HHS awards $65.5M contract to Abbott for TBI diagnostic test clinical studies

Contract Overview

Contract Amount: $65,469,511 ($65.5M)

Contractor: Abbott Laboratories

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-21

End Date: 2029-11-15

Contract Duration: 2,612 days

Daily Burn Rate: $25.1K/day

Competition Type: NOT COMPETED

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: ABBOTT: TO CONDUCT CLINICAL TRAINING AND VALIDATION STUDIES TO SUPPORT A FUTURE FDA MARKETING APPLICATION WITH AN EXPANDED INDICATION FOR USE OF THE ABBOTT TBI TEST ? TO AID IN THE DIAGNOSIS OF TRAUMATIC BRAIN INJURY IN ADULTS AND PEDIATRIC PATIENTS.

Place of Performance

Location: NORTH CHICAGO, LAKE County, ILLINOIS, 60064

State: Illinois Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $65.5 million to ABBOTT LABORATORIES for work described as: ABBOTT: TO CONDUCT CLINICAL TRAINING AND VALIDATION STUDIES TO SUPPORT A FUTURE FDA MARKETING APPLICATION WITH AN EXPANDED INDICATION FOR USE OF THE ABBOTT TBI TEST ? TO AID IN THE DIAGNOSIS OF TRAUMATIC BRAIN INJURY IN ADULTS AND PEDIATRIC PATIENTS. Key points: 1. Contract supports development of a traumatic brain injury diagnostic test. 2. Focus on clinical training and validation studies for FDA approval. 3. Long-term contract duration of over 7 years. 4. Sole-source award raises questions about competition and potential cost savings. 5. Research and Development sector contract with significant federal investment. 6. Potential to improve diagnosis of TBI in adult and pediatric patients.

Value Assessment

Rating: fair

The contract value of $65.5 million for clinical training and validation studies appears substantial. Without comparable contracts for similar TBI diagnostic test development, it's difficult to benchmark the value for money. The firm fixed-price structure provides some cost certainty, but the lack of competition means there's no direct market comparison to assess pricing efficiency. Further analysis of the specific tasks and deliverables is needed to fully evaluate the value proposition.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, meaning Abbott Laboratories was the only bidder considered. This approach is typically used when only one responsible source can satisfy the agency's needs. While it ensures the specific expertise of Abbott is leveraged, it bypasses the competitive process, potentially leading to higher costs than if multiple companies had bid.

Taxpayer Impact: Sole-source awards limit opportunities for other companies to compete and may result in less favorable pricing for taxpayers compared to a competitively bid contract.

Public Impact

Patients suffering from traumatic brain injuries, both adults and children, may benefit from improved diagnostic capabilities. The contract will fund clinical training and validation studies, crucial steps for regulatory approval. The geographic impact is primarily within Illinois, where Abbott Laboratories is headquartered, but the ultimate benefit is national. The contract supports the research and development sector, potentially leading to advancements in medical diagnostics.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competitive pricing and potential cost savings for taxpayers.
Long contract duration could lead to scope creep or cost overruns if not managed effectively.
Reliance on a single contractor may create dependency and reduce market options for future needs.

Positive Signals

Supports development of a critical diagnostic tool for traumatic brain injury.
Leverages the expertise of a known entity in the medical device sector.
Firm fixed-price contract provides cost predictability for the defined scope.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical area for medical innovation. The market for diagnostic tools, particularly for conditions like TBI, is significant and growing, driven by increased awareness and the need for faster, more accurate diagnoses. Federal investment in this area supports the advancement of healthcare technologies and public health preparedness. Comparable spending benchmarks are difficult to establish without more specific details on the R&D phase and the nature of the clinical studies.

Small Business Impact

This contract does not appear to have a small business set-aside. As a sole-source award to a large corporation, there are no direct subcontracting implications for small businesses specified within this award. The focus is on Abbott's internal capabilities for conducting these specific clinical studies.

Oversight & Accountability

Oversight will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures will be tied to the achievement of milestones within the clinical training and validation studies. Transparency may be limited due to the sole-source nature of the award, but progress reports and final study outcomes should be available upon completion. Inspector General jurisdiction would apply to any potential fraud, waste, or abuse.

Related Government Programs

Biotechnology Research and Development
Medical Device Development
Traumatic Brain Injury Research
FDA Marketing Applications Support
Clinical Trials Management

Risk Flags

Sole-source award may limit cost-effectiveness.
Long contract duration increases potential for unforeseen issues.
Reliance on a single contractor for critical development phase.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $65.5 million to ABBOTT LABORATORIES. ABBOTT: TO CONDUCT CLINICAL TRAINING AND VALIDATION STUDIES TO SUPPORT A FUTURE FDA MARKETING APPLICATION WITH AN EXPANDED INDICATION FOR USE OF THE ABBOTT TBI TEST ? TO AID IN THE DIAGNOSIS OF TRAUMATIC BRAIN INJURY IN ADULTS AND PEDIATRIC PATIENTS.

Who is the contractor on this award?

The obligated recipient is ABBOTT LABORATORIES.

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 $65.5 million.

What is the period of performance?

Start: 2022-09-21. End: 2029-11-15.

What is the specific justification for awarding this contract on a sole-source basis to Abbott Laboratories?

The provided data does not detail the specific justification for the sole-source award. Typically, sole-source contracts are awarded when only one responsible source is capable of providing the required product or service. This could be due to proprietary technology, unique expertise, or urgent needs where competition is not feasible. For this contract, it's possible that Abbott possesses unique intellectual property or established infrastructure for the TBI test that makes them the only viable option for conducting these specific clinical training and validation studies required for a future FDA marketing application with an expanded indication.

How does the $65.5 million contract value compare to typical R&D spending for similar diagnostic test development?

Benchmarking this $65.5 million contract value against typical R&D spending for similar diagnostic test development is challenging without more granular data. The contract covers clinical training and validation studies, which are late-stage R&D activities crucial for FDA approval. The cost can vary significantly based on the complexity of the test, the number of study sites, patient recruitment rates, and the duration of the validation period. Given the long-term nature (over 7 years) and the specific requirements for FDA submission support, the amount may be within a reasonable range for such a specialized undertaking, especially considering the sole-source nature which removes competitive pressure to lower costs.

What are the key performance indicators (KPIs) or milestones associated with this contract?

The provided data does not explicitly list the Key Performance Indicators (KPIs) or milestones for this contract. However, based on the description, the contract's objective is to 'Conduct clinical training and validation studies to support a future FDA marketing application with an expanded indication for use of the Abbott TBI Test.' Therefore, key milestones would likely include the successful completion of training protocols, the enrollment and monitoring of study participants, the collection and analysis of validation data demonstrating the test's accuracy and reliability for the expanded indication, and the preparation of documentation required for the FDA submission. Performance would be measured against the timely and accurate completion of these study phases.

What is the potential impact of this contract on the availability of TBI diagnostic tools?

This contract has the potential to significantly impact the availability of TBI diagnostic tools by supporting the development and validation of the Abbott TBI Test for an expanded indication. Successful completion of the clinical studies funded by this contract could lead to FDA approval for a more widely applicable diagnostic tool, potentially benefiting both adult and pediatric patients. Improved diagnostic capabilities can lead to earlier and more accurate treatment decisions, potentially improving patient outcomes and reducing the long-term consequences of untreated or misdiagnosed TBI. The contract aims to facilitate the regulatory pathway for this specific test.

Are there any known risks associated with Abbott Laboratories as a contractor for this type of work?

Abbott Laboratories is a well-established global healthcare company with extensive experience in developing and manufacturing medical devices and diagnostic tests. As such, their track record in research and development, clinical trials, and regulatory submissions is generally strong. However, risks inherent in any large-scale R&D and clinical validation project exist. These could include unforeseen scientific challenges, difficulties in patient recruitment for clinical studies, delays in regulatory review processes, or potential issues with the test's performance in real-world clinical settings. The sole-source nature of this award also presents a risk of complacency or less rigorous cost management compared to a competitive environment.

How does this contract fit into the broader federal strategy for addressing traumatic brain injuries?

This contract aligns with a broader federal interest in improving the diagnosis and treatment of traumatic brain injuries (TBI). Agencies like the Department of Health and Human Services (HHS), particularly the Office of the Assistant Secretary for Preparedness and Response (ASPR), are involved in public health initiatives, including those related to medical countermeasures and diagnostic capabilities. Investing in the development and validation of diagnostic tools like the Abbott TBI Test supports the goal of enhancing medical readiness and improving health outcomes for individuals affected by TBI, which can result from military service, accidents, or other incidents. It contributes to the scientific and technological infrastructure needed to address this public health concern.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

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

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 100 ABBOTT PARK RD, ABBOTT PARK, IL, 60064

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

Financial Breakdown

Contract Ceiling: $83,713,827

Exercised Options: $65,469,511

Current Obligation: $65,469,511

Actual Outlays: $15,663,973

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline