Opportunity Information: Apply for RFA AR 10 004
Apply for RFA AR 10 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translation and/or Commercialization of Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Research SBIR R43/R44" 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 Apr 24, 2009 and posted on Apr 24, 2009.
- Applicants must submit their applications by Nov 19, 2009. (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.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
This grant opportunity, titled "Translation and/or Commercialization of Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Research SBIR R43/R44" (Funding Opportunity Number RFA-AR-10-004), was issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) within the National Institutes of Health. It is a discretionary health research funding opportunity aimed specifically at small business concerns that are developing products or enabling technologies in musculoskeletal and skin tissue engineering and regenerative medicine. The central intent is to push promising tissue engineering and regenerative medicine work closer to real-world use by supporting the kinds of studies that reduce risk for investors, regulators, and clinical partners and that position a project to move into early human testing or credible preclinical evaluation.
The scientific emphasis is explicitly translational and commercialization-oriented rather than basic discovery. NIAMS is looking for projects that either (1) carry out preclinical studies that are sufficiently mature and compelling to directly support the start of a Phase I human clinical trial, or (2) develop and refine preclinical animal models that can be used to assess the safety and efficacy of candidate commercial products in this space. In practical terms, this frames the work around near-term deliverables like robust in vivo proof-of-concept, safety and biodistribution signals where relevant, functional outcomes tied to musculoskeletal or skin repair, performance benchmarks for engineered tissues or biomaterials, and preclinical packages that help justify an Investigational New Drug (IND) or Investigational Device Exemption (IDE) path. The FOA also signals that model development itself can be fundable when it fills a clear gap and enables credible safety/efficacy testing for tissue-engineered or regenerative products.
Funding is provided through the Small Business Innovation Research program using the NIH SBIR Phase I (R43) and Phase II (R44) grant mechanisms. That means applicants are expected to be eligible small businesses under SBIR rules and to propose milestone-driven R and D that aligns with early feasibility work in Phase I and more advanced development in Phase II. A notable constraint is that Fast Track applications are not allowed under this announcement, so applicants cannot combine Phase I and Phase II into a single streamlined submission under Fast Track for this particular FOA. The opportunity does not require cost sharing or matching funds, which can matter for early-stage companies trying to conserve capital while generating the preclinical data needed for the next step toward commercialization.
From a funding and competition standpoint, NIAMS projected a total of about $1.5 million in total costs available in fiscal year 2010, with an expectation of making roughly 3 to 5 awards under this announcement. The FOA also makes clear that funding in future years would depend on annual appropriations, which is standard language indicating that multi-year support and follow-on budgets are ultimately subject to federal budget decisions. The CFDA listing associated with this program is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research), reinforcing that the primary mission area is conditions affecting bones, joints, connective tissues, and skin.
Key administrative details in the public record include a posted and created date of April 24, 2009, an original and current closing date of November 19, 2009, and an archive date of December 20, 2009. Eligible applicants are limited to small businesses, consistent with SBIR requirements. The full announcement was hosted on the NIH grants site, and the contact provided for access or linking issues was the NIH Office of Extramural Research webmaster. Overall, the opportunity is best understood as targeted SBIR support for product-focused regenerative medicine and tissue engineering efforts that are close to clinical translation, with a strong preference for well-justified preclinical studies or enabling animal model development that can credibly de-risk a commercial therapeutic or device aimed at musculoskeletal or skin indications.
FAQs: Translation and/or Commercialization of Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Research SBIR R43/R44 (RFA-AR-10-004)
What is the title of this grant opportunity?
The opportunity is titled "Translation and/or Commercialization of Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Research SBIR R43/R44."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AR-10-004.
Which agency and institute issued this funding opportunity?
This FOA was issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) within the National Institutes of Health (NIH).
What type of funding opportunity is this?
It is a discretionary health research funding opportunity delivered through the NIH Small Business Innovation Research (SBIR) program.
Who is eligible to apply?
Eligibility is limited to small business concerns that meet SBIR eligibility requirements.
What research area does this FOA focus on?
The scientific focus is musculoskeletal and skin tissue engineering and regenerative medicine, especially efforts that are positioned for translation and commercialization.
Is this FOA intended for basic research or for translational work?
The emphasis is explicitly translational and commercialization-oriented rather than basic discovery. The intent is to move promising work closer to real-world use.
What is the overall goal or intent of this FOA?
The central intent is to support studies that reduce risk for investors, regulators, and clinical partners and help position a project for early human testing or credible preclinical evaluation.
What kinds of projects is NIAMS looking to fund under this announcement?
NIAMS is looking for projects that either: (1) conduct preclinical studies mature enough to directly support the start of a Phase I human clinical trial, or (2) develop and refine preclinical animal models used to assess safety and efficacy of candidate commercial products in tissue engineering and regenerative medicine for musculoskeletal and skin indications.
Are preclinical animal model development projects eligible?
Yes. The FOA indicates that animal model development itself can be fundable when it fills a clear gap and enables credible safety and efficacy testing for tissue-engineered or regenerative products.
What types of deliverables or study outputs does this FOA emphasize?
The FOA frames work around near-term deliverables such as robust in vivo proof-of-concept, safety signals, biodistribution signals where relevant, functional outcomes tied to musculoskeletal or skin repair, performance benchmarks for engineered tissues or biomaterials, and preclinical packages that help justify an IND or IDE pathway.
Does the FOA mention IND or IDE relevance?
Yes. It references assembling preclinical packages that help justify an Investigational New Drug (IND) or Investigational Device Exemption (IDE) path.
What grant mechanisms are used for this opportunity?
Funding is provided through the NIH SBIR Phase I (R43) and Phase II (R44) grant mechanisms.
How does the Phase I and Phase II structure relate to the work expected?
Applicants are expected to propose milestone-driven research and development aligned with early feasibility work in Phase I and more advanced development in Phase II.
Are Fast Track applications allowed?
No. Fast Track applications are not allowed under this announcement, meaning applicants cannot combine Phase I and Phase II into a single Fast Track submission for this FOA.
Is cost sharing or matching funding required?
No. The opportunity does not require cost sharing or matching funds.
How much funding was NIAMS projecting for this FOA?
NIAMS projected a total of about $1.5 million in total costs available in fiscal year 2010 for this announcement.
How many awards were expected to be made?
NIAMS expected to make roughly 3 to 5 awards under this FOA.
Is future-year funding guaranteed?
No. The FOA states that funding in future years would depend on annual appropriations.
What is the CFDA number associated with this program?
The CFDA listing associated with this program is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
When was this opportunity created and posted?
The posted and created date listed is April 24, 2009.
What was the application closing date?
The original and current closing date listed is November 19, 2009.
When was this FOA archived?
The archive date listed is December 20, 2009.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants site.
Who was listed as the contact for access or linking issues?
The contact provided for access or linking issues was the NIH Office of Extramural Research webmaster.
What kinds of products or technologies are in scope?
The FOA targets small businesses developing products or enabling technologies in musculoskeletal and skin tissue engineering and regenerative medicine, with an orientation toward commercialization and near-term translation.
What is the best high-level way to describe this opportunity?
It is targeted SBIR support for product-focused regenerative medicine and tissue engineering efforts that are close to clinical translation, with a strong preference for well-justified preclinical studies or enabling animal model development that can credibly de-risk a commercial therapeutic or device aimed at musculoskeletal or skin indications.
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