Fox Foundation Inc. awarded $3.4M contract for nicotine enantiomeric ratio research by HHS

Contract Overview

Contract Amount: $3,408,203 ($3.4M)

Contractor: THE FOX Foundation Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-24

End Date: 2027-09-23

Contract Duration: 1,094 days

Daily Burn Rate: $3.1K/day

Competition Type: COMPETED UNDER SAP

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: INVESTIGATING THE IMPACT OF NON-TOBACCO NICOTINE ENANTIOMERIC RATIO ON ENDS ABUSE LIABILITY

Place of Performance

Location: TAMPA, HILLSBOROUGH County, FLORIDA, 33611

State: Florida Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $3.4 million to THE FOX FOUNDATION INC for work described as: INVESTIGATING THE IMPACT OF NON-TOBACCO NICOTINE ENANTIOMERIC RATIO ON ENDS ABUSE LIABILITY Key points: 1. Contract focuses on a niche scientific area, potentially limiting broad applicability. 2. Research aims to understand abuse liability, a critical public health concern. 3. Fixed-price contract structure may offer cost certainty but could limit flexibility. 4. Sole-source award raises questions about competition and potential value. 5. Contract duration of nearly three years suggests a substantial research scope. 6. Geographic location in Florida may not align with broader national research hubs.

Value Assessment

Rating: fair

The contract value of $3.4 million for scientific consulting services appears within a reasonable range for specialized research. However, without specific benchmarks for this particular scientific niche (nicotine enantiomeric ratios and abuse liability), a precise value-for-money assessment is challenging. The fixed-price nature suggests the government has a clear understanding of the scope and cost, but it could also mean the contractor bears less risk for unforeseen research challenges. Comparison to similar contracts in specialized toxicology or pharmaceutical research would be beneficial.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded as a sole-source procurement, indicating that only one vendor, The Fox Foundation Inc., was considered capable of performing the required services. The rationale for this sole-source designation is not detailed but typically implies unique capabilities, proprietary knowledge, or a critical need that cannot be met by other sources. The lack of competition means that price discovery through a bidding process was bypassed, potentially leading to a higher cost than if multiple vendors had competed.

Taxpayer Impact: Sole-source awards limit opportunities for other businesses and may result in taxpayers paying a premium due to the absence of competitive pressure to lower prices.

Public Impact

The primary beneficiaries are public health initiatives aimed at understanding and mitigating nicotine addiction. The research delivered will contribute to scientific knowledge regarding the pharmacological effects of different nicotine forms. The geographic impact is primarily concentrated in Florida, where the contractor is based. Workforce implications include specialized scientific roles within The Fox Foundation Inc.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competition and potentially increases cost to taxpayers.
Lack of transparency in the sole-source justification.
Limited geographic distribution of research activities.

Positive Signals

Addresses a critical public health issue related to nicotine abuse.
Fixed-price contract provides cost predictability.
Contractor has a defined period to deliver research outcomes.

Sector Analysis

This contract falls within the broader scientific research and development sector, specifically focusing on pharmaceutical and health-related R&D. The market for specialized toxicology and pharmacodynamics research is often characterized by a limited number of highly specialized firms. Government spending in this area supports advancements in understanding drug mechanisms and public health interventions. Benchmarking would require comparison to other federal grants or contracts awarded for similar niche scientific investigations.

Small Business Impact

This contract does not appear to involve small business set-asides, as it was awarded sole-source to The Fox Foundation Inc. There is no indication of subcontracting requirements for small businesses. The impact on the small business ecosystem is therefore minimal, as opportunities were not specifically created or directed towards small entities through this procurement.

Oversight & Accountability

Oversight for this contract would primarily reside with the Food and Drug Administration (FDA) within the Department of Health and Human Services. Accountability measures are tied to the delivery of research milestones and final reports as stipulated in the contract. Transparency is limited due to the sole-source nature of the award, with public details on the justification for this approach being scarce. Inspector General jurisdiction would apply to any potential fraud, waste, or abuse.

Related Government Programs

National Institute on Drug Abuse (NIDA) research grants
FDA Center for Tobacco Products research initiatives
Substance Abuse and Mental Health Services Administration (SAMHSA) grants

Risk Flags

Sole-source award lacks competitive justification.
Potential for cost overruns due to lack of competition.
Limited transparency regarding contractor's unique qualifications.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $3.4 million to THE FOX FOUNDATION INC. INVESTIGATING THE IMPACT OF NON-TOBACCO NICOTINE ENANTIOMERIC RATIO ON ENDS ABUSE LIABILITY

Who is the contractor on this award?

The obligated recipient is THE FOX FOUNDATION INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $3.4 million.

What is the period of performance?

Start: 2024-09-24. End: 2027-09-23.

What is the specific scientific expertise of The Fox Foundation Inc. in the area of nicotine enantiomeric ratios and abuse liability?

The provided data does not detail the specific scientific expertise of The Fox Foundation Inc. beyond its classification under 'Other Scientific and Technical Consulting Services.' To assess this, one would need to review the contractor's past performance, publications, and any documentation submitted during the sole-source justification process. Federal agencies typically require evidence of specialized knowledge, prior successful research in the field, and the availability of qualified personnel when awarding sole-source contracts. Without this information, it's difficult to definitively confirm their suitability beyond the agency's own determination.

How does the $3.4 million contract value compare to similar research projects on nicotine or addiction?

Benchmarking the $3.4 million contract value requires comparing it to similar federal or private research grants and contracts focused on nicotine, tobacco products, or substance abuse liability. For instance, grants from the National Institutes of Health (NIH), including NIDA, often fund research in these areas. The scope and duration (nearly three years) are significant factors. A preliminary search of federal contract databases and grant award portals would be necessary to identify comparable projects. However, given the specialized nature of 'nicotine enantiomeric ratio,' this specific research may command a higher price due to limited expertise, making direct comparisons challenging without a detailed understanding of the research objectives and deliverables.

What are the potential risks associated with a sole-source award for this research?

The primary risk associated with a sole-source award is the lack of competitive pressure, which can lead to inflated pricing and potentially lower overall value for the government. Taxpayers may end up paying more than necessary because alternative vendors were not given the opportunity to bid. Additionally, sole-source awards can sometimes indicate a lack of market research or an over-reliance on a single contractor, potentially limiting innovation and access to a broader range of expertise. There's also a risk that the chosen contractor, without competition, might not be as incentivized to perform at the highest level or deliver the most cost-effective solution.

What is the expected impact of this research on public health policy or regulatory decisions?

The research aims to investigate the 'abuse liability' of non-tobacco nicotine enantiomeric ratios. Understanding how different ratios affect the potential for abuse is crucial for informing public health policy and regulatory decisions related to novel nicotine products. For example, findings could influence regulations on the composition of e-cigarettes, nicotine pouches, or other alternative nicotine delivery systems. If certain enantiomeric ratios are found to be significantly more addictive or prone to abuse, regulatory bodies like the FDA could use this data to restrict their availability, mandate labeling changes, or set product standards to mitigate public health risks associated with nicotine addiction.

What is the historical spending pattern of the Food and Drug Administration (FDA) on nicotine-related research?

The FDA, particularly through its Center for Tobacco Products (CTP), has consistently allocated significant funding towards research related to tobacco products and nicotine. Historical spending patterns show a strong emphasis on understanding the health effects, addictiveness, and abuse potential of various tobacco and nicotine delivery systems. This includes research into different forms of nicotine, flavorings, and their impact on user behavior and health outcomes. While specific figures for 'nicotine enantiomeric ratio' research might be granular, the overall trend indicates a sustained commitment to evidence-based regulatory science in this domain, driven by the public health imperative to reduce tobacco-related diseases and addiction.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Other Scientific and Technical Consulting Services

Product/Service Code: SPECIAL STUDIES/ANALYSIS, NOT R&D › SPECIAL STUDIES - NOT R and D

Competition & Pricing

Extent Competed: COMPETED UNDER SAP

Solicitation Procedures: SIMPLIFIED ACQUISITION

Solicitation ID: 75F40124R00126

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 4846 W. GANDY BLVD, TAMPA, FL, 33611

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

Financial Breakdown

Contract Ceiling: $3,408,203

Exercised Options: $3,408,203

Current Obligation: $3,408,203

Actual Outlays: $684,138

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline