HHS FDA awards $24.5M for Pathology Services to Toxicologic Pathology Associates Inc
Contract Overview
Contract Amount: $24,501,226 ($24.5M)
Contractor: Toxicologic Pathology Associates Inc
Awarding Agency: Department of Health and Human Services
Start Date: 2009-11-01
End Date: 2017-08-04
Contract Duration: 2,833 days
Daily Burn Rate: $8.6K/day
Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES
Number of Offers Received: 1
Pricing Type: COST PLUS FIXED FEE
Sector: R&D
Official Description: PATHOLOGY SERVICES
Place of Performance
Location: JEFFERSON, JEFFERSON County, ARKANSAS, 72079
State: Arkansas Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $24.5 million to TOXICOLOGIC PATHOLOGY ASSOCIATES INC for work described as: PATHOLOGY SERVICES Key points: 1. Significant contract value of $24.5 million over its life. 2. Toxicologic Pathology Associates Inc. is the sole awardee. 3. Contract duration of 2833 days indicates a long-term need. 4. Research and Development in Biotechnology sector. 5. Awarded under Full and Open Competition after Exclusion of Sources.
Value Assessment
Rating: fair
The contract type is Cost Plus Fixed Fee, which can lead to higher costs if not managed carefully. Benchmarking against similar pathology service contracts is difficult without more detailed cost breakdowns.
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,' suggesting a competitive process but with specific source exclusions. This method aims for competition while potentially limiting the pool of bidders.
Taxpayer Impact: The $24.5 million awarded represents taxpayer investment in critical FDA research and development activities.
Public Impact
Supports FDA's mission in toxicology and pathology research. Ensures continuity of specialized scientific services for regulatory functions. Potential for innovation in biotechnology research through contracted services.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Cost Plus Fixed Fee contract type can incentivize higher spending.
- Long contract duration may not reflect current market pricing.
- Exclusion of sources in competition could limit price discovery.
Positive Signals
- Awarded under full and open competition, indicating a structured procurement.
- Supports critical government research and development functions.
- Specific NAICS code (541711) aligns with specialized scientific services.
Sector Analysis
This contract falls within the Research and Development in Biotechnology sector, specifically NAICS code 541711. Spending in this sector is crucial for scientific advancement and regulatory oversight, with benchmarks varying widely based on research scope and duration.
Small Business Impact
The data indicates this contract was not awarded to small businesses (ss: false, sb: false). Analysis of subcontracting opportunities for small businesses is not provided in this data.
Oversight & Accountability
The contract was awarded by the Food and Drug Administration (FDA), a key agency within HHS. Oversight would typically involve program managers ensuring deliverables meet research objectives and financial oversight to manage the Cost Plus Fixed Fee structure.
Related Government Programs
- Research and Development in Biotechnology
- Department of Health and Human Services Contracting
- Food and Drug Administration Programs
Risk Flags
- Cost Plus Fixed Fee contract type.
- Long contract duration (2833 days).
- Exclusion of sources in competition.
- No indication of small business participation.
Tags
research-and-development-in-biotechnolog, department-of-health-and-human-services, ar, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $24.5 million to TOXICOLOGIC PATHOLOGY ASSOCIATES INC. PATHOLOGY SERVICES
Who is the contractor on this award?
The obligated recipient is TOXICOLOGIC PATHOLOGY ASSOCIATES 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 $24.5 million.
What is the period of performance?
Start: 2009-11-01. End: 2017-08-04.
What was the rationale for excluding specific sources during the 'Full and Open Competition' process?
The rationale for excluding specific sources, even within a full and open competition framework, typically relates to unique capabilities, specialized equipment, proprietary knowledge, or prior performance that makes certain entities uniquely qualified. This ensures the government secures the best possible solution for highly specialized needs, though it requires careful justification to maintain fairness and maximize competition.
How does the Cost Plus Fixed Fee structure impact the government's ability to control costs for these pathology services?
The Cost Plus Fixed Fee (CPFF) structure provides the contractor with reimbursement for allowable costs plus a predetermined fixed fee. While the fixed fee provides some cost certainty for the contractor's profit, it can incentivize cost overruns as the government bears the risk of increased expenses. Effective oversight is crucial to scrutinize allowable costs and ensure the contractor remains efficient.
What is the expected impact of these pathology services on the FDA's regulatory effectiveness and public health outcomes?
These pathology services are integral to the FDA's research and development efforts, likely supporting the safety and efficacy testing of drugs, medical devices, and other regulated products. By providing critical toxicological and pathological data, these services directly contribute to informed regulatory decisions, ultimately safeguarding public health and ensuring the integrity of products entering the market.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology
Product/Service Code: MEDICAL SERVICES › MEDICAL, DENTAL, AND SURGICAL SVCS
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES
Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE
Solicitation ID: 9222SOL00029
Offers Received: 1
Pricing Type: COST PLUS FIXED FEE (U)
Evaluated Preference: NONE
Contractor Details
Address: 220 N MARKET ST LL1, FREDERICK, MD, 21701
Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $24,501,226
Exercised Options: $24,501,226
Current Obligation: $24,501,226
Contract Characteristics
Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED
Timeline
Start Date: 2009-11-01
Current End Date: 2017-08-04
Potential End Date: 2017-08-04 00:00:00
Last Modified: 2017-08-07
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