Opportunity Information: Apply for PAR 15 165
Apply for PAR 15 165
- 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 Mar 31, 2015 and posted on Mar 31, 2015.
- Applicants must submit their applications by Mar 1, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments For profit organizations other than small businesses Special district governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Independent school districts 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) State governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities.
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIAMS Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number PAR 15 165, is a National Institutes of Health discretionary funding opportunity designed to support the actual conduct and execution of investigator-initiated interventional clinical trials that fall within the mission area of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The focus is on implementation rather than early concept development, meaning applicants are expected to be ready to launch and run a clinical trial, including all phases of interventional research. NIAMS emphasizes that supported trials should be hypothesis-driven and structured around clear, pre-specified milestones, and they should represent work NIAMS considers a high programmatic priority in arthritis, musculoskeletal, and skin diseases research (CFDA 93.846). Because this is a cooperative agreement (U01) rather than a standard research grant, recipients should expect substantial NIH program involvement during the life of the award, typically including coordination around milestones, progress monitoring, and other hands-on stewardship consistent with the cooperative agreement mechanism.
A key feature of this FOA is its typical two-step pathway for NIAMS clinical trials. Most applicants are normally expected to complete a U34 planning phase first (Part 1), and then apply for the U01 implementation award (Part 2). The U34 stage is generally used to finalize essential pre-trial elements such as protocol details, operational plans, recruitment and retention strategies, site readiness, data and safety oversight plans, and other logistics that reduce risk before participant enrollment begins. However, NIAMS explicitly allows a direct application to the U01 for investigators who have already completed all necessary pre-trial planning and preparation through other mechanisms. In practical terms, that means if a team can demonstrate that the protocol and operational infrastructure are fully developed and trial-ready, they may skip the U34 and still be considered for U01 support.
The opportunity is open to a broad range of domestic applicant organizations across government, nonprofit, academic, and private sectors. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status, small businesses and other for-profit organizations (other than small businesses), and multiple levels of government such as state governments, county governments, city or township governments, special district governments, and independent school districts. It also includes public housing authorities/Indian housing authorities and tribal entities, including federally recognized Native American tribal governments and other tribal organizations. The FOA also lists additional eligible applicant categories 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 (AANAPISISs), as well as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components as defined in the NIH Grants Policy Statement may be allowed, which can matter for studies that need some international element while retaining a U.S.-based applicant organization.
From an administrative standpoint, the FOA was posted on March 31, 2015, with an original and current closing date of March 1, 2016, and it was archived on April 1, 2016. It does not require cost sharing or matching. The activity category is Health, and the funding instrument is a cooperative agreement, signaling that NIAMS expects active involvement consistent with managing complex clinical trial implementation. For applicants who need the full text and requirements, the announcement is available through the NIH Grants Guide at the provided link (http://grants.nih.gov/grants/guide/pa-files/PAR-15-165.html). For technical access issues, NIH directs users to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs): NIAMS Clinical Trial Implementation Cooperative Agreement (U01) - PAR-15-165
1) What is this funding opportunity?
This opportunity is the NIAMS Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number (FOA) PAR-15-165. It is an NIH discretionary funding opportunity intended to support the conduct and execution of investigator-initiated interventional clinical trials within the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
2) What does the U01 support in practical terms?
The U01 supports implementation of an interventional clinical trial, meaning the work of launching and running the study (including the phases of interventional research). The emphasis is on actually carrying out the trial rather than developing early-stage concepts.
3) Is this opportunity meant for early concept development or planning?
No. The focus is on implementation rather than early concept development. Applicants are expected to be ready to start the clinical trial, with planning and operational readiness already in place.
4) What kinds of clinical trials are in scope?
The FOA supports investigator-initiated interventional clinical trials that fall within NIAMS mission areas and that NIAMS considers high programmatic priority in arthritis, musculoskeletal, and skin diseases research.
5) Do supported trials need to be hypothesis-driven?
Yes. NIAMS emphasizes that supported trials should be hypothesis-driven.
6) Are milestones required?
Yes. Trials are expected to be structured around clear, pre-specified milestones, which NIAMS may use for coordination and monitoring during the project.
7) What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.846.
8) What does it mean that this is a cooperative agreement (U01) instead of a standard research grant?
A cooperative agreement indicates substantial NIH program involvement during the life of the award. Under this FOA, recipients should expect hands-on NIH stewardship, such as coordination around milestones, progress monitoring, and related involvement consistent with the cooperative agreement mechanism.
9) What is the typical pathway NIAMS expects for clinical trials under this program?
NIAMS typically uses a two-step pathway: a U34 planning phase (Part 1) followed by the U01 implementation award (Part 2).
10) What is the purpose of the U34 planning phase?
The U34 planning stage is generally used to finalize essential pre-trial elements that reduce risk before enrollment begins. Examples noted include protocol details, operational plans, recruitment and retention strategies, site readiness, and data and safety oversight plans, along with other logistics.
11) Is a U34 required before applying for the U01?
Most applicants are normally expected to complete a U34 planning phase first. However, NIAMS allows direct application to the U01 for investigators who have already completed all necessary pre-trial planning and preparation through other mechanisms.
12) When is a direct-to-U01 application allowed?
A direct U01 application is allowed when the team can demonstrate that the protocol and operational infrastructure are fully developed and the trial is ready to launch without needing the U34 planning phase.
13) Who can apply (in general)?
The opportunity is open to a broad range of domestic applicant organizations across government, nonprofit, academic, and private sectors, as described in the FOA.
14) Are public and state-controlled institutions of higher education eligible?
Yes. Public and state-controlled institutions of higher education are listed as eligible applicants.
15) Are private institutions of higher education eligible?
Yes. Private institutions of higher education are listed as eligible applicants.
16) Are nonprofit organizations eligible, including those without 501(c)(3) status?
Yes. The FOA lists nonprofits with and without 501(c)(3) status as eligible applicants.
17) Are for-profit organizations eligible?
Yes. The FOA includes small businesses and other for-profit organizations (other than small businesses) among eligible applicants.
18) Are government entities eligible to apply?
Yes. The FOA includes multiple levels of government such as state governments, county governments, city or township governments, special district governments, and independent school districts. Eligible federal agencies are also listed.
19) Are Tribal entities eligible?
Yes. The FOA includes tribal entities, including federally recognized Native American tribal governments and other tribal organizations.
20) Are public housing authorities/Indian housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
21) Are HBCUs, Hispanic-serving institutions, and other minority-serving institutions eligible?
Yes. The FOA lists 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 (AANAPISISs) as eligible applicant categories.
22) Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are listed among eligible applicants.
23) Are regional organizations eligible?
Yes. Regional organizations are listed as eligible applicants.
24) Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicants.
25) Can foreign (non-U.S.) institutions apply as the applicant organization?
No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply as the applicant organization under this FOA.
26) Are foreign components allowed in any form?
Possibly. The FOA notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed. This can matter for studies that need an international element while still having a U.S.-based applicant organization.
27) When was the FOA posted and when did it close?
The FOA was posted on March 31, 2015. The original and current closing date is March 1, 2016. It was archived on April 1, 2016.
28) Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
29) What is the activity category?
The activity category is Health.
30) Where can applicants find the full FOA text and official requirements?
The announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-165.html
31) Who should be contacted for technical access issues related to the announcement?
For technical access issues, NIH directs users to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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