First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01)

The summary for the First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01): 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. PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports feasibility and pilot studies of novel devices. 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, 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.

Federal Grant Title:	First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01)
Federal Agency Name:	National Institutes of Health
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-14-107
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.242
CFDA Descriptions:	Mental Health Research Grants
Current Application Deadline:	May 7, 2017
Original Application Deadline:	May 7, 2017
Posted Date:	Feb 24, 2014
Creation Date:	Feb 24, 2014
Archive Date:	Jun 7, 2017
Total Program Funding:
Maximum Federal Grant Award:	none
Minimum Federal Grant Award:	none
Expected Number of Awards:
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: County governments
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Native American tribal governments (Federally recognized)
Private institutions of higher education
State governments
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Additional Information on Eligibility: 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.
Link to Full Grant Announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-14-107.html
Grant Announcement Contact: NIH OER Webmaster [email protected]
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

National Institutes of Health 301-496-3405
Similar Government Grants: • National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of...; • National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of...; • Multimodal Artificial Intelligence to Accelerate HIV Clinical Care (R01 Clinical Trial Opt...; • Understanding the Intersection of Social Inequities to Optimize Health and Reduce Health D...; • Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Not Allowed); • Development of Biomarkers for Mental Health Research and Clinical Utilities: (STTR [R41/R4...; • Development of Biomarkers for Mental Health Research and Clinical Utilities (SBIR [R43/R44...; • Pharmacologic Agents and Drugs for Mental Disorders (SBIR [R43/R44])
More Grants from the National Institutes of Health: • Short Courses on Innovative Methodologies and Approaches in the Behavioral and Social Scie...; • New Investigator Gateway Awards for Collaborative T1D Research (R03 Clinical Trial Not All...; • Behavioral and Integrative Treatment Development Program (R34 Clinical Trial Optional); • Intervention Research to Improve Native American Health (R01 Clinical Trial Optional); • Intervention Research to Improve Native American Health (R34 Clinical Trial Optional)