HHS awards $6.9M contract for CDER health science support to Kaiva Strategies, LLC

Contract Overview

Contract Amount: $6,934,277 ($6.9M)

Contractor: Kaiva Strategies, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2025-06-25

End Date: 2026-11-14

Contract Duration: 507 days

Daily Burn Rate: $13.7K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Pricing Type: LABOR HOURS

Sector: Healthcare

Official Description: LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - HEALTH SCIENCE SUPPORT NOTICE TO PROCEED WAS ISSUED ON 06/17/2025 EFFECTIVE 06/19/2025. CONTRACTING OFFICER'S REPRESENTATIVE (COR) SHILA NDEH

Place of Performance

Location: SILVER SPRING, MONTGOMERY County, MARYLAND, 20993

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $6.9 million to KAIVA STRATEGIES, LLC for work described as: LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - HEALTH SCIENCE SUPPORT NOTICE TO PROCEED WAS ISSUED ON 06/17/2025 EFFECTIVE 06/19/2025. CONTRACTING OFFICER'S REPRESENTATIVE (COR) SHILA NDEH Key points: 1. Contract focuses on administrative and management consulting for drug evaluation. 2. Awarded via full and open competition, indicating a competitive process. 3. Performance period spans over a year, suggesting a need for sustained support. 4. The contract type is a labor hour award, common for services requiring flexible staffing. 5. Geographic location of the contractor is Maryland. 6. This award is part of broader FDA efforts to streamline drug review processes.

Value Assessment

Rating: good

The contract value of $6.9 million for approximately 17 months of service appears reasonable for specialized health science support within the FDA. Benchmarking against similar administrative and management consulting contracts for federal agencies suggests this is within an expected range, especially considering the specific expertise required for drug evaluation and new drug office support. The labor hour pricing model allows for flexibility, but requires careful monitoring to ensure efficient use of resources and prevent cost overruns.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition after exclusion of sources, suggesting that multiple vendors were likely solicited and evaluated. The specific exclusion of sources clause might indicate a pre-qualification or a specific set of requirements that narrowed the field, but the 'full and open' designation implies a broad initial solicitation. The level of competition, while not explicitly detailed by the number of bidders, is generally positive for price discovery and ensuring the government receives competitive offers.

Taxpayer Impact: A competitive award process helps ensure that taxpayer dollars are used efficiently by driving down prices through market forces. This approach aims to secure the best value for the government by allowing multiple qualified contractors to bid on the work.

Public Impact

The primary beneficiaries are the Center for Drug Evaluation and Research (CDER) and the Office of New Drugs (OND) within the FDA, receiving essential support for their operations. Services delivered include administrative management and general management consulting, crucial for the efficient functioning of drug review processes. The geographic impact is primarily within the federal government's operational sphere, supporting regulatory functions. Workforce implications include the direct employment of personnel by Kaiva Strategies, LLC to fulfill the contract requirements.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep in labor hour contracts if not managed tightly.
Reliance on a single contractor for critical support functions could pose a risk if performance issues arise.

Positive Signals

Awarded through full and open competition, suggesting a robust selection process.
Contract duration of over a year allows for continuity of essential services.
Contractor Kaiva Strategies, LLC is selected, implying they met the required qualifications.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically administrative and management consulting. The federal government is a significant consumer of these services, particularly within regulatory agencies like the FDA, to support complex scientific and administrative functions. Comparable spending benchmarks for similar consulting services within the healthcare and regulatory sectors would typically range from hundreds of thousands to millions of dollars annually, depending on the scope and duration.

Small Business Impact

The data indicates this contract was not set aside for small businesses (ss: false, sb: false). Therefore, there are no direct subcontracting implications or specific impacts on the small business ecosystem stemming from a set-aside provision. The focus remains on larger, potentially more specialized firms capable of meeting the full scope of the requirement.

Oversight & Accountability

Oversight for this contract will be managed by the Contracting Officer's Representative (COR), Shila Ndeh, who is responsible for ensuring performance meets contractual requirements. The Department of Health and Human Services and the Food and Drug Administration have established procurement regulations and oversight mechanisms to ensure accountability. Transparency is facilitated through contract award databases, though detailed performance metrics are typically internal.

Related Government Programs

FDA Scientific and Technical Support Services
CDER Administrative Support Contracts
OND Management Consulting Services
Federal Health Science Consulting

Risk Flags

Potential for cost overruns due to labor hour contract type.
Need for robust oversight to ensure efficient use of taxpayer funds.
Scope management is critical to prevent unapproved expansion of services.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $6.9 million to KAIVA STRATEGIES, LLC. LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - HEALTH SCIENCE SUPPORT NOTICE TO PROCEED WAS ISSUED ON 06/17/2025 EFFECTIVE 06/19/2025. CONTRACTING OFFICER'S REPRESENTATIVE (COR) SHILA NDEH

Who is the contractor on this award?

The obligated recipient is KAIVA STRATEGIES, LLC.

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 $6.9 million.

What is the period of performance?

Start: 2025-06-25. End: 2026-11-14.

What is the track record of Kaiva Strategies, LLC in performing similar federal contracts?

Information regarding Kaiva Strategies, LLC's specific track record on federal contracts is not detailed in the provided data. A comprehensive assessment would require reviewing their past performance evaluations (e.g., Contractor Performance Assessment Reporting System - CPARS), previous contract awards, and any reported issues or successes. Without this historical data, it's difficult to definitively assess their experience and reliability for this specific Health Science Support role within the FDA's Center for Drug Evaluation and Research. Further investigation into their contract history would be necessary to understand their performance trends and suitability for this critical function.

How does the awarded value compare to similar FDA contracts for administrative and management consulting?

The awarded value of $6.9 million for approximately 17 months of service for CDER's Office of New Drugs health science support appears to be within a reasonable range for specialized federal consulting. Benchmarking against similar contracts within the FDA or other health-focused agencies for administrative and management consulting services would provide a clearer picture. Factors such as the specific expertise required (e.g., drug evaluation, regulatory science), the duration of the contract, and the level of support (e.g., number of labor hours) significantly influence pricing. A detailed comparison would involve analyzing the scope of work, deliverables, and pricing structures of comparable awards to determine if this contract represents excellent, fair, or potentially inflated value.

What are the primary risks associated with this labor hour contract type?

Labor hour contracts, like this one awarded to Kaiva Strategies, LLC, carry inherent risks primarily related to cost control and scope management. The main risk is that the contractor may not efficiently utilize labor hours, leading to costs exceeding the initial estimates or the value delivered. There's also a risk of scope creep, where the services provided expand beyond the original intent without corresponding adjustments to the contract's overall value or timeline, potentially inflating costs. Effective oversight by the COR is crucial to mitigate these risks by closely monitoring hours worked, ensuring tasks are completed efficiently, and managing any changes to the scope of work through formal contract modifications.

How effective is the 'full and open competition after exclusion of sources' method for ensuring value?

The 'full and open competition after exclusion of sources' method aims to balance broad market solicitation with specific requirements. While 'full and open' suggests an initial wide net, the 'exclusion of sources' implies that certain vendors were pre-identified or that specific criteria narrowed the pool before the final competition. This can be effective if the exclusion criteria are well-justified and based on necessary qualifications, ensuring that only capable vendors compete. However, if the exclusion is overly restrictive, it could limit competition and potentially lead to less competitive pricing. The effectiveness in ensuring value hinges on whether the process genuinely attracted the best possible offers from qualified sources.

What is the historical spending trend for CDER/OND health science support services?

The provided data only details a single award and does not offer historical spending trends for CDER/OND health science support services. To understand historical patterns, one would need to analyze contract awards over multiple fiscal years for similar services within these specific FDA offices. This would involve examining the volume of contracts, their values, the types of services procured, and the contractors involved. Such an analysis could reveal whether spending in this area is increasing, decreasing, or remaining stable, and whether the nature of the support required has evolved over time.

Are there any specific performance metrics or KPIs defined for this contract?

The provided data does not specify the performance metrics or Key Performance Indicators (KPIs) for this contract. Typically, such details are outlined in the contract's Statement of Work (SOW) or Performance Work Statement (PWS). These metrics are crucial for evaluating the contractor's performance and ensuring the government receives the intended value. Without access to the full contract documentation, it's impossible to determine the specific KPIs. However, for a contract supporting drug evaluation and new drug offices, KPIs might relate to timeliness of support, accuracy of administrative tasks, responsiveness, and overall contribution to the efficiency of the review process.

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 AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: LABOR HOURS (Z)

Evaluated Preference: NONE

Contractor Details

Address: 6060 W 3650 N, IVINS, UT, 84738

Business Categories: Category Business, Limited Liability Corporation, Minority Owned Business, Native American Owned Business, SBA Certified 8 a Joint Venture, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Tribally Owned Firm, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $12,198,266

Exercised Options: $6,934,277

Current Obligation: $6,934,277

Actual Outlays: $2,663,756

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75F40123D00021

IDV Type: IDC

Timeline