Opportunity Information: Apply for RFA AR 12 006

  • 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 (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 Jun 10, 2011 and posted on Jun 10, 2011.
  • Applicants must submit their applications by Oct 11, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $300,000.00 in funding.
  • Eligible applicants include: Small businesses.
Apply for RFA AR 12 006

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Opportunity Summary:

The Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (R43) opportunity (Funding Opportunity Number RFA-AR-12-006) is a National Institutes of Health grant solicitation aimed specifically at small business concerns that want to run preclinical research projects focused on rare diseases affecting the musculoskeletal system, rheumatic conditions, or skin. The core purpose is to push early-stage, nonclinical development work forward in areas that often struggle to attract enough commercial investment because patient populations are small. In this FOA, a "rare disease" is defined using the standard U.S. threshold of fewer than 200,000 affected individuals nationwide, which helps clarify the intended scope and ensures the initiative targets conditions that are genuinely uncommon and underserved.

The FOA emphasizes two broad kinds of preclinical work: development of biomarkers and development of treatments. On the biomarker side, projects might involve identifying or validating biological signals that can help diagnose a rare condition earlier, stratify patients, predict progression, or measure whether a therapy is working in a clinical study. On the treatment side, projects are expected to support the development pipeline prior to human testing, such as generating proof-of-concept data, conducting nonclinical efficacy studies, optimizing leads, or completing other preclinical steps that strengthen the case for eventual clinical translation. The announcement also explicitly notes that studies involving FDA-designated orphan products are eligible when they relate to musculoskeletal, rheumatic, or skin diseases, which is important because orphan designation often comes with a distinct regulatory and commercialization pathway that can make niche therapies more feasible to bring to market.

This is a discretionary funding opportunity using the grant mechanism under the SBIR program, specifically the R43 phase structure (commonly associated with Phase I feasibility and early proof-of-concept work). Eligible applicants are limited to small businesses, aligning with SBIRs broader mission of stimulating technological innovation and encouraging small companies to meet federal research and development needs while building commercialization potential. There is no cost sharing or matching requirement stated, which reduces barriers for smaller firms that might not have substantial capital to commit upfront.

The administering agency is NIH, with the programmatic area tied to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The FOA points applicants to the NIAMS Long Range Plan as a way to understand the institutes broader priorities and research interests, which effectively signals that proposals should not only be scientifically strong but also fit the institute's mission and strategic direction in arthritis, musculoskeletal, rheumatic, and skin disease research. For teams shaping an application, that typically means showing a clear line of sight from the proposed preclinical work to meaningful impact for patients with rare conditions, and a rationale for why the project is positioned to advance the field rather than replicate existing efforts.

From a funding and timing standpoint, the opportunity listed an estimated total funding amount of $1,500,000 and an award ceiling of $300,000. The FOA was posted on June 10, 2011, with an original and current closing date of October 11, 2011, and an archive date of November 11, 2011, indicating the solicitation was time-limited and is now archived. The CFDA number associated with the program is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). For anyone seeking the full details, the FOA provided an official NIH link to the complete announcement text, along with NIH Office of Extramural Research (OER) webmaster contacts for access or technical issues related to the posting.

Frequently Asked Questions (FAQs)

1) What is the name of this funding opportunity?

The opportunity is titled "Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (R43)."

2) What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-AR-12-006.

3) Which agency is offering this grant?

The administering agency is the National Institutes of Health (NIH).

4) Which NIH institute is tied to this solicitation?

The programmatic area is tied to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

5) What is the main purpose of this FOA?

The core purpose is to support early-stage, preclinical (nonclinical) research and development for rare musculoskeletal, rheumatic, and skin diseases, especially in areas where limited commercial investment is common due to small patient populations.

6) Who is eligible to apply?

Eligible applicants are limited to small business concerns, consistent with the Small Business Innovation Research (SBIR) program.

7) What grant mechanism is being used?

This is an SBIR funding opportunity using the NIH grant mechanism under the R43 phase structure, which is commonly associated with Phase I feasibility and early proof-of-concept work.

8) What kinds of diseases does this FOA focus on?

The FOA targets rare diseases affecting the musculoskeletal system, rheumatic conditions, and skin diseases.

9) How does the FOA define a "rare disease"?

A rare disease is defined using the standard U.S. threshold of fewer than 200,000 affected individuals nationwide.

10) What types of preclinical projects are emphasized?

The FOA emphasizes two broad categories of preclinical work: (1) development of biomarkers and (2) development of treatments.

11) What does "biomarker development" include under this FOA?

Biomarker projects may include identifying or validating biological signals that can help diagnose a rare condition earlier, stratify patients, predict disease progression, or measure whether a therapy is working in a clinical study.

12) What does "treatment development" include under this FOA?

Treatment-focused projects are expected to support the development pipeline prior to human testing. Examples mentioned include generating proof-of-concept data, conducting nonclinical efficacy studies, optimizing leads, and completing other preclinical steps that strengthen the case for eventual clinical translation.

13) Are FDA-designated orphan products eligible under this announcement?

Yes. The announcement explicitly notes that studies involving FDA-designated orphan products are eligible when they relate to musculoskeletal, rheumatic, or skin diseases.

14) Why does the FOA highlight rare diseases and orphan products?

The FOA is designed to advance early-stage development work in areas that often struggle to attract commercial investment because patient populations are small. Orphan designation is also relevant because it is associated with a distinct regulatory and commercialization pathway that can make niche therapies more feasible to bring to market.

15) Is cost sharing or matching required?

No cost sharing or matching requirement is stated in the provided description, which can reduce barriers for small firms with limited upfront capital.

16) What is the estimated total funding amount for this opportunity?

The opportunity listed an estimated total funding amount of $1,500,000.

17) What is the award ceiling?

The award ceiling is $300,000.

18) When was the FOA posted?

The FOA was posted on June 10, 2011.

19) What was the closing date for applications?

The original and current closing date listed was October 11, 2011.

20) Is this funding opportunity still open?

No. The solicitation is time-limited and is now archived. An archive date of November 11, 2011 is listed.

21) What is the CFDA number associated with this program?

The CFDA number associated with the program is 93.846, titled "Arthritis, Musculoskeletal and Skin Diseases Research."

22) Does the FOA reference NIAMS strategic priorities?

Yes. The FOA points applicants to the NIAMS Long Range Plan to understand broader institute priorities and research interests, signaling that proposed projects should align with NIAMS mission areas in arthritis, musculoskeletal, rheumatic, and skin disease research.

23) What does the FOA suggest about how applicants should position their projects?

Based on the description, applicants are expected to show a clear line of sight from the proposed preclinical work to meaningful impact for patients with rare conditions, and to explain why the project would advance the field rather than replicate existing efforts.

24) Where can applicants find the full official announcement?

The FOA provided an official NIH link to the complete announcement text for full details.

25) Who is listed for technical or access issues related to the posting?

The FOA lists NIH Office of Extramural Research (OER) webmaster contacts for access or technical issues related to the posting.

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