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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same category: Health
Next opportunity: Understanding Factors in Infancy and Early Childhood (Birth to 24 months) That Influence Obesity Development (R01 Clinical Trial Optional)
Previous opportunity: Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 17 327
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 17 327) also looked into and applied for these:
| Funding Opportunity |
|---|
| Central Neural Mechanisms of Age-Related Hearing Loss (R01) Apply for RFA AG 18 017 Funding Number: RFA AG 18 017 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| NIMH Administrative Supplement Program to Enable Continuity of Research Experiences of MD/PhDs during Clinical Training (Admin Supp) Apply for PA 17 328 Funding Number: PA 17 328 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Tobacco Regulatory Science (R01) Apply for RFA OD 17 013 Funding Number: RFA OD 17 013 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| Tobacco Regulatory Science (R21) Apply for RFA OD 17 014 Funding Number: RFA OD 17 014 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| NIAID Physician-Scientist Pathway to Independence Award (K99/R00) Apply for PAR 17 329 Funding Number: PAR 17 329 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Small Grants on Primary Immunodeficiency Diseases (R03) Apply for PAR 17 332 Funding Number: PAR 17 332 Agency: National Institutes of Health Category: Health Funding Amount: $50,000 |
| Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21) Apply for PAR 17 333 Funding Number: PAR 17 333 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Discovery of cell-based Chemical Probes for Novel Brain Targets (R21) Apply for PAR 17 335 Funding Number: PAR 17 335 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Coordinating Center Apply for RFA HG 17 010 Funding Number: RFA HG 17 010 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Clinical Groups (U01) Apply for RFA HG 17 008 Funding Number: RFA HG 17 008 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Enhanced Diversity Clinical Groups (U01) Apply for RFA HG 17 009 Funding Number: RFA HG 17 009 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Tailoring Cardiac Rehabilitation to Enhance Participation of Older Adults (R01) Apply for RFA AG 18 016 Funding Number: RFA AG 18 016 Agency: National Institutes of Health Category: Health Funding Amount: $700,000 |
| Domestic Violence Prevention Initiative Apply for HHS 2017 IHS DVPI 0001 Funding Number: HHS 2017 IHS DVPI 0001 Agency: Indian Health Service Category: Health Funding Amount: $208,000 |
| Administrative Supplement for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (Admin Supp) Apply for PA 17 442 Funding Number: PA 17 442 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Limited Competition: Small Research Grant Program for NIAID K01/K08/K23 Recipients (R03) Apply for PAR 17 439 Funding Number: PAR 17 439 Agency: National Institutes of Health Category: Health Funding Amount: $50,000 |
| Metabolomic Data Analysis and Interpretation Tools (U01) Apply for RFA RM 17 012 Funding Number: RFA RM 17 012 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| Compound Identification Development Cores (U2C) Apply for RFA RM 17 013 Funding Number: RFA RM 17 013 Agency: National Institutes of Health Category: Health Funding Amount: $600,000 |
| National Metabolomics Data Repository (NMDR) (U2C) Apply for RFA RM 17 011 Funding Number: RFA RM 17 011 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Stakeholder Engagement and Program Coordination Center (SEPCC) (U2C) Apply for RFA RM 17 014 Funding Number: RFA RM 17 014 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| Point of Care Technologies Research Network: Point of Care Centers (U54) Apply for PAR 17 453 Funding Number: PAR 17 453 Agency: National Institutes of Health Category: Health Funding Amount: $1,200,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 17 327", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.