HHS awards $33M for stabilized isoamyl nitrite to treat cyanide exposure, with R&D in biotechnology

Contract Overview

Contract Amount: $32,952,759 ($33.0M)

Contractor: Emergent Product Development Gaithersburg Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2017-09-15

End Date: 2024-06-03

Contract Duration: 2,453 days

Daily Burn Rate: $13.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF - ADVANCING STABILIZED ISOAMYL NITRITE FOR INTRANASAL TREATMENT OF CYANIDE EXPOSURE

Place of Performance

Location: GAITHERSBURG, MONTGOMERY County, MARYLAND, 20879

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $33.0 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. for work described as: IGF::OT::IGF - ADVANCING STABILIZED ISOAMYL NITRITE FOR INTRANASAL TREATMENT OF CYANIDE EXPOSURE Key points: 1. Contract awarded to Emergent Product Development for a critical medical countermeasure. 2. Focus on R&D in biotechnology for a novel treatment. 3. Potential for significant public health impact in cyanide exposure incidents. 4. Long contract duration of 2453 days suggests complex development.

Value Assessment

Rating: good

The contract type is Cost Plus Fixed Fee, which is common for R&D where costs are uncertain. The total award amount of $32.9M over 2453 days appears reasonable for advanced product development in a specialized field.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating a competitive bidding process. This method is expected to yield fair pricing and identify the most capable vendor for this specialized R&D.

Taxpayer Impact: This contract aims to develop a life-saving medical countermeasure, potentially saving taxpayer money by preventing severe health outcomes and reducing emergency response costs.

Public Impact

Development of a new treatment for cyanide poisoning could save lives. Ensures preparedness for potential chemical or industrial accidents. Supports innovation in biopharmaceutical research and development. Addresses a critical public health need for rapid response countermeasures.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

  • Long contract duration may indicate development challenges.
  • Cost Plus Fixed Fee contracts can sometimes lead to cost overruns if not managed closely.

Positive Signals

  • Addresses a critical public health threat.
  • Awarded through full and open competition.
  • Supports advanced biotechnology research.

Sector Analysis

This contract falls under the Research and Development in Biotechnology sector (NAICS 541711). Spending in this area is crucial for national security and public health preparedness, often involving significant investment due to the inherent risks and complexities of scientific discovery.

Small Business Impact

The contract was awarded to Emergent Product Development, a single entity. There is no explicit indication of small business participation in this specific award, which is common for large-scale, specialized R&D contracts.

Oversight & Accountability

The contract is managed by the Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response, indicating a focus on emergency preparedness. Oversight would involve monitoring research progress, adherence to cost controls, and milestone achievement.

Related Government Programs

  • Research and Development in Biotechnology
  • Department of Health and Human Services Contracting
  • Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

  • Long contract duration.
  • Potential for R&D delays.
  • Reliance on a single vendor for critical development.
  • Uncertainty in R&D outcomes.

Tags

research-and-development-in-biotechnolog, department-of-health-and-human-services, md, definitive-contract, 10m-plus

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $33.0 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.. IGF::OT::IGF - ADVANCING STABILIZED ISOAMYL NITRITE FOR INTRANASAL TREATMENT OF CYANIDE EXPOSURE

Who is the contractor on this award?

The obligated recipient is EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $33.0 million.

What is the period of performance?

Start: 2017-09-15. End: 2024-06-03.

What is the projected timeline for the development and availability of the stabilized isoamyl nitrite treatment?

The contract duration is 2453 days, ending in June 2024, suggesting the development phase is nearing completion or has recently concluded. Further information would be needed to confirm the exact status of the product's readiness for deployment and its efficacy in real-world scenarios.

What are the key performance indicators and milestones for this R&D contract to ensure value for money?

Key performance indicators likely include successful synthesis and stabilization of isoamyl nitrite, demonstration of efficacy in preclinical and potentially clinical trials, and meeting safety profiles. Milestones would track progress through these stages, with payments tied to their achievement, ensuring the government receives tangible progress for its investment.

How does this investment compare to alternative treatments or research efforts for cyanide exposure?

This contract represents a specific investment in advancing a particular countermeasure. The value comparison would depend on the established efficacy, safety, and cost-effectiveness of isoamyl nitrite against existing treatments like hydroxocobalamin or other investigational therapies. The 'full and open competition' suggests this approach was deemed promising among potential solutions.

Industry Classification

NAICS: Professional, Scientific, and Technical ServicesScientific Research and Development ServicesResearch and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENTN – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA16100SOL00001

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: Emergent Biosolutions Inc.

Address: 300 PROFESSIONAL DR, GAITHERSBURG, MD, 20879

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

Financial Breakdown

Contract Ceiling: $73,947,282

Exercised Options: $32,952,759

Current Obligation: $32,952,759

Actual Outlays: $13,223,116

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline

Start Date: 2017-09-15

Current End Date: 2024-06-03

Potential End Date: 2025-07-25 00:00:00

Last Modified: 2024-04-26

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