Opportunity Information: Apply for PAR 14 060

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21)" 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 Jan 3, 2014 and posted on Jan 3, 2014.
  • Applicants must submit their applications by Nov 3, 2014. (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 $200,000.00 in funding.
  • Eligible applicants include: State governments Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses City or township governments Public and State controlled institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Private institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments).
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21) funding opportunity (PAR 14-060) is a National Institutes of Health (NIH) discretionary grant program that supports early stage, exploratory clinical research focused on preventing or treating diseases, conditions, and injuries within the arthritis, musculoskeletal, and skin disease areas. The core purpose is to give investigators room to launch short term, proof of concept style clinical studies that can test fresh ideas without needing extensive preliminary data upfront. In practice, this mechanism is meant to help researchers move quickly from a promising concept to a small, well designed human study that can clarify whether the idea is worth pursuing in a larger, definitive clinical trial.

The studies supported under this program are intended to be pilot and feasibility efforts rather than full scale trials. A key expectation is that the work will generate critical preliminary data that directly strengthens a future planned clinical trial, such as evidence on feasibility, early signals of efficacy, dose or regimen considerations, recruitment and retention capability, adherence, safety/tolerability observations, or the performance of outcome measures and biomarkers in the target population. Projects can involve testing new treatment approaches, prevention strategies, novel interventions, or unusual and potentially synergistic combinations of therapies. NIH also flags translational value as a high priority, meaning applications that help move credible laboratory or preclinical advances toward practical clinical use are especially aligned with the program’s intent.

Administratively, this opportunity was posted on January 3, 2014, with an original and current closing date of November 3, 2014, and an archive date of December 4, 2014. The activity category is Health, and it is listed under CFDA number 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). The funding instrument is a grant, and the program does not require cost sharing or matching. The maximum award amount listed is an award ceiling of $200,000, which signals that projects should be scoped to fit a modest budget appropriate for a short term exploratory clinical effort.

Eligibility is broad and includes many types of U.S. based organizations as well as foreign entities. Eligible applicants include state, county, city or township, and special district governments; public and state controlled and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; Native American tribal governments and tribal organizations; nonprofits with and without 501(c)(3) status; small businesses and other for profit organizations (including those other than small businesses); and other categories called out in the announcement. The eligibility section further specifies inclusion of a wide range of mission focused or underserved serving institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith based or community based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Non U.S. (foreign) organizations and foreign institutions are explicitly eligible to apply, non U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.

For applicants seeking the official requirements, application instructions, and any NIH specific details on allowable clinical study designs and expectations under the R21 mechanism, the full announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-14-060.html. Technical access issues are directed to the NIH Office of Extramural Research (OER) webmaster via FBOWebmaster@OD.NIH.GOV, including problems accessing the announcement or linking to the funding notice.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity and what mechanism does it use?

The opportunity is titled Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21) under PAR 14-060. It uses the NIH R21 grant mechanism, which is designed for early stage, exploratory projects.

Which agency offers this funding opportunity?

This is a National Institutes of Health (NIH) discretionary grant program.

What is the main purpose of this R21 program?

The core purpose is to support short term, proof-of-concept style clinical studies that test fresh ideas in humans without requiring extensive preliminary data upfront. It is intended to help investigators move quickly from a promising concept to a small, well designed human study that can determine whether the idea is worth pursuing in a larger clinical trial.

What scientific areas or diseases does this opportunity focus on?

It focuses on clinical research related to arthritis, musculoskeletal diseases/conditions, and skin diseases, including efforts aimed at preventing or treating diseases, conditions, and injuries within these areas.

What kinds of studies are expected (pilot vs. full-scale trials)?

Supported projects are intended to be pilot and feasibility efforts rather than full-scale, definitive clinical trials. The expectation is that the work will generate critical preliminary data that strengthens a future planned clinical trial.

What types of preliminary data or outcomes is NIH looking for from these studies?

The announcement highlights preliminary data that directly informs a future planned clinical trial, such as evidence related to:

  • Feasibility
  • Early signals of efficacy
  • Dose or regimen considerations
  • Recruitment and retention capability
  • Adherence
  • Safety and tolerability observations
  • Performance of outcome measures and biomarkers in the target population

What kinds of interventions or approaches can be proposed?

Projects can involve testing new treatment approaches, prevention strategies, novel interventions, or unusual and potentially synergistic combinations of therapies, as long as they fit the pilot/feasibility intent.

Is translational research emphasized?

Yes. NIH flags translational value as a high priority. Applications that help move credible laboratory or preclinical advances toward practical clinical use are especially aligned with the program’s intent.

What is the funding instrument and activity category?

The funding instrument is a grant. The activity category is Health.

What is the CFDA number for this opportunity?

The CFDA number is 93.846, listed as Arthritis, Musculoskeletal and Skin Diseases Research.

What is the maximum award amount?

The listing includes an award ceiling of $200,000, indicating projects should be scoped for a modest budget appropriate for a short term exploratory clinical effort.

Is cost sharing or matching required?

No. The program does not require cost sharing or matching.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations as well as foreign entities. Examples of eligible applicants include:

  • State, county, city or township, and special district governments
  • Public and state controlled and private institutions of higher education
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • Native American tribal governments and tribal organizations
  • Nonprofits with and without 501(c)(3) status
  • Small businesses
  • Other for-profit organizations (including those other than small businesses)
  • Other categories identified in the announcement

Are mission-focused or underserved-serving institutions explicitly included?

Yes. The eligibility section specifically includes institutions and organizations such as:

  • Historically Black Colleges and Universities (HBCUs)
  • Hispanic Serving Institutions
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
  • Faith-based or community-based organizations
  • Regional organizations
  • U.S. territories or possessions
  • Eligible federal agencies

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-U.S. (foreign) organizations and foreign institutions are explicitly eligible to apply.

Are foreign components allowed as part of a U.S. organization’s application?

Yes. Non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.

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

The opportunity was posted on January 3, 2014. The original and current closing date was November 3, 2014. The archive date was December 4, 2014.

Where can applicants find the official announcement and application instructions?

The full announcement is available at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-060.html. This is the source for official requirements, application instructions, and NIH-specific details on allowable clinical study designs and expectations under the R21 mechanism.

Who should be contacted for technical problems accessing the announcement?

Technical access issues (such as problems accessing the announcement or linking to the funding notice) are directed to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

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