NIH Spends $15.5M on Rodent Reproductive Toxicity Testing Over 10 Years

Contract Overview

Contract Amount: $15,471,273 ($15.5M)

Contractor: Research Triangle Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2007-05-01

End Date: 2017-12-15

Contract Duration: 3,881 days

Daily Burn Rate: $4.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: REPRODUCTIVE TOXICITY TESTING OF ENVIRONMENTAL AGENTS IN RODENTS. REPRODUCTIVE ASSESSMENT BY CONTINUOUS BREEDING.

Place of Performance

Location: DURHAM, DURHAM County, NORTH CAROLINA, 27709

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $15.5 million to RESEARCH TRIANGLE INSTITUTE for work described as: REPRODUCTIVE TOXICITY TESTING OF ENVIRONMENTAL AGENTS IN RODENTS. REPRODUCTIVE ASSESSMENT BY CONTINUOUS BREEDING. Key points: 1. Significant investment in long-term research for environmental agent toxicity. 2. Competition was full and open, suggesting a competitive bidding process. 3. Contract type (Cost Plus Fixed Fee) may lead to cost overruns. 4. Focus on R&D in life sciences, a critical area for public health.

Value Assessment

Rating: fair

The contract's Cost Plus Fixed Fee structure, while allowing flexibility, can be prone to cost escalation. Benchmarking against similar long-term R&D contracts is difficult due to the specialized nature of the research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating a robust price discovery process. However, the Cost Plus Fixed Fee award type might not have fully optimized cost savings.

Taxpayer Impact: Taxpayers funded extensive research into environmental agents' reproductive toxicity, aiming to inform public health policy and safety regulations.

Public Impact

Provides crucial data for understanding environmental impacts on reproduction. Informs regulatory agencies on potential health risks from environmental exposures. Supports advancements in toxicology and reproductive health research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contract type can lead to higher costs.
Long contract duration (10 years) may not reflect current needs or technologies.
Lack of small business participation noted.

Positive Signals

Full and open competition ensures a broad range of potential bidders.
Research addresses critical public health concerns.
Definitive contract provides a clear framework for the work.

Sector Analysis

This contract falls under Research and Development in the Physical, Engineering, and Life Sciences sector. Spending benchmarks for highly specialized, long-term toxicological studies are difficult to establish due to their unique nature and duration.

Small Business Impact

The data indicates that small businesses were not involved in this contract, which is common for large-scale, long-term research projects requiring significant infrastructure and specialized expertise.

Oversight & Accountability

The long duration of the contract and its specialized nature suggest a need for ongoing oversight to ensure research quality, adherence to protocols, and effective use of funds. The definitive contract structure provides a framework for accountability.

Related Government Programs

Research and Development in the Physical, Engineering, and Life Sciences
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Cost Plus Fixed Fee contract type.
Long contract duration.
No small business participation.
Specialized research area with limited direct comparables.
Potential for cost overruns due to contract type and duration.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $15.5 million to RESEARCH TRIANGLE INSTITUTE. REPRODUCTIVE TOXICITY TESTING OF ENVIRONMENTAL AGENTS IN RODENTS. REPRODUCTIVE ASSESSMENT BY CONTINUOUS BREEDING.

Who is the contractor on this award?

The obligated recipient is RESEARCH TRIANGLE INSTITUTE.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $15.5 million.

What is the period of performance?

Start: 2007-05-01. End: 2017-12-15.

What was the specific methodology used for reproductive toxicity testing, and how does it align with current scientific standards?

The contract specifies 'REPRODUCTIVE ASSESSMENT BY CONTINUOUS BREEDING' in rodents. This method is a standard approach for evaluating a wide range of reproductive and developmental effects. Continuous breeding allows for assessment across multiple generations and exposure periods, providing comprehensive data. Its alignment with current standards would depend on the specific protocols implemented and adherence to Good Laboratory Practice (GLP) guidelines, which are crucial for regulatory acceptance.

Given the Cost Plus Fixed Fee structure, what mechanisms were in place to control costs and ensure value for money over the 10-year period?

Cost Plus Fixed Fee contracts typically include provisions for cost monitoring and reporting. However, the fixed fee component might offer less incentive for contractor efficiency compared to other contract types. Mechanisms to ensure value likely involved regular performance reviews, milestone tracking, and potentially independent cost audits. The long duration necessitates proactive management to prevent scope creep and ensure the research remains relevant and cost-effective.

How has the data generated from this contract influenced public health policy or regulatory decisions regarding environmental agents?

The data generated from this extensive study on reproductive toxicity of environmental agents is intended to inform public health policy and regulatory decisions. Its direct influence would be documented through subsequent reports by agencies like the EPA or FDA, risk assessments, and the establishment or revision of exposure limits or safety guidelines for specific agents. The long-term nature of the research suggests its impact may be foundational for understanding chronic or cumulative environmental risks.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences

Product/Service Code: RESEARCH AND DEVELOPMENT › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: NIHES0606

Offers Received: 2

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 3040 CORNWALLIS ROAD, RESEARCH TRIANGLE PARK, NC, 27709

Business Categories: Category Business, Nonprofit Organization, Not Designated a Small Business

Financial Breakdown

Contract Ceiling: $29,955,798

Exercised Options: $29,955,798

Current Obligation: $15,471,273

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline