HEAL Initiative: Toward Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management (R61/R33, Clinical Trial Required) | RFA AT 24 003

Opportunity Information: Apply for RFA AT 24 003

This NIH funding opportunity (RFA-AT-24-003) supports research aimed at creating and validating objective, quantitative ways to evaluate myofascial tissues in the context of clinical pain management. It sits under the NIH HEAL (Helping to End Addiction Long-term) Initiative, which is a large, cross-NIH effort designed to accelerate practical scientific solutions to the opioid crisis by both improving prevention and treatment of opioid misuse and opioid use disorder and by strengthening pain management options that can reduce reliance on opioids. The central idea of this NOFO is that better, more measurable indicators of myofascial tissue status could help clinicians and researchers understand pain mechanisms, track responses to treatment, and ultimately guide more effective, non-opioid pain care.

The NOFO specifically calls for development of quantitative imaging and other relevant biomarkers that can capture abnormalities in myofascial tissues and detect meaningful changes over time. Proposed measures can come from minimally invasive imaging approaches, electrophysiological recordings, or combinations of multiple modalities (for example, integrating multiparametric imaging with electrophysiology). Applicants are also encouraged to explore approaches that combine these tissue-focused measures with other types of markers, such as immune factors, genomic markers, or broader physiological measures. To pull these different signal types together, the NOFO explicitly allows advanced analytic strategies like multiscale modeling and machine learning, as long as the end goal remains clinically relevant measurement of myofascial tissue features tied to pain and pain relief.

Funding is structured through a two-phase R61/R33 mechanism and requires clinical trial involvement (research with participants). The first phase (R61) can last up to three years and is focused on developing the quantitative measures and demonstrating that they can distinguish abnormal myofascial tissue from healthy tissue. This phase emphasizes cross-sectional work, meaning the measures should be linked to clinical signs and symptoms at a point in time to show they have real-world clinical relevance rather than being purely technical readouts. The R61 period also needs to include concrete planning for the second phase, so investigators should use this stage not only to build and refine the measurement tools but also to prepare the study infrastructure, protocols, and design elements needed for a stronger longitudinal evaluation later.

The second phase (R33) supports a more rigorous, longitudinal clinical study to test whether the measures developed in the R61 can reliably track tissue changes in response to interventions. In other words, the R33 is about determining whether the proposed biomarkers are sensitive and specific enough to detect change when therapies or manipulations intended to relieve pain are delivered, and whether those measured tissue changes relate to clinical improvement. Because the R33 is centered on longitudinal design, it typically implies repeated measurements over time, careful control of confounding factors, and a level of methodological rigor that can support future clinical translation. The total combined project period across both phases cannot exceed five years, and moving from the R61 to the R33 is not automatic; it depends on an administrative review that assesses whether the predefined milestones and other transition criteria were successfully met.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations: state, county, city, township, and special district governments; public housing authorities; independent school districts; public and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The NOFO also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined by NIH policy may be allowed, which generally means certain elements of the work can involve foreign collaborations or sites under NIH rules even though the applicant organization must be eligible and primarily U.S.-based.

Administrative details in the source information include that the agency is the National Institutes of Health, the funding instrument is a grant, and the activity categories fall within education/health/income security and related social services classifications. Multiple CFDA numbers are associated with the opportunity (93.121, 93.213, 93.286, 93.313, 93.395, 93.846, 93.853, 93.865, 93.866), reflecting the NIH’s multi-institute involvement typical of HEAL-related programs. The opportunity was created on 2023-06-08 and listed an original closing date of 2023-10-18 in the provided record.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Toward 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, 93.395, 93.846, 93.853, 93.865, 93.866.
• This funding opportunity was created on 2023-06-08.
• Applicants must submit their applications by 2023-10-18. (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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