Opportunity Information: Apply for RFA AR 11 005

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Accelerating Research Translation (ART) in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Competitive Revision Award (P01 and P50)" 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 Feb 26, 2010 and posted on Feb 26, 2010.
  • Applicants must submit their applications by Aug 4, 2010. (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.
  • Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Independent school districts Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

This funding opportunity (RFA-AR-11-005) is a National Institutes of Health program from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) focused on accelerating the translation of tissue engineering and regenerative medicine (TE/RM) advances for musculoskeletal and skin conditions. The core idea is to push promising TE/RM therapies and enabling platforms out of earlier-stage research and into the kind of preclinical evidence package that can realistically support near-term first-in-human studies. Rather than funding brand-new standalone projects, NIAMS is offering competitive revision support (what used to be called a competing supplement) to expand the scope of already active NIAMS-funded parent awards so investigators can complete major translational steps that are often too large or costly to handle under the original grant budget and timeline.

A defining feature of the announcement is its emphasis on large animal preclinical studies. NIAMS is explicitly looking for work in species and models that more closely approximate human anatomy, biomechanics, and physiology than typical rodent work, because the goal is to generate data that can directly support Phase I/II clinical trials or immediately set up the path to those trials. Applications are expected to do at least one of three things: (1) generate the specific preclinical data needed to justify and design Phase I/II studies in musculoskeletal or skin TE/RM, (2) demonstrate efficacy of a TE/RM therapy in a large animal context where the results are meaningfully predictive for humans, or (3) develop or refine preclinical large animal models that can serve as a practical bridge to Phase I/II clinical testing for TE/RM approaches. In contrast, early translational studies limited to small animals (for example rodents or rabbits) are called out as not responsive to the announcement, which signals that reviewers will be looking for a clear rationale for large animal selection, clinically relevant endpoints, and a direct line of sight to human trial readiness.

The mechanism is specifically a revision to existing P01 and P50 awards. That means only investigators with active NIAMS parent grants of the appropriate type can use this route to request additional, competitively reviewed support to add substantial translational activities to their ongoing program project (P01) or specialized center (P50). NIAMS notes that this P01/P50 revision opportunity runs in parallel with a companion announcement of identical scientific scope aimed at the R01 community (RFA-AR-11-004), which collectively indicates an institute-wide push to move the most mature TE/RM concepts toward clinical entry regardless of whether the underlying parent grant is investigator-initiated (R01) or multi-project/center-based (P01/P50).

Funding is limited and competitive. NIAMS planned to commit a total of $1,000,000 in FY 2011 to make 1 to 3 ART awards across both the R01 and the P01/P50 ART announcements combined, so the number of awards under this specific FOA would be a subset of that total. Awards are also contingent on the availability of funds and the receipt of sufficiently strong applications, reinforcing that only projects with clear translational urgency, strong feasibility, and compelling clinical relevance are likely to be supported.

Eligibility, as listed in the source data, is broad in terms of institution type and includes many domestic public and private entities (such as higher education institutions, nonprofits, small businesses, and various government units), as well as certain non-U.S. entities and other special categories (including HBCUs, Hispanic-serving institutions, tribal organizations, and U.S. territories/possessions). Practically, though, the key gating requirement is that applicants must be positioned to submit a competitive revision tied to an active, eligible NIAMS parent P01 or P50 grant, since the award is not designed as an independent grant for new applicants without an appropriate parent award to revise.

Administratively, the opportunity was posted February 26, 2010, with an application due date of August 4, 2010, and an archive date of September 4, 2010. It falls under CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research), has no cost sharing or matching requirement, and is categorized as a discretionary health research grant. The full announcement was hosted through the NIH grants guide, and NIH’s Office of Extramural Research provided standard web support contacts for access and linking issues.

Frequently Asked Questions (FAQs) - NIH NIAMS RFA-AR-11-005

What is RFA-AR-11-005?

RFA-AR-11-005 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It supports activities intended to accelerate translation of tissue engineering and regenerative medicine (TE/RM) advances for musculoskeletal and skin conditions toward clinical testing.

What is the overall goal of this funding opportunity?

The goal is to move promising TE/RM therapies and enabling platforms from earlier-stage research into a preclinical evidence package that can realistically support near-term first-in-human studies, including preparation for Phase I/II clinical trials.

Is this opportunity meant for brand-new standalone projects?

No. This opportunity is for competitive revision support (formerly called a competing supplement) to expand the scope of already active NIAMS-funded parent awards, rather than funding new independent projects.

What NIH grant mechanism does this opportunity use?

This announcement supports revisions to existing P01 (program project) and P50 (specialized center) awards. Only investigators with active, eligible NIAMS parent P01 or P50 grants can use this mechanism.

What types of studies does NIAMS emphasize under this announcement?

A defining emphasis is on large animal preclinical studies, using species and models that more closely approximate human anatomy, biomechanics, and physiology than typical rodent studies. The intent is to generate data that can directly support entry into Phase I/II trials or clearly set up the path to those trials.

What kinds of projects are considered responsive to this announcement?

Applications are expected to do at least one of the following:

  • Generate specific preclinical data needed to justify and design Phase I/II studies in musculoskeletal or skin TE/RM.
  • Demonstrate efficacy of a TE/RM therapy in a large animal context where results are meaningfully predictive for humans.
  • Develop or refine preclinical large animal models that can serve as a practical bridge to Phase I/II clinical testing for TE/RM approaches.

Are small animal studies allowed under this opportunity?

Early translational studies limited to small animals (for example rodents or rabbits) are specifically described as not responsive. The announcement signals that applications should provide a clear rationale for large animal selection, clinically relevant endpoints, and a direct line of sight to human trial readiness.

What disease or condition areas does this opportunity target?

The scientific focus is on musculoskeletal and skin conditions, specifically in the context of tissue engineering and regenerative medicine (TE/RM).

Who is eligible to apply?

The listed institutional eligibility is broad and includes many domestic public and private entities (such as higher education institutions, nonprofits, small businesses, and various government units), as well as certain non-U.S. entities and other special categories (including HBCUs, Hispanic-serving institutions, tribal organizations, and U.S. territories/possessions). However, the key requirement is that the application must be a competitive revision tied to an active, eligible NIAMS parent P01 or P50 award.

Can an organization apply if it does not currently have an active NIAMS P01 or P50 parent award?

Not through this specific mechanism as described. The opportunity is designed as a competitive revision to an existing, active, eligible NIAMS P01 or P50 parent grant, not as an independent award for new applicants without the appropriate parent award.

How does this opportunity relate to RFA-AR-11-004?

NIAMS noted a companion announcement with identical scientific scope aimed at the R01 community (RFA-AR-11-004). Together, these announcements indicate an institute-wide push to move mature TE/RM concepts toward clinical entry, whether the parent grant is an R01 or a multi-project/center-based P01/P50.

How much funding was planned, and how many awards were expected?

NIAMS planned to commit a total of $1,000,000 in FY 2011 to make 1 to 3 ART awards across both the R01 and the P01/P50 ART announcements combined. The number of awards under RFA-AR-11-005 would be a subset of that combined total.

Is funding guaranteed if an application is submitted?

No. Awards are contingent on the availability of funds and the receipt of sufficiently strong applications, and the program is described as limited and competitive.

When was this opportunity posted, and what were the key dates?

The opportunity was posted on February 26, 2010. The application due date was August 4, 2010. The archive date was September 4, 2010.

What CFDA number is associated with this funding opportunity?

The opportunity falls under CFDA 93.846, Arthritis, Musculoskeletal and Skin Diseases Research.

Is there a cost sharing or matching requirement?

No. The source information states there is no cost sharing or matching requirement.

How is this opportunity categorized?

It is categorized as a discretionary health research grant.

Where was the full announcement hosted?

The full announcement was hosted through the NIH grants guide.

Who provided support contacts for access or linking issues?

NIH's Office of Extramural Research provided standard web support contacts for access and linking issues.

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