NIH awards $10.4M for pediatric off-patent drug study, focusing on lorazepam sedation

Contract Overview

Contract Amount: $10,433,832 ($10.4M)

Contractor: Case Western Reserve University

Awarding Agency: Department of Health and Human Services

Start Date: 2004-04-01

End Date: 2013-11-27

Contract Duration: 3,527 days

Daily Burn Rate: $3.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 3

Pricing Type: COST NO FEE

Sector: Healthcare

Official Description: PEDIATRIC OFF-PATENT DRUGS STUDY (PODS) CENTER FOR LORAZEPAM SEDATION

Place of Performance

Location: CLEVELAND, CUYAHOGA County, OHIO, 44106

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.4 million to CASE WESTERN RESERVE UNIVERSITY for work described as: PEDIATRIC OFF-PATENT DRUGS STUDY (PODS) CENTER FOR LORAZEPAM SEDATION Key points: 1. Contract awarded for a long-term study on pediatric drug efficacy and safety. 2. Focus on lorazepam sedation highlights a specific area of pediatric care. 3. The contract spans nearly a decade, indicating a significant research commitment. 4. Awarded to a university research center, suggesting a focus on academic expertise. 5. The 'Cost No Fee' contract type implies reimbursement of allowable costs without profit. 6. This award falls under professional, scientific, and technical services.

Value Assessment

Rating: fair

The contract value of $10.4 million over approximately 9.6 years represents an average annual expenditure of roughly $1.08 million. Without specific benchmarks for similar pediatric drug efficacy studies, it is difficult to definitively assess value for money. The 'Cost No Fee' (CNF) contract type is typically used when the contractor is a non-profit organization and the government wants to avoid paying profit, which can be advantageous for taxpayer cost. However, it also means that cost control and efficient resource management by the contractor are critical.

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 offers. The presence of 3 bidders suggests a reasonable level of competition for this specialized research. Full and open competition generally leads to better price discovery and ensures that the government receives offers from a wide range of qualified entities, potentially leading to more innovative solutions and cost-effective outcomes.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it drives down costs through market forces and encourages a broader pool of talent, ensuring the government isn't limited to a single provider and can secure the best value.

Public Impact

The primary beneficiaries are pediatric patients requiring sedation, with the study aiming to improve the safety and efficacy of lorazepam in this population. The study will deliver critical data and insights into the use of a specific sedative in children. The geographic impact is primarily within Ohio, where Case Western Reserve University is located, but the findings will have national and potentially international implications for pediatric healthcare. The contract supports research personnel and potentially clinical staff at the university, contributing to the scientific workforce.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns if not managed tightly under the 'Cost No Fee' structure.
The long duration of the contract could lead to scope creep or evolving research needs not fully anticipated.
Ensuring the scientific rigor and timely completion of a multi-year research project can be challenging.

Positive Signals

Award to a university research center suggests strong academic and scientific credentials.
Full and open competition indicates a robust selection process and potential for high-quality research.
The focus on a specific pediatric drug addresses a clear need in clinical practice.

Sector Analysis

This contract falls within the broader 'Professional, Scientific, and Technical Services' sector, specifically focusing on health and medical research. The market for such services involves academic institutions, contract research organizations (CROs), and specialized scientific consultancies. Government spending in this area supports advancements in medical knowledge, drug development, and public health initiatives. Comparable spending benchmarks would typically involve other NIH-funded research grants and contracts for clinical studies.

Small Business Impact

This contract was awarded to Case Western Reserve University, an academic institution, and does not appear to have specific small business set-aside provisions. Given the nature of the research and the awardee, it is unlikely that significant subcontracting opportunities for small businesses would arise directly from this award, unless specialized services are required. The focus is on academic research rather than typical procurement of goods or services where small business participation is often mandated.

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 No Fee' contract, oversight would focus on ensuring that expenditures are allowable, reasonable, and allocable to the research objectives. Progress reports, financial reviews, and adherence to research protocols would be key accountability measures. Transparency is generally maintained through public research publications and NIH reporting mechanisms.

Related Government Programs

National Institutes of Health Research Grants
Pediatric Clinical Trials
Drug Efficacy Studies
Sedation Research

Risk Flags

Long contract duration
Cost-reimbursement without fee (potential for less contractor cost-efficiency focus)
Broad NAICS code may obscure specific service details

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.4 million to CASE WESTERN RESERVE UNIVERSITY. PEDIATRIC OFF-PATENT DRUGS STUDY (PODS) CENTER FOR LORAZEPAM SEDATION

Who is the contractor on this award?

The obligated recipient is CASE WESTERN RESERVE UNIVERSITY.

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 $10.4 million.

What is the period of performance?

Start: 2004-04-01. End: 2013-11-27.

What is the specific scientific objective of the Pediatric Off-Patent Drugs Study (PODS) Center for Lorazepam Sedation?

The provided data does not detail the specific scientific objectives of the PODS Center for Lorazepam Sedation. However, based on the contract title and the nature of NIH-funded research, the study likely aims to evaluate the efficacy, safety, pharmacokinetics, and optimal dosing of lorazepam for sedation in various pediatric populations. This could involve comparing it to other sedatives, identifying specific patient subgroups that benefit most or are at higher risk, and establishing evidence-based guidelines for its use in children, particularly since lorazepam is an off-patent drug where comprehensive pediatric-specific data may be lacking.

How does the 'Cost No Fee' (CNF) contract type influence cost management and contractor incentives compared to other contract types?

A 'Cost No Fee' (CNF) contract is a type of cost-reimbursement contract where the contractor is reimbursed for all allowable costs incurred in performing the contract, but receives no fee or profit. This type of contract is typically used with non-profit organizations, educational institutions, or state and local governments where profit is not an objective. For the government, it can be cost-effective as it avoids paying profit margins. However, it places a strong emphasis on the contractor's internal cost controls and efficient management, as there is no direct financial incentive for the contractor to minimize costs beyond avoiding disallowed expenses. The government's oversight is crucial to ensure costs are reasonable and allocable.

What are the potential risks associated with a long-duration contract like this (over 9 years)?

Long-duration contracts, such as this one spanning over 9 years, present several potential risks. Firstly, the cost of the contract can escalate due to inflation or unforeseen changes in resource requirements over time. Secondly, the scope of work may need to adapt to evolving scientific understanding, technological advancements, or changes in regulatory requirements, potentially leading to scope creep or the need for contract modifications. Thirdly, maintaining consistent performance and engagement from the contractor over such an extended period can be challenging. Finally, there's a risk that the initial assumptions or objectives of the study might become less relevant or outdated by the time the contract concludes, impacting the ultimate utility of the research findings.

Given the award to Case Western Reserve University, what is the typical track record of academic institutions in managing large federal research contracts?

Academic institutions like Case Western Reserve University generally have a strong track record in managing large federal research contracts, particularly those funded by agencies like the NIH. They possess specialized expertise, research infrastructure, and often collaborate with leading scientists. Their primary focus is on research and education, aligning well with the objectives of many federal grants and contracts. However, managing the administrative and financial aspects of large contracts requires robust internal systems for compliance, financial reporting, and project oversight. While many institutions excel, occasional challenges can arise related to administrative burdens, indirect cost recovery, or ensuring timely project milestones, necessitating strong partnership and oversight from the funding agency.

How does the 'All Other Professional, Scientific, and Technical Services' (NAICS 541990) classification inform our understanding of this contract's scope?

The NAICS code 541990, 'All Other Professional, Scientific, and Technical Services,' is a broad category that encompasses establishments primarily engaged in providing specialized professional, scientific, and technical services not elsewhere classified. For this contract, it indicates that the work performed by Case Western Reserve University is highly specialized and falls outside more specific categories like research and development in the life sciences (which might be NAICS 541714), or other specific consulting or testing services. This broad classification suggests the contract could involve a unique combination of scientific research, data analysis, technical consultation, and potentially the development of novel methodologies related to pediatric drug sedation.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Other Professional, Scientific, and Technical Services › All Other Professional, Scientific, and Technical Services

Product/Service Code: RESEARCH AND DEVELOPMENT › Community and Regional Development R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation ID: RFPNICHD200311

Offers Received: 3

Pricing Type: COST NO FEE (S)

Contractor Details

Address: 10900 EUCLID AVE, CLEVELAND, OH, 44106

Business Categories: Category Business, Educational Institution, Higher Education, Not Designated a Small Business

Financial Breakdown

Contract Ceiling: $22,798,639

Exercised Options: $19,574,003

Current Obligation: $10,433,832

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline