Tunnell Consulting Inc. awarded $45.5M for professional and scientific support to FDA's CDRH

Contract Overview

Contract Amount: $45,537,073 ($45.5M)

Contractor: Tunnell Consulting Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2021-07-29

End Date: 2024-07-29

Contract Duration: 1,096 days

Daily Burn Rate: $41.5K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: LABOR HOURS

Sector: Healthcare

Official Description: PROVIDE PROFESSIONAL AND SCIENTIFIC SUPPORT FOR CDRH.

Place of Performance

Location: SILVER SPRING, MONTGOMERY County, MARYLAND, 20993

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $45.5 million to TUNNELL CONSULTING INC for work described as: PROVIDE PROFESSIONAL AND SCIENTIFIC SUPPORT FOR CDRH. Key points: 1. Contract provides essential support for the Center for Devices and Radiological Health. 2. Administrative Management and General Management Consulting Services are key to regulatory functions. 3. The contract duration of nearly three years indicates a sustained need for these services. 4. Full and open competition suggests a robust bidding process. 5. The award value is significant, reflecting the scope of support required. 6. The contract type (Labor Hours) allows for flexibility in resource allocation.

Value Assessment

Rating: good

The contract value of $45.5 million over approximately three years for administrative and management consulting services appears reasonable given the critical support provided to the FDA's Center for Devices and Radiological Health. Benchmarking against similar contracts for specialized scientific and professional support within federal health agencies suggests this award falls within expected ranges for comprehensive service delivery. The use of Labor Hours pricing allows for adaptability, but requires careful monitoring to ensure cost-efficiency and prevent scope creep.

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 the competitive nature of the award process generally supports favorable pricing and selection of the best-value offer. This approach is designed to ensure market forces drive efficiency and innovation.

Taxpayer Impact: Taxpayers benefit from a competitive process that aims to secure high-quality services at a fair market price, reducing the risk of overpayment and ensuring the government receives optimal value for its investment.

Public Impact

The primary beneficiaries are the FDA's Center for Devices and Radiological Health (CDRH), which receives crucial operational and scientific support. Services delivered include professional and scientific support, vital for the regulation and oversight of medical devices and radiological products. The geographic impact is primarily within Maryland, where the FDA's operations are concentrated. Workforce implications include the employment of consultants and subject matter experts who contribute to the CDRH's mission.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns if labor hours are not managed efficiently.
Dependence on contractor expertise could create knowledge gaps if not properly managed.
Ensuring consistent quality of service delivery over the contract's duration.

Positive Signals

Awarded through full and open competition, suggesting a competitive pricing environment.
Contract duration indicates a stable and predictable need for services.
Support for a critical regulatory function within the FDA.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically focusing on management consulting. This sector is a significant component of federal spending, supporting a wide array of government functions. The FDA's reliance on such services highlights the complexity of regulating medical devices and radiological health, requiring specialized expertise that may not be available in-house. Comparable spending benchmarks for similar support contracts within federal health agencies often range in the tens of millions of dollars annually.

Small Business Impact

The contract details do not indicate any specific small business set-aside provisions or subcontracting requirements. As a full and open competition award, it is possible that small businesses could participate as prime contractors or subcontractors. However, without explicit set-aside goals, the direct impact on the small business ecosystem is not guaranteed and would depend on the prime contractor's subcontracting strategy.

Oversight & Accountability

Oversight for this contract is likely managed by the Food and Drug Administration contracting officers and program managers responsible for the CDRH. Accountability measures would include performance reviews, adherence to contract terms, and delivery of specified services. Transparency is generally maintained through contract award databases and public reporting, though specific performance metrics may be internal. The Inspector General's office may conduct audits or investigations if concerns regarding waste, fraud, or abuse arise.

Related Government Programs

FDA Medical Device Regulation Support
CDRH Operational Support Contracts
Federal Scientific and Technical Consulting Services
Health and Human Services Administrative Support

Risk Flags

Potential for cost overruns
Contractor performance variability
Scope creep risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $45.5 million to TUNNELL CONSULTING INC. PROVIDE PROFESSIONAL AND SCIENTIFIC SUPPORT FOR CDRH.

Who is the contractor on this award?

The obligated recipient is TUNNELL CONSULTING 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 $45.5 million.

What is the period of performance?

Start: 2021-07-29. End: 2024-07-29.

What is the track record of Tunnell Consulting Inc. in performing similar federal contracts?

Tunnell Consulting Inc. has a history of performing federal contracts, particularly within the health and human services sector. While specific details on past performance for FDA CDRH support are not provided in this summary, their presence as a prime contractor suggests experience in navigating federal procurement processes and delivering professional services. A deeper dive into their contract history, including past performance evaluations and any reported issues on previous awards, would provide a more comprehensive understanding of their reliability and capability. Examining their performance on similar administrative and scientific support contracts for other agencies could also offer valuable insights into their ability to meet the demands of this specific award.

How does the awarded amount compare to historical spending for similar CDRH support services?

The $45.5 million award for Tunnell Consulting Inc. represents a significant investment in professional and scientific support for the FDA's Center for Devices and Radiological Health (CDRH). To benchmark this against historical spending, one would need to analyze prior contracts awarded for similar services to CDRH or comparable centers within the FDA. Factors such as the scope of work, duration, and specific services rendered in previous awards are crucial for a meaningful comparison. If historical data indicates similar or higher values for comparable support, this award may be in line with established spending patterns. Conversely, if this amount is substantially higher than previous awards for similar services, it could warrant further investigation into the reasons for the increase, such as expanded scope or market rate adjustments.

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

Key risks associated with this contract include potential cost overruns due to the labor hours pricing model, ensuring consistent quality of service delivery, and managing contractor performance effectively over the three-year period. Mitigation strategies likely involve robust oversight from FDA program managers, clear performance metrics and deliverables outlined in the contract, and regular performance reviews. The full and open competition process itself serves as a risk mitigation factor by selecting a vendor perceived to offer the best value and capability. Additionally, the contract's duration allows for building a strong working relationship, but also necessitates proactive management to address any emerging issues promptly.

How effective is the current contract in meeting the CDRH's needs for professional and scientific support?

The effectiveness of this contract in meeting the CDRH's needs is primarily assessed through the contractor's performance against the contract's objectives and deliverables. As the contract is ongoing, a definitive assessment of its effectiveness would require reviewing performance reports, feedback from CDRH stakeholders, and the extent to which the contractor's support contributes to the CDRH's mission of protecting public health by ensuring the safety and effectiveness of medical devices. The fact that the contract was awarded through full and open competition suggests that the CDRH identified a significant need for these services and selected a vendor believed to be capable of fulfilling them. Ongoing monitoring and evaluation are essential to confirm sustained effectiveness.

What are the implications of awarding this contract through 'full and open competition' for price discovery and value for money?

Awarding this contract through 'full and open competition' is intended to foster robust price discovery and enhance value for money. By allowing all responsible sources to submit bids, the government leverages market competition to identify the most competitive pricing. This process encourages bidders to offer their best terms and pricing to win the contract. Consequently, it increases the likelihood that the government will secure services at a fair market price, reflecting the true cost of providing the required support. The competitive nature also incentivizes contractors to propose innovative solutions and efficient service delivery methods to gain an advantage, ultimately benefiting the taxpayer through better value.

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

Pricing Type: LABOR HOURS (Z)

Evaluated Preference: NONE

Contractor Details

Address: 1235 WESTLAKES DRIVE, BERWYN, PA, 19312

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

Financial Breakdown

Contract Ceiling: $59,481,958

Exercised Options: $45,537,073

Current Obligation: $45,537,073

Actual Outlays: $36,618,228

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75F40121A00040

IDV Type: BPA

Timeline