Office of Strategic Coordination (Common Fund)
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/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Center for Advancing Translational Sciences (NCATS/NIH) on behalf of the NIH.
Reissue of RFA-RM-18-021
The goal of this funding opportunity announcement (FOA) for the Common Fund Program "Illuminating the Druggable Genome" (IDG; https://commonfund.nih.gov/idg/index) is to solicit applications for pilot projects on IDG-eligible understudied proteins (non-olfactory GPCRs, protein kinases, and ion channels) in order to study them beyond what the IDG’s Centers can accomplish and to validate and demonstrate the utility of IDG-generated reagents, data, and approaches.
Awards will support the generation of additional data and tools around understudied protein(s) identified by the IDG Program to elucidate the function of these proteins in the context of human disease. Data collected and tools generated by these projects will enhance the overall goals of the IDG Program by demonstrating the quality and utility of IDG-generated data and reagents to the scientific community, increasing awareness of the IDG Program through use of IDG-generated resources, and/or extending the characterization of IDG-eligible proteins.The overall goal of the IDG Program is to catalyze research in areas of biology that are currently understudied but that have high potential to impact human health by (1) identifying biochemical, cellular, or animal model phenotypes for understudied proteins from druggable gene families, (2) enabling further investigation of those proteins by providing reagents and tools, and (3) generating, maintaining, and facilitating the use of a minable knowledge base.
July 10, 2019
September 28, 2019
October 28, 2019, 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.
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.
This funding opportunity announcement (FOA) aims to promote innovative research to increase knowledge of understudied non-olfactory G protein-coupled receptors (GPCRs), ion channels, and protein kinases. The submission of small research (R03) applications is encouraged from institutions and organizations proposing projects leading to a better understanding of eligible proteins identified as understudied by the Common Fund Program "Illuminating the Druggable Genome" (IDG; https://commonfund.nih.gov/idg/index).
Small research (R03) grants provide flexibility for initiating discrete, well-defined projects that realistically can be completed in one year and require only limited levels of funding. This program supports different types of projects including, but not limited to, the following:
These awards will support generation of preliminary data and tools around eligible understudied protein(s) identified by the IDG Program with the intent of elucidating the function of these proteins in the context of human disease and obtaining sufficient preliminary and/or validation data for subsequent R01 applications or drug discovery projects. These grants are non-renewable.
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. 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.
This Funding Opportunity Announcement does not accept applications proposing clinical trial(s).
The human genome has revealed a great deal about the human proteome, though significant portions remain understudied that could have implications in various diseases. 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), defined as a subset of the ~20,000 genes in the human genome encoding proteins that have the potential to bind drug-like molecules. 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 or reagent can accelerate research into a previously understudied protein, such as was the case for BRAF. Many interesting and critical biological processes and potential therapeutic avenues remain unexplored because an initial catalyzing event has not yet occurred. Thus, the IDG Program is addressing this issue by systematically querying these understudied proteins to find phenotypic associations and develop useful research tools that could one day translate into new methods for treating diseases.
The IDG Program inspires innovative research by revealing a number of new activities and potential drug targets amongst these understudied proteins. Moreover, it is anticipated that the IDG Program will enhance our understanding of on- and off-target effects by establishing functional relationships among understudied members of the commonly targeted IDG-eligible protein families.
Thus, the overall goal of the IDG Program is to catalyze research in areas of biology that are currently understudied but that have high potential to impact human health by:
The IDG Program is a Consortium made up of a Knowledge Management Center (KMC; RFA-RM-16-024), three Data and Resource Generation Centers (DRGCs; RFA-RM-16-026), a Resource Dissemination and Outreach Center (RDOC; RFA-RM-16-025), and Cutting Edge Informatics Tools (CEITs; RFA-RM-18-011) awardees. More information about the IDG Program can be found at https://commonfund.nih.gov/IDG. Individual awardee information can be found at DruggableGenome.net.
Objectives and Scope
The goal of this FOA is to fund small research projects on IDG-eligible understudied proteins (ion channels, GPCRs and protein kinases) beyond what the IDG’s Centers can accomplish, and/or to validate and demonstrate the utility of IDG-generated reagents, data, and approaches. Awards will support the generation of additional data and tools around understudied protein(s) identified by the IDG Program to elucidate the function of these proteins in the context of human conditions. These projects should be carried out in a short period of time with limited resources as defined by the funding mechanism.
It has been recognized through workshops and publications that understudied proteins become “illuminated” when (1) there are tools to study the protein (e.g., tools that modulate protein activity) and/or (2) there is biochemical, cellular, or animal model evidence of disease/physiological relevance. This FOA was developed to address the need for expanded research and validation experiments on IDG-eligible understudied protein(s), with the intent of producing preliminary data to address the lack of biochemical, cellular, or animal model data associated with many IDG-eligible proteins. IDG-eligible proteins listed below meet at least two of the following three criteria: the protein (1) has a low number of publications/citations, with a Jensen Pubmed score of <50, (2) has minimal or no NIH funding and/or (3) has reagents developed by the IDG Consortium available for characterization of the protein in the context of disease.
IDG-eligible proteins open for study under this FOA:
ADCK1, ADCK2, ADCK5, ALPK2, ALPK3, BCKDK, BRSK1, CAMK1D, CAMK1G, CAMKK1, CAMKV, CDC42BPA, CDC42BPB, CDC42BPG, CDK10, CDK11A, CDK11B, CDK12, CDK13, CDK14, CDK15, CDK16, CDK17, CDK18, CDK19, CDK20, CDKL1, CDKL2, CDKL3, CDKL4, CLK3, CLK4, COQ8A, COQ8B, CSNK1A1L, CSNK1G1, CSNK1G2, CSNK1G3, CSNK2A3, DCLK3, DSTYK, DYRK1B, DYRK2, DYRK3, DYRK4, EEF2K, ERN2, HIPK1, HIPK3, HIPK4, ICK, LMTK2, LMTK3, LRRK1, LTK, MAP3K10, MAP3K14, MAP3K15, MAP3K21, MAPK15, MAPK4, MARK1, MARK3, MARK4, MAST2, MAST3, MAST4, MKNK2, NEK1, NEK10, NEK11, NEK3, NEK4, NEK5, NEK6, NEK7, NEK9, NIM1K, NRBP2, NRK, NUAK2, PAK3, PAK5, PAK6, PAN3, PDIK1L, PHKG1, PHKG2, PI4KA, PIK3C2B, PIK3C2G, PIP4K2C, PIP5K1A, PIP5K1B, PIP5K1C, PKMYT1, PKN3, PNCK, POMK, PRKACB, PRKACG, PRPF4B, PSKH1, PSKH2, PXK, RIOK1, RIOK2, RIOK3, RPS6KC1, RPS6KL1, SBK2, SBK3, SCYL2, SCYL3, SGK494, SRPK3, STK17A, STK17B, STK19, STK3, STK31, STK32A, STK32B, STK32C, STK33, STK36, STK38L, STK40, STKLD1, TAOK1, TAOK2, TBCK, TESK1, TESK2, TLK1, TLK2, TP53RK, TSSK1B, TSSK2, TSSK3, TSSK4, TSSK6, TTBK1, TTBK2, ULK4, VRK2, VRK3, WEE2, WNK2, WNK3
ASIC4, BEST4, CACNA2D2, CACNA2D3, CACNA2D4, CACNG1, CACNG3, CACNG4, CACNG5, CACNG6, CACNG7, CACNG8, CALHM4, CALHM5, CALHM6, CATSPER2, CHRNA10, CHRNB1, CLCA4, CLCC1, CLCN6, CLIC6, GABRP, GPR89A, GPR89B, GRID1, KCNA6, KCNA7, KCNAB2, KCNAB3, KCND1, KCNG2, KCNG3, KCNG4, KCNH4, KCNH6, KCNH8, KCNJ15, KCNJ18, KCNK12, KCNK7, KCNMB3, KCNN1, KCNS1, KCNS2, LRRC38, LRRC55, PKD1L2, PKD1L3, PKD2L2, PLLP, SCN7A, SLC26A1, TMC3, TMC4, TMC5, TMC7, TMEM38B, TMEM63A, TMEM63B, TTYH1, TTYH2
ADGRA1, ADGRA3, ADGRB2, ADGRB3, ADGRD1, ADGRD2, ADGRE1, ADGRE3, ADGRF1, ADGRF2, ADGRF3, ADGRF4, ADGRF5, ADGRG2, ADGRG3, ADGRG4, ADGRG5, ADGRG7, FZD10, GNRHR2, GPR101, GPR12, GPR135, GPR137, GPR139, GPR141, GPR142, GPR146, GPR149, GPR150, GPR151, GPR152, GPR153, GPR156, GPR157, GPR160, GPR162, GPR171, GPR173, GPR174, GPR18, GPR19, GPR20, GPR21, GPR22, GPR25, GPR26, GPR27, GPR3, GPR31, GPR32, GPR34, GPR37L1, GPR4, GPR45, GPR52, GPR6, GPR61, GPR62, GPR63, GPR65, GPR68, GPR75, GPR78, GPR82, GPR85, GPR87, GPR88, GPRC5A, GPRC5B, GPRC5C, GPRC5D, HCAR1, HCAR3, LPAR6, MRGPRE, MRGPRF, MRGPRG, MRGPRX1, MRGPRX2, MRGPRX3, MRGPRX4, NPBWR1, NPBWR2, OXER1, OXGR1, P2RY10, PROKR1, QRFPR, RXFP4, TAAR2, TAAR3P, TAAR8, TAAR9, TAS2R1, TAS2R10, TAS2R13, TAS2R14, TAS2R16, TAS2R19, TAS2R20, TAS2R3, TAS2R30, TAS2R31, TAS2R39, TAS2R4, TAS2R40, TAS2R41, TAS2R42, TAS2R43, TAS2R46, TAS2R5, TAS2R50, TAS2R60, TAS2R7, TAS2R8, TAS2R9
This FOA accepts different types of projects with the intent of generating preliminary and/or validation data for subsequent funding including, but not limited to, the following:
Sufficient justification should be provided to indicate why particular protein(s) were chosen for study. Those projects employing methods that identify multiple proteins for study from the above lists are acceptable but require justification as to why those proteins were chosen, beyond the fact that they are on the eligible protein lists provided.
Applicants are strongly encouraged to use IDG-generated resources either to develop their project or to assist in completing the proposed studies and must include an IDG Resource Usage Statement as noted in the Research Plan. All IDG-generated resources can be found either via the IDG Program's data repository and search engine Pharos, which includes all relevant data associated with understudied proteins collected by the IDG Program, or through the Druggable Genome Protein Illumination Timelines, on the IDG Consortium's website, where applicants can explore available tools developed by the IDG Consortium. If the appropriate resources are not available, the applicant should indicate how their work will add value to the IDG program.
Consistent with achieving the goals of this program, the NIH expects that information such as collected data, technical protocols, tools, software and any other metadata collected under this FOA is to be made accessible to the RDOC for subsequent upload to IDG-approved repositories, databases and/or Pharos (see Resource Sharing Plan).
The following will be considered non-responsive under this FOA:
Frequently Asked Questions regarding this FOA will be posted on the Common Funds IDG website. Applicants are encouraged to review the FAQs prior to submitting their applications.
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, identifying relevant pathways, or identifying ligands or other modulators. Proposed studies must be applicable to at least one protein from the above list of IDG-eligible proteins.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIH Common Fund intends to commit approximately $1,750,000 in FY 2020, contingent upon receiving scientifically meritorious applications. 9-11 awards are anticipated from this solicitation.
The scope of the proposed project should determine the project period. The maximum project period for an application submitted under this FOA is 1 year.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
Karlie Sharma, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
6701 Democracy Blvd. Suite 900
Bethesda, MD 20892
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: The proposed project must focus on one or more of the IDG-eligible proteins listed above and proposed research must be suitable and appropriate for generating preliminary and/or validation data for subsequent submission of an R01 application or initiation of a drug discovery project. Sufficient justification should be provided to indicate why particular protein(s) were chosen for study. Those projects employing methods that identify multiple proteins for study from the above lists are acceptable but require justification as to why those proteins were chosen, beyond the fact that they are on the eligible protein lists provided. Appropriate justification for the proposed approach can be provided through literature citations, data from other sources, or from investigator-generated data. The project should address critical barriers to understanding the role of understudied proteins in fundamental physiology, in disease processes, and/or as novel therapeutic agents.
Projects that propose work identical to that currently being performed by the IDG Consortium will be considered non-responsive. All applicants should consult? DruggableGenome.net for IDG Consortium current projects and ensure that their work will not overlap that currently being done by the IDG Consortium.
Applicants should ensure that the scientific question being addressed contributes to the overall goals of the IDG program by increasing knowledge of understudied proteins. Projects should elucidate the function and/or structure of the understudied protein(s) in relevant models that will ultimately inform human conditions.
IDG Resource Usage Statement
All applicants should leverage available IDG-generated resources when developing their application. All IDG-generated resources can be found either via the IDG Program's data repository and search engine Pharos, which includes all relevant data associated with understudied proteins collected by the IDG Program or through the Druggable Genome Protein Illumination Timelines on the IDG Consortium website, where applicants can explore available tools developed by the IDG Consortium. As a part of the Research Plan, each applicant is required to submit a short statement describing how IDG program resources are used to develop their project or to assist in completion of the proposed studies. This statement should provide adequate information concerning why (or why not) IDG resources were used. If the appropriate resources are not available, the applicant should indicate how their works will add value to the IDG program.
Applications that do not include an IDG Resource Usage statement will be considered nonresponsive.
Well studied proteins may only be used in projects proposed for this FOA as controls for experiments involving IDG-eligible proteins from the approved list and shall not be the focus of experimental work.
The applicant should have sufficient information to give confidence to the reviewers that the proposed work is feasible, will advance the overall goals of the IDG program by increasing knowledge of understudied proteins and that the data derived from the project would likely be suitable as preliminary and/or validation data for a subsequent R01 application or drug discovery project. Applicants should identify the IDG-eligible protein(s) they propose to study and indicate how their project will help to illuminate the function of the understudied protein(s), what hypothesis will be tested and what tools (if any) will be validated. Projects should help to elucidate the function and/or structure of the understudied protein(s) in relevant models that will ultimately inform human conditions and should address critical barriers to understanding the role of understudied proteins in fundamental physiology, in disease processes, and/or as novel therapeutic agents. Applicants should not propose work identical to that currently being performed by the IDG Consortium (consult the DruggableGenome.net website for IDG Consortium current projects).
The following modifications also apply:
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:
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R03 small grant supports discrete, well-defined projects that realistically can be completed in one year and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, from investigator-generated data including information found on DruggableGenome.net (https://druggablegenome.net/index) and/or from Pharos (https://pharos.nih.gov/index). Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: How will the scientific questions being addressed advance the overall goals of the IDG program by increasing knowledge of understudied proteins? Does the project help to elucidate the function and/or structure of the understudied protein(s) in relevant models that will ultimately inform human conditions? Will the project address critical barriers to understanding the role of understudied proteins in fundamental physiology, in disease processes, and/or as novel therapeutic agents? Does the stated hypothesis provide sufficient justification to indicate why particular protein(s) were chosen?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Is the proposed approach suitable and appropriate for generating preliminary experimental and/or validation data for subsequent submission of an R01 application or initiation of a drug discovery project? Does the IDG Resource Usage Statement provide adequate information concerning why (or why not) IDG resources were used?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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.
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 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.
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.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by NCATS Advisory Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 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 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.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Karlie Sharma, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
Brian Quillin II
National Center for Advancing Translational Sciences (NCATS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.