This grant, offered by the National Institute of Neurological Disorders and Stroke (NINDS), is for supporting biomarker validation or exploratory clinical trials. The primary purpose is to investigate novel drugs, biologics, surgical therapies, or devices for treating neurologic diseases. The goal is to gather crucial data that can justify and inform the design of future Phase III efficacy trials. Applicants must provide compelling scientific evidence for their proposed investigational agents. Successful projects will gain access to the NeuroNEXT infrastructure, including the Clinical Coordinating Center for efficient implementation, the Data Coordinating Center for statistical and data management support, and NeuroNEXT clinical sites for patient recruitment and retention. Studies should align with NINDS’s strategic plan and clinical research interests.
Opportunity ID: 123853
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-343 |
| 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: | Sep 21, 2011 |
| Last Updated Date: | Jul 03, 2013 |
| Original Closing Date for Applications: | Aug 01, 2014 |
| Current Closing Date for Applications: | Aug 02, 2013 |
| Archive Date: | Sep 02, 2013 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal 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 Organizations) and 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 biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III trial) in the treatment of neurologic disease. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. 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. 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-11-343.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 Archive Date based on new Expiration Date, per NOT-NS-13-034. | Jul 03, 2013 | |
| Jul 03, 2013 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-343 |
| 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: | Sep 21, 2011 |
| Last Updated Date: | Jul 03, 2013 |
| Original Closing Date for Applications: | Aug 01, 2014 |
| Current Closing Date for Applications: | Aug 02, 2013 |
| Archive Date: | Sep 02, 2013 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal 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 Organizations) and 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 biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III trial) in the treatment of neurologic disease. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. 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. 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-11-343.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-11-343 |
| 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: | Jul 03, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 01, 2014 |
| Archive Date: | Sep 01, 2014 |
| 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 Public housing authorities/Indian housing authorities Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Private 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 Independent school districts Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Public and State controlled 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) and 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 biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III trial) in the treatment of neurologic disease. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. 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. 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-11-343.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 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00079271 | Nov 02, 2011 | Aug 02, 2013 | View |
Package 1
Mandatory forms
123853 RR_SF424_1_2-1.2.pdf
123853 PerformanceSite_1_4-1.4.pdf
123853 RR_OtherProjectInfo_1_3-1.3.pdf
123853 RR_KeyPersonExpanded_1_2-1.2.pdf
123853 PHS398_CoverPageSupplement_1_4-1.4.pdf
123853 PHS398_ResearchPlan_1_3-1.3.pdf
123853 PHS398_Checklist_1_3-1.3.pdf
Optional forms
123853 RR_SubawardBudget30-1.2.pdf
123853 PHS398_ModularBudget_1_2-1.2.pdf
123853 RR_Budget-1.1.pdf
123853 PHS_CoverLetter_1_2-1.2.pdf
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