NIH awards $13M for Myelodysplastic Syndromes study, extending research through February 2026

Contract Overview

Contract Amount: $12,953,436 ($13.0M)

Contractor: H. LEE Moffitt Cancer Center and Research Institute Hospital, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2016-08-30

End Date: 2026-02-28

Contract Duration: 3,469 days

Daily Burn Rate: $3.7K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST NO FEE

Sector: R&D

Official Description: IGF::OT::IGF THE NATIONAL MYELODYSPLASTIC SYNDROMES (MDS) NATURAL HISTORY STUDY, CENTRAL LAB AND BIOREPOSITORY (CLB), TASK ORDER 03, SEPTEMBER 1, 2016-FEBRUARY 28, 2018

Place of Performance

Location: TAMPA, HILLSBOROUGH County, FLORIDA, 33612

State: Florida Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $13.0 million to H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC. for work described as: IGF::OT::IGF THE NATIONAL MYELODYSPLASTIC SYNDROMES (MDS) NATURAL HISTORY STUDY, CENTRAL LAB AND BIOREPOSITORY (CLB), TASK ORDER 03, SEPTEMBER 1, 2016-FEBRUARY 28, 2018 Key points: 1. Contract supports a critical natural history study for Myelodysplastic Syndromes (MDS). 2. H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc. is the awardee. 3. The contract is structured as a Cost No Fee award. 4. This task order extends the existing study duration. 5. The research falls under the R&D sector, specifically life sciences. 6. The awardee is a well-established cancer center, suggesting relevant expertise.

Value Assessment

Rating: good

The contract's Cost No Fee structure means the government reimburses allowable costs up to a ceiling, with no fee paid to the contractor. This is common for research grants and studies where the exact costs are difficult to predict. Benchmarking value is challenging without detailed cost breakdowns, but the duration and scope suggest a reasonable allocation of resources for a complex scientific study. The extension indicates continued progress and the need for further data collection.

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. This process generally leads to a more competitive environment, potentially resulting in better pricing and terms for the government. The specific number of bidders is not provided, but the competitive nature of the award is a positive indicator for price discovery.

Taxpayer Impact: Full and open competition ensures that taxpayer dollars are used efficiently by fostering a marketplace where contractors vie for the best value, driving down costs and improving service quality.

Public Impact

Patients with Myelodysplastic Syndromes (MDS) benefit from expanded research into their condition. The study aims to gather crucial data on the natural history of MDS. Research is conducted at H. Lee Moffitt Cancer Center, a leading cancer institution. The findings could lead to improved understanding and treatment strategies for MDS. The contract supports scientific research and development in Florida.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns if research expenses exceed projections, though the 'Cost No Fee' structure mitigates contractor profit risk.
The long duration of research studies can sometimes lead to scope creep or evolving research needs that may require contract modifications.

Positive Signals

Award to a specialized cancer research institute suggests strong technical capability.
Full and open competition indicates a robust selection process.
The extension of the contract suggests positive progress and continued scientific merit.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. The market for biomedical research is substantial, with significant government investment aimed at advancing medical knowledge and developing new treatments. Comparable spending benchmarks would involve other NIH-funded research grants and contracts for similar long-term studies in oncology and hematology.

Small Business Impact

Information regarding small business participation or set-asides is not explicitly detailed in the provided data. As this is a research-focused award to a large cancer center, it is less likely to have a significant direct small business set-aside component. However, the prime contractor may engage small businesses for subcontracting opportunities related to specialized services or supplies.

Oversight & Accountability

Oversight for this contract would typically be managed by the National Institutes of Health (NIH), likely through a Contracting Officer's Representative (COR) who monitors scientific progress and adherence to the contract terms. Transparency is generally maintained through public databases of federal contracts and research publications stemming from the study. Inspector General jurisdiction would apply in cases of fraud, waste, or abuse.

Related Government Programs

National Institutes of Health Research Grants
National Cancer Institute Funding
Biomedical Research Contracts
Clinical Trial Support Services

Risk Flags

Potential for cost growth in Cost No Fee contracts.
Long duration may require scope adjustments.
Complexity of R&D may lead to unforeseen challenges.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $13.0 million to H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.. IGF::OT::IGF THE NATIONAL MYELODYSPLASTIC SYNDROMES (MDS) NATURAL HISTORY STUDY, CENTRAL LAB AND BIOREPOSITORY (CLB), TASK ORDER 03, SEPTEMBER 1, 2016-FEBRUARY 28, 2018

Who is the contractor on this award?

The obligated recipient is H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC..

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 $13.0 million.

What is the period of performance?

Start: 2016-08-30. End: 2026-02-28.

What is the specific scientific objective of the Myelodysplastic Syndromes (MDS) Natural History Study?

The primary objective of the Myelodysplastic Syndromes (MDS) Natural History Study, supported by this contract, is to meticulously document the progression and clinical course of MDS in patients over time. This involves collecting comprehensive data on disease evolution, treatment responses, and patient outcomes. Understanding the natural history is fundamental for identifying key biomarkers, predicting disease trajectory, and developing more effective therapeutic strategies. The study aims to build a robust dataset that can inform future clinical trial designs and personalized medicine approaches for MDS patients.

How does the 'Cost No Fee' contract structure impact the government's financial risk?

The 'Cost No Fee' (CNF) contract structure significantly alters the financial risk profile compared to fixed-price or cost-plus-fee contracts. In a CNF arrangement, the government agrees to reimburse the contractor for all allowable costs incurred in performing the contract, but the contractor does not receive any additional fee or profit. This structure is common for research and development efforts where the scope and final costs are inherently uncertain. For the government, the risk is that the total allowable costs could exceed initial estimates. However, the government avoids paying a profit margin, which can be substantial in other contract types. The contractor's incentive is to perform the work efficiently to manage costs, as their reimbursement is tied to actual expenses rather than a pre-determined profit.

What is the significance of extending the contract for this study?

The extension of the contract for the Myelodysplastic Syndromes (MDS) Natural History Study signifies the ongoing importance and progress of the research. Extending the period allows for continued data collection, potentially capturing longer-term disease progression, treatment effects, and patient outcomes that are crucial for a comprehensive understanding of MDS. Such extensions are common in scientific research where longitudinal studies require significant time to yield meaningful results. It suggests that the initial phases of the study have been successful and that further data acquisition is deemed necessary by the National Institutes of Health (NIH) to achieve the study's scientific objectives.

What are the potential challenges in managing a long-term R&D contract like this?

Managing long-term Research and Development (R&D) contracts presents several challenges. Firstly, scientific objectives and methodologies may need to evolve as new discoveries are made or technologies advance, requiring careful contract modifications to remain relevant. Secondly, cost estimation for R&D is inherently difficult, increasing the risk of budget overruns if not closely monitored. Thirdly, ensuring consistent data quality and adherence to protocols over an extended period requires robust oversight and quality control mechanisms. Finally, maintaining contractor engagement and scientific rigor throughout the contract's lifecycle is crucial for achieving the desired outcomes. Effective communication between the government and the contractor is paramount to navigate these complexities.

How does this contract contribute to the broader understanding of cancer research?

This contract contributes significantly to the broader understanding of cancer research by focusing on the natural history of Myelodysplastic Syndromes (MDS), a group of blood cancers. By meticulously documenting how MDS progresses in patients without immediate intervention or with standard treatments over time, researchers can identify critical disease pathways, genetic mutations, and clinical factors that influence patient outcomes. This foundational knowledge is essential for developing targeted therapies, improving diagnostic tools, and designing more effective clinical trials for MDS and potentially related hematologic malignancies. The data generated can serve as a benchmark for evaluating new treatments and understanding disease heterogeneity.

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 › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 12902 MAGNOLIA DR, TAMPA, FL, 33612

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

Financial Breakdown

Contract Ceiling: $12,953,436

Exercised Options: $12,953,436

Current Obligation: $12,953,436

Actual Outlays: $6,889,648

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: HHSN268201400003I

IDV Type: IDC

Timeline