HHS FDA Awards $4.5M Contract to IVYHILL-ZAI for Document Room Operations

Contract Overview

Contract Amount: $4,496,578 ($4.5M)

Contractor: Ivyhill-Zai, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2025-12-05

End Date: 2026-06-08

Contract Duration: 185 days

Daily Burn Rate: $24.3K/day

Competition Type: NOT AVAILABLE FOR COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Other

Official Description: CDER/OBI DOCUMENT ROOM OPERATIONS

Place of Performance

Location: HYATTSVILLE, PRINCE GEORGES County, MARYLAND, 20785

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $4.5 million to IVYHILL-ZAI, LLC for work described as: CDER/OBI DOCUMENT ROOM OPERATIONS Key points: 1. Contract value of $4.5M for document room operations. 2. Sole-source award to IVYHILL-ZAI, LLC. 3. Potential risk due to lack of competition. 4. Services fall under 'All Other Professional, Scientific, and Technical Services'.

Value Assessment

Rating: questionable

The contract value of $4.5M for document room operations is not directly comparable without specific service benchmarks. The lack of competition makes a pricing assessment difficult.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, indicating no competitive bidding process. This limits price discovery and potentially leads to higher costs for taxpayers.

Taxpayer Impact: The sole-source nature of this award raises concerns about whether the government secured the best possible price for these services.

Public Impact

Ensures continued operation of critical document management for the FDA. Impacts the efficiency of regulatory processes reliant on document access. Potential for increased costs due to lack of competitive pressure.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

  • Sole-source award
  • Lack of competition
  • Potential for overpricing

Positive Signals

  • Essential service provision
  • Fixed-price contract

Sector Analysis

This contract falls under professional, scientific, and technical services, specifically document management. Benchmarks for similar sole-source document operations contracts are difficult to ascertain without more data.

Small Business Impact

The contract was awarded to IVYHILL-ZAI, LLC. Information regarding whether this is a small business is not provided, nor is there any indication of subcontracting opportunities for small businesses.

Oversight & Accountability

The sole-source award warrants scrutiny to ensure the price is fair and reasonable. Further oversight is needed to understand the justification for not seeking competition.

Related Government Programs

  • All Other Professional, Scientific, and Technical Services
  • Department of Health and Human Services Contracting
  • Food and Drug Administration Programs

Risk Flags

  • Sole-source award limits competition.
  • Potential for price inflation due to lack of competition.
  • Limited transparency on justification for sole-source.
  • No clear small business participation noted.

Tags

all-other-professional-scientific-and-te, department-of-health-and-human-services, md, definitive-contract, 1m-plus

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $4.5 million to IVYHILL-ZAI, LLC. CDER/OBI DOCUMENT ROOM OPERATIONS

Who is the contractor on this award?

The obligated recipient is IVYHILL-ZAI, 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 $4.5 million.

What is the period of performance?

Start: 2025-12-05. End: 2026-06-08.

What is the justification for awarding this contract on a sole-source basis?

The justification for a sole-source award typically involves unique capabilities, urgent needs, or a lack of available sources. Without specific documentation from the FDA, it's impossible to determine the precise reason. This lack of transparency is a concern for accountability and ensuring taxpayer funds are used efficiently.

What is the risk associated with a sole-source contract for document operations?

The primary risk of a sole-source contract is the absence of competitive pressure, which can lead to inflated prices and reduced service quality. For document operations, this could mean higher operational costs for the FDA and potentially less efficient document handling if the contractor is not incentivized to innovate or optimize.

How does this contract contribute to the FDA's overall mission effectiveness?

Efficient and accurate document management is crucial for the FDA's regulatory functions, including drug approvals, safety monitoring, and compliance. This contract ensures the continuity of these essential operations. However, the effectiveness could be hampered if the lack of competition leads to suboptimal service delivery or excessive costs.

Industry Classification

NAICS: Professional, Scientific, and Technical ServicesOther Professional, Scientific, and Technical ServicesAll Other Professional, Scientific, and Technical Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT)PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: NOT AVAILABLE FOR COMPETITION

Solicitation Procedures: ONLY ONE SOURCE

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 4301 GARDEN CITY DR STE 410, HYATTSVILLE, MD, 20785

Business Categories: Black American Owned Business, Category Business, Corporate Entity Not Tax Exempt, Joint Venture Economically Disadvantaged Women Owned Small Business, Joint Venture Women Owned Small Business, Limited Liability Corporation, Minority Owned Business, SBA Certified 8 a Joint Venture, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, U.S.-Owned Business, Woman Owned Business

Financial Breakdown

Contract Ceiling: $4,496,578

Exercised Options: $4,496,578

Current Obligation: $4,496,578

Actual Outlays: $1,400,286

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline

Start Date: 2025-12-05

Current End Date: 2026-06-08

Potential End Date: 2026-06-08 00:00:00

Last Modified: 2026-02-25

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