National Institutes of Health (NIH)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). The FOA will be administered by the National Center for Advancing Translational Sciences (NCATS) on behalf of the NIH.
Resource Dissemination and Outreach Center for Illuminating the Druggable Genome (U24)
U24 Resource-Related Research Projects – Cooperative Agreements
RFA-RM-16-024, U24 Resource-Related Research Projects – Cooperative Agreements
RFA-RM-16-026, U24 Resource-Related Research Projects – Cooperative Agreements
The overarching goal of this FOA and its companion announcements is to generate a research consortium to facilitate the unveiling of the functions of selected understudied proteins in the Druggable Genome using experimental and informatics approaches. This research consortium will be a part of the Implementation Phase of the Common Fund program, “Illuminating the Druggable Genome” (IDG; https://commonfund.nih.gov/idg/index) and will be composed of multiple Data and Resource Generation Centers (DRGCs; RFA-RM-16-026), a Knowledge Management Center (KMC; RFA-RM-16-024), and a Resource Dissemination and Outreach Center (RDOC; RFA-RM-16-025). Pending availability of funds, a future initiative may be issued to focus on Cutting Edge Informatics Tools (CEITs).
This FOA calls for the creation of a Resource Dissemination and Outreach Center (RDOC) to facilitate wide spread access to consortium-generated data and resources as well as to provide overall administration to the IDG Consortium and its relationships with external partners.
November 10, 2016
February 14, 2017
February 14, 2017
March 14, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
March 15, 2017
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
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
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.
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 has been defined as “…the subset of the ~30,000 genes in the human genome that express proteins potentially able 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 6,000, 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. While there are numerous valid approaches to defining understudied proteins, for the purpose of the IDG Program the NIH determined that use of bibliometric measures, e.g., the Jensen PubMed Score (JS; a fractional count of publications correcting for a number of sources of false positives) coupled with a lack of R01 funding was the most useful in terms of identifying a common, working definition of understudied proteins. At the time of preparation of these FOAs, 395 of the 1325 proteins in the GPCR, ion channel, and protein kinase families met these criteria; 143 GPCRs, 118 ion channels, and 134 kinases had a JS < 50, no R01s, and a PubTator score < 150.
The HUGO Gene Nomenclature Committee symbols for the protein targets that will be the initial focus of the IDG Program can be found here:
PRKAG1, PRKAB1, ADCK2, ADCK5, ALPK3, ADCK4, ALPK2, BCKDK, CAMKV, CDKL3, CDKL4, CDKL1, CDKL2, CDK15, CDK17, CDK11B, CDK14, CDK18, CLK4, CDK10, CLK3, CSNK2A2, DGKH, DYRK3, DYRK1B, DYRK4, EEF2K, DYRK2, ERN2, FASTK, GK2, HIPK4, ITPKA, CSNK1G3, CSNK1G2, PRKACG, CSNK1G1, ITPK1, PSKH2, CAMK1D, TK2, PRKACB, PNCK, CAMK1G, CAMKK1, PSKH1, PHKA1, RPS6KC1, PRKCQ, LMTK3, MARK4, MAST3, LRRK1, MAP3K14, LTK, MAP3K10, MAST4, MAST2, MAPK15, MAPK4, MKNK2, CDC42BPG, CDC42BPB, NEK11, NEK5, NEK10, NIM1K, NEK4, NEK6, NRK, NEK7, SCYL1, NRBP2, PIK3C2G, PAK7, PANK3, PIK3C2B, PAK3, PAK6, SCYL3, PDIK1L, PIP4K2C, PIP5K1A, PLK5, PHKG1, PHKG2, PI4KA, PIP5K1B, PKMYT1, PKN3, PRPF4B, TP53RK, PRKRA, PRKY, PXK, RIOK1, RIOK3, RPS6KL1, SBK2, SCYL2, SBK3, SGK494, POMK, SGK223, SRPK3, STK32C, STK33, STK32B, STK40, STK17A, STK36, STK32A, STK38L, STKLD1, STK3, STK31, TESK2, TESK1, TBCK, TLK1, TPK1, TLK2, TSSK6, TSSK1B, TTBK2, TSSK4, TTBK1, TSSK3, UCK1, ULK4, UCK2, WNK2, VRK2, WEE2
HTR3B, HTR3E, HTR3D, CHRNB2, HTR3C, CHRND, CHRNB1, CHRNA10, CHRNA2, CHRNA9, CHRNG, ASIC4, ASIC5, BEST4, CACNA2D1, CACNA2D3, CACNA2D4, CACNB1, CACNB2, CACNB3, CACNA2D2, CACNG6, CACNA1F, CACNB4, CACNG1, CACNG5, CACNG3, CACNG7, CACNG4, CACNG8, CLCNKA, CLIC6, CLIC2, CLCA4, CLCC1, CLCA3P, CNGA4, CLCN6, CLIC5, CLCA2, CLIC3, CATSPER4, CATSPER2, FAM26F, FAM26D, FAM26E, FXYD3, FXYD7, FXYD6P3, GABRA6, GABRG3, GABRR3, GABRB1, GABRG1, GABRP, GABRA5, GABRR1, GPR89A, GLRA3, GLRA4, GLRB, GPR89A, GRID1, GRIK3, HCN3, KCND1, KCNK4, KCNK7, KCNS1, KCNS2, KCNIP1, KCNJ15, KCNMB4, KCNK16, ITPR2, KCNH6, KCNH7, KCNH8, KCNK12, KCNMB3, KCNA6, KCNG2, KCNN1, KCNAB2, KCNIP4, KCNC4, KCNG3, KCNH4, KCNS3, KCNAB3, KCNG4, KCNA7, KCNT1, KCNJ14, KCNJ18, KCNV1, LRRC52, LRRC55, LRRC38, PANX3, PANX2, PLLP, PKD1L2, PKD2L2, PKD1L3, SLC26A1, SCN3B, SCN7A, SCNN1D, SCN2B, SCNN1B, TMC5, TMC7, TMEM38B, TMC3, TMC4, TTYH2, TTYH1
HTR1E, HTR5A, ADGRD1, ADGRE2, ADGRF5, ADGRG4, ADGRG7, ADGRB2, ADGRF2, ADGRF4, CHRM5, ADGRF1, ADGRG3, ADGRG5, ADGRD2, ADGRE1, ADGRE3, ADGRF3, ADGRG2, ADGRB3, ADGRA1, ADGRE4P, ADGRL3, CELSR2, GPR137, FZD10, GPR32P1, GALR3, GPR139, GPR149, GPR171, GPR174, GPR142, GPR151, GPR156, GPRC5D, GPR153, GPR33, GPR25, GPR45, GPR75, GPR88, GNRHR2, GPR150, GPR18, GPR62, GPR82, GPR87, GPR101, GPR173, GPRC5C, GPR32, GPR63, GPRC5B, GPR12, GPR135, GPR141, GPR146, GPR152, GPR157, GPR160, GPR42, GPR52, GPR143, GPR162, GPR26, GPR21, GPR61, GPR20, GPR27, GPR31, GPR34, GPR39, GPR4, GPR6, GPR78, GPR85, GPR19, GPR22, HCAR1, HCAR3, MAS1L, LPAR6, MRGPRX4, MRGPRG, MRGPRX2, MTNR1A, MRGPRE, MRGPRX3, NPBWR1, NPBWR2, NPY6R, NPY2R, NPY5R, OPN1MW2, OXGR1, P2RY10, OXER1, RRH, P2RY11, PROKR1, QRFPR, GPRC5A, RXFP3, RXFP4, S1PR4, SSTR4, SUCNR1, TAS2R31, TAS2R14, TAAR3, TAS2R10, TAS2R41, TAS2R43, TAS2R50, TAAR2, TAAR8, TAS2R19, TAS2R7, TAS2R9, TAS2R13, TAS2R20, TAS2R40, TAS2R60, TAS2R3, TAS2R4, TAS2R5, TAS2R16, TAS2R8, TAAR9, TAS2R39, TAS2R1, TAS2R30, TAS2R42, TAS2R46, TPRA1, AVPR1B, VN1R17P, VN1R3, VN1R5, VN1R1, VN1R4, VN1R2
It is expected that the priorities among the targets 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 accomplish these goals the IDG will be composed of awardees from at least the three initiatives described below. These awardees, in conjunction with future IDG initiative awardees, 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.
Contingent on availability of funds, the NIH plans a future funding opportunity for a set of Cutting Edge Informatics Tools (CEITs) that will augment the capability of the KMC as well as the broader IDG Consortium by deploying tools to enhance the community’s ability to process, analyze, and visualize data around the understudied proteins. Awardees are expected to work together across initiatives to accomplish the overall goals of the IDG and to disseminate resources to the broad scientific community.
The Resource Dissemination and Outreach Center (RDOC) will provide the administrative infrastructure necessary to facilitate and coordinate external partnerships and outreach, as well as internal IDG activities to maximize the impact of the program. The overall programmatic goals of the RDOC are to ensure facile access to resources, including reagents, for the research community and to facilitate collaboration and communication among IDG Consortium participants. In particular, the RDOC will work closely with the other IDG awardees to enable access to all data, protocols, reagents, resources, and methods developed by the IDG investigators, and to provide the public information related to the program.
NIH intends that tools and reagents generated by the IDG Consortium be broadly available and distributed at minimal cost, and without undue intellectual property constraints. The data, tools and reagents generated should be available to be used as widely as possible, thus enabling downstream study of understudied proteins by the larger scientific community. NIH also recognizes that while advertising of resources and dissemination of information about the program are responsibilities of all members of the IDG Consortium, having a center dedicated to these activities can greatly increase the impact of the program. The IDG RDOC will work 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 that will be developed by the Knowledge Management Center. With the other IDG Consortium investigators, the IDG RDOC will develop solutions to facilitate the request and distribution of IDG Consortium-generated tools and reagents within and outside of the IDG Consortium. Whether tools and reagents are distributed by individual investigators, through public repositories, or public private partnerships, the IDG RDOC, via the IDG Portal, is expected to serve as a common community resource for IDG Consortium-generated data, tools, and reagents.
The RDOC will work closely with the KMC, DRGCs, and NIH staff. The RDOC will not only facilitate collaboration within the IDG Consortium, but facilitate collaborations with outside organizations including pharmaceutical companies, professional societies and other scientific programs in order to maximize dissemination of information, data, and resources generated by the program.
Specifically, RDOC will be tasked to:
All applicants are strongly encouraged to contact NIH program staff identified in this FOA to discuss the alignment of their proposed work with the goals of the FOA and with the IDG Program. A Technical Assistance teleconference will be held for potential applicants to this FOA and companion FOAs on December 13, 2016 at 3:30 PM, EST. NIH staff will present an overview of these FOAs, and NIH program, grants management, and review staff will be available to answer questions from prospective applicants. Details for joining this teleconference can be found here: https://commonfund.nih.gov/idg/index. The information session is open to all prospective applicants, but participation is not a prerequisite to apply.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIH intends to commit $500,000 total costs in FY 2018 to fund 1 award.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 6 years.
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.
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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
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.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
This FOA is open to all investigators, including those who are not currently participating in the IDG pilot phase program. Applicants are free to apply to the companion FOAs. However, to encourage participation from a broad representation of the research community, when making funding decisions, NIH intends to consider whether an applicant will be funded as a PD/PI through other IDG FOAs and may choose to limit awards from multiple FOAs. In addition, the IDG Consortium is expected to be open to investigators beyond those funded through the IDG FOAs, as determined by the IDG Steering Committee.
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.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.
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:
Jenna Baker, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
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.
Effective management will require a significant commitment by the Program Director(s)/Principal Investigator(s). For an application proposing a single PD/PI, that PD/PI is expected to devote at least 3 person months annually to the project. If multi-PDs/PIs are proposed, then one PD/PI is expected to commit at least 2 person months annually and the other(s) should devote at least 1 person month each.
The IDG Program will have regular conference calls and meetings. In addition to budgeting for the personnel needed to do the work, applicants should request funds for meeting space and support for an annual meeting of the Consortium in rotating locations (not all will be in Bethesda) and for a biennial international meeting. Applicants should request funds for 2-6 group members to attend the annual meetings, Consortium-led tutorials, and biennial international open innovation meetings organized by the RDOC, as appropriate. The RDOC budget should also include travel costs for 6 NIH-selected External Scientific Consultants for the annual in person meeting.
The RDOC should budget at least 6 person months for an overall program manager that will take responsibility for the day-to-day operations of the RDOC. This person may be a PD/PI. If it is the PD/PI, the person must increase their effort to at least 6 person months for the project.
Budgets should also include costs for monthly Consortium calls/virtual meetings for up to 100 participants and 10 bi-weekly working group calls for approximately 20 participants each.
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:
Research Strategy: The applications sought in this FOA will propose to provide the administrative infrastructure and strategic outreach and resource dissemination for a research consortium. In order to fully assess the potential of the applicant to fulfill this important responsibility, plans must address all the tasks described in Section I Objective and Scope as well as plans for how the IDG RDOC will support and manage the IDG SC in executing its responsibilities as detailed in Section VI Terms & Conditions. In addition, applicants should describe prior experience:
Before knowing the specifics of the projects that will be supported by the IDG Program, it may be difficult for the IDG RDOC applicant to predict the exact volume and types of data and resources that will be generated by IDG Consortium investigators over the lifetime of the IDG Program. As the data/resource storage, analysis, and dissemination needs of the IDG Consortium change with time, and administrative needs evolve (creation of new working group and committees, organization of small meetings and workshops, etc.), the IDG RDOC may be asked to implement modifications to their workflow as agreed upon by the IDG SC. IDG RDOC applicants should indicate their willingness and aptitude to be flexible in their implementation of IDG RDOC coordination.
Management Plan - Describe the plans for management and integration of the IDG RDOC activities, who will oversee the day-to-day activities (e.g., a project manager if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed project; its management structure; personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. The plan should also describe how the various units will be integrated, and how collaborations or subcontracts, if proposed, will be managed.
Outreach and Training - Applicants should describe a plan and allocate sufficient resources to provide outreach to the user communities to educate investigators within and outside of the IDG Consortium about the data, resources, and tools being developed by IDG investigators. Examples include presentations, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community; web-based tutorials; detailed walkthroughs; and user manuals and training guides that describe the features of the consortium resources.
Milestones and Progress - Applicants should define a clear set of goals for the proposed project and semi-annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Applicants should include plans for critically evaluating and revising these milestones on a regular basis. The number and duration of milestones will depend on the project being proposed, so applicants should include these items for every year, as appropriate. Applicants should describe how they will prioritize their activities to ensure that the main goals of the IDG will be achieved. Milestones may be revised at the time of the award.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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.
This initiative is not subject to intergovernmental review.
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.
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.
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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
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 proposed Center address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?
Specific to this FOA: If the proposed IDG RDOC is fully successful in carrying out its plan and mission, will it have a synergistic effect on the overall performance of the IDG Consortium, collaborations between IDG investigators, and the dissemination of data and reagents to the broader scientific community?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA: What is the team’s track record as a facilitator and organizer of large and international groups? What is the team’s experience working with the private sector non-profit and for profit organizations, particularly pharmaceutical and biotech companies?
Does the application propose novel organizational concepts, or management strategies in coordinating the research consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Specific to this FOA: How will the approach enhance the impact and reach of the program?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Specific to this FOA: Is the applicant organization concentrating on its core competencies in order to maximize its chances of success?
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.
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 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).
For consortia involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCATS Advisory Council. The following will be considered in making funding decisions:
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.
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.
This award is excluded from automatic carryover. All carryover actions require IC prior approval.
The final budget period of this award may not be automatically extended. All extension, including the first, require IC prior approval.
This award is excluded from the Streamlined Noncompeting Award Process (SNAP).
All awards will be incrementally funded for a project period up to 6 years – multi-year funded grants will not be awarded under the FOA.
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.
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.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 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.
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 from a multiple PI award will be one. Votes will inform recommendations to the NIH.
External Scientific Consultants (ESCs): 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 ESCs input on progress made by individual awardee, progress made towards the overall goals of 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:
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIH Program Officer
NIH Project Scientists
Other NIH Program Staff
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. ESCs 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:
External Scientific Consultants (ESCs):
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.
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 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.
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.
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)
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
Contact Center Telephone: 800-518-4726
(Questions regarding application instructions and process, finding NIH grant
Email: GrantsInfo@nih.gov (preferred method of contact)
Christine M. Colvis, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
National Center for Advancing Translational Science (NCATS)
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.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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