FDA Spends $6.1M on IT Services for Adverse Event Monitoring System Modernization

Contract Overview

Contract Amount: $6,148,259 ($6.1M)

Contractor: Chickasaw Aerospace, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2025-12-12

End Date: 2026-12-11

Contract Duration: 364 days

Daily Burn Rate: $16.9K/day

Competition Type: NOT AVAILABLE FOR COMPETITION

Number of Offers Received: 1

Pricing Type: LABOR HOURS

Sector: IT

Official Description: IT SERVICES: FDA ADVERSE EVENT MONITORING SYSTEM CAPABILITIES MODERNIZATION

Place of Performance

Location: NORMAN, CLEVELAND County, OKLAHOMA, 73071

State: Oklahoma Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $6.1 million to CHICKASAW AEROSPACE, LLC for work described as: IT SERVICES: FDA ADVERSE EVENT MONITORING SYSTEM CAPABILITIES MODERNIZATION Key points: 1. Contract awarded to Chickasaw Aerospace, LLC for IT services. 2. Focus on modernizing the FDA's Adverse Event Monitoring System. 3. Contract value is $6.15 million. 4. Duration is 364 days, ending December 2026. 5. This is a sole-source award.

Value Assessment

Rating: questionable

The contract value of $6.15 million for a 364-day period suggests a potentially high per-unit cost, especially given the 'Other Computer Related Services' NAICS code. Without specific deliverables or benchmarks, it's difficult to assess value for money.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

The contract was awarded on a sole-source basis, indicating a lack of competition. This limits price discovery and may result in higher costs than if multiple vendors had competed.

Taxpayer Impact: The lack of competition for this sole-source contract raises concerns about potential overspending, impacting taxpayer funds.

Public Impact

Ensures continued functionality of a critical public health system. Modernization aims to improve data processing and analysis of adverse events. Potential for enhanced patient safety through better monitoring. Contract duration is relatively short, suggesting a need for future, potentially larger, investments.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competition and price discovery.
Lack of clear performance metrics or benchmarks.
Potential for cost overruns due to lack of competition.

Positive Signals

Addresses critical need for system modernization.
Supports FDA's mission of public health and safety.
Contract awarded to a single entity, potentially streamlining execution.

Sector Analysis

The IT services sector is highly competitive, making sole-source awards for general IT services less common. Benchmarks for similar system modernization projects vary widely based on scope and complexity.

Small Business Impact

The contract was awarded to Chickasaw Aerospace, LLC, which is not identified as a small business in the provided data. There is no indication of subcontracting opportunities for small businesses.

Oversight & Accountability

Oversight will be crucial to ensure the modernization meets its objectives and that costs remain within reasonable bounds, especially given the sole-source nature of the award. The FDA should monitor performance closely.

Related Government Programs

Other Computer Related Services
Department of Health and Human Services Contracting
Food and Drug Administration Programs

Risk Flags

Sole-source award.
Lack of competition.
Potential for inflated pricing.
Limited transparency on specific modernization goals.
No clear performance metrics provided.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $6.1 million to CHICKASAW AEROSPACE, LLC. IT SERVICES: FDA ADVERSE EVENT MONITORING SYSTEM CAPABILITIES MODERNIZATION

Who is the contractor on this award?

The obligated recipient is CHICKASAW AEROSPACE, LLC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $6.1 million.

What is the period of performance?

Start: 2025-12-12. End: 2026-12-11.

What specific capabilities are being modernized, and how do they align with current and future public health needs?

The modernization of the FDA Adverse Event Monitoring System is intended to enhance the agency's ability to collect, process, and analyze data on adverse events related to medical products. This includes improving data integrity, enabling faster identification of safety signals, and supporting regulatory decision-making. The specific capabilities being upgraded are not detailed but are expected to align with evolving public health surveillance requirements and technological advancements in data analytics.

What is the justification for the sole-source award, and what steps are being taken to ensure fair pricing?

The justification for the sole-source award is not provided in the data. However, agencies typically pursue sole-source contracts when only one vendor possesses the unique capabilities, technology, or proprietary knowledge required for the specific requirement. To ensure fair pricing, the agency should conduct a thorough price analysis, comparing proposed costs against historical data, independent cost estimates, or market research for similar services.

How will the success of this modernization be measured, and what are the key performance indicators?

Success will likely be measured by the system's ability to handle increased data volumes, improve the speed and accuracy of adverse event reporting and analysis, and provide actionable insights for regulatory action. Key performance indicators could include metrics related to system uptime, data processing speed, reduction in manual data entry, and the timely identification of emerging safety trends. The FDA should establish clear, measurable KPIs before or at the start of the contract.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Computer Systems Design and Related Services › Other Computer Related Services

Product/Service Code: IT AND TELECOM - INFORMATION TECHNOLOGY AND TELECOMMUNICATIONS › IT AND TELECOM - APLLICATIONS

Competition & Pricing

Extent Competed: NOT AVAILABLE FOR COMPETITION

Solicitation Procedures: ONLY ONE SOURCE

Offers Received: 1

Pricing Type: LABOR HOURS (Z)

Evaluated Preference: NONE

Contractor Details

Address: 2600 JOHN SAXON BLVD STE 2222, NORMAN, OK, 73071

Business Categories: 8(a) Program Participant, American Indian Owned Business, Category Business, Corporate Entity Not Tax Exempt, Limited Liability Corporation, Minority Owned Business, Native American Owned Business, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Tribally Owned Firm, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $9,222,389

Exercised Options: $6,148,259

Current Obligation: $6,148,259

Actual Outlays: $167,719

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline