Opportunity Information: Apply for PAR 14 107
Apply for PAR 14 107
- 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 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 Mental Health Research Grants.
- This funding opportunity was created on Feb 24, 2014 and posted on Feb 24, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments.
- 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 NIH funding opportunity PAR-14-107, titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01)," is a cooperative agreement program designed to move promising psychiatric treatments from the lab into early clinical testing as efficiently as possible. Its main focus is on novel investigational drugs or drug candidates with new mechanisms of action aimed at psychiatric disorders where current treatment options fall short. The program is structured to generate the kind of early human data that can clarify whether a candidate is worth the larger investment required for later-stage clinical trials and, ultimately, FDA approval.
A defining feature of this FOA is that it supports milestone-driven early stage clinical trials in both adult and pediatric populations. The trials it targets sit at the "translation" point between preclinical research and larger efficacy studies. For first-in-human (FIH) and Phase Ib studies, applicants are expected to do more than simply dose participants and watch for adverse events. These early studies must examine whether the drug actually engages its intended target in humans, including evidence of adequate brain exposure when relevant. They must also measure pharmacological effects, along with safety and tolerability, to determine whether moving forward to Phase II or proof-of-concept (PoC) testing is scientifically and operationally realistic. In other words, the FOA emphasizes the full early-development package: not just "is it safe enough," but also "does it reach the brain, does it do what it is supposed to do biologically, and do the results justify the next step."
For proof-of-concept studies, the FOA expects investigators to evaluate signals of clinical relevance while still keeping the work in an early-stage, decision-informing frame. PoC trials under this program should assess the drug's impact on clinically relevant physiological systems using functional measures, alongside clinical indicators of effect. This framing is important because it pushes applicants to connect biological action to measurable functional outcomes and early symptom or behavioral changes, rather than relying solely on broad clinical rating scales without a mechanistic bridge. The intention is to produce results that reduce uncertainty around the candidate's mechanism, dosing strategy, and likelihood of producing meaningful benefit in the targeted psychiatric population.
Although much of the emphasis is on drugs and drug candidates, the FOA also allows feasibility and pilot studies of novel devices, and it recognizes that combination approaches may be part of what needs to be tested to address unmet needs in psychiatry. The unifying theme is early, practical testing that quickly generates high-value data to "de-risk" development. De-risking here means identifying, as early as possible, whether a treatment is likely to fail due to inadequate target engagement, insufficient brain exposure, unacceptable tolerability, weak biological effects, or lack of promising clinical signals, thereby avoiding costly late-stage failures.
This opportunity uses the U01 activity code, meaning it is a cooperative agreement rather than a standard research project grant. In practice, that signals substantial NIH scientific/programmatic involvement during the project, often through collaborative planning, progress monitoring tied to milestones, and go/no-go decision points. The FOA explicitly encourages collaborative partnerships between biomedical researchers and biotechnology or industry researchers, reflecting the reality that successful psychiatric drug and device development typically requires coordinated expertise across discovery science, clinical trial execution, regulatory strategy, manufacturing, and commercialization planning. A major program goal is to produce the kind of credible early clinical package that can attract private investment or industry partnership for the larger and more expensive stages of development required to reach approval and broad clinical use.
From an administrative standpoint, the opportunity is categorized as discretionary funding through the NIH under CFDA 93.242 (Mental Health Research Grants), and it does not require cost sharing or matching. Eligible applicants are broad and include many domestic public and private institutions of higher education, nonprofit and for-profit organizations (other than small businesses are explicitly listed, but small businesses are also included among eligible applicants), state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and other regional or special district entities. The eligibility language also highlights inclusion of institutions serving specific populations (for example, HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions), as well as faith-based or community-based organizations and eligible federal agencies. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply, although "foreign components" as defined in NIH policy are allowed, which typically refers to discrete elements of a project that may take place outside the U.S. under a U.S. applicant organization.
Key timeline details in the record show the FOA was posted and created on February 24, 2014, with an original and current closing date listed as May 7, 2017, and an archive date of June 7, 2017, indicating that this specific announcement is no longer open. The full archived announcement was hosted on the NIH Grants Guide website, and the NIH Office of Extramural Research webmaster contact was provided for access or linking issues. Overall, PAR-14-107 reflects NIH's push to strengthen the pipeline for psychiatric therapeutics by funding early clinical trials that explicitly test mechanism, target engagement, safety, and early signals of function and clinical effect, while building cross-sector partnerships that make it more likely that promising candidates can continue into later-stage development.
FAQs: NIH PAR-14-107 (U01) - First-in-Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders
What is PAR-14-107?
PAR-14-107 is an NIH funding opportunity announcement (FOA) titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01)." It is a cooperative agreement program designed to move promising psychiatric treatments from preclinical research into early clinical testing as efficiently as possible.
What is the overall purpose of this FOA?
The purpose is to fund milestone-driven early stage clinical trials that generate high-value early human data to help determine whether an investigational treatment is worth the much larger investment required for later-stage trials and, ultimately, FDA approval. The program is explicitly geared toward reducing uncertainty early ("de-risking") and avoiding expensive failures in late-stage development.
What kinds of interventions are the main focus?
The main focus is on novel investigational drugs or drug candidates with new mechanisms of action intended to treat psychiatric disorders where current treatment options are inadequate.
Does the FOA only support drugs?
No. While the emphasis is on drugs and drug candidates, the FOA also allows feasibility and pilot studies of novel devices, and it recognizes that combination approaches may be necessary to address unmet needs in psychiatry.
What clinical trial stages does the FOA target?
The FOA targets early stage clinical trials at the translation point between preclinical research and larger efficacy studies. This includes first-in-human (FIH) and Phase Ib studies, as well as proof-of-concept (PoC) studies designed to provide decision-informing results.
Are both adult and pediatric trials allowed?
Yes. The FOA supports milestone-driven early stage clinical trials in both adult and pediatric populations.
What is expected in first-in-human (FIH) and Phase Ib studies under this FOA?
FIH and Phase Ib studies are expected to go beyond basic dosing and adverse event monitoring. They should examine whether the drug engages its intended target in humans, including evidence of adequate brain exposure when relevant, and they must measure pharmacological effects along with safety and tolerability. The goal is to determine whether progression to Phase II or PoC testing is scientifically and operationally realistic.
What does "target engagement" mean in the context of this FOA?
Based on the FOA description, target engagement refers to evidence in humans that the investigational drug interacts with its intended biological target in a way consistent with its proposed mechanism of action. The FOA emphasizes generating early human data that can confirm whether the drug is doing what it is supposed to do biologically.
Why does the FOA emphasize brain exposure?
For psychiatric indications, whether a drug adequately reaches the brain can be a key determinant of success. The FOA highlights the need to demonstrate adequate brain exposure when it is relevant to the mechanism and indication, as part of an early development package that supports informed go/no-go decisions.
What is expected in proof-of-concept (PoC) studies?
PoC studies are expected to evaluate signals of clinical relevance while remaining early-stage and decision-focused. Under this FOA, PoC trials should assess the drug's impact on clinically relevant physiological systems using functional measures, alongside clinical indicators of effect. The emphasis is on connecting biological action to measurable functional outcomes and early symptom or behavioral changes.
Does the FOA prioritize functional or mechanistic measures over broad clinical rating scales?
The FOA framing pushes applicants to connect mechanism to measurable functional outcomes and early clinical indicators, rather than relying only on broad clinical rating scales without a mechanistic bridge. The intention is to reduce uncertainty about mechanism, dosing strategy, and likelihood of meaningful benefit.
What does "milestone-driven" mean for projects funded under this FOA?
Milestone-driven means the project is structured around defined progress points and decision criteria, often including go/no-go decision points. The FOA describes early testing designed to generate clear, decision-informing data to support continuation, modification, or discontinuation based on results.
What does "de-risking" mean in this program?
In this FOA, de-risking means identifying as early as possible whether a candidate is likely to fail due to issues such as inadequate target engagement, insufficient brain exposure, unacceptable tolerability, weak biological effects, or lack of promising clinical signals. The aim is to avoid costly late-stage failures by generating decisive early evidence.
What is a U01, and how is it different from a standard grant?
This FOA uses the U01 activity code, which is a cooperative agreement rather than a standard research project grant. In practice, that means there is substantial NIH scientific/programmatic involvement during the project, including collaborative planning, progress monitoring tied to milestones, and go/no-go decision points.
What does "substantial NIH involvement" typically imply for awardees?
As described in the FOA summary, substantial NIH involvement often includes collaboration with NIH staff on planning, monitoring progress against milestones, and participating in go/no-go decision making as the project generates early clinical data.
Does the FOA encourage partnerships with industry?
Yes. The FOA explicitly encourages collaborative partnerships between biomedical researchers and biotechnology or industry researchers. This reflects the need for coordinated expertise across discovery science, clinical trial execution, regulatory strategy, manufacturing, and commercialization planning.
What is the program trying to produce for downstream development?
A major goal is to generate a credible early clinical data package that can support the next stages of development and help attract private investment or industry partnership for larger and more expensive trials required for approval and broad clinical use.
What is the funding category and CFDA number associated with this opportunity?
The opportunity is categorized as discretionary funding through the NIH under CFDA 93.242 (Mental Health Research Grants).
Is cost sharing or matching required?
No. The FOA record indicates that cost sharing or matching is not required.
Who is eligible to apply?
Eligible applicants are broad and include domestic public and private institutions of higher education, nonprofit and for-profit organizations (with small businesses included among eligible applicants), state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and other regional or special district entities. The eligibility language also highlights institutions serving specific populations (such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, and Alaska Native and Native Hawaiian serving institutions), as well as faith-based or community-based organizations and eligible federal agencies.
Are foreign institutions eligible to apply directly?
No. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply directly under this FOA.
Are any international activities allowed at all?
Yes, "foreign components" as defined in NIH policy are allowed. In general terms, that refers to discrete elements of a project that may take place outside the U.S. under a U.S. applicant organization, even though the applicant organization itself must be eligible and U.S.-based.
Is this FOA still open?
No. The record indicates the FOA was posted/created on February 24, 2014, with a closing date of May 7, 2017, and an archive date of June 7, 2017. That indicates the specific announcement is no longer open for applications.
Where was the original announcement posted?
The full (archived) announcement was hosted on the NIH Grants Guide website.
Who was listed as the contact for access or linking issues?
The NIH Office of Extramural Research webmaster contact was provided for access or linking issues related to the archived announcement.
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