HHS Awards $34M for Clinical Trial Planning and Execution to ICON Government and Public Health Solutions

Contract Overview

Contract Amount: $34,081,098 ($34.1M)

Contractor: Icon Government and Public Health Solutions, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-27

End Date: 2026-07-31

Contract Duration: 1,038 days

Daily Burn Rate: $32.8K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CLINICAL TRIAL PLANNING AND EXECUTION (CTPE)

Place of Performance

Location: HINCKLEY, MEDINA County, OHIO, 44233

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $34.1 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. for work described as: CLINICAL TRIAL PLANNING AND EXECUTION (CTPE) Key points: 1. Contract awarded to a single, established vendor for specialized clinical trial services. 2. The award represents a significant investment in R&D for biotechnology preparedness. 3. Potential for cost overruns exists given the Cost Plus Fixed Fee contract type. 4. Focus on preparedness highlights a critical national health security objective.

Value Assessment

Rating: fair

The Cost Plus Fixed Fee (CPFF) contract type allows for cost reimbursement plus a fixed fee. While this can incentivize efficiency, it also carries a risk of cost overruns if initial estimates are inaccurate. Benchmarking against similar CPFF contracts for clinical trial services is difficult without more granular cost data.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting a robust price discovery process. However, the specific awardee, ICON Government and Public Health Solutions, Inc., implies they were selected based on their qualifications and proposed price, which may not represent the absolute lowest cost achievable.

Taxpayer Impact: Taxpayer funds are being utilized for critical research and development in biotechnology, aiming to enhance public health preparedness. The effectiveness of this spending will be measured by the successful execution of clinical trials and the resulting advancements.

Public Impact

Enhances national capacity for responding to public health emergencies through advanced clinical trial capabilities. Supports the development of new biotechnologies and medical countermeasures. Invests in critical research infrastructure and expertise within the government and its contractors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contract type may lead to cost overruns.
Limited visibility into specific cost breakdowns for benchmarking.
Contract duration of nearly three years requires ongoing monitoring.

Positive Signals

Awarded under full and open competition.
Addresses a critical national security and public health need.
Contractor has relevant expertise in government and public health solutions.

Sector Analysis

This contract falls under Research and Development in Biotechnology (NAICS 541714), a sector crucial for innovation in healthcare and national security. Spending in this area is often characterized by high upfront investment and long development cycles, with outcomes that can be unpredictable but potentially high-impact.

Small Business Impact

The contract was awarded to ICON Government and Public Health Solutions, Inc., a large business. There is no indication of small business participation in this specific award, suggesting a missed opportunity for subcontracting and supporting the small business ecosystem.

Oversight & Accountability

The Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS is responsible for this contract. Oversight will be critical to ensure the Cost Plus Fixed Fee structure does not lead to excessive spending and that the project milestones are met effectively and efficiently.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Cost Plus Fixed Fee contract type.
Lack of specific small business participation.
Potential for scope creep in R&D projects.
Long contract duration requires sustained oversight.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $34.1 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC.. CLINICAL TRIAL PLANNING AND EXECUTION (CTPE)

Who is the contractor on this award?

The obligated recipient is ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC..

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 $34.1 million.

What is the period of performance?

Start: 2023-09-27. End: 2026-07-31.

What is the projected return on investment for this clinical trial planning and execution contract, considering the potential for groundbreaking biotechnological advancements?

The return on investment (ROI) for this contract is inherently difficult to quantify upfront due to the nature of R&D. Success hinges on the development of effective countermeasures or treatments, which could yield significant public health benefits and economic value by preventing or mitigating widespread health crises. The $34 million investment aims to build critical capacity, the ultimate ROI will be realized through successful trial outcomes and their subsequent application.

What are the primary risks associated with the Cost Plus Fixed Fee (CPFF) contract type in this context, and how are they being mitigated?

The primary risk with CPFF is that the contractor may incur costs exceeding the initial estimates, leading to higher overall spending than anticipated, while still receiving their fixed fee. Mitigation strategies typically involve robust government oversight, detailed cost tracking, clear performance metrics, and potentially incentive clauses tied to efficiency or specific outcomes. The government's ability to monitor expenditures and enforce contract terms is crucial.

How effectively will this contract contribute to the nation's preparedness for future public health emergencies, beyond the immediate scope of the awarded trials?

This contract is expected to significantly enhance preparedness by building and refining the infrastructure and expertise for rapid clinical trial execution. This includes strengthening relationships with research institutions, improving logistical planning, and developing standardized protocols. The knowledge gained and capabilities developed are intended to be transferable and scalable for future, unforeseen public health threats, thereby increasing overall national resilience.

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: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 1265 RIDGE RD STE A, HINCKLEY, OH, 44233

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

Financial Breakdown

Contract Ceiling: $34,482,767

Exercised Options: $34,081,098

Current Obligation: $34,081,098

Actual Outlays: $17,744,503

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50120D00017

IDV Type: IDC

Timeline