Attachment 2-DRAFT STMD SOO 3-12-2026.pdf

ATTACHMENT 2

DRAFT Statement of Objectives (SOO)

U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response (ASPR)

Center for the Strategic National Stockpile (SNS)

Container Door Security and Temperature Monitoring Devices

1.0 Objective

The Strategic National Stockpile (SNS) seeks to obtain a validated, secure, scalable, and reliable environmental monitoring capability to ensure continuous pharmaceutical storage integrity across approximately 1,350 CHEMPACK storage locations nationwide encompassing approximately 1,974 containers.

This requirement is structured as a performance-based acquisition. The Government does not prescribe a specific system architecture.

Offerors shall propose a monitoring capability capable of maintaining controlled room temperature storage conditions of 20°C–25°C, providing real-time remote temperature monitoring and door opening alarm notifications, ensuring regulatory compliance, and operating reliably across diverse facility environments.

2.0 Background

SNS manages CHEMPACK containers located across healthcare and emergency response facilities nationwide.

These containers store pharmaceutical countermeasures that must be maintained within controlled room temperature conditions to preserve product integrity and regulatory compliance.

Variability in monitoring capabilities across storage environments requires a nationwide monitoring capability capable of reliable operation across diverse facility infrastructures.

3.0 Required Outcomes

The Contractor shall provide an integrated environmental monitoring capability that achieves the following outcomes.

1. Continuous monitoring of controlled room temperature storage conditions of 20°C–25°C.

2. Automated alarm notification for temperature excursions and container access events.

3. System resiliency through redundancy and backup capability.

4. Operation independent of facility IT infrastructure unless authorized by the Government.

5. Compliance with applicable regulatory requirements including FDA cGMP, 21 CFR Parts 11 and

211, applicable USP guidance, and NIST calibration standards.

6. Government ownership and unrestricted access to monitoring data generated under the contract.

7. Nationwide scalability and the ability to support additional monitoring locations if required.

8. Continuous monitoring capability during deployment, transition, or system upgrades.

9. Secure storage and retention of monitoring data for the duration of the contract.

4.0 Performance Thresholds

• System uptime ≥ 99.5%

• Alarm notification ≤ 5 minutes

• Temperature sensor accuracy ±0.5°C

• Sensors calibrated annually with NIST-traceable calibration

• Monitoring gap during system transition ≤ 30 minutes

• Data completeness ≥ 99.9%

• Repair response ≤ 72 hours nationwide

• Remote support response ≤ 30 minutes

• On-site response for critical failures ≤ 24 hours

• Disaster Recovery

• Recovery Time Objective ≤ 4 hours

Recovery Point Objective ≤ 15 minutes

Monitoring reports available in PDF, Word, Excel, and machine-readable formats.

5.0 Contractor Responsibilities

The Contractor shall provide equipment, software, communications capability, system validation, deployment services, and operational support necessary to achieve the outcomes described in this SOO.

Technical support shall be available 24 hours per day, 7 days per week.

6.0 Transition Requirements

The Contractor shall deploy the monitoring capability across CHEMPACK storage locations while maintaining monitoring continuity.

• Monitoring interruptions shall not exceed 30 minutes per site.

• Deployment may include pilot implementation followed by phased rollout.

• If applicable, historical monitoring data migration shall ensure ≥99.9% data completeness.

• At contract completion, the Contractor shall support transition-out activities ensuring

Government access to monitoring data and operational records.

7.0 Deliverables

• Transition-In Plan

• Data Migration Plan (if applicable)

• Installation Schedule

• Validation documentation

• Monthly performance reports

• Mean Kinetic Temperature reports

• Calibration certificates

• Disaster recovery test reports

• Cybersecurity documentation supporting FedRAMP and RMF requirements

• Final monitoring data archive package at contract completion.