Opportunity Information: Apply for RFA NS 18 046
This NIH funding opportunity (RFA-NS-18-046) supports projects that take an already-promising pain biomarker (or biomarker signature/endpoint) and push it through the kinds of analytical and clinical validation steps needed for it to be credible and useful in real-world drug development and clinical research. The larger goal is to speed progress on non-opioid pain therapeutics by giving researchers validated tools that can help measure pain biology, identify meaningful patient subgroups, and detect whether a therapy is engaging its target or producing a true clinical benefit. The FOA is set up to move beyond early discovery work and instead focus on the hard validation work that makes a biomarker reliable enough to use in Phase II clinical trials and, eventually, broader clinical practice.
A key point is what the FOA assumes is already in hand. Applicants are not expected to discover a brand-new biomarker from scratch. Instead, the program expects that (1) a specific candidate biomarker has already been identified, (2) the assay technology to measure it has already been developed, and (3) there is a working hypothesis for the biomarker's "Context of Use" (in other words, a clear idea of what the biomarker is supposed to indicate, in which patient population, under what conditions, and for what decision it will help inform). With those prerequisites met, the grant is aimed at advanced validation: showing the biomarker can be measured consistently and that its changes track with clinically meaningful variables.
The scientific emphasis is on demonstrating that the biomarker or endpoint behaves in a dependable, interpretable way across studies and settings. The FOA describes validation outcomes such as showing biomarker change is reliably correlated with clinical outcomes, with identifiable pathophysiologic subsets of pain (for example, biologically distinct pain phenotypes), or with therapeutic target engagement and/or response to a pain therapy. Another major expectation is specificity: the biomarker response should be specific to the pain condition being studied or to the therapeutic mechanism being tested, rather than reflecting nonspecific factors. The program also highlights the importance of demonstrating performance across multiple clinical sites, which is a practical requirement if the biomarker is going to be used broadly in multisite clinical trials.
Methodologically, the FOA allows both retrospective and prospective approaches. That flexibility supports different validation strategies, such as leveraging existing datasets and stored specimens to test associations and performance characteristics, and then confirming findings prospectively in new cohorts or study designs. The mechanism listed in the title is R61/R33, which is commonly used for staged, milestone-driven projects where an initial phase supports proof-of-feasibility and rigorous setup work, and a later phase supports expanded validation once predefined milestones are met. The announcement also notes that clinical trials are optional, meaning applicants can propose clinical trial activities if they are necessary to validate the biomarker in its intended context, but a clinical trial is not mandatory for every application.
From an eligibility standpoint, the opportunity is broad and includes many types of organizations. Eligible applicants include state and local governments, special districts, independent school districts, public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (including entities other than small businesses), and small businesses. It also explicitly includes a range of mission- and community-focused institutions and groups, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, tribal governments and tribal organizations (including those other than federally recognized), U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. The sponsoring agency is the National Institutes of Health. The original closing date shown in the source information is March 12, 2020, and the FOA is categorized as a discretionary grant opportunity within health-related program areas (with multiple CFDA/assistance listing numbers associated with NIH institutes and programs).
In practical terms, a competitive application under this FOA would typically revolve around a clearly defined biomarker candidate and a well-justified Context of Use, paired with a rigorous plan to demonstrate measurement reliability and clinical relevance. That means careful analytical validation of the assay (so results are reproducible and comparable) and clinical validation that links biomarker behavior to outcomes that matter in pain research and treatment development, ideally with evidence that holds up across sites and populations. The intended end result is a biomarker or endpoint that is robust enough to be used confidently in mid-stage clinical testing of non-opioid pain therapeutics and to support more objective, biology-informed decision-making in pain clinical trials.Apply for RFA NS 18 046
- 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 "Analytical and/or Clinical Validation of a Candidate Biomarker 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, 93.361, 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 2018-09-19.
- 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 (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 |
| HEAL Initiative: Development and Validation of Non-Rodent Mammalian Models of Pain(R01 Clinical Trial Not Allowed) Apply for RFA NS 22 070 Funding Number: RFA NS 22 070 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $750,000 |
| Catalyst Award for Early-Stage Investigators (ESIs) Pursuing Research on HIV Comorbidities, Coinfections, and Complications (DP1- Clinical Trial Optional) Apply for PAR 23 024 Funding Number: PAR 23 024 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $350,000 |
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