DARPA-BAA-15-06_-_ElectRx_FINAL.docx

DARPA-BAA-15-06, Electrical Prescriptions (ElectRx)

Broad Agency Announcement Electrical Prescriptions (ElectRx) Biological Technologies Office

DARPA-BAA-15-06

December 11, 2014

TABLE OF CONTENTS

Part One: Overview Information

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

· Funding Opportunity Title – Electrical Prescriptions (ElectRx)

· Announcement Type – Initial Announcement

· Funding Opportunity Number – DARPA-BAA-15-06

· Catalog of Federal Domestic Assistance Numbers (CFDA) – 12.910 Research and Technology Development

· Dates

· Posting Date: 11 December 2014

· Proposal Due Date: 25 February 2015

· Estimated period of performance start: 1 August 2015

· Concise description of the funding opportunity – The DARPA ElectRx program seeks innovative research proposals for creating closed-loop neuromodulation systems that utilize innate neurophysiological circuits to achieve therapeutic benefits. To achieve this goal, ElectRx will simultaneously drive biological understanding and technology development. Specifically, ElectRx is looking to develop and leverage fundamental understanding of the anatomy and physiology of neural circuits in the spinal cord or peripheral nerves that mediate health status. This knowledge will be leveraged to design and demonstrate feedback-controlled neuromodulation systems for the direct regulation of immune system functions and CNS disorders. In parallel, technology development focused on next-generation minimally-invasive neural interfaces and biosensors will enable interaction with the neurophysiology of interest at unmatched spatiotemporal resolution, precision, and specificity. These neuromodulation treatments will be tuned automatically and continuously to the unique physiology of each individual and will produce no off-target effects.

· Total amount of money to be awarded – It is anticipated that the total funding of approximately $50M will be awarded across the technical areas discussed in this BAA. The actual amount of resources available under this BAA will depend on the quality of proposals received and availability of funds.

· Anticipated individual awards – Multiple awards are anticipated.

· Anticipated funding type – 6.2

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

· Any cost sharing requirements – None

· Agency contact Dr. Douglas Weber, Program Manager BAA Coordinator: DARPA-BAA-15-06@darpa.mil

DARPA/BTO

ATTN: DARPA-BAA-15-06

675 North Randolph Street Arlington, VA 22203-2114

Part Two: Full Text of Announcement

1. FUNDING OPPORTUNITY DESCRIPTION

The Defense Advanced Research Projects Agency often selects its research efforts through the Broad Agency Announcement (BAA) process. This BAA is being issued, and any resultant selection will be made, using procedures under Federal Acquisition Regulation (FAR) 35.016 and the Department of Defense Grant and Agreement Regulatory System (DoDGARS) Part 22 for Grants and Cooperative Agreements. Any negotiations and/or awards will use procedures under FAR 15.4, Contract Pricing, as specified in the BAA (including DoDGARS Part 22 for Grants and Cooperative Agreements). Proposals received as a result of this BAA shall be evaluated in accordance with evaluation criteria specified herein through a scientific review process. DARPA BAAs are posted on the Federal Business Opportunities (FedBizOpps) website, https://www.fbo.gov/, and, as applicable, the Grants.gov website at http://www.grants.gov/. The following information is for those wishing to respond to the BAA.

The DARPA ElectRx program seeks innovative research proposals to develop biological science and technology capabilities for creating feedback-controlled (i.e. closed-loop) neuromodulation systems that achieve therapeutic benefits by regulating peripheral neural circuits. ElectRx will support fundamental biological research aimed at elucidating the anatomy and physiology of neural circuits mediating health status. These studies will identify actionable peripheral targets and inform the design of advanced technologies for neural interfacing and biosensing. These foundational efforts will culminate with in vivo demonstrations of feedback-controlled neuromodulation to treat individual medical conditions ranging from inflammatory disease to mental health disorders. In parallel, technology development focused on next-generation neural interfaces and biosensors will target capabilities that enable interaction with the neurophysiology of interest at unmatched spatiotemporal resolution, precision, and specificity. These neuromodulation treatments will ultimately be tuned automatically and continuously to the unique physiology of each individual and produce no off-target effects.

1.1. PROGRAM OVERVIEW

The peripheral nervous system (PNS) governs a broad range of physiological activities. Abnormal activity in peripheral nerve circuits is associated with many diseases (e.g. cardiac hypertension, rheumatoid arthritis, and others). Given the breadth of function conveyed by the PNS and the relative ease with which we can access it, peripheral neuromodulation offers a promising alternative to traditional pharmacological interventions through the application of electrical stimulation via a physical interface that can enhance or interrupt neural signaling to treat disease or maintain health. While neuromodulation systems for treating a range of diseases (e.g. epilepsy, pain, etc.) have existed for decades, such systems lack sufficient efficacy to be considered front line interventions and are typically implemented as treatments of last resort. The DARPA ElectRx program aims to make neuromodulation the premier intervention for treating a wide range of diseases.

One factor limiting adoption is the ineffectiveness and off-target effects due to a combination of biological and technological limitations. Incomplete knowledge of the physiological mechanisms of neuromodulation makes it difficult to optimize devices and treatment protocols. Clinically-available electrode technologies rely on bulk stimulation of the whole nerve and do not afford precise targeting of select fibers or even fascicles in the nerve. As a result, stimulation parameters are often restricted to a narrow therapeutic window, confined by the need to avoid excessive recruitment of off-target nerve fibers. Existing peripheral neuromodulation devices are not equipped with sensors, making it impossible to monitor physiological responses to stimulation as needed to confirm target engagement and enable closed-loop control. Moreover, existing devices are large and require surgery to implant.

The ElectRx program aims to simultaneously drive biological understanding and technology development to elevate neuromodulation interventions from last resort to premier choice. Knowledge gained from biological studies will inform the design and implementation of technologies that provide transformative capabilities in the clinic. Overall success will be determined by validation of neurophysiological circuit structure and function in regulating health status, and the ability to translate this knowledge into safe and effective closed-loop neuromodulation systems with advanced targeting capability absent off-target effects.

The DARPA ElectRx program seeks innovative research proposals to develop biological science and technology capabilities for creating feedback-controlled neuromodulation technologies that target the peripheral nerve and/or spinal cord, hereafter referred to as peripheral neuromodulation. These interventions will utilize the body’s innate neurophysiology to achieve therapeutic benefits. ElectRx platforms will leverage advanced sensing and stimulating technologies to target specific neural circuits to monitor health status and intervene as needed to deliver therapeutic patterns of neural stimulation that restore desired physiological state (Figure 1). The ElectRx program is specifically interested in peripheral neuromodulation treatments for inflammatory diseases and mental health disorders.

Figure 1: ElectRx concept. Physiological health status is monitored and regulated by peripheral nerve circuits that control organ functions.

1.1.1. OBJECTIVES

General scientific and technical goals of the ElectRx program include:

Significantly advance understanding of neurophysiological circuits that monitor and regulate health status to enable novel treatments for inflammatory diseases and mental health disorders.

Create novel bio-interface technologies required to study, elucidate, and modulate neural circuits and physiological state (i.e. neural interfaces and in vivo biosensors).

Integrate neurobiological knowledge and bio-interface technologies into feedback-controlled neuromodulation systems capable of disease intervention and health restoration.

In order to achieve the scientific and technical goals of the ElectRx program, the following elements will be required:

Functional maps of neural circuitry: Elucidate the anatomy and physiology of neuromodulatory circuits implicated in disease and therapeutic interventions.

Physiological state determination: Define and characterize physiological health status based on, e.g., relative biomolecular concentrations and kinetics, afferent and efferent nerve signals, or other biomarkers associated with health and disease-related pathways.

In vivo biosensors: Develop physiological monitoring technologies to sense physiological status and response to neuromodulation.

Peripheral neuromodulation interfaces: Create scalable, atraumatic bio-interface technologies to sense and stimulate neural activity at high precision.

Closed-loop control algorithms: Integrate a real-time feedback control system that measures physiological state and stimulates the PNS and/or spinal cord to produce a desired physiological response in vivo.

1.1.2. SCOPE

The ElectRx program consists of two Technical Areas (TAs). Each proposal may only respond to one TA (either TA1 or TA2). Individuals and institutions may participate in multiple proposals.

TECHNICAL AREA 1 (TA1): Biological foundations for feedback-controlled neuromodulation Identify a disease of interest to study and treat with peripheral neuromodulation technologies. The ElectRx program is particularly interested in strategies to improve immune system functions to expedite and enhance recovery from injury or infection and to treat inflammatory diseases. Also of interest are neuromodulation approaches to treating mental health disorders including PTSD, depression, suicidality and anxiety.

A primary goal of the program is to create new knowledge of neurophysiological circuits (anatomy and function) and to leverage that knowledge to inform neuromodulation system design. Proposals to TA1 should aim to elucidate the neurophysiological mechanisms of the proposed disease target and use the new insights to inform closed-loop neuromodulation systems. These efforts should culminate with in vivo demonstrations of physiological state tuning via feedback-controlled neurostimulation in humans (clinical) or non-human primates (preclinical).

DARPA is particularly interested in innovative studies of human physiology and demonstration of novel neuromodulation strategies in humans. Efforts involving human-use studies must obtain regulatory guidance from the FDA throughout all stages of the program. Some TA1 studies of human physiology may involve devices and/or procedures that require approval by the FDA, for example under an Investigational Device Exemption (IDE). Proposers must describe their capabilities, timeframe, and milestones to design, plan, and execute acute and long-term trials of their system in humans to ensure compliance with all regulatory guidelines. All proposals involving human-use and/or animal-use must provide a detailed schedule for obtaining required protocol approvals (e.g. IRB, IACUC, FDA, ACURO, and others as needed). DARPA will facilitate FDA interactions for those performers needing assistance with this requirement. Such engagement will provide performers with the opportunity to inform the FDA about new technology plans and seek guidance for clinical transition strategies

Since the primary goal of TA1 is to obtain this foundational knowledge, proposers should place secondary emphasis on novel technology development in TA1. High-risk technology development efforts should be pursued in TA2. Proposers to TA1 should leverage or adapt existing state-of-the-art technologies for biological studies and only develop novel technologies as needed to overcome critical limitations in the existing toolset.

Hypothesis-driven approaches are encouraged for studies aimed at elucidating the anatomy and physiology of potential neuromodulatory circuit targets. TA1 proposals that do not provide clear and complete descriptions of the known or hypothesized physiological mechanisms will be deemed non-responsive.

Proposals to TA1 must specifically address the following:

Identify a primary disease condition to be studied with a detailed description of the neurophysiological mechanisms for regulating disease and health status, including:

Provide a clear and complete description of the interface technologies and implementation strategies to be used in the program.

Clear and complete description of mathematical approaches to modeling the function of targeted neurophysiological circuits

TA1 studies will require interdisciplinary teams spanning fields such as neurophysiology, molecular biology, immunology, computational modeling, biosensors, microelectronics, implantable medical devices, and biomedical engineering. Proposers to TA1 are strongly encouraged to collaborate with industry partners that can facilitate the translation of the developed systems.

TECHNICAL AREA 2 (TA2): Disruptive bio-interface technologies TA2 proposals will develop and demonstrate high risk, disruptive neural interfaces and/or in vivo biosensors whose development timeline precludes their integration into TA1 efforts. Of particular interest are neural interface and biosensing technologies that offer advanced capability for long-term use in vivo and can be deployed without surgery. Specifically excluded is research that results in incremental improvements to the state-of-the-art. Proposers may leverage or combine existing and emerging technologies (e.g. optical, acoustic, electromagnetic, genetically modified cells, etc.), but are required to identify the key innovations and performance gains expected with the proposed technologies. Proposers should provide detailed rationale for the approach and expected performance characteristics (i.e., sensitivity, specificity, etc.) with a theoretical basis supported by biophysical models and simulations.

TA2 proposals must address one or more of the following technologies:

Nerve interface capable of stimulating and/or inhibiting relevant neural activity;

Nerve interface capable of recording relevant neural activity;

Biosensor capable of detecting biomolecules or other biosignals relevant to determining physiological status.

TA2 neural interface proposals must represent highly innovative solutions for sensing and/or stimulating neural activity in vivo with high reliability over long time-scales, at high resolution with no negative off-target effects, and be scalable to provide access to large populations of nerve fibers. Existing microelectrode technologies offer limited ability to create high-resolution, high-coverage nerve interfaces for sensing, stimulating, and suppressing neural activity. This BAA seeks novel approaches to neural recording and stimulation that can surpass by orders of magnitude the resolution, coverage, and reliability achieved by state-of-the-art technologies such as microelectrode arrays. Electrode-like approaches are not of interest in TA2. DARPA strongly encourages fundamentally new approaches to overcoming longstanding challenges in measuring and regulating neural activity in vivo. Novel examples include, but are not limited to, functionalized nanoparticle switches, engineered molecular bioswitches, acoustic, optical, and electromagnetic methods. Proposers must provide quantitative performance metrics for the proposed interface technologies in comparison with state-of-the-art technologies. While the ultimate requirements of resolution and scale will be determined through TA1 research, proposed bio-interface technologies should push the limits of precise measurement and/or stimulation of circuit-specific nerve activity. Ideally, neural interface approaches will be scalable to single-neuron resolution (i.e., able to target select locations and cell types) and be capable of full coverage across all nerve fibers involved in relevant neural circuits. Preference will be given to approaches that can be delivered without surgical intervention (e.g. injectable devices).

TA2 also seeks novel solutions for creating chronically reliable in vivo biosensors for measuring biomarkers in ElectRx-relevant target diseases (i.e., inflammatory or mental health disorders). Proposals should represent impactful and innovative technical approaches to in vivo sensing of physiologically-relevant, but currently difficult to assess, biomarkers such as inflammatory mediators (e.g. cytokines, chemokines, etc.) and other large biomolecules. Examples include, but are not limited to, functionalized sensor scaffolds, advanced particle-display technologies, and biotic and abiotic voltage sensitive sensors.

Proposed biosensor approaches should support chronic, real-time, in vivo (e.g., at or near a target organ or CNS structure) monitoring of biomarkers relevant to at least one disease identified in the ElectRx program (i.e., inflammatory or mental health). Proposals should provide rationale for the chosen biomarkers with regards to their currently understood role in the identified disease state. While proposals will be designed for the intended biomarkers, TA1 research may identify additional, critical biomarkers for detection. Therefore, biosensor proposals should address final technology capabilities across a range of functions and constraints, including:

Physical, chemical, electrical, etc. constraints for detection;

Feasible sensing locations, e.g. blood, interstitial fluid, target organs, CNS, etc.;

Timescale precision, e.g. seconds or minutes, with discussion of the physiological relevance;

Sensitivity, specificity, and dynamic range.

1.1.3. GENERAL REQUIREMENTS

Performers are expected to attend annual program reviews to provide scientific and technical updates to the entire ElectRx community on progress towards their milestones and scientific goals, and to summarize outstanding challenges and limitations that must still be overcome to achieve the overarching ElectRx goals.

1.2. PROGRAM PLAN

The ElectRx program will proceed in two 24-month phases. Although proposers to TA1 and TA2 will submit separate proposals, all teams will be expected to share ideas and data throughout the program. Interactions facilitated through program reviews, site visits, and PI meetings will serve as opportunities for TA2 performers to demonstrate their technology’s efficacy and readiness for integration into TA1 efforts as appropriate. Additionally, TA1 performers will apply the knowledge gained about disease models to inform the design parameters of TA2 technologies as appropriate. Performers will be evaluated based on their ability to meet program metrics and milestones, demonstrations of utility, and identification of realistic paths to integration. Table 1 summarizes the TA1 and TA2 goals by phase.

1.2.1. TA1: BIOLOGICAL FOUNDATIONS FOR FEEDBACK CONTROLLED NEUROMODULATION

Proposals to TA1 should span two Phases totaling four years. Phase I (24 months) will focus on neurobiology, identification/validation of actionable targets (neural and biomarker), and system definition. Phase II (24 months) will demonstrate capabilities for in vivo, feedback-controlled neuromodulation to monitor and control disease/health state in humans (clinical) or non-human primates (preclinical). Proposals must specify intermediate and final technical milestones and metrics (at a minimum every six (6) months) that demonstrate progress towards the overall goals of each phase.

Table 1: Summary of TA1 and TA2 goals in Phase I and Phase II

Phase I (24 months): Establish neurobiological foundations through target identification and validation with in vivo proof-of-concept demonstration.

Phase I should yield elucidated neurobiology of the performer-defined disease target and resultant system design specifications. Proposals must provide detailed descriptions of their scientific and technical approaches. Phase I efforts should identify actionable targets for neural stimulation and primary or surrogate biomarkers indicative of physiological state. Performers will need to create and validate mathematical models linking neural circuit activity to physiological status. Additional models are needed to predict the physiological response to neuromodulation and to create feedback-control algorithms. Proposers must describe procedures for developing and validating their models with in vivo studies.

As detailed knowledge of neurophysiology emerges and improves, the system specifications should be refined to ensure precise targeting of relevant neural pathways and neuromodulation system designs must be delivered by the end of Phase I. Proposals must define specific quantitative metrics to meet system performance goals and a plan to achieve these with a clear milestone schedule for incorporating neurobiology results to firm up system design.

Phase I technical milestones should include, but are not limited to, the following:

Identify and validate actionable neural targets for supporting feedback-controlled neuromodulation therapies for specific diseases. Proposals should explain the rationale for target selection based on physiological mechanisms.

Identify biomarkers (primary or surrogate) and sensors relevant to proposed disease target and candidate biomarkers for measuring on- and off-target effects.

Determine physiologically-relevant dynamics and kinetics associated with physiological state monitoring and control.

Validate neuromodulation parameters and physiological conditions that lead to predictable changes in physiological status.

Validate mathematical modeling of neural circuit function in preclinical or clinical model.

Demonstrate proofs-of-concept for monitoring and effecting neurophysiological circuits associated with target disease (no feedback required) in animal models or human studies.

Deliverables:

Detailed anatomical map and computational models of function for target neurophysiological circuits.

Preliminary design and specifications for a feedback-controlled neuromodulation system.

Phase II (24 months): Demonstrate feedback-controlled neuromodulation in vivo in non-human primate or human studies.

Phase II efforts should demonstrate capabilities for feedback-controlled neuromodulation of health/disease status to validate and refine neurobiological models of target disease and provide initial in vivo demonstrations of (at a minimum) physician-in-the-loop feedback control with limited to no off-target effects. Performers must validate physiological state monitoring and demonstrate application of stimulation parameters to the neural targets that produce the desired physiological response and establishes the intended, healthy physiological state. Fully automated feedback control is not an essential requirement of Phase II studies, but physiological state sensing is required to monitor the on- and off-target responses to neuromodulation and guide selection of neuromodulation parameters that achieve the desired therapeutic response. These Phase II studies should inform control algorithm design and guide development of a fully automated controller. Continued clarification of the underlying neurobiology will enable refinement of system specifications during Phase II.

Phase II milestones should include the following:

Design and validate therapeutic control algorithms for neuromodulation in preclinical or clinical model.

Validate that physiological state sensing effectively monitors target disease status.

Demonstrate neurobiological circuit specificity and absence of off-target responses to neurostimulation.

Demonstrate feedback-enabled neuromodulation in human (clinical) or non-human primate (preclinical).

Quantify on-target responses to neurostimulation to validate feedback targets and therapeutic benefit to demonstrate circuit specificity.

Design an integrated sensing and stimulation system for feedback-controlled neuromodulation.

Deliverable Demonstrate capabilities for achieving closed-loop neuromodulation in non-human primate or human studies.

Anticipated second BAA: Early feasibility study of fully integrated, closed-loop neuromodulation technologies in humans.

Based on the progress achieved in Phase 1, DARPA anticipates releasing a second BAA shortly after the start of Phase II (i.e. during Year 3 of the program). The second ElectRx BAA will define the objectives and scope for a potential Phase III extension of the ElectRx program, which will span two years starting in Year 4 of the program. DARPA anticipates that the goal of Phase III will be to create a fully integrated closed-loop neuromodulation system and perform an early feasibility study in humans. Technical approaches should be minimally invasive, producing limited to no damage to any tissue upon delivery or during use.

1.2.2. TA2: DISRUPTIVE BIO-INTERFACE TECHNOLOGIES

TA2 is aimed at developing and demonstrating highly innovative solutions for neural interfacing and biomarker sensing.

Phase I (24 months): Demonstrate proof-of-concept for novel bio-interface technologies.

Phase I efforts in TA2 will produce proof-of-concept demonstrations of real-time, in vivo physiological state sensors and scalable, high-resolution peripheral neuromodulation interfaces. Proposals must define quantitative metrics that are comprehensive measures of the specific technology’s performance and viability for in vivo deployment. Relevant metrics include resolution, scale, precision, specificity, sensitivity, toxicity, and functional lifetime in the anticipated deployment environment. Performance metrics for proposed technologies must be contrasted against relevant SOA technologies and should nominally yield orders of magnitude improvements or represent fundamentally different technical implementations (e.g., employing non-electrical signals for neural stimulation).

Phase I milestones should include the following (as applicable):

Demonstrate technology concepts for achieving high precision, scalable neural interfaces for measuring and controlling (stimulating and suppressing) neural activity in an ex vivo or acute in vivo experiment.

Demonstrate capabilities for achieving high spatial resolution and/or cell type specificity.

Demonstrate proof-of-concept technique to install bio-interface technologies using minimally- or non-invasive technologies.

Demonstrate performance metrics for in vivo molecular biosensors of e.g. cytokines, neurotransmitters, other biomarkers (metrics: dynamic range, sensitivity, selectivity).

Phase II (24 months): Demonstrate chronic bio-interface functionality in vivo.

The proposed statement of work for Phase II should demonstrate the chronic functionality of the components in vivo. The Phase II milestones should include the following, as well as other considerations specific to the proposed technology:

Demonstrate robust signal quality over time.

Demonstrate immunity to biofouling.

Determine chronic biocompatibility.

Demonstrate repeatable and surgery-free application of bio-interfaces.

Evaluate safety – tissue damage, toxicity.

1.2.3. MILESTONES

Proposals are required to provide intermediate and end-of-phase milestones every six (6) months that represent logical steps toward achieving the final milestones for each phase. Milestones must be accompanied by proposer-defined quantitative metrics for evaluating progress toward achieving the goals of each phase of the program. The aggressiveness of the proposer-defined timeline will be taken into account during the proposal evaluation.

1.2.4. PROGRAM METRICS

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program objectives, proposals should provide a series of metrics that, if successfully achieved, will demonstrate the performer’s increasing understanding and capability as their effort progresses. These proposer-defined metrics should be relevant to the target disease physiology or technological capability developed through the effort and may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. While these goals should clearly define the scope of effort, they should also afford the maximum flexibility, creativity, and innovation in proposing solutions to the stated problem. Proposals should cite the quantitative and qualitative success criteria that the proposed effort will achieve by the time of each milestone within each Phase.

Ethical, Legal, and Social Implications:

DARPA maintains its commitment to ensuring that efforts funded under this BAA adhere to ethical and legal regulations currently in place for federally- and DoD-funded research involving human and animal use. Proposers to this BAA should address potential ethical, legal, and social implications of the proposed technology. All ElectRx technology will be developed in a manner that seeks to understand the biological science and technological capabilities required to enable monitoring and control of health status via peripheral neuromodulation. DARPA will not fund any proposals aimed at enhancing human performance capability.

Data Sharing:

All performers funded by the DARPA ElectRx program shall participate in data sharing with other program performers. Data sharing will be conducted in a manner that provides enough description for a third party to look at and conduct appropriate analysis and interpretation of the data. This data sharing includes, but is not limited to, raw and processed experimental data, processing methods used, algorithms used to process the data, artifact information, research reports, metadata, and software including source code and executables.

2. AWARD INFORMATION

Multiple awards are anticipated. 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 at the end of one or more of the phases.

Awards under this BAA will be made to proposers on the basis of the evaluation criteria listed below (see section labeled “Application Review Information”, section 5.), and program balance to provide overall value to the Government. 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. The Government reserves the right to remove proposers from award consideration should the parties fail to reach agreement on award terms, conditions and cost/price within a reasonable time or the proposer fails to timely provide requested additional information. Proposals identified for negotiation may result in a procurement contract, grant, 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.

In all cases, the Government contracting officer shall have sole discretion to select award instrument type and to negotiate all instrument terms and conditions with selectees. Proposers are advised that if they propose grants or cooperative agreements, DARPA may select other award instruments, as it deems appropriate. 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.

2.1. 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 established the national policy for controlling the flow of scientific, technical, and engineering information produced in federally funded fundamental research at colleges, universities, and laboratories. The Directive defines fundamental research as follows:

Fundamental research means basic or 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. The Government 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 publication requirements and other restrictions, as appropriate.

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

The following statement or similar provision will be incorporated into any resultant non-fundamental research procurement contract or other transaction:

There shall be no dissemination or publication, except within and between the contractor and any subcontractors, of information developed under this contract or contained in the reports to be furnished pursuant to this contract without prior written approval of DARPA’s Public Release Center (DARPA/PRC). All technical reports will be given proper review by appropriate authority to determine which Distribution Statement is to be applied prior to the initial distribution of these reports by the contractor. With regard to subcontractor proposals for Contracted Fundamental Research, papers resulting from unclassified contracted fundamental research are exempt from prepublication controls and this review requirement, pursuant to DoD Instruction 5230.27 dated October 6, 1987.

When submitting material for written approval for open publication, the contractor/awardee must submit a request for public release to the PRC and include the following information: (1) Document Information: document title, document author, short plain-language description of technology discussed in the material (approx. 30 words), number of pages (or minutes of video) and document type (e.g., briefing, report, abstract, article, or paper); (2) Event Information: event type (conference, principal investigator meeting, article or paper), event date, desired date for DARPA's approval; (3) DARPA Sponsor: DARPA Program Manager, DARPA office, and contract number; and (4) Contractor/Awardee's Information: POC name, e-mail and phone. Allow four weeks for processing; due dates under four weeks require a justification. Unusual electronic file formats may require additional processing time. Requests may be sent either by-mail to prc@darpa.mil or via 675 North Randolph Street, Arlington VA 22203-2114, telephone (571) 218-4235. Refer to the following for link for information about DARPA’s public release process: http://www.darpa.mil/NewsEvents/Public_Release_Center/Public_Release_Center.aspx.

3. ELIGIBILITY INFORMATION

All responsible sources capable of satisfying the Government’s needs may submit a proposal that shall be considered by DARPA. The ElectRx program encourages participation by non-traditional performers, academic institutions, not-for-profit institutes, and industrial partners of all sizes. DARPA also encourages partnerships between academia and industry to facilitate the translation of emerging technologies.

3.1. ELIGIBLE APPLICANTS

3.1.1. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTERS (FFRDCS) AND GOVERNMENT ENTITIES FFRDCs and Government entities (e.g., Government/National laboratories, military educational institutions, etc.) 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 and; (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 and terms and conditions. This information is required for FFRDCs proposing to be prime contractors or subcontractors. 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. 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 eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the proposer.

3.1.2. NON-U.S. ORGANIZATIONS

Non-U.S. organizations are/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. See Section 4.2 “Security and Proprietary Issues” regarding the proposers capabilities to perform research and development at the classification level they propose.

3.1.3. APPLICANTS CONSIDERING CLASSIFIED SUBMISSIONS

Applicants considering classified submissions (or requiring access to classified information during the life-cycle of the program) shall ensure all industrial, personnel, and information system processing security requirements are in place and at the appropriate level (e.g., Facility Clearance (FCL), Personnel Security Clearance (PCL), certification and accreditation (C&A)) and any Foreign Ownership Control and Influence (FOCI) issues are mitigated prior to such submission or access. Additional information on these subjects can be found at: www.dss.mil.

3.2. PROCUREMENT INTEGRITY, STANDARDS OF CONDUCT, ETHICAL CONSIDERATIONS, AND ORGANIZATIONAL CONFLICTS OF INTEREST Current federal employees are prohibited from participating in particular matters involving conflicting financial, employment, and representational interests (18 U.S.C. § 203, 205, and 208). Once the proposals have been received, and prior to the start of proposal evaluations, the Government will assess potential conflicts of interest and will promptly notify the Proposer if any appear to exist. The Government assessment does NOT affect, offset, or mitigate the proposer’s responsibility to give full notice and planned mitigation for all potential organizational conflicts, as discussed below.

Without prior approval or a waiver from the DARPA Director, in accordance with FAR 9.503, a contractor cannot simultaneously provide scientific, engineering, technical assistance (SETA) or similar support and also be a technical performer. As part of the proposal submission, all members of the proposed team (prime proposers, proposed subcontractors, and consultants) must affirm whether they (their organizations and individual team members) are providing SETA or similar support to any DARPA technical office(s) through an active contract or subcontract. All affirmations must state which office(s) the proposer, subcontractor, consultant, or individual supports and identify the prime contract number(s). All facts relevant to the existence or potential existence of organizational conflicts of interest (FAR 9.5) must be disclosed. The disclosure must include a description of the action the proposer has taken or proposes to take to avoid, neutralize, or mitigate such conflict. If in the sole opinion of the Government after full consideration of the circumstances, a proposal fails to fully disclose potential conflicts of interest and/or any identified conflict situation cannot be effectively mitigated, the proposal will be rejected without technical evaluation and withdrawn from further consideration for award.

If a prospective Proposer believes a conflict of interest exists or may…