NIH awards $60.5M for toxicological studies, with Battelle Memorial Institute as primary contractor

Contract Overview

Contract Amount: $60,474,130 ($60.5M)

Contractor: Battelle Memorial Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2005-05-01

End Date: 2015-04-30

Contract Duration: 3,651 days

Daily Burn Rate: $16.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: STUDIES TO EVALUATE TOXIC AND CARCINOGENIC POTENTIAL OF TEST ARTICLES

Place of Performance

Location: COLUMBUS, FRANKLIN County, OHIO, 43201

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $60.5 million to BATTELLE MEMORIAL INSTITUTE for work described as: STUDIES TO EVALUATE TOXIC AND CARCINOGENIC POTENTIAL OF TEST ARTICLES Key points: 1. Contract awarded through full and open competition, suggesting a robust market. 2. Long duration (10 years) indicates a sustained need for toxicological research. 3. Cost-plus-fixed-fee contract type allows for flexibility but requires careful cost oversight. 4. Research and Development sector spending is crucial for public health advancements. 5. Focus on toxic and carcinogenic potential addresses significant public health concerns. 6. Contract value represents a substantial investment in understanding chemical safety.

Value Assessment

Rating: good

The contract value of $60.5 million over 10 years averages to $6.05 million annually. Benchmarking this against similar large-scale toxicological research contracts is challenging without more specific service details. However, the duration and scope suggest a significant, long-term investment. The cost-plus-fixed-fee structure necessitates diligent oversight to ensure costs remain reasonable and the fixed fee is appropriate for the effort involved. Without specific per-unit cost data for the studies, a precise value-for-money assessment is difficult, but the competitive award process provides some assurance of fair pricing.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified contractors had the opportunity to bid. The presence of two bids suggests a competitive environment, though the exact number of solicitations and proposals received is not detailed. A competitive process generally leads to better price discovery and potentially more innovative solutions as contractors vie for the award.

Taxpayer Impact: Taxpayers benefit from a competitive process that aims to secure the best value for the government's investment in critical health research.

Public Impact

The public benefits from research that identifies potential health risks associated with various substances. Services delivered include comprehensive toxicological and carcinogenic potential evaluations. The geographic impact is national, as findings inform public health policy across the U.S. The contract supports scientific workforce development in the fields of toxicology and research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost-plus-fixed-fee contracts can incentivize cost overruns if not managed tightly.
Long contract durations may not always reflect the most current scientific methodologies or needs.
Limited competition (2 bids) could indicate a specialized field or potential barriers to entry for other firms.

Positive Signals

Awarded through full and open competition, ensuring broad market access.
Long-term commitment suggests a critical and ongoing need for this research.
Contractor's extensive experience in research and development is a positive signal.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and toxicology. The NAICS code 541710 covers R&D in physical, engineering, and life sciences. Spending in this area is vital for regulatory agencies and public health organizations to assess the safety of chemicals, pharmaceuticals, and other substances. Comparable spending benchmarks would typically be found within NIH's overall R&D budget allocations for toxicology and related fields.

Small Business Impact

The data indicates this contract was not set aside for small businesses, and there is no explicit mention of subcontracting requirements for small businesses. Given the specialized nature of toxicological research and the large contract value, it is likely that larger, established research institutions were the primary bidders. Further investigation would be needed to determine if any small business subcontracting opportunities were mandated or voluntarily pursued by the prime contractor.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a cost-plus-fixed-fee contract, rigorous financial oversight is essential to monitor expenditures and ensure the fixed fee remains appropriate. Transparency is generally maintained through contract reporting mechanisms, and the Inspector General for HHS would have jurisdiction over any potential fraud, waste, or abuse.

Related Government Programs

National Toxicology Program (NTP)
Environmental Protection Agency (EPA) Chemical Safety Research
Food and Drug Administration (FDA) Drug Safety Studies
Agency for Toxic Substances and Disease Registry (ATSDR) Health Consultations

Risk Flags

Long contract duration may require periodic reviews for continued relevance.
Cost-plus-fixed-fee structure necessitates robust cost monitoring.
Limited number of bids could indicate specialized market or barriers to entry.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $60.5 million to BATTELLE MEMORIAL INSTITUTE. STUDIES TO EVALUATE TOXIC AND CARCINOGENIC POTENTIAL OF TEST ARTICLES

Who is the contractor on this award?

The obligated recipient is BATTELLE MEMORIAL 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 $60.5 million.

What is the period of performance?

Start: 2005-05-01. End: 2015-04-30.

What is the track record of Battelle Memorial Institute in conducting large-scale toxicological studies for federal agencies?

Battelle Memorial Institute has a long-standing reputation and extensive experience in conducting research and development, including significant work in toxicology and chemical safety for various government agencies. They are known for operating large research facilities and managing complex scientific projects. Their history includes numerous contracts with agencies like the Department of Defense, EPA, and NIH, often involving testing, analysis, and risk assessment of various substances. This specific contract's duration and value suggest a level of trust and proven capability by NIH in Battelle's ability to execute such critical and long-term research.

How does the annual spending of approximately $6 million compare to other NIH toxicological research contracts?

Without access to a comprehensive database of all NIH toxicological research contracts, a direct comparison of the annual spending of approximately $6 million is difficult. However, NIH is a major funder of biomedical research, and toxicology is a critical component. Large, multi-year contracts like this are common for significant research initiatives that require sustained effort and specialized facilities. The annual amount is substantial enough to support a dedicated research team and infrastructure, suggesting it is in line with major research endeavors within the agency, though specific benchmarks would require detailed market analysis.

What are the primary risks associated with a Cost-Plus-Fixed-Fee (CPFF) contract for toxicological research?

The primary risk with a CPFF contract is the potential for cost overruns. While the contractor is reimbursed for allowable costs, the fixed fee provides a profit incentive. If the project scope expands or unforeseen challenges arise, the government bears the cost of increased expenses. For toxicological research, risks can include the complexity of biological systems, the need for specialized equipment, and the potential for unexpected results requiring further investigation. Effective oversight by the contracting agency is crucial to manage these risks, ensuring that costs are reasonable and the fixed fee remains justified throughout the contract's life.

How does the 'full and open competition' award mechanism impact the quality and cost of toxicological research?

Full and open competition generally enhances both quality and cost-effectiveness. By allowing all responsible sources to submit bids, the government can access a wider pool of talent and potentially receive more innovative approaches to research challenges. This competitive pressure incentivizes bidders to offer their best technical solutions and pricing to win the contract. For toxicological research, this means NIH could benefit from diverse methodologies and potentially more efficient study designs. While only two bids were received in this instance, the process itself is designed to foster a market that drives value and quality.

What are the implications of a 10-year contract duration for the relevance of toxicological findings?

A 10-year contract duration for toxicological studies implies a long-term commitment to understanding the potential health effects of specific substances or classes of substances. This extended timeframe allows for chronic toxicity studies, which are crucial for assessing long-term health risks that may not be apparent in shorter studies. However, it also presents a risk that scientific understanding or regulatory needs might evolve significantly over a decade. The contract should ideally include mechanisms for periodic review and adaptation to ensure the research remains relevant and addresses current scientific priorities and public health concerns throughout its lifespan.

What is the significance of the NAICS code 541710 (Research and Development in the Physical, Engineering, and Life Sciences) for this contract?

The NAICS code 541710 signifies that the primary business activity of the contractor under this award is conducting research and development in the physical, engineering, and life sciences. For this specific contract, it confirms the focus on scientific inquiry and experimentation related to understanding the physical and biological effects of test articles. This classification helps categorize government spending, allows for industry analysis, and ensures that the contract is awarded to entities with the appropriate scientific expertise and infrastructure required for complex R&D projects like toxicological evaluations.

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

Offers Received: 2

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 505 KING AVE, COLUMBUS, OH, 43201

Business Categories: Category Business, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $107,085,950

Exercised Options: $100,782,728

Current Obligation: $60,474,130

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline