The National Institutes of Health offers this grant to support innovative pilot studies focused on novel compounds for treating psychiatric disorders. This funding opportunity encourages cooperative agreement applications for experimental medicine-based first-in-human (FIH) and proof-of-concept (POC) studies involving new mechanism of action, IND-ready candidate medications. The core objective is to accelerate the development of pharmacological treatments by facilitating early phase human clinical testing. FIH studies should assess target engagement, pharmacological effects, safety, and tolerability. POC studies will evaluate compound impact on clinically relevant physiological systems and clinical indicators. The overarching goal is to rapidly collect data, de-risk novel treatments, attract private funding for further development, and foster partnerships between academia and industry.
Opportunity ID: 130033
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: | 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 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: | State governments Public and State controlled institutions of higher education 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 Small businesses Independent school districts Nonprofits that do not have 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 Public housing authorities/Indian housing authorities County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments |
| 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-12-007.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 |
|---|---|---|
| This funding opportunity is being closed and archived, and has been reissued as PAR-14-107. | Feb 24, 2014 | |
| Feb 24, 2014 |
DISPLAYING: Synopsis 2
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: | 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 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: | State governments Public and State controlled institutions of higher education 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 Small businesses Independent school districts Nonprofits that do not have 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 Public housing authorities/Indian housing authorities County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments |
| 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-12-007.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 |
DISPLAYING: Synopsis 1
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: | 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: | – |
| Current Closing Date for Applications: | Jan 07, 2015 |
| Archive Date: | Feb 07, 2015 |
| Estimated Total Program Funding: | $5,000,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments County governments State governments 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 Small businesses City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) 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; 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-12-007.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 |
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 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00084870 | Jan 05, 2012 | Sep 24, 2013 | View |
| 93.242 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180685 | Sep 08, 2013 | Feb 25, 2014 | View |
Package 1
Mandatory forms
130033 RR_SF424_1_2-1.2.pdf
130033 PerformanceSite_1_4-1.4.pdf
130033 RR_OtherProjectInfo_1_3-1.3.pdf
130033 RR_KeyPersonExpanded_1_2-1.2.pdf
130033 PHS398_CoverPageSupplement_1_4-1.4.pdf
130033 PHS398_ResearchPlan_1_3-1.3.pdf
130033 PHS398_Checklist_1_3-1.3.pdf
Optional forms
130033 RR_SubawardBudget30-1.2.pdf
130033 PHS398_ModularBudget_1_2-1.2.pdf
130033 RR_Budget-1.1.pdf
130033 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
130033 RR_SF424_2_0-2.0.pdf
130033 PHS398_ResearchPlan_2_0-2.0.pdf
130033 PHS398_CoverPageSupplement_2_0-2.0.pdf
130033 RR_KeyPersonExpanded_2_0-2.0.pdf
130033 RR_OtherProjectInfo_1_3-1.3.pdf
130033 PerformanceSite_2_0-2.0.pdf
Optional forms
130033 RR_SubawardBudget30_1_3-1.3.pdf
130033 PlannedReport-1.0.pdf
130033 PHS398_CumulativeInclusionReport-1.0.pdf
130033 PHS398_ModularBudget_1_2-1.2.pdf
130033 RR_Budget_1_3-1.3.pdf
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