SPECIAL NOTICE
A -- REDACTED CLASS J&A Notice of Intent to Use Other than Full and Open Competition
- Notice Date
- 8/8/2023 8:33:53 AM
- Notice Type
- Special Notice
- Contracting Office
- HEALTH AND HUMAN SERVICES, DEPARTMENT OF Washington DC 20201 US
- ZIP Code
- 20201
- Response Due
- 7/26/2023 1:00:00 PM
- Archive Date
- 09/08/2023
- Point of Contact
- Ethan Mueller, Phone: 2028160732
- E-Mail Address
-
Ethan.Mueller@HHS.Gov
(Ethan.Mueller@HHS.Gov)
- Description
- The purpose of this AMENDMENT/REVISION is to in accordance with FAR Part 6.305 post a redacted Class Justification and Approval for 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 requirement to conduct and facilitate 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 Pharm-OLAM LLC (Pharm-Olam) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. --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 $250M to $400M. --Contract 75A50120D00018 with Technical Resources, Inc. (TRI) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. The 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 26 July 2023, 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 Pharm-OLAM LLC (Pharm-Olam) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. --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 $250M to $400M. --Contract 75A50120D00018 with Technical Resources, Inc. (TRI) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. 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 requirement for the immediate requirement to conduct and facilitate 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 26 July 2023, 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 three 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 three 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 three CTPE contracts are Indefinite Delivery Indefinite Quantity (IDIQ) type contracts. Estimated award amount: � --Contract 75A50120D00016 with Pharm-OLAM LLC (Pharm-Olam) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. --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 $250M to $400M. --Contract 75A50120D00018 with Technical Resources, Inc. (TRI) for Clinical Trial Planning and Execution will be modified to increase the maximum ordering amount by $150M from $250M to $400M. 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 requirement to conduct and facilitate 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: PHARM-OLAM LLC 1570631 450 N SAM HOUSTON PKWY E STE 250 HOUSTON TX 770603556 ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS. INC S 1265 RIDGE RD STE A HINCKLEY OH 442339801 TECHNICAL RESOURCES INTL, INC. 348169 6500 ROCK SPRING DR STE 650 BETHESDA MD 208171197
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/10a699608e12472ebb7339a5080ec474/view)
- Record
- SN06780523-F 20230810/230808230055 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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