DIGET_BAA Attachment 3_SOW Template for Routing FINAL.docx

DOCX document 42 KB Posted

Attached to
Detect It with Gene Editing Technologies (DIGET) Federal contract opportunity
Solicitation number
HR001120S0016
Issued by
Defense Advanced Research Projects Agency

About this file

This document provides a statement of work template guide for the Defense Advanced Research Projects Agency's Detect It with Gene Editing Technologies program. The template outlines the required structure for proposals, including categories, tasks, and subtasks to be completed over base and option periods. Proposals must not exceed 10 pages and include draft language for scope of work, background, and program management expectations that will be finalized under contract. The template requires tasks and subtasks to include start and end months and describe goals, efforts required for completion, milestones for measurement of success, and deliverables. Technical areas will include platform integration, capability demonstrations, informatics and data sharing, and regulatory engagement. Performers must support data sharing, engage with regulatory agencies, and participate in program reviews and site visits.

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Other files attached to Detect It with Gene Editing Technologies (DIGET), newest first.
File Type Posted
HR001120S0016-Amendment-01.pdf PDF
Updated DARPA Cost Proposal Spreadsheet - DIGET HR001120S0016.xlsx XLSX spreadsheet
DIGET_BAA Attachment 3_SOW Template (UPDATE).docx DOCX document
HR001120S0016.pdf PDF
DIGET_BAA Attachment 1_Executive Summary Slide for Routing FINAL.PPTX PPTX presentation
DARPA Cost Proposal Spreadsheet - DIGET HR001120S0016.xlsx XLSX spreadsheet
DIGET_BAA Attachment 2_Specific_Program_Plan_Template FINAL.xlsx XLSX spreadsheet

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Statement of Work Template Guide Proposers are required to submit a Statement of Work (SOW) that provides a clear, concise outline of the work performed during the proposed effort, the milestones, and the deliverables to be agreed upon between DARPA and the proposer. Proposers are strongly encouraged to use this template as it highlights the technical areas and requirements described in the BAA, aligns to the budget template, and is organized to include the appropriate level of detail over three hierarchical levels: Categories, Tasks, and Subtasks.

Categories should consist of Technical Areas (TA), Platform Integration, Capability Demonstrations, Informatics and Data Sharing, and Regulatory Engagement. Each of these Categories will be comprised of high-level Tasks that are required to accomplish Category goals. Each Task will be comprised of Subtasks that describe the specific, technical work performed to accomplish Task goals. It is the proposers’ responsibility to identify the appropriate number of Tasks and Subtasks that are necessary to meet the goals of the program.

All Tasks and Subtasks must include start and end months in relation to the beginning of the program. For example, a task or subtask with a six-month duration beginning the first day of the effort should be labeled “Start: Month 1, End: Month 6.”

Instructions for Section C Section C should be written in a concise manner and must not exceed 10 pages (Times New Roman, 12-pt font, single-spaced, normal margins). The general format should follow the structure below. Colors should be removed from final submission, as well as these instructions.

CATEGORY

Task 1: [Title]; [Start: Month X, End Month: Z] Describe the goal of the Task (2-4 sentences).

Subtask 1.1: [Title]; [Performing institution(s)]; [Start: Month X, End: Month Y] Describe specific efforts (e.g., experiments) required to achieve Task goal (1-2 sentences).

Milestone 1.1: [End: Month Y] Describe how success will be measured in this Subtask (1 sentence).

Metrics/Completion Criteria 1.1:

Outline specific, quantitative metric(s) to demonstrate successful Milestone completion (1-2 sentences).

Deliverables 1.1:

Describe the final technical achievement(s), product(s), etc. that are generated during this Task (1-2 sentences).

STATEMENT OF WORK

<<insert Proposer Organization>> <<insert PI name>> <<insert BAA control number>>

STATEMENT OF WORK

Title – <<Insert Proposal Title>>

A. SCOPE

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should:

1. Describe the overarching goal of the project (1-2 sentences)

2. Outline the approach for each technical area (2-3 sentences each)

3. Describe the major outcomes or deliverables expected at the end of the period of performance (1-2 sentences each)

4. Address the path to regulatory approval (1-2 sentences) Unique aspects of the Capability Demonstrations may be described succinctly to indicate the anticipated samples to be tested, gold-standard assays to be used for benchmarking, and preparations to be made for working with Independent Verification and Validation teams (2-3 sentences each).

A.1. BACKGROUND

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should resemble the introduction section of a research manuscript. It should (a) provide scientific and technical context that supports both the technical merit and the DoD relevance of the proposal, and (b) summarize the information included in the proposal, but not duplicate it. Figures, graphs, tables, and datasets should not be included in this section. Section A.1 may not exceed 1 page (Times New Roman, 12-pt font, single-spaced, standard margins).

B. APPLICABLE DOCUMENTS

(a) HR001117SXXXX-DIGET

(b) <<Organization>> Proposal Titled “<<Proposal Title>>” dated <<submission date>>.

C. PROJECT WORK DESCRIPTION AND REQUIREMENTS

The Contractor shall provide the facilities and equipment necessary to develop the effort as described herein.

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should address expectations of the proposer to meet DARPA and BAA requirements.

Activities to address Ethical, Legal, and Social Issues (ELSI) are anticipated in this effort. The Recipient shall support ELSI activities with DARPA including semi-annual teleconference calls with the ELSI Panel and regular feedback from the Panel regarding the performer’s activities. ELSI activities will be reported regularly to DARPA.

BASE PERIOD (PHASE I)

CATEGORY 1

Task 1: [Title]; [Start: Month X, End Month: Z] Describe the goal of the Task (2-4 sentences).

Subtask 1.1: [Title]; [Performing institution(s)]; [Start: Month X, End: Month Y] Describe specific efforts (e.g., experiments) required to achieve Task goal (1-2 sentences).

Milestone 1.1: [End: Month Y] Describe how success will be measured in this Subtask (1 sentence).

Metrics/Completion Criteria 1.1:

Outline specific, quantitative metric(s) to demonstrate successful Milestone completion (1-2 sentences).

Deliverables 1.1:

Describe the final technical achievement(s), product(s), etc. that are generated during this Task (1-2 sentences).

CATEGORY 2 [Insert additional categories as needed.]

OPTION PERIOD (PHASE II)

CATEGORY 1

Task 1: [Title]; [Start: Month X, End Month: Z] Describe the goal of the Task (2-4 sentences).

Subtask 1.1: [Title]; [Performing institution(s)]; [Start: Month X, End: Month Y] Describe specific efforts (e.g., experiments) required to achieve Task goal (1-2 sentences).

Milestone 1.1: [End: Month Y] Describe how success will be measured in this Subtask (1 sentence).

Metrics/Completion Criteria 1.1:

Outline specific, quantitative metric(s) to demonstrate successful Milestone completion (1-2 sentences).

Deliverables 1.1:

Describe the final technical achievement(s), product(s), etc. that are generated during this Task (1-2 sentences).

CATEGORY 2 [Insert additional categories as needed.]

D. PROGRAM MANAGEMENT AND REVIEW

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should address expectation of the proposer to meet DARPA and BAA requirements.

The Government will actively monitor, review, and approve the Contractor's performance to ensure the performers are in sync and matched with the Government's requirements. At the Government PI meeting, all performers shall demonstrate their technical capabilities and engage or challenge each other in a cooperative and challenge environment. Along these lines, the Government will ensure that the performers each share technical information with each other, as appropriate, to enable the testing/challenging of each other's capabilities. The Government will further oversee the program and will review, approve, and participate in the demonstrations, as well as determine which performers will advance to the Option Period (Phase II).

Academic contractors considered to be conducting fundamental research on this program may publish papers describing scientific or engineering advances that are general in nature and adhere to the above guidance. Should the character of the research change during award performance so that the research is no longer considered fundamental, the award will be modified to impose the restrictions on public release and dissemination of information that apply to those research efforts that are not considered fundamental research. Non-academic performers shall submit any publications to DARPA’s Public Release Center (DARPA/PRC) to process for pre-publication review.

D.1. Informatics and Data Sharing Sharing of data and methods for information processing is a material requirement of the agreement. The Contractor shall support data sharing including sharing of raw and processed experimental data, processing methods used, algorithms used to process the data, artifact information, research reports, and software including source code and executables. The Contractor shall deliver to DARPA in a form agreed upon by the PM, all the experimental data collected in this effort within four months of completion of data collection (or at a date agreed upon in the statement of work). Experimental data should be accompanied with sufficient meta-data to capture laboratory conditions, equipment, supplies/reagents, procedures and methodologies. Data sharing will be included in the project milestones and reported regularly to DARPA.

D.2. Regulatory Strategy Proposers must present a detailed plan for early and continued engagement with US regulatory agencies appropriate for use case/indication (e.g., Clinical Laboratory Improvement Amendments, CLIA; Food and Drug Administration, FDA) to discuss the developing technologies and challenges. This engagement is necessary to meet the program regulatory milestones (e.g., Investigational Device Exemption, IDE), to inform and to improve the design of the capability demonstrations, and to facilitate technological advancement and the eventual translation transition of the technology to field deployment. Ideally, proposers will identify the applicant for IDE/Emergency Use Authorization (EUA) submission at the time of proposal submission. Additionally, although pre-EUA activities may be pursued they should not replace efforts to develop diagnostic devices for FDA approval through the appropriate pathways and, where possible, EUA activities should proceed in parallel. It is anticipated that the point-of-need, handheld device will be the first device from this program suitable for FDA submission, and this submission must be for a DoD-relevant indication. Ideally, proposers will identify this indication, or a strategy to identify this indication, at the time of proposal submission.

D.3. Kick-off Meeting The Contractor shall attend a kick-off meeting at a location selected by DARPA. In this meeting, the Contractor shall introduce the leads on the team, present their scope of work as well as a program management plan and financial tracking plan.

D.4.Monthly Financial Reports
The Contractor shall provide monthly financial progress reports to US Department of the Interior, Interior Business Center (DOINBC), the Contracting Officer (KO) and Contracting Officer’s Representative (COR), and DARPA. The purpose of these reports is to provide a brief project progress and inform DARPA Program Manager of any potential issues. A template will be provided for monthly reports.Comment by Wegrzyn, Renee: Is this accurate?Comment by Wegrzyn, Renee: Accurate?

D.5. Quarterly Financial Reports The Contractor shall provide quarterly financial progress reports to the DOINBC, KO, COR, and DARPA. The purpose of these reports is to provide a brief project progress and inform the DOINBC, SPAWAR, and DARPA of any potential issues.

D.6. Technical Reporting The Contractor shall provide technical progress reports to DOINBC, KO, COR, and DARPA every 6 weeks. The purpose of these reports is to present a summary of work completed by SOW tasking and milestones met, discuss any problems encountered, update the program schedule, present the program financial status, and discuss remaining work. A template will be provided for monthly reports.

D.7. Quarterly Technical Reporting The Contractor shall provide detailed technical quarterly progress reports to DOINBC, KO, COR, and DARPA. The purpose of these reports is to present a summary of work completed and milestones met; discuss any problems encountered; update the program schedule; present the program financial status; and discuss remaining work regarding technical tasks, data sharing, and ELSI activities. Quarterly reports shall also include all technical data items generated under this agreement but not limited to experimental data; processed data, along with methods of processing used; research reports and publications; and software (source code and executables). A template will be provided for quarterly reports.

D.8. PI Meetings DARPA will actively engage with and manage the performer teams throughout the project, to include program level meetings and site visits held every 6 months for the program duration.

All DIGET performer teams will participate in the program review meetings by sharing their accomplishments to date as well as the planned work for the next six-month period. Program review meetings may be attended by other performer teams or U.S. Government stakeholders at the discretion of the DARPA Program Manager.

The Contractor shall host annual site visits of DOINBC, KO, COR and DARPA. The purpose of this visit is to present a summary report of all work completed and milestones accomplished and to discuss ongoing or future technical tasks, data sharing, and ELSI activities.

D.9. Final Contract/Cooperative Agreement Review The Recipient shall prepare and deliver a final cooperative agreement report that completely and clearly describes all work completed, the results obtained and the implications of those results. The Recipient shall discuss milestones accomplished and relevant and/or related future efforts which may be pursued. The Recipient shall provide a copy of the final report to DOINBC, KO, COR, and DARPA.

D. GOVERNMENT FURNISHED EQUIPMENT (GFE) / CONTRACTOR ACQUIRED PROPERTY (CAP)

Leave blank - Will be finalized by DARPA and proposer during negotiations.

E. TRAVEL

Travel is anticipated for meetings between collaborators and meetings with DARPA.

F. PLACE OF PERFORMANCE

<<Insert prime institution name and address>>

<<Insert subcontractor institution name and address>>

G. SECURITY

This work is unclassified.

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