Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Pilot Projects Investigating Understudied Proteins Associated with Rare Diseases (R03 Clinical Trial Not Allowed)
Activity Code

R03 Small Grant Program

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-TR-22-030
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.350, 93.242
Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications for pilot projects to elucidate a role for understudied proteins associated with rare diseases. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This FOA is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins associated with rare disease.

Key Dates

Posted Date
June 28, 2022
Open Date (Earliest Submission Date)
September 17, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 17, 2022 October 17, 2022 Not Applicable February 2023 May 2023 August 2023
March 15, 2023 March 15, 2023 Not Applicable July 2023 October 2023 December 2023
July 17, 2023 July 17, 2023 Not Applicable November 2023 January 2024 April 2024
October 17, 2023 October 17, 2023 Not Applicable February 2024 May 2024 July 2024
January 16, 2024 January 16, 2024 Not Applicable May 2024 October 2024 December 2024
July 15, 2024 July 15, 2024 Not Applicable November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
July 16, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Introduction

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients.

This funding opportunity announcement (FOA) aims to promote innovative research to increase knowledge of understudied proteins associated with rare diseases. The submission of small research grant (R03) applications is encouraged from institutions and organizations proposing projects leading to a better understanding of eligible proteins listed below.

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:

  • Pilot or feasibility studies;
  • Small, self-contained research projects;
  • Development of research methodology; and/or
  • Development of assays to support compound screening projects;
  • Development of human cell or animal based models.

These awards will support generation of preliminary data and tools around eligible understudied protein(s) with the intent of elucidating the function of these proteins in the context of rare disease and obtaining sufficient preliminary data and/or research resources for subsequent grant applications and/or drug discovery projects. These grants are non-renewable.

This Funding Opportunity Announcement does not accept applications proposing clinical trial(s).

Background
The human genome has revealed a great deal about the human proteome, though significant portions of the genome 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 studied in the “Druggable Proteome” (DP), which can be defined as the fraction of proteins which have the ability 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 DP is upwards of 4,500, the existing clinical pharmacopeia is represented by only a few hundred targets, leaving a huge swath of druggable biology unexploited.

The expanded exploration of the relationship between the protein and the rare disease phenotype, or the development of a useful tool or reagent can accelerate research into a previously understudied protein. Many interesting and critical biological processes and potential therapeutic avenues remain unexplored because an initial catalyzing event (e.g., association with a biologic process or phenotype, creation of tools or reagents for the protein, etc.) has not yet occurred. The purpose of this FOA is to spark such catalyzing events through the support of small R03 awards to identify novel drug targets for the treatment of human disease, specifically rare disease


Objectives and Scope

The goal of this specific solicitation is to provide a needed opportunity for the collection of preliminary data around the role of understudied proteins associated with rare diseases. This FOA will provide funding to support research that will characterize new targets for treatment of human disease among the understudied proteins of the Druggable Proteome. 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 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 understudied proteins. It is expected that the award will be used to obtain preliminary data and/or research resources for subsequent grant applications and/or drug discovery projects.

The NIH supports research on a broad range of diseases that are defined as rare; that is diseases affecting fewer than 200,000 individuals in the United States (per the Rare Disease Act of 2002). Collectively, there are an estimated 7,000 rare diseases, which affect approximately 25-30 million people in the United States. Most are serious or life-threatening, with a disproportionate number of rare diseases affecting children. At this time, effective treatments are available for fewer than 5%. The IDG Program has linked over 6,000 proteins to rare diseases, with over 80% of these proteins considered extremely understudied. For the purposes of this FOA, eligible proteins are those that have an association with rare disease through data mining of the encyclopedia of rare disease annotations for precision medicine (eRAM) and Orphanet, are considered understudied (those proteins that lack small molecule binders and/or have limited biological characterization) and are within a protein family that is traditionally considered druggable.

Proteins open for study under this FOA:

Enzymes:

ARSA, ARSB, ARSE, ATAD3A, BTD, DDAH2, DTX1, DTX4, ERAL1, ETHE1, FANCL, GALNS, GCH1, GNS, HACE1, HECW1, HUWE1, ITCH, MEX3C, MIB1, MIB2, MKRN3, NEDD4L, NGLY1, NHLRC1, OPLAH, OSGEP, PRKN, PSMC5, PTER, RAC1, RAC2, RAP1B, RAP2A, RBX1, RFWD3, RHOA, RHOB, RHOH, RHOJ, RIT1, RRAS, RRAS2, SGSH, UPB1, UROS

Epigenetic Proteins:

AIRE, ARID4B, ASXL1, ASXL2, ASXL3, BAZ1B, BRWD1, BRWD3, CHD2, CHD5, CHD6, CHD7, CHD8, DPF2, DPF3, FMR1, ING1, ING3, JMJD1C, KMT2B, KMT2C, KMT2D, KMT2E, L3MBTL2, LBR, MBD5, MECOM, MLLT10, MORF4L1, MSH6, NSD1, PHF19, PHF21A, PHF6, PRDM1, PRDM12, PRDM14, PRDM15, PRDM16, PRDM5, PRDM6, PRDM8, PWWP2B, RAG2, RAI1, SCML2, SETD4, SETD5, SETDB1, SFMBT1, SMYD4, SP110, SP140, TDRD9, TRIM28, UBR7, UHRF1, ZCWPW1, ZGPAT, ZMYND11

Transcription Factors:

ADNP, AFF1, AFF2, AFF3, AFF4, ALX1, ALX3, ALX4, AP5Z1, ARID1A, ARID1B, ARID2, ARID5B, ARNT, ARNT2, ARNTL, ARNTL2, ARX, ASCL1, ATF3, ATF6, ATOH1, ATOH7, BACH1, BACH2, BARX1, BATF2, BCL11A, BCL11B, BHLHA9, BHLHE40, BNC2, C11orf95, CAMTA1, CEBPA, CEBPD, CEBPE, CERS3, CIC, CREB1, CREB3L1, CREB3L2, CREB3L3, CREM, CRX, CTCF, CUX2, DBX1, DEAF1, DLX3, DLX4, DLX5, DLX6, DMBX1, DMRT1, DMRT3, DNAJC1, DUX4L5, E2F1, EAF2, EBF1, EBF3, EGR1, EGR2, ELF1, ELF2, ELF3, ELF4, EMX2, EN1, EOMES, ERF, ERG, ETS1, ETS2, ETV1, ETV4, ETV6, FEV, FEZF1, FEZF2, FIGLA, FLI1, FOS, FOSB, FOSL1, FOSL2, FOXC1, FOXC2, FOXE1, FOXE3, FOXF1, FOXG1, FOXH1, FOXI1, FOXL2, FOXM1, FOXN1, FOXO1, FOXO3, FOXP1, FOXP2, FOXP3, GABPA, GATA1, GATA2, GATA3, GATA4, GATA5, GATA6, GATAD1, GATAD2B, GBX2, GCM2, GFI1, GFI1B, GLI3, GLIS2, GLIS3, GRHL2, GRHL3, GSC, GSX2, GTF2I, GTF2IRD1, HAND2, HES1, HES7, HESX1, HEY1, HEY2, HHEX, HIC1, HIVEP2, HLF, HMG20A, HMGA1, HMGA2, HMGB3, HMX1, HNF1A, HNF1B, HOXA1, HOXA11, HOXA13, HOXA2, HOXA3, HOXA4, HOXA5, HOXA9, HOXB1, HOXB13, HOXB8, HOXC13, HOXD10, HOXD11, HOXD12, HOXD13, HSF4, ID1, ID2, ID3, IKZF1, IKZF2, IKZF3, INSM1, IRF4, IRF5, IRF6, IRF8, IRX2, IRX4, IRX5, ISL1, JUNB, JUND, KLF1, KLF11, KLF4, LCOR, LHX1, LHX2, LHX3, LHX4, LIN28B, LITAF, LMX1B, LYL1, MAF, MAFB, MAFF, MAFG, MAX, MEF2C, MEIS2, MEOX1, MESP2, MGA, MLXIPL, MNT, MNX1, MSGN1, MSX1, MSX2, MTF1, MXI1, MYB, MYBL1, MYCL, MYCN, MYF6, MYNN, MYOD1, MYSM1, MYT1L, NEUROD1, NEUROG3, NFIA, NFIB, NFIX, NKX2-1, NKX2-3, NKX2-5, NKX2-6, NKX3-2, NKX6-1, NOBOX, NRL, OLIG1, OLIG2, OTX2, OVOL2, PAX1, PAX2, PAX3, PAX4, PAX5, PAX6, PAX7, PAX9, PBX1, PDX1, PEG3, PHOX2A, PHOX2B, PITX1, PITX2, PITX3, PLAG1, PLAGL1, PMS1, POU1F1, POU2F2, POU3F1, POU3F4, POU4F1, POU4F3, POU5F1, POU6F2, PROP1, PROX1, PRRX1, PTF1A, RAX, RAX2, RCOR1, REL, RERE, REST, RFX5, RFX6, RFX7, RNF138, RREB1, RUNX1, RUNX2, RUNX3, SALL1, SALL2, SALL3, SALL4, SATB2, SHOX, SIM1, SIX1, SIX2, SIX3, SIX5, SIX6, SMAD1, SMAD4, SMAD6, SMAD9, SMARCE1, SNAI1, SNAI2, SNAI3, SOHLH1, SOX10, SOX11, SOX15, SOX17, SOX18, SOX2, SOX3, SOX4, SOX5, SOX8, SOX9, SP6, SP7, SPI1, SPIB, SRY, ST18, STAT2, TAL1, TAL2, TBR1, TBX1, TBX15, TBX18, TBX19, TBX2, TBX20, TBX22, TBX3, TBX4, TBX5, TBX6, TBXT, TCF12, TCF15, TCF3, TCF4, TCF7L1, TCF7L2, TCFL5, TEAD2, TFAM, TFAP2A, TFAP2B, TFDP1, TFE3, TFEB, TFEC, TGIF1, THAP1, THAP3, TLX1, TLX3, TP63, TP73, TRERF1, TRPS1, TSHZ1, TUB, TULP1, TWIST1, TWIST2, UBTF, VAX1, VSX1, VSX2, VTN, WT1, YY1, ZBED4, ZBTB16, ZBTB17, ZBTB18, ZBTB20, ZBTB24, ZBTB40, ZEB1, ZEB2, ZFAT, ZFHX3, ZFHX4, ZFP57, ZFP90, ZFPM2, ZIC1, ZIC2, ZIC3, ZIC4, ZIC5, ZIM2, ZMIZ1, ZNF131, ZNF141, ZNF148, ZNF205, ZNF230, ZNF254, ZNF335, ZNF408, ZNF41, ZNF423, ZNF430, ZNF469, ZNF513, ZNF526, ZNF536, ZNF596, ZNF668, ZNF711, ZNF765, ZNF774, ZNF81, ZNF816, ZNF831

Transporters:

ABCA12, ABCA3, ABCA4, ABCA5, ABCA7, ABCB4, ABCB5, ABCB6, ABCB7, ABCC3, ABCC6, ABCD1, ABCD3, ABCD4, ABCE1, ABCG1, ABCG5, ABCG8, ATP10A, ATP11A, ATP13A2, ATP2B1, ATP2B2, ATP2B3, ATP2B4, ATP2C1, ATP8A2, ATP8B1, SLC11A1, SLC12A6, SLC14A2, SLC16A11, SLC16A12, SLC16A13, SLC16A2, SLC17A5, SLC17A8, SLC19A2, SLC19A3, SLC1A4, SLC20A1, SLC20A2, SLC22A16, SLC22A18, SLC22A23, SLC22A4, SLC22A5, SLC24A1, SLC24A3, SLC24A4, SLC24A5, SLC25A1, SLC25A12, SLC25A13, SLC25A15, SLC25A19, SLC25A20, SLC25A22, SLC25A24, SLC25A26, SLC25A3, SLC25A32, SLC25A38, SLC25A4, SLC25A44, SLC25A45, SLC25A46, SLC26A2, SLC26A3, SLC26A4, SLC26A5, SLC26A8, SLC26A9, SLC27A5, SLC28A1, SLC29A3, SLC2A10, SLC2A9, SLC30A10, SLC30A4, SLC30A5, SLC30A6, SLC30A8, SLC30A9, SLC31A1, SLC34A3, SLC35A1, SLC35A2, SLC35A3, SLC35C1, SLC35D1, SLC35G2, SLC38A2, SLC38A8, SLC39A11, SLC39A12, SLC39A13, SLC39A14, SLC39A4, SLC39A6, SLC39A8, SLC3A1, SLC43A3, SLC44A4, SLC45A1, SLC45A2, SLC4A1, SLC4A10, SLC4A11, SLC4A2, SLC4A4, SLC4A8, SLC51A, SLC51B, SLC52A1, SLC52A2, SLC52A3, SLC5A3, SLC5A5, SLC6A17, SLC6A18, SLC6A20, SLC6A8, SLC7A14, SLC7A7, SLC7A9, SLC9A3R1, SLC9A6, SLCO3A1

G-Protein Coupled Receptors:

ACKR1, ADGRE2, ADGRG1, ADGRG2, ADGRV1, FZD2, FZD5, FZD6, GPR101, GPR143, GPR15, GPR153, GPR161, GPR179, GPR65, GPRC5A, MRGPRF, OPN1LW, OPN1MW, OPN1SW, RGR, RHO

Ion Channels:

ANO6, BEST1, CACNA2D4, CACNB2, CACNB4, CACNG2, CLCA2, CLCA4, CLCN1, CLCN5, CLIC1, CLIC2, CLIC5, CLIC6, CNGB1, FXYD6, GPR89B, GRID2, ITPR2, KCNAB2, KCNE2, KCNE3, KCNJ10, KCNJ15, KCNJ18, KCNJ8, KCNK16, KCNMB2, MLC1, PIEZO2, PKD1L1, SCN1B, SCN2B, SCN3B, SCN4B, SLC26A1, TMC1, TMC6, TMC8, TMEM38B

Kinases:

AK1, AK2, AK9, AMHR2, BCKDK, BUB1B, CHKB, CKB, CKM, COQ8A, CSNK2B, DGUOK, ETNK1, FGGY, GALK1, GALK2, GK, GLYCTK, GUCY2D, IKBKG, IP6K2, IPMK, KSR1, LRRK1, MASTL, MYO3A, NADK2, NME1, NMRK1, NPR2, OXSR1, PANK2, PCK1, PCK2, PDXK, PFKM, PHKA1, PHKA2, PINK1, PIP4K2A, PKLR, POMK, PRKRA, PRPS1, PXK, ROR1, ROR2, RYK, SCYL1, SHPK, SPEG, STK36, STRADA, TBCK, TEX14, TP53RK, TPK1, TRIB3, TRIO, TTBK1, TTBK2, TTN, UCK2, ULK4, VRK1, WNK4

Other Druggable Protein:

AGL, ANKS1A, ANTXR1, AP2A2, AP4E1, ARHGEF10, ATP6AP2, ATXN3, BAIAP2L1, CAPN10, CAPN14, CAPN3, CAPN5, CCDC28B, CD36, CENPJ, CFLAR, CNTN2, CNTN4, CNTN6, COCH, COL12A1, COL14A1, COL21A1, COL6A1, COL6A2, COL6A3, COL7A1, CUL1, CUL4B, DERL1, DLG1, DLG2, DLGAP5, DNAH1, DNAH11, DNAH14, DNAH5, DNAH6, DNAH8, DNHD1, DNM1, DYNC1H1, DYNC2H1, EEFSEC, EFL1, EFTUD2, EIF2S3, ELOVL4, ELOVL5, EVI2A, F5, F8, FCGR2A, FCGR2B, FCGR2C, FCGR3B, FCRL3, FCRL5, FGFRL1, FXN, GAB2, GDI1, GDI2, GIPC3, GNB1, GNB3, GNB4, GNB5, GP1BA, GRB10, GRB14, GUF1, HNRNPK, HP, IGF2BP2, IGF2BP3, IGFALS, IPO7, ITGB4, ITGB5, ITGB6, ITGBL1, KHSRP, LINGO1, LMBR1, LRIG2, LRRN2, LTF, M6PR, MAGEA2, MAGEC1, MAGED2, MAGEL2, MATN3, MBL2, MMD, MPV17, MS4A3, MS4A4A, MS4A6A, MX1, MX2, MYMK, NDRG1, NR0B1, NR2F1, NR4A3, NYX, OTUD3, OTUD6B, PDCD6IP, PDGFRL, PEX14, PIGW, PTCHD1, PYCARD, RAPH1, RHOBTB1, RHOBTB2, RNF113A, ROBO3, RP2, RS1, SCAMP3, SCARA3, SCARB2, SCARF2, SEPTIN12, SEPTIN14, SHARPIN, SPRED1, SPRED2, STAP1, TAZ, TBC1D4, TF, THADA, TLR3, TNFAIP3, TRAPPC12, TRIM2, UNC5C, USP6NL, VAC14, VNN2, VNN3

APPLICATIONS MUST FOCUS ON PROTEINS ON THE ABOVE LIST TO BE RESPONSIVE TO THIS FOA. ALL OTHER APPLICATIONS WILL BE CONSIDERED NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW.

This FOA accepts different types of projects with the intent of generating preliminary and/or validation data including, but not limited to, the following:

  • Isolation and purification of understudied proteins and initial in vitro characterization;
  • Characterization of cell- and tissue-specific protein expression, localization, and function of understudied protein(s) in native environments;
  • Verification or placement of understudied protein(s) in signaling cascades, including upstream signals and downstream activities;
  • Pre-clinical animal studies of understudied proteins that help to illuminate the role of an understudied protein in the context of human disease;
  • Use of novel tools to validate preliminary disease or physiological associations with understudied proteins in animal models, biomimetic systems, or ex vivo human samples;
  • Development of accessory reagents (e.g., antibodies, peptide fragments, labeled versions of the protein, etc.) for use in downstream studies to generate preliminary data;
  • Assay development, optimization, and validation with the intent of using these assays for further study of selected understudied protein(s);
  • Use of data mining and experimental validation to analyze public data resources to identify and study protein-protein interaction networks or generate hypotheses about the function of understudied protein(s);
  • Studies to identify endogenous ligands for understudied proteins that could lead to study of preliminary structure-activity-relationships (SAR));
  • Structure determination or preparation of understudied proteins for structure determination and characterization by x-ray crystallography, cryo-electron microscopy, or similar approaches.

This FOA is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins associated with rare disease. The proposed project must focus on one or more of the eligible proteins listed above. Preliminary data are not required, and appropriate justification for the proposed approach can be provided through literature citations, data from other sources, or from investigator-generated data if any are available. 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.


The following will be considered non-responsive under this FOA and returned to the applicant without review:

  • Projects that meet the NIH definition of a clinical trial;
  • Projects where the majority of the proposed work focuses on proteins outside of those featured on the above lists;
  • Applications that propose clinical drug development studies for understudied protein(s).

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The NIH intends to commit approximately $1,500,000 in FY23, contingent upon receiving scientifically meritorious applications. 8-10 awards are anticipated from this solicitation. Future year amounts will depend on annual appropriations.

Award Budget

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.

Award Project Period

The maximum project period for an application submitted under this FOA is 1 year.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Eligible Agencies of the Federal Government, including the NIH Intramural Research Program
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Jing Chen, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-827-3268
E-mail: chenjing@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

This FOA is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins associated with rare disease. The proposed project must focus on one or more of the eligible proteins listed above. Preliminary data are not required, and appropriate justification for the proposed approach can be provided through literature citations, data from other sources, or from investigator-generated data if any are available. 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.

Proteins not listed above as eligible for study under this FOA may only be used in projects proposed for this FOA as controls for experiments involving eligible proteins from the approved list and shall not be the focus of experimental work.

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 additional instructions:

Note: for applications for receipt dates on/after January 25 2023, visit the NIH Scientific Data Sharing website (https://sharing.nih.gov/) to learn what is expected of investigators and institutions under the 2023 NIH Data Management & Sharing Policy.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applications Involving the NIH Intramural Research Program

Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, 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.

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 in the NIH Intramural Source Book.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  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. This FOA is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins associated with a rare disease. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies and appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data.

Overall Impact

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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the 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:

To what extent 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? How will the project address critical barriers to understanding the role of understudied proteins in fundamental physiology, in disease processes, and/or as novel therapeutic targets? In what way does the stated hypothesis provide sufficient justification to indicate why the approach was chosen?

Investigator(s)

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?

Innovation

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

Approach

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?

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?

Specific to this FOA: How will the proposed approach further characterize the understudied protein in the context of rare disease or enable such characterization (in instances where the focus is generation of reagents/tools)?

Environment

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

Additional Review Criteria

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.

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCATS, 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 will receive a written critique.

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

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Increasing the diversity of approaches applied to the study of understudied proteins.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients 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: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

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.

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 and 2 CFR Part 200.206 “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

Not Applicable

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Karlie Sharma, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-4965
Email: DruggableGenome@mail.nih.gov

Enrique Michelotti, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-5415
Email: michelottiel@mail.nih.gov

Peer Review Contact(s)

Jing Chen, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-827-3268  
E-mail: chenjing@mail.nih.gov

Financial/Grants Management Contact(s)

Steve Elsberg
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-0961
Email: steve.elsberg@nih.gov

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: weissh@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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