Opportunity Information: Apply for PAR 11 219
Apply for PAR 11 219
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Implementation Cooperative Agreement (U01)" 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 May 27, 2011 and posted on May 27, 2011.
- Applicants must submit their applications by Mar 3, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Small businesses County governments Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Special district governments State governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public housing authorities/Indian housing authorities.
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are not allowed.
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Opportunity Summary:
The NIAMS Clinical Trial Implementation Cooperative Agreement (U01) (Funding Opportunity Number PAR-11-219) is a National Institutes of Health discretionary funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to support the actual conduct and implementation of investigator-initiated interventional clinical trials across all phases. The focus is on hypothesis-driven studies that align with the NIAMS mission in arthritis, musculoskeletal, and skin diseases research (CFDA 93.846). This is not a planning award; it is intended to fund the launch and execution of a well-prepared clinical trial, with clear, predefined milestones that NIAMS considers high priority. Because it is a cooperative agreement (U01), awardees should expect substantial involvement from NIAMS staff during the life of the project, typically around oversight, milestone tracking, and coordination expectations that are stronger than in a standard research project grant.
A key feature of this FOA is that it enables electronic submission for single-site clinical trial projects, and it is positioned as a complement to the separate NIAMS UM1 mechanism that, at the time, supported multi-site projects and permitted paper submissions. In practical terms, investigators proposing a single-site interventional trial that is ready to implement would look to this U01 pathway, while multi-site efforts were generally directed to the UM1 route described as complementary in the announcement.
NIAMS generally expects applicants to come through a two-step process for clinical trials. The typical pathway starts with a U34 planning phase (Part 1), which is used to finalize essential pre-trial elements such as protocol details, operational plans, and other readiness activities, and then proceeds to the U01 implementation application (Part 2) once the study is fully prepared to begin. However, the FOA also leaves room for investigators who have already completed all required pre-trial planning through other mechanisms to apply directly for the NIAMS U01 without having previously held a U34, as long as they can demonstrate that the trial is truly implementation-ready.
The announcement strongly encourages consultation with NIAMS program staff before submission. That pre-submission interaction is emphasized as important for confirming fit with NIAMS priorities, ensuring the proposed clinical trial meets institute expectations (especially around hypothesis-driven design and milestone-based management), and avoiding misalignment on scope, readiness, or trial type. In other words, NIAMS is signaling that applicants should not treat this as a generic clinical trial funding mechanism, but as one where early alignment with the institute’s mission and operational expectations matters.
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and other nonprofits), for-profit organizations (other than small businesses as a specific category also listed), small businesses, and various government entities (state, county, city/township, special districts, public housing authorities), as well as tribal governments and tribal organizations. The FOA also explicitly includes a range of special categories such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, it clearly excludes non-U.S. entities: foreign (non-U.S.) organizations are not eligible to apply, and foreign components of U.S. organizations are not allowed under this opportunity.
There is no cost sharing or matching requirement. The opportunity was posted and created on May 27, 2011, with an original and current closing date of March 3, 2014, and an archive date of April 3, 2014, meaning it is no longer active as a current competition but remains available as a historical FOA record. The full announcement was hosted through the NIH Grants Guide (link provided in the notice), and the NIH Office of Extramural Research (OER) webmaster contact information is included for access or linking issues.
Frequently Asked Questions (FAQs): NIAMS Clinical Trial Implementation Cooperative Agreement (U01) - PAR-11-219
What is this funding opportunity?
This opportunity is the NIAMS Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number PAR-11-219. It is a National Institutes of Health (NIH) discretionary funding opportunity administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What does this award support?
It supports the actual conduct and implementation of investigator-initiated interventional clinical trials across all phases. The intent is to fund trials that are ready to launch and execute, not to fund early planning activities.
Is this a planning grant?
No. This is explicitly not a planning award. It is intended to support the launch and execution of a well-prepared, implementation-ready clinical trial.
What kinds of studies are NIAMS looking for under this FOA?
The focus is on hypothesis-driven interventional clinical trials that align with the NIAMS mission in arthritis, musculoskeletal, and skin diseases research. The FOA emphasizes predefined milestones and NIAMS priority for studies with clear, trackable progress expectations.
What is the CFDA number associated with this opportunity?
The CFDA number listed for this opportunity is 93.846.
What does it mean that this is a cooperative agreement (U01)?
Because the mechanism is a cooperative agreement (U01), awardees should expect substantial involvement from NIAMS staff during the life of the project. This typically includes oversight, milestone tracking, and coordination expectations that are stronger than what is usually seen in a standard research project grant.
Does NIAMS require milestones for this U01 clinical trial?
Yes. The FOA highlights the expectation of clear, predefined milestones, and notes that NIAMS considers milestone-based management a high priority for these implementation awards.
Is this FOA intended for single-site or multi-site clinical trials?
This U01 is positioned for single-site interventional clinical trial projects and enables electronic submission for those projects. The announcement describes it as complementary to a separate NIAMS UM1 mechanism that, at the time, supported multi-site projects (and permitted paper submissions).
If my project is multi-site, should I use this U01 mechanism?
Based on the information provided in the announcement summary, multi-site efforts were generally directed to the complementary NIAMS UM1 route, while single-site implementation-ready interventional trials would look to this U01 pathway.
What is the typical NIAMS pathway for clinical trial applications?
NIAMS generally expects a two-step process. The typical pathway begins with a U34 planning phase (Part 1) to finalize key pre-trial elements (such as protocol details and operational plans), and then proceeds to the U01 implementation application (Part 2) once the study is fully prepared to begin.
Do applicants have to complete a U34 before applying to this U01?
Not always. While the typical NIAMS pathway starts with a U34 planning phase, the FOA allows investigators who have already completed all required pre-trial planning through other mechanisms to apply directly for the U01, as long as they can demonstrate the trial is truly implementation-ready.
What does NIAMS mean by "implementation-ready"?
From the information provided, implementation-ready means the clinical trial is well prepared to launch and execute, with essential pre-trial planning completed and with clear, predefined milestones suitable for NIAMS oversight and tracking.
Is consultation with NIAMS program staff required or recommended?
The announcement strongly encourages consultation with NIAMS program staff before submission. The purpose is to confirm fit with NIAMS priorities, ensure the study meets expectations (including hypothesis-driven design and milestone-based management), and reduce the risk of misalignment on scope, readiness, or trial type.
Why does NIAMS encourage pre-submission consultation?
NIAMS signals that this is not a generic clinical trial funding mechanism. Early alignment is emphasized to confirm that the proposed trial matches NIAMS mission areas and operational expectations, including readiness to implement and the cooperative agreement management approach.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types. This includes public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and other nonprofit types); for-profit organizations; small businesses; and many government entities (including state, county, city/township, special district governments, and public housing authorities). It also includes tribal governments and tribal organizations, U.S. territories or possessions, regional organizations, faith-based or community-based organizations, and eligible federal agencies.
Are any specific institution types explicitly included?
Yes. The FOA explicitly includes categories such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and other similar categories called out in the eligibility description.
Are foreign organizations eligible?
No. Foreign (non-U.S.) organizations are not eligible to apply under this opportunity.
Are foreign components of U.S. organizations allowed?
No. The FOA states that foreign components of U.S. organizations are not allowed under this opportunity.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
When was this opportunity posted, and is it still open?
The opportunity was posted and created on May 27, 2011. The original and current closing date listed is March 3, 2014, and the archive date is April 3, 2014. This means it is no longer an active competition and is available as a historical FOA record.
Where was the full announcement hosted?
The full announcement was hosted through the NIH Grants Guide (a link was provided in the notice).
Who is listed for technical issues related to access or linking?
The NIH Office of Extramural Research (OER) webmaster contact information is included in the announcement for access or linking issues.
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