The Centers for Disease Control and Prevention intends to award a sole source cost reimbursable modification to Vitalant Research Institute (6210 E Oak St, Scottsdale, AZ 85257). Vitalant was awarded (12 May 2020) a contract (75D30120C08170; “COVID Seroincidence Study in Blood Donors”) to estimate the proportion of people that have been infected or vaccinated with SARS-CoV-2 during the ongoing epidimic over time by geographic locations and demographic subcategories. This 24 month study has three (3) primary tasks: (1) Identify the ideal antibody screening and confirmation tests for study; (2) Conduct blood donor seroprevelence testing and administration of surveys among repeat donors; and (3) Conduct longitudinal study to characterize the antibody responses. The period of performance of this contract is from 12 May 2020 through 11 May 2022. CDC requires a new modification to expand the number of longitudinal participants to approximately 130,000 donors and conduct these tasks over an addition 12 months (through 11 May 2023) to provide highly important data on the stability of potentially protective antibody responses and therefore the risk of reinfection in future outbreaks, as well as critical data to refine the analysis of the serosurvey results to account for waning seroreactivity based on the study testing algorithm. This does not modify the overall amount of monthly blood donations, rather this effort will track the same 130,000 blood donors who will be tested on average 3 to 5 times a year. Vitalant Research Institute (VRI) is one of the largest national blood collection organizations and serves as the central laboratory of an ongoing NIH-funded blood safety study (REDS-IV-P). VRI has already been awarded and has been executing a contract with CDC since May 2020 to track the prevalence of SARS-CoV-2 antibodies in blood donor populations and perform analyses to extrapolate prevalence estimates to the general population in these areas. Given the current contracts and expertise of VRI, this vendor is the only vendor capable to perform the longitudinal expansion of the blood donor serosurvey and increase the number of months of collection. VRI has the technical capacity to collect and conduct testing of the samples, has access to high-quality screening assays though existing agreements with manufactures, and has ongoing collaborations with other major blood collection organizations and their respective testing laboratories. In addition, VRI has an existing subcontract in place with a highly experienced vendor for data management and analysis. Based on previous experience working with blood collection organizations and other federal agencies, CDC is aware that there is no other vendor with an existing collaboration of blood collection organizations, laboratories, and research partners in place that would encompass a nationally-representative geographic sampling, nor could be stood up immediately to meet the urgent needs of the COVID-19 emergency response. Given the work has progressed 18 months from Contract start by VRI and its network of partners, it would not be possible for another vendor to enter the project at this time and establish an entire network of nationally representative sites. The ability to work within existing, ongoing contracts and agreements that VRI has in place makes this vendor uniquely able to provide this service. This contract action (modification) is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 and 41 U.S.C. 3304(a)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the Government. A determination by the Government to compete this proposed contract action (modification) based upon the responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to Mark Draluck at
[email protected] by 9:00 A.M. EST., 3 January 2022.