HHS Awards $38M for E-Beam/X-Ray Sterilization Capacity to Advanced Technology International

Contract Overview

Contract Amount: $38,000,006 ($38.0M)

Contractor: Advanced Technology International

Awarding Agency: Department of Health and Human Services

Start Date: 2024-01-12

End Date: 2037-06-11

Contract Duration: 4,899 days

Daily Burn Rate: $7.8K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: Healthcare

Official Description: DEVELOPMENT OF E-BEAM AND/OR X-RAY STERILIZATION CAPACITY FOR DOMESTIC STERILIZATION CAPACITY UNDER THE BIOMAP-CONSORTIUM

Place of Performance

Location: SUMMERVILLE, BERKELEY County, SOUTH CAROLINA, 29486

State: South Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $38.0 million to ADVANCED TECHNOLOGY INTERNATIONAL for work described as: DEVELOPMENT OF E-BEAM AND/OR X-RAY STERILIZATION CAPACITY FOR DOMESTIC STERILIZATION CAPACITY UNDER THE BIOMAP-CONSORTIUM Key points: 1. Significant investment in domestic biodefense sterilization capabilities. 2. Contract awarded via full and open competition, suggesting market availability. 3. Long-term contract (13+ years) indicates a strategic, ongoing need. 4. Focus on advanced sterilization methods points to evolving public health threats.

Value Assessment

Rating: fair

The contract's Cost Plus Fixed Fee (CPFF) structure allows for cost reimbursement plus a fixed fee, which can incentivize contractor efficiency but also carries risk of cost overruns if not managed closely. Benchmarking CPFF contracts in advanced manufacturing and R&D is complex due to unique project scopes.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The award was made under full and open competition, indicating that multiple vendors were likely considered. This method generally promotes competitive pricing and innovation by allowing any qualified source to bid.

Taxpayer Impact: The substantial investment aims to bolster national biodefense infrastructure, potentially reducing reliance on foreign sterilization capabilities and ensuring domestic supply chain resilience for critical medical products.

Public Impact

Enhances national preparedness for biological threats by securing domestic sterilization capacity. Supports the development of advanced manufacturing technologies for medical countermeasures. Could lead to job creation in South Carolina's advanced manufacturing sector. Ensures a more robust supply chain for essential medical products during emergencies.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost overruns possible with CPFF contract type.
Long-term duration may not adapt to rapidly changing technology.
Reliance on a single awardee for critical capacity.

Positive Signals

Strengthens domestic biodefense infrastructure.
Promotes technological advancement in sterilization.
Ensures supply chain resilience.

Sector Analysis

This contract falls within the advanced manufacturing and biotechnology sector, specifically focusing on sterilization technologies crucial for biological products. Spending benchmarks in this niche area are difficult to establish due to the specialized nature of e-beam and X-ray sterilization development.

Small Business Impact

While the contract was awarded to Advanced Technology International, the data does not indicate specific subcontracting goals for small businesses. Further analysis would be needed to determine the extent of small business participation in this project.

Oversight & Accountability

The Office of Assistant Secretary for Preparedness and Response (ASPR) is responsible for this contract, indicating a focus on public health emergency preparedness. Oversight will be critical to manage the CPFF structure and ensure the development meets stringent requirements.

Related Government Programs

Biological Product (except Diagnostic) Manufacturing
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Cost uncertainty inherent in CPFF contracts.
Long contract duration may lead to technological obsolescence.
Potential for sole-source reliance if follow-on contracts are needed.
Complexity of scaling advanced sterilization technologies.
Dependence on specific vendor expertise.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $38.0 million to ADVANCED TECHNOLOGY INTERNATIONAL. DEVELOPMENT OF E-BEAM AND/OR X-RAY STERILIZATION CAPACITY FOR DOMESTIC STERILIZATION CAPACITY UNDER THE BIOMAP-CONSORTIUM

Who is the contractor on this award?

The obligated recipient is ADVANCED TECHNOLOGY INTERNATIONAL.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $38.0 million.

What is the period of performance?

Start: 2024-01-12. End: 2037-06-11.

What is the projected cost-effectiveness of developing domestic e-beam/X-ray sterilization capacity compared to existing or alternative methods?

The cost-effectiveness hinges on the long-term utilization and the avoided costs associated with supply chain disruptions or reliance on external sterilization services. While the initial $38 million investment is significant, it aims to build a strategic national asset. Quantifying the exact cost-effectiveness requires detailed lifecycle cost analysis and comparison against potential emergency response expenditures or the cost of maintaining less advanced, but potentially cheaper, sterilization methods.

What are the primary technological risks associated with developing and implementing e-beam and/or X-ray sterilization capacity, and how are they being mitigated?

Key risks include achieving the required sterilization efficacy and dose uniformity across diverse biological products, ensuring equipment reliability and safety, and managing the high energy requirements. Mitigation strategies likely involve rigorous testing protocols, phased development, adherence to strict regulatory standards (e.g., FDA), and potentially redundant system designs. The CPFF contract structure may also incentivize the contractor to proactively address technical challenges to control costs.

How will the effectiveness of this new sterilization capacity be measured and validated to ensure it meets national biodefense needs?

Effectiveness will be measured through a combination of technical performance metrics, such as validated sterilization dose delivery, material compatibility, and process throughput, alongside operational readiness assessments. Regular audits and reviews by ASPR will ensure the capacity meets evolving biodefense requirements and can be rapidly deployed during emergencies. Success will also be gauged by the successful integration into the broader biodefense supply chain and its ability to support critical medical countermeasures.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 315 SIGMA DR, SUMMERVILLE, SC, 29486

Business Categories: Category Business, Corporate Entity Tax Exempt, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $38,000,007

Exercised Options: $38,000,006

Current Obligation: $38,000,006

Actual Outlays: $18,352,833

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50123D00003

IDV Type: IDC

Timeline