ADRL_POGS_Prototype.pdf

Agreement Data Requirements List (ADRL) | v1.0

Agreement Data Requirements List (ADRL)

Portable Oxygen Generator System (POGS) Prototype Project Status Active Author Project Management Office Date June 29, 2026 Version 1.0

Agreement Data Requirements List (ADRL)

Portable Oxygen Generator System (POGS) Prototype Project

1.0 Background and Purpose

2.0 Deliverable Instructions

3.0 ADRL Matrix

4.0 Notes and Additional Requirements

1.0 Background and Purpose

This document outlines the Agreement Data Requirements List (ADRL) for the Portable Oxygen Generator System (POGS) Prototype Project. This prototype effort is executed under the Other Transaction Authority (OTA) pursuant to 10 U.S.C. § 4022. The POGS is a critical medical device used in deployed field hospitals at Role of Care (ROC) 3. The system provides medical-grade oxygen to support patient care, anesthesia equipment, ventilators, and high-pressure cylinder refilling in austere and remote operational environments. The deliverables outlined in this ADRL are critical for ensuring the prototype meets all operational, technical, and regulatory requirements, including FDA clearance, cyber security compliance (MDERA), and MIL-STD-810H environmental survivability.

2.0 Deliverable Instructions

The Performer shall provide the following deliverables in accordance with the specified due dates, frequencies, and formats. Deliverables encompass hardware prototypes, technical manuals, regulatory documentation, and programmatic reports. The Agreements Officer Representative (AOR) and designated Government stakeholders will review all submitted data and documentation to ensure adherence to the Critical Operational Device Specifications (CODS) and Critical Logistical Specifications

(CLS).

3.0 ADRL Matrix

ADRL Deliverable Due Date / Frequency Format / Notes

D-001 Prototype POGS Units (2 per vendor)

120–180 days after award

Physical delivery (Per CODS/CLS specifications)

D-002 User/Operator Manual With unit delivery 1 Physical, 1 Digital per device (English language)

D-003 Maintenance/Service Manual With unit delivery 1 Physical, 1 Digital per device (English language)

D-004 Repair Parts List 15 days after award Electronic spreadsheet (Identifying high-failure parts, OEM/commercial availability)

D-005 MDERA Questionnaire 30 days after award Digital PDF (Completed PM SMD template)

D-006 TAA Compliance Certificate With proposal / At Award Signed Document (DFARS 252.225-7020)

D-007 Training - On-Site CONUS Operator Sessions

TBD - coordinated with Government

2 Sessions (Approx. 5–10 personnel per session)

ADRL Deliverable Due Date / Frequency Format / Notes

D-008 Operational Training Video TBD - per device Digital delivery or access to training site

D-009 FDA Pre-Submitted Package TBD – before FDA submission

Digital copy of FDA pre-submitted FDA approval

D-010 FDA Clearance Documentation

Within 12–24 months of award

Official FDA clearance letter (510(k) or Class I)

D-011 Special Tools List 15 days after award Electronic Document (Identifying tools and procurement sources)

D-012 Copyright/Distribution Release

60 days after award Written release letter (Supporting Army TM distribution)

D-013 Test Support - Technical Representative

During Government T&E events

Vendor-funded representation

D-014 Bi-Weekly Meetings Commencing 15 days after award

Virtual / Teleconference & digital documentation

D-015 Risk Reporting Within 2 business days of identification

Email/Digital notification to the Agreements Officer Representative (AOR)

D-016 Item Unique Identification (IUID) registration

TBD -Before delivery of device

Email/ IUID registration confirmation

4.0 Notes and Additional Requirements

• Language Requirements: All physical and digital technical manuals (D-002 and D-003) must be provided in the English language.

• FDA Clearance (D-009): This is a Key Performance Parameter (KPP) for this effort. The Performer must maintain regular communication regarding their regulatory pathway and milestone schedule to achieve this within the proposed 12 to 24-month timeframe.

• Bi-weekly Meetings (D-014): Meeting agenda, meeting minutes, and all relevant briefing materials will be provided for each bi-weekly meeting. These documents should be shared in advance whenever possible to allow adequate time for review and to help facilitate productive discussions.

Timely submission of these materials will support effective coordination and ensure that all stakeholders remain informed and aligned.

• Risk Reporting (D-015): Added based on Section 4.1 of the Statement of Work (SOW), which requires the performer to proactively notify the AOR of any risks or issues that impact the delivery schedule or technical performance within two (2) business days of identification.

• IUID Marking(D-016): The contractor shall apply one Item Unique Identification (IUID) mark to each POGS unit in accordance with DFARS 252.211-7003. The IUID shall be a compliant 2D Data Matrix placed in a visible, durable, and permanent location on the exterior of the unit. The contractor is responsible for ensuring accuracy, permanence, and readability of the mark, and shall register all required data elements in the DoD IUID Registry prior to shipment. No internal components require IUID marking unless otherwise specified by the Government. All IUID data must accompany shipment documentation to support Government acceptance, accountability, and lifecycle management.