BD21_RFI_20190827_Final_w_Sample_NDA.pdf

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP or Broad Agency Announcement (BAA). This RFI does not commit the Department of Homeland Security (DHS) Countering Weapons of Mass Destruction Office (CWMD) to contract for any supply or service. DHS CWMD is not at this time seeking proposals. Responders are advised that the CWMD will not pay any cost incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP or BAA. If a solicitation is released, it will be released via the Government-Wide Port of Entry (GPE) at (http://www.fedbizopps.gov). In order to receive an award from any resultant solicitation, should one be issued, the successful offeror must be registered in the System for Award Management (SAM). The SAM website is https://www.sam.gov. It is the responsibility of the potential responders to monitor the website for any information that may pertain to this RFI. The information provided in this RFI is subject to change and is not binding on the Government. All submissions become the property of the CWMD, and will not be returned. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations’ capabilities. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Proprietary, confidential, privileged commercial or financial information submitted in the RFI response should be marked accordingly to ensure appropriate handling and disposition by the Government. No classified information shall be submitted in the RFI response. Do not use Government security classification markings. Do not mark the entire response as proprietary.

The Department of Homeland Security (DHS) Countering Weapons of Mass Destruction (CWMD) Office seeks to acquire a

Biological Detection for the 21st Century (BD21) system of systems (SoS). BD21 is intended to replace the currently fielded

BioWatch system with a capability that is more cost effective, significantly timelier, and less duplicative of other agency mission spaces. The BD21 program has been approved to enter the Analyze / Select phase of the DHS acquisition lifecycle.

The Analyze / Select phase aims to demonstrate technologies’ performance in the context of program requirements. To support this objective, the BD21 program management office (PMO) is requesting additional information from the industry on their ability to provide technologies that would satisfy BD21 notional requirements, as listed below. The BD21 PMO will use the information acquired from this Request for Information (RFI) to support the BD21 acquisition strategy. Information and data gathered from RFI responses will also support an independent Alternative Analysis (AA) effort.

BACKGROUND/DESCRIPTION

Since September 11, 2001, multiple strategic documents have called for increased protection from biological threats.

Surveillance and near real-time detection are key to protecting target populations from releases of biological threat agents.

Weaponized, aerosolized forms of biological agents are most dangerous against populations in terms of both exposure and mortality/morbidity. Consequently, there is a need for a surveillance and detection system that enables timely detection of potential bioterrorism incidents involving aerosolized pathogenic microorganisms. Surveillance of ambient air for the presence of aerosolized pathogens is the most effective mode for early detection of biological threats over large areas and within facilities. This system would address the detect-to-respond function for which DHS has primary responsibility.

BioWatch, the current system, is the operational DHS program that provides national biosurveillance capabilities for combatting biological terrorism in response to Homeland Security Presidential Directive (HSPD) 10, Biodefense for the 21st

Century guidelines. It serves as a reference system and baseline for many technical aspects against which proposed BD21 solutions will be compared and measured.

Alerting government agencies charged with the public health response to a bioterrorism event is a significant, impactful, and https://www.sam.gov/ complicated requirement. It demands an extraordinary level of understanding and coordination to enable officials to make prudent decisions and ensure responders operate safely and effectively. Surveillance, detection, warning, and response are integrally connected functions. BD21 is intrinsically a system of highly connected and interdependent systems. The data gathered from BD21 instruments must effectively inform the decision making of responders and other stakeholders.

Accordingly, stakeholders will be integrally involved with, and contribute to, the development of the systems and technologies that will produce the alert used in other places to which they must respond.

System Description:

BD21 will be a system-of-systems that provides detection of a widespread release of aerosolized pathogenic microorganisms to state, local, and federal agencies. The BD21 system(s) will be designed to be interoperable with information architectures at all levels of government, enabling common understanding of situational awareness across the affected mission space by the appropriate agencies at all levels of government.

Request for Industry Information:

The BD21 PMO is seeking technologies for a system that provides detection of bio-agents in population centers. The entire

BD21 SoS will need to have the following attributes:

• Anomaly Detection – Analysis of environmental conditions consistent with the presence of airborne microorganisms

• Timeliness / Near Real-Time Detection – Speed an alert is delivered and response is initiated

• Environment Coverage – Types of locations covered by the system, including indoor, partially indoor, and outdoor locations

• Geographic Coverage – Area protected by the system

• Incident Parameters – Ability to assess biological release characteristics, i.e., detection time, location, meteorological conditions, particle count, particle size

• Centralized Surveillance Capability / Information Management – Ability to integrate active and passive surveillance activities and information

The BD21 PMO is interested in mature technologies with an estimated technology readiness level (TRL) (See Attachment 1) of no less than seven (TRL ≥ 7) with respect to the Measures of Performance (MOPs) and Methods of Effectiveness (MOEs) outlined below.

The intent of the BD21 acquisition is to leverage commercial off-the-shelf (COTS) / non-developmental item (NDI) technology to the extent possible. Technology must be flexible enough to accommodate an information architecture, provided as an internal interface by the government. The components, and associated tasks, that make up the total system are composed of the categories below. The technologies and processes in response to this RFI must address at least one of these component categories:

1) Environmental Monitoring (i.e. Triggers)

2) Collection Systems (Airborne Particulates Collectors)

3) Field Biological Identifiers

4) Data Analytical / Anomaly Detection Tools (Data Analytics)

5) System Integration

Trigger:

A biological trigger continuously samples the air in a local environment and detects environmental conditions consistent with presence of microbial aerosols. The trigger must interface with the Data Analytical tool, described below, to be able to produce a response to an anomaly detection. Provide overall information on the trigger technology. Additionally, specific data on the following attributes may be addressed for the trigger component:

• Airflow Rate

• Operating Environmental Conditions

• Applicable Particle Sizes

• Sensitivity (as a Function of Monitoring Time and Agent, as applicable)

• False Alarm Rate or False Positives as a Function of a Specified Operating Time

• False Negatives as a Function of a Specified Operating Time

• Time to Monitor / Alert

• Rough Order of Magnitude (ROM) for Consumables (including calibration and maintenance packages)

Collectors:

The collector may be autonomously engaged by the trigger, following an anomaly detection and will collect and concentrate particulates in the air for a specified amount of time. Provide overall information on the collector technology. Additionally, specific data on the following attributes may be addressed for the collector component:

• Collection Media and/or Sample Matrix o Final sample volume or final sample size

• Airflow Rate

• Recommended collection time (or range of collection times)

• Ability for collection to be started by an external/remote signal

• Operating Environmental Conditions

• Collection Efficiency

• Applicable Particle Sizes

• ROM for additional consumables (including maintenance packages)

Field Biological Identifier:

Biological identifiers are intended for rapid presumptive identification of a biological agent, allowing implementation of rapid responses or a return to normal operations. Provide overall information on the Field Biological Identifier technology.

Additionally, specific data on the following attributes may be addressed for the Biological Identifier component:

• Sample Preparation: Biological identifier must have capability to perform sample preparation in the field.

o Sample Preparation (and Matrix Extraction) Efficiency (by Matrix, if applicable) o Sample Preparation Consumables including estimated cost per Sample o Initial Sample Volume/Matrix Required for Sample Preparation

• Sample Volume/Matrix Required for Identification

• Threat Agents Identified

• Sensitivity and Specificity (including ROC curves, if available)

• False positive rate (per number of samples or operating time)

• False negative rate (per number of samples or operating time)

• Throughput (Number of samples per identifier run)

• Time to Screening/Result for a single run (or Number of Samples Analyzed per Hour)

• Power Options and Weight

• Operating Environmental Conditions

• ROM for consumables (including calibration and maintenance packages)

Data Analytics/Anomaly Detection Tools:

One of the stated aspects of the BD21 mission is anomaly detection of biological particulate releases in the air. Biological particles are present in almost all environments, including pollen, fungal spores, bacteria, viruses, and skin dander. The

Anomaly Detection component of the overall BD21 system would integrate data from various available sources such as meteorological data and neighboring trigger systems to initiate a collection event. The following attributes must be considered for the data analytics/anomaly detection tools component:

• Applicable data streams or feeds

• Threshold/Alert examples (as a function of time, if applicable)

• Description of threshold/alert modification (i.e., time required, skills required)

• Types of Alerts Generated (i.e., at a central location, sent via phone)

• Hardware requirements

• Connectivity requirements

System Integration:

The separate components listed above must be integrated into an SoS and tested against simulants and threat agents. The components must be integrated in such a way that they are compatible and interoperable within a single system. Responses may include interface processes, configuration management processes, or a technology solution.

Notional Requirements:

The notional requirements for the BD21 system are expressed in terms of MOEs and MOPs as no formal requirement document exists at this time. The MOEs and MOPs are expressed in the following table and may be used in lieu of a formal performance specification. Please provide any quantifiable metrics associated with the MOEs and MOPs below.

Performance Parameter

Measure of Effectiveness

(MOE)

Measure of Performance

(MOP)

Detect Agents

Ability to detect specified agents of concern

Shall detect threat agents within samples of ambient air through continuous surveillance

Identify Agents

Ability to identify specified agents of concern (down to species level for bacterial and viral agents)

Shall identify threat agents within samples of ambient air through continuous surveillance

System Specificity

Ability to detect and identify agents of concern and differentiate from other background organisms

Shall detect and identify threat agents in various specified operational environments and differentiate from non-threat agents

System Sensitivity

Ability to detect and identify infectious levels of threat agent expressed in terms of concentration/ volume of air

Shall detect and identify a minimum specified total integrated concentration, or Level of Detection (LOD) for specified bioagents of concern:

e.g. (orgs/m3) x (min)

Time to Detect

Elapsed time between threat agent intake and communication of analytical results

Shall conduct continuous surveillance of the environment; detect threat agents;

quickly communicate results/alerts

False Positive Rate

The frequency at which the detection and/or preliminary identification of a threat agent is determined to be false (#/unit time)

Shall ensure a sufficiently low per unit rate such that the overall system false positive rate is acceptable.

False Negative Rate

Number of undetected and/or unidentified biothreat releases per unit time

Shall detect and preliminarily identify all biothreat events which could result in

PLEASE NOTE THAT THIS IS NOT A REQUEST FOR PROPOSAL, NO SOLICITATION EXISTS AT THIS TIME.

Responses should include your company’s capability statement. Oral Communications ARE NOT acceptable in response to this notice. However, follow-up discussions / market research may be performed. Any price/cost requested in this RFI should only be an estimate (ROM). It will only be used for market research purposes.

Responses should provide the following information:

A. Company Information (e.g. name, business address, headquarters location, point of contact, telephone number, e-mail address and URL). Also include DUNS Number or CAGE Code

B. Socio-economic indicator of your company as designated by GSA (i.e., (O)= other than small business, (S) small business, (W) women-owned business, (WO/WOSB) women-owned small business, (EW/EDWOSB) economically disadvantaged women-owned small business, (V) veteran-owned small business, (DV/SDVOSB) service-disabled veteran-owned small business, (D) SBA- certified small disadvantaged business,(8a) SBA- certified 8(a) firm, (H) SBA- certified

HUBZone firm.)

C. Product Availability through GSA

D. Responses are to discuss:

1. System Description:

-A brief description of the key technology/technologies

-Pictures of the system and, at least, a rendition of the end state system.

-A description of performance characteristics per guidance in this document.

-Describe how application of the technology is applicable to BD21 needs. Has its performance been demonstrated against live biological agents, including those implicated in nosocomial infections, or simulants? Has independent testing occurred and by what organization?

-Is the technology currently being produced / manufactured?

-Provide approximate TRL in accordance with TRL attachment and task areas described above

-Has this technology been used to support the Department of Defense or other US government agencies?

2. Technical Maturation:

-If and when necessary, describe your methodology to maturing your system(s) to meet BD21 needs and achieving TRL=7 or higher.

-Discuss biggest risks to meeting task areas described above.

-If needed, describe the methodology for maturing the technology from TRL=7 or higher.

3. Cost- Provide a ROM cost estimate of the described system to modify and procure

4. Schedule- Approximate timeline (schedule) to perform any modifications in accordance with the system description to meet requirements detailed in this document

5. Other- Any other information, not described here, that is pertinent or relevant to the Government for completeness of this RFI

Submission requirements:

The responses to this RFI must address at least one of the component categories described above.

1. All responses shall be unclassified

2. Document format shall be either Microsoft Word (.doc or .docx) or Adobe PDF format

3. Page limit – Five (5) 8 ½ x 11 pages

4. 1-inch margins (top, bottom, and sides)

5. Times New Roman font – 11 point

6. Page limitation does not include: 1 cover page or 1 letter of introduction

7. Do not include promotional materials

Questions pertaining to this RFI are due to the Contracting Officer, Annemarie Spence, annemarie.spence@dhs.gov and

Contract Specialist Keisha Pullen-Perry keisha.pullen-perry@hq.dhs.gov no later than 2:00 PM (EST) on Monday, September 23rd 2019. The subject line of the email shall contain the following: Questions for RFI TBD – BD21-

Surveillance & Detection Technologies.

Only electronic submissions will be accepted and are to be sent only to the Contracting Officer, Annemarie Spence, annemarie.spence@hq.dhs.gov and Contract Specialist Keisha Pullen-Perry keisha.pullen-perry@hq.dhs.gov no later than

2:00 PM (EST) on Friday, September 27th, 2019. The subject line of the email shall contain the following: Response to RFI

Notice TBD – BD21- Surveillance & Detection Technologies.

CWMD reserves the right to review late RFI submissions.

Company-to-Company NDA

Responses to this RFI will be reviewed by technical experts within the CWMD and other federal agencies. DHS uses support contractor personnel to assist in the review of RFI responses. The support contractors are bound by NDAs with the Government. Nonetheless, the Federal Acquisition Regulation (FAR) at Subpart 9.505-4(b) requires that whenever a Government contractor gains access to proprietary information of other companies in performing advisory and assistance services for the Government, the companies must agree to protect the information from unauthorized use or disclosure for as long as it remains proprietary and refrain from using the information for any purpose other than that for which it was furnished.

The FAR further requires that the contracting officer shall obtain copies of these agreements and ensure that they are properly executed.

Accordingly, any submission in response to this RFI that is considered to be proprietary, and contains proprietary information must include a signed NDA with the following companies:

• HWC, Andy Klein, aklein@hwcinc.com, (703) 901-5232

• SAIC, John Laszakovits, John.laszakovits@associates.hq.dhs.gov, (202) 203-3228

• Gryphon Shaffer, Jeanne Ralls, Agreements@GryphonTechnologies.com, (202) 621-1100

• JRADS, Terri Hague, thague@jrad.us, (804) 965-1561

• SPA, Gerri Harper; gharper@spa.com, (703) 399-702

The Government does not dictate the form or content of the NDA; that is a business decision between the companies. However, a sample NDA is included as an Attachment. This form has been pre-approved by the companies named above. Use of the sample agreement, or one substantially similar to the sample, will expedite signature. It is important for all respondents to mailto:annemarie.spence@dhs.gov mailto:keisha.pullen-perry@hq.dhs.gov mailto:annemarie.spence@hq.dhs.gov mailto:keisha.pullen-perry@hq.dhs.gov mailto:aklein@hwcinc.com mailto:John.laszakovits@associates.hq.dhs.gov mailto:Agreements@GryphonTechnologies.com mailto:thague@jrad.us mailto:gharper@spa.com understand that without signed NDAs with all above-named contractors, your RFI submission cannot be reviewed. It is the vendor’s responsibility to provide these signed NDAs in order to be responsive to this RFI. The companies named above are under no obligation or compunction to agree to other more onerous company-provided NDAs, and potential quoters/offerors that submit onerous NDAs for signature assume the risk that the above-named companies will not agree to such terms.

IMPORTANT NOTE: If your response to this RFI does not contain proprietary information, and is not marked as such, there is no requirement for a Non-Disclosure Agreement.

ATTACHMENT 1

Technology Readiness Levels

Technology Readiness Levels are a set of nine graded definitions or a description of stages of technology maturity. A copy of the definitions is provided below for convenience.

Technology Readiness Level Description

1. Basic principles observed and reported.

Lowest level of technology readiness. Scientific research begins to be translated into applied research and development.

Examples might include paper studies of a technology's basic properties.

2. Technology concept and/or application formulated.

Invention begins. Once basic principles are observed, practical applications can be invented. Applications are speculative and there may be no proof of detailed analysis to support the assumptions. Examples are limited to analytic studies.

3. Analytical and experimental critical function and/or characteristic proof of concept.

Active research and development is initiated. This includes analytical studies and laboratory studies to physically validate analytical predictions of separate elements of the technology.

Examples include components that are not yet integrated or representative.

4. Component and/or breadboard validation in laboratory environment.

Basic technological components are integrated to establish that they will work together. This is relatively "low fidelity" compared to the eventual system. Examples include integration of "ad hoc" hardware in the laboratory.

5. Component and/or breadboard validation in relevant environment.

Fidelity of breadboard technology increase significantly. The basic technological components are integrated with reasonably realistic supporting elements so it can be tested in a simulated environment. Examples include "high fidelity" laboratory integration of components.

6. System/subsystem model or prototype demonstration in a relevant environment.

Representative model or prototype system, which is well beyond that of TRL 5, is tested in a relevant environment. Represents a major step up in a technology's demonstrated readiness.

Examples include testing a prototype in a high-fidelity laboratory environment or in a simulated operational environment.

Technology Readiness Level Description

7. System prototype demonstration in an operational environment.

Prototype near, or at, planned operational system. Represents a major step up from TRL 6, requiring demonstration of an actual system prototype in an operational environment such as an aircraft, vehicle, or space craft. Examples include testing the prototype in a test bed aircraft.

8. Actual system completed and qualified through test and demonstration.

Technology has been proven to work in its final form and under excepted conditions. In almost all cases, this TRL represents the end of true system development. Examples include developmental test and evaluation of the system in its intended weapon system to determine if it meets design specifications.

9. Actual system proven through successful mission operations.

Actual application of the technology in its final form and under mission conditions, such as those encountered in operational test and evaluation. Examples include using the system under the operational mission conditions.

Technology Readiness Levels Determination Flowchart

Request for Information # – Attachment

SAMPLE

COMPANY TO COMPANY

NON-DISCLOSURE AGREEMENT

As prescribed in the Federal Acquisition Regulation (FAR) at Subpart 9.505-4(b), the Parties to this Non-Disclosure Agreement hereby agree that [Name of CWMD Support Contractor] may have access to proprietary information of [Name of Company Submitting Proposal] contained within the information submitted to the U.S. Department of Homeland Security (DHS) Countering Weapons of Mass Destruction (CWMD) in response to Request for Information No. [fill in RFI Number] solely to perform technical advisory services for the Government, in reviewing information submitted in response to the above-referenced RFI.

The Parties Agree to protect the proprietary information from unauthorized use or disclosure for as long as it remains proprietary, and to refrain from using the information for any purpose other than for that which it was furnished. This Agreement is enforceable at law. A signed copy of this Agreement will be furnished by the quoter/offeror to the Contracting Officer.

Name of CWMD Support Contractor Name of Submitting Company

Printed Name of Printed Name of Authorized CWMD Support Contractor Authorized Submitting Company Official Company Official

Signature of Signature of Authorized CWMD Support Contractor Authorized Submitting Company Official Company Official

Dated Dated

NOTE: A Non-Disclosure Agreement (NDA) is not required unless the RFI submission contains company proprietary information, and is marked as such. Non-proprietary RFI submissions may be made with an accompanying NDA.