RAPIID_TA3_Attachment_F_Schedule_of_Milestones_and_Payments.xlsx
XLSX spreadsheet 25 KB Posted
- Solicitation number
- DARPA-PA-26-09
About this file
This is a Schedule of Milestones and Payments template for Task Area 3 (TA-3) proposals submitted to DARPA-PA-26-09, the Resuscitation and Prevention of Ischemia-Induced Dysfunction (RAPIID) program. Proposers are required to complete this spreadsheet to document all proposed milestones, deliverables, due dates, and associated payments for their TA-3 efforts. The template provides prepopulated mandatory milestones and deliverables based on Section 1.7 of the Program Announcement, with instructions to use blue text for edits to required items and red text for additional proposer-defined milestones. All tasks and targets must be keyed to the Task Description Document (Attachment E), and all payment amounts must align with costs in the Cost Proposal (Attachment B) and Cost Proposal Spreadsheet (Attachment C).
Phase 1 spans months 1-12 after contract award and includes critical milestones such as kick-off meetings, animal and human subjects protocol submissions and approvals, CMMC Level 2 certification, coordination plans with TA-1 and TA-2 performers, GLP IND-enabling studies plans, safety and efficacy reports for blood analog combinations, engagement with clinical guideline organizations, and IND submission documentation. Phase 2 extends from month 13 through month 36 and encompasses FDA IND approval and IRB protocol submission, initiation and completion of Phase I and Phase II clinical trials, diagnostic/device validation activities, draft and final Clinical Practice Guidelines development, and a final technical report due within 60 calendar days of agreement termination. The spreadsheet includes columns for Milestone number, RAPIID TA-3 Milestones, Exit Criteria/Deliverables, Due Date, Payment amount, Funded CLIN, SUBCLIN, and ACRN, with highlighted sections designated as not to be completed by proposers.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| RAPIID_TA3_Attachment_G_RAPIID_CUI_Guide.pdf | ||
| RAPIID_TA3_Attachment_D_Sample_OT_R_.docx | DOCX document | |
| DARPA-PA-26-09.pdf | ||
| RAPIID_TA3_Attachment_A_Technical_Management_Proposal.docx | DOCX document | |
| RAPIID_TA3_Attachment_E_Task_Description_Document.docx | DOCX document | |
| RAPIID_TA3_Attachment_C_DARPA_Standard_Cost_Proposal_Spreadsheet.xlsx | XLSX spreadsheet | |
| RAPIID_TA3_Attachment_B_Cost_Proposal.docx | DOCX document |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
INSTRUCTIONS
Please complete the schedule of milestones and payments spreadsheet for your TA-3 proposal to DARPA-PA-26-09.
This should contain information about proposed milestones, due dates, deliverables, and payments associated. Tasks and targets should be keyed to the Task Description Document (Attachment E).
The spreadsheet contains the required milestones, deliverables, and schedule (indicated in black text).
Blue text should indicate any edits to the required milestones, deliverables, or schedule.
Red text should be used to indicate any milestones and associated deliverables and schedule that have been added by the proposers.
Note that "ACA" denotes "after contract award," and the highlighted sections are not to be filled out by proposers.
TA-3 Milestone Schedule
| Milestone # | RAPIID TA-3 Milestones | Exit Criteria/Deliverable(s) | Due | |
| Date | Payment | Funded | CLIN | |
| SUBCLIN | ACRN | |||
| # | INSTRUCTIONS: This schedule of deliverables, milestones, and payments is prepopulated with the minimal milestones and deliverables described in Section 1.7 of the Program Announcement DARPA-PA-26-09. Proposers are expected define and include their own additional milestones and deliverables as needed, based on their specific approaches to achieving the objectives of the RAPIID program described in Sections 1.4 and 1.6 of the Program Announcement. |
Payments for each milestone and deliverable must be consistent with costs indicated in the Cost Proposal (Attachment B) and the Cost Proposal Spreadsheet (Attachment C).
| TA-3, Phase 1 - Deliverables and Milestones | |||||
| RAPIID Phase 1 Kick-off Meeting: Performers are expected to participate in a kick-off meeting at the beginning of the RAPIID program. This meeting may be held with individual or all performer teams, to be determined by DARPA | Kickoff meeting briefing slides that describe the project work plan, anticipated challenges, and risk mitigation strategies. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 1 ACA | |||
| Initial Animal Subjects Research Protocol and/or Human Subjects Research Protocol Submission(s) | Documented confirmation of protocol submission(s). Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 1 ACA | |||
| Initial Animal Subjects Research Protocol and/or Human Subjects Research Protocol Approval(s) | Documented confirmation of protocol approval(s). If approval is not received, a documented justification, estimated timeline for approval, and risk mitigation plan must be provided. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 3 ACA | |||
| Cybersecurity Maturity Model Certification (CMMC) Level 2 | Documented confirmation of CMMC Level 2 and registration in the DoD's Supplier Performance Risk System (SPRS). Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 3 ACA | |||
| Coordination Plan(s) for TA-1 and TA-2 | Documented agreement with the coordination plan provided by the TA-1 and/or TA-2 performer(s). Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 5 ACA | |||
| Good Laboratory Practice (GLP) Investigational New Drug (IND)-enabling studies plan (TA-1) | Written plan detailing the IND-enabling studies to be performed, including justification for included studies, success metrics, and documentation of TA-1 performers commitment that sufficient materials will be provided to TA-3. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 5 ACA | |||
| Safety and Efficacy Report - Combination Blood Analog (TA-1) | Report with results from safety and efficacy studies comparing combinations of blood analog components to stored whole blood to identify combination(s) of TA-2 components meeting Month 6 performance criteria (non-inferiority to whole blood within 20% with ≤10% decrease in individual component performance). Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 6 ACA | |||
| Initial engagement with Joint Trauma System and relevant civilian organizations for drafting Clinical Practice Guidelines (CPGs) | Report from meeting(s) with organizations responsible for approving military and civilian CPGs, including feedback on development plan. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 6 ACA | |||
| Safety and Efficacy Report - Combination Blood Analog (TA-1) | Report with results from safety and efficacy studies comparing combinations of blood analog components to stored whole blood to identify combination(s) of TA-2 components meeting Month 9 performance criteria (non-inferiority to whole blood within 10% with ≤10% decrease in individual component performance). Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 9 ACA | |||
| IND-enabling studies Report, including initial absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics (PK) studies (TA-1) | Report with results from at least half of the IND-enabling studies, including ADME and PK studies. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 9 ACA | |||
| Clinical Trial Plan (TA-1) | Written clinical trial plan to assess the safety and efficacy of the blood analog. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 10 ACA | |||
| IND-enabling studies report and IND submission (TA-1) | Report with results from all IND-enabling studies, and documented confirmation of IND package submission to the FDA. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 12 ACA | |||
| … Propose your own as needed … | |||||
| TA-3, Phase 2 - Deliverables and Milestones | |||||
| IND Approval and Clinical Trial Protocol Submitted to the Institutional Review Board (IRB) | Documented confirmation that IND approval has been received from the FDA, and confirmation of protocol submission. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 13 ACA | |||
| Initiate Phase I Clinical Trial for Blood Analog and Components (TA-1) | Documented confirmation that the Phase I clinical trial has begun. If there are any delays, a risk mitigation plan must be submitted. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 14 ACA | |||
| Diagnostic/Device Validation Plan (TA-2) | Documented agreement with the clinical validation study plan developed in coordination with TA-2. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 17 ACA | |||
| Initiate Diagnostic/Device Validation (if necessary; TA-2) | Documented confirmation that the clinical validation study has begun. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 20 ACA | |||
| Complete Phase I Clinical Trial (TA-1) | Report with results from the Phase I clinical trial. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 24 ACA | |||
| Draft Clinical Practice Guidelines (CPGs) | Draft version of the CPGs providing guidance for using the blood analog system. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 24 ACA | |||
| Initiate Phase II Clinical Trial for Blood Analog and Components (TA-1) | Documented confirmation that the Phase II clinical trial has begun. If there are any delays, a risk mitigation plan must be submitted. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 25 ACA | |||
| Complete Diagnostic/Device Validation (TA-2) | Report with results from the clinical validation study. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 32 ACA | |||
| Complete Phase II Clinical Trial (TA-1) | Report with results from the Phase II clinical trial. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 36 ACA | |||
| Final CPGs | Final version of the CPGs providing guidance for using the blood analog system. Exit Criteria: Government acceptance of the completed milestone deliverable. | Month 36 ACA | |||
| Final Report | Written technical report describing the completed technical and transition efforts, key results and findings, challenges and limitations to the project, and potential next steps | Within 60 calendar days of termination of this Agreement | |||
| … Propose your own as needed … | |||||
| Total Agreement | $ - 0 | $ - 0 |
Please ensure that Tasks and targets are keyed to Task Description Document (Attachment E).
HIGHLIGHTED SECTION NOT TO BE FILLED OUT BY PROPOSERS
Attachment 3 - Schedule of Milestones and Payments
File details come from the government source that posted it. Updated .