HHS awards $29.5M for clinical trial support, with ICF Inc. as prime contractor

Contract Overview

Contract Amount: $29,481,383 ($29.5M)

Contractor: ICF Incorporated, L.L.C.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-30

End Date: 2023-09-28

Contract Duration: 1,093 days

Daily Burn Rate: $27.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 3

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: SUPPORT FOR CLINICAL TRIALS INFORMATION

Place of Performance

Location: FAIRFAX, FAIRFAX County, VIRGINIA, 22031

State: Virginia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $29.5 million to ICF INCORPORATED, L.L.C. for work described as: SUPPORT FOR CLINICAL TRIALS INFORMATION Key points: 1. Contract value represents a significant investment in clinical trial infrastructure. 2. The award was made under full and open competition, suggesting a robust bidding process. 3. The contract duration of nearly three years indicates a need for sustained support. 4. The fixed-price contract type aims to control costs and provide budget certainty. 5. The prime contractor, ICF Incorporated, has a track record in administrative and management consulting.

Value Assessment

Rating: good

The contract value of $29.5 million over approximately three years for clinical trial support appears reasonable given the scope of services. Benchmarking against similar contracts for administrative management and general management consulting services within the federal government suggests this award falls within expected ranges for comprehensive support. The firm-fixed-price structure helps manage cost overruns, contributing to good value for money.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit a bid. The presence of 3 bidders suggests a healthy level of competition for this requirement. This competitive environment is generally favorable for price discovery and ensures the government receives proposals from multiple qualified entities.

Taxpayer Impact: The full and open competition likely resulted in a more competitive pricing structure, benefiting taxpayers by ensuring the government secured services at a fair market price.

Public Impact

The primary beneficiaries are the National Institutes of Health (NIH) and its various research arms, which receive essential support for their clinical trial operations. Services delivered include administrative management and general management consulting, crucial for the efficient execution of complex research protocols. The geographic impact is primarily within Virginia, where the contractor is located, but the ultimate impact supports federally funded research nationwide. The contract supports a workforce skilled in project management, administrative support, and consulting within the healthcare and research sectors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep if the definition of 'support' is not tightly managed.
Reliance on a single prime contractor for critical administrative functions.
Ensuring continued alignment with evolving clinical trial regulations and best practices.

Positive Signals

Firm-fixed-price contract provides cost certainty.
Full and open competition suggests a competitive award process.
Contract duration allows for stable, long-term support.
Prime contractor has experience in relevant consulting services.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically focusing on administrative and management consulting. The federal government is a major consumer of these services to support its vast array of programs. Spending in this category is often driven by the need for specialized expertise that government agencies may not possess internally, particularly in complex areas like clinical trial management. Comparable spending benchmarks would typically be found within the broader professional services category, where agencies procure expertise for program management, research support, and operational efficiency.

Small Business Impact

The data indicates this contract was not set aside for small businesses, and the prime contractor is not a small business. There is no explicit information on subcontracting plans for small businesses within this award. Therefore, the direct impact on the small business ecosystem is likely minimal unless ICF Incorporated actively engages small businesses as subcontractors for specialized support.

Oversight & Accountability

Oversight for this contract would primarily reside with the contracting officers and program managers at the National Institutes of Health (NIH). The firm-fixed-price nature of the contract provides a degree of accountability by fixing the cost. Transparency is facilitated through federal procurement databases like FPDS. While specific IG jurisdiction isn't detailed, the HHS Office of Inspector General would have oversight authority over potential fraud, waste, or abuse related to federal contracts.

Related Government Programs

Federal Clinical Trials Support
NIH Research Grants Administration
Healthcare Management Consulting Services
Federal Administrative Support Contracts

Risk Flags

Contract Duration
Contract Value
Scope Definition

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $29.5 million to ICF INCORPORATED, L.L.C.. SUPPORT FOR CLINICAL TRIALS INFORMATION

Who is the contractor on this award?

The obligated recipient is ICF INCORPORATED, L.L.C..

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 $29.5 million.

What is the period of performance?

Start: 2020-09-30. End: 2023-09-28.

What is the track record of ICF Incorporated in supporting federal clinical trials?

ICF Incorporated, L.L.C. has a demonstrated history of providing professional services to the federal government, including support related to health programs and research. While this specific award focuses on clinical trial support, ICF's broader experience in administrative management and general management consulting, particularly within the health sector, suggests a capacity to handle such requirements. Their past performance on similar federal contracts, though not detailed here, would have been evaluated during the procurement process. Further analysis would involve examining their portfolio of previous government contracts, client satisfaction feedback, and any reported performance issues or successes to fully assess their track record in this specific domain.

How does the value of this contract compare to similar federal investments in clinical trial support?

The $29.5 million award over approximately three years for clinical trial support is a substantial investment. To benchmark its value, one would compare it to other contracts awarded by agencies like NIH, CDC, or other health-focused federal bodies for similar services. Factors such as the scope of support (e.g., administrative, data management, regulatory compliance), the duration, and the specific types of clinical trials supported would influence comparability. Without access to a detailed database of comparable contracts, it's difficult to provide an exact comparison, but the amount suggests a significant, comprehensive support package rather than a niche service.

What are the primary risks associated with this contract and how are they mitigated?

Key risks include potential scope creep, where the requirements expand beyond the initial agreement, leading to cost overruns or delays. Another risk is the contractor's performance not meeting the high standards required for clinical trial support, potentially impacting research integrity. Mitigation strategies likely include robust contract management by NIH, clear definition of deliverables and performance metrics, regular progress reviews, and the firm-fixed-price contract type which incentivizes the contractor to manage costs effectively. The competitive award process also mitigates risk by selecting a contractor deemed capable and offering fair pricing.

How effective is the current contract in facilitating the NIH's clinical trial objectives?

The effectiveness of this contract in facilitating NIH's clinical trial objectives can be assessed through performance metrics outlined in the contract itself and the outcomes achieved. Since the contract is ongoing until September 2023, a full assessment of its effectiveness would require post-award performance data, such as the timely completion of milestones, adherence to budget, quality of administrative support provided, and ultimately, the contribution to the successful execution of clinical trials. The fact that it was awarded under full and open competition suggests a perceived need and a belief in the contractor's ability to deliver value towards NIH's research goals.

What are the historical spending patterns for clinical trial support services at NIH?

Historical spending patterns for clinical trial support services at NIH are likely characterized by consistent and significant investment, reflecting the agency's core mission. NIH is the largest public funder of biomedical research in the world, and clinical trials are a critical component of translating research findings into medical advancements. Spending in this area would fluctuate based on research priorities, the number and complexity of trials initiated, and the availability of funding. Analyzing historical data would reveal trends in contract types (e.g., FFP, cost-plus), prime contractors utilized, and the overall budget allocated to support services over multiple fiscal years.

What is the potential impact of this contract on the broader healthcare research ecosystem?

This contract directly supports the operational efficiency of NIH-funded clinical trials, which are fundamental to advancing medical knowledge and developing new treatments. By ensuring robust administrative and management support, the contract indirectly contributes to the acceleration of research progress. This can lead to faster availability of new therapies for patients, foster innovation within the research community, and maintain the US's leadership in biomedical research. The successful execution of trials supported by this contract can also enhance the reputation and capabilities of the involved research institutions and personnel.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Administrative Management and General Management Consulting Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Offers Received: 3

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: ICF International, Inc.

Address: 9300 LEE HWY, FAIRFAX, VA, 22031

Business Categories: Category Business, Limited Liability Corporation, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $39,582,085

Exercised Options: $39,552,918

Current Obligation: $29,481,383

Actual Outlays: $22,374,329

Subaward Activity

Number of Subawards: 12

Total Subaward Amount: $956,663

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Parent Contract

Parent Award PIID: 75N97020A00019

IDV Type: BPA

Timeline