NIH Awards $4.2M for Novel Radiation Countermeasure Development to Ceramedix Holding, LLC

Contract Overview

Contract Amount: $4,223,612 ($4.2M)

Contractor: Ceramedix Holding, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2023-07-01

End Date: 2027-06-30

Contract Duration: 1,460 days

Daily Burn Rate: $2.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 16

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: DEVELOPMENT OF ANTICERAMIDE TREATMENT AS A NOVEL MEDICAL COUNTERMEASURE FOR ACUTE EFFECTS OF RADIATION EXPOSURE

Place of Performance

Location: NEW YORK, NEW YORK County, NEW YORK, 10022

State: New York Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $4.2 million to CERAMEDIX HOLDING, LLC for work described as: DEVELOPMENT OF ANTICERAMIDE TREATMENT AS A NOVEL MEDICAL COUNTERMEASURE FOR ACUTE EFFECTS OF RADIATION EXPOSURE Key points: 1. This contract focuses on a critical area of medical preparedness: radiation exposure countermeasures. 2. The award is a definitive contract, suggesting a well-defined scope and expected outcome. 3. Competition method is 'Full and Open', indicating broad market access and potential for competitive pricing. 4. The sector is R&D in Biotechnology, a high-innovation and often high-cost field.

Value Assessment

Rating: fair

The contract type is Cost Plus Fixed Fee, which can lead to higher costs if not managed carefully. Benchmarking is difficult without specific cost breakdowns, but the total award of $4.2M over 4 years for R&D is within a reasonable range for novel medical countermeasures.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, allowing any qualified vendor to bid. This method generally promotes competitive pricing and ensures the government receives the best value. The fixed fee component provides some cost control for the government.

Taxpayer Impact: Taxpayer funds are being invested in a critical national security and public health need, aiming for a breakthrough medical treatment.

Public Impact

Development of a medical countermeasure for radiation exposure could significantly improve response capabilities during emergencies. This research has the potential to save lives and reduce long-term health consequences for individuals exposed to radiation. The investment supports innovation in the biotechnology sector, potentially leading to broader applications.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts can incentivize cost overruns if not closely monitored.
The effectiveness of the developed countermeasure is not guaranteed and depends on successful R&D outcomes.
Long-term viability and scalability of the treatment post-development require further assessment.

Positive Signals

Addresses a critical unmet need in medical preparedness.
Awarded through full and open competition, suggesting a robust selection process.
Supports advanced biotechnology research with potential for significant public health impact.

Sector Analysis

The contract falls within the Research and Development in Biotechnology sector, which is characterized by high innovation, long development cycles, and significant investment. Spending benchmarks in this area are highly variable, depending on the specific research and development stage and the novelty of the technology.

Small Business Impact

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

Oversight & Accountability

The National Institutes of Health (NIH) is responsible for overseeing this contract. Standard NIH oversight procedures for R&D contracts, including milestone reviews and financial reporting, should be in place to ensure accountability and effective use of funds.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Cost Plus Fixed Fee contract type.
Uncertainty inherent in R&D projects.
Potential for cost overruns without strict oversight.
Dependence on successful scientific outcomes.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $4.2 million to CERAMEDIX HOLDING, LLC. DEVELOPMENT OF ANTICERAMIDE TREATMENT AS A NOVEL MEDICAL COUNTERMEASURE FOR ACUTE EFFECTS OF RADIATION EXPOSURE

Who is the contractor on this award?

The obligated recipient is CERAMEDIX HOLDING, 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 $4.2 million.

What is the period of performance?

Start: 2023-07-01. End: 2027-06-30.

What is the projected timeline for achieving key development milestones for this anticeramide treatment?

The contract duration is set for 1460 days (4 years), ending June 30, 2027. Key milestones would typically be defined within the contract's statement of work, with periodic reviews by NIH to track progress. Specific milestone details are not provided in this summary but are crucial for assessing R&D effectiveness and value.

What are the primary risks associated with the Cost Plus Fixed Fee contract structure for this R&D project?

The main risk with CPFF is that the contractor may not have a strong incentive to control costs, as the government covers all allowable costs plus a fixed fee. This can lead to budget overruns if not rigorously monitored. For R&D, the inherent uncertainty of achieving desired outcomes also adds risk, potentially requiring contract modifications or additional funding.

How will the effectiveness of the anticeramide treatment be validated and measured by the NIH?

Effectiveness validation will likely involve a series of preclinical and potentially clinical trials, depending on the contract's scope. The NIH will monitor adherence to the research plan, review data for efficacy and safety, and assess whether the treatment meets the defined performance criteria for mitigating acute radiation effects. Success metrics should be clearly outlined in the contract.

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: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 75N93021R00019

Offers Received: 16

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 555 MADISON AVE STE 1201, NEW YORK, NY, 10022

Business Categories: Category Business, Limited Liability Corporation, Not Designated a Small Business, Partnership or Limited Liability Partnership, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $4,223,612

Exercised Options: $4,223,612

Current Obligation: $4,223,612

Actual Outlays: $2,872,773

Subaward Activity

Number of Subawards: 5

Total Subaward Amount: $1,344,459

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline