The Department of Defense offers the Tuberous Sclerosis Complex Pilot Clinical Trial Award to fund exploratory studies focusing on diagnostic or therapeutic information, safety, and tolerability in TSC. The grant supports studies to develop interventions and clinical biomarkers for improving TSC outcomes, and does not fund preclinical research. Acceptable study areas include identifying study populations, intervention dosages, feasibility, biomarker development, efficacy, and safety assessment. Applicants must submit necessary FDA approvals for investigational drug use or investigational device exemption, as well as be prepared to provide documentation of approval prior to programmatic review.
Opportunity ID: 276402
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-TSCRP-PCTA |
| Funding Opportunity Title: | DoD Tuberous Sclerosis Complex Pilot Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 06, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 27, 2015 |
| Current Closing Date for Applications: | Jul 27, 2015 |
| Archive Date: | Aug 26, 2015 |
| Estimated Total Program Funding: | $960,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The PCTA mechanism supports exploratory studies involving limited human exposure that produce diagnostic or therapeutic information, safety, and tolerability studies and studies to determine the mechanism of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions, as well as clinical biomarkers, with the potential to improve TSC outcomes. Preclinical studies will not be supported by this mechanism. Examples of acceptable studies include but are not limited to the following: • Identification of an appropriate population for the proposed study. • Identification of the dosage, duration, and/or delivery strategy of an intervention. • Evaluation of the feasibility of the intervention in TSC. • Development of clinical biomarkers or outcome measures for future clinical trials. • Evaluation of efficacy and safety. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) must be submitted to the FDA prior to the application submission deadline. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA prior to the application submission deadline, or that the device is exempt from an IDE, is required. Documentation of approval or exemption of the IND or IDE prior to programmatic review must be obtained and submitted to the CDMRP Help Desk (help@eBRAP.org), otherwise the Government reserves the right to withdraw the application |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
Phone: 301-682-5507 Email:help@eBRAP.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 276402 Full Announcement-1 -> tscrp_fy15 pcta ind documentation form_gg.pdf
Folder 276402 Full Announcement-1 -> tscrp_fy15_pcta_pa_gg.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00216693 | May 06, 2015 | Jul 27, 2015 | View |
Package 1
Mandatory forms
276402 RR_SF424_2_0-2.0.pdf
276402 RR_Budget_1_3-1.3.pdf
276402 RR_KeyPersonExpanded_2_0-2.0.pdf
276402 PerformanceSite_2_0-2.0.pdf
Optional forms
276402 RR_SubawardBudget30_1_3-1.3.pdf
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