Notice of Intent to Use Other than Full and Open Competition

The Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Division of Contract Management & Acquisition (DCMA), and Office of the Biomedical Advanced Research and Development Authority (BARDA), has an immediate need to revise the requirements for the ongoing Phase 2b clinical studies due to FDA changes regarding the updated COVID-19 vaccine formula to be used, to include a safety lead-in cohort to the study, for the ongoing Phase IIb clinical trials in support of the development of second generation 2019 Novel Coronavirus (COVID-19) countermeasures.

To support this requirement, the Government intends to award bilateral modifications on a sole source basis to increase the maximum ordering amounts for the following Clinical Trial Execution & Planning (CTPE) contracts: --Contract 75A50120D00016 with Allucent Government Services (formerly known as Pharm-Olam LLC) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M. --Contract 75A50120D00017 with ICON Government and Public Health Solutions, Inc. (ICON) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M.

This sole source is based under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1, Only One Responsible Source and No Other Supplies or Services will satisfy Agency Requirements. This notice of intent to award a sole source contract will be posted for fifteen (15) calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements.

This fifteen (15) calendar day notice shall expire on September 10, 2024, 4:00 PM Eastern Standard Time.

If no credible responses to the intent to sole source are received by the Government, bilateral modifications will be awarded to increase the maximum ordering amounts for the following CTPE contracts: --Contract 75A50120D00016 with Allucent Government Services (formerly known as Pharm-Olam LLC) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M. --Contract 75A50120D00017 with ICON Government and Public Health Solutions, Inc. (ICON) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M.

In accordance with FAR Part 6.305, 14 days after the award of these bilateral contract modifications, the Government will amend the intent to sole source by posting the redacted Justification and Approval (J&A) for 30 days. This notice of intent is not a request for competitive proposals.

Interested individuals may identify their interest and capability to respond to the requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified efforts above. Responses shall be limited to ten (10) pages or less, including all attachments.

Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and that they can meet the revised requirements due to FDA changes regarding the updated COVID-19 vaccine formula to be used, to include a safety lead-in cohort to the study for the ongoing Phase IIb clinical trials in support of the development of second generation 2019 Novel Coronavirus (COVID-19) countermeasures.

All capability statements, proposals, or quotes received prior to September 09, 2024, 4:00 PM Eastern Standard Time will be considered by the Government. The Government will not be responsible for any costs incurred by responding to this notice. The Government will notify parties of the outcome of any capability statements. A determination by the Government not to compete the proposed contract modifications based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Anticipated Award Date and Period of Performance: The two CTPE Indefinite Delivery Indefinite Quantity (IDIQ) contracts include a two-year base period and 3 one-year option periods. If all options are exercised, the contract period performance will end on 9/27/2025.

Performance Schedule: The two CTPE IDIQ contracts include a two-year base period and 3 one-year option periods. If all options are exercised, the contract period performance will end on 9/27/2025. Contract type: The two CTPE contracts are Indefinite Delivery Indefinite Quantity (IDIQ) type contracts.

Estimated award amount: --Contract 75A50120D00016 with Allucent (formerly known as Pharm-Olam LLC) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M. --Contract 75A50120D00017 with ICON Government and Public Health Solutions, Inc. (ICON) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $400M to $550M.

Background: The Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Division of Contract Management & Acquisition (DCMA), and Office of the Biomedical Advanced Research and Development Authority (BARDA), has an immediate need to revise the requirements for the ongoing Phase 2b studies due to FDA changes regarding the updated COVID-19 vaccine formula to be used, to include a safety lead-in cohort to the study, for ongoing Phase IIb clinical trials in support of the development of second generation 2019 Novel Coronavirus (COVID-19) countermeasures.

Contracting Office Address: Office of the Secretary, Administration for Strategic Preparedness and Response (ASPR), Division of Contracts Management and Acquisition (DCMA) on behalf of the Office of Biomedical Advanced Research and Development Authority (BARDA) 400 7th Street, SW, Washington, District of Columbia 20024 United States.

Place of Performance: Allucent Government Services (US) LLC 1570631 2000 Centre Green Way, Suite 300 Cary, NC 27513-5756 ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC 731 Arbor Way, Suite 100 Blue Bell, PA 19422-1987