DARPA-BAA-11-39 DxOD-LRS.pdf

Broad Agency Announcement Autonomous Diagnostics to Enable Prevention and

Therapeutics:

Diagnostics on Demand – Limited Resource Settings

(ADEPT: DxOD - LRS) Defense Sciences Office

DARPA-BAA-11-39

MARCH 14, 2011

I. FUNDING OPPORTUNITY DESCRIPTION

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

A. Eligible Applicants B. Cost Sharing/Matching C. Other Eligibility Criteria

IV. APPLICATION AND SUBMISSION INFORMATION

A. Address to Request Application Package B. Content and Form of Application Submission C. Proposal Abstract and Full Proposal Information

1. Submission Instructions

2. Proposal Abstract Format

3. Full Proposal Format

4. Submission Dates and Times

D. Intergovernmental Review E. Funding Restrictions F. Other Submission Requirements B. Review and Selection Process

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices B. Administrative and National Policy Requirements

1. Meeting and Travel Requirements

2. Human Use

3. Animal Use

4. Publication Approval

5. Export Control

6. Subcontracting

7. Electronic and Information Technology

8. Employment Eligibility Verification

9. Central Contractor Registration & Universal Identifier Requirements

10. Reporting Executive Compensation and First-Tier Subcontract Awards

11. Updates of Information Regarding Responsibility Matters

C. Reporting D. Electronic Systems

1. Representations and Certifications

2. Wide Area Work Flow (WAWF)

3. i-Edison

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

A. Intellectual Property

1. Procurement Contract Proposers B. Non-Procurement Contract Proposers C. All Proposers – Patents

1. All Proposers – Intellectual Property Representations D. All Proposers – Teaming

APPENDIX A

APPENDIX B

Part One: Overview Information

• Federal Agency Name – Defense Advanced Research Projects Agency

(DARPA), DSO

• Funding Opportunity Title – Autonomous Diagnostics to Enable Prevention and Therapeutics: Diagnostics on Demand – Limited Resource Settings (ADEPT: DxOD - LRS)

• Announcement Type – Initial Announcement

• Funding Opportunity Number – Broad Agency Announcement (BAA)

DARPA-BAA-11-39

• Catalog of Federal Domestic Assistance Numbers (CFDA) – 12.910

Research and Technology Development

• Dates o Posting Date: March 14, 2011 o Proposal abstracts are due by 4:00PM ET, April 14, 2011.

o Full Proposals are due by 4:00PM ET, May 19, 2011.

o Closing Date, 4:00PM ET, May 19, 2011.

• Description of the Funding Opportunity – DARPA is soliciting innovative research proposals for the development of on-site critical diagnostics tailored for rapid, self-performed tests in limited resource settings.

• Multiple Awards are Anticipated

• Types of Instruments That May be Awarded – Procurement contract, grant, cooperative agreement, or other transaction for research.

• Teaming Website – https://team.sainc.com/DxOD

• Question and Answer Page - https://team.sainc.com/DxOD/faq.aspx

• Agency Contact o Points of Contact:

The BAA Technical POC is Dr. Daniel Wattendorf, who can be reached at DARPA-BAA-11-39@darpa.mil

The BAA Administrator for this effort can be reached at:

Electronic mail: DARPA-BAA-11-39@darpa.mil

DARPA/DSO

ATTN: DARPA-BAA-11-39

3701 North Fairfax Drive Arlington, VA 22203-1714

Solicitations can be viewed at:

http://www.darpa.mil/Opportunities/Solicitations/DSO_Solicitations.aspx https://team.sainc.com/DxOD https://team.sainc.com/DxOD/faq.aspx mailto:DARPA-BAA-11-39@darpa.mil mailto:DARPA-BAA-11-39@darpa.mil

Part Two: Full Text of Announcement

I. FUNDING OPPORTUNITY DESCRIPTION

The Defense Advanced Research Projects Agency often selects its research efforts through the Broad Agency Announcement (BAA) process. The BAA will appear first on the FedBizOpps website, http://www.fedbizopps.gov/, and the Grants.gov website http://www.grants.gov/. The following information is for those wishing to respond to the

BAA.

DARPA is soliciting proposals to develop new diagnostic capabilities as components of the Autonomous Diagnostics to Enable Prevention and Therapeutics (ADEPT) program.

Two research efforts are envisioned and described in this and a companion BAA. In these solicitations, DARPA is seeking proposals for new methods to enable devices that can address present unmet clinical needs as well as decrease the time to design, manufacture, and distribute valid new assays when future needs for individual assessment for health or performance arise. To achieve these goals DARPA will invest in efforts that provide 1) on-site critical diagnostics tailored for rapid self-performed tests; and,

2) point-of-care highly multiplexed reconfigurable devices. This effort, Autonomous Diagnostics to Enable Prevention and Therapeutics: Diagnostics on Demand - Limited Resource Settings (DxOD - LRS) focuses specifically on the first objective.

Development of highly multiplexed devices appropriate for medical facilities is described in the companion BAA, Autonomous Diagnostics to Enable Prevention and Therapeutics:

Diagnostics on Demand – Point of Care (ADEPT: DxOD - PoC), DARPA-BAA-11-38.

The DxOD-LRS is envisioned by DARPA as an interdisciplinary research effort to develop diagnostic capabilities that are deployable with military personnel in limited resource settings. This effort will develop and demonstrate clinically valid devices for the detection of multiple critical analytes in relevant self-collected biospecimens. The additional goal is to develop diagnostic devices that can be operated by unskilled users in these settings.

The primary goal of this effort is to demonstrate an "Alpha-level" prototype (or Technology Readiness Level (TRL) 5: component and/or breadboard validation in a pre-clinical environment). It is expected that a pre-Investigational Device Exemption (IDE) meeting will be held with the Food and Drug Administration (FDA) by end of effort.

The prototype attributes are described below under "Program Elements." Performers should include measurable prototype performance metrics and describe the test methodology for as many attributes as possible, based on the scope of the proposal.

Complementary to DARPA's interest in demonstrating a prototype device, this effort also considers supporting high risk efforts for the development of highly sensitive and stable molecular recognition, signal transduction and analysis approaches which could be incorporated into a prototype by the end of this effort.

http://www.fedbizopps.gov/ http://www.grants.gov/

The research and development described below is expected to integrate multiple approaches and technologies across many basic and applied scientific disciplines in academia and industry (for example: chemistry, molecular biology, theoretical and experimental engineering disciplines, biophysics, materials science, microfluidics, biostatistics, as well as clinical and laboratory medicine specialties). The effort will require expertise in system integration and device engineering.

The DxOD-LRS effort aims to significantly advance point-of-need diagnostics and enable development of capabilities that far exceed current technologies. Proposals are expected to require significant interdisciplinary efforts. Project scope and budget should be appropriate for the level of effort required for development of advanced methods and technologies and demonstration of a prototype device. Specifically excluded is research that primarily results in evolutionary improvements to the existing state of the art.

Proposals that aim to simply integrate existing methods and technologies will be considered non-responsive.

BACKGROUND

Despite progress in discovery of biomarkers associated with human health and disease, qualification for their use in diagnostic tests has been limited mostly to centralized reference laboratories with the ability to perform laboratory developed tests (LDTs), particularly for multiplexed nucleic acid based tests. Reliance on centralized facilities requires shipping of biospecimens and limits the ability to provide results within a sufficient timeframe to guide an immediate clinical action. Notwithstanding the virtues of laboratory centralization and LDTs, the limited capability to test biomarkers at the point-of-need challenges the military’s ability to provide timely health care and maintain the operational readiness of its service members in deployed settings. Thus, new diagnostic devices are needed that provide clinically valid results and meet Department of Defense (DoD) operational requirements, such as field portability and storage, operation by unskilled users, and performance across a broad range of environmental conditions.

As such devices would also require FDA approval, proposers are encouraged to consider appropriate FDA regulations as well as the Clinical Laboratory Improvement Amendment (CLIA)-waiver designations (http://wwwn.cdc.gov/clia/regs/toc.aspx).

Although a small number of diagnostic devices with limited capabilities for use by unskilled users are available, such as blood chemistry assays and blood glucose monitors, it remains a major technology challenge to develop simple to use devices that can reliably prepare, process, and quantify multiple protein or nucleic acid targets to obtain a valid clinical result while at the same time meeting the stringent requirements needed to achieve CLIA waiver. For example, clinical analyses often require quantification of multiple analytes, over different concentration ranges, for a single disease. Measurement of low abundance analytes is particularly challenging and can be confounded by interfering analytes whose concentration is several orders of magnitude higher. The polymerase chain reaction (PCR) has been a game-changing invention for molecular diagnostics enabling clinically valid measurement over 12 orders of magnitude in concentration. Methods using this technology, however, require extensive sample http://wwwn.cdc.gov/clia/regs/toc.aspx processing, are only applicable to nucleic acids, and have not been approved for use in limited resource settings, and thus are not practical for many DoD scenarios.

DARPA is seeking to develop and demonstrate new diagnostic devices that enable unskilled users to perform clinically valid measurements directly from biospecimens.

New methods must be applicable to proteins and/or nucleic acids, provide sufficient multiplexing for critical diagnosis, require low or no power burden on warfighter resources, have sufficient shelf life, provide clinically valid results in an actionable time, and be operable by unskilled users. Multiple analytes for one or more conditions challenging to diagnose in limited resource settings must be addressed. Examples of these conditions include infectious diseases, trauma, sepsis, toxic exposures, or others where timely intervention is required. DARPA will consider proposals that meet a present unmet clinical need in US health care, as well as conditions of high priority to military medicine. Performers should clearly describe the applicability and adaptability of the methods and technologies for other clinical diagnostic applications. Such technologies should also be compatible with a cost and production model that sustains their market presence, e.g., leveraging economies of scale that enable current and future use “on demand”.

TECHNICAL AREAS OF INTEREST

DARPA is soliciting proposals for DxOD-LRS, a new effort seeking interdisciplinary solutions to develop diagnostic capabilities for critical applications in limited resource settings. Collaborative efforts and teaming are encouraged (see Section III.C.1).

Proposers should aim towards demonstrating fully integrated devices capable of quantifying, analyzing and reporting clinically valid results in limited resource settings, and compatible with CLIA-waiver. Proposers should clearly articulate how they will address end-to-end solutions that encompass all aspects of diagnostic analysis. Aspects to be addressed, as needed, are the following: a) user sample collection, preparation, and interface, b) molecular recognition (such as antibodies, molecularly imprinted polymers, aptamers, nucleic acid binding constructs) and novel forms of molecular amplification compatible with room temperature storage while retaining high functionality, c) highly sensitive and specific signal transduction methods (such as optical, electrical or magnetic with requisite amplification) and, d) analyses that can ultimately be used to provide an immediate result or have reliable data wirelessly transmitted for interpretation by remote specialists. Proposals that address only one aspect of the development, such as signal transduction or sample preparation, will be considered non-responsive.

Proposals that do not articulate how the approach exceeds the current state of the art by addressing known limitations in current methods will be considered non-responsive.

Proposals that do not address complete device development comprehensively (from sample to clinically valid answer) will be considered non-responsive as will proposals that merely integrate conventional methods into a handheld device.

To guide proposers towards a comprehensive solution and appropriate teaming, this solicitation is organized into three major technical areas. All three technical areas must be addressed in an integrated fashion and substantiated by having personnel on each team with demonstrated prior accomplishments in each area. If substantial efforts in any of the technical areas are deemed unnecessary by the proposer, evidence must be presented to justify the claim. Specifically excluded are proposals that only incrementally advance the current state of the art.

Technical Area One: User Sample Interface, Processing and Delivery

Minimally invasive sample collection techniques often yield small sample volumes limiting the quantity of biomarker available for analysis. Biospecimens of particular interest include blood or those collected from nasopharyngeal swabs. Urine, stool, wound swab, saliva, and sweat are optional biospecimens; others will be considered if proposed. Proposals should detail how the sample collection would be performed in a CLIA-waiver compatible method and the expected specimen volume to be collected.

Proposers are encouraged to develop methods to increase specimen collection volume if probability of detection would decrease statistical sampling error.

Various methods exist to separate analytes from interferents to obtain more specific and sensitive detection, but often these are complex multi-step processes that have not been integrated into a simple to use device. Therefore, proposers should address new methods for sample preparation and/or processing as required but are still compatible with limited resource settings.

Proposals should address the envisioned fluidic control and describe sample movement, reagent addition and storage, multiplex capability, capacity for inclusion of controls and calibration, as well as materials issues as appropriate. All reagents and fluidics must be integrated or easily added to the device as required to obtain a CLIA-waiver.

Technical Area Two: Highly Sensitive, Stable and Specific Molecular Recognition, Signal Transduction, Analysis and Interpretation

DARPA is interested in new molecular methods that are amenable to stable storage, enable direct detection of analytes in biospecimens with minimal sample preparation and combined with appropriate signal transduction methods (e.g., optical, electrical, magnetic) provide enhanced sensitivity and specificity for protein or nucleic acid analytes. These measurements should be unaffected by the presence of interferents in the sample. Novel methods for amplifying analytes and/or molecular recognition events that are amenable to simple system architectures are encouraged. The use of molecular species that can be evolved for improving operational performance and are capable of being rapidly produced for new assays is also encouraged.

Proposals may include current signal transduction methods coupled with developed molecular recognition methods, or alternatively, proposals may develop new signal transduction methods. Proposals should detail the anticipated quantitative performance as it pertains to the relevant selected analytes. The envisioned translation from the raw data to a clinically valid diagnostic should be described.

Optional Component to Technical Area Two:

As an optional additional activity in this area, proposers are encouraged to develop new methodologies that can specifically shorten the large time lag from biomarker discovery to development of a diagnostic test that can be used to measure it. Ongoing biomedical investigations are rapidly uncovering new biomarkers. As new correlations between biomarker signatures and disease are discovered and validated, there will be a growing need for rapid translation into portable diagnostic tests. This component of the proposed effort would specifically focus on the rapid production of recognition molecules (e.g.

antibodies, aptamers, primers) compatible with existing platform components (developed as part of the effort) to enable rapid fielding of a diagnostic capability from a newly defined set of biomarkers.

Technical Area Three: Quantitative Framework for Device Characterization and System Level Integration

Component Characterization:

DARPA encourages approaches that are quantifiable and can be used to predict and improve the performance of a proposed platform device. A theoretical framework for the behavior of device components would enable design, performance evaluation, troubleshooting, and greater adaptability to improvements in variables such as recognition probes for new threats, collection volumes, geometry, diffusion and binding kinetics, transducer dynamic range, or surface area to volume ratios. Proposers are encouraged to carefully consider the critical variables affecting platform performance at the system level in order to minimize size, weight, power and cost (see Device Integration and Table 1).

Device Integration:

The demonstration of a complete integrated prototype unit at the alpha level (TRL5) is required by the end of the program. While the expectation is that the demonstrated prototype is consistent with the requirements for FDA clearance and CLIA-waiver, DARPA will not fund clinical studies for regulatory submissions. Devices may be one self-contained unit, similar to a commercial lateral flow assay test, or a test unit (e.g. strip or cartridge) and a reader. If a reader is included, the device must still be a handheld, portable unit. Proposers should clearly describe all aspects of the device, including biospecimen introduction and user interface, fluidic transport, materials issues, projected power use, data read-out, and estimated costs for the unit and individual analysis.

Proposals should clearly explain the trade-offs considered with regard to device complexity, logistics and performance.

Proposers must choose at least one medical condition of interest to demonstrate their technology and describe relevant experiments to be performed. Characterization must be performed directly from biospecimens. Biospecimens of particular interest include blood and those collected from a nasopharyngeal swab. Urine, stool, wound swab, saliva, and sweat are optional biospecimens; others will be considered if proposed. In addition, the proposers should describe how the proposed technology could be applied to other medical conditions of interest to the military.

By the end of this effort DARPA requires an engineering study of an expected commercial instrument based on the prototype that addresses specifications such as sensitivity, specificity, limit of quantification, reproducibility, throughput, size, weight, power, and consumables cost per biospecimens analyzed. Table 1 details prototype performance metrics that teams should consider as part of this study.

PROGRAM METRICS

The DxOD-LRS effort should not exceed 60 months. Proposers should identify quantitative milestones that facilitate tracking of the research progress towards the overall program goals. A detailed technical rationale supporting the ability to achieve milestones should be provided. Proposers should plan for the test and evaluation of their components at each milestone. Continuation of funding over the 60-month period will be contingent on technical progress. Specifically excluded are proposals that only incrementally advance the state of the art.

Technical Elements:

Proposers are encouraged to develop their own intermediate, quantitative metrics to demonstrate progress throughout the effort. Provided below are example metrics that would represent significant advancements in the state of the art, yet proposers are cautioned not to simply recapitulate metrics from this BAA, but to include technically appropriate metrics for the proposed work. These metrics should be shown as milestones on the program schedule (e.g. Gantt chart).

Example metrics:

• Quantification of biospecimen collection volume.

• Quantification of sample purification and/or processing efficiency.

• Capability to quantify both absolute concentrations and ratios of analytes to a reliable internal reference.

• Multiplexed measurement of biomarkers (proteins and nucleic acids) able to diagnose one or more conditions that demonstrates platform capability beyond state of the art.

• Dynamic range suitable for clinically valid detection of high abundance and low abundance analytes simultaneously present in a biospecimen.

• Total analysis time < 10 minutes from collection to clinical answer or data export.

• No external power or low power (e.g. compatible with USB laptop port (2.5 W)).

• Cost < $10 / test.

• evice volume including reader < 50 cm3.

D

• > 90 day storage in operational environment.

As described above, the demonstration of an integrated prototype at the alpha level (TRL5) is required by the end of the program. The device should be evaluated for the selected conditions using standard metrics for evaluation of diagnostics devices. Table 1 details prototype performance metrics that teams should consider as a means to quantify their accomplishments by the conclusion of the program.

Table #1: Diagnostic Device Attributes

ATTRIBUTE DIMENSION DEFINITION

LOD/LOQ Concentration, for example pg/mL, copies/mL, or molarity

Limit of detection/quantification.

TAT minutes Turnaround time. This is the total time from patient sample acquisition to definitive device result. It includes hands-on time, and test time.

Multiplex Level # Number of independent analytes (targets) that the instrument can detect simultaneously.

Dynamic Range Logs (decades) The range of an analyte titration that the instrument is capable of accurately detecting.

CV % Coefficient of variation. Standard deviation normalized to the mean. At titrations near the LOD, CV’s of FDA 510(k) cleared assays typically are ≤ 20%.

Size cm3 Current size of the device or sizes of the strip/cartridge and the reader, and predicted size if commercialized.

Weight kg Current weight of the device or weights of the strip/cartridge and the reader, and predicted weight(s) if commercialized.

Power W Current electrical power consumption, and predicted consumption of a commercial device.

COGS $ Current Cost of Goods Sold and predicted COGS of a commercial device.

MTBF weeks Mean Time Between Failure

Repeatability % Similar to CV, this value is based on variations between instruments.

Reproducibility % Similar to CV, this value is based on variations on a single instrument over time.

PPV % Positive predictive value. This value takes into account the a priori distribution of disease within the targeted population.

NPV % Negative predictive value. This value takes into account the a priori distribution of disease within the targeted population.

SENSITIVITY % Describes the frequency of true positives (TP). Based on the algebraic expression: 100*TP/(TP + FN). (FN = false negatives)

The abscissa for the ROC (receiver operating characteristic).

When plotted against specificity (see below), one obtains the ROC curve.

SPECIFICITY % Describes the frequency of true negatives (TN). Based on the algebraic expression: 100*TN/(TN + FP). (FP = false positives)

The ordinate for the receiver operating characteristic.

(Typically one plots the quantity (1 – SPECIFICITY) for the ordinate.

AUC % Area under the curve. This is the area under a ROC curve and represents the mathematical accuracy of the test. It is important to note that AUC considers a complex convolution of factors affecting outcome including the instrument, assay, and processing protocols.

II. 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. 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”, Sec. V.), and program balance to provide overall value to the Government. Proposals identified for negotiation may result in a procurement contract, grant, cooperative agreement, or other transaction for research depending upon the nature of the work proposed, the required degree of interaction between parties, and other factors. 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.

As of the date of publication of this BAA, DARPA expects that program goals for this BAA may be met by proposers intending to perform 'fundamental research,' i.e., 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. Notwithstanding this statement of expectation, DARPA 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. In all cases, the contracting officer shall have sole discretion to select award instrument type and to negotiate all instrument provisions with selectees.

III. ELIGIBILITY INFORMATION

A. Eligible Applicants

All responsible sources capable of satisfying the Government's needs may submit a proposal that shall be considered by DARPA. Historically Black Colleges and Universities (HBCUs), Small Businesses, Small Disadvantaged Businesses and Minority Institutions (MIs) are encouraged to submit proposals and join others in submitting proposals; however, no portion of this announcement will be set aside for these organizations’ participation due to the impracticality of reserving discrete or severable areas of this research for exclusive competition among these entities.

Federally Funded Research and Development Centers (FFRDCs) and Government entities (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. FFRDCs must clearly demonstrate that the work is not otherwise available from the private sector AND they must also provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to government solicitations and compete with industry in compliance with the associated FFRDC sponsor agreement terms and conditions. This information is required for FFRDCs proposing to be prime 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 (as well as, where relevant, contractual authority) 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 eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the Proposer.

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 USC 203, 205, and 208). The DARPA Program Manager for this BAA is Dr. Daniel Wattendorf.

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. (Please note the Government assessment does NOT affect, offset, or mitigate the proposer’s own duty to give full notice and planned mitigation for all potential organizational conflicts, as discussed below.)

All Proposers and proposed subcontractors must affirm whether they are providing scientific, engineering, and technical assistance (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 supports and identify the prime contract numbers. Affirmations shall be furnished at the time of proposal submission. All facts relevant to the existence or potential existence of organizational conflicts of interest (FAR 9.5) must be disclosed. The disclosure shall include a description of the action the Proposer has taken or proposes to take to avoid, neutralize, or mitigate such conflict. In accordance with FAR 9.503 and without prior approval or a waiver from the DARPA Director, a Contractor cannot simultaneously be a SETA and Performer. Proposals that fail to fully disclose potential conflicts of interests and/or do not have plans to mitigate this conflict will be rejected without technical evaluation and withdrawn from further consideration for award.

If a prospective Proposer believes that any conflict of interest exists or may exist (whether organizational or otherwise), the Proposer should promptly raise the issue with DARPA by sending Proposer's contact information and a summary of the potential conflict by email to the mailbox address for this BAA at DARPA-BAA-11- 39@darpa.mil, before time and effort are expended in preparing a proposal and mitigation plan. If, in the sole opinion of the Government after full consideration of the circumstances, any conflict situation cannot be effectively mitigated, the proposal may be rejected without technical evaluation and withdrawn from further consideration for award under this BAA.

mailto:DARPA-BAA-11-XX@darpa.mil

B. Cost Sharing/Matching

Cost sharing is not required for any particular program; however, cost sharing will be carefully considered where there is an applicable statutory condition relating to the selected funding instrument (e.g., for any Other Transactions under the authority of 10 U.S.C. § 2371). Cost sharing is encouraged where there is a reasonable probability of a potential commercial application related to the proposed research and development effort.

C. Other Eligibility Criteria

Collaborative Efforts

Collaborative efforts/teaming are encouraged. A teaming website, https://team.sainc.com/DxOD, will facilitate the formation of teams with the necessary expertise. Specific content, communications, networking, and team formation are the sole responsibility of the participants. Neither DARPA nor the Department of Defense (DoD) endorses the destination website or the information and organizations contained therein, nor does DARPA or the DoD exercise any responsibility at the destination. This website is provided consistent with the stated purpose of this BAA.

IV. APPLICATION AND SUBMISSION INFORMATION

A. Address to Request Application Package

This solicitation contains all information required to submit a proposal. No additional forms, kits, or other materials are needed. This notice constitutes the total BAA. No additional information is available, nor will a formal Request for Proposal (RFP) or additional solicitation regarding this announcement be issued. Requests for same will be disregarded.

B. Content and Form of Application Submission

Security and Proprietary Issues

NOTE: If proposals are classified, the proposals must indicate the classification level of not only the proposal itself, but also the anticipated award document classification level.

The Government anticipates proposals submitted under this BAA will be unclassified.

However, if a proposal is submitted as “Classified National Security Information” as defined by Executive Order 13526, as amended, then the information must be marked and protected as though classified at the appropriate classification level and then submitted to DARPA for a final classification determination.

Proposers choosing to submit a classified proposal from other classified sources must first receive permission from the respective Original Classification Authority in order to https://team.sainc.com/DxOD use their information in replying to this BAA. Applicable classification guide(s) should also be submitted to ensure the proposal is protected at the appropriate classification level.

Classified submissions shall be appropriately and conspicuously marked with the proposed classification level and declassification date. Submissions requiring DARPA to make a final classification determination shall be marked as follows:

CLASSIFICATION DETERMINATION PENDING. Protect as though classified (insert the recommended classification level: [e.g., Top Secret, Secret or Confidential])

Classified submissions shall be in accordance with the following guidance:

Confidential and Secret Collateral Information: Use classification and marking guidance provided by previously issued security classification guides, the Information Security Regulation (DoD 5200.1-R), and the National Industrial Security Program Operating Manual (DoD 5220.22-M) when marking and transmitting information previously classified by another Original Classification Authority. Classified information at the Confidential and Secret level may be mailed via appropriate U.S.

Postal Service methods (e.g., (USPS) Registered Mail or USPS Express Mail). All classified information will be enclosed in opaque inner and outer covers and double wrapped. The inner envelope shall be sealed and plainly marked with the assigned classification and addresses of both sender and addressee. The inner envelope shall be addressed to:

Defense Advanced Research Projects Agency

ATTN: DSO

Reference: DARPA-BAA-11-39

The outer envelope shall be sealed with no identification as to the classification of its contents and addressed to:

Defense Advanced Research Projects Agency Security & Intelligence Directorate, Attn: CDR

All Top Secret materials: Top Secret information should be hand carried by an appropriately cleared and authorized courier to the DARPA CDR. Prior to traveling, the courier shall contact the DARPA CDR at 571.218.4842 to coordinate arrival and delivery.

Special Access Program (SAP) Information: SAP information must be transmitted via approved methods. Prior to transmitting SAP information, contact the DARPA SAPCO at 703.526.4052 for instructions.

Sensitive Compartmented Information (SCI): SCI must be transmitted via approved methods. Prior to transmitting SCI, contact the DARPA Special Security Office (SSO) at 703.248.7213 for instructions.

Proprietary Data: All proposals containing proprietary data should have the cover page and each page containing proprietary data clearly marked as containing proprietary data. It is the proposer’s responsibility to clearly define to the Government what is considered proprietary data.

Security classification guidance via a DD Form 254 will not be provided at this time since DARPA is soliciting ideas only. After reviewing the incoming proposals, if a determination is made that the award instrument may result in access to classified information, a DD Form 254 will be issued and attached as part of the award.

Proposers must have existing and in-place prior to execution of an award, approved capabilities (personnel and facilities) to perform research and development at the classification level they propose. It is the policy of DARPA to treat all proposals as competitive information, and to disclose their contents only for the purpose of evaluation. Proposals will not be returned. The original of each proposal received will be retained at DARPA and all other non-required copies destroyed. A certification of destruction may be requested, provided the formal request is received at this office within 5 days after unsuccessful notification.

C. Proposal Abstract and Full Proposal Information

Proposers are strongly encouraged to submit a proposal abstract in advance of a full proposal. This procedure is intended to minimize unnecessary effort in proposal preparation and review. The time and date for submission of proposal abstracts is specified in Section IV.C.4.a. Proposal Abstract Date. DARPA will acknowledge receipt of the submission and assign a control number that should be used in all further correspondence regarding the proposal abstract.

DARPA will respond to proposal abstracts with a statement as to whether DARPA is interested in the idea. DARPA will attempt to reply to proposal abstracts via letter within thirty (30) calendar days of receipt. Should a proposer be discouraged from submitting a full proposal, the letter must contain feedback for the proposer regarding the rationale for the decision not to recommend that a full proposal be submitted. Proposal abstracts will be reviewed in the order they are received. Early submissions of proposal abstracts and full proposals are strongly encouraged because selections may be made at any time during the period of solicitation. Regardless of DARPA’s response to a proposal abstract, proposers may submit a full proposal. DARPA will review all full proposals submitted using the published evaluation criteria and without regard to any comments resulting from the review of a proposal abstract.

Proposers are required to submit full proposals by the time and date specified in the BAA in order to be considered during the initial round of selections. DARPA may evaluate full proposals received after this date for a period up to one year from date of posting on FedBizOpps and Grants.gov. Ability to review late submissions remains contingent on availability of funds.

The typical full proposal should express a consolidated effort in support of one or more related technical concepts or ideas. Disjointed efforts should not be included into a single proposal.

Restrictive notices notwithstanding, proposals may be handled, for administrative purposes only, by a support contractor. This support contractor is prohibited from competition in DARPA technical research and is bound by appropriate non-disclosure requirements. Proposal abstracts and full proposals may not be submitted by fax or e-mail; any so sent will be disregarded.

Abstracts/proposals not meeting the format described in the BAA may not be reviewed.

1. Submission Instructions

For Proposal Abstract Being Submitted as Hard Copies/On CD-ROM:

An original and 1 copy of the proposal abstract [in PDF format (preferred)] on a CD- ROM shall be submitted.

For Proposers Submitting Full Proposals as Hard Copies/ On CD-ROM:

Proposers must submit an original and 1 copy of the full proposal [in PDF format (preferred)] on a CD-ROM. Each copy must be clearly labeled with DARPA-BAA-11- 39, proposer organization, proposal title (short title recommended).

For Proposers Posting Proposal Abstracts and Full Proposals to Grants.Gov:

Grant or cooperative agreement proposal abstracts or full proposals may only be submitted to DARPA through Grants.gov or in hard-copy. Grant or cooperative agreement abstracts/proposals may not be submitted through any other means (including T-FIMS and other comparable systems). If proposers intend to use Grants.gov as their means of submission, then they must submit their entire abstract/proposal through Grants.gov; applications cannot be submitted in part to Grants.gov and in part as a hard-copy. Proposers using the Grants.gov APPLY do not submit paper proposals in addition to the Grants.gov APPLY electronic submission.

Proposers must complete the following steps in the order listed below before submitting abstracts/proposals on Grants.gov (these steps are also detailed at www.grants.gov/applicants/get_registered.jsp):

• Proposers must obtain a DUNS number

• Proposers must register their organization in the Central Contractor Registration

(CCR) (https://www.bpn.gov/CCRSearch/Search.aspx) https://www.bpn.gov/CCRSearch/Search.aspx

• Proposers must register the Authorized Organization Representative (AOR) in Grants.gov

• Proposers must have the organization’s E-BIZ point of contact authorize the AOR to submit applications.

Proposers electing to submit grant or cooperative agreement abstracts/proposals as hard copies must complete the SF 424 R&R form (Application for Federal Assistance, Research and Related) available on the Grants.gov website http://www.grants.gov/agencies/aapproved_standard_forms.jsp#2. Attach the abstract/proposal (if submitting a full proposal please upload two separate documents, Volume I, Technical and Management Proposal and Volume II, the Cost Proposal) as attachments to the application package. No other Grants.gov forms are required. Please note that Grants.gov does not accept zipped or encrypted abstracts/proposals. More detailed instructions for using Grants.gov can be found on the Grants.gov website.

For Proposers Submitting Proposal Abstracts and Full Proposals through DSO’s BAA Submission Portal:

Proposal abstracts and full proposals sent in response to DARPA-BAA-11-39 may be submitted via DSO’s BAA Website (https://dsobaa.sainc.com). Visit the website to register for an account (via the ”Register your Organization” link along the left side of the homepage), view submission instructions, and upload/finalize abstracts/proposals.

All submissions must be compressed and encrypted as described below. Proposers using the DSO BAA Website may encounter heavy traffic on the submission deadline date; it is highly advised that submission process be started as early as possible.

All proposals/abstracts submitted electronically by means of an Electronic Business Application Tool or proposal submission website (not including Grants.gov) must be encrypted using Winzip or PKZip with 256-bit AES encryption. Please submit full proposals as two separate documents, Volume I (Technical and Management Proposal) and Volume II (Cost Proposal), uploaded as one single encrypted .zip file. Submissions not zipped/encrypted will be rejected by DARPA. An encryption password form must be completed and e-mailed to DARPA-BAA-11-39@darpa.mil at the time of submission.

See https://dsobaa.sainc.com for the encryption password form.

Note the word “PASSWORD” must appear in the subject line of the above email and there are minimum security requirements for establishing the encryption password.

Failure to provide the encryption password may result in the abstract/proposal not being evaluated. For further information and instructions on how to zip and encrypt abstract/proposal files, see https://dsobaa.sainc.com.

http://www.grants.gov/agencies/aapproved_standard_forms.jsp#2 https://dsobaa.sainc.com/ mailto:DARPA-BAA-11-39@darpa.mil https://dsobaa.sainc.com/ http://www.sainc.com/dsobaa

All administrative correspondence and questions on this solicitation, including requests for information on how to submit abstracts/proposals to this BAA, should be directed to one of the administrative addresses below; e-mail is preferred.

BAA Administrator E-mail: DARPA-BAA-11-39@darpa.mil

DARPA/DSO

ATTN: DARPA-BAA-11-39

3701 North Fairfax Drive

DARPA intends to use e-mail and fax for correspondence regarding DARPA-BAA-11-39. Proposal abstracts and full proposals may not be submitted by fax or e-mail; any so sent will be disregarded. DARPA encourages use of the Internet for retrieving the BAA and any other related information that may subsequently be provided.

2. Proposal Abstract Format

It is STRONGLY ENCOURAGED that a proposal abstract be submitted to determine the acceptability of the proposed concept to the BAA. This allows for comments to the proposer prior to full proposal submission. Proposal abstracts should follow the same general format as described for Volume I under FULL PROPOSAL FORMAT (see below), but include ONLY Sections I and II. (However, no formal transmittal letter is required.) The cover sheet should be clearly marked “PROPOSAL ABSTRACT” and the total length should not exceed 8 pages, excluding cover page and official transmittal letter. 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 proposal abstracts includes all figures, tables, and charts. No formal transmittal letter is required. All proposal abstracts must be written in English.

3. Full Proposal Format

All full proposals must be in the format given below. Nonconforming proposals may be rejected without review. Proposals shall consist of two separate files, Volume I (Technical and Management Proposal) and Volume II (Cost Proposal). All pages shall be printable on single-spaced, 8-1/2 by 11 inch paper with type not smaller than 12 point font. 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. Intellectual Property/Patents Requirements and the bibliography are not included in the page counts. The submission of other supporting materials along with the proposals is strongly discouraged and will not be considered for mailto:DARPA-BAA-11-39@darpa.mil review. Except for the attached bibliography and Section I, Volume I shall not exceed 40 pages. Maximum page lengths for each section are shown in braces { } below.

Volume I, Technical and Management Proposal

Section I. Administrative

COVER SHEET TO INCLUDE:

A. Cover sheet to include:

(1) BAA number

(2) Technical area

(3) Lead organization submitting proposal

(4) Type of business, selected among the following categories: “LARGE

BUSINESS,” “SMALL DISADVANTAGED BUSINESS,” “OTHER

SMALL BUSINESS,” “HBCU,” “MI,” “EDUCATIONAL,”

“NONPROFIT” OR NOT-FOR -PROFIT;

(5) Contractor’s reference number (if any)

(6) Other team members (if applicable) and type of business for each

(7) Proposal title

(8) Technical point of contact to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, electronic mail

(9) Administrative point of contact to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, electronic mail

(10) Total funds requested from DARPA, separated by Base Award and Options (if any), and the amount of cost share (if any); AND

(11) Date proposal was submitted.

B. Official Signed Transmittal Letter.

Section II. Summary of Proposal

A. {4} Executive Summary. This should clearly and concisely summarize the following:

a. Innovative claims for the proposed research and comparison to current technology and related on-going research;

b. Description of the technical solutions and innovative approaches proposed and their uniqueness and benefits relative to the current state-of-art alternate approaches;

c. Technical and Management Approach;

d. Technology Commercialization Strategy;

e. Cost, schedule and measurable milestones for the proposed research, including estimates of cost for each task in each year of the effort delineated by the prime and major subcontractors, total cost and company cost share, if applicable. (Note: Measurable milestones should capture key development points in tasks and should be clearly articulated and defined in time relative to start of effort.);

f. A single PowerPoint slide summarizing the program and effort; use the template provided on the Teaming Website, https://team.sainc.com/DxOD.

Submit the PowerPoint (or equivalent) file in addition to Volume I and Volume II of your full proposal submission.

Section III. Detailed Proposal Information

A. {20} Technical Rationale and Approach. This section is the centerpiece of the proposal and should succinctly describe the uniqueness and benefits of the proposed…