Opportunity Information: Apply for RFA AR 14 005
Apply for RFA AR 14 005
- 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)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Mar 1, 2013 and posted on Mar 1, 2013.
- Applicants must submit their applications by Aug 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The funding opportunity titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43)" (Funding Opportunity Number RFA-AR-14-005) is a National Institutes of Health (NIH) grant program aimed specifically at small business concerns that are working on early-stage, preclinical research for rare diseases affecting the musculoskeletal system, rheumatic conditions, or skin disorders. It sits within NIH's health research mission area and is associated with CFDA (Catalog of Federal Domestic Assistance) number 93.846, which covers Arthritis, Musculoskeletal and Skin Diseases Research. The overall purpose is to help small companies generate the kind of preclinical evidence needed to move promising scientific ideas toward real-world diagnostics and therapies for patient populations that are often underserved because of small market size and limited commercial incentives.
The focus of the announcement is on preclinical studies that materially advance either (1) biomarker development or (2) treatment development for rare musculoskeletal, rheumatic, or skin diseases. In this context, "rare" is defined using the common U.S. standard of a condition affecting fewer than 200,000 people in the United States. Projects responding to this FOA would typically be expected to produce concrete, decision-enabling outputs, such as validation data supporting a biomarker's relevance and performance, or proof-of-concept and supporting preclinical packages that de-risk a therapeutic candidate. The announcement also explicitly notes that studies involving FDA-designated orphan products for musculoskeletal, rheumatic, or skin diseases may be eligible, which is significant because orphan designation often signals both a regulatory pathway and a recognized unmet need in a rare disease area. This emphasis suggests the program is trying to pull forward assets and approaches that could plausibly transition into clinical development or regulatory discussion after the preclinical phase is complete.
Mechanistically, this is an SBIR Phase I style opportunity using the R43 grant mechanism. It is categorized as a discretionary grant program (not a formula program), and it does not require cost sharing or matching funds, which lowers the barrier for small businesses that may not have substantial non-federal capital available at the earliest stages. Eligibility is limited to small businesses, consistent with SBIR requirements, meaning academic institutions or non-profits would generally participate only as subcontractors, consultants, or collaborators rather than as the primary applicant organization.
From a funding standpoint, the FOA listed an estimated total program funding level of $1,000,000. The award ceiling was stated as $225,000, which indicates an upper bound on the amount a single award could request or receive under this solicitation. In practical terms, that ceiling is aligned with a focused Phase I preclinical effort, such as generating initial efficacy data in relevant disease models, conducting feasibility studies for biomarker assays, producing preliminary analytical validation, or assembling early safety and pharmacology signals that justify a next-stage development plan.
The opportunity was posted and created on March 1, 2013, with an original and current closing date of August 1, 2013, and an archive date of September 1, 2013. Those dates indicate this specific solicitation window is historical rather than currently open, but the details remain useful as a template for what NIH has sought in rare-disease SBIR efforts in the arthritis, musculoskeletal, and skin research space. The full announcement was made available through an NIH Grants Guide link (http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-005.html), which would typically include the detailed scientific scope, application instructions, review criteria, budget guidance, and any special requirements that apply to SBIR submissions.
For administrative help, the point of contact listed is the NIH Office of Extramural Research (OER) Webmaster (FBOWebmaster@OD.NIH.GOV), specifically for issues accessing the announcement or problems linking to it. This is an access/support contact rather than a scientific program officer, so applicants seeking guidance on fit or scope would normally look within the full FOA for programmatic contacts, while technical access issues would be routed to OER via the provided email.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AR-14-005.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) funding opportunity.
What NIH mission area or research domain does this fit under?
It sits within NIH's health research mission area and is associated with Arthritis, Musculoskeletal and Skin Diseases Research.
What is the CFDA number associated with this opportunity?
The CFDA (Catalog of Federal Domestic Assistance) number listed is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
What is the main purpose of the program?
The purpose is to help small companies generate preclinical evidence needed to move promising ideas toward real-world diagnostics and therapies for rare musculoskeletal, rheumatic, or skin diseases, particularly where patient populations are underserved due to small market size and limited commercial incentives.
What kinds of projects are specifically encouraged under this FOA?
The FOA focuses on preclinical studies that materially advance either (1) biomarker development or (2) treatment development for rare musculoskeletal, rheumatic, or skin diseases.
How does this opportunity define "rare" disease?
"Rare" is defined as a condition affecting fewer than 200,000 people in the United States.
What stage of research is this opportunity targeting?
This opportunity is aimed at early-stage, preclinical research.
What types of outputs are applicants expected to produce?
Projects would typically be expected to produce concrete, decision-enabling outputs such as validation data supporting a biomarker's relevance and performance, or proof-of-concept and supporting preclinical packages that de-risk a therapeutic candidate.
Are projects involving FDA-designated orphan products eligible?
Yes. The announcement notes that studies involving FDA-designated orphan products for musculoskeletal, rheumatic, or skin diseases may be eligible.
What is the grant mechanism used for this opportunity?
This is an SBIR Phase I style opportunity using the R43 grant mechanism.
Is this a formula grant or a discretionary grant?
It is categorized as a discretionary grant program (not a formula program).
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching funds.
Who is eligible to apply?
Eligibility is limited to small business concerns, consistent with SBIR requirements.
Can universities, nonprofits, or other organizations apply as the primary applicant?
Based on the information provided, academic institutions or non-profits would generally participate only as subcontractors, consultants, or collaborators rather than as the primary applicant organization.
What is the estimated total program funding level for this solicitation?
The FOA listed an estimated total program funding level of $1,000,000.
What is the maximum award amount (award ceiling)?
The award ceiling was stated as $225,000.
What does the $225,000 ceiling imply about the expected scope of work?
It suggests a focused Phase I preclinical effort, such as generating initial efficacy data in relevant disease models, conducting feasibility studies for biomarker assays, producing preliminary analytical validation, or assembling early safety and pharmacology signals to justify a next-stage development plan.
When was this funding opportunity posted/created?
It was posted and created on March 1, 2013.
What was the closing date for applications?
The original and current closing date listed was August 1, 2013.
When was this opportunity archived?
The archive date listed was September 1, 2013.
Is this solicitation currently open?
No. Based on the dates provided (closing date August 1, 2013 and archive date September 1, 2013), this specific solicitation window is historical rather than currently open.
Where can the full announcement be found?
The full announcement was made available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-005.html.
What information would the full NIH Grants Guide announcement typically include?
It would typically include the detailed scientific scope, application instructions, review criteria, budget guidance, and any special requirements that apply to SBIR submissions.
Who is the listed administrative/technical point of contact?
The point of contact listed for administrative help is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What types of issues should be directed to the OER Webmaster contact?
This contact is specifically for issues accessing the announcement or problems linking to it (technical access/support), rather than scientific or programmatic questions.
Does the provided contact email function as a scientific program officer contact?
No. The information provided describes it as an access/support contact. Applicants seeking guidance on fit or scope would normally look within the full FOA for programmatic contacts.
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