Opportunity Information: Apply for PAR 14 200
Apply for PAR 14 200
- 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 30, 2014 and posted on May 1, 2014.
- Applicants must submit their applications by Mar 2, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments For profit organizations other than small businesses Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Public and State controlled institutions of higher education Private institutions of higher education.
- 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 14 200, is a National Institutes of Health discretionary funding program designed to support the actual conduct and delivery of investigator-initiated interventional clinical trials across all phases, as long as they fall within the scientific mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). In practical terms, this opportunity is meant for research teams that are ready to move beyond trial design and planning and are prepared to implement a clinical trial, including launching sites, enrolling participants, delivering the intervention, monitoring safety, managing data, and completing analysis and reporting. Because it is a cooperative agreement (U01) rather than a standard grant, NIAMS expects to have substantial scientific and/or programmatic involvement during the project, which usually means closer coordination with NIAMS staff around progress, milestones, and any major decisions that affect trial conduct.
A central feature of the program is its typical two-part pathway for NIAMS clinical trials. Most applicants are normally expected to first complete a U34 planning phase (Part 1) and then apply for the U01 implementation award (Part 2). The U34 is generally used to finalize the protocol and essential operational elements before a full trial is funded, such as developing the manual of operations, building the recruitment and retention plan, refining the statistical analysis plan, confirming feasibility assumptions, setting up data and safety oversight, and ensuring regulatory readiness. That said, NIAMS allows a direct application to the U01 without a prior U34 when investigators can credibly demonstrate that all necessary pre-trial planning and preparation have already been completed through other mechanisms. Regardless of the pathway, NIAMS strongly encourages applicants to consult with NIAMS program staff before submitting a U01 application, which is a common expectation for NIH clinical trial cooperative agreements because early communication can clarify fit with NIAMS priorities, expectations for milestones, and operational requirements.
NIAMS emphasizes that supported trials should be hypothesis-driven and milestone-defined. "Hypothesis-driven" signals that the clinical trial should be structured around a clear, testable scientific question rather than being primarily exploratory or descriptive. "Milestone-defined" indicates that the project should include explicit, measurable go/no-go benchmarks used to track progress and guide NIAMS involvement during implementation. The institute also states that the trial must align with the NIAMS research mission, meaning it should address arthritis, musculoskeletal diseases, and skin diseases or related conditions within NIAMS scope, and that proposed studies should be considered high priority by the institute. This language implies that scientific relevance alone is not enough; NIAMS is looking for trials that match its programmatic priorities and are positioned to have meaningful impact.
The FOA is categorized under Health as the funding activity area and is associated with CFDA number 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). It does not require cost sharing or matching, which reduces the financial burden on applicants compared with programs that demand institutional or third-party contributions. The opportunity was posted May 1, 2014, with an original and current closing date of March 2, 2015, and an archive date of April 2, 2015, meaning it was time-limited and is no longer open under that specific announcement, though similar NIAMS clinical trial implementation mechanisms may exist under newer FOAs.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education, nonprofits with and without 501(c)(3) status (with the noted limitations), for-profit organizations (including small businesses and other than small businesses), and a wide range of government entities such as state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Tribal entities are also included, covering federally recognized Native American tribal governments as well as other tribal organizations, and the FOA explicitly lists several institution types often highlighted in federal eligibility statements, 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). It also allows eligible agencies of the federal government and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.
At the same time, the announcement is clear that non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, which typically means that certain parts of the research effort may occur outside the United States under appropriate justification and NIH policy, even though the primary applicant institution must be U.S.-based.
For applicants seeking more detail than a high-level summary, the FOA provides an official NIH link to the full announcement at http://grants.nih.gov/grants/guide/pa-files/PAR-14-200.html. For access or technical difficulties with the announcement, the listed contact is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV, which is mainly meant for issues opening or linking to the FOA rather than scientific or programmatic questions. For scientific fit and trial planning expectations, the most important practical step implied by the FOA is direct consultation with NIAMS staff before submission, since NIAMS explicitly encourages this and because cooperative agreements usually involve institute-level coordination throughout the award.
FAQs: NIAMS Clinical Trial Implementation Cooperative Agreement (U01) - PAR-14-200
What is this funding opportunity?
The NIAMS Clinical Trial Implementation Cooperative Agreement (U01), Funding Opportunity Number PAR-14-200, is an NIH discretionary funding program intended to support the actual conduct and delivery of investigator-initiated interventional clinical trials that fall within the scientific mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What does the U01 support in practical terms?
This U01 is aimed at teams that are ready to implement a clinical trial, not just plan one. It supports activities such as launching clinical sites, enrolling participants, delivering the intervention, monitoring safety, managing trial data, and completing analysis and reporting.
Is this opportunity for clinical trial planning or clinical trial implementation?
This specific mechanism is focused on implementation. While NIAMS commonly expects applicants to have completed a U34 planning phase first, the U01 itself is intended for conducting the trial once planning and operational readiness are in place.
What does it mean that this award is a cooperative agreement (U01)?
Because it is a cooperative agreement rather than a standard research project grant, NIAMS expects to have substantial scientific and/or programmatic involvement during the project. In practice, that usually means closer coordination with NIAMS staff around progress, milestones, and major decisions that affect trial conduct.
What types of clinical trials are supported?
The FOA is for investigator-initiated interventional clinical trials across all phases, as long as the trial is within the NIAMS scientific mission and is considered a high priority by the institute.
Does NIAMS require the trial to be hypothesis-driven?
Yes. NIAMS emphasizes that supported trials should be hypothesis-driven, meaning the clinical trial should be built around a clear, testable scientific question rather than being primarily exploratory or descriptive.
What does "milestone-defined" mean for this program?
NIAMS expects projects to be milestone-defined, meaning the application should include explicit, measurable benchmarks (including potential go/no-go criteria) used to track progress and guide NIAMS involvement during trial implementation.
How important is alignment with the NIAMS mission and priorities?
Alignment is essential. The trial must fit within NIAMS scope (arthritis, musculoskeletal diseases, skin diseases, or related conditions within NIAMS mission). The FOA also indicates that studies should be high priority to NIAMS, which implies that relevance alone may not be sufficient if the proposed work does not match current programmatic priorities.
Is there a typical two-part pathway involving a U34 first?
Yes. A central feature described in the FOA is a typical two-part pathway: a U34 planning phase (Part 1) followed by a U01 implementation award (Part 2). The U34 is generally used to finalize protocol and key operational elements before full implementation funding begins.
What kinds of activities are usually completed during the U34 planning phase?
As described, the U34 is generally used to finalize the protocol and essential operational elements such as developing the manual of operations, building recruitment and retention plans, refining the statistical analysis plan, confirming feasibility assumptions, setting up data and safety oversight, and ensuring regulatory readiness.
Can an applicant apply directly to the U01 without a prior U34?
Yes. NIAMS allows direct application to the U01 when investigators can credibly demonstrate that all necessary pre-trial planning and preparation have already been completed through other mechanisms.
Should applicants contact NIAMS before submitting a U01 application?
Yes. NIAMS strongly encourages applicants to consult with NIAMS program staff before submitting a U01 application. This is especially relevant for cooperative agreements, where early communication can clarify fit with NIAMS priorities, expectations for milestones, and operational requirements.
What is the funding activity area and CFDA number associated with this FOA?
The FOA is categorized under Health as the funding activity area and is associated with CFDA number 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
Is cost sharing or matching required?
No. The FOA specifies that it does not require cost sharing or matching.
When was this opportunity posted, and is it still open?
The opportunity was posted on May 1, 2014. The original and current closing date listed is March 2, 2015, and the archive date is April 2, 2015. Based on those dates, this specific FOA is no longer open, although similar NIAMS clinical trial implementation opportunities may exist under newer announcements.
What organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organization types, including public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (with noted limitations); for-profit organizations (including small businesses and other than small businesses); and many governmental entities (state, county, city/township, special district governments, independent school districts, and public housing authorities/Indian housing authorities).
Are tribal organizations eligible?
Yes. The FOA includes federally recognized Native American tribal governments and other tribal organizations. It also explicitly lists institution types commonly noted in federal eligibility language, including Tribally Controlled Colleges and Universities (TCCUs) and Alaska Native and Native Hawaiian Serving Institutions.
Are minority-serving institutions specifically included in eligibility?
Yes. The FOA explicitly lists institutions 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), among others.
Are faith-based, community-based, regional organizations, or U.S. territories eligible?
Yes. The FOA states that faith-based or community-based organizations are eligible, along with regional organizations and U.S. territories or possessions.
Are federal government agencies eligible to apply?
Yes. The FOA allows eligible agencies of the federal government.
Are non-U.S. (foreign) institutions eligible to apply as the applicant organization?
No. The FOA is clear that non-U.S. (foreign) institutions are not eligible to apply as the applicant organization.
Are non-domestic components of U.S. organizations eligible to apply?
No. The FOA states that non-domestic components of U.S. organizations are also not eligible to apply.
Are "foreign components" allowed at all under this FOA?
Yes. The FOA indicates that "foreign components" (as defined in the NIH Grants Policy Statement) are allowed, meaning certain parts of the research effort may occur outside the United States when appropriately justified and consistent with NIH policy, while the primary applicant organization must be U.S.-based.
Where can applicants find the official full announcement?
The FOA points to the official NIH listing at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-200.html
Who should be contacted for technical problems accessing the FOA?
For access or technical difficulties with the announcement itself (for example, issues opening or linking to the FOA), the listed contact is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Who is the best point of contact for scientific fit and trial planning expectations?
The FOA emphasizes consultation with NIAMS program staff before submission as the most important practical step for clarifying scientific fit, NIAMS priorities, milestone expectations, and operational requirements under a cooperative agreement.
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