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 on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
HEAL Initiative-Early-Stage Discovery of New Pain Targets Within the Understudied Druggable Proteome (R03 Clinical Trial Not Allowed)
Activity Code

R03 Small Grant Program

Announcement Type
New
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
PAR-24-197
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.350, 93.865, 93.866, 93.279, 93.853, 93.213, 93.846, 93.121
Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to identify new druggable targets for pain within the understudied druggable proteome. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s) listed in this NOFO. This NOFO is intended to jumpstart research on understudied proteins within the context of pain and pain management and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins to identify new druggable targets for pain.  This NOFO is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, to accelerate the development of novel medications to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose

Key Dates

Posted Date
April 17, 2024
Open Date (Earliest Submission Date)
May 16, 2024
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
June 16, 2024 * July 16, 2024 * Not Applicable November 2024 January 2025 April 2025
October 16, 2024 * November 16, 2024 * Not Applicable March 2025 May 2025 July 2025
February 16, 2025 * March 16, 2025 * Not Applicable July 2025 October 2025 December 2025
June 16, 2025 * July 16, 2025 * Not Applicable November 2025 January 2026 April 2026
October 16, 2025 * November 16, 2025 * Not Applicable March 2026 May 2026 July 2026
February 16, 2026 * March 16, 2026 * Not Applicable July 2026 October 2026 December 2026
June 16, 2026 * July 16, 2026 * Not Applicable November 2026 January 2027 April 2027

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 17, 2026
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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. Notice of Funding Opportunity Description

Introduction

This study is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative® , to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/

This notice of funding opportunity (NOFO) aims to promote innovative research to increase knowledge of understudied proteins in the context of pain and pain management. 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 pain 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).

Objectives and Scope

The goal of this notice of funding opportunity (NOFO) is to provide a needed opportunity for the collection of preliminary data around the role of understudied proteins in the context of pain and pain management. This NOFO would provide funding to support research that will identify new targets for pain among the understudied proteins of the Druggable Proteome (DP). Many understudied proteins have been linked to pain or pain perception, acute and chronic pain. This indicates that there could be many more proteins within the DP that could serve as markers and/or drug targets for novel pain treatment and/or pain management.

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 NOFO 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. These projects should be carried out in a short period of time with limited resources as defined by the funding mechanism.

Understudied proteins eligible for study under this NOFO are from well-established druggable protein families with a high potential to impact human health once a disease association is made.  Proteins considered eligible for this funding opportunity have a Pubmed score of less than 10 (derived from text mining Pubmed extracts, this counts the number of publications that focus on a particular protein, and includes fractional counting of abstracts that mention multiple proteins [Pletscher-Frankild’s et al. 2015]) and have minimal funded awards associated with their study.

Proteins open for study under this NOFO:

Ion Channels

SHANK3, CLCA3P, FXYD6P3, CALHM4, KCNMB2, CACNG6, CALHM5, LRRC38, KCNK7, CACNG7, CACNG5, KCTD3, CALHM3, OTOP3, LRRC8B, CACNG3, TMEM109, LRRC55, CACNG8, TMC3, PKD1L2, OTOP2, TMEM63B, TMC7, TMEM63A, ENKUR, LRRC8E, LRRC52, PKD2L2, CLDN17, TM9SF2, FXYD4, CALHM2, LRRC8D, KCNK12, TMC5, TTYH2, CACNG4, CACNG1, KCNAB3, LRRC8C, TTYH3, KCNMB3, KBTBD13

Transcription Factors

DANCR, SRY, TRBC1, TRBC2, TRAC, HSFX4, HSFY1, HSFX3, SUPT20HL2, SUPT20HL1, TRBD1, TGIF2LY, TRAV38-1, TRAV30, TRAV34, TRAV40, TRBV4-1, TRBV4-2, TRAV8-1, TRBV5-5, TRBV5-8, TRAV9-1, TRAV9-2, TRAV26-1, TRAV26-2, TRBV13, TRBV18, TRBV19, TRBV24-1, TRBV29-1, TRAV4, TRBV6-5, TRBV7-4, TRBV16, TRBV10-1, TRBV10-2, TRBV11-3, TRBV12-3, TRBV12-4, TRBV12-5, TRAV17, TRAV18, TRAV19, TRAV22, TRAV23DV6, TRAV24, TRAV29DV5, TRAV2, TRAV35, TRAV36DV7, TRAV39, TRAV3, TRAV41, TRAV5, TRAV8-2, TRAV8-4, TRAV8-6, TRBV6-2, TRBV6-4, TRAV12-3, TRBV6-8, TRAV13-2, TRBV7-6, TRBV7-7, TRBV27, TRBV28, TRBV10-3, TRBV11-1, TRBV11-2, TRBV20-1, TRAV38-2DV8, TRAV10, TRAV1-1, TRAV1-2, TRAV14DV4, TRAV16, TRAV20, TRAV21, TRAV25, TRAV27, TRBV2, TRBV30, TRBV3-1, TRAV6, TRAV7, TRBV4-3, TRBV5-1, TRBV5-4, TRAV8-3, TRBV5-6, TRBV6-1, TRBV6-3, TRAV12-1, TRAV12-2, TRBV6-6, TRAV13-1, TRBV6-9, TRBV7-2, TRBV14, TRBV7-8, TRBV7-9, TRBV9, TRBV25-1, ZFY, ZNF806, TRBJ1-1, TRAJ3, , NFE4, TAF9, RHOXF2B, ZBTB49, ZNF287, DMRTC1, ZNF19, GTF3C6, RFX8, TCF24, GTF2H2C, ZNF280C, ZNF317, ZNF157, TAF4B, ZNF595, TAF6L, C16orf89, ZNF280D, ZNF253, OVOL3, BTF3L4, AKNAD1, GTF3C3, CSRNP2, GABPB2, KCTD21, ZNF449, DMRTC2, KCTD6, GTF3C5, HES2, PHTF2, GPBP1L1, DMRTB1, FHL5, NKX1-1, IKZF5, GTF2E1, GPR153, HMGXB3, ZNF75D, ATF7IP2, ZNF385A, ZNF260, ELK3, NKX1-2, ARGFX, POU5F2, SP5, TAF5L, NKX2-4, TAF1D, EID3, FIZ1, FOXD4L1, GTF3C4, MYPOP, ZFP69, ZNF704, CC2D1B, GTF2A1L, ZNF195, ZNF280B, FOXB2, ZNF280A, ZGLP1, ZNF674, ZCCHC13, TFAP2D, ASCL4, DPRX, VSTM2A, ZNF81, GTF2IRD2, METTL23, GTF3C2, ZNF496, ZSCAN31, YPEL5, EDRF1, CHP2, ZFP2, GPBP1, GTF2E2, GTF2IRD2B, BHLHB9, CALCOCO1, RNF141, ZNF608, CARF, ZNF622, SPOCD1, ZNF215, ZNF304, IKZF4, TSHZ2, TFDP2, MED9, TAF1A, FOXR1, ZNF382, RHOXF2, HOXC12, NOL7, ELK1, TAF1C, PRR14, NKX6-3, GID8, RHOXF1, KIF12, TSSK4, ZNF124, ZFP37, FOXD4

Transporters

SLC22A20P, SLC7A5P1, SLC7A5P2, C2orf83, SLC35E4, SLC35F4, PRELID3A, SLC22A31, SLC35E3, SLC35F6, SLC35E2A, TBC1D13, TMCO3, SVOPL, SLCO1B7, SLC35A5, SLC35E1, SLC35F5, SLC6A16, SLC35E2B, GRAMD1C, SLC25A30, MFSD5, SLC25A47, DENND4C, SLC35A4, SFXN5, SPNS3, C2CD5, SLC35F1, SLC39A3, SLC18B1, SLC35F3, RSC1A1, NIPAL1, SLC22A15, SFXN2, SLC38A10, MFSD2B, SLC22A14, ABCF3, SLC17A4, XKRX, SLC35C2, DENND3, SLC35B1, SLC41A2, SLC38A6, LIN7B, TM9SF2, SLC25A33, SLC45A1, SFXN4, SLC25A2, SLCO5A1, SLC5A10, SLC38A11, MMGT1, SLC46A3, SLC48A1, GRAMD1B, SLC38A7, ABCA10, SLC25A39, SLC43A3, SLC6A18, GRAMD1A, SFXN3, SLC25A42, RCN3, PQLC2, SLC26A11, CNNM1

Proteases

CST9LP1, ERVK-7, ERVK-8, GGT3P, ERVK-8, ERVK-10, PRSS43, PRSS44, PRSS47, PRSS51, PRSS29P, ERVK-7, NPEPPSL1, PRSS41, ERVK-8, USP17L21, USP9Y, ERVK-7, FOLH1B, ERVK-8, ERVK-10, SERPINA13P, SEC11B, ERVK-9, LMLN2, MST1L, CASP12, HLA-DRB4, ERVK-8, ERVK-19, USP17L6P, ERVK-7, ERVK-24, ERVK-18, HERVK_113, ERVK-6, ERVK-21, ERVK-9, ERVK-10, ERVK-25, HERV-K104, OVOS2, OVOS1, ERVK-7, USP17L10, USP17L17, USP17L18, USP17L11, USP17L19, USP17L15, USP17L12, USP17L3, USP17L13, USP17L22, USP17L20, USP17L5, WFDC9, USP17L1, PRSS48, ITIH6, PRSS46P, SPINK14, WFDC6, USP31, PGPEP1L, ERVK-10, SPINT3, WFDC3, TMPRSS7, PRSS45, WFDC10B, SERPINA11, WFDC10A, SERPINE3, WFDC11, TMPRSS11F, COL28A1, TRIML1, TMPRSS11B, MINDY4, CPO, PRSS42, SPINK8, CAPNS2, MINDY2, NPEPL1, SPINT4, ATXN3L, WFDC8, PRSS33, CELA2B, WFDC13, PRSS36, ADAM20, RHBDL3, PSMA8, OTUD6A, ADAM30, KAZALD1, OVCH1, CARD17, CST9L, OVCH2, CAPN12, JOSD2, F2RL2, PRSS53, SPINK9, DESI1, CAPN13, PRSS22, AMZ1, SEC11C, TRABD2A, TYSND1, TMPRSS12, UFSP1, USP27X, PRSS37, MAIP1, SPCS2, PRSS54, MINDY1, METAP1D, USP17L24, SERPINB12, FBXL17, DPEP2, CSTL1, WFDC12, WFIKKN2, PSMB3, CELA2A, TMPRSS5, PRADC1, USP51, CAPN11, MMP27, PRSS35, JOSD1, CPXM1, IMMP1L, ADAM21, ZUP1, SPPL2C, CTRB2, RHBDD2, ADAM11, TMPRSS9, AMZ2, TPSD1, UFSP2, USPL1, C1RL, PRSS38, SPINK13, SPCS3, USP34, DPEP3, ADAMTS19

GPCRs

OR10D4P, OR10J6P, OR13C6P, OR14L1P, OR1F2P, OR2B8P, OR2I1P, OR2W5, OR2W6P, OR3A4P, OR4A4P, OR52L2P, OR52P1P, OR56B2P, OR5AK3P, OR7A2P, OR8G2P, OR8G3P, OR9A1P, VN1R17P, OR10D3, OR2B3, GPR62, CNIH4, MRGPRX3, ADGRG5, GPR156, GPR150, GPR33, PKD1L2, GPR160, EFR3A, GPR27

ONLY APPLICATIONS THAT FOCUS ON PROTEINS LISTED ON THIS LIST, AS WELL AS MEETING THE RESPONSIVENESS CRITERIA BELOW, WILL BE CONSIDERED RESPONSIVE TO THIS NOFO. ALL OTHER APPLICATIONS WILL BE CONSIDERED NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW.

Applicants should provide the protein acronym(s) as listed above that will be the focus of their application at the top of page one of their Research Plan, which will allow NIH to quickly identify those projects that are responsive to this NOFO.

A significant percentage of the proteins within the above protein families are considered understudied, thus there is sizable opportunity for the discovery and development of new targets for pain and pain management within the understudied druggable proteome. Sufficient justification should be provided to indicate why particular protein(s) were chosen for study in the context of their potential role in pain. Those projects employing methods that identify multiple proteins for study from the above link are acceptable but require justification as to why those proteins were chosen for study within the context of pain, beyond the fact that they are on the eligible protein list provided.

Examples of potential research areas could include:

  • Isolation and purification of understudied proteins and in vitro/in vivo characterization with the intent of developing future novel therapeutics;
  • Verification or placement of understudied protein(s) in signaling cascades, including upstream signals and downstream activities in order to better understand pain targets;
  • Identification and validation of new pain biomarkers;
  • Pre-clinical animal studies of understudied proteins focused on therapeutic development;
  • Characterization of cell- and tissue-specific protein expression, localization, and function of understudied protein(s) in native environments as they pertain to pain;
  • Use of novel tools to validate preliminary disease or physiological associations with understudied proteins in animal models, biomimetic systems, or ex vivo human samples;
  • Studies to establish preliminary structure-activity-relationships (SAR) between functions of an understudied protein and its ligands (e.g., small molecules, macrocycles, synthetic peptides) for future drug discovery projects.

Promoting Diversity

Applicants are encouraged to recruit prospective program participants from diverse backgrounds, including those from underrepresented groups in the biomedical research workforce. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details. Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants or faculty as an eligibility or selection criteria. The race, ethnicity, or sex of candidates will not be considered by NIH in the application review process or when making funding decisions. 

PI Meeting Attendance

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative award recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

  • 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 in the above protein lists;
  • Applications that propose clinical drug development studies for understudied protein(s);
  • Applications proposing studies of diseases/conditions not related to pain and/or pain management.

National Center for Complementary and Integrative Health (NCCIH)

NCCIH supports research exploring novel therapeutic targets for complementary and integrative health intervention to treat pain, opioid use disorder (OUD), and/or overdose (OD). Complementary interventions include natural products (e.g., dietary supplements, botanicals, probiotics, and microbial-based therapies). Natural products are defined by NCCIH to include therapeutically relevant lead compounds derived from plants fungi, bacteria, marine organisms, or animals. Additionally, psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, devices) approaches, or a combination of psychological and physical approaches (e.g., yoga, tai chi, dance therapies, some forms of art therapies), are also research topics within scope. NCCIH is particularly interested in identification and validation of understudied proteins within druggable proteome that can be modulated with complementary and integrative health approaches in the context of pain, OUD and/or OD.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. NIAMS encourages investigators to discuss their research interests with NIAMS program staff prior to submitting their grant application. In the context of this NOFO, NIAMS is interested in the investigation of understudied, novel targets that could lead to more effective and safer treatment of pain in rheumatological, orthopedic, dermatological, bone and cartilage, and muscle diseases.

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR strongly encourages investigators to discuss their research interests with NIDCR program staff prior to submitting their grant application. NIDCR encourages applications that investigate understudied, novel targets associated with orofacial pain conditions such as temporomandibular disorders, trigeminal neuropathic pain, orofacial dyskinesias and dystonias, and burning mouth syndrome.

National Institute on Aging (NIA)

NIA strongly encourages investigators to discuss their research interests with NIA program staff prior to submitting their grant application. NIA encourages applications that investigate understudied, novel targets associated with pain in the context of aging and dementias to facilitate the development of safe and efficacious medications to treat and/or prevent pain in older adults and comorbidities including Alzheimer’s disease and related dementias. NIA intends to administer applications under this NOFO that meet requirements central to NIA’s mission of improving the health and well-being of older adults through research.

National Institute of Neurological Disorders and Stroke (NINDS)

NINDS is interested in the discovery and development of non-addictive therapeutics to treat pain disorders. These disorders include, but are not limited to headache, migraine, post-stroke pain, neuropathic pain, pain following traumatic brain injury, pain associated with spinal cord injury, pain associated with Alzheimer’s Disease-related dementias, pain associated with Parkinson’s Disease and chronic overlapping pain conditions.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance 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 How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. 

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 NOFO 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 NOFO.

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 Governments

  • 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
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from 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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

HEAL Investigators’ Meeting: For budgeting purposes, include travel costs to support the attendance of one PD/PI (one person) at a 2-day, in-person HEAL Investigators meeting in the Washington DC area, annually for the duration of the award. 

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

The goal of this notice of funding opportunity (NOFO) is to jumpstart research on understudied proteins that are associated with pain and/or pain management, and to provide applicants with funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins in the context of pain and pain management.

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 NOFO may only be used in projects proposed for this NOFO 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 How to Apply - Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The HEAL Initiative has additional requirements that must be addressed in the Data Management and Sharing plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

HEAL has developed additional details and resources to fulfill these requirements (https://www.healdatafair.org/resources/road-map). 

HEAL Public Access and Data Sharing Policy: 

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy.  Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. 

  • For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access. 
  • Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 field of 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 NOFO 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 How to Apply - Application Guide.

See more tips for avoiding common errors.

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

Applications Involving the NIH Intramural Research Program

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

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed in accord with established policy of NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 NOFO, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in one year and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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.

 

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 NOFO: 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? To what extent does the project help to elucidate the function and/or structure of the understudied protein(s) in pain? 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?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

 

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

 

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

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 NOFO: How will the proposed approach further characterize the understudied protein in the context of pain or enable such characterization (in instances where the focus is generation of reagents/tools)?  To what extent is the proposed approach suitable and appropriate for generating preliminary experimental data and/or research resources for subsequent grant applications or initiation of a drug discovery project?  

 

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.

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

 

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. 

 

Not Applicable.

 

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not Applicable.

 

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

 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, 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.

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. 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 variety 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 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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.6. 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 NOFO 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: Generaland 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

HEAL Data Sharing Requirements

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.  All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem (https://heal.nih.gov/about/heal-data-ecosystem), as described in HEAL’s compliance guidance (See “Already Funded” section: https://heal.nih.gov/data/complying-heal-data-sharing-policy):  

1. Select a HEAL – Compliant data repository (https://www.healdatafair.org/resources/guidance/selection)  

  • Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant, data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
  • Some repositories require use of specific data dictionaries or structured data elements, so knowing your repository’s requirements up front can help reduce the burden of preparing data for submission.
  • HEAL-funded awardees must follow requirements for selected repository  

2. Within one year of award, register your study with the HEAL platform (https://heal.github.io/platform-documentation/study-registration/

  • This process will connect the Platform to information about your study and data, including metadata, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.

3. Within one year of award, submit HEAL-specific study-level metadata. 

4. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository  

4. 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.

Report and ensure immediate public access to HEAL-funded publications  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication.

For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access.   

Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests.  

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.  

Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication: “This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov/) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654].” 

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 NOFOs 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition 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: https://www.era.nih.gov/need-help (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: 301-480-7075

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: karlie.sharma@nih.gov

Subramaniam Ananthan, Ph.D.
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-435-2199
E-mail: sam.ananthan@nih.gov

Helena H. Ahn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Telephone: 301-827-3207
Email: helena.ahn@nih.gov 
 

Rebecca N Lenzi
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: (301) 402-2446
E-mail: rebecca.lenzi@nih.gov

D.P. Mohapatra, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: dp.mohapatra@.nih.gov

Melissa M Ghim, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: none
E-mail: ghimm@mail.nih.gov

David Frankowski, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
E-mail: dave.frankowski@nih.gov

Patrick C. Still, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-682-1895
Email: patrick.still@nih.gov  

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Katie Lynn Matthews
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-7060
Email: katie.matthews@nih.gov

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Shellie Wilburn, MBA
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov.

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov

Kathleen Moy
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301.827.2856
E-mail: kathleen.moy@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@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 2 CFR Part 200.

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