HHS awards $22.3M for RADx clinical evaluation services to National Collegiate Inventors & Innovators Alliance, Inc

Contract Overview

Contract Amount: $22,278,964 ($22.3M)

Contractor: National Collegiate Inventors & Innovators Alliance, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-06-01

End Date: 2026-06-30

Contract Duration: 1,125 days

Daily Burn Rate: $19.8K/day

Competition Type: NOT COMPETED

Pricing Type: FIRM FIXED PRICE

Sector: Other

Official Description: RAPID ACCELERATION OF DIAGNOSTICS (RADX) CLINICAL EVALUATION SERVICES -TASK ORDER 06

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20892

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.3 million to NATIONAL COLLEGIATE INVENTORS & INNOVATORS ALLIANCE, INC. for work described as: RAPID ACCELERATION OF DIAGNOSTICS (RADX) CLINICAL EVALUATION SERVICES -TASK ORDER 06 Key points: 1. The contract focuses on clinical evaluation services for the RADx initiative. 2. Competition was limited, with a sole-source award. 3. The firm fixed-price contract aims to control costs. 4. This falls under professional, scientific, and technical services.

Value Assessment

Rating: good

The award amount of $22.3 million for a 3-year period appears reasonable for specialized clinical evaluation services. Benchmarking against similar large-scale clinical trial management contracts would provide a more precise assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This was a sole-source award, meaning competition was not sought. This approach may limit price discovery and potentially lead to higher costs than a competitive process.

Taxpayer Impact: The lack of competition could mean taxpayers are not receiving the best possible price for these critical services.

Public Impact

Supports the critical RADx initiative for accelerating diagnostic testing. Ensures rigorous evaluation of diagnostic technologies. Impacts public health preparedness and response capabilities. Funds specialized scientific and technical expertise.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competition.
Potential for higher costs due to lack of competition.

Positive Signals

Supports a critical public health program (RADx).
Firm fixed-price contract provides cost certainty.
Long-term engagement allows for sustained effort.

Sector Analysis

This contract falls under 'All Other Professional, Scientific, and Technical Services,' a broad category. Spending in this sector is significant, often driven by research, development, and specialized consulting needs, with benchmarks varying widely based on the specific service.

Small Business Impact

The contract was awarded to National Collegiate Inventors & Innovators Alliance, Inc., which is not explicitly identified as a small business. There is no indication of subcontracting opportunities for small businesses within this award.

Oversight & Accountability

The award was made by the National Institutes of Health (NIH), a major agency within HHS. Oversight would typically involve program managers monitoring performance and adherence to contract terms, with financial oversight from the contracting office.

Related Government Programs

All Other Professional, Scientific, and Technical Services
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Lack of competition may lead to suboptimal pricing.
Potential for vendor lock-in due to sole-source nature.
Reliance on a single entity for critical evaluation services.
Need for robust government oversight to ensure value.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.3 million to NATIONAL COLLEGIATE INVENTORS & INNOVATORS ALLIANCE, INC.. RAPID ACCELERATION OF DIAGNOSTICS (RADX) CLINICAL EVALUATION SERVICES -TASK ORDER 06

Who is the contractor on this award?

The obligated recipient is NATIONAL COLLEGIATE INVENTORS & INNOVATORS ALLIANCE, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $22.3 million.

What is the period of performance?

Start: 2023-06-01. End: 2026-06-30.

What is the justification for the sole-source award, and how was the price determined to be fair and reasonable without competition?

The justification for a sole-source award typically involves demonstrating that only one responsible source can provide the required services. This could be due to unique capabilities, proprietary knowledge, or urgent needs. The price is then assessed for fairness and reasonableness through various means, such as historical pricing, cost analysis, or market research on similar services, though competition usually provides a stronger basis for this determination.

What are the specific performance metrics and deliverables for these clinical evaluation services, and how will their effectiveness be measured?

Effectiveness will be measured through the successful completion of defined clinical evaluation protocols, timely reporting of results, and adherence to scientific and regulatory standards. Specific metrics likely include the accuracy, sensitivity, and specificity of the diagnostics evaluated, as well as the efficiency of the evaluation process itself. The contract should detail these deliverables and performance standards.

How does the funding for these services align with the overall objectives and budget of the RADx initiative?

The funding of $22.3 million is allocated to support critical clinical evaluation services essential for the RADx initiative's goal of accelerating diagnostic development and deployment. Its alignment with the overall RADx budget would depend on the initiative's total funding and priorities, ensuring that these services contribute proportionally to achieving broader public health objectives.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Other Professional, Scientific, and Technical Services › All Other Professional, Scientific, and Technical Services

Product/Service Code: QUALITY CONTROL, TEST, INSPECTION › EQUIPMENT AND MATERIALS TESTING

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 100 VENTURE WAY STE 8, HADLEY, MA, 01035

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: $22,278,964

Exercised Options: $22,278,964

Current Obligation: $22,278,964

Actual Outlays: $11,430,390

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N92022D00010

IDV Type: IDC

Timeline