NIH awards $13.9M for preclinical drug toxicology and pharmacology research to SRI International

Contract Overview

Contract Amount: $13,945,190 ($13.9M)

Contractor: SRI International

Awarding Agency: Department of Health and Human Services

Start Date: 2004-04-01

End Date: 2015-09-07

Contract Duration: 4,176 days

Daily Burn Rate: $3.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 8

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS

Place of Performance

Location: MENLO PARK, SAN MATEO County, CALIFORNIA, 94025

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $13.9 million to SRI INTERNATIONAL for work described as: PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS Key points: 1. Contract awarded through full and open competition, suggesting a competitive bidding process. 2. The contract duration of over 11 years indicates a long-term research and development effort. 3. SRI International, a significant research organization, is the sole awardee. 4. The contract type (Cost Plus Fixed Fee) allows for cost reimbursement plus a fixed fee, common in R&D. 5. The award falls under the 'Research and Development in the Physical, Engineering, and Life Sciences' NAICS code. 6. The geographic location of the contractor is California.

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging without specific deliverables or comparable R&D projects. The Cost Plus Fixed Fee structure means costs can fluctuate, but the fixed fee provides some predictability. The long duration suggests significant investment, but the total value over 11 years averages around $1.27 million annually, which may be reasonable for specialized preclinical research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'full and open competition,' indicating that all responsible sources were permitted to submit a bid. The presence of 8 bidders suggests a healthy level of interest and competition for this research opportunity. This broad competition is generally favorable for price discovery and ensuring the government receives competitive proposals.

Taxpayer Impact: A competitive bidding process helps ensure taxpayer funds are used efficiently by driving down costs and encouraging innovative solutions from multiple offerors.

Public Impact

The primary beneficiary is the National Institutes of Health (NIH), which gains access to critical preclinical research capabilities. The services delivered involve toxicology and pharmacology studies essential for drug development. The geographic impact is primarily within California, where SRI International is located, but the research findings can have national and global implications for public health. The contract supports a specialized workforce in scientific research and development.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration (over 11 years) could lead to scope creep or evolving research needs that may not be fully captured in the initial award.
Cost Plus Fixed Fee contracts can incentivize cost overruns if not closely monitored, although the fixed fee component provides some control.
The specific scientific outcomes and their impact on drug development are not detailed, making it hard to assess ultimate value for money.

Positive Signals

Awarded through full and open competition with 8 bidders, indicating a robust and fair selection process.
SRI International is a reputable research institution with a track record in scientific endeavors.
The contract supports critical research in drug development, aligning with NIH's mission to advance health.

Sector Analysis

This contract falls within the Research and Development (R&D) sector, specifically focusing on life sciences and pharmaceutical development. The market for preclinical toxicology and pharmacology services is specialized, involving contract research organizations (CROs) and academic institutions. Spending in this area is driven by the pharmaceutical industry's pipeline and government initiatives to accelerate drug discovery and safety testing. Comparable spending benchmarks would typically be found within NIH's broader R&D portfolio or through industry reports on CRO services.

Small Business Impact

There is no indication that this contract was specifically set aside for small businesses, nor is there information about subcontracting plans. Given the nature of specialized R&D and the awardee (SRI International), it is likely that the primary focus was on technical capability rather than small business participation. Further review of subcontracting reports would be needed to assess any impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would typically be managed by the contracting officers and program managers within the National Institutes of Health (NIH). The Cost Plus Fixed Fee structure necessitates diligent financial oversight to ensure costs are reasonable and allocable. Transparency is generally maintained through contract databases, but specific project details and progress reports may be proprietary. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

NIH Research Grants
Pharmaceutical Development Contracts
Biomedical Research Support
Drug Safety and Efficacy Studies

Risk Flags

Long contract duration may increase risk of scope drift.
CPFF contract type requires diligent cost oversight.
Specific R&D outcomes not detailed, impacting value assessment.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $13.9 million to SRI INTERNATIONAL. PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS

Who is the contractor on this award?

The obligated recipient is SRI INTERNATIONAL.

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 $13.9 million.

What is the period of performance?

Start: 2004-04-01. End: 2015-09-07.

What is SRI International's track record with NIH and similar federal agencies for R&D contracts?

SRI International is a well-established research institute with a long history of receiving federal funding, including significant support from agencies like NIH, DARPA, and others. Their portfolio typically includes a wide range of scientific and technological research. For NIH specifically, SRI has been involved in various biomedical research projects, often focusing on areas like drug discovery, diagnostics, and medical devices. Their extensive experience suggests a strong capability to manage complex R&D projects and deliver on scientific objectives, as evidenced by their consistent ability to win competitive federal awards over decades. Specific details on past performance metrics for individual contracts would require deeper database analysis.

How does the $13.9 million total award value compare to similar preclinical toxicology and pharmacology contracts?

Comparing this $13.9 million award requires context regarding the contract's duration and scope. Awarded in 2004 and ending in 2015, the total value spread over approximately 11 years averages about $1.27 million annually. This figure is within a reasonable range for specialized preclinical R&D services, especially those involving complex toxicology and pharmacology studies. However, direct comparisons are difficult without knowing the specific assays, animal models, or therapeutic areas involved. Larger, multi-year programs in drug development can easily reach tens or hundreds of millions of dollars, while smaller, focused studies might be in the hundreds of thousands. This contract appears to represent a substantial, long-term commitment to a specific research area.

What are the primary risks associated with a Cost Plus Fixed Fee (CPFF) contract for preclinical R&D?

The primary risks with a CPFF contract for preclinical R&D revolve around cost control and the potential for inefficient resource allocation. While the fixed fee provides a defined profit margin for the contractor, the cost-reimbursement aspect means the government bears the risk of actual project expenses. If the contractor does not manage costs effectively, the total expenditure can exceed initial estimates. For R&D, predicting costs accurately is inherently difficult due to the experimental nature of the work. This can lead to budget overruns if unforeseen challenges arise or if the scope needs to expand. Robust oversight, clear milestones, and detailed reporting are crucial to mitigate these risks and ensure the government receives good value.

How effective is full and open competition in ensuring value for money in specialized R&D contracts?

Full and open competition is generally considered the most effective method for ensuring value for money in federal contracting, including specialized R&D. By allowing all responsible sources to compete, the government benefits from a wider range of technical approaches, potentially lower prices, and increased innovation. In this case, with 8 bidders, the competition likely drove proposals towards more efficient methodologies and realistic pricing. However, the effectiveness also depends on the clarity of the solicitation, the evaluation criteria, and the government's ability to accurately assess the technical merit and cost proposals. For highly specialized R&D, technical expertise can be as critical as price, and competition must balance these factors.

What is the historical spending pattern for preclinical toxicology and pharmacology research by NIH?

NIH has a consistent and substantial historical spending pattern on preclinical toxicology and pharmacology research, reflecting its core mission to advance biomedical knowledge and facilitate drug development. This spending occurs through various mechanisms, including grants to academic institutions and contracts with research organizations like SRI International. Annual outlays can fluctuate based on research priorities, emerging scientific opportunities, and budget allocations. Over the years, NIH has invested billions in research aimed at understanding disease mechanisms, identifying potential drug targets, and evaluating the safety and efficacy of candidate therapeutics before human trials. This specific contract represents a portion of that broader, ongoing investment in the drug development pipeline.

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

Offers Received: 8

Pricing Type: COST PLUS FIXED FEE (U)

Contractor Details

Address: 333 RAVENSWOOD AVE, MENLO PARK, CA, 94025

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

Financial Breakdown

Contract Ceiling: $67,787,765

Exercised Options: $62,580,524

Current Obligation: $13,945,190

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline