NIH awards $63.7M for Zika vaccine research and clinical testing to Leidos Biomedical Research Inc

Contract Overview

Contract Amount: $63,695,016 ($63.7M)

Contractor: Leidos Biomedical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-22

End Date: 2021-09-21

Contract Duration: 1,825 days

Daily Burn Rate: $34.9K/day

Competition Type: NOT COMPETED

Pricing Type: COST NO FEE

Sector: R&D

Official Description: IGF::OT::IGF RESEARCH, DEVELOPMENT, MANUFACTURE OF CLINICAL MATERIALS, AND CLINICAL TESTING OF VACCINES TO PROTECT AGAINST ZIKA VIRUS

Place of Performance

Location: FREDERICK, FREDERICK County, MARYLAND, 21702

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $63.7 million to LEIDOS BIOMEDICAL RESEARCH INC for work described as: IGF::OT::IGF RESEARCH, DEVELOPMENT, MANUFACTURE OF CLINICAL MATERIALS, AND CLINICAL TESTING OF VACCINES TO PROTECT AGAINST ZIKA VIRUS Key points: 1. Contract awarded on a cost-plus-fixed-fee basis, indicating potential for cost overruns. 2. Leidos Biomedical Research Inc. is the sole awardee, raising questions about competition. 3. The contract duration of five years suggests a long-term commitment to this research area. 4. The award falls under Facilities Support Services, a broad category that may obscure specific research activities. 5. The absence of small business set-asides suggests large-scale operations are expected. 6. The contract's focus on vaccine development aligns with critical public health needs.

Value Assessment

Rating: fair

The contract's cost-plus-fixed-fee structure requires careful monitoring to ensure value for money. Without comparable contract data for Zika vaccine development, it is difficult to benchmark the pricing effectively. The total award amount of $63.7 million over five years suggests a significant investment, but the value proposition hinges on the successful development of effective vaccines.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, meaning there was no open competition. This approach is typically used when a specific contractor possesses unique capabilities or when urgency dictates a rapid award. The lack of competition limits price discovery and may result in higher costs for taxpayers compared to a competitively bid contract.

Taxpayer Impact: Sole-source awards mean taxpayers do not benefit from the cost savings that can arise from competitive bidding processes.

Public Impact

The primary beneficiaries are public health organizations and the general population, through the development of vaccines against Zika. Services delivered include research, development, manufacturing of clinical materials, and clinical testing of vaccines. The geographic impact is national, with potential global implications for disease prevention. Workforce implications include employment for scientists, researchers, and support staff involved in vaccine development.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competitive pressure on pricing.
Cost-plus-fixed-fee contract requires diligent oversight to control costs.
Broad NAICS code (561210) may obscure the specific nature and cost drivers of the research.

Positive Signals

Focus on critical public health issue (Zika virus).
Long-term commitment (5 years) allows for sustained research effort.
Award to a known entity (Leidos Biomedical Research Inc.) may indicate established expertise.

Sector Analysis

This contract falls within the broader 'Facilities Support Services' sector but is specifically focused on biomedical research and development, particularly in vaccine technology. The market for vaccine development is highly specialized, driven by public health needs and significant R&D investment. Comparable spending benchmarks are difficult to establish due to the unique nature of infectious disease research and the proprietary aspects of vaccine development.

Small Business Impact

The contract was not awarded as a small business set-aside, and the prime contractor, Leidos Biomedical Research Inc., is a large business. There is no indication of subcontracting requirements for small businesses within the provided data. This suggests that the scale and complexity of the work are likely beyond the capacity of most small businesses, or that specific expertise held by the prime contractor was prioritized.

Oversight & Accountability

Oversight for this contract would typically fall under the National Institutes of Health (NIH), a component of the Department of Health and Human Services. Accountability measures would include performance reviews, milestone tracking, and financial audits, especially given the cost-plus-fixed-fee nature of the award. Transparency may be limited due to the sole-source award and the proprietary nature of research and development.

Related Government Programs

National Institutes of Health Research and Development Contracts
Department of Health and Human Services Vaccine Development Programs
Biomedical Research and Clinical Trials
Infectious Disease Research Funding

Risk Flags

Sole-source award
Cost-plus-fixed-fee contract type
Broad NAICS code classification

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $63.7 million to LEIDOS BIOMEDICAL RESEARCH INC. IGF::OT::IGF RESEARCH, DEVELOPMENT, MANUFACTURE OF CLINICAL MATERIALS, AND CLINICAL TESTING OF VACCINES TO PROTECT AGAINST ZIKA VIRUS

Who is the contractor on this award?

The obligated recipient is LEIDOS BIOMEDICAL RESEARCH 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 $63.7 million.

What is the period of performance?

Start: 2016-09-22. End: 2021-09-21.

What is Leidos Biomedical Research Inc.'s track record with the NIH and in vaccine development?

Leidos Biomedical Research Inc. has a significant history of working with the National Institutes of Health (NIH), often managing large-scale research programs and facilities. They are known for their expertise in managing complex scientific endeavors, including those related to infectious diseases and vaccine development. Their track record typically involves supporting government research initiatives, managing clinical trials, and providing scientific support services. Specific details on their past performance related to Zika or similar viral vaccine development would require a deeper dive into NIH contract databases and performance reports, but their established relationship with NIH suggests a level of trust and proven capability in handling such critical research.

How does the $63.7 million award compare to other federal spending on Zika vaccine research?

The $63.7 million award represents a substantial investment in Zika vaccine research by the NIH. To provide a comprehensive comparison, one would need to analyze historical federal spending data specifically allocated to Zika vaccine development across various agencies (e.g., NIH, BARDA, DoD) and over different fiscal years. This contract appears to be a significant, multi-year commitment. Without access to a complete dataset of all federal Zika-related R&D contracts, it's challenging to definitively state how this single award ranks, but its duration and value indicate it's a major component of the federal effort in this specific research area.

What are the primary risks associated with this sole-source, cost-plus-fixed-fee contract?

The primary risks associated with this contract stem from its sole-source and cost-plus-fixed-fee (CPFF) nature. The sole-source award means there was no competitive bidding, potentially leading to a higher price than if multiple vendors had competed. Taxpayers do not benefit from the price discovery inherent in a competitive process. The CPFF structure carries the risk of cost overruns, as the contractor is reimbursed for allowable costs plus a fixed fee. This necessitates robust government oversight to ensure costs remain reasonable and that the contractor is incentivized to control expenses. Without strong oversight, the total cost could exceed initial projections, diminishing the overall value for money.

How effective has the NIH been in managing similar large-scale R&D contracts?

The NIH has a long and generally effective history of managing large-scale research and development contracts across a vast array of scientific disciplines. They employ various contract types and oversight mechanisms to ensure scientific progress and responsible stewardship of taxpayer funds. While specific contract performance can vary, the NIH's overall track record in advancing medical research and public health through contracted efforts is strong. Their success often depends on the clarity of research objectives, the expertise of the contracting officers, and the diligence of scientific and administrative oversight teams. Challenges can arise in highly specialized or rapidly evolving fields, but the NIH typically has established processes to address these.

What is the historical spending pattern for Facilities Support Services (NAICS 561210) at the NIH?

Historical spending on NAICS code 561210 (Facilities Support Services) at the NIH can be substantial, as it encompasses a wide range of services necessary to maintain and operate extensive research facilities. This category often includes maintenance, repair, custodial services, security, and logistical support. While this specific contract is for R&D, it is categorized under 561210, which might indicate that Leidos is providing integrated support services that include facility management alongside their research activities, or it could be an administrative categorization. Analyzing NIH's historical spending in this broad category would reveal significant annual outlays, but isolating spending specifically for R&D within this code would require more granular data.

What are the potential implications of the 'NOT COMPETED' status for future contract opportunities?

The 'NOT COMPETED' status for this contract signifies that it was awarded without seeking bids from multiple sources. This is typically done under specific circumstances, such as when only one source is capable of fulfilling the requirement or in cases of urgent need. For future contract opportunities, this specific award does not inherently preclude future competition. However, if the rationale for the sole-source award was based on unique capabilities that remain exclusive to Leidos Biomedical Research Inc., it could influence future competitive strategies. Agencies are generally encouraged to compete contracts whenever possible to ensure best value and foster market competition.

Industry Classification

NAICS: Administrative and Support and Waste Management and Remediation Services › Facilities Support Services › Facilities Support Services

Product/Service Code: OPERATION OF GOVT OWNED FACILITY › OPERATE GOVT OWNED BUILDINGS

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Solicitation ID: N01CO5240180

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Parent Company: Leidos Holdings, Inc. (UEI: 611641312)

Address: 1050 BOYLES ST, FREDERICK, MD, 21702

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

Financial Breakdown

Contract Ceiling: $63,695,016

Exercised Options: $63,695,016

Current Obligation: $63,695,016

Actual Outlays: $284,060

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: HHSN261201500003I

IDV Type: IDC

Timeline