HHS Awards $32M Other Transaction for Biologic Production Under BioMAP Consortium

Contract Overview

Contract Amount: $32,000,000 ($32.0M)

Contractor: Advanced Technology International

Awarding Agency: Department of Health and Human Services

Start Date: 2023-12-12

End Date: 2027-12-31

Contract Duration: 1,480 days

Daily Burn Rate: $21.6K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: Healthcare

Official Description: OTHER TRANSACTION: PRODUCTION OF THREE (3) BIOLOGICALLY DERIVED SMALL MOLECULE REGULATORY STARTING MATERIALS AND/OR ACTIVE PHARMACEUTICAL INGREDIENTS AT COMMERCIAL SCALE UNDER THE BIOMAP-CONSORTIUM

Place of Performance

Location: SUMMERVILLE, BERKELEY County, SOUTH CAROLINA, 29486

State: South Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $32.0 million to ADVANCED TECHNOLOGY INTERNATIONAL for work described as: OTHER TRANSACTION: PRODUCTION OF THREE (3) BIOLOGICALLY DERIVED SMALL MOLECULE REGULATORY STARTING MATERIALS AND/OR ACTIVE PHARMACEUTICAL INGREDIENTS AT COMMERCIAL SCALE UNDER THE BIOMAP-CONSORTIUM Key points: 1. Contract awarded to Advanced Technology International for commercial-scale production of regulatory starting materials. 2. The award utilizes an Other Transaction (OT) authority, often used for rapid prototyping and novel technologies. 3. Full and open competition was cited, suggesting a broad search for qualified vendors. 4. The contract spans nearly four years, indicating a long-term production need.

Value Assessment

Rating: good

The contract type is Cost Plus Fixed Fee, which can lead to higher costs if not managed carefully. Benchmarking against similar OT agreements for biologic production is difficult due to the unique nature of OT authorities and specific project requirements.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, which generally promotes competitive pricing. The use of an Other Transaction authority, however, may bypass some standard procurement regulations, potentially impacting price discovery compared to traditional FAR-based contracts.

Taxpayer Impact: Taxpayer funds are being used for the development and production of critical pharmaceutical ingredients, supporting public health preparedness goals.

Public Impact

Ensures domestic production capacity for essential biologically derived materials. Supports the BioMAP Consortium's mission to advance biopharmaceutical manufacturing. Contributes to national biodefense and pandemic preparedness efforts. Potential for follow-on contracts or expanded production based on initial success.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contract type can incentivize cost overruns.
Other Transaction agreements can have less transparent oversight than traditional contracts.
Reliance on a consortium model may introduce coordination complexities.

Positive Signals

Addresses a critical need for domestic biopharmaceutical production.
Utilizes a competitive process to select the vendor.
Supports a strategic national initiative (BioMAP).

Sector Analysis

This contract falls within the broader healthcare and pharmaceutical manufacturing sector. Spending in this area is often driven by national security, public health initiatives, and the need for advanced medical countermeasures. Benchmarks are difficult due to the specialized nature of OT agreements.

Small Business Impact

The awardee, Advanced Technology International, is a non-profit organization that manages consortia. While the contract itself doesn't explicitly mention small business participation, the nature of consortium management often involves subcontracting opportunities for smaller firms within the biotech and manufacturing space.

Oversight & Accountability

Oversight will be crucial given the Cost Plus Fixed Fee structure and the use of Other Transaction authority. The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response, is responsible for ensuring the contractor meets production milestones and manages costs effectively.

Related Government Programs

Biological Product (except Diagnostic) Manufacturing
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Potential for cost overruns due to Cost Plus Fixed Fee structure.
Limited transparency often associated with Other Transaction agreements.
Complexity in managing consortium-based production.
Dependence on a single awardee for critical materials.
Potential for schedule delays in complex biologic manufacturing.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $32.0 million to ADVANCED TECHNOLOGY INTERNATIONAL. OTHER TRANSACTION: PRODUCTION OF THREE (3) BIOLOGICALLY DERIVED SMALL MOLECULE REGULATORY STARTING MATERIALS AND/OR ACTIVE PHARMACEUTICAL INGREDIENTS AT COMMERCIAL SCALE UNDER THE BIOMAP-CONSORTIUM

Who is the contractor on this award?

The obligated recipient is ADVANCED TECHNOLOGY INTERNATIONAL.

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 $32.0 million.

What is the period of performance?

Start: 2023-12-12. End: 2027-12-31.

What is the specific breakdown of the $32 million cost, and how does it align with projected production expenses?

The provided data does not detail the cost breakdown. A Cost Plus Fixed Fee contract requires the government to reimburse allowable costs plus a predetermined fixed fee. Understanding the projected expenses for raw materials, labor, overhead, and the fixed fee is essential for assessing value. Without this detail, it's difficult to ascertain if the $32 million is efficiently allocated.

How will the government ensure cost control and prevent potential overruns under this Cost Plus Fixed Fee agreement, especially given the use of an Other Transaction authority?

Effective oversight is paramount. The government should implement rigorous monitoring of incurred costs, regular performance reviews against milestones, and clear communication channels with the contractor. Establishing detailed reporting requirements and potentially independent cost audits can help mitigate risks associated with cost-plus contracts and the less standardized nature of OT agreements.

What are the key performance indicators (KPIs) for this contract, and how will the success of the biologic production be measured?

Key performance indicators would likely include timely delivery of the specified regulatory starting materials and/or APIs, meeting quality and purity standards, and achieving commercial-scale production targets. Success measurement will involve rigorous testing, validation of production processes, and confirmation that the materials are suitable for their intended downstream use within the BioMAP Consortium's objectives.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 315 SIGMA DR, SUMMERVILLE, SC, 29486

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

Financial Breakdown

Contract Ceiling: $32,000,000

Exercised Options: $32,000,000

Current Obligation: $32,000,000

Actual Outlays: $14,133,487

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50123D00003

IDV Type: IDC

Timeline