DARPA-PA-20-01-04-Amendment-01.pdf

DARPA-20-01-04

Disruption Opportunity DARPA-PA-20-01-04 Amendment 1

SenSARS I. Opportunity Description

The Defense Advanced Research Projects Agency (DARPA) Defense Sciences Office (DSO) is issuing a Disruption Opportunity (DO) inviting submissions of innovative basic or applied research concepts in the technical domain of environmental pathogen sensing. This DO is issued under the Program Announcement for Disruptioneering, DARPA-PA-20-01. All awards will be made in the form of an Other Transaction (OT) for prototype project. The total award value for the combined Phase 1 base and Phase 2 option is limited to $1,000,000. This total award value includes Government funding and performer cost share, if required or if proposed.

To view the original DARPA Program Announcement for Disruptioneering, visit beta.SAM.gov (formerly FedBizOpps) under solicitation number DARPA-PA-20-01:

https://beta.sam.gov/opp/336f958130b8410992c43471ef83eacf/view.

A. Introduction and Background The COVID-19 pandemic has highlighted the need for improved environmental sensing of pathogens. Sensing SARS-CoV-2 virus in the air with high sensitivity and specificity could provide a new mechanism for public health monitoring, enabling safer conditions for a wide range of basic activities including work, travel, and school. SenSARS aims to identify SARS- CoV-2 signatures suitable for rapid indoor air monitoring and use these signatures to develop and demonstrate a technology readiness level (TRL) 4 prototype sensor.

Environmental monitoring for pathogens has historically been, and continues to be, an extremely challenging area of study. Techniques explored to date have included spectral techniques, affinity techniques, and sampling and assay techniques. Driven by small and variable signals available from the virus and dynamic and complex backgrounds, achieving desired performance characteristics using a single measurement technique is a formidable challenge.

Most SARS-CoV-2 detection assays require a sample to be collected and sent to a lab for detection of viral genetic signatures or associated antigens. Depending on whether amplification of genetic material is required, results are available on time scales ranging from 10s of minutes to days. While generally offering required specificity, processing times are too slow to be of use for atmospheric sampling. On the other hand, current air-breathing environmental sensors using optical techniques offer fast detection times but limited ability to discriminate between benign and pathogenic material, such as the SARS-CoV-2 virus. In general, current methods are not suitable for room-sized, indoor environmental monitoring and lack practical combinations of sensitivity, specificity (precision and recall), acceptable false positive rates, and speed and/or have substantial barriers to scaling due to cost or size, weight, and/or power requirements.

Recent developments in radiofrequency vibrometry, improvements in terahertz sources and sensors, improvements in mass spectrometric techniques, emerging immunosensing techniques, electrochemical detection methods, and advances in signal analysis using machine learning approaches could potentially surmount these challenges. The continually expanding knowledge base regarding the virus provides much needed data to allow for signature development for these and other detection modalities. These approaches have the potential to enable sample agnostic detection of low viral concentrations within seconds to minutes, characteristics that are paramount for real-time aerosol detection. Improvements in portability of traditional methods of https://beta.sam.gov/opp/336f958130b8410992c43471ef83eacf/view detection – immunoassays and nucleic acid-based assays – out of the lab setting may enable onsite confirmation of results.

B. Structure The SenSARS program is structured in two phases. The 9-month Phase 1 focuses on determining environmental SARS-CoV-2 signature feasibility. The 9-month Phase 2 option seeks to refine signatures and produce and demonstrate a TRL 4 prototype sensor. Selection for the Phase 2 option depends on Phase 1 results and funding availability.

Proposals submitted in response to this DO must be UNCLASSIFIED and must address two independent and sequential project phases (a Phase 1 Feasibility Study (base) and a Phase 2 Proof of Concept (option)). The periods of performance for these phases are 9 months for the Phase 1 base effort and 9 months for the Phase 2 option effort. Combined Phase 1 base and Phase 2 option efforts for this DO must not exceed 18 months. The Phase 1 (base) award value is limited to $500,000. The Phase 2 (option) award value is limited to $500,000. The Phase 1 and Phase 2 limits each include performer cost share, if required or if proposed. As previously stated, the total award value for the combined Phase 1 base and Phase 2 option is limited to $1,000,000.

This total award value includes Government funding and performer cost share, if required.

C. Technical Description The ultimate goal of SenSARS is to develop a prototype sensor that can detect SARS-CoV-2 in the air with enough sensitivity, specificity, and speed to enable practical concepts of operation to be employed before infection can occur within an indoor environment. Three potential use cases of interest are an office of 50 m3, a conference room or classroom of 300 m3, and central monitoring of buildings up to 10 stories through the heating, ventilation, and air conditioning (HVAC) system. Proposers can address one or more use cases. For the purposes of this solicitation, an infectious dose of several hundred plaque forming units (PFUs) can be assumed1.

During Phase 1, SARS-CoV-2 signatures will be examined and developed to meet threshold performance metrics including sensitivity, specificity, and time to detect. These metrics are captured in the following table along with objectives for the TRL 4 Phase 2 option prototype.

Threshold Metrics Objective Metrics Sensitivity2 < 1 particles/L < 0.1 particles/L

Specificity Area under the precision-recall curve, 70% against defined panel

Area under the precision-recall curve, 95% against defined panel

False Alarm Rate <10-5 / analysis <10-6 / analysis

Time to Detect < 15 min < 5 min

Specificity is not trivial to roll up into a single metric, and more nuanced discussions are envisioned as part of the program; however, area under the precision-recall curve will be used as a starting point. Testing of SARS-CoV-2 should be conducted against a panel of other viruses and common environmental contaminants and should at minimum contain dust, influenza, and rhinovirus.

1 Infectious dose is highly variable and depends on many factors. Proposers are welcome to use alternate numbers for any calculations so long as sufficient justification is provided.

2 Assuming 1 PFU / particle

Size, weight, and power (SWaP) of the technical approach, once realized, should be appropriate to the specific use case(s) being addressed. Similarly, proposed technical approaches should have a path to low unit, operation, and maintenance costs and offer additional suitability factors such as ease of use and ease of maintenance. Technical approaches that do not address the desired SWaP, cost, and suitability factors above are discouraged.

A number of secondary objectives are also of interest and must be addressed in the proposal:

Extensibility to other pathogens beyond SARS-CoV-2 Adaptability to detect new pathogens within 1 week to a month after discovery Ability to save samples for additional analysis

While simulants and models can provide valuable data and insights, testing with actual, viable, replication competent SARS-CoV-2 is desired, and proposals using purely simulants and/or models are strongly discouraged. Proposers will be expected to provide data to the Government for independent verification and validation.

D. Schedule, Milestones, and Deliverables Proposers must address the Research Project Objectives, metrics, and deliverables, along with fixed payable milestones in their proposals. The task structure must be consistent across the proposed schedule, Task Description Document (TDD), and the Volume 2 - Price Summary.

Proposers must complete the Attachment 1: Schedule of Milestones and Payments Excel Amendment 1 template provided with this DO as part of submitting a complete proposal and fulfilling the requirements under Volume 2 Price Summary. If selected for award negotiation, the fixed payable milestones provided will be directly incorporated as Attachment 3 of the OT agreement (“Schedule of Milestones and Payments”). Proposers are encouraged to use the TDD template provided as an attachment to DARPA-PA-20-01, which will be Attachment 1 in the OT agreement.

In Phase 1 (9 months), performers will demonstrate via modeling, experimentation and analysis proof-of-feasibility of the proposed concept(s). This includes demonstrating a robust signature for the SARS-CoV-2 virus that is both sensitive and specific for the virus even when comingled in a complex and variable background. This will include producing early in the phase an experimental research plan that actually employs SARS-CoV-2 to validate performance claims against the above metrics. In Phase 2 (9 months), performers will develop and execute a plan to produce several prototype sensors suitable for field trials. The sensors should demonstrate that they are manufacturable, scalable, and are performant against the metrics of this DO. By the end of Phase 2, the final report and sensors will be ready for demonstration in one or more use cases defined above. Decisions to proceed with the Phase 2 Option will be made based on funding availability and a technical evaluation of the Phase 1 feasibility study which will consider the viability, risk, and payoff of the proposed technical approach to meet the above defined metrics, and addresses appropriate suitability factors for one or more use cases.

In order to achieve the goals of SenSARS, the following milestones are established: Phase 1 (9 months) M1 (month 1): Phase 1 kick off M2 (month 2): Signature summary, development and test plan M3 (month 5): Mid-phase testing progress

M4 (months 9): Signature sensitivity and specificity report

Phase 2 (9 months) M5 (month 10): Phase 2 kick off M6 (month 10): Prototype system requirements review (SRR) M7 (month 12): Prototype delivery design review (PDR) M8 (month 14): Prototype critical design review (CDR) M9 (month 18): Final technical report.

For planning and budgetary purposes, proposers should assume a program start date of January 29, 2021. Schedules may be synchronized across performers, as required, and monitored/ revised as necessary throughout the program.

All proposals must include the following meetings in the proposed schedule and costs:

Virtual kickoffs for Phase 1 and the Phase 2 option.

Regular bi-weekly or monthly teleconference meetings will be scheduled with the

Government team for progress reporting as well as problem identification and mitigation.

Proposers typically prepare a slide deck to aid the discussion.

Depending on travel conditions, proposers should anticipate one site visit during the Phase 2 option period by the DARPA Program Manager during which they will have the opportunity to demonstrate progress towards agreed-upon milestones.

Performers will be expected to provide, at a minimum, the following deliverables:

Phase 1 kickoff slide deck providing background on the performer, signature(s) under study, and technical approach to meet Phase 1 objectives, risks and risk mitigations, and schedule.

Phase 1 signature summary, development and test plan that details the signature(s) under investigation and the plan by which performance metrics will be met.

Phase 1 mid-period testing progress report for month 5 indicating progress in achieving DO metrics

Phase 1 final report of signature sensitivity and specificity for month 9 indicating DO metrics can be achieved in a sensor that would be realized in Phase 2

Phase 2 kickoff slide deck summarizing technical approach to meet Phase 2 objectives, including risks and risk mitigations and schedule.

Prototype system requirements review for month 10 that allocates performance and suitability goals of the sensor to proposed sensor components

Prototype preliminary design review report for month 12 that provides an initial design of the sensor and all key components that when integrated, achieves DO performance and suitability goals for the proposed use case

Prototype critical design review report for month 14 that provides a final design of the sensor and all key components that when integrated, achieves DO performance and suitability goals for the proposed use case

Final report summarizing the assessment of sensor performance and 3 working prototype sensors for month 18 Monthly written technical progress reports (see Attachment 2 for a template)

II. Award Information Selected proposals that are successfully negotiated will result in award of an OT for prototype project. See Section 3 of DARPA-PA-20-01 for information on awards that may result from proposals submitted in response to this notice.

Proposers must review the sample OT for Prototype agreement provided as an attachment to DARPA-PA-20-01 prior to submitting a proposal. DARPA has provided the sample OT in order to expedite the negotiation and award process and ensure DARPA achieves the goal of Disruptioneering which is to enable DARPA to initiate a new investment in fewer than 90 days from idea inception. The sample OT is representative of the terms and conditions that DARPA intends to award for all DO Awards. The task description document, schedule of milestones and payments, and data rights assertions requested under Volumes 1, 2, and 3 will be included as attachments to the OT agreement upon negotiation and award.

Proposers may suggest edits to the sample OT for consideration by DARPA and provide a copy of the sample OT with track changes as part of their proposal package. Suggested edits may not be accepted by DARPA. The Government reserves the right to remove a proposal from award consideration should the parties fail to reach agreement on OT award terms and conditions. If edits to the sample OT are not provided as part of the proposal package, DARPA assumes that the proposer has reviewed and accepted the award terms and conditions to which they may have to adhere and the sample OT agreement provided as an attachment, indicating agreement (in principle) with the listed terms and conditions applicable to the specific award instrument.

It is expected that work performed under these OTs will not be considered fundamental research and publications resulting from this work will not be eligible for release without written permission from the DARPA Public Release Center at PRC@darpa.mil.

In order to ensure that DARPA achieves the goal of award within 90 days from the posting date (November 2, 2020) of this announcement, DARPA reserves the right to cease negotiations when an award is not executed by both parties (DARPA and the selected organization) on or before January 29, 2021.

III. Eligibility

See Section 4 of DARPA-PA-20-01 for information on who may be eligible to respond to this notice.

IV. Opportunity Responses A. Proposal Content and Format

All proposals submitted in response to this notice must comply with the content and format instructions in Section 5 of DARPA-PA-20-01. All proposals must use the templates provided as Attachments to DARPA-PA-20-01 and the Attachments provided with this DO and follow the instructions therein.

Information not explicitly requested in DARPA-PA-20-01, its Attachments, or this notice may not be evaluated.

mailto:PRC@darpa.mil

B. Proposal Submission Instructions Responses to DARPA-PA-20-01-04 must be submitted through one of the following methods:

(1) electronic upload (DARPA-preferred) or (2) direct mail/hand-carry. Proposers must submit all parts of their submission package using the same method.

Electronic submission must be through DARPA’s BAA Portal (https://baa.darpa.mil). Proposals must only be submitted in response to this DO (DARPA-PA-20-01-04). Proposals submitted in response to the PA (DARPA-PA-20-01), as opposed to in response to the appropriate DO, may be disregarded.

Proposers electing to submit proposals via direct mail or hand-carried must provide one paper copy and one electronic copy on CD or DVD of the full proposal package. All parts of the proposal package must be mailed or hand-carried in a single delivery to the mailing address noted in DARPA-PA-20-01 Section 1. Overview Information.

DARPA will acknowledge receipt of complete submissions via email and assign identifying numbers that should be used in all further correspondence regarding those submissions. If no confirmation is received within two business days, please contact SenSARS@darpa.mil to verify receipt.

When planning a response to this DO, proposers should take into account the submission time zone and that some parts of the submission process may take from one business day to one month to complete (e.g., registering for a Data Universal Numbering System (DUNS) number or Tax Identification Number (TIN)).

Electronic Upload First-time users of the DARPA BAA Portal must complete a two-step account creation process.

The first step consists of registering for an extranet account by going to the URL listed above and selecting the “Account Request” link. Upon completion of the online form, proposers will receive two separate emails; one will contain a user name and the second will provide a temporary password. Once both emails have been received, the second step requires proposers to go back to the submission website and log in using that user name and password. After accessing the extranet, proposers may then create a user account for the DARPA Submission website by selecting the “Register your Organization” link at the top of the page. Once the user account is created, proposers will be able to see a list of solicitations open for submissions, view submission instructions, and upload/finalize their proposal.

Proposers who already have an account on the DARPA BAA Portal may simply log in at https://baa.darpa.mil, select this solicitation from the list of open DARPA solicitations and proceed with their proposal submission. Note: proposers who have created a DARPA Submission website account to submit to another DARPA Technical Office’s solicitations do not need to create a new account to submit to this solicitation.

All full proposals submitted electronically through the DARPA Submission website must meet the following requirements: (1) uploaded as a zip file (.zip or .zipx extension); (2) only contain the document(s) requested herein; (3) only contain unclassified information; and (4) must not exceed 100 MB in size. Only one zip file will be accepted per full proposal. Full proposals not uploaded as zip files will be rejected by DARPA. Technical support for the DARPA Submission website is available during regular business hours, Monday – Friday, 9:00 a.m. – 5:00 p.m.

https://baa.darpa.mil/ mailto:SenSARS@darpa.mil https://baa.darpa.mil/

Requests for technical support must be emailed to BAAT_Support@darpa.mil with a copy to SenSARS@darpa.mil. Questions regarding submission contents, format, deadlines, etc. should be emailed to SenSARS@darpa.mil. Questions/requests for support sent to any other email address may result in delayed/no response.

Since proposers may encounter heavy traffic on the web server, DARPA discourages waiting until the day proposals are due to request an account and/or upload the submission. Note:

Proposers submitting a proposal via the DARPA Submission site MUST (1) click the “Finalize” button in order for the submission to upload AND (2) do so with sufficient time for the upload to complete prior to the deadline. Failure to do so will result in a late submission.

C. Proposal Due Date and Time Proposals in response to this notice are due no later than 4:00 PM on December 1, 2020. Full proposal packages as described in Section 5 of DARPA-PA-20-01 must be submitted per the instructions outlined in this DO and received by DARPA no later than the above time and date.

Proposals received after this time and date may not be reviewed.

Proposers are warned that the proposal deadline outlined herein is in Eastern Time and will be strictly enforced. When planning a response to this notice, proposers should take into account that some parts of the submission process may take from one business day to one month to complete.

V. Proposal Evaluation and Selection Proposals will be evaluated and selected in accordance with Section 6 of DARPA-PA-20-01.

Proposers will be notified of the results of this process as described in Section 7.1 of DARPA-

PA-20-01.

VI. Administrative and National Policy Requirements Section 7.2 of DARPA-PA-20-01 provides information on Administrative and National Policy Requirements that may be applicable for proposal submission as well as performance under an award.

VII. Point of Contact Information Mark Wrobel, Program Manager, DARPA/DSO, SenSARS@darpa.mil

VIII. Frequently Asked Questions (FAQs) All technical, contractual, and administrative questions regarding this notice must be emailed to SenSARS@darpa.mil. Emails sent directly to the Program Manager or any other address may result in delayed or no response.

All questions must be in English and must include name, email address, and the telephone number of a point of contact. DARPA will attempt to answer questions publicly in a timely manner; however, questions submitted within 7 days of the proposal due date listed herein may not be answered.

DARPA will post an FAQ list under the DO on the DARPA/DSO Opportunities page at (http://www.darpa.mil/work-with-us/opportunities?tFilter=&oFilter=2&sort=name). The list will be updated on an ongoing basis until one week prior to the proposal due date. In addition to the FAQ specific to this notice, proposers should also review the Program Announcement for DO General FAQ list on the DARPA/DSO Opportunities page under the Program Announcement for mailto:BAAT_Support@darpa.mil mailto:SenSARS@darpa.mil mailto:SenSARS@darpa.mil mailto:SenSARS@darpa.mil mailto:SenSARS@darpa.mil http://www.darpa.mil/work-with-us/opportunities?tFilter=&oFilter=2&sort=name

Disruptioneering (DARPA-PA-20-01) to check for any general Disruptioneering FAQs.

IX. Live Question and Answer (Q&A) Session This topic will feature a live question and answer session with the Program Manager in the SenSARS incubator on Polyplexus (https://start.polyplexus.com/). Polyplexus is an online, professional, technical conversation between the research community and DARPA Program Managers. The live question and answer session will be held on November 9, 2020 from 12:00 PM to 1:30 PM Eastern, and further details will be available on polyplexus.com.

https://start.polyplexus.com/