This NINDS grant supports exploratory clinical trials of investigational agents, including drugs, biologics, surgical therapies, or devices. The primary purpose is to generate data for designing future trials, validate biomarkers, or conduct proof-of-mechanism studies. Proposed research should align with the NINDS strategic plan and clinical interests. Successful applicants gain access to the comprehensive NeuroNEXT infrastructure, which provides crucial support for study implementation. This includes assistance from the Clinical Coordinating Center for protocol execution, statistical and data management support from the Data Coordinating Center, and recruitment/retention services from NeuroNEXT clinical sites. Importantly, applicants are not required to be part of the pre-existing NeuroNEXT network to apply.
Opportunity ID: 241456
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-343 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (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: | Aug 30, 2013 |
| Last Updated Date: | Sep 17, 2015 |
| Original Closing Date for Applications: | Dec 03, 2015 |
| Current Closing Date for Applications: | Apr 04, 2016 |
| Archive Date: | May 04, 2016 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Special district governments Independent school districts Native American tribal governments (Federally recognized) County governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| 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 Organizations) and foreign components of U.S. Organizations are eligible to apply, but will have to work with the U.S.-based NeuroNEXT infrastructure.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS’ strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-343.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 |
|---|---|---|
| Modified the close date, in accordance with NOT-NS-15-042. | Sep 17, 2015 | |
| Sep 17, 2015 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-343 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (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: | Aug 30, 2013 |
| Last Updated Date: | Sep 17, 2015 |
| Original Closing Date for Applications: | Dec 03, 2015 |
| Current Closing Date for Applications: | Apr 04, 2016 |
| Archive Date: | May 04, 2016 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Special district governments Independent school districts Native American tribal governments (Federally recognized) County governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| 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 Organizations) and foreign components of U.S. Organizations are eligible to apply, but will have to work with the U.S.-based NeuroNEXT infrastructure.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS’ strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-343.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-13-343 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (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: | Sep 17, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Dec 03, 2015 |
| Archive Date: | Jan 03, 2016 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments County governments Nonprofits having 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) Independent school districts For profit organizations other than small businesses Public and State controlled institutions of higher education Private institutions of higher education Small businesses Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) 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); 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 Organizations) and foreign components of U.S. Organizations are eligible to apply, but will have to work with the U.S.-based NeuroNEXT infrastructure. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS’ strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.
Applicants do not need to be part of the existing NeuroNEXT infrastructure. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-343.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 | FORMS-C | Forms-C | PKG00184472 | Nov 02, 2013 | Apr 04, 2016 | View |
Package 1
Mandatory forms
241456 RR_SF424_2_0-2.0.pdf
241456 PHS398_ResearchPlan_2_0-2.0.pdf
241456 PHS398_CoverPageSupplement_2_0-2.0.pdf
241456 RR_KeyPersonExpanded_2_0-2.0.pdf
241456 RR_OtherProjectInfo_1_3-1.3.pdf
241456 PerformanceSite_2_0-2.0.pdf
Optional forms
241456 RR_SubawardBudget30_1_3-1.3.pdf
241456 PlannedReport-1.0.pdf
241456 PHS398_CumulativeInclusionReport-1.0.pdf
241456 PHS398_ModularBudget_1_2-1.2.pdf
241456 RR_Budget_1_3-1.3.pdf
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