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PRE-SOLICITATION NOTICE **NOTICE OF INTENT

NOI-NIAID-2176712

NAICS – 541380

This is a Notice of Intent, not a request for proposal. The Laboratory of Immunoregulation (LIR) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with University of Louisville Sequencing Technology Center, to procure COVID-19 SARS-CoV-2 sequencing services.

This requirement is for COVID-19 SARS-CoV-2 sequencing services. COVID-19 is caused by the novel SARS-CoV-2 and is associated with a hyper-inflammatory immune response which leads to severe and potentially life-threatening symptoms. Little is known about how and the extent to which COVID-19 presents in people with immunodeficiencies, but because of the known severity of the illness in the general population, vaccination against SARS-CoV-2 is critical. Understanding whether immunodeficient individuals produce an adequate immune response to the COVID-19 vaccine is necessary.

The goal of this is study is to research the crucial role of T and B cells in the induction of effector and memory responses to viral infections. Limited information is available on T and B cell-mediated responses to SARS-CoV-2 in immunocompetent and immunocompromised individuals. Studies have shown that an impaired adaptive immune response may contribute to worse clinical outcomes in individuals with immune disorders, and an impaired B cell response could result in a blunted antibody response post infection and vaccination. While multiple SARS-CoV-2 vaccines have become widely available in the US, there is still limited information available on T and B cell-mediated responses to post SARS-CoV-2 vaccination status in immunocompetent and immunocompromised individuals.

The NIAID aim is to evaluate this by studying the SARS-CoV-2 specific TCR repertoire along with TRBV and TRBJ gene usage. It is also critical to evaluate the B cell repertoire in these individuals, given that heavy (IgH) and light chain immunoglobulin rearrangements during B cell maturation and post-vaccination somatic hypermutation are responsible for fine-tuning the SARS-CoV-2-specific immune response. By conducting this sequencing through the University of Louisville Sequencing Technology Center, NIAID will be able to fulfill this mission using advanced and novel techniques to characterize IGHV, IGHD, IGHJ, and IGHC gene diversity for the most comprehensive view of bulk-expressed antibody repertoires to date.

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement by email (subject line to reference NOI-NIAID-2176712 to Dana Monroe at dana.monroe@nih.gov, by 12:00pm EDST Tuesday, May 30, 2023. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.