal (Pharos) that includes the aggregated data and metadata, a query interface, and deployed informatics tools along with community access to resources developed by the IDG Consortium (see below for further specifics). The main goal of Pharos is to provide access to aggregated data and IDG resources for the broad scientific community.
• The Data and Resource Generation Centers (DRGCs; RFA-RM-16-026) generate and validate new knowledge and/or tools relevant to the understudied members of the protein kinase, ion channel, and non-olfactory GPCR families with the intent of broadly and rapidly disseminating knowledge and tools to the research community. As one of the essential goals of this program, NIH intends that tools and reagents generated by the IDG Consortium will be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be used as widely as possible, enabling further investigation of understudied proteins by the larger scientific community.
• The Resource Dissemination and Outreach Center (RDOC; RFA-RM-16-025) assists in the dissemination of data and tools and the overall coordination of the IDG Consortium. The IDG RDOC works with all IDG Consortium investigators to collect, curate, and disseminate information regarding critical tools and reagents being developed by the IDG Consortium through the IDG Portal.

Contingent on the availability of future funds, the NIH intends to issue additional FOAs to assist in obtaining preliminary experimental data around select understudied proteins.

Objectives and Scope

The purpose of this specific FOA is to solicit applications to build a set of Cutting Edge Informatics Tools (CEITs) that will augment the capability of the KMC as well as the broader IDG Consortium in the following ways: (1) by developing and deploying tools to enhance the community's ability to process, analyze, visualize IDG data, (2) to prioritize new data resources and methods to be incorporated into Pharos that will strengthen predictions about physiological and disease associations around the understudied proteins, and (3) by developing methods to prioritize understudied IDG proteins (non-olfactory GPCRs, protein kinases, and ion channels) for deeper study using experimental assays both within the IDG pipeline or by the larger community. Awardees are expected to work together across the different IDG initiatives to help accomplish the overall goals of the IDG and to disseminate resources developed by them to the broad scientific community.

Details about the planned informatics and experimental activities of the IDG Consortium can be found https://commonfund.nih.gov/idg. The datasets, tools and capabilities currently available in Pharos can be found here.

This FOA solicits applications that would enhance existing tools/approaches and add value (for example, by incorporating data not covered currently by the KMC that facilitates generating associations with disease and physiology) to the capabilities available to the community. These new methods should be focused towards increasing the predictive strength of disease and physiological associations for future investigator-driven studies on understudied proteins. Multiple community workshops held during the pilot phase of the IDG program have concluded that understudied proteins become studied when (1) there are tools to study the protein (e.g., tools that modulate protein activity) and (2) there is biochemical, cellular, or animal model evidence of disease/physiological relevance. Specifically, this FOA solicits applications that would enhance the following capabilities within the IDG: (1) building predictive informatics tools that identify specific understudied proteins with suggestive links to disease, cellular function or phenotype the expectation is that such connections would provide scientific incentives (preliminary data) for these understudied targets to be investigated by researchers in the biomedical community, (2) enhancing the scientific community's capabilities in visualizing complex datasets in Pharos (and other resources) that enable prioritizing understudied proteins for study in relevant disease and physiological cellular and animal models, and (3) generate preliminary experimental data validating the informatics tool.

It is important to note that modeling and informatics activities within the IDG consortium are not necessarily meant for starting drug discovery and development projects; at this point most activities will be focused on finding the role of understudied proteins in physiology and disease, relevant pathways, or identifying ligands or other modulators for them. Proposed approaches may have broad protein family applicability, but at the least must be applicable to all members of at least one of the three protein families of relevance to the IDG program, namely, non-olfactory GPCRs, protein kinases, and ion channels. Methods proposed should keep in mind the domain of focus is understudied proteins. This will require, at the very least, creative approaches to both modeling and validation of such models.

Plans for Experimental Validation: Approaches that aim to build predictive models for prioritizing proteins for further experimental characterization in disease and physiological models within the IDG program should adopt standard algorithmic validation approaches using existing datasets. However, preliminary experimental validation of predictions is key to establishing the utility of a novel algorithm, thus enhancing its adoption in the community. Therefore, applicants proposing to build predictive models should also propose a set of experiments that would provide a validation of their predictions. Proposed experimental validation need not be comprehensive across all proteins, but must include a subset of understudied proteins in either the non-olfactory GPCRs, protein kinases, and ion channels. Validated predictions (or specific prioritizations that come out of baseline experimental validation) will be considered as a factor in prioritization and further study by the IDG Data and Resource Generating Centers (DRGCs) and will be provided to the broader community for their use. It is expected that the algorithms will be made available to the biomedical community in a timely manner as per the data, resource and software sharing plan in this RFA.

The essential elements of a CEIT application must address one or both of the following:

1. Build & experimentally validate predictive model(s) that can be used both by the IDG Consortium and the wider biomedical community. Such predictive models should improve the community's capabilities in associating understudied proteins to their biological, disease, or pharmaceutical relevance. The predictive models along with relevant existing data should be made available to the community via Pharos. The proposals would need to articulate and scientifically justify (a) the value of the proposed predictive model to encourage the community to study an understudied protein, (b) the approaches used to build these models along with a likelihood of success and, (c) alternative or backup options. Methods proposed may be valid for any family of proteins, but should be demonstrated to work on at least one of the IDG protein families. The following list, which is not intended to be comprehensive, describes examples of activities that the awardees to this RFA aim to support to achieve the overall goals of the IDG program:

• Propose scientifically justified datasets to add to Pharos (and make them available through Jupyter Notebooks or similar technologies) that would increase the value of Pharos to the community and enable improved disease and physiological associations for understudied proteins. It is expected that the data in Pharos would enable improved preliminary evidence for future investigator-driven studies.
• Generate and leverage tools to identify proteins most associated with specific phenotypes (understood in a broad sense, causal or modulation, etc., in human or model organism) and prioritize them for study in experimental systems. Phenotypes should place IDG relevant understudied proteins into disease and/or physiologically relevant biochemical, signaling, and biological networks under tissue, healthy, disease, ethnic, or aged conditions.
• Use novel tools to rank predictions of understudied proteins disease/physiology by integrating evidence from model organism data or, human genetic, structural, and biochemical data.
• Enable statistically robust ways to utilize GWAS or sequencing (whole-genome or exome) data to (1) rank predictions for experimental study, (2) to support variant based queries in Pharos, or (3) effect of, for example, GPCR variants on tissue absorption/retention of small molecules.
• Enable utilization of multiple functional genomics efforts underway in the scientific community for IDG prioritizations and characterizing understudied proteins.
• Develop methods to effectively integrate existing large data resources generated by NIH and other community projects to enable the community to study understudied proteins of relevance to IDG.
• Build effective (with appropriate validation and incorporating patient protection as necessary) understudied protein disease relevant predictive ranking models based on Electronic Health Records data.

2. Build new visualizations that would enable the user to navigate the complex data available from Pharos, being generated by the IDG or other datasets not yet being effectively mined in Pharos. The visualizations should enable decision making and ranked prioritization of proteins for further study in relevant disease/physiological models. Visualizations developed can help with data integration or be used to identify gaps in knowledge that prevent making a disease/physiological association for a single or a list of proteins. The following list, which is not intended to be comprehensive, describes examples that applicants to this RFA might propose in order to achieve the overall goals of the IDG program:

• Creating suitable summaries and effective data summaries and visualizations that would enable prioritization of proteins to study within specific contexts (disease, pathways, cellular).
• Generating specific visualizations to enhance the understanding of the role of a protein (family specific) within the context of its interacting partners in the cell or tissue of relevance.
• Developing multi-omics correlation visualizations to integrate different data types and discover the most relevant players in a given pathway, function, and/or phenotype.
• Developing exploratory visualizations that enable users to navigate evidence about single or groups of targets. Highlighting evidence from multiple/orthogonal experimental and predictive perspectives. Likely the visualization methods will need suitable tuning between a broad perspective and the rate at which users can zoom into a specific narrow set of targets that fit specific criteria.
• Exploring temporal cause and effect relationships between proteins, pathways, and tissue context that shed light on disease/physiological associations for an understudied protein.
• Assessing strength of evidence for disease/physiological association for a protein of interest or identify gaps in knowledge in making strong associations.

Utilization of Existing Repositories
Applications may propose interaction with NIH-funded existing research consortia that are focused on generating significant datasets of physiological and disease relevance to components of the NIH. A partial list of NIH-supported data repositories available for reuse can be found here: https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html. However, applications may propose to use other datasets as long as they are publicly available.

Technical Assistance Webinar
The NIH will conduct a Technical Assistance webinar for prospective applicants. An informational/technical assistance pre-application webinar for investigators who are planning to submit an application in response to this RFA will be held on May 31, 2018 at 11:00 am ET. The intent of the webinar is to provide prospective applicants with information on the IDG Program and to address questions pertinent to preparing applications. The webinar is optional and not required for application submission. No pre-registration is required, but questions will be taken in advance and can be sent to DruggableGenome@mail.nih.gov. For more information on the Illuminating the Druggable Genome Program and details on the webinar, please visit the program website https://commonfund.nih.gov/idg/. Frequently Asked Questions regarding the RFA will also be posted on the Common Funds IDG website after the webinar. Applicants are encouraged to review the FAQs and the webinar recording prior to submitting their applications.

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

Section II. Award Information

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

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 - NIH Intramural Program
• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:
Michael Tenuto
Scientific Program Analyst for The IDG Program
6707 Democracy Blvd. Suite 6076
Bethesda, MD 20892
Telephone: 301-827-7090
Fax: 301-480-3503
Email: DruggableGenome@mail.nih.gov

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

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.

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

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

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

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.

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

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

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

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

• All applications, regardless of the amount of direct costs requested for any one year, should include a Resource Sharing Plan.

• Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the IDG SC and approved by NIH staff. A primary goal of the IDG Program is to facilitate discoveries of the broad scientific community for the improvement of public health. Restrictive licensing and sharing practices for IDG-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. Sharing practices that would prevent or block access to or use of IDG program data, tools, and resources for research purposes will be considered to be hindering the goals of the IDG Program. The development of policies, methods, and standards for such sharing is critically important. The NIH expects that the awardees, through the IDG SC, will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing.

• Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. Data should also be made available as appropriate via the IDG Portal that will serve as the central access point for information regarding data, critical tools, and reagents being developed by the IDG Consortium. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to it in the data sharing plan.

• Specific Plan for Protocol, Tool, and Reagent Sharing: As one of the primary goals of this program is to advance research through development, establishment, broad dissemination and use of community resources across the research community, NIH intends that protocols, tools, and reagents generated by the IDG Consortium be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations of understudied proteins by the larger scientific community. For all applications and where otherwise applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, biomaterials, and reagents. The IDG RDOC will work with all IDG Consortium investigators to collect, curate, and disseminate information regarding tools and reagents being developed by the IDG Consortium to be disseminated through the IDG Portal and other sources as appropriate.

• Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected in applications that are developing software. 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. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A dissemination plan guided by the following principles is thought to promote the largest impact:
  • The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  • The terms should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • The software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

• The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

• To help ensure that the IDG KMC and RDOC can provide comprehensive data and tool sets for each understudied IDG protein, Consortium members will be expected to share complete data and tool sets for the studied proteins, including, as appropriate, any preliminary data and tools from the application. Sharing preliminary data used in the application will enhance the study of understudied proteins by the larger scientific community and will be consistent with achieving the goals of the program. Applicants should describe which preliminary data would be shared and how.

• Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).

• Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

Delayed Onset Study

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

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 described throughout the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII. Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

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

If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as 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

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. 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.
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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: How significant are the scientific questions being addressed and will they enable the overall goals of the IDG program by enhancing the ability of the IDG Consortium to make accurate predictions about the biological roles of an understudied protein? If relevant, is the proposed experimental validation approach suitable and appropriate for generating preliminary (not deep) experimental validation of the method(s)? Are the tools likely to increase the predictive power of making disease/physiological associations?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or thoseNew 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?

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: Does the applicant efficiently use available tools and resources to accomplish the goals of the project?

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

Specific to this FOA: Are the datasets identified to build and validate the models scientifically justified? If the applicants are using a non-IDG informatics resource, is it freely available for re-use and/or have appropriate licensing rights been obtained? Does this application adequately account for lack of appropriate prior information about the proteins? Has adequate attention been paid to considerations such as containerization, provenance, and will this approach enhance the FAIRness of the resource? Are the experimental approaches to iterative validation of the algorithms appropriate and sufficient?
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 children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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.

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 children 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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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.

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.

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).

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) Are the plans for making the tools available within Pharos and to the community adequate and appropriate?.

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

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 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.
The review will be convened by {locus of review}

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

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

Applications will be assigned 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 National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
  • Evidence that the applicant and investigators are committed to policies as established by the SC including with regard to confidentiality, sharing of information and resources, and cooperative interaction.
  • Evidence of previous productive, cooperative, collaborative interaction.
  • Evidence that the project will contribute to the diversity of technical and intellectual approaches within the KMC and across the IDG Consortium.

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 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 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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

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.

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

Definitions

NIH IDG Working Group (WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH. This group will be primarily responsible for the stewardship of the IDG Program.

Steering Committee (SC): The SC will provide coordination activities for the IDG Program. The SC will include PDs/PIs of each of the awards and NIH IDG WG members. The SC will be chaired by two PD/PIs that are nominated by the SC and approved by the NIH. The SC will establish subcommittees to oversee the development and implementation of consortium policies including data release. The number of NIH votes may not exceed one third of the total number of votes on the SC. The number of votes for all CEIT awardees will collectively count as one vote. Votes will inform recommendations to the NIH.

External Program Consultants (EPCs): The NIH IDG WG will recruit outside experts (non-awardees) of relevance to the IDG Program to provide advice to NIH. The NIH IDG WG may solicit from the EPCs input on progress made by individual awardee, progress made towards the overall goals of the IDG Program, and any changes in scope or governance that might help the make the output of the IDG Program more effective and useful to the biomedical community.

IDG Consortium: The IDG Consortium will be made up of IDG awardees, the NIH IDG WG and other scientists and groups the SC agrees to include within the Consortium. The Consortium structure is meant to enable the overall goals of the IDG Program.

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

• Determining research approaches, designing protocols, and setting project milestones.
• Conducting the scientific research in the project, reporting progress and milestones or objectives to NIH staff, reporting results to the scientific community, and disseminating approaches, methods, and tools broadly.
• Working with the RDOC and other awardees to maximize impact of the IDG Program and meet program goals and objectives.
• Agreeing to the governance of the IDG Consortium through the SC and the NIH IDG WG, including accepting approved recommendations from the EPCs.
• Actively participating in the IDG SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and subcommittees. At least one in-person SC meeting will be held per year, for which IDG awardees will pay the travel for their attending members.
• Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH IDG WG and Project Scientists as appropriate.
• Ensuring that data are deposited in a timely manner in the appropriate public databases as agreed upon by the IDG SC and approved by the NIH IDG WG. Ensuring that software and other tools and resources developed as part of this project are made publicly available according to IDG policies, and that results of the project are published in a timely manner.
• Agreeing to abide by any policies -- including those regarding intellectual property, data and software release, publication of IDG Consortium papers, quality control metrics, standardization, metadata requirements, and public copyright licensing -- that are recommended by the IDG SC and approved by the NIH IDG WG, as well as applicable NIH policies, laws, and regulations.
• Being prepared for annual administrative site visits by NIH staff.
• Agreeing to participate in the collaborative activities of the Consortium, and agreeing not to disclose confidential information obtained from other members of the IDG Consortium.
• Retaining custody of and having primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

NIH Program Officer

• A NIH Program Officer (PO) will provide the standard programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, and any other programmatic issues that may arise.
• Has the option to recommend, following consultation with the NIH IDG WG, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award. NIH reserves the right to withhold funding or curtail an award in the event of: (a) Substantive changes in the project, or failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Sharing Plans; or (b) Ethical or conflict of interest issues.

NIH Project Scientists

• One or more NIH Program Staff will serve as Project Scientists (PSs), for each IDG award and, as appropriate, to oversee collaborative projects amongst IDG awardees and/or other Consortium members. The PS will serve as the scientific representative of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. If there is more than one PS, one of them will be designated as the Lead PS. The PSs will provide substantial NIH scientific programmatic involvement with the awardee that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones.
• The NIH IDG WG will provide final assessment, review, and approval of IDG project milestones and any renegotiation.

Other NIH Program Staff

• May serve on sub-committees of the IDG SC, as needed. The staff will assist the IDG SC in developing operating guidelines and consistent policies for dealing with situations that require coordinated actions.
• Will help the IDG SC members to coordinate the group process of exchanging information about research approaches and protocol designs and of developing additional IDG policies.
• Will serve as liaisons between the awardees and the EPCs, the Office of Strategic Coordination (Common Fund), and the NIH Institute and Center Advisory Councils.
• Will review and approve, in consultation with the EPCs (as needed), recommendations and plans provided by the IDG SC for collaborative activities amongst IDG awardees or outside groups.

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to develop the IDG Implementation Phase. The awardees, the PSs, and other designated NIH Staff will participate in the annual in-person SC meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. EPCs will attend the annual in person meetings. Other government staff may attend the IDG SC meetings.

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

• The SC will be responsible for coordinating the activities of the IDG projects and is the committee through which the NIH IDG WG formally interacts with the IDG investigators. SC membership will include the PI(s) of each Project, (collectively all CEIT awardees will have one vote on the SC and will designate an individual to cast that vote) and NIH staff appointed by the NIH IDG WG (voting limited to one third of total SC votes). The IDG SC Chair(s) will be appointed by the NIH and drawn from the individual project PIs. The IDG SC may add additional, non-voting, members, as needed.
• The SC will develop a plan to generate, promote, and maintain a name awareness of the IDG Program and the IDG Consortium, including making decisions on names for outward-facing components of IDG Consortium efforts such as, but not limited to, the IDG Portal.
• The SC may choose to open Consortium membership to collaborators not funded through the IDG Program, provided that such members agree to abide by policies enacted by the SC. The SC may generate additional conditions that apply to non-awardee members of the Consortium.
• The IDG SC may set up subcommittees as needed to address particular issues. These subcommittees will include representatives from the IDG and the NIH and possibly other experts. The IDG SC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees. It is anticipated that multiple subcommittees may need to be formed, for example, to address topics such as:
  • Data and Reagent Deposition and Sharing
  • Quality Control and Validation
  • Publications and Outreach
• Under direction of the SC, NIH staff and each awardee will be responsible for outreach. Outreach includes advertising IDG resources (including the KMC, Consortium-generated data and material resources) to potential users in both the public and private sectors. Outreach will include providing letters of support in applications proposing to use IDG-generated resources and applications proposing illumination of ion channels, non-olfactory GPCRs, and protein kinases that have been identified by IDG as understudied.

External Program Consultants (EPCs) will serve as consultants to the NIH:

• The EPCs will provide input and advice to the NIH IDG WG. This could include reviewing and evaluating the progress of the entire IDG Program or individual awardees as well as recommending changes in priorities for the IDG Program based on scientific advances within and outside of the IDG Consortium. The EPCs will be senior, scientific experts who are not directly involved in the activities of the IDG Program. NIH will appoint the EPCs. The NIH IDG WG, and other NIH staff may attend executive meetings with the EPCs.
• The EPCs will meet at least once a year in conjunction with a meeting of the IDG Consortium. The EPCs may also meet by phone or web at other times of the year, as needed.
• Annually, the EPCs will provide individual assessments to the NIH of the progress of the IDG Consortium and will present recommendations regarding any changes in the IDG Program as necessary. The assessments and recommendations will be provided through the IDG WG to the Director of the Office of Strategic Coordination, NIH.

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267