Inactive

The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Reg... The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Regents of the University of California, San Francisco, 1855 Folsom St STE 425, San Francisco CA 94143-4249. UCSF was awarded a contract (75D30120C08009) on 6.1.2020 to establish a longitudinal cohort to examine risk factors for household transmission and the natural history of SARS-CoV-2 infection, including: duration of viral shedding and potential infectiousness; viral sequencing; long term (12 month) immune responses and clinical outcomes, including post-COVID conditions; epidemiologic and clinical risk factors for infection, viral shedding, clinical severity, and outcomes. Enrollment in the study involves serial specimen collection for virologic and immunologic testing, and repeat epidemiologic and clinical surveys. UCSF has finalized the protocol and procedures, obtained Institutional Review Board approvals and is in the process of establishing a cohort of up to 80 index (infected) cases and 210 household members. Enrollment in this cohort is due to stop at the end of 2021. However, the rapidly evolving SARS-CoV-2 landscape, including emerging SARS-CoV-2 variants, vaccinations, and breakthrough infections make it imperative to be able to continue to collect and analyze data on new infections, virus transmission, outcomes, and the dynamics of virus shedding and immunity. The current study infrastructure is now well-established and provides an excellent platform to answer key questions about emerging variants in a timely way, and to allow for robust comparisons of key features to that of prior variants. CDC plans to approximately double the enrollment in this study, adding an additional 60-80 index cases and 150-210 family members, whilst continuing enrollment through the end of 2022, to capture vaccinated or unvaccinated participants experiencing infection or reinfection with new SARS-CoV-2 variants. The project includes on-going follow-up of this study population. UCSF is uniquely qualified to perform the needed expansion of an existing longitudinal cohort to examine household transmission and the natural history of SARS-CoV-2 infection including: duration of viral shedding and potential infectiousness; viral sequencing; long term (12 month) immune responses and clinical outcomes, including post-COVID conditions; epidemiologic and clinical risk factors for infection, viral shedding, clinical severity, and outcomes. The established cohort with extensive data collection (epidemiologic, clinical, and biological) will ensure the success of the project through continued follow-up of study participants and ensuring consistent protocol and methods of data collection for the expanded cohort. UCSF has infrastructure for continued data collection and has virologic and immunologic testing capacity (which has included extensive assay development and validation). Furthermore, because of the extensive databank UCSF has already accumulated (multiple types of data collected over multiple time points within a 12 month period per participant), UCSF is the only contractor that can effectively and efficiently compare and contrast data findings among the various waves of SARS-CoV-2 circulation and different variants of interest or concern (wild-type virus, Alpha, Delta and newly emerging variants). This is a modification to contract 75D301-20-C-08009. Given the work that has already been started through UCSF and its network of partners, it would not be possible for another vendor to enter the project at this time. The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as cited in FAR 6.302-1, " Only one responsible source and no other supplies or services will satisfy agency requirements." Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement which shall be considered by the agency. Please forward the capability statement to Maria Shamburger, MShamburger@cdc.gov, Contracting Officer, Reference 2022-032922, Centers for Disease Control, Office of Acquisition Services, District at Chamblee, Building #2900, 2900 Woodcock Blvd, MS TCU-4, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. The Government will review any/all capabilities statements information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, negotiations will be conducted with UCSF as the only source and a modification will be issued without any additional notices being posted.