Opportunity Information: Apply for PAR 17 327
The National Institutes of Health (NIH) funding opportunity titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01)" (Funding Opportunity Number PAR-17-327) is designed to move promising new psychiatric treatments into early clinical testing, with a strong emphasis on speed, rigor, and decision-quality data. It supports milestone-driven studies of investigational drugs, drug candidates, and certain novel devices or combination approaches aimed at psychiatric disorders where there is clear unmet medical need. The core idea is to generate the kind of early human evidence that can clarify whether a new approach is worth advancing into larger and more expensive trials, and ultimately help position successful projects for later-stage private investment and FDA-approved development.
This FOA focuses on first-in-human (FIH) and other early phase studies in both pediatric and adult populations. For drugs and drug candidates, supported studies include FIH and Phase Ib trials that do more than simply show basic safety. Applicants are expected to assess whether the intervention reaches and engages the intended biological target, including evidence of brain exposure when relevant, alongside pharmacologic and functional effects. In practice, this means projects should be structured to answer key translational questions early: is the drug getting to the brain at meaningful levels, is it affecting the intended mechanism, what does the safety and tolerability profile look like, and is there enough evidence to justify moving to Phase II proof-of-concept work in a defined psychiatric indication.
For proof-of-concept (PoC) studies, the FOA emphasizes evaluating impact on clinically relevant physiological systems and functional measures, along with clinical indicators that suggest an effect. The intent is not necessarily to deliver definitive efficacy in the way a large Phase IIb or Phase III trial might, but to provide a credible signal tied to mechanism and meaningful outcomes. That combination of mechanistic validation plus early clinical relevance is framed as essential to "de-risking" development, since psychiatric drug development often fails when early studies do not convincingly connect target engagement to downstream functional or symptom changes.
The announcement also covers first-in-human and early feasibility studies (EFS) for novel devices. For devices, the required early evidence similarly centers on target engagement (in the device sense, meaning that the device is affecting the intended neural or physiological pathway), safety, tolerability, and early indications of efficacy. This creates a parallel pathway to support non-pharmacologic or technology-based interventions, including devices and potentially combination strategies, as long as the project is designed to produce clear, decision-ready results that can guide subsequent development.
A notable structural feature is that this is a U01 cooperative agreement rather than a traditional grant. Cooperative agreements generally imply substantial NIH program involvement during the project, often including active collaboration, milestone monitoring, and go/no-go decision points. This aligns with the FOA’s milestone-driven language: applicants should anticipate a development-style framework with predefined milestones, timelines, and objective criteria to evaluate progress. The overall goal is to produce rapid, high-value data packages that make it easier for later-stage funders and partners to commit resources to full clinical development.
The FOA explicitly encourages collaborative partnerships between academic or biomedical researchers and biotechnology or industry researchers. This reflects the practical reality that moving a drug or device from early clinical testing to approval requires coordinated work across discovery, clinical operations, manufacturing, regulatory strategy, and commercialization planning. By emphasizing collaboration early, the program aims to reduce common handoff failures and help projects align with the expectations of later-stage investors and regulators.
Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding those that are institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, and eligible federal agencies.
There are also clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. Non-domestic components of U.S. organizations are not eligible to apply, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, the applicant organization and the work supported under this FOA must remain within allowable domestic boundaries as defined by NIH policy.
Administratively, the opportunity is categorized as discretionary funding and sits within the health activity category, with CFDA number 93.242. The sponsoring agency is NIH, and the original closing date listed in the source information is December 6, 2017, with a creation date of July 18, 2017. While those dates indicate the specific posting is historical, the scientific and programmatic structure is representative of how NIH and NIMH-style development programs are often framed: early, milestone-based clinical translation with an emphasis on mechanism, measurable target engagement, and practical de-risking to enable the next stage of investment and development.Apply for PAR 17 327
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
- This funding opportunity was created on 2017-07-18.
- Applicants must submit their applications by 2017-12-06. (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.
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Frequently Asked Questions (FAQs)
What is the name and funding opportunity number of this NIH grant?
The opportunity is titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01)" and the Funding Opportunity Number is PAR-17-327.
What is the main purpose of this funding opportunity?
The FOA is designed to move promising new psychiatric treatments into first-in-human and early-stage clinical testing, with a strong emphasis on speed, rigor, and producing decision-quality data. The goal is to generate early human evidence that clarifies whether a novel drug, device, or combination approach is worth advancing into larger, more expensive trials and to help position successful projects for later-stage private investment and FDA-oriented development.
What types of interventions are supported?
The FOA supports milestone-driven studies of investigational drugs, drug candidates, certain novel devices, and some combination approaches aimed at psychiatric disorders where there is a clear unmet medical need.
Which clinical trial stages does this FOA focus on?
This FOA focuses on first-in-human (FIH) and other early phase clinical studies. For drugs and drug candidates, it includes FIH and Phase Ib trials. For devices, it includes FIH and early feasibility studies (EFS).
Does the program support both adult and pediatric studies?
Yes. The FOA covers first-in-human and early phase studies in both pediatric and adult populations.
For drug studies, is demonstrating basic safety enough?
No. The FOA emphasizes that early drug trials should do more than demonstrate basic safety. Applicants are expected to assess whether the intervention reaches and engages the intended biological target and evaluate pharmacologic and functional effects. Where relevant, evidence of brain exposure is expected.
What kind of evidence is expected for "target engagement" in drug trials?
Based on the FOA description, drug trials are expected to provide evidence that the intervention reaches and engages the intended biological target. When relevant to the mechanism, applicants should also include evidence of brain exposure, along with measurable pharmacologic and functional effects.
What translational questions should early drug studies be designed to answer?
The FOA highlights several early, decision-oriented questions: whether the drug gets to the brain at meaningful levels (when relevant), whether it affects the intended mechanism, what the safety and tolerability profile looks like, and whether there is enough evidence to justify moving to Phase II proof-of-concept work in a defined psychiatric indication.
What does the FOA mean by proof-of-concept (PoC) studies?
In this FOA, proof-of-concept studies emphasize evaluating impact on clinically relevant physiological systems and functional measures, along with clinical indicators that suggest an effect. The intent is to generate a credible, mechanism-linked signal and meaningful early outcomes rather than definitive efficacy of the type expected in large Phase IIb or Phase III trials.
Is the goal to prove full clinical efficacy?
No. The FOA frames the objective as generating credible early signals tied to mechanism and meaningful outcomes to support decision-making and de-risk development, not to deliver definitive efficacy like a large late-stage trial.
Why is "de-risking" emphasized for psychiatric treatment development?
The FOA notes that psychiatric drug development often fails when early studies do not convincingly connect target engagement to downstream functional or symptom changes. By requiring mechanistic validation plus early clinical relevance, the program aims to reduce uncertainty and produce data that better supports go/no-go decisions.
What types of device studies are included?
The FOA covers first-in-human and early feasibility studies (EFS) for novel devices intended for psychiatric disorders.
For devices, what is meant by "target engagement"?
In the device context described by the FOA, target engagement means the device is affecting the intended neural or physiological pathway. The early evidence package is expected to include target engagement (in this sense), safety, tolerability, and early indications of efficacy.
What is the award mechanism, and why does it matter?
This is a U01 cooperative agreement rather than a traditional grant. Cooperative agreements generally involve substantial NIH program involvement during the project, often including active collaboration, milestone monitoring, and go/no-go decision points. The FOA is explicitly milestone-driven, so applicants should plan for predefined milestones, timelines, and objective progress criteria.
What does "milestone-driven" mean in practical terms for applicants?
From the FOA description, milestone-driven means the project should be structured like a development program: predefined milestones, timelines, and objective criteria are used to evaluate progress, with monitoring and go/no-go decisions aligned to producing rapid, high-value, decision-ready data.
Does the FOA encourage academic-industry partnerships?
Yes. The FOA explicitly encourages collaborative partnerships between academic or biomedical researchers and biotechnology or industry researchers, reflecting the coordinated work typically needed for clinical operations, manufacturing, regulatory strategy, and commercialization planning.
What kinds of organizations are eligible to apply?
Eligibility is broad across many U.S.-based organization types, including state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (with the stated exclusions when applicable); for-profit organizations other than small businesses; and small businesses.
Are certain institution types specifically called out as eligible?
Yes. The FOA calls out additional eligible applicant categories including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also mentions faith-based or community-based organizations, regional organizations, and eligible federal agencies.
Are foreign organizations eligible to apply?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this FOA.
Can a U.S. organization include a non-U.S. component or foreign component in the project?
No. Non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. The applicant organization and the supported work must stay within allowable domestic boundaries as defined by NIH policy.
What federal agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the CFDA number and activity category?
The CFDA number listed is 93.242. The opportunity is categorized under the health activity category and is described as discretionary funding.
What were the original posting and closing dates listed?
The source information lists a creation date of July 18, 2017, and an original closing date of December 6, 2017.
Does the information provided indicate this specific posting is historical?
Yes. The listed closing date of December 6, 2017 indicates that the specific posting referenced is historical, although the description notes that the structure is representative of NIH/NIMH-style milestone-based clinical translation programs.
What kind of outcomes is NIH trying to enable with this FOA?
The FOA aims to produce rapid, high-value early data packages that help decision-making about whether to advance a drug or device into later-stage trials, and to make it easier for later-stage funders and partners to commit resources to full clinical development.
What disorders are the target focus of the FOA?
The FOA targets psychiatric disorders, specifically emphasizing projects that address areas of clear unmet medical need.
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