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 reagents, data, and approaches.
Awards will support the generation of additional data around understudied protein(s) identified by the IDG. Data collected by these projects will enhance the overall goals of the IDG program by demonstrating the quality and utility of IDG data and reagents to the scientific community, increasing awareness of the IDG program, and/or extending the characterization of IDG-eligible proteins.The IDG consortium's purpose is to facilitate the unveiling of the functions of selected understudied proteins in the Druggable Genome using experimental and informatics approaches. Currently, this research consortium is composed of multiple Data and Resource Generation Centers (DRGCs), a Knowledge Management Center (KMC), a Resource Dissemination and Outreach Center (RDOC), and future Cutting Edge Informatics Tools (CEITs).
No late applications will be accepted for this Funding Opportunity Announcement.
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 across multiple disciplines 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 limited levels of funding. This program supports different types of projects including, but not limited to, the following:
The award will support generation of preliminary data around eligible understudied protein(s) identified by the IDG with the intent of producing new knowledge and obtaining sufficient preliminary/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. Only a subset of expressed proteins demonstrates the requisite properties to serve as targets for the development of therapeutics. Many bona fide drug targets likely remain to be discovered in the “Druggable Genome” (DG), which can be defined as a subset of the ~20,000 genes in the human genome encoding proteins that have the potential to bind drug-like molecules. The term "drug-like" refers to the physical, biochemical, and pharmacological attributes of small molecule compounds that are generally recognized to be required for efficacious clinical drugs in humans. While the number of proteins in the DG is upwards of 3,000, the existing clinical pharmacopeia is represented by only a few hundred targets, leaving a huge swath of biology that remains unexploited.
The discovery of a disease association or the development of a useful tool or 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 program will be on the understudied members in the families of non-olfactory GPCRs, ion channels, and protein kinases, as these families contain adequate numbers of understudied members and are well-established druggable families with high potential to impact human health once disease associations are made. It is expected that experimental priorities of the proteins within these three families will change over the period of the IDG program.
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 protein families.
Thus, the overall long-term goals of the IDG Program are two-fold:
To accomplish these goals, awardees of this FOA will be working closely with the existing awardees in the IDG program in the generation of new knowledge and testing of tools and reagents. Awardees from all IDG FOAs will form the nucleus of the IDG Consortium that will pursue the overall goals of the program. Additional non-IDG-funded members could be included in the IDG Consortium in the future.
The current IDG Consortium is made up of awardees from the following FOAs:
The goal of this FOA is to fund pilot projects on IDG-eligible understudied proteins beyond what the IDG’s Centers can accomplish, and/or to validate and demonstrate the utility of IDG reagents, data, and approaches. Specifically, this FOA supports small research projects that focus on pilot/validation studies associated with understudied protein(s) (IDG-eligible proteins; ion channels, GPCRs, and protein kinases) that are of interest to the IDG consortium. These projects should be carried out in a short period of time with limited resources.
Multiple community workshops held during the pilot phase of the IDG program concluded that understudied proteins become “illuminated” when (1) there are tools to study the protein (e.g., tools that modulate protein activity) and (2) there is biochemical, cellular, or animal model evidence of disease/physiological relevance. This FOA was developed to address the need for expanded research and validation experiments on IDG-identified 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 have low Jensen and PubTator Scores and minimal or no R01s.
IDG-eligible proteins open for study under this FOA:
ADCK1, ADCK2, ADCK5, ALPK2, ALPK3, BCKDK, CAMK1D, CAMK1G, CAMKK1, CAMKV, CDC42BPB, CDC42BPG, CDK10, CDK11B, CDK14, CDK15, CDK17, CDK18, CDKL1, CDKL2, CDKL3, CDKL4, CLK3, CLK4, COQ8A, COQ8B, CSNK1G1, CSNK1G2, CSNK1G3, CSNK2A2, DSTYK, DYRK1B, DYRK2, DYRK3, DYRK4, EEF2K, ERN2, HIPK4, LMTK3, LRRK1, LTK, MAP3K10, MAP3K14, MAPK15, MAPK4, MARK4, MAST2, MAST3, MAST4, MKNK2, NEK10, NEK11, NEK4, NEK5, NEK6, NEK7, NIM1K, NRBP2, NRK, PAK3, PAK5, PAK6, PAN3, PDIK1L, PHKG1, PHKG2, PI4KA, PIK3C2B, PIK3C2G, PIP4K2C, PIP5K1A, PIP5K1B, PKMYT1, PKN3, PNCK, POMK, PRAG1, PRKACB, PRKACG, PRKCQ, PRPF4B, PSKH1, PSKH2, PXK, RIOK1, RIOK2, RIOK3, RPS6KC1, RPS6KL1, SBK1, SBK2, SBK3, SCYL1, SCYL2, SCYL3, SGK494, SRPK3, STK17A, STK3, STK31, STK32A, STK32B, STK32C, STK33, STK36, STK38L, STK40, STKLD1, TBCK, TESK1, TESK2, TLK1, TLK2, TP53RK, TSSK1B, TSSK3, TSSK4, TSSK6, TTBK1, TTBK2, ULK4, VRK2, VRK3, WEE2, WNK2
ASIC4, BEST4, CACNA2D2, CACNA2D3, CACNA2D4, CACNB1, CACNB2, CACNB3, CACNB4, CACNG1, CACNG3, CACNG4, CACNG5, CACNG6, CACNG7, CACNG8, CATSPER2, CHRNA10, CHRNA2, CHRNB1, CHRND, CLCA2, CLCA4, CLCC1, CLCN6, CLCNKA, CLIC2, CLIC3, CLIC5, CLIC6, CNGA4, FAM26D, FAM26E, FAM26F, FXYD3, FXYD7, GABRG1, GABRP, GABRR1, GLRA3, GLRA4, GLRB, GPR89A, GPR89B, GRID1, GRIK3, HTR3C, HTR3D, HTR3E, KCNA6, KCNA7, KCNAB2, KCNAB3, KCNC4, KCND1, KCNG2, KCNG3, KCNG4, KCNH4, KCNH6, KCNH8, KCNIP1, KCNIP4, KCNJ14, KCNJ15, KCNJ18, KCNK12, KCNK4, KCNK7, KCNMB3, KCNMB4, KCNN1, KCNS1, KCNS2, KCNS3, KCNT1, KCNT2, KCNV1, LRRC38, LRRC55, PANX2, PKD1L2, PKD1L3, PKD2L2, PLLP, SCN2B, SCN3B, SCN7A, SCNN1B, SCNN1D, SLC26A1, TMC3, TMC4, TMC5, TMC7, TMEM38B, TMEM63A, TMEM63B, TMEM63C, TTYH1, TTYH2
ADGRA1, ADGRB2, ADGRB3, ADGRD1, ADGRD2, ADGRE1, ADGRE2, ADGRE3, ADGRF1, ADGRF2, ADGRF3, ADGRF4, ADGRF5, ADGRG2, ADGRG3, ADGRG4, ADGRG5, ADGRG7, FZD10, GNRHR2, GPR101, GPR12, GPR135, GPR137, GPR139, GPR141, GPR142, GPR143, GPR146, GPR149, GPR150, GPR151, GPR152, GPR153, GPR156, GPR157, GPR160, GPR162, GPR171, GPR173, GPR174, GPR18, GPR19, GPR20, GPR21, GPR22, GPR25, GPR26, GPR27, GPR31, GPR32, GPR32P1, GPR34, GPR37L1, GPR39, GPR4, GPR45, GPR50, GPR52, GPR6, GPR61, GPR62, GPR63, GPR68, GPR75, GPR78, GPR82, GPR85, GPR87, GPR88, GPRC5A, GPRC5B, GPRC5C, GPRC5D, HCAR1, HCAR3, LPAR6, MAS1L, MRGPRE, MRGPRF, MRGPRG, MRGPRX2, MRGPRX3, MRGPRX4, NPBWR1, NPBWR2, NPY2R, NPY5R, OXER1, OXGR1, P2RY10, P2RY11, PROKR1, QRFPR, RXFP3, RXFP4, SUCNR1, TAAR2, TAAR3, TAAR8, TAAR9, TPRA1
This FOA accepts different types of projects with the intent of generating preliminary/validation data for subsequent funding including, but not limited to, the following:
All relevant datasets and capabilities associated with understudied proteins collected by the IDG can be found in Pharos. Applicants are strongly encouraged to use available resources in Pharos when applying to this FOA as part of the justification for the approach selected and/or to assist in accomplishing the goals of the project. Applicants should also review DruggableGenome, the IDG Consortium website, to explore available tools developed by the IDG Consortium and to ensure proposed work does not overlap with ongoing studies being performed by the IDG Consortium.
The following will be considered non-responsive and these applications could be withdrawn:
The applicant should have sufficient information to give confidence to the reviewers that the proposed work is feasible, and that data derived from the project would likely be suitable as preliminary/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 elucidate the function of the understudied protein(s). Projects should help to elucidate the function and/or structure of the understudied protein(s) in relevant models that will ultimately inform human conditions. Consistent with achieving the goals of this program, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be made accessible via Pharos.
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.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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Application budgets are limited to $100,000 in direct costs (excluding subcontract F&A) for one year and need to reflect the actual needs of the proposed project.
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
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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.
With the following additional instructions:
The budget should allocate funds to allow for the applicant to travel and attend the annual IDG face to face meeting.
Research Strategy: Applicants should provide appropriate justification for the proposed approach by including literature citations, data from other sources, or from investigator-generated data.
Applicants should use available resources in Pharos the repository for all understudied protein data produced by the IDG, when applying to this FOA as part of the justification for the approach selected and/or to assist in accomplishing the goals of the project. In addition, applicants should review the additional resources are available on DruggableGenome.net concerning ongoing studies being performed by the IDG Consortium and available IDG-generated tools and reagents prior to submitting an application.Well studied proteins should only be used in projects proposed in this FOA as controls for experiments involving IDG-eligible proteins from the approved list and s?h?o?u?l?d not be the focus of experimental work.
The following modifications also apply:
No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
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.
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.
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.
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.
This FOA 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, a 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 to this FOA can be provided through literature citations, data from other sources, or from investigator-generated data and/or from Pharos. 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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: How will the scientific questions being addressed enable 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?
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 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: Does the proposed project focus on one or more of the IDG-eligible proteins listed? Is the proposed approach suitable and appropriate for generating preliminary experimental/validation data for subsequent submission of an R01 application or initiation of a drug discovery project? How does the applicant use tools and resources available on Pharos to justify the approach and/or accomplish the goals of the project?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
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).
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.
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.
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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://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 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 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)
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Contact Center Telephone: 800-518-4726
Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
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