The National Institute of Neurological Disorders and Stroke (NINDS) offers a grant for exploratory clinical trials of investigational agents aimed at contributing to designing future trials, biomarker validation studies, or proof of mechanism clinical studies. Applicants need to focus on diseases outlined in NINDS’ strategic plan. Successful applicants will gain access to the NeuroNEXT infrastructure, including the Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC). The grant provides support for recruitment, retention, and on-site implementation of clinical protocols. Applicants do not need to be part of the existing NeuroNEXT infrastructure. Closing date for applications is March 5, 2021.
Opportunity ID: 299594
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-528 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (U01 – Clinical Trial Optional) |
| 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: | Dec 21, 2017 |
| Last Updated Date: | Aug 10, 2020 |
| Original Closing Date for Applications: | Jan 07, 2021 |
| Current Closing Date for Applications: | Mar 05, 2021 |
| Archive Date: | Apr 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments For profit organizations other than small businesses Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) 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. |
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-18-528.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 |
|---|---|---|
| Updated expiration date in accordance with NOT-NS-20-084 | Aug 10, 2020 | |
| Dec 21, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-528 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (U01 – Clinical Trial Optional) |
| 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: | Dec 21, 2017 |
| Last Updated Date: | Aug 10, 2020 |
| Original Closing Date for Applications: | Jan 07, 2021 |
| Current Closing Date for Applications: | Mar 05, 2021 |
| Archive Date: | Apr 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments For profit organizations other than small businesses Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) 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. |
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-18-528.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-18-528 |
| Funding Opportunity Title: | NeuroNEXT Clinical Trials (U01 – Clinical Trial Optional) |
| 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: | Dec 21, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 07, 2021 |
| Archive Date: | Feb 12, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education State governments 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. |
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-18-528.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 |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00237242 | Jan 05, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00259495 | Jan 05, 2018 | Mar 05, 2021 | View |
Package 1
Mandatory forms
299594 RR_SF424_2_0-2.0.pdf
299594 PHS398_CoverPageSupplement_4_0-4.0.pdf
299594 RR_OtherProjectInfo_1_4-1.4.pdf
299594 PerformanceSite_2_0-2.0.pdf
299594 RR_KeyPersonExpanded_2_0-2.0.pdf
299594 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
299594 RR_Budget_1_4-1.4.pdf
299594 RR_SubawardBudget30_1_4-1.4.pdf
299594 PHS398_ModularBudget_1_2-1.2.pdf
299594 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
299594 RR_SF424_2_0-2.0.pdf
299594 PHS398_CoverPageSupplement_5_0-5.0.pdf
299594 RR_OtherProjectInfo_1_4-1.4.pdf
299594 PerformanceSite_2_0-2.0.pdf
299594 RR_KeyPersonExpanded_2_0-2.0.pdf
299594 PHS398_ResearchPlan_4_0-4.0.pdf
299594 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
299594 RR_Budget_1_4-1.4.pdf
299594 RR_SubawardBudget30_1_4-1.4.pdf
299594 PHS398_ModularBudget_1_2-1.2.pdf
299594 PHS_AssignmentRequestForm_3_0-3.0.pdf
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