HHS awards $4.8M contract for drug evaluation data management to Lumendata Inc

Contract Overview

Contract Amount: $4,816,915 ($4.8M)

Contractor: Lumendata Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-28

End Date: 2023-09-27

Contract Duration: 1,094 days

Daily Burn Rate: $4.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 12

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: BAA CONTRACT ENTITLED "MASTER DATA MANAGEMENT INFORMATICS ANALYSIS FOR THE CENTER FOR DRUG EVALUATION AND RESEARCH"

Place of Performance

Location: SANTA CLARA, SANTA CLARA County, CALIFORNIA, 95054

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $4.8 million to LUMENDATA INC for work described as: BAA CONTRACT ENTITLED "MASTER DATA MANAGEMENT INFORMATICS ANALYSIS FOR THE CENTER FOR DRUG EVALUATION AND RESEARCH" Key points: 1. Contract focuses on critical data management for drug evaluation, aiming to improve regulatory processes. 2. Competition was full and open, suggesting a potentially competitive bidding environment. 3. The contract duration of nearly three years indicates a significant, ongoing need for these services. 4. Fixed-price contract type helps manage cost certainty for the government. 5. The awardee, Lumendata Inc., is positioned to deliver specialized informatics analysis. 6. This contract supports the FDA's mission to ensure the safety and efficacy of drugs.

Value Assessment

Rating: good

The contract value of $4.8 million over approximately three years appears reasonable for specialized data management and informatics analysis services. Benchmarking against similar contracts for custom computer programming services (NAICS 541511) within the federal government suggests this award is within a typical range for projects of this scope and duration. The firm fixed-price structure provides cost predictability, which is a positive indicator for value.

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 bids. With 12 bids received, the level of competition was robust. This suggests that the government had a good opportunity to solicit competitive pricing and select the best-value offer. The presence of multiple bidders generally leads to better price discovery and potentially lower costs for the government.

Taxpayer Impact: A full and open competition with 12 bidders is beneficial for taxpayers as it increases the likelihood of securing services at a competitive market rate, preventing potential overpayment.

Public Impact

The Center for Drug Evaluation and Research (CDER) at the FDA benefits directly through enhanced data management capabilities. Services delivered include informatics analysis crucial for drug review and approval processes. The geographic impact is primarily within the federal government's operational sphere, supporting national public health initiatives. Workforce implications include the engagement of specialized IT and data analysis professionals.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for vendor lock-in if data systems become highly proprietary.
Ensuring data integrity and security throughout the contract lifecycle is paramount.
Dependence on contractor expertise for critical data analysis functions.

Positive Signals

Clear definition of services through a firm fixed-price contract.
Robust competition indicates market validation of the service need.
Contract supports a critical public health mission of the FDA.

Sector Analysis

This contract falls within the Custom Computer Programming Services sector (NAICS 541511), a significant segment of the federal IT market. The federal government spends billions annually on IT services, with a substantial portion dedicated to data management, analytics, and custom software development. This contract aligns with the broader trend of federal agencies leveraging advanced informatics to improve operational efficiency and mission outcomes, particularly in complex areas like drug regulation.

Small Business Impact

The contract was not set aside for small businesses, and there is no indication of specific subcontracting requirements for small businesses in the provided data. This suggests that the primary award went to a large business or a business that did not meet small business criteria for this specific procurement. The impact on the small business ecosystem is neutral to potentially negative if small businesses were capable of performing the work but were not specifically solicited or incentivized to participate.

Oversight & Accountability

Oversight is likely managed by the Food and Drug Administration contracting officers and program managers. Accountability measures are embedded in the firm fixed-price contract terms, requiring delivery of specified services. Transparency is facilitated by federal contract databases, though detailed performance metrics are typically internal. Inspector General jurisdiction would apply in cases of fraud, waste, or abuse.

Related Government Programs

FDA Data Modernization Initiative
Center for Drug Evaluation and Research (CDER) IT Modernization
Federal Health IT Spending
Custom Computer Programming Services Contracts

Risk Flags

Data Security and Privacy
Vendor Lock-in Potential
Performance and Delivery Risk
Technological Obsolescence
Regulatory Compliance Changes

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $4.8 million to LUMENDATA INC. BAA CONTRACT ENTITLED "MASTER DATA MANAGEMENT INFORMATICS ANALYSIS FOR THE CENTER FOR DRUG EVALUATION AND RESEARCH"

Who is the contractor on this award?

The obligated recipient is LUMENDATA INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $4.8 million.

What is the period of performance?

Start: 2020-09-28. End: 2023-09-27.

What is Lumendata Inc.'s track record with federal contracts, particularly within the Department of Health and Human Services?

Lumendata Inc. has a history of federal contracting, primarily with agencies like the Department of Health and Human Services (HHS). While specific details on past performance metrics for this exact contract are not publicly available, their ability to win a competitive bid for a critical function like data management within the FDA suggests a level of established capability and past success. Further analysis would involve reviewing their contract history for similar services, past performance evaluations (if accessible), and any reported issues or commendations on federal procurement platforms. Their presence in this award indicates they meet the technical and financial qualifications required by the FDA for complex informatics tasks.

How does the $4.8 million contract value compare to similar federal informatics analysis contracts?

The $4.8 million contract value for Master Data Management Informatics Analysis over approximately three years is generally considered moderate within the federal IT services landscape. Comparable contracts for custom computer programming and data analytics services awarded by agencies like HHS, NIH, or CDC often range from a few hundred thousand to several million dollars, depending on the scope, duration, and complexity. Contracts involving large-scale data integration, advanced analytics, and regulatory compliance, as this one does for CDER, can command higher values. The firm fixed-price nature also helps in comparing value, as it sets a ceiling on costs. Without specific details on the exact deliverables and service levels, a precise benchmark is difficult, but the award appears aligned with market rates for specialized federal informatics support.

What are the primary risks associated with this Master Data Management Informatics Analysis contract?

Key risks include data security and privacy breaches, given the sensitive nature of drug evaluation data. There's also a risk of vendor lock-in if the implemented solutions are highly proprietary or difficult to transition. Performance risk exists if Lumendata Inc. fails to deliver the required analytical insights or maintain data integrity, potentially impacting the FDA's drug review processes. Schedule slippage could delay critical regulatory functions. Finally, there's a risk related to the evolving regulatory landscape and technological advancements, requiring continuous adaptation by the contractor to maintain relevance and effectiveness throughout the contract period.

How effective is this contract likely to be in improving the FDA's drug evaluation processes?

The effectiveness of this contract hinges on the successful implementation of robust data management and informatics analysis. By improving how CDER manages and analyzes data, the contract has the potential to streamline the drug review process, enhance the accuracy of safety and efficacy assessments, and accelerate the identification of potential issues. Effective data management can lead to better-informed decisions, faster regulatory actions, and ultimately, quicker access to safe and effective medications for the public. The success will depend on Lumendata's technical expertise, the clarity of FDA requirements, and ongoing collaboration and oversight.

What are the historical spending patterns for similar data management and informatics services at the FDA?

Historical spending patterns at the FDA for data management and informatics services show a consistent and increasing trend over the years, driven by the growing volume and complexity of data generated from clinical trials, post-market surveillance, and research. Agencies like the FDA are increasingly investing in IT modernization and data analytics capabilities to keep pace with scientific advancements and regulatory demands. Spending in this area typically includes custom software development, database management, data warehousing, business intelligence tools, and specialized analytical services. The FDA has historically awarded numerous contracts in these categories, reflecting a sustained commitment to leveraging data for public health protection and drug innovation.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Computer Systems Design and Related Services › Custom Computer Programming Services

Product/Service Code: RESEARCH AND DEVELOPMENT › General Science and Technology R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: BASIC RESEARCH

Solicitation ID: FDABAA-20-00123

Offers Received: 12

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 5201 GREAT AMERICA PKWY STE 320, SANTA CLARA, CA, 95054

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Minority Owned Business, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Indian (Subcontinent) American Owned Business, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $4,816,915

Exercised Options: $4,816,915

Current Obligation: $4,816,915

Actual Outlays: $3,911,082

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline