HHS awards $1.3M for diagnostic substance manufacturing, with NIH overseeing the contract

Contract Overview

Contract Amount: $1,314,390 ($1.3M)

Contractor: Biofire Diagnostics LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2016-12-20

End Date: 2020-12-23

Contract Duration: 1,464 days

Daily Burn Rate: $898/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: BIOFIRE DIAGNOSTICS INC:1109738 [17-002148]

Place of Performance

Location: SALT LAKE CITY, SALT LAKE County, UTAH, 84108

State: Utah Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $1.3 million to BIOFIRE DIAGNOSTICS LLC for work described as: BIOFIRE DIAGNOSTICS INC:1109738 [17-002148] Key points: 1. The contract value of $1.3 million appears modest for a multi-year federal award. 2. The fixed-price contract type suggests a defined scope and predictable costs. 3. The award was made under full and open competition, indicating a broad search for qualified vendors. 4. The contract duration of approximately four years provides a stable period for service delivery. 5. The geographic location of the contractor in Utah may influence logistics and regional economic impact. 6. The specific product code is not detailed, making direct comparisons to similar substance manufacturing contracts challenging.

Value Assessment

Rating: good

The contract value of $1.3 million for a four-year period, covering in-vitro diagnostic substance manufacturing, seems reasonable. Without specific details on the quantity and type of substances, a direct comparison to similar contracts is difficult. However, the firm fixed-price structure suggests that the government has a clear understanding of costs and risks, aiming for value by locking in prices.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, meaning that all responsible sources were permitted to submit a bid. The data does not specify the number of bidders, but the designation implies a robust competitive process. This approach is generally expected to yield competitive pricing and ensure the government receives the best value available in the market.

Taxpayer Impact: Full and open competition maximizes the potential for cost savings for taxpayers by encouraging multiple vendors to offer their best prices.

Public Impact

The primary beneficiaries are likely the National Institutes of Health (NIH) and potentially other Department of Health and Human Services (HHS) agencies requiring in-vitro diagnostic substances for research and development. The services delivered involve the manufacturing of specialized diagnostic substances, crucial for medical research and potentially for diagnostic test development. The geographic impact is primarily centered in Utah, where the contractor is located, potentially creating or sustaining local jobs. Workforce implications may include skilled labor in chemical manufacturing, quality control, and logistics within the contractor's operations.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of detailed product specifications makes it hard to assess the true value and uniqueness of the manufactured substances.
Limited information on the number of bidders in the full and open competition makes it difficult to gauge the intensity of price pressure.
The contract is for 'substance manufacturing,' which could encompass a wide range of materials; specificity is needed for deeper analysis.

Positive Signals

Awarded under full and open competition, suggesting a fair and broad market solicitation.
Firm fixed-price contract type provides cost certainty for the government.
Contract duration of over four years indicates a stable, long-term need for these substances.

Sector Analysis

The contract falls within the broader 'Healthcare' and 'Manufacturing' sectors, specifically focusing on the niche of in-vitro diagnostic substance manufacturing. This market is critical for medical research, diagnostics, and pharmaceutical development. While specific market size data for this sub-sector is not readily available, the overall diagnostics market is substantial and growing, driven by advancements in personalized medicine and disease detection. This contract represents a small but essential component of the federal government's procurement in this vital area.

Small Business Impact

The data indicates that this contract was not set aside for small businesses (ss: false) and there is no explicit mention of small business subcontracting requirements (sb: false). Therefore, this award does not appear to directly benefit small businesses through a set-aside. The lack of subcontracting information means its impact on the broader small business ecosystem in this specific manufacturing niche is not directly quantifiable from the provided data.

Oversight & Accountability

Oversight for this contract would primarily reside with the contracting officers and program managers within the National Institutes of Health (NIH), a sub-agency of the Department of Health and Human Services (HHS). Accountability is established through the firm fixed-price contract terms, requiring delivery of specified substances. Transparency is facilitated by the federal procurement data system, which publishes contract awards. While no specific Inspector General jurisdiction is mentioned, the HHS Office of Inspector General would have oversight authority over potential fraud, waste, or abuse related to this contract.

Related Government Programs

NIH Research and Development Contracts
HHS Medical Supplies Procurement
In-Vitro Diagnostic Manufacturing
Federal Substance Procurement

Risk Flags

Lack of specific product details
Limited bidder count information
Potential for price premium in FFP contracts
Geographic delivery considerations

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $1.3 million to BIOFIRE DIAGNOSTICS LLC. BIOFIRE DIAGNOSTICS INC:1109738 [17-002148]

Who is the contractor on this award?

The obligated recipient is BIOFIRE DIAGNOSTICS LLC.

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 $1.3 million.

What is the period of performance?

Start: 2016-12-20. End: 2020-12-23.

What is the specific nature and application of the 'In-Vitro Diagnostic Substance' being manufactured under this contract?

The provided data categorizes the contract under 'In-Vitro Diagnostic Substance Manufacturing' (ND: 325413) but does not specify the exact type or application of the substances. These could range from reagents for diagnostic tests, components for laboratory assays, or specialized biological materials used in research. Without further details, it's difficult to ascertain the precise scientific or medical purpose. The National Institutes of Health (NIH), as the awarding agency, likely requires these substances for its extensive biomedical research programs, potentially supporting studies in disease diagnosis, drug development, or fundamental biological research. The lack of specificity in the data limits a precise understanding of the contract's direct impact on specific health outcomes or research advancements.

How does the awarded amount of $1.3 million compare to typical federal spending on similar in-vitro diagnostic substance manufacturing contracts?

Benchmarking the $1.3 million award against similar contracts is challenging without more specific data on the type and quantity of substances procured. Federal spending on diagnostic substances can vary widely based on complexity, volume, and research application. Contracts for basic reagents might be smaller, while those for highly specialized or custom-synthesized materials could be significantly larger. The duration of this contract (approximately four years) suggests a steady, ongoing need. To provide a more accurate comparison, one would need to identify contracts with similar product service codes (PSC) or North American Industry Classification System (NAICS) codes, and analyze their total values and durations. However, $1.3 million over four years ($325,000 annually) appears to be a moderate investment, potentially indicating a focus on specific, perhaps niche, diagnostic components rather than large-scale production.

What are the potential risks associated with a firm fixed-price contract for manufacturing specialized diagnostic substances?

A firm fixed-price (FFP) contract for manufacturing specialized diagnostic substances carries several potential risks. For the contractor, the primary risk is underestimating production costs, leading to reduced profit margins or even losses if material prices increase unexpectedly or production complexities arise. For the government, the risk lies in potentially paying a premium if the contractor inflates the price to cover perceived risks, or if the scope of work needs to change significantly, requiring costly modifications or a new contract. If the substances are highly specialized, there might be limited competition, allowing the incumbent contractor to command higher prices. Furthermore, if quality control issues arise, the FFP structure might incentivize the contractor to cut corners, necessitating rigorous government oversight to ensure product efficacy and safety, which can add indirect costs.

What is the track record of BIOFIRE DIAGNOSTICS LLC in fulfilling federal contracts, particularly for the Department of Health and Human Services?

Reviewing the federal contract history of BIOFIRE DIAGNOSTICS LLC (contractor ID: 1109738) reveals this specific award from the National Institutes of Health (NIH) as a Delivery Order (DO) under a larger contract vehicle. The data provided focuses on this single award, showing a value of $1,314,390 with a duration from December 20, 2016, to December 23, 2020. Without access to a comprehensive federal procurement database search for this contractor across all agencies and contract types, it's difficult to provide a complete track record. However, the existence of this NIH contract suggests prior engagement and successful performance, at least to the extent required for a delivery order to be issued. Further investigation into other awards, past performance evaluations, and any reported issues would be necessary for a thorough assessment of their track record.

How does the geographic location of the contractor in Utah potentially impact the delivery and cost-effectiveness of these diagnostic substances?

The contractor's location in Utah (SN: UTAH) has several potential implications for this contract. From a logistical standpoint, it may increase shipping times and costs for delivery to federal facilities located elsewhere in the United States, particularly on the East Coast. However, if the primary users or research facilities are also located in the western US, the location could be advantageous. Utah has a growing biotech and life sciences sector, suggesting a potential pool of skilled labor and supporting infrastructure for manufacturing. The cost-effectiveness can be influenced by regional labor costs and operational expenses, which may differ from those in other parts of the country. While not explicitly stated, the government likely considered these factors during the procurement process, especially under full and open competition, to ensure overall value.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › In-Vitro Diagnostic Substance Manufacturing

Product/Service Code: INSTRUMENTS AND LABORATORY EQPT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: M5Q52AR3

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Compagnie Merieux Alliance

Address: 515 COLOROW DR, SALT LAKE CITY, UT, 84108

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign-Owned and U.S.-Incorporated Business, Limited Liability Corporation, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $1,314,390

Exercised Options: $1,314,390

Current Obligation: $1,314,390

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Parent Contract

Parent Award PIID: V797D30085

IDV Type: FSS

Timeline