AGISOL LLC awarded $3.5M for FDA's CDER regulatory systems analysis and sunset support

Contract Overview

Contract Amount: $3,508,732 ($3.5M)

Contractor: Agisol LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2025-07-16

End Date: 2027-01-20

Contract Duration: 553 days

Daily Burn Rate: $6.3K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: IT

Official Description: FIRM FIXED PRICE AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - REGULATORY REVIEW SYSTEMS ANALYSIS AND SUNSET SUPPORT CONTRACTING OFFICER REP (COR) JONATHAN RAPPAPORT TEL: 301-525-8444 JONATHAN RAPPAPORT@FDA.HHS.GOV CONTRACTING SPEC

Place of Performance

Location: SILVER SPRING, MONTGOMERY County, MARYLAND, 20993

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $3.5 million to AGISOL LLC for work described as: FIRM FIXED PRICE AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - REGULATORY REVIEW SYSTEMS ANALYSIS AND SUNSET SUPPORT CONTRACTING OFFICER REP (COR) JONATHAN RAPPAPORT TEL: 301-525-8444 JONATHAN RAPPAPORT@FDA.HHS.GOV CONTRACTING SPEC Key points: 1. Contract focuses on critical regulatory systems analysis and sunset support for the Center for Drug Evaluation and Research (CDER). 2. The award is a Firm Fixed Price Delivery Order, indicating a defined scope and cost. 3. AGISOL LLC, the contractor, will provide Computer Systems Design Services. 4. The contract duration is 553 days, ending January 20, 2027. 5. The award was made under full and open competition after exclusion of sources. 6. The contract value is approximately $3.5 million. 7. The primary place of performance is Maryland.

Value Assessment

Rating: good

The contract value of $3.5 million for 553 days of support appears reasonable for specialized IT services supporting regulatory functions. Benchmarking against similar contracts for system analysis and sunsetting in the federal space would provide a more precise value-for-money assessment. The firm fixed-price nature suggests that the government has a clear understanding of the scope and associated costs, which can lead to better cost control.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'full and open competition after exclusion of sources.' This suggests that while the competition was open, specific circumstances led to the exclusion of certain sources, which warrants further investigation into the justification for exclusion. The number of bidders is not specified, but the 'full and open' aspect generally implies a competitive process that should drive better pricing.

Taxpayer Impact: A competitive award process, even with exclusions, is generally favorable for taxpayers as it aims to secure the best value through market forces.

Public Impact

The Food and Drug Administration (FDA) benefits through improved management of its regulatory systems. The Center for Drug Evaluation and Research (CDER) will receive support for analyzing and sunsetting critical systems, ensuring efficient operations. The services delivered will enhance the FDA's ability to regulate drugs and medical devices. The primary geographic impact is Maryland, where the place of performance is located. The contract supports the IT workforce within the federal government and potentially the contractor's organization.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'exclusion of sources' in the competition type requires clarification to ensure no potential value was lost.
Lack of specific performance metrics in the provided data makes it difficult to assess the contractor's performance trajectory.
The specific systems being sunsetted are not detailed, which could impact the understanding of the project's complexity and risk.

Positive Signals

Firm Fixed Price contract type provides cost certainty for the government.
The contract is awarded to AGISOL LLC, whose track record would need further review for performance history.
The duration of the contract (553 days) allows for focused execution of the defined scope.

Sector Analysis

This contract falls within the Computer Systems Design Services sector, a crucial component of the broader IT services market supporting government operations. The federal IT services market is substantial, with agencies continually investing in system modernization, analysis, and lifecycle management. This specific contract addresses the critical need for regulatory system analysis and sunsetting, a specialized area within IT that ensures compliance and efficiency for agencies like the FDA.

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 for small businesses arising from a set-aside. The primary impact on the small business ecosystem would be indirect, through AGISOL LLC's potential use of small business subcontractors if it aligns with their business strategy.

Oversight & Accountability

Oversight for this contract would typically be managed by the Contracting Officer's Representative (COR), Jonathan Rappaport, who is listed with contact information. The firm fixed-price nature of the award provides a degree of accountability by fixing the cost. Transparency would be enhanced by public contract databases and the FDA's internal procurement policies. Inspector General jurisdiction would apply if any fraud, waste, or abuse is suspected.

Related Government Programs

FDA IT Modernization Efforts
CDER Regulatory Operations Support
Federal IT Services Procurement
Computer Systems Design Services Contracts
Government IT Lifecycle Management

Risk Flags

Competition Exclusion Rationale
Performance Risk Assessment
System Interdependencies Analysis
Data Security During Sunset
Regulatory Compliance Continuity

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $3.5 million to AGISOL LLC. FIRM FIXED PRICE AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - REGULATORY REVIEW SYSTEMS ANALYSIS AND SUNSET SUPPORT CONTRACTING OFFICER REP (COR) JONATHAN RAPPAPORT TEL: 301-525-8444 JONATHAN RAPPAPORT@FDA.HHS.GOV CONTRACTING SPEC

Who is the contractor on this award?

The obligated recipient is AGISOL 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 $3.5 million.

What is the period of performance?

Start: 2025-07-16. End: 2027-01-20.

What is the specific justification for the 'exclusion of sources' in the 'full and open competition after exclusion of sources' award type?

The provided data states the contract was awarded under 'FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES'. This classification typically means that while the solicitation was publicly advertised and open to all responsible sources, certain pre-identified sources were excluded from consideration for specific, documented reasons. These reasons often relate to proprietary data, unique capabilities, national security concerns, or prior work on a system that makes only a specific vendor capable of performing the follow-on work. Without further documentation from the agency (e.g., Justification for Other Than Full and Open Competition - JOFOC), the precise rationale for excluding other sources remains unclear. Understanding this justification is crucial for assessing whether the competition was truly as broad as possible and if the government secured the best possible value.

How does the $3.5 million contract value compare to similar IT system analysis and sunsetting contracts within the federal government?

Benchmarking the $3.5 million contract value requires comparing it against similar contracts for IT system analysis and sunsetting services within the federal government. Factors such as contract duration (553 days), scope complexity, specific technologies involved, and the agency's mission criticality influence pricing. Contracts for large-scale system decommissioning or complex regulatory system analysis can range from hundreds of thousands to several million dollars. Given the specialized nature of supporting the FDA's Center for Drug Evaluation and Research (CDER), which involves sensitive regulatory data and processes, this value appears within a reasonable range for a firm-fixed-price award. However, a detailed comparison with contracts of similar scope, duration, and complexity, ideally from agencies with comparable IT infrastructures and regulatory oversight functions, would be necessary for a definitive value-for-money assessment.

What are the key performance indicators (KPIs) or deliverables expected from AGISOL LLC under this contract?

The provided data does not specify the key performance indicators (KPIs) or detailed deliverables for AGISOL LLC. However, given the contract's description as 'REGULATORY REVIEW SYSTEMS ANALYSIS AND SUNSET SUPPORT,' expected deliverables likely include comprehensive analysis reports detailing the current state of specified regulatory systems, risk assessments for continued operation or decommissioning, proposed sunsetting strategies, and execution plans for system retirement. Performance would likely be measured against the timely completion of these reports, the accuracy and thoroughness of the analysis, and the successful execution of the sunsetting activities according to the approved plan. The Contracting Officer's Representative (COR), Jonathan Rappaport, would be responsible for monitoring adherence to the contract's statement of work and ensuring these deliverables meet the FDA's requirements.

What is the historical spending pattern for similar regulatory systems analysis and sunset support at the FDA or CDER?

Historical spending patterns for similar regulatory systems analysis and sunset support at the FDA or CDER are not detailed in the provided data. To establish such a pattern, one would need to analyze past contracts awarded by CDER or other FDA centers for system analysis, modernization, decommissioning, or sunsetting activities. This would involve searching federal procurement databases (like FPDS or SAM.gov) for relevant keywords, contract types, and NAICS codes (like 541512 for Computer Systems Design Services). Analyzing the number of awards, contract values, durations, and awarded contractors over several fiscal years would reveal trends. Understanding this history is crucial for assessing whether the current $3.5 million award represents an increase, decrease, or stable level of investment in these critical support functions.

What is the track record of AGISOL LLC in performing similar federal IT contracts, particularly those involving regulatory systems?

The provided data identifies AGISOL LLC as the contractor but does not detail their specific track record. To assess their performance history, one would need to consult federal procurement databases (e.g., FPDS, SAM.gov) to review their past contract awards. Key aspects to examine would include the types of services they have provided, the agencies they have served, contract values, performance ratings (if available), and any history of contract modifications, disputes, or terminations. Particular attention should be paid to whether AGISOL LLC has successfully completed similar IT system analysis, design, or sunsetting projects, especially within highly regulated environments like the FDA. A strong track record in similar complex IT projects would indicate a lower performance risk for this new contract.

Industry Classification

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

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 11035 STRATFIELD CT, MARRIOTTSVILLE, MD, 21104

Business Categories: 8(a) Program Participant, Category Business, Corporate Entity Not Tax Exempt, Economically Disadvantaged Women Owned Small Business, Limited Liability Corporation, Minority Owned Business, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Indian (Subcontinent) American Owned Business, U.S.-Owned Business, Woman Owned Business, Women Owned Small Business

Financial Breakdown

Contract Ceiling: $3,508,732

Exercised Options: $3,508,732

Current Obligation: $3,508,732

Actual Outlays: $1,565,364

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: 47QTCB22D0589

IDV Type: GWAC

Timeline