HHS Awards $46M Contract to Lovelace Biomedical for E-Cigarette Aerosol Toxicity Study

Contract Overview

Contract Amount: $46,048,623 ($46.0M)

Contractor: Lovelace Biomedical Research Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2019-09-26

End Date: 2025-06-30

Contract Duration: 2,104 days

Daily Burn Rate: $21.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: STUDY OF E-CIGARETTE AEROSOL TOXICITY IN IN VIVO NONCLINICAL MODELS.

Place of Performance

Location: SILVER SPRING, MONTGOMERY County, MARYLAND, 20903

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $46.0 million to LOVELACE BIOMEDICAL RESEARCH INSTITUTE for work described as: STUDY OF E-CIGARETTE AEROSOL TOXICITY IN IN VIVO NONCLINICAL MODELS. Key points: 1. The contract focuses on critical public health research into e-cigarette toxicity. 2. Competition was full and open, suggesting a competitive bidding process. 3. The fixed-price contract type helps manage cost certainty for the government. 4. Research is conducted in Maryland, a state with a significant biotech sector.

Value Assessment

Rating: good

The contract value of $46M over approximately 5.8 years appears reasonable for a complex, multi-year scientific study. Benchmarking against similar large-scale toxicology studies would provide a more precise assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and ensures the government receives the best value.

Taxpayer Impact: The taxpayer impact is the investment in crucial public health research, aiming to inform regulatory policy and protect citizens from potential harms of e-cigarette use.

Public Impact

Informs FDA regulations on e-cigarette products. Contributes to understanding public health risks associated with vaping. Supports scientific advancement in toxicology and aerosol research. Potential to influence public health campaigns and consumer behavior.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep in long-term research projects.
Reliance on a single contractor for a critical study.

Positive Signals

Clear research objective with public health implications.
Fixed-price contract provides cost predictability.
Full and open competition likely yielded competitive pricing.

Sector Analysis

This contract falls within the scientific research and testing services sector, specifically focusing on health and environmental toxicology. Spending in this area is driven by regulatory needs and public health initiatives.

Small Business Impact

The data does not indicate whether small businesses were involved in this contract. Further analysis would be needed to determine the extent of small business participation.

Oversight & Accountability

The Food and Drug Administration (FDA) is overseeing this contract. Standard government oversight mechanisms for research contracts, including progress reports and milestone reviews, are expected to be in place.

Related Government Programs

Testing Laboratories and Services
Department of Health and Human Services Contracting
Food and Drug Administration Programs

Risk Flags

Long contract duration increases risk of scope creep or changing research needs.
Potential for scientific challenges impacting timely completion.
Reliance on specific expertise of the awarded contractor.
Need for ongoing monitoring to ensure research integrity and relevance.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $46.0 million to LOVELACE BIOMEDICAL RESEARCH INSTITUTE. STUDY OF E-CIGARETTE AEROSOL TOXICITY IN IN VIVO NONCLINICAL MODELS.

Who is the contractor on this award?

The obligated recipient is LOVELACE BIOMEDICAL RESEARCH INSTITUTE.

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 $46.0 million.

What is the period of performance?

Start: 2019-09-26. End: 2025-06-30.

What is the specific methodology and expected output of the toxicity study?

The study aims to assess e-cigarette aerosol toxicity in vivo using nonclinical models. Expected outputs likely include detailed toxicological reports, identification of harmful constituents, and dose-response relationships, which will inform regulatory decisions and public health guidance regarding e-cigarette safety.

What are the primary risks associated with the long duration and complexity of this research contract?

Risks include potential scientific irrelevance if research methods become outdated, challenges in maintaining consistent research quality over time, and the possibility of unforeseen scientific obstacles delaying or altering expected outcomes. Managing these requires robust project management and adaptive research protocols.

How will the findings of this study be effectively translated into actionable public health policy or consumer guidance?

Effective translation requires clear communication of findings by the FDA, potentially through public reports, regulatory updates, and educational materials. Collaboration between researchers, regulators, and public health communicators is crucial to ensure the scientific data informs policy and empowers consumers with accurate information.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Architectural, Engineering, and Related Services › Testing Laboratories and Services

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: FDA19SOL1207956

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 2425 RIDGECREST DR SE, ALBUQUERQUE, NM, 87108

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: $46,048,623

Exercised Options: $46,048,623

Current Obligation: $46,048,623

Actual Outlays: $18,710,374

Subaward Activity

Number of Subawards: 3

Total Subaward Amount: $136,702

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline