FDA Awards $22.16M for Biologics Data Infrastructure to Acumen LLC
Contract Overview
Contract Amount: $22,161,469 ($22.2M)
Contractor: Acumen LLC
Awarding Agency: Department of Health and Human Services
Start Date: 2023-09-27
End Date: 2025-09-29
Contract Duration: 733 days
Daily Burn Rate: $30.2K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 1
Pricing Type: TIME AND MATERIALS
Sector: IT
Official Description: BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) INITIATIVE: INFRASTRUCTURE AND DATA FOR SURVEILLANCE OF BIOLOGICS (TASK ORDER 0005)
Place of Performance
Location: BURLINGAME, SAN MATEO County, CALIFORNIA, 94010
Plain-Language Summary
Department of Health and Human Services obligated $22.2 million to ACUMEN LLC for work described as: BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) INITIATIVE: INFRASTRUCTURE AND DATA FOR SURVEILLANCE OF BIOLOGICS (TASK ORDER 0005) Key points: 1. This contract focuses on critical infrastructure for biologics surveillance. 2. Acumen LLC secured the award through full and open competition. 3. The task order is part of the larger BEST Initiative. 4. Potential risks include data security and integration challenges.
Value Assessment
Rating: good
The award amount of $22.16 million for a 2-year period appears reasonable for computing infrastructure and data processing services. Benchmarking against similar FDA contracts for IT support would provide further validation.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded using full and open competition, suggesting a robust price discovery process. This method typically leads to competitive pricing as multiple vendors had the opportunity to bid.
Taxpayer Impact: The competitive award process is expected to ensure taxpayer funds are used efficiently for essential public health infrastructure.
Public Impact
Enhances FDA's ability to monitor the safety and effectiveness of biologics. Supports public health by improving surveillance of critical medical products. Invests in IT infrastructure crucial for regulatory functions.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Data security and privacy concerns
- Potential for vendor lock-in
- Integration with existing FDA systems
Positive Signals
- Supports critical public health initiative
- Utilizes competitive bidding process
- Invests in modern IT infrastructure
Sector Analysis
This contract falls within the IT and data processing sector, specifically supporting healthcare regulatory functions. Spending benchmarks for similar government IT infrastructure contracts vary widely based on scope and duration.
Small Business Impact
The contract was awarded through full and open competition, and there is no specific indication of small business participation in this particular task order. Future efforts may involve subcontracting opportunities.
Oversight & Accountability
The FDA's oversight will be crucial to ensure Acumen LLC meets performance requirements and data security standards. Regular reviews and performance metrics will be key accountability mechanisms.
Related Government Programs
- Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- Department of Health and Human Services Contracting
- Food and Drug Administration Programs
Risk Flags
- Data security and privacy
- System integration complexity
- Vendor performance and reliability
- Scalability of infrastructure
Tags
computing-infrastructure-providers-data-, department-of-health-and-human-services, ca, delivery-order, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $22.2 million to ACUMEN LLC. BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) INITIATIVE: INFRASTRUCTURE AND DATA FOR SURVEILLANCE OF BIOLOGICS (TASK ORDER 0005)
Who is the contractor on this award?
The obligated recipient is ACUMEN 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 $22.2 million.
What is the period of performance?
Start: 2023-09-27. End: 2025-09-29.
What is the specific impact of this infrastructure on the speed and accuracy of biologics safety alerts?
The new infrastructure is intended to streamline data collection and analysis, potentially leading to faster identification of safety signals and more accurate risk assessments for biologics. This improved capability allows the FDA to respond more rapidly to emerging public health concerns related to these critical medical products.
What are the primary cybersecurity risks associated with this data infrastructure, and how are they being mitigated?
Key risks include unauthorized access, data breaches, and potential disruptions to service. Mitigation strategies likely involve robust encryption, access controls, regular security audits, and adherence to strict government cybersecurity protocols to protect sensitive health information.
How does this initiative contribute to the overall effectiveness of the FDA's regulatory mission for biologics?
This initiative directly enhances the FDA's effectiveness by providing the necessary technological foundation for robust post-market surveillance. It enables better monitoring of real-world product performance, supporting informed regulatory decisions and ultimately safeguarding public health.
Industry Classification
NAICS: Information › Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services › Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
Product/Service Code: SPECIAL STUDIES/ANALYSIS, NOT R&D › SPECIAL STUDIES - NOT R and D
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY
Solicitation ID: RFTOP-CBER-2023-116135
Offers Received: 1
Pricing Type: TIME AND MATERIALS (Y)
Evaluated Preference: NONE
Contractor Details
Address: 500 AIRPORT BLVD STE 100, BURLINGAME, CA, 94010
Business Categories: Category Business, Limited Liability Corporation, Not Designated a Small Business, Partnership or Limited Liability Partnership, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $22,161,469
Exercised Options: $22,161,469
Current Obligation: $22,161,469
Actual Outlays: $22,087,425
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: NO
Parent Contract
Parent Award PIID: 75F40118D10020
IDV Type: IDC
Timeline
Start Date: 2023-09-27
Current End Date: 2025-09-29
Potential End Date: 2025-09-29 00:00:00
Last Modified: 2025-07-22
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