REQUEST FOR INFORMATION_NSIS_PM Final.docx

Request for Information (RFI) Non-Targeted Sequencing Identification System (NSIS)

W911SR-25-RFI-NSIS

DISCLAIMER.

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 in the future. Solicitations are not available at this time. Requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this RFI is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on SAM.gov. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement.

The information provided in this RFI is subject to change and is not binding on the Government.

All submissions become the property of the Government and will not be returned. 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.

The results of this market research will contribute to determining the method of procurement if a requirement materializes. Based on the responses to this RFI/market research, this requirement may be set-aside for small businesses (in full or in part), procured through full and open competition, or awarded against a single- or multi-vendor Indefinite Delivery/Indefinite Quantity (ID/IQ), including a GSA vehicle. Multiple awards may be made. All small business set-aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding submissions.

1.0 INTRODUCTION

Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Joint Project Manager – Chemical, Biological, Radiological, and Nuclear Sensors (JPM CBRN Sensors), Joint Product Manager for Biological Detection Systems (JPM BDS) office is interested in gathering information from industry on capabilities for untargeted metagenomic sequencing and advanced bioinformatics solutions. These capabilities are in support of the Non-Targeted Sequencing Identification System (NSIS) for the National Guard Bureau (NGB) Weapons of Mass Destruction Civil Support Teams (WMD-CST) and other Joint Force customers (US Army, US Marine Corps, US Navy, US Air Force). The industry source(s) must have expertise in the development of sequencing technologies appropriate for both field operators with little to no technical acumen in sequencing and related microbiological workflows, as well as more advanced technical users operating within a mobile laboratory setting. Special emphasis will be placed on technologies that are portable and can be used in a field environment. Automated solutions for sample and library preparation are preferred but not required.

Potential NAICS Code: 541714 - Research and Development in Biotechnology (Except Nanobiotechnology)

2.0 BACKGROUND

The NSIS is an untargeted metagenomic sequencing-based program for the NGB WMD-CST and other Joint Force customers. It provides a mature, rapid biological sequencing capability with the potential to identify an unlimited number of biological warfare agents (BWA), including emerging, engineered, or enhanced organisms. NSIS benefits the warfighter by reducing identification time, enabling decision support to all command echelons.

In its Title 32 capacity, NGB deploys WMD-CST units in support of an Incident Commander at the federal, state or local level, providing analysis of CBRN threats at National Security Special Events (NSSE) and other domestic incidents of suspected terrorist use of WMD. WMD-CST units operate the Analytical Laboratory Suite, utilizing specialized instrumentation (accredited by the American Association for Laboratory Accreditation to conform to ISO 17025 Laboratory Standards) to identify potential chemical and biological threat agents at the field confirmatory level. Through the Unified Command Suite, the WMD-CST has the capability to transmit digital sample information (both NIPR and SIPR interfaces) to state and federal laboratories for more advanced analysis by appropriate experts. WMD-CST units also send a split sample of the suspected substance to reachback facilities within the Integrated Consortium of Laboratory Networks (ICLN), to obtain theater validation and/or definitive confirmation of the identity of a CBRN agent. NSIS will allow the WMD-CST units to rapidly identify emerging or modified pathogens whose targets are not present in currently fielded biological identification technologies, providing Integrated Early Warning for first responders and medical professionals.

JPM CBRN Sensors is also interested in industry capabilities in untargeted, metagenomic sequencing to support other potential Joint Force customers (US Army, US Marine Corps, US Navy, US Air Force). The Government is interested in workflows and End User Devices that can be used by both General Purpose Forces and more technically trained CBRN Defense formations. Solutions for the General Purpose Forces should be portable and usable by nontechnical personnel wearing CBRN protective garments up to Mission-Oriented Protective Posture (MOPP) IV. These users should be able to demonstrate proficiency with the system following a brief training period of 1-2 weeks. Solutions for more technically trained CBRN Defense formations should also be portable and usable by personnel wearing up to MOPP IV. Automated sample and library preparation instruments are preferred, but not required, for these users. For both sets of users, reagents and consumables that are shelf-stable for one year or more are preferred to those requiring cold-chain storage; however, the Government will consider cold-chain storage at this time.

3.0 REQUESTED INFORMATION OF INTEREST

The Government is interested in parties who have the capability and technology to meet the requirements set forth below, has a mature (Technology Readiness Level (TRL) 8 or above) sequencing hardware solution, and is preferably commercially available. Technology should be able to identify organisms within both simple and complex sample types (see C below for definitions), down to 10^3 colony-forming units/mL for bacteria and 10^4 plaque-forming units/mL for viruses. If the capability is currently not that sensitive, the Government will consider alternatives, provided there is a documented plan, including test and evaluation, for achieving this sensitivity level.

The Government is interested in vendors who can provide bioinformatics software usable by Joint Force General Purpose Forces and CBRN Defense formations who operate outside of a laboratory environment. Software should present a clear “Threat/No Threat” result to the user within 120 minutes of beginning a sequencing run (preferably sooner). The data file should be exportable/downloadable to a Government-approved storage device to be sent to a Reachback laboratory for confirmatory analysis as needed.

The Government is interested in vendors who can provide bioinformatics software usable by technically trained CBRN forces in a mobile laboratory environment. Solutions should meet the following requirements within a 36-48 month development timeline (preferably sooner):

A) Threat detection software/algorithms for DNA and RNA pathogens should operate on a commodity hardware device, such as a tablet or laptop. The ideal bioinformatics software would be capable of being used on existing government computing assets. To that end, please provide the computer hardware requirements needed to use the identified bioinformatics solution. Special emphasis will be given to solutions that employ Artificial Intelligence/Machine Learning tools that can detect threat signatures much more quickly upon subsequent encounter.

B) Graphical User Interface (GUI), visualizations, and reporting frameworks should enable real-time, in-field interpretation with the ability to provide detailed technical sequencing reports for advanced analyses as needed (greater level of detail than a simple “Threat/No Threat” result).

C) Software should be able to assess the functional threat potential of multiple sequences identified together in one sample, for both simple and complex sample types. Examples of simple sample matrices include bulk powders, liquid cultures, and colonies from a petri dish. Examples of complex sample matrices include air filters, swabs/swipes, vegetation, soil, and wastewater.

D) Provide the User the ability to optionally download and export interactive reports for analysis at a validated Reachback facility.

E) Provide a robust genomic database (both DNA and RNA) suitable for identification of Sequences of Concern and Genetically Modified Organisms. The database should be able to be run offline in areas where internet connectivity is limited.

F) Bioinformatics reports should be compatible with NGB WMD-CST reporting channels through the Unified Command Suite, out to federal, state, and local partner laboratories and agencies. Special consideration will be given to software solutions that are able to integrate into the Android Team Awareness Kit (ATAK), Mobile Field Kit (MFK), and CBRN Support to Command and Control (CSC2) information-sharing environments.

NOTE: The sequencing hardware and bioinformatics software may be from the same vendor, or from multiple vendors.

If your organization has the potential capability to provide the required products/services, please provide the following information:

1) Organization name, address, primary points of contact (POCs) and their email address, website address, telephone number, type of ownership for the organization and North American Industry Classification System (NAICS). Unique Identity ID (created in SAM.gov).

2) Please identify your business as either Small Business (including Alaska Native Corporation and Indian tribes), Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUB-zone Small Business, Small Disadvantaged Business (including Alaska Native Corporation and Indian tribes), Women-Owned Small Business, or a Large Business.

3) A brief capability statement with the ability to meet the requirements set forth in this RFI, and provide feedback indicating if your technology can or cannot meet the requirements. In the event the technology cannot currently meet the requirements, but is intended to in the future, the Respondent shall provide the specified timeline for meeting the requirements. Each submission shall include: 1) Proposed System Description, 2) Describe if it meets the Government’s requirements “as is” or needs modification (either minor or significant), 3) Estimated Technology Readiness Level (TRL) of the proposed system, both currently and at completion.

4) Please provide (if available) test reports and/or third-party accreditation or other documentation that demonstrates the system’s ability to meet the NSIS requirements.

5) If applicable, if the system has achieved American Association for Laboratory Accreditation ISO 17025 Laboratory Standards, please provide a copy of the scope and categories of the accreditation.

6) If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. (Please note the 50% limitation on subcontracting under Small Business Set Aside, in accordance with FAR 52.219-14 Limitations on Subcontracting).

7) Provide a Rough Order of Magnitude (ROM) per unit manufactured to include warranty. Provide information on price breaks for quantity, if applicable.

8) The average number of units per month currently produced (if any); the projected minimum and maximum number of units per month production capacity; time required to obtain critical component(s).

9) Describe any Intellectual Property and type of Data Rights.

10) If the development has been funded in the past by the federal government, including Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs, please indicate year awarded, federal agencies participating, phase, and project title.

4.0 SUBMISSION, PAGE LIMITATIONS, AND DUE DATES

The Government is requesting that responses to this RFI do not exceed ten (10) total pages. Your response to this RFI, including any capabilities statement, shall be electronically submitted to Contract Specialist, Kevin Rohe (kevin.t.rohe.civ@army.mil) in Portable Document Format (PDF), via email no later than 12:00 p.m. Eastern Standard Time on 12 December 2024 and reference “W911SR-25-RFI-NSIS” RFI in the subject line of the-mail and on all enclosed documents. Information and materials submitted in response to this request will become property of the Government and WILL NOT be returned. DO NOT SUBMIT CLASSIFIED MATERIAL. No phone calls will be accepted.

All questions must be submitted no later than 12:00 p.m. Eastern Standard Time on 27 November 2024. Questions shall NOT contain proprietary or classified information. An unattributed list of questions and answers will be posted at the same location of this RFI.

5.0 ATTACHED DOCUMENTS

1) TRL Definitions