Opportunity Information: Apply for RFA AR 20 003
The National Institutes of Health (NIH) announced a Small Business Innovation Research (SBIR) funding opportunity focused on speeding up early-stage, preclinical research for rare musculoskeletal, rheumatic, and skin diseases. The opportunity is titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43 - Clinical Trial Not Allowed)" and is listed under Funding Opportunity Number RFA-AR-20-003. Its core purpose is to support small business concerns that are developing promising biomarkers or therapeutic approaches and need targeted preclinical work to move those candidates closer to eventual clinical development. Because it uses the SBIR R43 mechanism, the work proposed must remain preclinical; clinical trials are explicitly not allowed under this announcement.
The program is specifically aimed at "rare" diseases, defined here using the common U.S. threshold of fewer than 200,000 affected individuals nationwide. Within that scope, NIH is looking for projects that can credibly advance either (1) biomarker development (such as diagnostic, prognostic, predictive, pharmacodynamic, or response biomarkers) or (2) treatment development (such as drugs, biologics, or other therapeutic strategies) for rare conditions that fall into musculoskeletal, rheumatic, or dermatologic categories. In addition to rare-disease projects defined strictly by prevalence, the announcement also welcomes studies involving products that have received FDA orphan designation for musculoskeletal, rheumatic, or skin diseases. That means a company developing an FDA-designated orphan product in these disease areas may be within the intended target of this FOA, even as it focuses on generating the kinds of preclinical evidence needed to justify later-stage development.
Eligibility is restricted to small businesses, consistent with SBIR rules. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible as applying entities. However, the announcement notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowed in certain circumstances, which typically means limited, well-justified parts of a project can be carried out outside the U.S. under NIH rules, but the applicant organization itself must be an eligible U.S. small business and the overall project must meet NIH policy requirements. Applicants are expected to consult the full FOA text for the precise eligibility boundaries and definitions.
From an administrative standpoint, this is a discretionary grant opportunity issued by NIH in the health funding category, with the CFDA number 93.846. The original closing date listed for the opportunity was July 10, 2019, and the award ceiling shown in the provided data is $250,000. Overall, the announcement is designed to help small companies de-risk and advance preclinical biomarker and therapeutic candidates for rare rheumatic, musculoskeletal, and skin diseases, with a clear emphasis on translational progress while stopping short of human clinical trial activity.Apply for RFA AR 20 003
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
- This funding opportunity was created on 2019-04-26.
- Applicants must submit their applications by 2019-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: Small businesses.
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