SIS FINAL SOO 05May2026 FINAL.pdf

Unclassified

DISTRIBUTION: DoW COMMUNITY ONLY

DISTRIBUTION: DoW COMMUNITY ONLY

1.0 PROJECT TITLE: Shipboard Isolation System (SIS)

2.0 BACKGROUND/DESCRIPTION:

The SIS program on behalf of the Capability Program Executive Chemical, Biological, Radiological, and Nuclear Defense (CPE-CBRND) and Joint Project Manager for CBRN Protection is seeking prototypes to rapidly test and evaluate viable solutions to mitigate, contain, and prevent the spread of communicable disease. SIS will provide the capability to temporarily isolate or quarantine personnel, effectively preventing the spread of biological threats. The SIS will align with the United States Navy (USN) and United States Navy (USAF) priorities of enabling isolation capabilities for individuals who are experiencing symptoms of a communicable disease (i.e., biological warfare agent (BWA) or infectious disease) and/or have been exposed, or presumed to have been exposed, but are asymptomatic. Isolation and/or quarantine in the SIS will commence based on intelligence and warning, or upon detection for presence of a biological agent and in accordance with (IAW) guidelines defined in NTRP 4-02.10 para 4.3.3.

This SIS project will focus on delivering a rapid, readily available solution to address the USN and USAF requirements for an Individual Isolation and Quarantine capability. The SIS program developed requirements based on the Concept of Employment provided by USN and USAF. Attachment 1 is a complete list of SIS requirements that will be evaluated throughout the program. These requirements include Key Performance Parameters (KPPs), Key System Attributes (KSAs), and Additional Performance Attributes (APAs). Threshold and objective values are specified for each parameter.

The Government intends on making multiple prototype awards under Title 10 Section 4022 for readily available SIS solutions based on availability of Government funding. A prototype is considered successful if it, at a minimum, meets the KPP threshold requirements (Attachment 1) along with the ability to obtain FDA marketing authorization.

Follow on Production Authority In accordance with 10 U.S.C. 4022, and upon a determination that the prototype project for this transaction has been successfully completed, any competitively awarded prototype Other Transaction Authority (OTA) as a result of this Call for Solutions may result in a single award of a follow-on production contract, or transaction without the use of competitive procedures. If follow-on production is pursued, the potential magnitude could include up to 150 systems in support of operations and sustainment.

3.0 STATEMENT OF OBJECTIVES (SOO):

This Statement of Objectives will lead to the procurement of a system for assessment that will facilitate isolation and quarantine by encapsulating a patient on an ICU hospital bed or Acute Care Ward bed, or encapsulating the patient and bed, while allowing for provider care via access ports/windows. The system will maintain negative pressure to contain airborne pathogens as well as provide a physical barrier between the medical provider and any fluid-borne pathogens.

SIS will minimize medical equipment contamination, and the requirement for extensive disinfection, by providing cable/wire access through ports while allowing auxiliary equipment to remain external to the set up. The system will allow for the quick and secure delivery of food or other personal items for the patient as well as materials for routine procedures and the removal of waste or other items without breaking the airborne isolation precautions.

Contractors shall include test plans and reports and any other relevant documentation to support claimed performance characteristics including maintaining negative pressure, filtration, patient and equipment access, and operational size and weight. In addition, contractors shall disclose any unique test methods required to assess the performance of their solution.

The contractor will use this SOO as a basis for preparing a draft Statement of Work (SOW), which will be included as an integral part of the proposal. The contractor shall propose a delivery schedule in the SOW to include the number of systems that can be produced per month. The contractor shall also provide logistic details including packaging, handling, storage, and transportation requirements, as well as logistical footprints and shelf-life estimates.

The Government requires sufficient data rights to operate, maintain, and sustain the SIS.

The Government's preference is for Government Purpose Rights for all technical data and software developed with Government funding under this effort, for technical data related to interfaces (physical, electrical) necessary to comply with Modular Open System Approach (MOSA) requirements including to connect the SIS to shipboard and medical systems, and also for technical data related to form, fit and function (FFF) and operation, maintenance, installation, and training (OMIT). The specific data deliverables (e.g., as-built drawings, operations manuals, specifications) and IP licenses will be negotiated for each phase.

The contractor shall include in the Solution Brief a table form, its data rights assertions for all technical data and computer software (including non-commercial technical data and non-commercial computer software as well as commercial technical data and commercial computer software) being provided to the Government with less than an unlimited or unrestricted rights license and explain how the approach will result in the best approach, considering life cycle costs. The Government will consider the impact of the data rights

DISTRIBUTION: DoW COMMUNITY ONLY assertions in making selection decision(s). Please note that the Government reserves the right to evaluate any proposed approach that provides less than Government Purpose Rights (GPR) for the prototype design documentation and/or does not facilitate competitive procurement of hardware maintenance/sustainment services for SIS, described herein, negatively and use that information as part of its selection decision(s).

The Contractor shall provide the cost estimate in a format that allows for clear evaluation and comparison, ensuring completeness and accuracy. If possible, include assumptions, methodologies, and any relevant supporting documentation used to derive the estimate.

1. Production Costs Estimated costs for full-scale production, including materials, labor, and compliance with FDA Marketing Authorization and Berry Amendment requirements.

2. Life-Cycle Cost Estimate (LCCE) A comprehensive assessment of the system's affordability and long-term sustainment costs, including maintenance, operational support, and disposal.

3. Additional Costs Any other costs associated with meeting the requirements outlined in the Statement of Objectives (SOO) and achieving successful completion criteria for follow-on production.

The Government intends to make up to three (3) SIS prototype awards, under Title 10 Section 4022 based on availability of Government funding. All awards will undergo Phase I prototype performance testing. Upon completion of Phase I testing, the Government will downselect offeror(s) to continue to Phase II. This decision will be based on final Phase I criteria testing (Table 1) results, early user feedback, affordability of the prototype, and the availability of funds. Upon completion of testing on the Phase II prototypes, up to two (2) solutions will be selected to move forward into production based on Phase II testing (TBD prior to execution of Phase II) results, user feedback, and affordability of the prototype.

OTA Award Criteria

Technical maturity, item cost and performance will be assessed during submission evaluation. The Government will evaluate proposals for the initial Phase I award based on the following factors, listed in descending order of importance:

1. Performance Evaluate how the proposed prototype shall meet the KPP threshold requirements in Attachment 1, delivery schedule, logistics details, and data rights and assertions

2. Technical Maturity Evaluate the readiness level of the proposed solution, including prior laboratory or operational testing, Technology Readiness Level (TRL), and supporting documentation

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3. Item Cost The proposed price for the prototype system includes supporting cost breakdowns. The cost will be evaluated to determine if prices are fair and reasonable. Performance is significantly more important than technical maturity, which is more important than cost. The Government will select up to three offerors for Phase I award based on the evaluation of these factors. The evaluation of proposed solutions will be conducted in accordance with the criteria and methodologies described in this solicitation.

Phase I Prototype Testing Objective

The contractor shall deliver fifteen (15) of the same prototype systems for Phase I testing within 90 days after award. Following verification of biocontainment requirements and a user touch point to down select prototypes to continue on to Phase II. Table 1 below outlines the test objectives and methodologies and the criteria for downselect.

If an offeror does not currently have FDA authorization, they shall provide supporting documentation of their request for authorization submission.

The Government will evaluate Phase I prototypes to determine which candidates will continue to Phase II, based on the following factors, listed in descending order of importance:

1. Performance The extent to which the prototype meets or exceeds the requirements and test objectives outlined in Table 1, Phase I Criteria, as demonstrated by Government test results, data, and analysis.

2. Technical Maturity The readiness level of the prototype, including prior laboratory or operational testing with the Government’s validation, TRL, and supporting documentation that demonstrates the system’s ability to meet the KPP threshold requirements in Attachment 1.

3. Item Cost The proposed price for the prototype system including supporting cost breakdowns.

The Government plans to take up to two (2) vendors into Phase II.

The Government reserves the right to update or refine evaluation criteria prior to Phase II award to ensure alignment with program objectives and operational needs, provided such updates do not alter the requirements specified in Attachment 1.

Table 11: Phase I Test Criteria

Requirement Test Objective Test Method (or Equivalent)

Primary Criteria Secondary Criteria

Operational Size

Evaluate system operational size. Verify ICU bed

(NSNs 6530-01-690-8324 & 6530-01-527-3820) enclosure and surrounding space.

Laboratory Testing/EUT Pass/fail at Threshold

Operational Weight

Evaluate individual component weight MIL-STD-1472 Pass/fail at Threshold

Negative Pressure

Assess pressure during mission operations

Test Plan, Centers for Disease Control and Prevention Morbidity and Mortality Weekly

Report, Vol. 54 No. RR- 17, 30 December 2005

Negative pressure differential of 2.5

Pascals

Higher than 2.5 Pascals but not to exceed 12.5 Pascals

Air Exchange Assess air changes per hour (CFM x 60min)/Volume ≥12 ACH More is best

Directional Airflow Assess airflow direction Laboratory Testing/EUT Pass/fail

Filtration Efficiency

Assess filtration efficiency during mission operations DOE-STD-3025-2022

99.97% at 0.3-micron particle diameter More is best

System Interruption Alert

Evaluate alarm(s) when pressure increases above limits Laboratory Testing/EUT

Alert system visually and/or audibly when pressure differential is not within limits

Visual and audible alerts

Liquid Containment Demonstrate containment Laboratory Testing/EUT No leakage

Set up Demonstrate set up requirements Laboratory Testing/EUT 2-person

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Access

Evaluate patient entry and exit Laboratory Testing/EUT Pass/fail at Threshold

Evaluate patient access through glove and trunk ports

Laboratory Testing/EUT; ASTM

D1003; ASTM F1671;

test method 2 of NFPA

701; ASTM D1922;

ASTM F1342.

Full patient access

Evaluate Patient Visibility Full patient visibility

Evaluate Equipment ports ≥5 cable/hoses; equipment/food

Power

Demonstrate power connectivity. Minimum battery operation of60 minutes and rechargeable in 4 hours.

Laboratory Testing/EUT Pass/fail at Threshold

Electromagnetic Effects

Assess electromagnetic interference (EMI) MIL-STD-461G Less is best

Noise Evaluate Noise level MIL-STD-1474 ≤60 dBa Continuous Operation

Demonstrate continuous operation Laboratory Testing/EUT 2-weeks

Maritime Stability Demonstrate bed security Laboratory Testing/EUT Must be secured Multiple fastening locations

Storage Size

Evaluate total storage size of all containers and that they can be transported throughout the ship.

Laboratory Testing/EUT

MIL-STD-2073-1

Smaller is best with the fewest storage containers

Storage Weight Demonstrate packed, individual storage containers MIL-STD-1472 Meet MIL-STD-1472

Lighter is best with the fewest storage containers.

Vibration of packed storage containers

Demonstrate MIL-STD-167-1, MIL-STD-810 Pass/fail at Threshold

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Environmental Conditions

Demonstrate protection from corrosive environments

MIL-STD-810H: Salt fog, hot/cold, sand/dust, humidity, fungus

Minimal damage, no operational impact

No physical or operational change

Shelf Life Verify shelf life ASTM F1980 5 years Longer is best

Disinfection Demonstrate material compatibility Laboratory Testing/EUT

Compatibility with 9% calcium hypochlorite

Longer is best

Human Systems Integration (HSI) Assess HSI EUT User feedback

Numerical comparison between prototypes *EUT – Early User Touchpoint: Structured event where representative users interact with a system or prototype to provide practical feedback that informs usability, human-systems integration, and acquisition decisions.

The Government reserves the right to update or refine evaluation criteria to ensure alignment with program objectives and operational needs, provided such updates do not alter the requirements specified in Attachment 1.

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Phase II Prototype Testing Objective:

Contractors selected for Phase II shall deliver fifteen (15) of the same prototype systems for testing within 60 days after notification of successful downselect. Phase II testing will include a logistics and maintenance demonstration conducted during an operational evaluation by the designated Lead Operational Test Agency (LOTA). While specific testing activities for the operational demonstration have not yet been finalized, the Government will provide detailed evaluation criteria and testing requirements to contractors at the time of Phase II award. All testing conducted during Phase II will focus on verifying that the prototype systems meet the requirements outlined in Attachment 1 of this solicitation, specifically those requirements that were not tested during Phase I.

Final Prototype Selection Criteria:

The evaluation factors for the final selection (following completion of Phase II testing) will include, at a minimum:

1. Performance Results of all testing conducted in Phases I and II, as measured against the requirements in Attachment 1 and successful FDA marketing authorization.

2. User Feedback Usability and human systems integration, as assessed during operational evaluation and user touchpoints.

3. Affordability Overall cost, including production cost, life-cycle cost, and sustainment.

The relative order of importance for these factors will be provided prior to Phase II award.

At this time, performance is anticipated to be the most important factor, followed by user feedback, then affordability. The Government reserves the right to update or refine evaluation criteria prior to Phase II award to ensure alignment with program objectives and operational needs, provided such updates do not alter the requirements specified in Attachment 1. The Government reserves the right to award one (1) or more production follow on contracts or transactions.

4.0 DATA DELIVERABLE(S):

The contractor will submit all reports to the Agreement Officer's Representative (AOR) in the final negotiated formats. The Government and contractor will agree on format and content.

4.1 Start of Work Meeting and Meeting Minutes.

The contractor shall conduct a Start of Work meeting that includes a technology and system overview at the contractor facility one month after award. The start of work meeting will include technology and system overview, establishment of baseline, schedule, and ss. Meeting minutes will also be provided as a deliverable.

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4.2 Integrated Master Schedule (IMS)

The contractor is expected to manage the prototype delivery using a shared IMS. The contractor should propose the creation, maintenance and update of an IMS. The IMS is expected to detail the durations of project tasks/sub-tasks. The Government anticipates that the IMS will be updated monthly. The contractor’s SOW should address this requirement fully.

4.3 Technical Data Package (TDP)

The contractor will develop and deliver a TDP, that includes detailed drawings, Cage Code, user manual, detailed information on the components, sub-assemblies, and materials upon delivery of the manufactured prototypes. The TDP will be IAW MIL-STD- 31000B. The final TDP shall be delivered with the prototypes in Phase II.

4.4 Safety and Environmental Documentation

The SOW will address the provisions of the Safety Assessment Report (SAR), Safety Data Sheets, and Storage/Disposal criteria. The SAR will summarize safety and health hazard data, provide a comprehensive evaluation of the safety and health risks, and identify procedures/precautions required for safe use of the system/subsystem and prototypes. All Safety and Environmental Documentation shall be delivered with the prototypes in Phase 1.

4.5 Berry Amendment Compliance

The contractor shall verify that they meet the specified domestic sourcing standards outlined in the Berry Amendment. Contractors will provide detailed information on all items manufactured or sourced from outside of the United States, per the Call for Solutions.

4.6 Manufacturing Capability

The contractor shall provide an overview of their manufacturing capabilities and quality system, current production rates, as well as ability to scale production for higher demands.

4.7 Regulatory Strategy

For systems that do not possess FDA marketing authorization at the time of award, the Awardee shall deliver a Regulatory Strategy that identifies and rationalizes a marketing pathway in alignment with ISO 13485:2016 NLT30 days after award. It is then expected that strategy be delivered following each update (for example, following receipt of FDA feedback, analysis of test data, etc.). Following each delivery, the Government will respond with comments and/or acceptance within 10 business days;

feedback will be incorporated as appropriate.

4.8 Quality Assurance Program Plan (QAPP)

The Awardee shall provide a QAPP, including the Awardee's Quality Manual, NLT 30 days after award. The QAPP will be updated and submitted when changes occur to the Quality Management Plan, following each delivery, the Government will respond with

DISTRIBUTION: DoW COMMUNITY ONLY comments and/or acceptance within 10 business days; feedback will be incorporated as appropriate.

4.9 Sponsor Authorization Letter

The Awardee shall include with any Regulatory Submission (Pre-Submission or Marketing Authorization Filing) a fully executed sponsor authorization letter enabling FDA to disclose information to CPE-CBRND and its government support contractors related to the proposed product under Public Law 115-92. See Attachment 2 for template of Sponsor Authorization Letter.

4.10 FDA Communications

The Awardee shall provide the Government regulatory representative with all communications to and from the FDA or other regulatory authorities regarding regulatory and quality activities relevant to the technology to include, but not limited to: informal communications, draft and final communications regarding formal meetings (e.g. Pre- Submission) and submissions under review, feedback, minutes, draft and final submissions for marketing authorization. The Government will respond with comments and/or acceptance within 10 business days of receipt. Government feedback will be incorporated as appropriate.

The Awardee, or regulatory sponsor if not the Awardee, must designate a Government representative as the co-contact for all such communications.

The Awardee shall ensure that the Government representative and at least one representative of the Government funding entity receive invitations to FDA meetings and regulatory discussions applicable to this Project.

4.11 Testing Documentation

The Awardee shall deliver the following documentation associated with validation and/or demonstrating performance: draft protocols/test plans, final versions of protocols/test plans with adjudication of Gov't provided review/comments.

The Awardee shall deliver documentation of Institutional review board (IRB) and Office of Human Research Oversight (OHRO) approval(s) in accordance with DFARS Clause 252.235-7004 prior to the start of any activities that make use of human specimens, data, and/or subjects.

4.12 Regulatory Audits and Inspections Data

In the event of an International Organization for Standards (ISO) or U.S. Food and Drug Administration (FDA) inspection that occurs at the Contractor facilities or of the Contractor records, the Contractor shall notify the USG within 48 hours. The Contractor shall provide the USG with a copy of the FDA Form 483 and the Establishment Inspection Report (EIR), and/or ISO Audit Findings and Non-conformances, upon receipt.

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The Contractor shall provide the plan for addressing areas of non-conformance as identified in the report, status updates during the plan’s execution, and a copy of all final responses to the FDA within 10 business days of generation.

The Contractor shall provide copies of any ISO or FDA audit or inspection reports received from subcontractors involved in or related to this technology, upon receipt.

For Government audits/site visits, documentation requested by the Audit team prior to audit will be provided.

Upon completion of Government audits/site visits of the Awardee, the Awardee shall provide a report capturing findings or results, to include plans for addressing findings or areas of concern to the Government within 15 business days of audit completion.

Upon completion of audits/site visits of subcontractors and suppliers, the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, concerns for addressing areas of non-conformance will be detailed and provided to the Government within 15 business days of audit completion.

5.0 PROTOTYPE DELIVERABLE(S):

The contractor shall deliver Phase I prototypes and associated data deliverables within 90 days of project award, unless an alternate timeframe is agreed upon with the Government. If authorized to proceed to Phase II, the contractor shall deliver Phase II prototypes and associated data deliverables within 60 days of authorization, or as otherwise agreed upon with the Government. Delivery locations for each phase are expected to be within CONUS.

6.0 PERIOD AND PLACE OF PERFORMANCE:

The contractor will propose a delivery schedule in its SOW to include prototype and data delivery. Prototype development will be conducted at the contractor’s facilities.

7.0 AGREEMENTS OFFICER REPRESENTATIVE (AOR):

Katrina Jewell

SIS

katrina.jewell@usmc.mil 703-617-2424 mailto:katrina.jewell@usmc.mil

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Attachement 1 – SIS Requirements

Parameters / Attributes

Requirements Threshold Objective

Key Performance Parameters

KPP 1:

Operational Size Encapsulate a shipboard ICU bed or a patient on the ICU bed and exterior height be no more than 76 in (H) to conform to ship class specifications. (T=O)

KPP 2:

Operational Weight

All individual components and sub-assemblies shall require no more than 2 Service members for set up. (T=O)

KPP 3: Storage container Size

As few and small as practicable; should be able to fit through a standard U.S. Navy shipboard door. A standard Quick Acting Watertight (QAWT) ship door is 26 in x 66 in with 8 in radius corners. (T=O) Entire system shall fit within one skid box (Tri-walls or ROPAK) with typical dimensions of 45.2 in (L) x 42 in (W) x 37 in (H). (T=O)

KPP 4: Storage Weight individual storage containers that, when packed, shall require no more than 2 Service members for transport. (T=O)

Entire system shall not exceed 200 lbs.

total. 150 lbs. total

KPP 5:

Shipboard

Adaptability

System must remain stable in operational configuration and not be damaged throughout maritime conditions, with provisions for securing the ICU bed to D-rings embedded in the ship floor. (T=O)

KPP 6: Negative Pressure

Differential

Maintain a consistent negative 2.5 Pa (0.01 IWG) pressure differential within the isolation space compared to the external space during standard operations to include performing patient care and passing medical equipment into isolation space.

Maintain a consistent negative 12.5 Pa pressure (0.05 IWG) pressure differential within the isolation space compared to the external space during standard operations to include performing patient care and passing medical equipment into isolation space.

Provide ≥12 Air Changes per Hour (ACH) with directional airflow inside the isolation space that flows from high to low and along the length of the isolation space.

Provide ≥25 ACH.

KPP 7: Filtration Efficiency

The system shall prevent the passage of particles from inside the containment system to outside the containment system: greater than or equal to 99.97% efficiency at 0.3 micron (i.e., HEPA) and have an inlet air filter.

The system shall prevent the passage of particles from inside the containment system to outside the containment system:

greater than 99.999% efficiency at 0.1 micron (i.e., ULPA).

KPP 8: Patient Access

System shall include glove ports located near patient’s head, torso, and feet.

Glove ports located near patient’s head, torso, and feet, on left and right side of the patient.

System shall have at least one gloved, lean-in window. Multiple gloved, lean-in windows.

System shall have a trunk port to capture patient vital signs while maintaining a protective barrier.

Trunk ports located near the patient’s head and torso, on left and right sides of the patient.

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The system shall provide a barrier between the patient and healthy individuals to prevent cross-contamination. The barrier must provide full visibility of the patient (T=O)

The system shall meet all regulatory compliance requirements to obtain FDA marketing authorization. (T=O)

KPP 9: Mission Length 2-week mission. 4-week mission.

KPP 10: Liquid Containment Shall contain at least 6L of liquid for the duration of the mission. (T=O)

Key System Attributes

KSA 1:

Operations at Elevation

72 hours at sea level at 10,000 ft elevation. 96 hours at sea level at 10,000 ft elevation.

KSA 2: Alarms Visual and/or audible alarms to alert when space is not within limits for pressure.

(e.g., green, yellow, red indicators).

Visual and audible alarms with digital readout for metrics.

KSA 3:

Equipment

Access

System should have pass-through interfaces from the system exterior to interior. Utility ports for at least 5 cables/hoses.

Larger utility port that allows medical supplies, food, and equipment to be passed from the outside to the inside of the isolation space without compromising negative pressure.

KSA 4:

Reusability

The system design should maximize reuse of system components not in direct contact with the patient contamination (frame, filtration, pressure sensors, lighting, etc.). (T=O)

KSA 5: Power

3-Pronged plugs with capabilities to support shipboard power and on a military power grid – 120 VAC, 60 Hz, single phase.

Capable of operating on a military power grid and back up battery power with (ability to hot swap; compatible with rechargeable and/or non-rechargeable batteries available within the DOD inventory; real-time display of battery power percentage remaining;

visible low battery warning). System must still operate without a battery installed.

System noise level will be ≤60 dBA.

Additional Performance Attributes

APA 1:

Supportability

The system should have reliability for continuous operations of ≥ 0.95 without an Operational Mission Failure.

≥0.99 without an Operational Mission Failure.

For all field level corrective maintenance actions, Mean Corrective Maintenance Time (MCMT) for the system must not exceed 30 minutes.

≤ 15 minutes.

Once familiarization training has been completed, receipt, storage, and set-up must be possible by two operators.

One operator.

Set up time to fully operational, including function checks, within 15 minutes. 10 minutes.

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APA 2:

Disinfection

System materials should not degrade during decontamination using 9% HTH solution in seawater for a contact time of 30 minutes.

System materials should not degrade during decontamination using 9% HTH solution in seawater for a contact time of 60 minutes.

APA 3: Storage Container

The stowed configuration should be transportable by air, ground, and sea modes. (T=O)

Storage containers should safeguard contents from possible corrosion due to exposure to salt-laden air/water

The system (excluding filters) will have an effective shelf life of 5 years. 10 years.

ATTACHMENT 2 – Sponsor Authorization Letter

MODEL AUTHORIZATION FOR FDA TO SHARE NON-PUBLIC INFORMATION WITH

THE DEPARTMENT OF DEFENSE

[To be completed on applicant/sponsor/information-owner letterhead]

[FDA Official – e.g., Center or Office Director]

United States Food and Drug Administration 10903 New Hampshire Avenue Building __, Room ____ Silver Spring, MD 20993

[Identify relevant FDA Tracking number - e.g., NDAIANDA / BLA, EUA/Pre-EUA, master file, etc.)]

Re: FDA Sharing of Non-Public Information Concerning [insert name of regulated product(s)] with Department of Defense (DoD) Partners1

On behalf of [insert name of information owner], I authorize the United States

Food and Drug Administration (FDA) to share with the U.S. Department of War’s Capability Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND), and with DoD Partners identified by the CPE-CBRND Senior Director Medical Regulatory in coordination with the Program Manager as necessary for the effort, all information concerning the above described product(s) that [insert name of information owner] has provided or will provide to FDA or to any other DoD Partner. I understand that JPEO-CBRND and DoD Partners have committed or are otherwise legally required to maintain the confidentiality of such information (or both), and that contractors to DoD are bound by their contracts to maintain the confidentiality of the information. I understand that the information may contain confidential commercial or financial information or trade secrets within the meaning of 18 USC § 1905, 21 USC § 331(j), and 5 USC§ 552(b)(4), that is exempt from public disclosure. I agree to hold FDA

1 DoD Partners include the U.S. Army Medical Research and Materiel Command (USAMRMC), Joint Science and Technology Office (JSTO) of the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and other DoD entities identified by the Senior Director Medical Regulatory in coordination with the CPE Program Manager as necessary for the effort.

DISTRIBUTION: DoW COMMUNITY ONLY harmless for any injury caused by FDA's disclosure of this information to JPEO-CBRND and its DoD Partners.

Authorization is given to FDA to share this information without deleting confidential commercial or financial or trade secret information. This authorization shall remain valid unless revoked in writing. As indicated by my signature, I am authorized to provide this consent on behalf of [insert name of information owner] and my full name, title, address, telephone number, and facsimile number are set out below for verification.

Sincerely, (Signature) (Printed name) (Title) (Address) (Telephone & Facsimile Numbers) cc:

Office of Counterterrorism and Emerging Threats (OCET), Office of the Chief Scientist, FDA (EUA.OCET@fda.hhs.gov)

The primary MCM Center, as follows:

For CBER, (Counterterrorism and Medical Countermeasures Staff or CBEREUA@fda.hhs.gov)

For CDER, (Counter-Terrorism and Emergency Coordination Staff or CDEREUA@fda.hhs.gov)

For CDRH, for IVD medical devices, (device@fda.hhs.gov) and for non-IVD medical devices (cdrhemcm@fda.hhs.gov)