Opportunity Information: Apply for PAR 16 271
Apply for PAR 16 271
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)" 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 SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44), Funding Opportunity Number PAR 16-271, is a discretionary NIH funding opportunity from HHS/NIH (NIAID) that supports small business-led, investigator-initiated clinical trials that align with the research mission of the National Institute of Allergy and Infectious Diseases. The emphasis is on Phase II SBIR projects that are ready to move into real-world clinical testing, with a clear scientific hypothesis and a practical, milestone-driven plan for executing the trial. Because the award mechanism is a cooperative agreement (U44), recipients should expect substantial involvement from NIAID during the project, typically meaning the Institute may play an active role in oversight, coordination, and ensuring key milestones and performance goals are being met.
This program is designed for hypothesis-driven clinical trials that are structured around measurable milestones, so applicants are expected to propose a trial where progress can be evaluated at defined decision points. While the FOA allows trials that are not considered high-risk, it explicitly encourages high-risk clinical studies. In this context, "high-risk" does not mean higher risk to human subjects; instead, it refers to studies that are scientifically or operationally more novel or unconventional. Examples include trials that use non-routine interventions, involve administration of an unlicensed product, or test an already licensed product for an indication that is not yet approved. In other words, NIAID is signaling interest in studies that may be more innovative, exploratory, or path-clearing, as long as they remain ethically and clinically appropriate.
Mechanistic studies are also encouraged under this opportunity. That means applicants can propose work that goes beyond simply testing whether an intervention works and instead also investigates how it works, such as immune correlates, biomarkers, pathogen dynamics, or other biological processes relevant to NIAID priorities. Even with that added scientific scope, the FOA draws a firm boundary on the overall application structure: no more than one clinical trial may be proposed per application. Applicants therefore need to focus their proposal around a single, well-justified trial rather than bundling multiple clinical trials into one submission.
NIAID highlights that it has a strong existing infrastructure for clinical research, including resources supported through grants, cooperative agreements, and contracts, and also resources embedded within established NIAID-supported clinical trial networks. Projects proposed under this FOA may use NIAID's independently managed clinical study infrastructure. However, the FOA makes an important restriction: NIAID will not provide support for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. Practically, that means applicants must plan their operational strategy carefully, ensuring they are not relying on network-dedicated resources that the FOA excludes from support, even though other NIAID-related infrastructure resources may still be leveraged when they are independently managed.
From an administrative standpoint, the opportunity falls under the Health funding activity category and lists CFDA numbers 93.855 and 93.856. The opportunity was posted May 18, 2016, with an original and current closing date of May 13, 2019. While the eligibility field in the source data lists many organization types, the FOA itself is an SBIR opportunity and is specifically aimed at small business concerns proposing SBIR-appropriate Phase II clinical trial implementation projects; any broader eligibility language should be interpreted in light of SBIR rules and the specific FOA instructions. Overall, the grant is best understood as a pathway for small businesses to conduct a single, well-defined, milestone-based clinical trial tied to NIAID priorities, with encouragement for innovative or unconventional clinical study designs and optional mechanistic components, all under a cooperative framework with active NIH involvement and specific constraints on the use of NIAID network-dedicated resources.
FAQs: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) - PAR 16-271
What is this funding opportunity?
This opportunity is the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). It is a discretionary NIH funding opportunity from HHS/NIH through the National Institute of Allergy and Infectious Diseases (NIAID) that supports small business-led, investigator-initiated clinical trials aligned with the NIAID research mission.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 16-271.
Which NIH institute is offering and overseeing this program?
The program is offered by NIAID (National Institute of Allergy and Infectious Diseases), part of the NIH within HHS.
What award mechanism does this program use?
The mechanism is a cooperative agreement (U44). This is different from a standard grant because it includes substantial involvement from NIAID during the project.
What does "substantial involvement" mean under a U44 cooperative agreement?
Recipients should expect NIAID to play an active role in areas such as project oversight, coordination, and helping ensure that key milestones and performance goals are being met throughout the clinical trial implementation effort.
What type of projects is this program intended to support?
This FOA supports Phase II SBIR projects that are ready to move into real-world clinical testing. Projects should be hypothesis-driven and include a practical, milestone-driven plan for executing the clinical trial.
Is this opportunity specifically for Phase II SBIR?
Yes. The emphasis is on Phase II SBIR projects focused on clinical trial implementation.
Who is this opportunity aimed at?
It is an SBIR opportunity aimed at small business concerns proposing SBIR-appropriate Phase II clinical trial implementation projects that align with NIAID priorities.
How should broader eligibility language be interpreted?
While the source data may list many organization types, this is an SBIR FOA. Eligibility should be interpreted in light of SBIR rules and the specific instructions within the FOA.
What is the overall scientific emphasis of the FOA?
The program is designed for hypothesis-driven clinical trials with measurable milestones, so progress can be evaluated at defined decision points.
Does the FOA require milestone-based planning?
Yes. Applicants are expected to propose a trial structured around measurable milestones and defined decision points.
Are high-risk clinical studies allowed or encouraged?
Yes. The FOA explicitly encourages high-risk clinical studies, while also allowing trials that are not considered high-risk.
What does "high-risk" mean in this FOA?
In this context, "high-risk" does not mean higher risk to human subjects. It refers to studies that are scientifically or operationally more novel or unconventional.
What are examples of high-risk studies under this program?
Examples include trials using non-routine interventions, administering an unlicensed product, or testing an already licensed product for an indication that is not yet approved.
Can the clinical trial include mechanistic studies?
Yes. Mechanistic studies are encouraged. These can include work that explores how an intervention works, such as immune correlates, biomarkers, pathogen dynamics, or other relevant biological processes tied to NIAID priorities.
Is the application limited to a certain number of clinical trials?
Yes. The FOA sets a firm boundary: no more than one clinical trial may be proposed per application.
Can an application bundle multiple clinical trials into one submission?
No. Applicants need to focus the proposal around a single, well-justified clinical trial rather than bundling multiple clinical trials into one application.
Can applicants use NIAID clinical research infrastructure?
NIAID notes it has strong existing clinical research infrastructure, including resources supported through grants, cooperative agreements, and contracts, as well as resources embedded within established NIAID-supported clinical trial networks. Projects may use NIAID's independently managed clinical study infrastructure.
Are there restrictions on using NIAID-supported clinical trial networks?
Yes. NIAID will not provide support for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network.
What is the practical impact of the restriction on network-dedicated resources?
Applicants need to plan operations carefully so they are not relying on network-dedicated resources that the FOA excludes from support, even if other independently managed NIAID-related infrastructure resources may still be leveraged.
What is the funding activity category?
The opportunity falls under the Health funding activity category.
What CFDA numbers are associated with this opportunity?
The listed CFDA numbers are 93.855 and 93.856.
When was this opportunity posted, and what were the closing dates?
The opportunity was posted on May 18, 2016. The original and current closing date is listed as May 13, 2019.
What is the intended "pathway" or purpose for small businesses under this FOA?
Overall, the FOA is best understood as a pathway for small businesses to conduct a single, well-defined, milestone-based clinical trial tied to NIAID priorities, with encouragement for innovative or unconventional study designs and optional mechanistic components, all under a cooperative framework with active NIH involvement and specific constraints on the use of NIAID network-dedicated resources.
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