HHS Awards $6.46M Contract for Biotin Red Blood Cell Lifespan Assessment Technology

Contract Overview

Contract Amount: $6,456,388 ($6.5M)

Contractor: Cincinnati Univ of

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-21

End Date: 2026-09-30

Contract Duration: 1,105 days

Daily Burn Rate: $5.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: THE SCOPE OF WORK FOR THIS CONTRACT INCLUDES THE DEVELOPMENT AND VALIDATION OF BIOTIN AS AN IN VIVO LABELLING AGENT FOR RED BLOOD CELLS TO REPLACE CHROMIUM 51 AS THE STANDARD FDA-APPROVED TECHNOLOGY FOR ASSESSING THE LIFESPAN OF RBCS IN CIRCULATION.

Place of Performance

Location: CINCINNATI, HAMILTON County, OHIO, 45221

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $6.5 million to CINCINNATI UNIV OF for work described as: THE SCOPE OF WORK FOR THIS CONTRACT INCLUDES THE DEVELOPMENT AND VALIDATION OF BIOTIN AS AN IN VIVO LABELLING AGENT FOR RED BLOOD CELLS TO REPLACE CHROMIUM 51 AS THE STANDARD FDA-APPROVED TECHNOLOGY FOR ASSESSING THE LIFESPAN OF RBCS IN CIRCULATION. Key points: 1. Focuses on developing a new FDA-approved method for assessing red blood cell lifespan. 2. Aims to replace the current Chromium 51 standard with a potentially safer biotin-based agent. 3. Contract awarded via full and open competition, suggesting a competitive bidding process. 4. The sector is primarily healthcare research and development within the Department of Health and Human Services.

Value Assessment

Rating: good

The contract value of $6.46 million for a 3.7-year period appears reasonable for specialized R&D in medical diagnostics. Benchmarking against similar NIH or FDA-funded research grants for assay development would provide further context.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and allows the government to select the best value offer.

Taxpayer Impact: By seeking competitive bids, the government aims to secure the most cost-effective solution for developing this critical medical technology, ultimately benefiting taxpayers.

Public Impact

Potential for improved patient safety by replacing Chromium 51 with a less toxic alternative. Advancement in medical diagnostic capabilities for assessing red blood cell health. Supports the FDA's mission to ensure safe and effective medical products. Could lead to more accurate and reliable diagnoses of blood disorders.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for delays in development or validation of the biotin agent.
Risk of the new technology not performing as expected or being less effective than Chromium 51.
Dependence on a single research institution for critical development.

Positive Signals

Addresses a clear need to replace an outdated and potentially hazardous diagnostic method.
Awarded through a competitive process, suggesting a focus on value.
Clear scope of work with defined deliverables for validation.

Sector Analysis

This contract falls within the healthcare and life sciences sector, specifically focusing on medical device and diagnostic technology development. Spending in this area is crucial for advancing public health and regulatory science, with benchmarks varying widely based on research complexity and phase.

Small Business Impact

The data does not indicate any specific provisions or set-asides for small businesses in this contract. Given the specialized nature of the research, it is possible that larger research institutions or established firms were the primary bidders.

Oversight & Accountability

The contract is managed by the Department of Health and Human Services, specifically the Office of the Assistant Secretary for Preparedness and Response. Standard government oversight mechanisms for research and development contracts would apply, including progress reporting and milestone reviews.

Related Government Programs

Colleges, Universities, and Professional Schools
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Potential for technology failure or underperformance.
Uncertainty in the FDA approval timeline and outcome.
Reliance on a single institution for critical R&D.
Limited information on specific risk mitigation strategies.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $6.5 million to CINCINNATI UNIV OF. THE SCOPE OF WORK FOR THIS CONTRACT INCLUDES THE DEVELOPMENT AND VALIDATION OF BIOTIN AS AN IN VIVO LABELLING AGENT FOR RED BLOOD CELLS TO REPLACE CHROMIUM 51 AS THE STANDARD FDA-APPROVED TECHNOLOGY FOR ASSESSING THE LIFESPAN OF RBCS IN CIRCULATION.

Who is the contractor on this award?

The obligated recipient is CINCINNATI UNIV OF.

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 $6.5 million.

What is the period of performance?

Start: 2023-09-21. End: 2026-09-30.

What is the projected timeline for the validation and potential FDA approval of the biotin-based labeling agent?

The contract end date is September 30, 2026, suggesting a development and validation period of approximately three years. The FDA approval process itself can be lengthy and is not guaranteed within this contract's duration. Further details on specific milestones and regulatory submission plans would be needed for a more precise timeline.

What are the specific risks associated with the transition from Chromium 51 to biotin, and how are they being mitigated?

Key risks include the potential for biotin to exhibit unforeseen toxicity in vivo, or for the labeling and detection methods to be less sensitive or specific than Chromium 51. Mitigation strategies likely involve rigorous preclinical testing, comparative studies against the existing standard, and adherence to FDA guidelines for new diagnostic agent development.

How will the effectiveness of the new biotin-based method be measured against the current Chromium 51 standard?

Effectiveness will be measured through direct comparison studies assessing accuracy, precision, sensitivity, specificity, and safety profiles of both methods in relevant biological models. The contract likely specifies key performance indicators (KPIs) that the biotin method must meet or exceed to be considered a viable replacement for Chromium 51.

Industry Classification

NAICS: Educational Services › Colleges, Universities, and Professional Schools › Colleges, Universities, and Professional Schools

Product/Service Code: MEDICAL SERVICES › SPECIALIZED TECHNICAL/ MEDICAL SUPPORT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 2600 CLIFTON AVE, CINCINNATI, OH, 45220

Business Categories: Category Business, Educational Institution, Government, Higher Education, U.S. National Government, Not Designated a Small Business, Higher Education (Public), U.S. Regional/State Government

Financial Breakdown

Contract Ceiling: $6,456,388

Exercised Options: $6,456,388

Current Obligation: $6,456,388

Actual Outlays: $2,198,456

Subaward Activity

Number of Subawards: 5

Total Subaward Amount: $769,204

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline