NIH awards $18.6M for HIV/AIDS clinical trials support services to Westat, Inc

Contract Overview

Contract Amount: $18,614,250 ($18.6M)

Contractor: Westat, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2017-11-27

End Date: 2022-11-29

Contract Duration: 1,828 days

Daily Burn Rate: $10.2K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF SUPPORT SERVICES FOR THE HIV AIDS CLINICAL TRIALS NETWORKS

Place of Performance

Location: ROCKVILLE, MONTGOMERY County, MARYLAND, 20850

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $18.6 million to WESTAT, INC. for work described as: IGF::OT::IGF SUPPORT SERVICES FOR THE HIV AIDS CLINICAL TRIALS NETWORKS Key points: 1. Contract awarded through full and open competition, suggesting a robust market for these services. 2. The contract duration of approximately 5 years provides a stable period for service delivery. 3. Westat, Inc. has secured this significant award, indicating a strong track record in research support. 4. The North American Industry Classification System (NAICS) code 541715 points to specialized R&D services. 5. The contract type is Cost Plus Fixed Fee, which allows for flexibility but requires careful cost monitoring. 6. The award was made via a Delivery Order, suggesting it's part of a larger indefinite-delivery/indefinite-quantity (IDIQ) vehicle.

Value Assessment

Rating: good

The contract value of $18.6 million over five years for HIV/AIDS clinical trials support services appears reasonable given the specialized nature of the work. Benchmarking against similar R&D support contracts would provide a more precise value-for-money assessment. The Cost Plus Fixed Fee structure necessitates diligent oversight to ensure costs remain within acceptable parameters while incentivizing efficient performance.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified vendors had the opportunity to bid. The specific number of bidders is not provided, but this approach generally fosters competitive pricing and encourages a wider pool of contractors to participate. The open competition suggests that the government sought the best value from the market.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it typically leads to more competitive pricing and a broader selection of qualified contractors, maximizing the potential for cost savings and service quality.

Public Impact

The primary beneficiaries are patients participating in HIV/AIDS clinical trials, who receive access to well-supported research studies. Services delivered include crucial support for the operational and administrative aspects of clinical trials networks. The geographic impact is likely national, given the scope of NIH-funded research, potentially benefiting various communities across the United States. Workforce implications include employment for researchers, data managers, and administrative staff involved in clinical trial operations.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts can sometimes lead to cost overruns if not managed tightly.
Reliance on a single delivery order under a potential IDIQ could indicate limited competition for this specific task order, despite the overall full and open nature of the IDIQ.

Positive Signals

Awarded through full and open competition, suggesting a competitive bidding process.
The contract duration of nearly five years provides stability for ongoing critical research.
Westat, Inc. is a known entity in research support, implying a level of established capability.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences support. The market for clinical trial support services is substantial, driven by pharmaceutical companies, government agencies like NIH, and academic institutions. Westat, Inc. operates in a competitive landscape with other contract research organizations (CROs) and research support firms. Spending benchmarks for similar NIH contracts would be valuable for a precise comparison.

Small Business Impact

The data indicates that small business participation was not a specific set-aside for this contract (ss: false, sb: false). While this contract was not directly set aside for small businesses, the prime contractor, Westat, Inc., may engage small businesses as subcontractors. Further analysis would be needed to determine the extent of small business subcontracting and its impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), the awarding agency. As a Cost Plus Fixed Fee contract, rigorous financial oversight and performance monitoring are essential to ensure funds are used effectively and objectives are met. The Inspector General of the Department of Health and Human Services would have jurisdiction for audits and investigations if any irregularities were suspected.

Related Government Programs

NIH HIV/AIDS Research Programs
Clinical Trials Support Services
Research and Development Contracts
Public Health Research Funding

Risk Flags

Cost Plus Fixed Fee contract type requires diligent oversight.
Potential for cost overruns inherent in CPFF structure.
Specific number of bidders not disclosed, limiting full competition assessment.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $18.6 million to WESTAT, INC.. IGF::OT::IGF SUPPORT SERVICES FOR THE HIV AIDS CLINICAL TRIALS NETWORKS

Who is the contractor on this award?

The obligated recipient is WESTAT, 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 $18.6 million.

What is the period of performance?

Start: 2017-11-27. End: 2022-11-29.

What is Westat, Inc.'s track record with the federal government, particularly with NIH?

Westat, Inc. has a significant history of contracting with the federal government, including numerous awards from the National Institutes of Health (NIH). Their portfolio often includes large-scale data collection, survey research, and support for health-related studies. For instance, they have been involved in major health surveys and research initiatives. Their experience with NIH suggests a familiarity with the agency's research priorities, administrative processes, and compliance requirements. This established relationship likely contributed to their successful bid for the HIV/AIDS clinical trials support services contract, indicating a level of trust and proven capability in delivering complex research support.

How does the $18.6 million contract value compare to similar NIH contracts for clinical trial support?

The $18.6 million value for approximately five years of support for HIV/AIDS clinical trials networks is within a typical range for contracts of this nature awarded by NIH. NIH frequently awards multi-million dollar contracts for research support, data management, and network coordination. The specific value is influenced by factors such as the scope of services, the number of trials supported, the geographic reach, and the complexity of the research. Without direct comparison data for identical services, it's challenging to definitively benchmark. However, considering the critical and specialized nature of HIV/AIDS research, this investment reflects the significant resources required to maintain and advance such vital clinical networks.

What are the primary risks associated with a Cost Plus Fixed Fee (CPFF) contract for R&D support?

The primary risk with a Cost Plus Fixed Fee (CPFF) contract is the potential for cost overruns. While the contractor is incentivized to control costs to protect their fixed fee, the government bears the risk of increased costs if the contractor's actual expenses exceed initial estimates. This requires robust oversight from the contracting agency to scrutinize all allowable costs and ensure they are reasonable and allocable to the contract. Another risk is that the contractor might prioritize cost recovery over innovation or efficiency if not properly managed. For R&D support, where unforeseen challenges are common, careful monitoring of expenditures and performance is crucial to mitigate these risks and ensure the government receives good value.

How effective is the full and open competition process in ensuring value for taxpayer money in R&D contracts?

The full and open competition process is generally considered the most effective method for ensuring value for taxpayer money in R&D contracts. By allowing all responsible sources to submit bids, it maximizes the pool of potential contractors, fostering a competitive environment that drives down prices and encourages innovation. This process allows the government to compare a wider range of technical approaches and cost proposals, leading to the selection of the offer that represents the best overall value. While it requires more upfront effort in solicitation and evaluation, the long-term benefits of competitive pricing, higher quality services, and reduced risk of contractor lock-in typically outweigh the initial investment, especially for significant R&D investments.

What is the historical spending trend for HIV/AIDS clinical trials support services by NIH?

NIH has consistently allocated substantial funding towards HIV/AIDS research, including significant investments in clinical trials support services, over several decades. Historical spending reflects a long-term commitment to combating the epidemic through rigorous scientific investigation. While specific annual figures fluctuate based on research priorities, funding cycles, and the number of active trials, the overall trend indicates sustained and significant financial support. This contract, valued at $18.6 million over its term, aligns with this historical pattern of robust investment in the infrastructure necessary for effective clinical trials, underscoring the ongoing importance of this research area.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: NIHNICHDMPIDB20181

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 1600 RESEARCH BLVD, ROCKVILLE, MD, 20850

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

Financial Breakdown

Contract Ceiling: $18,614,250

Exercised Options: $18,614,250

Current Obligation: $18,614,250

Actual Outlays: $5,350,872

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $890,000

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: HHSN275201800001I

IDV Type: IDC

Timeline