The National Institute of Neurological Disorders and Stroke (NINDS) is offering this Cooperative Program in Translational Research grant to support the preclinical development and testing of novel therapies for neurological disorders. This grant is for accelerating the translation of basic research discoveries into therapeutic candidates ready for clinical testing. Projects should feature therapeutic leads with a strong biological rationale and existing in vivo proof-of-concept where available. The program supports lead optimization and testing, aiming for an Investigational New Drug (IND), Investigational Device Exemption (IDE), or 510(k) submission to the FDA. It can also fund Phase 0 clinical trials for drugs or proof-of-concept for biologics/devices. Excluded are early discovery, most clinical research, diagnostics, or basic mechanistic studies.
Opportunity ID: 207674
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-022 |
| Funding Opportunity Title: | NINDS Cooperative Program in Translational Research (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: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Nov 19, 2012 |
| Last Updated Date: | Feb 13, 2014 |
| Original Closing Date for Applications: | Aug 20, 2014 |
| Current Closing Date for Applications: | Feb 13, 2014 |
| Archive Date: | Mar 13, 2014 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses State governments Small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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 eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are 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 goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should include therapeutic leads, a strong biological rationale for the intended approach, and where available in vivo proof-of-concept of efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND), Investigational Device Exemption (IDE), 510(k), or 510(k) de novo application to the Food and Drug Administration (FDA) can be submitted during the project period. The program can also support Phase 0 clinical trials for small molecule drugs, proof-of-concept for biologics, or proof-of-concept/pilot clinical trials for therapeutic devices. The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, other than those specified above, basic research, and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS program staff in the development of the project plan and monitoring of research progress. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-022.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, per NOT-NS-14-013. | Feb 13, 2014 | |
| Feb 13, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-022 |
| Funding Opportunity Title: | NINDS Cooperative Program in Translational Research (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: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Nov 19, 2012 |
| Last Updated Date: | Feb 13, 2014 |
| Original Closing Date for Applications: | Aug 20, 2014 |
| Current Closing Date for Applications: | Feb 13, 2014 |
| Archive Date: | Mar 13, 2014 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses State governments Small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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 eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are 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 goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should include therapeutic leads, a strong biological rationale for the intended approach, and where available in vivo proof-of-concept of efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND), Investigational Device Exemption (IDE), 510(k), or 510(k) de novo application to the Food and Drug Administration (FDA) can be submitted during the project period. The program can also support Phase 0 clinical trials for small molecule drugs, proof-of-concept for biologics, or proof-of-concept/pilot clinical trials for therapeutic devices. The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, other than those specified above, basic research, and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS program staff in the development of the project plan and monitoring of research progress. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-022.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-13-022 |
| Funding Opportunity Title: | NINDS Cooperative Program in Translational Research (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: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 13, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 20, 2014 |
| Archive Date: | Sep 20, 2014 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses City or township governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts County governments State governments Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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 eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are 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 goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should include therapeutic leads, a strong biological rationale for the intended approach, and where available in vivo proof-of-concept of efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND), Investigational Device Exemption (IDE), 510(k), or 510(k) de novo application to the Food and Drug Administration (FDA) can be submitted during the project period. The program can also support Phase 0 clinical trials for small molecule drugs, proof-of-concept for biologics, or proof-of-concept/pilot clinical trials for therapeutic devices. The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, other than those specified above, basic research, and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS program staff in the development of the project plan and monitoring of research progress. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-022.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 |
|---|---|---|---|---|---|---|
| 93.853 | ADOBE-FORMS-B2 | Adobe-Forms-B2 | PKG00152890 | Jan 07, 2013 | Sep 24, 2013 | View |
| 93.853 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180695 | Sep 08, 2013 | Feb 14, 2014 | View |
Package 1
Mandatory forms
207674 RR_SF424_1_2-1.2.pdf
207674 PerformanceSite_1_4-1.4.pdf
207674 RR_OtherProjectInfo_1_3-1.3.pdf
207674 RR_KeyPersonExpanded_1_2-1.2.pdf
207674 PHS398_CoverPageSupplement_1_4-1.4.pdf
207674 PHS398_ResearchPlan_1_3-1.3.pdf
207674 PHS398_Checklist_1_3-1.3.pdf
Optional forms
207674 RR_SubawardBudget30-1.2.pdf
207674 PHS398_ModularBudget_1_2-1.2.pdf
207674 RR_Budget-1.1.pdf
207674 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
207674 RR_SF424_2_0-2.0.pdf
207674 PHS398_ResearchPlan_2_0-2.0.pdf
207674 PHS398_CoverPageSupplement_2_0-2.0.pdf
207674 RR_KeyPersonExpanded_2_0-2.0.pdf
207674 RR_OtherProjectInfo_1_3-1.3.pdf
207674 PerformanceSite_2_0-2.0.pdf
Optional forms
207674 RR_SubawardBudget30_1_3-1.3.pdf
207674 PlannedReport-1.0.pdf
207674 PHS398_CumulativeInclusionReport-1.0.pdf
207674 PHS398_ModularBudget_1_2-1.2.pdf
207674 RR_Budget_1_3-1.3.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
