The Department of Health is offering a grant to support early stage clinical trials of novel investigational drugs for treating psychiatric disorders with unmet medical needs. The grant will fund milestone-driven trials in both pediatric and adult populations, focusing on target engagement, pharmacological effects, safety, and tolerability. It aims to assess the feasibility of Phase II studies and proof of concept in psychiatric disorders, as well as the impact on physiological systems and clinical indicators. The grant also covers feasibility and pilot studies of novel devices, encouraging collaborations between biomedical and industry researchers to de-risk novel treatments for attracting further private funding.
Opportunity ID: 251735
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-107 |
| Funding Opportunity Title: | First in Human and Early Stage Clinical Trials of Novel Investigational Drugs for Psychiatric Disorders (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 24, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 07, 2017 |
| Current Closing Date for Applications: | May 07, 2017 |
| Archive Date: | Jun 07, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Public housing authorities/Indian housing authorities |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-107.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.242 | FORMS-C | Forms-C | PKG00193173 | May 05, 2014 | Mar 30, 2016 | View |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00221997 | May 05, 2016 | May 07, 2017 | View |
Package 1
Mandatory forms
251735 RR_SF424_2_0-2.0.pdf
251735 PHS398_ResearchPlan_2_0-2.0.pdf
251735 PHS398_CoverPageSupplement_2_0-2.0.pdf
251735 RR_KeyPersonExpanded_2_0-2.0.pdf
251735 RR_OtherProjectInfo_1_3-1.3.pdf
251735 PerformanceSite_2_0-2.0.pdf
Optional forms
251735 RR_SubawardBudget30_1_3-1.3.pdf
251735 PlannedReport-1.0.pdf
251735 PHS398_CumulativeInclusionReport-1.0.pdf
251735 PHS398_ModularBudget_1_2-1.2.pdf
251735 RR_Budget_1_3-1.3.pdf
Package 2
Mandatory forms
251735 RR_SF424_2_0-2.0.pdf
251735 PHS398_CoverPageSupplement_3_0-3.0.pdf
251735 RR_OtherProjectInfo_1_3-1.3.pdf
251735 PerformanceSite_2_0-2.0.pdf
251735 RR_KeyPersonExpanded_2_0-2.0.pdf
251735 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
251735 RR_Budget_1_3-1.3.pdf
251735 RR_SubawardBudget30_1_3-1.3.pdf
251735 PHS398_ModularBudget_1_2-1.2.pdf
251735 PHS_Inclusion_Enrollment_Report-1.0.pdf
251735 PHS_AssignmentRequestForm-1.0.pdf
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