HHS awards $4.3M contract for CDER Electronic Submissions Program support to Infotrend Inc

Contract Overview

Contract Amount: $4,313,261 ($4.3M)

Contractor: Infotrend Incorporated

Awarding Agency: Department of Health and Human Services

Start Date: 2024-03-07

End Date: 2027-03-21

Contract Duration: 1,109 days

Daily Burn Rate: $3.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: IT

Official Description: THE CDER ELECTRONIC SUBMISSIONS PROGRAM (ESP) SUPPORT

Place of Performance

Location: COLLEGE PARK, PRINCE GEORGES County, MARYLAND, 20742

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $4.3 million to INFOTREND INCORPORATED for work described as: THE CDER ELECTRONIC SUBMISSIONS PROGRAM (ESP) SUPPORT Key points: 1. Contract awarded via full and open competition, suggesting a competitive bidding process. 2. The contract is a definitive contract with a firm fixed price, indicating defined scope and cost. 3. The duration of over 1100 days suggests a long-term need for these services. 4. The North American Industry Classification System (NAICS) code 541519 points to 'Other Computer Related Services'. 5. The contract is for support of the CDER Electronic Submissions Program (ESP). 6. The award is a single definitive contract, not a task order under a larger IDIQ. 7. The contract value is approximately $4.3 million over its period of performance.

Value Assessment

Rating: good

The contract value of $4.3 million over approximately three years for IT support services appears reasonable. Benchmarking against similar IT support contracts for federal agencies, especially those involving specialized program support like electronic submissions, would provide a more precise value assessment. The firm fixed-price structure helps control costs for the government, assuming the scope is well-defined and managed effectively. Without specific per-unit cost data or detailed service level agreements, a definitive value-for-money judgment is challenging, but the competitive award process is a positive indicator.

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 number of bidders is not specified in the provided data, but the competitive nature of the award suggests that multiple companies likely vied for this contract. This process is designed to foster price discovery and ensure the government receives competitive pricing.

Taxpayer Impact: A full and open competition generally benefits taxpayers by driving down costs through market competition, leading to a more efficient use of federal funds.

Public Impact

The primary beneficiary is the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), which relies on the Electronic Submissions Program (ESP). The services delivered will support the infrastructure and processes for electronic submissions of drug applications and related information. This contract supports a critical function within the FDA, impacting the efficiency of drug review and approval processes. The geographic impact is primarily national, supporting a federal agency's operations, with potential indirect impacts on pharmaceutical companies and ultimately patients nationwide.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep if the 'support' is not clearly defined, leading to cost overruns.
Reliance on a single contractor for a critical program could pose a risk if performance issues arise.
The long contract duration might lead to vendor lock-in or reduced incentive for innovation if not managed proactively.

Positive Signals

Awarded through full and open competition, indicating a competitive market for these services.
Firm fixed-price contract provides cost certainty for the government.
The contract supports a vital function for the FDA's drug review process, indicating alignment with agency mission.
The contract is awarded to a single entity, potentially allowing for focused expertise and streamlined communication.

Sector Analysis

This contract falls within the IT services sector, specifically focusing on computer systems design and related services. The market for federal IT support is substantial, with agencies increasingly relying on digital solutions for program management and data handling. Comparable spending benchmarks would involve analyzing other contracts for similar IT support services provided to federal health agencies or regulatory bodies, particularly those managing large-scale electronic data systems. The $4.3 million award is moderate for a multi-year IT support contract of this nature.

Small Business Impact

The provided data indicates that small business participation (ss and sb fields) is false for this contract. This suggests that the contract was not set aside for small businesses and that small business subcontracting may not be a primary focus, or at least not explicitly mandated or reported in this summary data. Further investigation into the contract's subcontracting plan, if any, would be necessary to fully assess its impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would typically fall under the Department of Health and Human Services (HHS), specifically the Office of the Assistant Secretary for Financial Resources, which awarded the contract. Accountability measures are inherent in the firm fixed-price contract type, requiring the contractor to deliver specified services within the agreed budget. Transparency is facilitated by the contract award being made under full and open competition, which is publicly reportable. The Inspector General for HHS would have jurisdiction to investigate any potential fraud, waste, or abuse related to this contract.

Related Government Programs

FDA IT Modernization Initiatives
CDER Program Management Support
Federal Electronic Records Management Systems
Health IT Infrastructure Support
Drug Approval Process Support Services

Risk Flags

Potential for vendor lock-in due to long contract duration.
Reliance on a single contractor for critical program support.
Need for clear definition of 'support' to prevent scope creep.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $4.3 million to INFOTREND INCORPORATED. THE CDER ELECTRONIC SUBMISSIONS PROGRAM (ESP) SUPPORT

Who is the contractor on this award?

The obligated recipient is INFOTREND INCORPORATED.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of the Assistant Secretary for Financial Resources).

What is the total obligated amount?

The obligated amount is $4.3 million.

What is the period of performance?

Start: 2024-03-07. End: 2027-03-21.

What is the specific nature of the 'support' provided under the CDER Electronic Submissions Program (ESP)?

The 'support' for the CDER Electronic Submissions Program (ESP) likely encompasses a range of IT services crucial for the program's operation. This could include system maintenance, software development and updates, database management, user support, cybersecurity measures, and ensuring compliance with relevant regulations for electronic data handling. Given that ESP facilitates the submission of drug applications and related information electronically, the support would be vital for maintaining the integrity, accessibility, and efficiency of this digital pipeline between pharmaceutical companies and the FDA. The firm fixed-price nature suggests a defined set of deliverables or service levels are expected.

How does this contract's value compare to similar IT support contracts within the FDA or other health agencies?

Comparing this $4.3 million contract to similar IT support contracts requires access to a broader dataset of federal procurements. However, for a multi-year definitive contract supporting a critical program like the FDA's electronic submissions, this value appears within a reasonable range. Contracts for enterprise-wide IT support, cybersecurity, or specialized program management systems within large federal agencies can range from several million to hundreds of millions of dollars. The specific nature of ESP support, its user base, and the criticality of its uptime and data integrity would influence its cost. A direct comparison would ideally involve contracts for electronic submission portals or regulatory data management systems in other health-related federal bodies.

What are the key performance indicators (KPIs) or service level agreements (SLAs) associated with this contract?

The provided data does not specify the Key Performance Indicators (KPIs) or Service Level Agreements (SLAs) for this contract. However, for a contract supporting the CDER Electronic Submissions Program (ESP), critical KPIs would likely revolve around system uptime and availability, response times for technical support, data processing speeds, security incident response times, and successful completion of system updates or maintenance with minimal disruption. SLAs would define the acceptable thresholds for these metrics, and failure to meet them could have implications for contractor performance and payment, especially under a firm fixed-price arrangement where performance is paramount.

What is Infotrend Incorporated's track record with federal IT support contracts, particularly within the Department of Health and Human Services?

Assessing Infotrend Incorporated's track record requires a review of their past federal contract awards and performance history. Information on their previous work with HHS or other agencies, the types of services rendered, contract values, and any performance evaluations (e.g., Contractor Performance Assessment Reporting System - CPARS) would be crucial. A history of successful contract completion, positive performance reviews, and experience with similar IT support functions, especially those involving regulatory compliance or sensitive data, would indicate a lower risk for this current award. Conversely, past performance issues or significant contract disputes could raise concerns.

What are the potential risks associated with relying on a single contractor for the long duration of this contract?

The primary risks associated with relying on a single contractor, Infotrend Incorporated, for over three years (1109 days) include potential vendor lock-in, reduced incentive for innovation, and the impact of contractor performance issues. Vendor lock-in can make it difficult and costly to switch providers if performance declines or needs change. A long-term, sole-source (from the perspective of this specific award, not the competition method) relationship might reduce the contractor's urgency to proactively improve services or adopt new technologies if they feel secure in their position. Furthermore, if Infotrend experiences significant staffing changes, financial instability, or management issues, it could directly disrupt the critical ESP operations, leading to delays in drug review processes.

How does the firm fixed-price contract type mitigate risks for the government in this scenario?

The firm fixed-price (FFP) contract type is a significant risk mitigation tool for the government in this scenario. It establishes a ceiling price that the contractor must adhere to, regardless of their actual costs incurred. This provides budget certainty and protects the government from cost overruns, assuming the contract's scope of work is clearly defined and well-managed. For Infotrend Incorporated, the FFP structure incentivizes efficient performance and cost control, as any savings achieved below the fixed price benefit the contractor, while any overruns are absorbed by them. This structure is particularly effective for IT support services where the scope of work can be reasonably predicted.

Industry Classification

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

Product/Service Code: IT AND TELECOM - APLLICATIONS

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 7761 DIAMONDBACK DRIVE, SUITE 02-113, COLLEGE PARK, MD, 20742

Business Categories: 8(a) Program Participant, Category Business, Corporate Entity Not Tax Exempt, DoT Certified Disadvantaged Business Enterprise, Minority Owned Business, Not Designated a Small Business, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Indian (Subcontinent) American Owned Business, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $4,498,787

Exercised Options: $4,313,261

Current Obligation: $4,313,261

Actual Outlays: $2,607,344

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline