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This grant aims to support experimental medicine-based studies of new mechanism of action compounds for treating mental disorders. The focus is on accelerating the development of innovative pharmacological treatments through early phase human clinical testing. Researchers are encouraged to conduct first in human and proof of concept studies to assess target engagement, pharmacological effects, safety, and tolerability of novel compounds. The goal is to de-risk novel treatments, attract private funding for further development, and foster partnerships between academia and industry. Deadline for applications is Feb 25, 2014.
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Opportunity ID: 130033
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | PAR-12-007 |
| Funding Opportunity Title:: | Innovative Pilot Studies of Novel Mechanism of Action Compounds for Treating Psychiatric Disorders (U01) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 2 |
| Posted Date:: | Nov 07, 2011 |
| Last Updated Date:: | Feb 24, 2014 |
| Original Closing Date for Applications:: | Jan 07, 2015 |
| Current Closing Date for Applications:: | Feb 25, 2014 |
| Archive Date:: | Mar 25, 2014 |
| Estimated Total Program Funding:: | $ 5,000,000 |
| Award Ceiling:: | $ |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility:: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; 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 experimental medicine-based first in human (FIH) and proof of concept (POC) studies of new mechanism of action, IND-ready candidate medications to treat mental disorders. The objective of the FOA is to accelerate the development of innovative pharmacological treatments through support of early phase human clinical testing. FIH pharmacology studies should assess target engagement, pharmacological effects, safety, and tolerability of novel compounds in order to build a pipeline for initial POC or efficacy trials in patients. POC studies of novel compounds should use pharmacologically based dosing, with assessment of target engagement and evaluation of the impact of compounds on clinically relevant physiological systems as well as clinical indicators of effect. The overall objective is to facilitate rapid collection of data to “de-risk” novel mechanism of action or combination treatments and to attract private funding for further clinical and commercial development of candidate medications. Partnerships between academia and industry are strongly encouraged. |
| Link to Additional Information:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 2 | This funding opportunity is being closed and archived, and has been reissued as PAR-14-107. | Feb 24, 2014 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.242 |
| Competition ID: | ADOBE-FORMS-B2 |
| Competition Title: | ADOBE-FORMS-B2 |
| Opportunity Package ID: | PKG00084870 |
| Opening Date: | Jan 05, 2012 |
| Closing Date: | Sep 24, 2013 |
| Agency Contact Information:: | Grants Info |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.1] PHS Cover Letter [V1.2] |
Package No: 2
| Assistance Listings: | 93.242 |
| Competition ID: | FORMS-C |
| Competition Title: | Use for due dates after 9/24/2013 |
| Opportunity Package ID: | PKG00180685 |
| Opening Date: | Sep 08, 2013 |
| Closing Date: | Feb 25, 2014 |
| Agency Contact Information:: | eRA Commons Help Desk |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V2.0] PHS 398 Research Plan [V2.0] PHS 398 Cover Page Supplement [V2.0] Research and Related Senior/Key Person Profile (Expanded) [V2.0] Research And Related Other Project Information [V1.3] Project/Performance Site Location(s) [V2.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3] Planned Enrollment Report [V1.0] PHS 398 Cumulative Inclusion Enrollment Report [V1.0] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.3] |
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