The National Institute of Neurological Disorders and Stroke (NINDS) is offering the NeuroNEXT Clinical Trials Grant to support biomarker validation or exploratory trials for neurologic diseases. Applicants should focus on drugs, biologics, surgical therapies, or devices that could lead to future Phase III trials. The chosen disease areas must align with NINDS’ strategic plan. Successful applicants will gain access to the NeuroNEXT infrastructure, including support from the Clinical Coordinating Center and Data Coordinating Center. Clinical sites will assist with recruitment and protocol implementation. Applicants do not need prior involvement in the NeuroNEXT infrastructure. Deadline: Aug 02, 2013.
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:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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 |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 2 | Modified Archive Date based on new Expiration Date, per NOT-NS-13-034. | Jul 03, 2013 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.853 |
| Competition ID: | ADOBE-FORMS-B2 |
| Competition Title: | ADOBE-FORMS-B2 |
| Opportunity Package ID: | PKG00079271 |
| Opening Date: | Nov 02, 2011 |
| Closing Date: | Aug 02, 2013 |
| Agency Contact Information:: | Grants Info |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.1] PHS Cover Letter [V1.2] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.853 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00079271 | Nov 02, 2011 | Aug 02, 2013 | View | Grants Info | Organization Applicants |