HR001123S0048.pdf

Broad Agency Announcement Assured Microbial Preservation in Harsh Or Remote Areas

(AMPHORA)

BIOLOGICAL TECHNOLOGIES OFFICE

HR001123S0048

August 8, 2023

HR001123S0048, AMPHORA

TABLE OF CONTENTS

PART I: OVERVIEW INFORMATION

PART II: FULL TEXT OF ANNOUNCEMENT

1. Funding Opportunity Description

1.1. Program Overview

1.2. Technical Approach and Program Structure

1.3. Program Metrics, Milestones, and Deliverables

1.4. Demonstrations and Independent Verification & Validation Testing (IV&V)

1.5. General Requirements

2. Award Information

2.1. General Award Information

2.2. Fundamental Research

3. Eligibility Information

3.1. Eligible Applicants

3.2. Organizational Conflicts of Interest

3.3. Cost Sharing/Matching

4. Application and Submission Information

4.1. Address to Request Application Package

4.2. Contact and Form of Application Submission

4.3. Funding Restrictions

4.4. Other Submission Information

5. Application Review Information

5.1. Evaluation Criteria

5.2. Review of Proposals

5.2.4. Countering Foreign Influence Program (CFIP)

5.3. Phase I Down-Selection Process

6. Award Administration Information

6.1. Submission Status Notifications

6.2. Administrative and National Policy Requirements

6.3. Reporting

6.4. Electronic Systems

7. Agency Contacts

8. Other Information

8.1. Proposers Day

8.2. University Funding

9. APPENDIX A – BSL-2 Microorganisms

10. APPENDIX B – Volume II checklist

PART I: OVERVIEW INFORMATION

Federal Agency Name – Defense Advanced Research Projects Agency (DARPA), Biological Technologies Office (BTO)

Funding Opportunity Title – Assured Microbial Preservation in Harsh Or Remote Areas (AMPHORA)

Announcement Type – Initial Announcement Funding Opportunity Number – HR001123S0048 North American Industry Classification System (NAICS) – 541714 Assistance Listing Number (ALN) – 12.910 Research and Technology

Development Dates o Posting Date: August 8, 2023 o Proposal Abstract Due Date and Time: August 24, 2023, 4:00 PM ET o Full Proposal Due Date and Time: October 4, 2023, 4:00 PM ET o BAA Closing Date: October 4, 2023 o Proposers Day: August 11, 2023 https://sam.gov/opp/2a9f5b6224544b3783fda8c18a504a95/view

Concise description of the funding opportunity – Emerging infectious disease hotspots are expected to increase globally within the next 50 years. While technology has advanced agnostic lab-based testing, agnostic sample preservation still relies on cold chain transport that can be difficult to acquire and often unreliable in remote, austere, and contested environments. Thus, samples critical to force health protection can be significantly degraded upon lab receipt. The AMPHORA program seeks to develop a portable, cold chain free system that can preserve any microbe (bacteria, fungus, virus) from any sample, environment, or clinical setting, increasing the DoD’s ability to surveil for emerging threats and protect force health and readiness. The AMPHORA program will decouple sample preservation from cold chains, enabling cold chain-free storage and viability maintenance in austere and remote environments. AMPHORA systems will preserve multiple samples in parallel, and ensure samples are compatible with downstream analyses. Preservation systems will be rigorously tested using contrived and real-world samples to demonstrate real-world capability and generalizability.

Anticipated individual awards – Multiple awards are anticipated.

Types of instruments that may be awarded – Procurement Contract, Cooperative

Agreement, or Other Transaction for Prototype.

Agency contact

The Program Manager for this effort is Dr. Tiffany Prest.

The BAA Coordinator for this effort may be reached at:

AMPHORA@darpa.mil

DARPA/BTO

ATTN: HR001123S0048

675 North Randolph Street Arlington, VA 22203-2114 https://sam.gov/opp/2a9f5b6224544b3783fda8c18a504a95/view mailto:AMPHORA@darpa.mil

PART II: FULL TEXT OF ANNOUNCEMENT

1. Funding Opportunity Description

This publication constitutes a Broad Agency Announcement (BAA) as contemplated in Federal Acquisition Regulation (FAR) 6.102(d)(2) and 35.016 and 2 CFR § 200.203. Any resultant award negotiations will follow all pertinent law and regulation, and any negotiations and/or awards for procurement contracts will use procedures under FAR 15.4, Contract Pricing, as specified in the BAA.

The Biological Technologies Office (BTO) is soliciting innovative proposals to develop portable systems for universal organism preservation in the field. Systems must preserve fungi, bacteria, and viruses. Proposed research should consider innovative approaches that enable and integrate revolutionary advances in cross-kingdom microbial ecology, chemistries and formulations, new materials, and/or microfluidics, for universal sample preservation. Specifically excluded is research that primarily results in incremental improvements to the existing state of practice.

1.1. PROGRAM OVERVIEW

Warfighters are currently deployed to emerging disease hotspots across a range of geographies, and thawing permafrost and climate change are projected to only increase pathogen exposure in the future. Current force health protection methods rely on collecting and preserving environmental and clinical samples using methods that can be both unreliable and difficult to access in such remote locations, inhibiting effective biosurveillance for warfighter protection. To protect the deployed warfighter from emerging disease, the Assured Microbial Preservation in Harsh Or Remote Areas Program (AMPHORA) will decouple sample preservation from cold chain reliance, enabling viable sample preservation in austere or remote locations for further field-forward lab-based assessment.

Current DoD entities tasked with force health protection, e.g., Global Emerging Infections Surveillance (GEIS), preserve both clinical and environmental samples in remote, austere, and contested locations via cold chain and transport media. These methods are unreliable (e.g., only 45% of the world has reliable power necessary for refrigeration), easily disrupted and inaccessible in remote locations (e.g., supply chain limitations), or limited in their utility (e.g., transport media is sample type and organism specific, limited to a few targeted microorganisms, and generally maintains viable organisms for ≈48 hours at 25℃. Thus, samples that are critical for identifying emerging pathogenic microorganisms but collected in remote, austere, or contested locations are often degraded and unusable once they reach a field-forward or state-side (continental United States) lab, inhibiting further sample and microorganism characterization.

AMPHORA seeks to develop a cold chain free system that begins to tackle universal microbial preservation by generating systems that preserve BSL-2 microorganisms, to include fungi, bacteria, and viruses, and maintains field sample microorganism diversity in extreme environments (e.g., arctic, desert, and the tropics).

1.2. TECHNICAL APPROACH AND PROGRAM STRUCTURE

AMPHORA aims to develop field portable microbial preservation systems via two 18-month Phases for a total program lifespan of 36 months (3 years). Technical approaches of interest include, but are not limited to: (a) physical protection from the environment, e.g., artificial or natural matrices, novel materials, encapsulation, etc.; (b) alteration of the sample environment, e.g., chemical and biological supplementation, atmospheric changes, chelators, etc.; (c) techniques leveraging the environment e.g., biofilms, cocoons, etc.; (d) or techniques removing or separating microorganisms from the environment and/or each other, e.g., microfluidics, filtration, etc. Technical approaches may include a combination of the aforementioned methods or others. Approaches that are not human portable and/or rely on portable lyophilization, micro-coolers, and reagents that require refrigeration in the field will be considered non-conforming and may be rejected without further review.

Phase I will focus on technology development and benchtop demonstrations, culminating in Independent Verification and Validation (IV&V) testing followed by an end of Phase down-select. Phase II will focus on prototype system integration, increased IV&V sample complexity, preservation time, and number of microorganisms to be preserved. Additionally, Phase II performers will develop a portable prototype and demonstrate functionality on real-world samples acquired from a US government (USG) partner(s) identified by performers at the end of Phase I. We encourage performers to identify Phase II USG partners that are distinct from those performing IV&V to enable unbiased system adjudication. While DARPA will help facilitate conversations between performers and USG partners/stakeholders that can provide real-world samples for end of Phase II demonstrations, DARPA will not directly pair/match performer/USG teams. Phase II teaming partners should not be declared during the initial proposal phase. For more information, please see Section 1.5.2. Transition strategies should be implemented at the start of the Phase II for successful technology transition and use at the end of the program.

Government-furnished Property/Equipment/Information:

To support research and development in Phase I and Phase II, DARPA IV&V partners will supply performer(s) with contrived samples of increasing matrix and organism complexity.

Samples provided throughout the program will be used to inform and validate AMPHORA preservation systems. To enable sample transfer, IV&V teams will prepare Material Transfer Agreements (MTAs) with performers for contrived sample transfer. Selected performer and IV&V teams should facilitate rapid negotiation and signing of approvals to prevent programmatic delays.

To support research and development in the Phase II USG partners will supply performer(s) with field samples (environmental or clinical) for system evaluation. Samples are meant to inform and validate AMPHORA preservation methods and system design. At the beginning of Phase II, selected Phase II Option performers and USG partners should work together to generate any agreements needed for sample transfer.

1.3. PROGRAM METRICS, MILESTONES, AND DELIVERABLES

Progress toward AMPHORA’s goal will be determined through the use of regular milestones, metrics, and deliverables. The Government specifies the following minimally-required milestones, metrics, and deliverables to bound the effort while still affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated problems. Proposers are expected to define additional quantitative and qualitative success criteria as needed.

Proposers must clearly itemize tasks needed to accomplish planned milestones and deliverables.

AMPHORA will evaluate progress using system-level metrics, milestones, and demonstrations against a range of microorganisms, sample types (see Table 2 for details), and environments.

Proposals must be written to address all metrics and milestones below as well as additional proposer defined metrics and milestones as necessary. Tests and demonstrations will be subject to key metrics, as outlined in Table 1. Phase-level metrics will be evaluated at the end of each Phase by IV&V testing. All abstracts and proposals must address ALL BSL-2 pathogens outlined in Appendix A, and provide a path towards a field portable prototype; those that do not will be considered non-conforming and may be rejected without further review. The minimum milestones and metrics for each technical area and phase are outlined below. Proposers must explain quantitative success criteria for each milestone and provide information on how these will be achieved in their Statement of Work (SOW). Proposers are also encouraged to identify metrics beyond the minimum defined below and shown in Table 1. Due to rapid time-lines and expedited research, such additional metrics and milestones will enable proposal specific technology development to be tracked and measured in a way that suits the specific technology.

Phase I (Months 1 through 18) Phase I demonstrations will show system functionality with increasing sample type complexity (Table 2) and number of organisms (Appendix A). IV&V samples will simulate an increasing number of environmental conditions (Table 3). Benchtop systems will demonstrate preservation of 60% (month 9) and 86% (month 16) of all BSL-2 organisms (Appendix A) with organism defined as a representative species from each genera/group. Preservation metrics are defined in Table 1 below. Proposers should justify system use in extreme environments (Table 3); however, for purposes of IV&V sample processing during Phase I, samples may be processed at room temperature; however, subsequent preservation and storage must be within extreme temperatures as outlined in Table 3. Additionally, because shipping/receiving BSL-2 samples requires shipment manifests, proposers will need to plan for effective blinding to IV&V samples upon receipt (e.g., enlist someone to receive the sample that will neither be involved with the evaluation nor be at risk of divulging what the sample contains). Additionally, proposers will need to outline how samples will be triaged for downstream viability assessment post sample preservation. Organism identification must be performed after samples are preserved. At month 17, prototype designs will be reviewed and transition plans assessed for Phase II implementation.

Submitted design(s) must demonstrate scalability (≥50 samples can be processed simultaneously), fieldability (no cold chain requirements) & portability (easily transported by one operator), and compliance with International Air Transport Association (IATA) Infectious Substances Shipping Regulations (ISSR). Transition plans should include strategies for technology and prototype hardening, prototype production, and generating appropriate manuals and/or tutorials for transition partner technology adoption after programmatic end, as described in Section 1.5.2. A performer down-select is anticipated at the end of Phase I, as described in Section 5.3. Additional Phase I metrics are described in more detail below.

Phase I Milestones and Metrics Month 3: Acquire relevant BSL-2 microorganisms (Appendix A) and demonstrate baseline ability to grow and assess microorganism viability with the throughput and speed necessary to support downstream preservation metric assessment.

Month 6: Demonstrate 25% of BSL-2 bacteria, fungi AND viruses (Appendix A) can be viably preserved and retrieved in ≤ 1 hour from ≥1 sample type (Table 2), benchtop.

Benchtop demonstrations do not need to have fully integrated parts. Bread-board technology, test-tube reactions, manual manipulation that may be automated later, etc., are all acceptable for benchtop demonstrations. Benchtop demonstrations, however, must support the feasibility of system(s) integration and prototype generation during Phase II.

o Preservation as defined by ≤ 2-log loss after 3 days in one Phase I CONOPS specific environment (Table 3)

Month 9: Demonstrate 60% of BSL-2 bacteria, fungi AND viruses can be viably preserved and retrieved in ≤ 1 hour from ≥1 contrived IV&V sample type (Table 2), benchtop o Preservation as defined by ≤ 2-log loss after 1 week in one Phase I CONOPS specific environments (Table 3)

Month 13: Demonstrate 60% of BSL-2 bacteria, fungi AND viruses can be viably preserved and retrieved in ≤ 1 hour from ≥2 sample types (Table 2), benchtop.

o Preservation as defined by ≤ 2-log loss after 1 week in two Phase I CONOPS specific environments (Table 3)

Month 16: Demonstrate 86% of BSL-2 organisms (Appendix A) can be viably preserved in ≤ 20 minutes with ≤ 5 operator steps from ≥3 contrived IV&V sample types (Table 2).

Operator steps include number of manual manipulations the user/operator will need to perform once a collected sample is in hand. For example, if all steps happen on chip, but the operator needs to load a portion of the sample on chip, that would be considered ONE operator step. If operators are required to do multiple pipetting steps, each step, spin, etc., will be individually counted. Sample collection is not included in number of operator steps.

o Preservation: ≤ 2-log loss after 2 weeks in all four Phase I CONOPS specific environment (Table 3) o Retrieval: Organisms must be retrieved in ≤ 1 hour Month 16: Demonstrate complex sample diversity can be preserved, as defined by maintenance of ≥80% diversity (alpha, beta, or another comparable metric) of all microorganisms from the IV&V contrived wastewater sample as well as maintain microorganism viability of added (spiked-in) microorganisms after 2 weeks.

Month 18: Identify USG teaming partner who will provide real world samples in Phase

II.

Phase II Option (Months 19 through 36)

During Phase II, performers will secure the necessary agreements for effective Phase II teaming with USG partners who can provide real world samples (month 21). Prototype systems must demonstrate preservation of 95% of all BSL-2 pathogen types from IV&V provided simulated samples, to include simulated soil and permafrost (Table 2; month 33). Phase II preservation is defined below in Table 1. Similar to Phase I, proposers should justify system use in extreme environments (Table 3); however, for purposes of IV&V sample processing during Phase II, samples may be processed at room temperature; however, subsequent preservation and storage must be within extreme temperatures as outlined in Table 3. Additionally, blinding to IV&V samples should continue. Proposers may employ similar triaging methods for downstream viability assessment post sample preservation; however, organism identification must be performed after samples have been preserved. Performers must also demonstrate that prototypes can process ≥50 samples simultaneously in at least one proposer chosen Concept of Operations (CONOPS) simulated environment (month 30) as outlined in Table 3 (Arctic, Desert, or Tropics). Final Phase II prototype system demonstrations (month 36) will show microbial preservation of USG partner sample(s) as defined by maintaining ≥ 95% -diversity, or similar, for ≥ 2 months in transition partner simulated environment (Table 1). Transition strategies should be fully implemented for technology hardening and support (Section 1.5.2).

Phase II Milestones and Metrics Month 21: Acquire relevant agreements for transition partner sample sharing.

Month 24: Demonstrate real-world sample can be viably preserved and retrieved in ≤ 1 hour, benchtop.

o Preservation as defined by ≤ 2-log microorganism viability loss after 2 weeks of spiked in microorganism controls in one Phase II CONOPS specific environment (Table 3) and 80% microbial diversity of complex samples is maintained.

Month 27: Demonstrate prototype scalability (≥ 50 samples preserved simultaneously) Month 30: Demonstrate ≥95% of BSL-2 organisms from IV&V provided blood and wipes and ≥95% sample diversity (wastewater, soil, permafrost) can be preserved in ≤ 10 minutes with ≤ 2 operator steps from all sample types (Table 2) using the prototype.

o Preservation: ≤ 1-log loss after 2 months in one Phase II CONOPS specific environment (Table 3). Diversity measured by alpha, beta, or another comparable metric.

o Retrieval: Organisms must be retrieved in ≤ 20 minutes.

Month 36: Demonstrate transition partner sample diversity can be preserved using prototype, as defined by maintaining ≥95% diversity (alpha, beta, or another comparable metric) in ≤ 10 minutes with ≤ 2 operator steps.

o Preservation: ≤ 1-log loss of spiked in microorganism(s) after 2 months in one Phase II CONOPS specific environment (Table 3).

Month 36: Demonstrate transition partner (real-world) samples can preserve a spiked in, known BSL-2 organism in ≤ 10 minutes with ≤ 2 operator steps.

o Preservation: ≤ 1-log loss of spiked in microorganism(s) after 2 months in one Phase II CONOPS specific environment (Table 3)

Table 1: Major AMPHORA metrics to be tested, by milestone and phase

*Organism defined here as a representative species from each genera/group as provided in Appendix A **One cycle defined as 1 full temperature and humidity swing in 24 hours

Organisms* Sample Type(s)

Viability Diversity CONOPS Environments See Table 3 below

Rapid Preservation

Retrieval System used

Month 6 25% of all

BSL-2

organisms

≥ 1 sample type

≤ 2-log loss for ≥ 3 days

N/A ≥ 1 Phase I environment

<1 hr to complete

<1 hr to retrieve 50%

Benchtop

Month 9 60% of all

BSL-2

organisms

≥1 IV&V

provided sample type

≤ 2-log loss for ≥ 7 days

N/A ≥ 2 Phase I environments

<1 hr to complete

<1 hr to retrieve 50%

Benchtop

Month 13 60% of all

BSL-2

organisms

≥ 2 sample types

≤ 2-log loss for ≥ 7 days

N/A ≥ 2 Phase I environments

<30 min to complete

<1 hr to retrieve 50%

Benchtop

Phase I

Month 16 86% of all

BSL-2

organisms

≥ 3 IV&V

provided sample types

≤ 2-log loss for ≥ 2 wks

≥ 80% diversity (from wastewater sample)

All Phase I environments

< 20 min & ≤ 5 operator steps to complete

≤ 1 hr to retrieve 50%

Benchtop

Month 24 N/A Real world sample

≤ 2-log loss at ≥ 2 wks

≥ 80% diversity ≥ 1 Phase II environment for ≥1 cycle**

<1 hr to complete

<1 hr to retrieve 75%

Prototype

Month 30 ≥95% of all

BSL-2

organisms

All ≥ 5

IV&V

provided sample types

≤ 1-log loss at ≥ 1 months

≥ 95% diversity (e.g., permafrost, soil, wastewater)

≥ 1 Phase II environment for ≥2 cycles**

<20 min ≤ 2 operator steps

<30 min to retrieve 75%

Prototype

Month 33 ≥95% of all

BSL-2

organisms

All ≥ 5

IV&V

provided sample types

≤ 1-log loss at ≥ 2 months

≥ 95% diversity (e.g., permafrost, soil, wastewater)

≥ 1 Phase II environment for ≥3 cycles**

< 10 min ≤ 2 operator steps

<15 min to retrieve 90%

Prototype

Phase

II

Month 36 Transition partner-provided organisms

USG-

provided real-world sample

≤ 1-log loss at ≥ 2 months

≥ 95% diversity (e.g., permafrost, soil, wastewater)

≥ 1 Phase II environment for ≥3 cycles**

< 10 min ≤ 2 operator steps

≤ 15 min to retrieve 90%

Prototype

Table 2: AMPHORA Sample Types

Table 3: AMPHORA CONOPS Environments Phase I Phase II

-20C at 50% humidity Arctic:

-50C+20C 20-95% humidity

-20C at 95% humidity Desert:

10C+65C 0-70% humidity

+20C at 50% humidity Tropics:

10C+65C 50-95% humidity

+20C at 95% humidity

Programmatic Deliverables

All products – material and otherwise – to be provided to the Government as outcomes from conducted research should be defined in the proposal. Performers need to allot time and budget to fulfill obligations for travel to review meetings and the transmission of report documentation.

End of Phase reports: One month prior to the end of Phase I (month 17), performers must draft and present to DARPA a written report of all research activities and metrics satisfied. This report will contain all relevant supporting data.

Monthly financial reports: Performers are required to provide financial status updates. The prime Performer shall include information for itself and all subawardees/subcontractors. These reports shall be in the form of an editable Microsoft (MS) ExcelTM file and shall provide financial data including, but not limited to:

Program spend plan by Phase and task Incurred program expenditures to date by Phase and task Invoiced program expenditures to date by Phase and task

Month 6 & 9 ≥ 1 sample type: Swipes/Wipes, Blood, or Wastewater

Month 15 ≥ 2 sample types: Swipes/Wipes, Blood, or WastewaterPhase I

Month 17 ≥ 3 sample types: Swipes/Wipes, Blood, and Wastewater

Month 30 & 33 ≥ 5 sample types: Swipes/Wipes, Blood, Wastewater, Soil, and PermafrostPhase II

Month 36 USG partner, real-world samples

Monthly technical progress reports: Performers are required to provide monthly research updates in the form of a standardized slide presentation given to DARPA and discussed with the program management team via teleconference. Length and level of detail is at the discretion of the Program Manager.

Quarterly technical progress reports: Performers are required to provide quarterly research updates in the form of a written report describing all research activities and metrics achieved during the quarter. Length and level of detail are at the discretion of the Program Manager.

Independent Verification and Validation (IV&V) Reports: Proposers should plan to receive simulated samples from the IV&V team for preservation within proposed systems (benchtop/bread-board, Phase I; Prototype, Phase II). Sample receipt should be coordinated with IV&V and samples should be processed upon arrival. Proposers must provide a summary of at least the following to IV&V partners and DARPA: what organisms were preserved in each sample, pre and post preservation viability assessment, and time to extraction. Summaries should be supplied to IV&V teams and DARPA no later than 1 week post sample viability assessment (e.g., IV&V reports will be expected for samples assessed for viability after ≥2 months at 2 months + 1 week) unless otherwise specified. Proposers will need to outline how samples will be triaged for downstream viability assessment; however, organism identification must be performed after samples are preserved. Proposers should be prepared to discuss results with the program management team and IV&V team via teleconference. Length and level of detail is at the discretion of the Program Manager.

Mid-Phase and End of Phase reviews: Leadership from each performer team (with additional key personnel at the discretion of the PI) will be required to present research progress in person at program review meetings. The purpose of these reviews is to ensure adequate engagement with the DARPA team to discuss details that might otherwise fall outside the scope of a routine technical brief; progress towards milestones and scientific goals; and any ongoing technical or programmatic challenges that must be overcome to achieve the overarching program goals.

Final Program Report: When the final funding Phase closes out, performer teams must provide a final report summarizing all research activities, outcomes, and molecular mechanisms discovered during the program; publications, research presentations, patent applications that result from the research pursued; and any additional deliverables requested by the contracting agent for this program.

Prototype Design: One month prior to the end of Phase I (month 17), performers must present to DARPA their system design to move from benchtop validation to field-portable prototype.

Design must address, at a minimum: requirements pertaining to: form factor, sample processing and associated material(s)/reagent(s) and power. Designs with lesser size, weight, and power, and those requiring fewer material(s)/reagents(s) may be viewed more favorably versus alternate designs.

Transition Plan: One month prior to the end of Phase I (month 17), performers must present to DARPA a detailed transition plan for their technology and prototype system. This transition plan must include, at a minimum: identified stakeholders that would benefit from transitioning the technology including at least one that has agreed to support Phase II prototype development, real-world sample sharing, and testing; commercial/industry support and capabilities to scale-up/produce prototype; associated material(s)/reagent(s) necessary for continued system operations; technical support and training of government operators.

Final Prototype: By completion of Phase II Option (month 36), performers must deliver their completed prototype to DARPA or alternate government entity, as determined by DARPA.

Prototype deliverable shall include, at a minimum: the physical prototype; a detailed operations manual and/or digital training videos sufficient for government technicians to operate the system;

material(s)/reagent(s) for 100 samples; and executables with source code for any prototype associated software.

1.4. DEMONSTRATIONS AND INDEPENDENT VERIFICATION & VALIDATION

TESTING (IV&V)

There will be five demonstrations or test events over the course of the program. These events will be either run by the performer or by the IV&V agent, as outlined below. For more information regarding IV&V sample reporting, please see Section 1.3 – Programmatic Deliverables.

Phase I Base:

Implement Material Transfer Agreements (MTAs) with performers and have appropriate documentation in place to send contrived samples to performers for IV&V testing (month 6)

Provide simulated samples to performers as mutually agreed upon by DARPA and IV&V team. Evaluate performer systems against associated metrics/milestones (month 9)

Provide simulated samples to performers as mutually agreed upon by DARPA and IV&V team. Evaluate performer systems against associated metrics/milestones (month 16)

Phase II Option:

Provide simulated samples to performers as mutually agreed upon by DARPA and IV&V team. Evaluate performer systems against associated metrics/milestones (month 30) Provide simulated samples to performers as mutually agreed upon by DARPA and IV&V team. Evaluate performer systems against associated metrics/milestones (month 33)

1.5. GENERAL REQUIREMENTS

1.5.1. Proposing Teams

It is expected that proposals will involve teams that have the expertise needed to achieve the goals of the entire program. Specific content, communications, networking, and team formation are the sole responsibility of the proposer teams. Proposer teams must submit a single, integrated proposal led by a Principal Investigator (PI), under a single prime contractor that addresses all program Phases, as applicable.

DARPA will hold a Proposers Day (see Section 8.1, Proposers Day) to facilitate the formation of proposer teams and enable sharing of information among interested proposers through the DARPA Opportunities Page and the Proposers Day registration website.

1.5.2. USG Teaming and Technology Transition Strategy

Phase I: While DARPA will help facilitate performer interactions with potential Phase II USG teaming partners and/or other transition partners via program reviews, etc., performers should anticipate continued interaction and engagement with potential teaming and/or transition partners outside of DARPA events, to include, for example, additional tech demonstrations, follow-on meetings, etc. While DARPA will help facilitate conversations between performers and USG partners/stakeholders, DARPA will not directly pair/match performer/USG teams. Additionally, Phase II teaming with USG partners outside of IV&V is preferred. Phase II teaming partners should not be declared during the initial proposal phase, but by the end of Phase I. As mentioned in Section 1.2, performers must identify a US government (USG) partner by the end of Phase I (month 18) that will provide the performer team with real-world samples for final Phase II prototype demonstrations, with agreements put in place by month 21. Performers will submit a Transition Plan at month 17 to include plans for potential transition partner technical support after programmatic end and how the system will be supplied and supported (system and material fabrication/production) for continued transition partner use.

Phase II:

The performer will directly interact with their USG teaming partner, along with other USG stakeholder organizations, for prototype refinement, system training, and real-world sample processing. The USG teaming partner and performer must have the appropriate agreements in place by month 21 to enable sample sharing in months 24 and 36 USG partners should demonstrate the ability for successful technology acquisition and use after programmatic end;

however, teaming partners do not need to be the sole transition partner. Transition plans will commence at or near the beginning of Phase II, including: training, ‘tech support,’ and system manufacturing. Performers must plan to directly transition technology to either the USG teaming partner or to other interested stakeholders and transition partners at the end of Phase II, as determined jointly between DARPA, the performer, and stakeholder organizations.

1.5.3. Permits and Compliance

It is the proposing team’s responsibility to obtain all necessary federal, state, and local government permits and approvals, and abide by all applicable laws where necessary for the proposed work to be conducted.

1.5.4. Other Requirements

Performers are expected to attend semi-annual program reviews to provide updates to the DARPA program management team and other AMPHORA performers on progress towards their milestones and scientific goals on the AMPHORA program. Performers will also summarize outstanding challenges and limitations that must still be overcome to achieve the overarching goals of the program.

2. Award Information

2.1. GENERAL AWARD INFORMATION

Multiple awards are possible. The amount of resources made available under this BAA will depend on the quality of the proposals received and the availability of funds.

The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this solicitation and to make awards without discussions with proposers. The Government also reserves the right to conduct discussions if it is later determined to be necessary. If warranted, portions of resulting awards may be segregated into pre-priced options. Additionally, DARPA reserves the right to accept proposals in their entirety or to select only portions of proposals for award. In the event that DARPA desires to award only portions of a proposal, negotiations may be opened with that proposer. The Government reserves the right to fund proposals in phases with options for continued work, as applicable.

The Government reserves the right to request any additional, necessary documentation once it makes the award instrument determination. Such additional information may include but is not limited to Representations and Certifications (see Section VI.B.2., “Representations and Certifications”). The Government reserves the right to remove proposers from award consideration should the parties fail to reach agreement on award terms, conditions, and/or cost/price within a reasonable time, and the proposer fails to timely provide requested additional information. Proposals identified for negotiation may result in a procurement contract, cooperative agreement, or other transaction, depending upon the nature of the work proposed, the required degree of interaction between parties, whether or not the research is classified as Fundamental Research, and other factors.

Proposers looking for innovative, commercial-like contractual arrangements are encouraged to consider requesting Other Transactions. To understand the flexibility and options associated with Other Transactions, consult http://www.darpa.mil/work-with-us/contract-management#OtherTransactions.

In accordance with 10 U.S.C. § 4022(f), the Government may award a follow-on production contract or Other Transaction (OT) for any OT awarded under this solicitation if: (1) that participant in the OT, or a recognized successor in interest to the OT, successfully completed the entire prototype project provided for in the OT, as modified; and (2) the OT provides for the award of a follow-on production contract or OT to the participant, or a recognized successor in interest to the OT.

In all cases, the Government contracting officer shall have sole discretion to select award instrument type, regardless of instrument type proposed, and to negotiate all instrument terms and conditions with selectees. DARPA will apply publication or other restrictions, as necessary, if it determines that the research resulting from the proposed effort will present a high likelihood of disclosing performance characteristics of military systems or manufacturing technologies that are unique and critical to defense. Any award resulting from such a determination will include a requirement for DARPA permission before publishing any information or results on the program. For more information on publication restrictions, see the section below on Fundamental Research http://www.darpa.mil/work-with-us/contract-management#OtherTransactions

2.2. FUNDAMENTAL RESEARCH

It is DoD policy that the publication of products of fundamental research will remain unrestricted to the maximum extent possible. National Security Decision Directive (NSDD) 189 defines fundamental research as follows:

‘Fundamental research’ means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons.

As of the date of publication of this solicitation, the Government expects that program goals as described herein may be met by proposers intending to perform fundamental research and does not anticipate applying publication restrictions of any kind to individual awards for fundamental research that may result from this solicitation. Notwithstanding this statement of expectation, the Government is not prohibited from considering and selecting research proposals that, while perhaps not qualifying as fundamental research under the foregoing definition, still meet the solicitation criteria for submissions. If proposals are selected for award that offer other than a fundamental research solution, the Government will either work with the proposer to modify the proposed statement of work to bring the research back into line with fundamental research or else the proposer will agree to restrictions in order to receive an award.

University or non-profit research institution performance under this solicitation will include effort categorized as fundamental research. In addition to Government support for free and open scientific exchanges and dissemination of research results in a broad and unrestricted manner, the academic or non-profit research performer or recipient, regardless of tier, acknowledges that such research may have implications that are important to U.S. national interests and must be protected against foreign influence and exploitation. As such, the academic or non-profit research performer or recipient agrees to comply with the following requirements:

(a) The University or non-profit research institution performer or recipient must establish and maintain an internal process or procedure to address foreign talent programs, conflicts of commitment, conflicts of interest, and research integrity. The academic or non-profit research performer or recipient must also utilize due diligence to identify Foreign Components or participation by Senior/Key Personnel in Foreign Government Talent Recruitment Programs and agree to share such information with the Government upon request.

i. The above described information will be provided to the Government as part of the proposal response to the solicitation and will be reviewed and assessed prior to award. Generally, this information will be included in the Research and Related Senior/Key Personnel Profile (Expanded) form (SF-424) required as part the proposer’s submission through Grants.gov.

1. Instructions regarding how to fill out the SF-424 and its biographical sketch can be found through Grants.gov.

ii. In accordance with USD(R&E) direction to mitigate undue foreign influence in DoD-funded science and technology, DARPA will assess all Senior/Key Personnel proposed to support DARPA grants and cooperative agreements for potential undue foreign influence risk factors relating to professional and financial activities. This will be done by evaluating information provided via the SF-424, and any accompanying or referenced documents, in order to identify and assess any associations or affiliations the Senior/Key Personnel may have with foreign strategic competitors or countries that have a history of intellectual property theft, research misconduct, or history of targeting U.S. technology for unauthorized transfer. DARPA’s evaluation takes into consideration the entirety of the Senior/Key Personnel’s SF-424, current and pending support, and biographical sketch, placing the most weight on the Senior/Key Person’s professional and financial activities over the last 4 years. The majority of foreign entities lists used to make these determinations are publicly available. The DARPA Countering Foreign Influence Program (CFIP) “Senior/Key Personnel Foreign Influence Risk Rubric” details the various risk ratings and factors. The rubric can be seen at the following link:

https://www.darpa.mil/attachments/092021DARPACFIPRubric.pdf

iii. Examples of lists that DARPA leverages to assess potential undue foreign influence factors include, but are not limited to:

1. Executive Order 13959 “Addressing the Threat From Securities Investments That Finance Communist Chinese Military Companies”:

https://www.govinfo.gov/content/pkg/FR-2020-11-17/pdf/2020-25459.pdf

2. The U.S. Department of Education’s College Foreign Gift and Contract Report: College Foreign Gift Reporting (ed.gov)

3. The U.S. Department of Commerce, Bureau of Industry and Security, List of Parties of Concern: https://www.bis.doc.gov/index.php/policy-guidance/lists-of-parties-of-concern

4. Georgetown University’s Center for Security and Emerging Technology (CSET) Chinese Talent Program Tracker:

https://chinatalenttracker.cset.tech

5. Director of National Intelligence (DNI) “World Wide Threat Assessment of the US Intelligence Community”: 2021 Annual Threat Assessment of the U.S. Intelligence Community (dni.gov)

6. Various Defense Counterintelligence and Security Agency (DCSA) products regarding targeting of US technologies, adversary targeting of academia, and the exploitation of academic experts: https://www.dcsa.mil/

(b) DARPA’s analysis and assessment of affiliations and associations of Senior/Key Personnel is compliant with Title VI of the Civil Rights Act of 1964. Information regarding race, color, or national origin is not collected and does not have bearing in DARPA’s assessment.

(c) University or non-profit research institutions with proposals selected for negotiation that have been assessed as having high or very high undue foreign https://www.darpa.mil/attachments/092021DARPACFIPRubric.pdf https://www.govinfo.gov/content/pkg/FR-2020-11-17/pdf/2020-25459.pdf https://sites.ed.gov/foreigngifts/ https://www.bis.doc.gov/index.php/policy-guidance/lists-of-parties-of-concern https://www.bis.doc.gov/index.php/policy-guidance/lists-of-parties-of-concern https://chinatalenttracker.cset.tech/ https://www.dni.gov/index.php/newsroom/reports-publications/reports-publications-2021/item/2204-2021-annual-threat-assessment-of-the-u-s-intelligence-community https://www.dni.gov/index.php/newsroom/reports-publications/reports-publications-2021/item/2204-2021-annual-threat-assessment-of-the-u-s-intelligence-community https://www.dcsa.mil/ influence risk, will be given an opportunity during the negotiation process to mitigate the risk. DARPA reserves the right to request any follow-up information needed to assess risk or mitigation strategies.

i. Upon conclusion of the negotiations, if DARPA determines, despite any proposed mitigation terms (e.g. mitigation plan, alternative research personnel), the participation of any Senior/Key Research Personnel still represents high risk to the program, or proposed mitigation affects the Government’s confidence in proposer’s capability to successfully complete the research (e.g., less qualified Senior/Key Research Personnel) the Government may determine not to award the proposed effort. Any decision not to award will be predicated upon reasonable disclosure of the pertinent facts and reasonable discussion of any possible alternatives while balancing program award timeline requirements.

(d) Failure of the academic or non-profit research performer or recipient to reasonably exercise due diligence to discover or ensure that neither it nor any of its Senior/Key Research Personnel involved in the subject award are participating in a Foreign Government Talent Program or have a Foreign Component with an a strategic competitor or country with a history of targeting U.S. technology for unauthorized transfer may result in the Government exercising remedies in accordance with federal law and regulation.

i. If, at any time, during performance of this research award, the academic or non-profit research performer or recipient should learn that it, its Senior/Key Research Personnel, or applicable team members or subtier performers on this award are or are believed to be participants in a Foreign Government Talent Program or have Foreign Components with a strategic competitor or country with a history of targeting U.S. technology for unauthorized transfer , the performer or recipient will notify the Government Contracting Officer or Agreements Officer within 5 business days.

1. This disclosure must include specific information as to the personnel involved and the nature of the situation and relationship. The Government will have 30 business days to review this information and conduct any necessary fact-finding or discussion with the performer or recipient.

2. The Government’s timely determination and response to this disclosure may range anywhere from acceptance, to mitigation, to termination of this award at the Government’s discretion.

3. If the University receives no response from the Government to its disclosure within 30 business days, it may presume that the Government has determined the disclosure does not represent a threat.

ii. The performer or recipient must flow down this provision to any subtier contracts or agreements involving direct participation in the performance of the research.

(e) Definitions

i. Senior/Key Research Personnel

1. This definition would include the Principal Investigator or Program/Project Director and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the award. These include individuals whose absence from the project would be expected to impact the approved scope of the project.

2. Most often, these individuals will have a doctorate or other professional degrees, although other individuals may be included within this definition on occasion.

ii. Foreign Associations/Affiliations

1. Association is defined as collaboration, coordination or interrelation, professionally or personally, with a foreign government-connected entity where no direct monetary or non-monetary reward is involved.

2. Affiliation is defined as collaboration, coordination, or interrelation, professionally or personally, with a foreign government-connected entity where direct monetary or non-monetary reward is involved.

iii. Foreign Government Talent Recruitment Programs

1. In general, these programs will include any foreign-state-sponsored attempt to acquire U.S. scientific-funded research or technology through foreign government-run or funded recruitment programs that target scientists, engineers, academics, researchers, and entrepreneurs of all nationalities working and educated in the U.S.

2. Distinguishing features of a Foreign Government Talent Recruitment Program may include:

a. Compensation, either monetary or in-kind, provided by the foreign state to the targeted individual in exchange for the individual transferring their knowledge and expertise to the foreign country.

b. In-kind compensation may include honorific titles, career advancement opportunities, promised future compensation or other types of remuneration or compensation.

c. Recruitment, in this context, refers to the foreign-state-sponsor’s active engagement in attracting the targeted individual to join the foreign-sponsored program and transfer their knowledge and expertise to the foreign state. The targeted individual may be employed and located in the U.S. or in the foreign state.

d. Contracts for participation in some programs that create conflicts of commitment and/or conflicts of interest for researchers. These contracts include, but are not limited to, requirements to attribute awards, patents, and projects to the foreign institution, even if conducted under U.S. funding, to recruit or train other talent recruitment plan members, circumventing merit-based processes, and to replicate or transfer U.S.-funded work in another country.

e. Many, but not all, of these programs aim to incentivize the targeted individual to physically relocate to the foreign state. Of particular concern are those programs that allow for continued employment at U.S. research facilities or receipt of U.S. Government research funding while concurrently receiving compensation from the foreign state.

3. Foreign Government Talent Recruitment Programs DO NOT include:

a. Research agreements between the University and a foreign entity, unless that agreement includes provisions that create situations of concern addressed elsewhere in this section,

b. Agreements for the provision of goods or services by commercial vendors, or

c. Invitations to attend or present at conferences.

iv. Conflict of Interest

1. A situation in which an individual, or the individual’s spouse or dependent children, has a financial interest or financial relationship that could directly and significantly affect the design, conduct, reporting, or funding of research.

v. Conflict of Commitment

1. A situation in which an individual accepts or incurs conflicting obligations between or among multiple employers or other entities.

2. Common conflicts of commitment involve conflicting commitments of time and effort, including obligations to dedicate time in excess of institutional or funding agency policies or commitments. Other types of conflicting obligations, including obligations to improperly share information with, or withhold information from, an employer or funding agency, can also threaten research security and integrity and are an element of a broader concept of conflicts of commitment.

vi. Foreign Component

1. Performance of any significant scientific element or segment of a program or project outside of the U.S., either by the University…