Notice of Intent to Publish a Funding Opportunity Announcement for First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required)

Notice Number: NOT-MH-18-013

Key Dates
Release Date: December 5, 2017

Estimated Publication Date of Announcement:


First Estimated Application Due Date:


Earliest Estimated Award Date:

Earliest Estimated Start Date:



Related Announcements

Issued by
National Institute of Mental Health (NIMH)


The purpose of this Notice is to inform potential applicants that the National Institute of Mental Health (NIMH) intends to reissue Funding Opportunity Announcement (FOA) PAR-17-327- First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required), which will expire on January 9, 2018.

?The FOA, which will use the U01 award mechanism, is expected to be published in January 2018 with the expected receipt date in February 2018. Details of the planned FOA are provided below.
Research Initiative Details
The purpose of this planned FOA is The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drug’s impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Funding Information
Estimated Total Funding

Expected Number of Awards


Estimated Award Ceiling

Primary CFDA Numbers


Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business

Applications are not being solicited at this time.



Please direct all inquiries to:

Margaret Grabb, Ph.D

National Institute of Mental Health (NIMH)