NIH awards $2.75M for BSL-3/4 virus challenge material, supporting critical biodefense research

Contract Overview

Contract Amount: $2,754,181 ($2.8M)

Contractor: American Type Culture Collection

Awarding Agency: Department of Health and Human Services

Start Date: 2022-01-17

End Date: 2027-03-14

Contract Duration: 1,882 days

Daily Burn Rate: $1.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THE PRODUCTION OF WELL CHARACTERIZED CHALLENGE MATERIAL OF BSL-3/4 VIRUSES.

Place of Performance

Location: MANASSAS, PRINCE WILLIAM County, VIRGINIA, 20110

State: Virginia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.8 million to AMERICAN TYPE CULTURE COLLECTION for work described as: THE PRODUCTION OF WELL CHARACTERIZED CHALLENGE MATERIAL OF BSL-3/4 VIRUSES. Key points: 1. Contract supports essential research into high-containment pathogens. 2. Competition was full and open, suggesting a competitive bidding process. 3. Contract type is Cost Plus Fixed Fee, which can lead to cost overruns if not managed carefully. 4. The duration of the contract is substantial, indicating a long-term need. 5. The North American Industry Classification System (NAICS) code points to biotechnology research and development. 6. The awardee has a history of providing biological materials. 7. The contract is a delivery order under a larger contract vehicle.

Value Assessment

Rating: good

The contract value of $2.75 million over approximately five years appears reasonable for the specialized nature of producing well-characterized challenge material for BSL-3/4 viruses. Benchmarking this specific type of material production is challenging due to its niche and high-risk nature. However, the fixed fee component suggests a defined profit margin for the contractor, which can be a positive indicator of controlled costs. The overall value is assessed in the context of supporting critical biodefense and public health research, where the cost of failure or unavailability of such materials would be significantly higher.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under a full and open competition, indicating that all responsible sources were permitted to submit a bid. The specific number of bidders is not provided, but the open competition suggests a healthy market for these specialized services. This approach is generally favorable for price discovery and ensuring the government receives competitive offers. The use of a delivery order implies this is part of a broader contract, which itself would have undergone a competitive process.

Taxpayer Impact: A full and open competition maximizes the potential for competitive pricing, which is beneficial for taxpayer dollars. It ensures that the government is not limited to a single provider, increasing the likelihood of obtaining the best value.

Public Impact

Researchers in biodefense and infectious disease will benefit from access to well-characterized viral challenge materials. The services delivered will enhance the development and testing of medical countermeasures, vaccines, and diagnostics. The geographic impact is national, supporting federal research initiatives across the United States. The contract supports specialized scientific workforce needs in biotechnology and virology.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts carry inherent risk of cost escalation if not rigorously monitored.
The specialized nature of BSL-3/4 materials requires stringent safety protocols and quality control, increasing operational risk.
Reliance on a single delivery order under a larger contract could present risks if the parent contract has issues.

Positive Signals

Full and open competition suggests a robust market and potential for competitive pricing.
The awardee, American Type Culture Collection (ATCC), is a reputable organization with extensive experience in biological material provision.
The contract directly supports critical national security and public health research priorities.

Sector Analysis

The contract falls within the Biotechnology (except Nanobiotechnology) sector, a rapidly growing area focused on life sciences research and development. This sector is crucial for advancements in medicine, agriculture, and environmental science. Spending in this area often involves significant investment in specialized facilities, equipment, and highly skilled personnel. Comparable spending benchmarks are difficult to establish precisely due to the unique nature of BSL-3/4 pathogen materials, but federal investment in biodefense and infectious disease research is substantial and ongoing.

Small Business Impact

The provided data does not indicate any specific small business set-aside provisions for this contract. As a research and development contract for highly specialized biological materials, it is likely that the primary awardee is a large, established organization. Subcontracting opportunities for small businesses might exist in areas such as specialized equipment supply or logistical support, but these are not explicitly detailed in the award information. The overall impact on the small business ecosystem for this specific award appears minimal based on the available data.

Oversight & Accountability

Oversight for this contract will likely be managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a Cost Plus Fixed Fee contract, rigorous financial oversight and performance monitoring are essential to ensure costs remain within the fixed fee parameters and that deliverables meet quality standards. Transparency is facilitated through federal contract databases, and the Inspector General for HHS would have jurisdiction over any potential fraud, waste, or abuse.

Related Government Programs

Biodefense and Pandemic Preparedness Programs
National Institute of Allergy and Infectious Diseases (NIAID) Research
Advanced Development and Manufacturing for Medical Countermeasures
Centers for Disease Control and Prevention (CDC) Laboratory Services

Risk Flags

Cost Plus Fixed Fee contract type requires diligent oversight.
High-containment biological materials necessitate stringent safety and quality controls.
Reliance on a delivery order under a larger contract vehicle.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.8 million to AMERICAN TYPE CULTURE COLLECTION. THE PRODUCTION OF WELL CHARACTERIZED CHALLENGE MATERIAL OF BSL-3/4 VIRUSES.

Who is the contractor on this award?

The obligated recipient is AMERICAN TYPE CULTURE COLLECTION.

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 $2.8 million.

What is the period of performance?

Start: 2022-01-17. End: 2027-03-14.

What is the track record of American Type Culture Collection (ATCC) in providing high-containment biological materials?

American Type Culture Collection (ATCC) is a well-established and highly reputable non-profit organization with decades of experience in the collection, preservation, and distribution of biological standards, including viruses, bacteria, cell lines, and other microorganisms. They are known for their rigorous quality control processes and adherence to safety standards. ATCC operates specialized facilities, including those capable of handling BSL-3 and BSL-4 agents, making them a primary resource for researchers requiring well-characterized and authenticated biological materials for various research applications, including vaccine development, diagnostic testing, and fundamental scientific inquiry. Their long history and specialized capabilities position them as a trusted provider for government agencies like NIH.

How does the Cost Plus Fixed Fee (CPFF) contract type compare to other contract types for R&D services?

Cost Plus Fixed Fee (CPFF) is a common contract type for research and development (R&D) where the scope of work is not precisely defined at the outset, making it difficult to establish a firm fixed price. In a CPFF contract, the government reimburses the contractor for all allowable costs incurred, plus a predetermined fixed fee representing profit. This contrasts with Firm-Fixed-Price (FFP) contracts, where the price is set and the contractor assumes most of the risk for cost overruns, or Cost-Plus-Incentive-Fee (CPIF) contracts, which include incentives for meeting cost, performance, or schedule targets. CPFF offers flexibility for R&D but requires robust government oversight to manage costs and prevent contractor inefficiencies, as the contractor has less financial incentive to control costs compared to FFP.

What are the primary risks associated with producing and handling BSL-3/4 viral challenge materials?

Producing and handling materials for Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) viruses presents significant risks due to the high potential for aerosol transmission and the severity of diseases they cause. Key risks include accidental exposure of personnel, leading to infection and potential community spread if containment is breached. There are also risks associated with maintaining the viability and genetic stability of the challenge material, ensuring its 'well-characterized' status throughout the production and storage process. Stringent containment protocols, specialized training for personnel, robust decontamination procedures, and secure storage are critical to mitigate these risks. Failure in any of these areas can have severe public health consequences and compromise research integrity.

What is the significance of 'well-characterized challenge material' in infectious disease research?

Well-characterized challenge material refers to infectious agents (like viruses) that have been thoroughly analyzed for their identity, purity, potency, and genetic stability. In infectious disease research, particularly for developing vaccines, therapeutics, or diagnostics, using such material is crucial for obtaining reliable and reproducible results. It ensures that researchers are testing their interventions against a consistent and known pathogen, rather than a variable or contaminated sample. This consistency is vital for regulatory approval processes (e.g., by the FDA) and for comparing results across different studies or laboratories. For BSL-3/4 viruses, ensuring this characterization is performed under strict safety conditions adds another layer of complexity and importance.

How does this contract align with broader federal investments in biodefense and pandemic preparedness?

This contract directly aligns with and supports broader federal investments in biodefense and pandemic preparedness. The Department of Health and Human Services, through agencies like NIH and CDC, plays a central role in developing countermeasures against infectious diseases, including those that pose a threat to national security or public health. The production of well-characterized challenge materials for high-containment viruses is a foundational requirement for advancing research into vaccines, antiviral drugs, and diagnostic tools. Federal funding in this area has seen significant increases following events like the COVID-19 pandemic, emphasizing the need for robust domestic capabilities to respond to emerging infectious disease threats. This award represents a specific, critical component within that larger strategic framework.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 10801 UNIVERSITY BLVD, MANASSAS, VA, 20110

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

Financial Breakdown

Contract Ceiling: $3,266,305

Exercised Options: $2,754,181

Current Obligation: $2,754,181

Actual Outlays: $2,694,776

Subaward Activity

Number of Subawards: 2

Total Subaward Amount: $8,234,103

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N93019D00002

IDV Type: IDC

Timeline