The U.S. Army Contracting Command-Aberdeen Proving Ground,Natick Contracting Division, Ft. Detrick Branch on behalf of the Joint Program Executive Office for Chemical Biological Radiological and Nuclear Defense (JPEO CBRND) is issuing this Request for Information (RFI) solely for information and planning purposes; it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP. This RFI does not commit the Government to a contract for any supply or service. Responders are advised that the US Government will not payany cost incurred in response to this RFI. Not responding to this RFI does not preclude participating in future RFPs. This RFI is for Joint Health Risk Management - Environmental Hazard and Health Effects Monitoring Technologies. While theNAICS Code being used to post this RFI is: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), size standard 1,000, we are also looking for companies who qualify under NAICS codes 334516 Analytical Laboratory Instrument Manufacturing, 334511 Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing, and 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing.
The JPEO-CBRND, in collaboration the Defense Health Agency (DHA), is conducting a Joint Health Risk Management (JHRM) Enhanced Capability Demonstration (ECD) in calendar years 2019 and 2020 with the intent of clarifying requirements and accelerating the formulation of an Joint acquisition program for Warfighter environmental exposure monitoring and health hazard assessment and mitigation capabilities. The desired outcome is a Joint health risk management system that is fully embedded with warfighting so that it is "always on" when needed and fully integrates exposure and health effects monitoring for a broad range of adverse exposures to include CBRN, Toxic Industrial Chemicals (TIC), Toxic Industrial Materials (TIM) (e.g., particulates), naturally occurring disease, and environmental hazards such as noise, heat, and blast. The JHRM ECD will be working with existing Department of Defense occupational environmental health programs and relevant research programs to avoid duplication of effort. TheJHRM ECD will focus on:
• Identifying and demonstrating the highest value, operationally suitable, and affordable individually wearable environmentalexposure monitoring applications for deployed environments that will be mature in the 2019 to 2024 time period
• Identifying advanced materiel solutions for point and area monitoring and field analytics for priority TIC and TIMs listed in the attachment.
• Methods for associating individually worn,point, area, and standoff environmental sensor data with unit and Service Member identity and location to better estimate actual exposures
• Ingestion of data from sensors and cloud base data repositories to decision support tools to enhance environmental health hazard assessment and mitigation decision making
• Ensuring individual exposure data collected is available to battlefield decision makers to support real time health risk assessment and mitigation decision making and is retained in individual longitudinal records
A broad range of potential "sensing" materiel solutions may be applicable tothe JHRM ECD:
• "Outward looking" Individually wearable environmental hazard detectors and/or samplers
• "Inward looking" Individually wearable physiological status, health effects, and biomarker monitoring applications (non-invasive and invasive in vitro and in vivo devices and validated model of health effects)
- note: wearable sensing applications will be integrated with existing DoDon-body communications solutions.
• Point / handheld sensors for TICs& TIMs
• Miniaturized unattended ground sensors for area hazard monitoring or meteorological data collection
• Innovative lightweight power solutions for sensor applications
• Geotagging and timing devices(for individuals and also those able to be added to legacy point and areas sensors)
• Portable field analytical platforms for rapid, on-site analysisof collected environmental samples for TICs and TIMs
• Information onvalidated biomarkers for pre-disposition and pre- and post-deployment screeningfor exposure or health effects of ambient environment and man-made environmental hazards. Biomarkers are defined in the Joint U.S. Food and Drug Administration(FDA) and the National Institutes of Health (NIH) Biomarkers, Endpoints, and other Tools (BEST) resource available for free download at https://www.ncbi.nlm.nih.gov/books/NBK326791/
• Self-sampling devices for collection and preservation of clinical sample matrices while deployed (related to post-deployment lab analysis of transient biomarkers of exposure or effect)
Envisioned Capability: The envisioned JHRM end state capability would employtask organized capability sets based on mission, threat, and the man-power and logistical capacity of the force to manage environmental health risks. A future capability set may include:
• Initial pre-disposition screening to allow individually tailored risk management strategies
• Pre-deployment baseline assessments (health and exposure biomarker baselines)
• Size, weight, power, hands-on-time, and expertise constrained set of combat deployable wearable, point, area sensors, environmental and clinical samplers, and field analytical tools appropriate to the mission and hazard - integrated with real time decision support tools for environmental hazard assessment and mitigation
• Post-deployment baseline assessments and analysis of on-mission collected clinical samples
Respondents are requested to address the followingin their response:
• The Offeror name, address, Point of Contact, email and telephone number.
• NAICS Code
• Availability of Commercial Off The Shelf (COTS) systems or prototypes for briefing or demonstrationin February 2019 timeframe
• Status of U.S. Federal or DoD regulatoryapprovals required, if applicable
• Status of UL or ENEC listings forelectrical hardware
• FDA regulated systems must be manufactured in compliance with current good manufacturing practice (cGMP)
• System is manufactured in the United States or a have a transition plan for manufacturing by a U.S. subsidiary
• Unit costs and consumable costs
• Degree of open architecture software / file formats readable without proprietary software
• Degree of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) and DoD Personally Identifiable Information (PII) as described in http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/540011p.pdf and Protected Health Information (PHI), as applicable.
• Current commercial or military applications of system
• Intellectual property position, licenses and Government Use Rights
• Technology Readiness Level (TRL) of the system - see attached TRL descriptions
• Description of the interfaces (data transmission, physical, etc.)
• Summary of Test results
• Available warranties and service agreements
Example Scenarios: The following scenarios are provided to help prospective respondents to this RFI determine the relevance of their system to the JHRM ECD.
• Sensing/sampling capability set for small independently operating teams, without a dedicated force health protection / environmental science/ preventive medicine specialist, operating in austere environments for extended periods of time (weeks). Total weight of point and area sensors < 10 lbs. per team + < 8 ozs per person for all applications combined.
• Sensing/sampling capability set for chemical decontamination company (operating in Personal Protective Equipment (PPE) on a work rest cycle for 72 hours) with dedicated force health protection support for monitoring operations.
• Sensing/sampling/field analytics capability set for employment by Force Health Protection specialist for Forward Operating Base (FOB) with air quality concerns and specific identified sources of environmental hazard (waste disposal, aircraft operations, near-by host nation chemical industries and waste disposal).
1) Technology Readiness Level Definitions
2)Priority TIC and TIM list
Email all questions to the Contracting Officer, Lee Hess at email@example.com, or Contract Specialist, Robert Edwards at firstname.lastname@example.org. All Offeror(s) must email their responses to this RFI to the Contracting Officer/Specialist no later than 11:59 PM (Eastern Time) 23 Jan 2019.
The Government will not pay for any information submitted in response hereto. Responders are solely responsible for all expenses associated with responding to this RFI. This notice does not obligate the Government to issue a solicitation orto award a contract. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessaryand 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 organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receiptof the information received or provide feedback to the respondents with respectto any information submitted.
All information received in response to thisRFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
Responders must include information on their organization:
1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address.
2. DUNS Number and Cage Code
3. Confirmation of Current Active Registration in System for Award Management (SAM), SAM registration information may be found at the following website: https://www.sam.gov/portal/public/SAM
4. Primary NAICS Code(s) and Business Size (i.e., small/large)