Opportunity Information: Apply for PAR 16 270
Apply for PAR 16 270
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NIAID 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): 93.855, 93.856,.
- This funding opportunity was created on May 18, 2016 and posted on May 18, 2016.
- Applicants must submit their applications by May 13, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIAID Clinical Trial Implementation Cooperative Agreement (U01), funding opportunity number PAR-16-270, is a discretionary NIH grant mechanism designed to support the actual conduct and implementation of investigator-initiated clinical trials that NIAID considers high-risk, along with mechanistic studies that are directly tied to those high-risk trials. In practical terms, this FOA is aimed at moving beyond planning and into executing a clinical trial, while also encouraging investigators to build in scientifically rigorous mechanistic components that can explain how and why an intervention works (or does not work) in humans. The emphasis on “high-risk” signals NIAID interest in bold, potentially high-impact studies that may carry greater uncertainty or operational complexity than more conventional trials, but that could materially advance the field if successful.
A central feature of this opportunity is the explicit encouragement of mechanistic research embedded within or closely associated with the clinical trial. Mechanistic work can include studies that probe immune responses, pathogen dynamics, host genetics, biomarkers, or other biologic pathways that help interpret trial outcomes. NIAID highlights this because mechanistic insights often outlast a single trial result: even if a clinical endpoint is negative, well-designed mechanistic data can clarify disease biology, identify responder subgroups, refine dosing or timing strategies, and guide next-generation therapeutics or preventive modalities. This FOA therefore supports not only clinical efficacy or safety questions, but also the deeper scientific understanding needed to develop future interventions.
The award uses the cooperative agreement instrument (U01), meaning the project is expected to be carried out with substantial scientific or programmatic involvement from NIH/NIAID staff compared with a standard research project grant. While the investigator team remains responsible for the study design and execution, the cooperative structure typically reflects a more collaborative relationship with the funding agency, which can be important for complex trials that require alignment with NIAID priorities, adherence to clinical trial oversight expectations, and coordination around regulatory, safety, and data quality considerations.
Eligibility is broad and includes many types of domestic organizations that can credibly conduct clinical trials. Eligible applicants listed for this FOA include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The listing also includes an “Other” category with a note to consult the FOA’s additional eligibility language for any clarifications or special cases. This wide eligibility reflects the reality that clinical trials may be led by universities, medical centers, research institutes, hospitals, nonprofit sponsors, or industry partners, depending on the intervention and trial setting.
Administratively, the opportunity was posted on May 18, 2016 (creation and posted date both May 18, 2016) by HHS/NIH (AgencyName: HHS-NIH11). The original and current closing date shown is May 13, 2019, indicating the final submission deadline for applications under this posting. The funding activity category is Health, and the CFDA numbers associated with the program are 93.855 and 93.856, which align with NIAID’s broader funding authorities and research mission areas. The public description does not specify an award ceiling or the expected number of awards in the provided fields, implying that applicants would need to consult the full FOA text, NIH Guide notice, or NIAID contacts for details on budget expectations, typical award sizes, and anticipated funding levels.
From a mission standpoint, the FOA explicitly points applicants to NIAID’s strategic research priorities and high-priority areas via the institute’s planning and priorities webpage. The intent is that proposed trials and mechanistic studies should fit within NIAID’s scientific scope and address important infectious disease, immunology, and allergy-related questions that align with institute priorities. Overall, the program is best understood as NIAID’s way of supporting ambitious, investigator-driven clinical trials that not only test interventions in people but also generate the mechanistic evidence needed to accelerate the broader pipeline of prevention and treatment strategies.
FAQs: NIAID Clinical Trial Implementation Cooperative Agreement (U01) - PAR-16-270
What is PAR-16-270?
PAR-16-270 is the NIAID Clinical Trial Implementation Cooperative Agreement (U01), a discretionary NIH funding opportunity intended to support the conduct and implementation of investigator-initiated clinical trials that NIAID considers high-risk, along with mechanistic studies directly tied to those trials.
What is the main purpose of this funding opportunity?
The purpose is to move beyond clinical trial planning and into actually executing a clinical trial, while encouraging scientifically rigorous mechanistic research that can explain how and why an intervention works (or does not work) in humans.
What kinds of clinical trials does this FOA target?
This FOA targets investigator-initiated clinical trials that NIAID considers high-risk, meaning studies that may involve greater uncertainty, bold approaches, or higher operational complexity than conventional trials, but that could have high impact if successful.
What does "high-risk" mean in this context?
In this context, "high-risk" signals NIAID interest in ambitious, potentially high-impact trials that may carry greater uncertainty in outcomes or involve complex implementation. The FOA description emphasizes the possibility of materially advancing the field if the trial is successful.
Does the FOA support only clinical endpoints, or also basic/mechanistic science?
It supports both. In addition to clinical efficacy or safety questions, it explicitly encourages mechanistic studies embedded within or closely associated with the clinical trial to deepen scientific understanding related to the intervention and disease biology.
What are mechanistic studies in the context of this FOA?
Mechanistic studies are research components designed to probe biologic pathways and explanatory signals related to the trial, such as immune responses, pathogen dynamics, host genetics, biomarkers, or other relevant biologic mechanisms that help interpret trial outcomes.
Why does NIAID emphasize mechanistic research alongside a clinical trial?
The FOA highlights that mechanistic insights can remain valuable even if a clinical endpoint is negative. Mechanistic data can clarify disease biology, identify responder subgroups, refine dosing or timing strategies, and guide future therapeutic or preventive approaches.
What grant mechanism is used for this opportunity?
The opportunity uses a U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply for how the project will be run?
A cooperative agreement implies substantial scientific or programmatic involvement from NIH/NIAID staff compared with a standard research project grant. The investigator team remains responsible for design and execution, but the structure reflects a more collaborative relationship with the funding agency, which can be important for complex trials and oversight expectations.
Who can apply?
Eligibility is broad and includes many domestic organization types that can credibly conduct clinical trials, including government entities, higher education institutions, tribal governments and organizations, housing authorities, nonprofits (with and without 501(c)(3) status, excluding institutions of higher education in those nonprofit categories), for-profit organizations (other than small businesses), and small businesses.
Are government organizations eligible to apply?
Yes. Eligible applicants include state, county, and local governments, as well as special district governments.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are tribal entities eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and other Native American tribal organizations.
Are nonprofit organizations eligible?
Yes. The eligibility list includes nonprofit organizations with 501(c)(3) status (other than institutions of higher education) and nonprofit organizations without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it separately includes small businesses.
Are public housing authorities eligible?
Yes. The eligibility list includes public housing authorities and Indian housing authorities.
What does the "Other" eligibility category mean?
The listing includes an "Other" category with a note to consult the FOA's additional eligibility language for clarifications or special cases.
Which agency is offering this opportunity?
This opportunity is offered by HHS/NIH (AgencyName: HHS-NIH11), through NIAID.
When was this opportunity posted?
The posted date (and creation date) shown is May 18, 2016.
What is the application deadline listed for this posting?
The original and current closing date shown is May 13, 2019, indicating the final submission deadline under this posting.
What is the funding activity category?
The funding activity category is Health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.855 and 93.856.
Does the provided description state the award ceiling or number of awards?
No. The provided fields do not specify an award ceiling or expected number of awards. The description indicates applicants would need to consult the full FOA text, NIH Guide notice, or NIAID contacts for budget expectations, typical award sizes, and anticipated funding levels.
How should applicants align their proposed trials with NIAID priorities?
The FOA points applicants to NIAID's strategic research priorities and high-priority areas via the institute's planning and priorities webpage. Proposed trials and mechanistic studies are intended to fit within NIAID's scientific scope and address important questions aligned with institute priorities.
What overall types of research areas are implied by NIAID's mission in this FOA?
The description frames NIAID's scope as including infectious disease, immunology, and allergy-related questions, and positions the FOA as supporting trials and mechanistic evidence that can accelerate prevention and treatment strategies.
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