Opportunity Information: Apply for RFA NS 18 041
The grant opportunity titled "Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)" (Funding Opportunity Number RFA-NS-18-041) is a National Institutes of Health (NIH) discretionary grant that focuses on accelerating the discovery of reliable, clinically meaningful biomarkers for pain. Its core aim is to strengthen the scientific foundation needed to develop and evaluate non-opioid therapies for pain conditions by identifying biological measures that can more objectively reflect pain states, predict treatment response, or track meaningful change over time. In practical terms, the opportunity is designed to move the field away from relying solely on subjective pain reporting and toward validated biological indicators and composite biomarker signatures that can serve as dependable endpoints in research and, eventually, clinical development.
A central theme of this FOA is rigor. It is not simply encouraging exploratory biomarker fishing; it is pushing for a structured biomarker discovery process that yields candidates capable of withstanding stringent analytical and clinical validation. That means applicants are expected to propose a credible pathway from early discovery through verification and on toward evidence that a biomarker is measurable, reproducible, interpretable, and relevant to pain biology and patient outcomes. By emphasizing biomarkers, biomarker signatures (combinations of markers that together perform better than any single measure), and endpoints for pain, the FOA signals interest in tools that can be used in trials and translational programs to speed decision-making, reduce uncertainty, and support the development of truly transformational non-opioid analgesics or pain-modifying interventions.
The mechanism referenced in the title, R61/R33, reflects a phased approach commonly used by NIH to support projects that need an initial, milestone-driven development period followed by an expansion phase if early goals are met. While the FOA is labeled "clinical trial optional," it does not require a clinical trial for every application; however, it allows trial-related work when it is appropriate to the biomarker discovery and validation plan. The overall design encourages investigators to set clear, testable milestones early and then build toward more definitive validation work, aligning the funding structure with the stepwise nature of biomarker development.
Eligibility is broad and intentionally inclusive, covering a wide range of institutions and organizational types. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This wide eligibility scope reflects the reality that impactful biomarker work may come from academic labs, clinical research networks, community-linked organizations, industry partners, government entities, or international collaborations.
Administratively, the opportunity is offered by NIH and is associated with multiple CFDA numbers (now commonly referred to under assistance listing structures), indicating that it spans several NIH institutes, centers, or program areas tied to health and biomedical research. The original posting date is August 2, 2018, and the original closing date listed is March 12, 2020, which is important for anyone looking at the notice historically or tracking related, newer solicitations that may have replaced or extended this one. The award ceiling and expected number of awards are not specified in the provided source data, suggesting that potential budgets and award counts were either described elsewhere in the full FOA text or handled through standard NIH budgeting policies and institute-specific funding decisions.
Overall, this FOA is best understood as part of a broader effort to improve how pain is measured and treated by building robust biomarker tools that can de-risk and accelerate non-opioid therapeutic development. By prioritizing biomarkers that can survive careful validation and serve as credible endpoints, the program aims to make pain research more predictive, more reproducible, and more directly useful for developing safer and more effective treatments.Apply for RFA NS 18 041
- The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.233, 93.273, 93.279, 93.286, 93.313, 93.350, 93.361, 93.393, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2018-08-02.
- Applicants must submit their applications by 2020-03-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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| Funding Opportunity |
|---|
| Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed) Apply for RFA NS 18 042 Funding Number: RFA NS 18 042 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $200,000 |
| Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional) Apply for RFA NS 18 046 Funding Number: RFA NS 18 046 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed) Apply for RFA NS 18 043 Funding Number: RFA NS 18 043 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Predoctoral Training in Advanced Data Analytics for Behavioral and Social Sciences Research (BSSR) - Institutional Research Training Program [T32] Apply for RFA OD 19 011 Funding Number: RFA OD 19 011 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA NS 19 010 Funding Number: RFA NS 19 010 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed) Apply for RFA EB 18 003 Funding Number: RFA EB 18 003 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $500,000 |
| HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional) Apply for RFA NS 19 016 Funding Number: RFA NS 19 016 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed) Apply for RFA NS 19 020 Funding Number: RFA NS 19 020 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional) Apply for RFA NS 19 017 Funding Number: RFA NS 19 017 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| Administrative Supplement for Research on Bioethical Issues Apply for PA 19 217 Funding Number: PA 19 217 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required) Apply for RFA NS 20 008 Funding Number: RFA NS 20 008 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required) Apply for RFA NS 20 010 Funding Number: RFA NS 20 010 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Developmental Centers for AIDS Research (P30 Clinical Trial Not Allowed) Apply for PAR 20 107 Funding Number: PAR 20 107 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Centers for AIDS Research (P30 Clinical Trial Not Allowed) Apply for PAR 20 106 Funding Number: PAR 20 106 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) Apply for RFA NS 21 010 Funding Number: RFA NS 21 010 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Time-Sensitive Obesity Policy and Program Evaluation (R01 Clinical Trial Not Allowed) Apply for PAR 21 305 Funding Number: PAR 21 305 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed) Apply for RFA NS 22 034 Funding Number: RFA NS 22 034 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed) Apply for RFA TR 22 013 Funding Number: RFA TR 22 013 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes and Cells (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 018 Funding Number: RFA NS 22 018 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 Clinical Trial Optional) Apply for RFA NS 23 003 Funding Number: RFA NS 23 003 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
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