HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management (R61/R33, Clinical Trial Required) | RFA AT 22 003

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The NIH funding opportunity "HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management (R61/R33, Clinical Trial Required)" (RFA-AT-22-003) is a two-phase grant program aimed at creating and testing objective biomarkers that can improve how clinicians evaluate and treat myofascial pain. It sits under the broader NIH Helping to End Addiction Long-term (HEAL) Initiative, which was launched to accelerate research-based solutions to the opioid crisis. In practical terms, this FOA focuses on the pain-management side of HEAL by supporting work that could help reduce reliance on opioids through better diagnosis, patient stratification, and treatment monitoring for myofascial pain conditions.

The core scientific goal is to develop innovative, quantitative biomarkers of myofascial tissues and determine whether those biomarkers can track treatment response and/or predict clinical outcomes across pain management regimens. The FOA is intentionally broad about what qualifies as a biomarker, as long as it is objective and relevant to myofascial tissues. Proposed approaches can include minimally invasive imaging technologies (for example, quantitative imaging-derived measures rather than purely qualitative radiology reads), electrophysiological recordings, or integrated multi-modal methods that combine imaging and electrophysiology. The announcement also encourages applicants to go beyond single-modality readouts by integrating imaging or electrophysiology with additional marker classes such as immune factors, genomic markers, and other physiological measures. Applicants may use multiscale modeling and machine learning to fuse these data sources, with the expectation that the output is a measurable indicator tied to myofascial tissue status and clinically meaningful pain outcomes.

The program uses the R61/R33 phased innovation mechanism, meaning projects are expected to mature from early development to later validation within the same overall award structure. The first phase (R61) provides up to three years of support and is geared toward biomarker development and initial clinical association work. During this phase, teams are expected to build quantitative measures capable of distinguishing myofascial tissue abnormalities across different states, specifically separating healthy tissue from latent myofascial pain and from active myofascial pain. The R61 work emphasizes cross-sectional study designs that correlate the candidate quantitative measures with clinical signs and symptoms, establishing that the biomarker signal aligns with real-world pain presentation. The R61 phase is also expected to include team-building and practical planning to enable a strong transition into the second phase, including preparation for interventional, longitudinal work.

The second phase (R33) provides up to two additional years of support and shifts from development to performance testing in treatment contexts. Here, the quantitative measures created during the R61 phase are evaluated in longitudinal interventional studies that involve specified therapies intended to relieve myofascial pain. The purpose is to determine whether the biomarkers can do at least one of two clinically important jobs: monitor responses to therapy over time and/or predict outcomes (for example, identifying who is likely to respond to a given intervention). Because the FOA explicitly states "Clinical Trial Required," the later-stage work is not just observational; it is expected to include prospective interventional research in human participants.

Eligibility is broad across public, private, nonprofit, and for-profit sectors, including state and local governments, independent school districts, public housing authorities/Indian housing authorities, public and private institutions of higher education, federally recognized tribal governments and certain other tribal organizations, small businesses, and other organizations that meet NIH eligibility requirements. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. However, non-U.S. (foreign) organizations and foreign institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, the FOA allows "foreign components" as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant may still include certain international elements if they meet NIH policy requirements and are justified.

Administratively, the opportunity is a discretionary NIH grant in the health domain (CFDA numbers listed include 93.121, 93.213, 93.286, 93.313, 93.350, 93.846, 93.853, 93.865, and 93.866). The original posting dates show a creation date of 2021-11-16 and an original closing date of 2022-02-11. An award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants need to refer to the full FOA text and NIH budget guidance for allowable costs and expectations.

Overall, the opportunity is designed to move the field toward objective, quantifiable measures of myofascial tissue pathology that can be used in real clinical decision-making: distinguishing disease stage, selecting or tailoring therapy, and measuring whether a treatment is working. By supporting both the technical development of biomarkers and their testing in longitudinal interventional studies, the FOA aims to produce tools that can translate into better pain care and, in the broader HEAL context, contribute to reducing the downstream pressures that drive opioid exposure and misuse.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management (R61/R33, Clinical Trial Required)" 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, 93.286, 93.313, 93.350, 93.846, 93.853, 93.865, 93.866.
• This funding opportunity was created on 2021-11-16.
• Applicants must submit their applications by 2022-02-11. (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.

Apply for RFA AT 22 003

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