HR001117S0002.pdf

Broad Agency Announcement Insect Allies

BIOLOGICAL TECHNOLOGIES OFFICE

HR001117S0002

November 1, 2016

HR001117S0002, Insect Allies

TABLE OF CONTENTS

PART I: OVERVIEW INFORMATION

PART II: FULL TEXT OF ANNOUNCEMENT

1. Funding Opportunity Description

1.1. PROGRAM OVERVIEW

1.2. PROGRAM STRUCTURE

1.3. PROGRAM OBJECTIVES

1.4. PROGRAM MILESTONES and DELIVERABLES

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. CONTENT AND FORM OF APPLICATION SUBMISSION

4.3. FUNDING RESTRICTIONS

5. Application Review Information

5.1. EVALUATION CRITERIA

5.2. REVIEW OF PROPOSALS

6. Award Administration Information

6.1. SELECTION NOTICES

6.2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

6.3. REPORTING

6.4. ELECTRONIC SYSTEMS

7. Agency Contacts

8. Other Information

9. APPENDIX 1 – Volume II checklist and sample templates

PART I: OVERVIEW INFORMATION

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

Funding Opportunity Title – Insect Allies Announcement Type – Initial Announcement Funding Opportunity Number – HR001117S0002 Catalog of Federal Domestic Assistance Numbers (CFDA) – 12.910 Research and

Technology Development Dates o Posting Date – November 1, 2016 o Proposal Abstract Due Date – December 6, 2016 o Proposal Due Date/BAA Closing Date – January 17, 2017 o Any other relevant date(s) – Proposers Day, November 18, 2016 https://fbo.gov/spg/ODA/DARPA/CMO/DARPA-SN-16-73/listing.html

Concise description of the funding opportunity: The Insect Allies program will develop a platform technology for delivering enhanced crop traits within a single growing season by delivering a modified virus to target plants by a mobile insect vector.

Anticipated individual awards - Multiple awards are anticipated.

Types of instruments that may be awarded - Procurement contract, cooperative agreement, or other transaction.

Agency contact o Points of Contact The BAA Coordinator for this effort may be reached at:

InsectAllies@darpa.mil

DARPA/BTO

ATTN: HR001117S0002

675 North Randolph Street Arlington, VA 22203-2114 https://fbo.gov/spg/ODA/DARPA/CMO/DARPA-SN-16-73/listing.html mailto:InsectAllies@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.

Defense Advanced Research Projects Agency (DARPA) is soliciting innovative research proposals that enable expression of crop traits within a single growing season at scale by delivering a modified virus to target plants by a mobile insect vector; thereby addressing national security challenges in agriculture domestically and abroad. Respondents to this BAA must propose novel approaches to modify an insect-transmitted virus to confer traits to a crop of agricultural value by means of a host-specific vector.

1.1. PROGRAM OVERVIEW

Agricultural food production is a fundamental human activity that contributes to defense preparedness, societal stability, and economic vitality. While traditional plant breeding and genetic modification have been successful at increasing yield, all crop development pipelines currently in use are constrained by common plant life history bottlenecks, including growth and reproduction. As a result, existing crop enhancement technologies require decades of development. This timeline is not sufficient to respond to future agricultural challenges as they are occurring; therefore, a new rapid and highly-specific crop-development solution is needed.

New tools for targeted gene editing (e.g., the CRISPR/Cas9 system) already allow swift adult plant transformation in the laboratory; however, the size of crop fields presents a major challenge for delivery of these technologies at scale. Overhead sprays, currently the most straightforward dispersal platform in agriculture, are unable to support large scale delivery of plant transformation technology as they require both water and irrigation infrastructure—resources that are not always present—and have loss rates that would preclude their sustained use in the delivery of relatively high cost biologics. An alternative approach to the delivery problem can be found in mobile insects that specifically associate with the target plant species and could efficiently deliver the genetic alteration agent.

Plant viruses hold significant promise as carriers of gene editing circuitry and are a natural partner for an insect-transmitted delivery platform. Viral mechanisms have already been used to investigate and modify plant phenotypes—for example, virus-induced gene silencing (VIGS) technique for impeding plant gene expression—and most (> 70%) of the > 1000 known viruses affecting plants in their mature states are naturally transmitted by insects. By leveraging the natural ability of insect vectors to deliver viruses with high host plant specificity, and combining this capability with advances in gene editing, rapid enhancement of mature plants in the field can be achieved over large areas and without the need for industrial infrastructure.

1.2. PROGRAM STRUCTURE

Insect Allies will encompass a four year effort organized into three consecutive phases (Table 1) lasting 12, 18, and 18 months, respectively. During Phase 1, performer teams will demonstrate successful delivery of a transgene to individual plants via an insect-mediated virus, and the subsequent expression of that transgene within the plant. Phase 2 will focus on modification of the components of the delivery platform (virus, insect, and plant) for improved transmission and expression of genetic material, so as to provide a robust and controllable system that can be scaled within a closed monoculture inside a greenhouse. During Phase 3, alteration of plant traits will be developed, likely using a multiple gene approach. In Phase 3, the transfer and expression of genes, resulting in the target plant’s gain of function, will be demonstrated in contained complex environments with multiple plant species present where only target plants are modified.

Intermediate and end-of-phase milestones as well as a demonstration (see Table 1) will be included in each phase to evaluate progress throughout the program.

The Insect Allies program consists of three Technical Areas (TAs) to be addressed concurrently.

Proposers must address all three TAs and must meet key milestones throughout the period of performance.

• TA1: Engineered plant virus (“Virus”)

• TA2: Viral delivery by insect vector (“Insect”)

• TA3: Rapid mature plant transformation (“Plant”)

A high-level overview of the structure of the Insect Allies program that highlights relationships between the three Technical Areas and gives general objectives across the three phases along with brief descriptions of the end-of-phase demonstrations is given in Table 1. A more detailed discussion of program objectives, metrics and milestones, and demonstrations is provided in Sections 1.3 and 1.4.

Table 1: Insect Allies Program Structure and Objectives – Overview

Tech Areas

Phase 1 12 Months

Phase 2 18 Months

Phase 3 18 Months

1-Virus

Select viruses specific to target crop and insect vector that can deliver a single transgene

Increase gene load and maintain stability of multiple transgenes

Deliver genes for enhanced plant trait(s) via one or more viral vectors

2-Insect

Identify and select insect vector appropriate for target crop and viruses

Reduce strain mortality, improve transmission qualities, and incorporate a single conditional lethal safeguard

Improve dispersal and host specificity for release in larger enclosure, and incorporate multi-factor conditional lethal safeguard(s)

3-Plant

Identify and select crop with established virus and insect vector interactions for transformation of mature plants

Stably transform multiple mature plants within a closed monoculture with multiple (≥3) genes

Stably transform multiple mature plants in a complex, multi-species contained community for enhanced trait(s)

End-of- Phase Demo

Demonstration One:

Phase 1 Integrated Laboratory Demo

Demonstration Two:

Phase 2 Integrated Small Greenhouse Demo

Demonstration Three:

Phase 3 Integrated Large Greenhouse Demo

1.3. PROGRAM OBJECTIVES

The Insect Allies program will develop integrated systems of modified viral agents that can be delivered to specific plants of interest via insects and can confer traits for combating biological and environmental threats. Agricultural threats of concern to the Department of Defense (DoD) include, but are not limited to, invasive pest or pathogen species, accidental or intended release of natural or engineered harmful biological agents, severe water (drought, flooding) or heat stress, and prolonged exposure to toxic compounds. Proposals aimed at addressing these issues in annual, perennial, and subsistence plant systems of high food biosecurity importance are especially encouraged. Proposers must fully describe approaches to address each of the three Technical Areas (TA) described below. Proposers must also include details about how they will complete integrated platform demonstrations at 12, 30, and 48 month intervals, as detailed below. These demonstrations are intended to assess integration across all three Technical Areas and show manipulation of viral pathology, insect fitness, and mature plant transformation.

Proposals that do not address all three Technical Areas and demonstrations will be considered non-conforming to the BAA.

Descriptions of the three Technical Areas are given below. The complete list of associated metrics, milestones, and deliverables can be found in Section 1.4.

Technical Area 1 (TA1): Engineered plant virus (Virus)

Selection, modification, and optimization of a plant virus capable of transforming individual mature plants.

Proposers must identify 5-10 virus candidates that may be carried by a competent insect vector (TA2) and can singly or together deliver the genetic material required for plant gain of function (TA3). Proposers must clearly pre-identify viruses that are candidates for the proposed work. Both currently known insect-transmitted viruses and novel viruses identified through genomic or transcriptomic analysis will be acceptable.

In Phase 1, prior to the demonstration of successful delivery of a single transgene (see Demonstrations in Section 1.4), performers must demonstrate stability of the genetically-modified plant virus (and transgene) within the plant for > 2 weeks. By Phase 2, viruses must support an increased gene load and maintain stability of multiple genes to allow for large scale multi-gene delivery, and to ultimately provide the plants’ gain of function in Phase 3. Gene regulatory elements essential to the gene delivery strategy must be indicated in all phases, whether or not a single virus strain or multi-virus with serial delivery strategy will be used. If necessary, the genetic architecture of the virus should be optimized to increase stability and maximize insect transmissibility while limiting plant virulence. It is expected that performers will establish and investigate those factors that play important roles in transmission in the chosen system – for example, protein interactions between virus/insect and virus/plant – and provide quantitative assessments that can be used to guide modification and improve transmission. Off-target effects must be assessed and minimized.

Technical Area 2 (TA2): Viral delivery by insect vector (Insect)

Selection, modification, and optimization of an insect vector capable of infecting a target mature plant.

Proposers must identify and use insect vectors to deliver modified viruses (TA1) to target plants.

Insect characteristics that play a role in viral delivery and that can be modified to improve delivery (as needed) must be identified; these characteristics include, but are not limited to, insect survival, longevity, dispersal ability, pathogen vulnerability, and plant feeding behavior.

Proposers may include additional metrics specific to their chosen system, as appropriate, to demonstrate effective virus delivery. (For example, if a sap sucking insect is proposed, stylet performance and physical changes with virus-insect tissue association should also be examined.)

Proposers are encouraged to identify and select insect vectors that are especially robust to the challenge of efficient viral transmission, and may propose methods to increase vector competency (e.g., microbiome manipulation). Dispersal behavior will be integral to successful vector design and will be assessed as part of the evaluation in Phase 3; specifically, insects should cover and feed on 50% of the target plants within a defined space in less than 48 hours with a level of feeding on non-target plants that does not sustain viral transmission.

Insect vector species must be amenable to being produced in large enough numbers to be released into large greenhouses that serve as a simulated field environments. Proposers should detail plans, permits, equipment, and facilities available and/or needed for contained/caged insect rearing (e.g., environmental chambers and greenhouse facilities).

Insect vectors must also have integrated conditional lethal safeguard(s) to demonstrate the capacity to manage insect populations that are released into a controlled environment.

Effectiveness of conditional lethal systems must be quantitatively assessed and must be used as part of the greenhouse demonstrations at the end of Phases 2 and 3. Multi-factor conditional lethal systems are required by the end of Phase 2. Innovative approaches to limiting insect survival are especially encouraged. For example, conditional lethal systems could include, but are not limited to, those triggered through antibiotic presence/absence, temperature extremes, and light presence/absence. Conditional lethal systems will be considered adequately successful with no insect survival after 2 weeks following release and no propagation of progeny.

Technical Area Three (TA3): Rapid mature plant transformation (Plant)

Performer teams must select a target crop species and identify the genes required for enhancement of traits of mature plants within a single growing season. Target crop must be an important annual, perennial, or subsistence plant. Crops of U.S. importance (including maize, wheat, potato, tree fruits, etc.), global agricultural importance (including rice, cassava, cowpea, tree fruits, etc.), and other plants of similar importance are encouraged. Proposals to work solely with model plants (e.g., Arabidopsis, Nicotiana, etc.), will not be considered responsive to this BAA. Once the target plant species is identified, performers must clearly establish, with reference to quantitatively-assessed plant characteristics, the plant growth stage that is sufficiently "mature" to allow useful (e.g., from the perspective of crop yield) benchmarks, and demonstrate successful transformation only on plants that have reached that stage.

Chosen traits(s) should reflect current or potential future major disruptions to agricultural production, such as drought, flood, excess salinity, and pathogen and pest outbreaks. The genetic basis of traits could rely on a single or multi-gene pathway alteration. Proposals should outline a scientifically justified progression from genetic modification in immature plant tissue (current state of the art) to mature plants.

For the goal of modifying multiple mature plants of the same target species, performer teams are to provide the quantitative and crop-system specific metric(s) by which success will be gauged.

Plants should display gene insertion and expression in all phases. In Phase 2 performers must demonstrate the entrance of ≥ 3 transgenes in series, in multiple mature plants in a monoculture setting. Phase 3 will be performed in a complex plant community containing ≥ 20 different plant species in order to demonstrate the species specificity of the genome modification strategy.

Transgene incorporation into non-target plant genomes must be below the limit of detection.

1.4. PROGRAM MILESTONES AND DELIVERABLES

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program objectives, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated problem.

Milestones and deliverables, with the appropriate metrics for each Technical Area are given below in Tables 1–4. Proposals should cite the specific quantitative and qualitative success criteria that the proposed effort will achieve. Proposals should define additional milestones and metrics, as well as any additional tasks needed to accomplish deliverables.

Table 2: Technical Area 1 – Engineered Plant Virus

PHASE OBJECTIVES MILESTONES METRICS

Produce a virus candidate library

Prospect viruses and provide rationale for virus choice(s)

5-10 candidate virus genomes sequenced and annotated

Propagate virus(es) Demonstrate successful virus propagation in culture

Demonstrate ability to manipulate growth in culture at significant levels

Stabilize virus within the plant

Demonstrate stability of the genetically-modified plant virus within the plant

No significant viral transgene loss for ≥ 2 weeks

Genetically modify plant virus

Quantify expression of single transgene

Significant transgene expression above control

Edit viral genome

Identify relevant promoter, terminator, spacer, and other important gene regulatory elements

Functioning viral multigene construct(s)

Deliver multi-transgene capability

Quantify expression of ≥ 3 transgenes

Significant transgene(s) expression above control

3 Deliver and express systemic transgene(s)

Quantify the presence of multiple transgenes using relative gene expression of plant tissues

Significant transgene(s) expression above control

Table 3: Technical Area 2 - Viral Delivery by Insect Vectors

PHASE OBJECTIVES MILESTONES METRICS

Domesticate and select insect strains

Demonstrate insect culturing fitness data of selected strains with significantly reduced mortality

Mortality rates < 30%

Modulate and monitor transmission capability

Demonstrate molecular characteristics of vector competency; increase viral acquisition and transmission rates

Viral acquisition rate > 75%

Transmission rate > 10%

Increase modulation of transmission capability at scale

Demonstrate molecular characteristics of vector competency; reduced mortality rates, increased transmission rates

Mortality rates < 10%

Transmission rate > 30%

Small greenhouse context (proposer defined)2

Implement single safeguard

Demonstrate elements of an effective (two-week window) single conditional lethal

Single conditional lethal (proposer defined)

No significant survival

Deliver virus community-wide

Demonstrate delivery to majority of target plants in less than 48 hours with no measurable off-target effects

> 50% target prevalence

No transgene expression in non-target plants

Large greenhouse context (proposer defined)

Implement multi-safeguard

Demonstrate elements of an effective multiple conditional lethal with no significant insect survival after 2 weeks

Multi-conditional lethal (proposer defined)

0% survival after a user defined time where 50% of non-transformed insects survive

Table 4: Technical Area 3 - Rapid Mature Plant Transformation

PHASE OBJECTIVES MILESTONES METRICS

1 Modify mature plant tissue

Quantify characteristics of mature plant tissue and transgene expression

Transgene expression 50% above control in mature tissue type

Validate modification parameters in monoculture

Quantify expression of transgenes

≥ 3 delivered transgenes expression above control

Demonstrate enhanced trait in target plants within community context

Quantify expression of transgenes with no off-target effects in community

> 50% of targeted plant population is successfully genetically modified within ≤ 1 week with no detection of off-target effects to other community organisms

DEMONSTRATIONS

All three Technical Areas are to be conducted concurrently and integrated for end-of-phase demonstrations. Demonstrations will build in complexity and scale over the course of the program. For the Phase 1 demonstration, proposers must demonstrate successful delivery of a single transgene (e.g., by expression of a reporter molecule) to a mature target plant using a single insect and modified viral strain at a laboratory scale. The Phase 2 demonstration will take place in a small greenhouse environment containing a single plant monoculture, and will require a demonstration of successful delivery of 3 genes by one or more insect-mediated viruses. The Phase 3 demonstration will take place in a large and complex greenhouse environment containing multiple plant species, and will require a demonstration of trait enhancement in the target plant species with no measurable off-target effects.

Additional details on the end-of-phase demonstrations are given below.

(i) Phase 1 demonstration (at 12 months/end of Phase 1, laboratory scale)

Proposers must demonstrate, with appropriate biological replicates, quantification and controls, successful delivery of a single transgene (e.g., by expression of a reporter molecule) to a single mature target plant using a single insect and modified viral strain. The virus should be altered to express at least a one sustainable transgene in the target plant, which will be delivered by a single insect vector. This must be performed in a small arena, as defined by the performer team to accommodate the selected crop, with a single plant and a single insect. The single plant arena experiments should be repeated to perform the required number of biological replicates. Insects are not required to demonstrate orientation or dispersal for this demonstration.

(ii) Phase 2 demonstration (at 30 months/end of Phase 2, small greenhouse scale)

Proposers must demonstrate the Insect Allies approach in a small greenhouse where the scale of the demonstration has increased from single plant experiments in the Phase 1 Demonstration to a community level experiment. Additional variables include: 1) multiple individual plants, 2) insect vectors that can disperse, and 3) a greater spatial extent (i.e. larger greenhouse). Instead of a single gene, ≥ 3 transgenes must be evident at the end of Phase 2 building towards plant modification of multi gene traits.

(iii) Phase 3 demonstration (at 48 months/end of phase 3, large greenhouse scale)

Proposers must demonstrate the use of a large number of independently mobile insects to deliver transgenes, via one or more modified viruses, to mature target plants in a large and complex greenhouse approximating the natural environment. The demonstration environment must be provided by the proposing team and described in detail; in particular, the characteristics that will allow for comparison with the natural environment. The greenhouse must contain ≥ 20 species of non-target plants and a distribution of additional non-target species of insects consistent with the natural environment being approximated. The set of additional insects must include ≥ 5 arthropod species, with at least one being a natural enemy of the chosen insect vector and another being a competitive species. Fifty percent of target plants should express at least one plant enhancing trait (chosen by the proposing team) within one week. The Phase 3 demonstration should reflect insect plant specificity and other TA-specific milestones and metrics given above.

1.5. GENERAL REQUIREMENTS

Regardless of the specific approach, proposers to the Insect Allies program must address each of the following features:

Proposing teams

It is expected that proposals will involve multidisciplinary teams that include expertise from multiple complementary disciplines (e.g., virology, vector entomology, and plant biotechnology).

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 single Program Integrator/Manager or prime contractor that addresses all program phases and TAs, as applicable.

DARPA will hold a Proposers Day (see Section 8 below) to facilitate the formation of proposer teams with the expertise necessary to meet the goals of the program and enable sharing of information among interested proposers through fbo.gov and the Proposers Day registration website.

Data Sharing

DARPA anticipates that a large amount of data will be generated under this program by each performer and that the analyses and validation will be strengthened by compiling and integrating information across all performers. Performers are strongly encouraged to establish the appropriate agreements to enable collaboration and data sharing. DARPA encourages sharing of pre-existing data including those generated through funding by other sources, although this is not a requirement of the program.

Biocontainment and Biosafety

The Insect Allies program seeks to provide a flexible and rapidly deployable platform for modification of mature plants at scale. This program is inspired by natural biological events that cause characteristics to be transferred within a plant community. While these traits are often negative, Insect Allies proposes to use this system to deliver positive characteristics to plants as they are challenged by harmful events. This program will be conducted in containment and will not support any proposals that include uncontained environmental release of such organisms.

DARPA anticipates that large, physically contained cage field trials of engineered organisms may be appropriate for some of the experimental demonstrations of Insect Allies capabilities.

Such trials should only be undertaken when they are necessary to demonstrate the efficacy and stability of tools and countermeasures, and after laboratory and computer modeling experiments have shown promising results, but are no longer adequate to advance the science.

Other Requirements

Performers are expected to attend semi-annual program reviews to provide scientific and technical updates to the selected performers on the Insect Allies program on progress towards their milestones and scientific goals, and to 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 6.2.4, “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 www.darpa.mil/work-with-us/contract-management#OtherTransactions.

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.

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 BAA, 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 BAA. 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 BAA 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.

Proposers should indicate in their proposal whether they believe the scope of the research included in their proposal is fundamental or not. While proposers should clearly explain the intended results of their research, the Government shall have sole discretion to select award instrument type and to negotiate all instrument terms and conditions with selectees. Appropriate clauses will be included in resultant awards for non-fundamental research to prescribe http://www.darpa.mil/work-with-us/contract-management#OtherTransactions publication requirements and other restrictions, as appropriate. This clause can be found at www.darpa.mil/work-with-us/additional-baa.

For certain research projects, it may be possible that although the research being performed by the awardee is restricted research, a subawardee may be conducting fundamental research. In those cases, it is the awardee’s responsibility to explain in their proposal why its subawardee’s effort is fundamental research

3. Eligibility Information

3.1. ELIGIBLE APPLICANTS

All responsible sources capable of satisfying the Government’s needs may submit a proposal that shall be considered by DARPA.

3.1.1. Federally Funded Research and Development Centers (FFRDCs) and Government Entities

FFRDCs

FFRDCs are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they meet the following conditions: (1) FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector. (2) FFRDCs must provide a letter on official letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to Government solicitations and compete with industry, and their compliance with the associated FFRDC sponsor agreement’s terms and conditions. This information is required for FFRDCs proposing to be awardees or subawardees.

Government Entities

Government Entities (e.g., Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations. Government entities must clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority and contractual authority, if relevant, establishing their ability to propose to Government solicitations.

Authority and Eligibility

At the present time, DARPA does not consider 15 U.S.C. § 3710a to be sufficient legal authority to show eligibility. While 10 U.S.C.§ 2539b may be the appropriate statutory starting point for some entities, specific supporting regulatory guidance, together with evidence of agency approval, will still be required to fully establish eligibility. DARPA will consider FFRDC and Government entity eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the proposer.

http://www.darpa.mil/work-with-us/additional-baa

3.1.2. Non-U.S. Organizations

Non-U.S. organizations and/or individuals may participate to the extent that such participants comply with any necessary nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances.

3.2. ORGANIZATIONAL CONFLICTS OF INTEREST

FAR 9.5 Requirements In accordance with FAR 9.5, proposers are required to identify and disclose all facts relevant to potential OCIs involving the proposer’s organization and any proposed team member (subawardee, consultant). Under this Section, the proposer is responsible for providing this disclosure with each proposal submitted to the BAA. The disclosure must include the proposer’s, and as applicable, proposed team member’s OCI mitigation plan. The OCI mitigation plan must include a description of the actions the proposer has taken, or intends to take, to prevent the existence of conflicting roles that might bias the proposer’s judgment and to prevent the proposer from having unfair competitive advantage. The OCI mitigation plan will specifically discuss the disclosed OCI in the context of each of the OCI limitations outlined in FAR 9.505-1 through FAR 9.505-4.

Agency Supplemental OCI Policy In addition, DARPA has a supplemental OCI policy that prohibits contractors/performers from concurrently providing Scientific Engineering Technical Assistance (SETA), Advisory and Assistance Services (A&AS) or similar support services and being a technical performer.

Therefore, as part of the FAR 9.5 disclosure requirement above, a proposer must affirm whether the proposer or any proposed team member (subawardee, consultant) is providing SETA, A&AS, or similar support to any DARPA office(s) under: (a) a current award or subaward; or (b) a past award or subaward that ended within one calendar year prior to the proposal’s submission date.

If SETA, A&AS, or similar support is being or was provided to any DARPA office(s), the proposal must include:

The name of the DARPA office receiving the support;

The prime contract number;

Identification of proposed team member (subawardee, consultant) providing the support; and An OCI mitigation plan in accordance with FAR 9.5.

Government Procedures In accordance with FAR 9.503, 9.504 and 9.506, the Government will evaluate OCI mitigation plans to avoid, neutralize or mitigate potential OCI issues before award and to determine whether it is in the Government’s interest to grant a waiver. The Government will only evaluate OCI mitigation plans for proposals that are determined selectable under the BAA evaluation criteria and funding availability.

The Government may require proposers to provide additional information to assist the Government in evaluating the proposer’s OCI mitigation plan.

If the Government determines that a proposer failed to fully disclose an OCI; or failed to provide the affirmation of DARPA support as described above; or failed to reasonably provide additional information requested by the Government to assist in evaluating the proposer’s OCI mitigation plan, the Government may reject the proposal and withdraw it from consideration for award.

3.3. COST SHARING/MATCHING

Cost sharing is not required; however, it will be carefully considered where there is an applicable statutory condition relating to the selected funding instrument. Cost sharing is encouraged where there is a reasonable probability of a potential commercial application related to the proposed research and development effort.

For more information on potential cost sharing requirements for Other Transactions for Prototype, see http://www.darpa.mil/work-with-us/contract-management#OtherTransactions

4. Application and Submission Information

4.1. ADDRESS TO REQUEST APPLICATION PACKAGE

This announcement, any attachments, and any references to external websites herein constitute the total solicitation. If proposers cannot access the referenced material posted in the announcement found at http://www.darpa.mil, contact the administrative contact listed herein.

4.2. CONTENT AND FORM OF APPLICATION SUBMISSION

All submissions, including abstracts and proposals must be written in English with type not smaller than 12 point font. Smaller font may be used for figures, tables, and charts. Copies of all documents submitted must be clearly labeled with the DARPA BAA number, proposer organization, and proposal title/proposal short title.

The typical proposal should express a consolidated effort in support all three technical areas and phases. Proposals for a single technical area will not be accepted.

4.2.1. Proposal Abstract Format

Proposers are highly encouraged to submit an abstract in advance of a proposal to minimize effort and reduce the potential expense of preparing an out of scope proposal. DARPA will respond to abstracts providing feedback and indicating whether, after preliminary review, there is interest within BTO for the proposed work. DARPA will attempt to reply within 30 calendar days of receipt. Proposals may be submitted irrespective of comments or feedback received in response to the abstract. Proposals are reviewed without regard to feedback given as a result of abstract review. For (abstract and) proposal submission dates, see Part I., Overview Information.

Submissions received after these dates and times may not be reviewed.

The abstract is a concise version of the proposal comprising a maximum of 8 pages including all figures, tables, and charts. The (optional) submission letter is not included in the page count.

All pages shall be formatted for printing on 8-1/2 by 11 inch paper with font size not smaller than 12 point. Smaller font sizes may be used for figures, tables, and charts.

http://www.darpa.mil/

Submissions must be written in English.

The page limit does NOT include:

1. Official transmittal letter (optional);

2. Cover sheet;

3. Executive summary slide;

4. Resumes; and,

5. Bibliography (optional).

Abstracts must include the following components:

A. Cover Sheet (LABELED “PROPOSAL ABSTRACT”):

1. BAA number HR001117S0002;

2. Lead organization (prime contractor);

3. Other team members/subcontractors (if applicable);

4. Proposal Abstract title;

5. Technical point of contact (Team Program Integrator/Manager or Principle

Investigator) to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

6. Administrative point of contract (Contracting Officer) to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

7. Estimated cost; and

8. Estimated period of performance

B. Executive Summary: Clearly describe what is being proposed and what difference it will make (qualitatively and quantitatively), including brief answers to the following questions:

1. What is the proposed work attempting to accomplish or do?

2. How is it done today? And what are the limitations?

3. What is innovative in your approach and how does it compare to SOA?

4. What are the key technical challenges in your approach and how do you plan to overcome these?

5. Who will care and what will the impact be if you are successful?

6. How much will it cost and how long will it take?

C. Executive Summary Slides (does not count towards page limit): Provide a summary in PowerPoint that effectively and succinctly conveys the information requested in the slide template provided as Attachment 1 to the BAA posted at https://www.fbo.gov. Use of this template is required.

D. Technical Plan: It is expected that all three Technical Areas will be addressed by a team. Therefore, all Technical Areas need to be addressed in the proposal and a plan should be summarized for accomplishing the program technical goals. Outline and https://www.fbo.gov/ address all technical challenges inherent in the approach and possible solutions for overcoming potential problems. In addition:

1. Identify the plant of interest and demonstrate a knowledge of the current state of the art for genetic modification within this cropping system.

2. Detail the virus, insect vector, and gene editing platform that will be utilized in this system.

3. Identify anticipated on target effects and how they will be monitored and measured.

4. Describe how the Insect Allies system will be tested and demonstrated in line with proposed phases.

5. Detail the approach to identifying, monitoring, and measuring off-target effects and provide an outline for the containment of the genetic editors and target species during development and testing.

6. Propose appropriate and sufficient qualitative and quantitative metrics and milestones at intervals no greater than 6 months to demonstrate progress and a brief plan for their accomplishment.

E. Management and Capabilities: It is expected that proposals will involve multidisciplinary teams that include expertise from multiple complementary disciplines (e.g., entomology, plant pathology, plant genomics, plant physiology, and synthetic biology). Provide a brief summary of expertise of the team, including subcontractors and key personnel.

A principal investigator for each of the project’s technical areas will need to be identified and must have a background commensurate with the subject area being led.

Provide a description of the team’s organization including how the technical areas will run congruently and will be integrated for the end of phase demonstrations. All teams should identify a Program Integrator/Manager to lead and coordinate the effort between the principal investigators of each technical area. The program Integrator/Manager can be a principal investigator of a technical area or an oversite entity. The end of phase demonstration is not an event but will generate data for a future presentation that establishes the performing group’s capabilities. There will be a presentation of team accomplishments to the other performing teams and the government at the end of phase PI meeting.

Include a description of the team’s organization including roles and responsibilities.

Team member descriptions should address the Technical Plan and delineate individuals to avoid duplication of efforts. Teams should describe the time and percent effort divisions for each member participating across multiple TAs. Describe the organizational experience in this area and existing intellectual property required to complete the project at a basic (non-technical) level.

Describe any specialized facilities to be used as part of the project, the extent of access to these facilities, and any biological containment, biosafety, and certification requirements.

List Government-furnished materials or data assumed to be available.

F. Cost and Schedule: Provide a cost estimate for resources over the proposed timeline of the project, broken down by phase and major cost items (e.g., labor, materials, etc.). Include cost estimates for each potential subcontractor (may be a rough order of magnitude).

G. Resumes (do not count towards page limit): Include resumes of key team members.

H. Bibliography (optional, does not count towards page limit): If desired, include a brief bibliography with links to relevant papers and reports. The bibliography should not exceed two (2) pages.

4.2.2. Proposal Format

All full proposals must be in the format given below. Proposals shall consist of two volumes: 1) Volume I, Technical and Management Proposal, and 2) Volume II, Cost Proposal. All pages shall be printed on 8-1/2 by 11 inch paper with type not smaller than 12 point. Smaller font may be used for figures, tables and charts. The page limitation for full proposals includes all figures, tables, and charts. Volume I, Technical and Management Proposal, may include an attached bibliography of relevant technical papers or research notes (published and unpublished) which document the technical ideas and approach upon which the proposal is based. Copies of not more than three (3) relevant papers may be included with the submission. The requested attachments, bibliography, attached papers, and submission letter are not included in the page counts given below. The submission of other supporting materials along with the proposals is strongly discouraged and will not be considered for review. The maximum page count for Volume 1 is 40 pages. Volume I should include the following components:

NOTE: Non-conforming submissions that do not follow the instructions herein may be rejected without further review.

a. Volume I, Technical and Management Proposal

Section I. Administrative

B. Cover Sheet (LABELED “PROPOSAL: VOLUME I”):

1. BAA number (HR001117S0002);

2. Lead organization submitting proposal (prime contractor);

3. Type of organization, selected from among the following categories: “LARGE

BUSINESS,” “SMALL DISADVANTAGED BUSINESS,” “OTHER SMALL

BUSINESS,” “HBCU,” “MI,” “OTHER EDUCATIONAL,” OR “OTHER

NONPROFIT”;

4. Proposer’s reference number (if any);

5. Other team members (if applicable) and type of business for each;

6. Proposal title;

7. Technical point of contact (Team Program Integrator/Manager or Principle

Investigator) to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

8. Administrative point of contact (Contracting Officer) to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

9. Award instrument requested: cost-plus-fixed-free (CPFF), cost-contract—no fee, firm-fixed-price, cooperative agreement, other transaction, or other type (specify);

10. Place(s) and period(s) of performance ;

11. Proposal validity period;

12. Total funds requested from DARPA, and the amount of cost share (if any); AND

13. Date proposal was submitted.

Information on award instruments is available at http://www.darpa.mil/work-with-us/contract-management.

B. Official Transmittal Letter.

C. Executive Summary Slides: Provide a five-slide summary in PowerPoint that effectively and succinctly conveys the main objective, key innovations, expected impact, and other unique aspects of the proposed project. The slide template is provided as Attachment 2. Use of this template is required.

D. Program Plan Summary: Provide key proposal details already described in the project narrative of the full proposal. Brief 1-3 sentence answers to each question are required. Submit in Excel spreadsheet format Attachment 3.

Section II. Detailed Proposal Information

A. Executive Summary: Provide a synopsis of the proposed project, including answers to the following questions:

What is the proposed work attempting to accomplish or do?

How is it done today, and what are the limitations?

What is innovative in your approach?

What are the key technical challenges in your approach and how do you plan to overcome these?

Who or what will be affected and what will be the impact if the work is successful?

How much will it cost, and how long will it take?

http://www.darpa.mil/work-with-us/contract-management http://www.darpa.mil/work-with-us/contract-management

B. Goals and Impact: Clearly describe what the team is trying to achieve and the difference it will make (qualitatively and quantitatively) if successful. Describe the innovative aspects of the project in the context of existing capabilities and approaches, clearly delineating the uniqueness and benefits of this project in the context of the state of the art, alternative approaches, and other projects from the past and present.

Describe how the proposed project is revolutionary and how it significantly rises above the current state of the art.