First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required)

The summary for the First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required) 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 or Devices for Psychiatric Disorders (U01-Clinical Trial Required): 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 drugs 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.

Federal Grant Title:	First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-18-427
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.242
CFDA Descriptions:	Information not provided
Current Application Deadline:	January 7th, 2021
Original Application Deadline:	January 7th, 2021
Posted Date:	December 6th, 2017
Creation Date:	December 6th, 2017
Archive Date:	February 12th, 2021
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	December 6th, 2017

Applicants Eligible for this Grant: 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 (see text field entitled "Additional Information on Eligibility" for clarification.)
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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 not allowed.
Link to Full Grant Announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-18-427.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
Similar Government Grants: • Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical T...; • Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH...; • Interaction between ARVs and Hormones in HIV and Coinfections (R01 Clinical Trial Optional...; • Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01 Clinical Trial Not Allowe...; • Developmental AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optio...; • 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: • The NCI Worta McCaskill-Stevens Career Development Award for Community Oncology and Preven...; • Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional); • Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Tri...; • Promoting Broad Participation in NIDCD's Extramural Workforce through Research Education E...; • HEAL Initiative-Early-Stage Discovery of New Pain Targets Within the Understudied Druggabl...