Battelle Memorial Institute awarded $28.1M contract for toxicological studies by NIH

Contract Overview

Contract Amount: $28,097,985 ($28.1M)

Contractor: Battelle Memorial Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2017-09-20

End Date: 2025-09-25

Contract Duration: 2,927 days

Daily Burn Rate: $9.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF - AWARD: SUPPORT FOR THE CONDUCT OF STUDIES TO EVALUATE THE TOXICOLOGIC POTENTIAL OF SELECT TEST AGENTS FOR THE NATIONAL TOXICOLOGY PROGRAM (NTP)

Place of Performance

Location: COLUMBUS, FRANKLIN County, OHIO, 43201

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $28.1 million to BATTELLE MEMORIAL INSTITUTE for work described as: IGF::OT::IGF - AWARD: SUPPORT FOR THE CONDUCT OF STUDIES TO EVALUATE THE TOXICOLOGIC POTENTIAL OF SELECT TEST AGENTS FOR THE NATIONAL TOXICOLOGY PROGRAM (NTP) Key points: 1. Contract awarded for critical toxicological research supporting the National Toxicology Program. 2. The contract value is substantial, indicating a significant investment in understanding chemical safety. 3. The duration of the contract suggests a long-term commitment to ongoing research needs. 4. The use of a Cost Plus Fixed Fee (CPFF) pricing structure requires careful monitoring of costs. 5. The contract is a definitive contract, implying a firm commitment for the specified period. 6. The contractor, Battelle Memorial Institute, is a well-established research organization.

Value Assessment

Rating: good

The contract value of approximately $28.1 million over its duration appears reasonable for the scope of toxicological research and development services. Benchmarking against similar large-scale toxicology studies managed by NIH or other federal agencies would provide a more precise value-for-money assessment. The CPFF structure necessitates robust oversight to ensure costs remain aligned with the fixed fee and project objectives, mitigating potential overruns.

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 bidders had the opportunity to submit proposals. The specific number of bidders is not provided, but this procurement method generally fosters competitive pricing and encourages a wider pool of potential contractors. The agency's commitment to full and open competition suggests a thorough evaluation process to select the most capable and cost-effective offeror.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it typically leads to more competitive pricing and ensures that the government receives the best value by considering a broad range of qualified contractors.

Public Impact

The primary beneficiaries are public health organizations and regulatory bodies that rely on toxicological data to assess the safety of various substances. The services delivered include conducting studies to evaluate the toxicologic potential of select test agents. The geographic impact is national, as the findings from the National Toxicology Program inform public health policies across the United States. The contract supports a workforce of scientists, researchers, and technicians involved in laboratory analysis and study design.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee (CPFF) contracts require diligent oversight to manage costs effectively and prevent scope creep.
The long duration of the contract (over 7 years) necessitates ongoing performance monitoring to ensure continued quality and adherence to objectives.
Ensuring the scientific rigor and validity of the toxicological studies conducted is paramount for the program's credibility.

Positive Signals

Awarded under full and open competition, suggesting a competitive bidding process that likely secured favorable pricing.
The contractor, Battelle Memorial Institute, has a strong reputation and extensive experience in research and development, particularly in toxicology.
The contract supports a critical public health initiative (National Toxicology Program), indicating alignment with important government objectives.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and toxicology. The market for contract research organizations (CROs) specializing in toxicology is substantial, with significant government and private sector investment. This contract represents a portion of the federal government's ongoing commitment to understanding the health effects of various chemical agents, aligning with broader public health and environmental safety goals.

Small Business Impact

The provided data does not indicate any specific small business set-aside provisions for this contract. Given the specialized nature and scale of toxicological research, it is possible that subcontracting opportunities may exist for smaller firms with niche expertise, but this is not explicitly detailed. The primary contractor is a large research institute, suggesting that direct small business participation may be limited unless specific subcontracting plans are in place.

Oversight & Accountability

Oversight for this contract would typically be managed by the contracting officer and the contract administration office within the National Institutes of Health (NIH). Performance monitoring, financial reviews, and adherence to the contract terms are key oversight mechanisms. Transparency is generally maintained through contract award databases and public reporting, though specific study results are subject to scientific publication and program dissemination protocols. The Inspector General's office for the Department of Health and Human Services would have jurisdiction over potential fraud, waste, or abuse.

Related Government Programs

National Toxicology Program (NTP)
Environmental Protection Agency (EPA) research grants
Food and Drug Administration (FDA) safety studies
National Institutes of Health (NIH) extramural research

Risk Flags

Cost Overruns Risk (CPFF)
Performance Delays Risk
Scientific Validity Risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $28.1 million to BATTELLE MEMORIAL INSTITUTE. IGF::OT::IGF - AWARD: SUPPORT FOR THE CONDUCT OF STUDIES TO EVALUATE THE TOXICOLOGIC POTENTIAL OF SELECT TEST AGENTS FOR THE NATIONAL TOXICOLOGY PROGRAM (NTP)

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 $28.1 million.

What is the period of performance?

Start: 2017-09-20. End: 2025-09-25.

What is Battelle Memorial Institute's track record with similar federal contracts, particularly in toxicology research?

Battelle Memorial Institute has a long and extensive history of performing research and development for various U.S. federal agencies, including significant work in toxicology and life sciences. They have managed numerous large-scale contracts involving complex scientific studies, often related to chemical safety, environmental impact, and health effects. Their experience typically includes study design, execution, data analysis, and reporting, aligning well with the requirements of the National Toxicology Program. While specific details of past performance on contracts of identical scope and value are not provided here, Battelle's general reputation and established presence in the federal contracting space suggest a strong capability to execute this type of work. A deeper dive into their contract history, including past performance evaluations and any reported issues, would offer further insight.

How does the awarded amount compare to the estimated cost or budget for this type of toxicological research?

The awarded amount of $28.1 million for a definitive contract spanning approximately 7 years (September 2017 to September 2025) provides a benchmark for the cost of conducting comprehensive toxicological studies under the National Toxicology Program. Without access to the agency's initial cost estimates or the specific details of the work statement, a direct comparison is challenging. However, large-scale, multi-year toxicology research projects are inherently expensive due to the need for specialized facilities, equipment, highly trained personnel, and rigorous scientific protocols. The Cost Plus Fixed Fee (CPFF) structure indicates that the contractor is reimbursed for allowable costs plus a negotiated fixed fee representing profit. This structure, combined with the total award amount, suggests a significant investment by the government in understanding the potential health risks of various agents.

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

The primary risks associated with a CPFF contract for toxicological research revolve around cost control and ensuring value for money. While the fixed fee provides some incentive for the contractor to manage costs efficiently, the reimbursement of allowable costs means that the government bears the financial risk of cost overruns. This necessitates robust government oversight to scrutinize incurred costs, ensure they are reasonable and allocable to the contract, and prevent scope creep. For toxicological research, risks also include potential delays in study execution due to unforeseen scientific challenges, equipment failures, or regulatory changes, which could impact timelines and potentially increase costs. Ensuring the scientific integrity and reproducibility of the research is also a critical risk factor; any compromise in quality could render the studies ineffective and a waste of taxpayer funds.

How effective is the National Toxicology Program (NTP) in translating research findings into actionable public health policies?

The National Toxicology Program (NTP) plays a crucial role in informing public health policies by providing scientifically sound data on the health effects of environmental agents. Its findings are utilized by various federal agencies, including the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA), to develop regulations, guidelines, and risk assessments. The NTP's peer-reviewed reports and summaries are foundational for evidence-based decision-making. While the direct translation into policy depends on the specific regulatory mandates and priorities of other agencies, the NTP's consistent output of high-quality toxicological data is widely recognized as essential for protecting public health. The program's effectiveness is measured by its contribution to risk assessment and the subsequent regulatory actions taken by other bodies based on its research.

What is the historical spending trend for toxicological research contracts awarded by the Department of Health and Human Services (HHS)?

Historical spending by the Department of Health and Human Services (HHS) on toxicological research contracts, particularly through agencies like the National Institutes of Health (NIH) and the National Toxicology Program (NTP), has been substantial and relatively consistent over the years. These programs require ongoing investment to address emerging chemical threats, evaluate existing substances, and update safety standards. While specific year-over-year figures fluctuate based on program priorities, research needs, and available appropriations, HHS consistently allocates significant resources to toxicology. This particular contract, awarded in 2017 with a total value of $28.1 million, falls within the expected range for major toxicological research initiatives. Analyzing broader HHS spending patterns would reveal a sustained commitment to this scientific domain, driven by public health imperatives.

Industry Classification

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

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: NIHES2016089

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: STATE RT 142, WEST JEFFERSON, OH, 43162

Business Categories: Category Business, Corporate Entity Tax Exempt, Manufacturer of Goods, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $28,097,985

Exercised Options: $28,097,985

Current Obligation: $28,097,985

Actual Outlays: $14,073,633

Subaward Activity

Number of Subawards: 31

Total Subaward Amount: $8,971,040

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline