Notice of Intent to Sole Source - Stability program for KLH used in clinical trials.

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch (VB) plans to procure, on a sole source basis, KLH injectable stability testing services from: Argonaut Manufacturing Services Inc. 2841 Loker Ave East Carlsbad CA 92010 The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is (Testing Laboratories and Services). The KLH injectables used by the Vaccine Branch (VB) were manufactured by Stellar Biotechnologies (Stellar) in 2019. These KLH injectables have been utilized in clinical trials by the VB, and as such are required to have ongoing stability testing to ensure injectables meet Federal Drug Administration (FDA) guidelines. Until 2022, stability testing was provided by Stellar; however, Stellar has ceased providing KLH manufacturing and is unable to extend testing services. Argonaut Manufacturing Services worked with Stellar as a subcontractor for KLH testing and has been identified by Stellar as possessing validated method by successful method transfer, original Stellar bulk material for reference standard, and quality control methodologies required for stability testing VB's KLH injectables. As such, to NCI's knowledge Argonaut Manufacturing Service is the only vendor that is currently capable of providing the required services without the need for substantial start-up cost to establish adequate methodologies which would lead to unacceptable cost and delays to the Government. This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government's needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI to determine if the party can perform the requirement. Responses to this notice shall be submitted via email to Contracting Officer, John Russell, at contact@example.gov no later than 10:00 A.M. EST on Wednesday, March 29, 2023 (03/21/23). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response Information received will be considered for the purpose of determining whether to conduct a competitive procurement. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number 75N91023Q00057 on all correspondence. ***Please reference attached Statement of Work for more details pertaining to the nature of the work to be performed. ***