brand name justification.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Reagents for Covid 19 Research

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

☒ New requirement ☐ Follow-on

B. Project Background

Ultimately, the results of these studies support the specific mission of the National Institute of Allergy and Infectious Disease to understand the pathology, progression, and disease mechanisms of COVID-19 by better understanding the underlying immunologic response with the hope of justifying the use of specific vaccines and vaccine dosing regiments. With additional variants of concern emerging (omicron), these studies allow policy decisions to be made about future directions of research regarding changing vaccine formulation and boosting frequency.

C. Project Description These reagents are used to examine blood and tissue derived immune cell subtypes and the cytokines they produce in animal studies where specimens have been exposed COVID-19. The samples acquired from these studies will be analyzed both pre- and post-vaccination as well as pre- and post-infection.

III. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s) BD Biosciences DBA BD Biosciences One Becton Drive Franklin Lakes, NJ 07417 Tel: 877.232.8995 Fax: 408.954.6306

These reagents have been selected based on their continued use in a qualified assay that relies on stringent reproducibility across experiments and users. The reagents have been titrated to ensure correct amount per assay, as well as the specific clone or isotype that yields the most consistent results. Deviation from these qualified reagents will require substantial person-hours to recertify new reagents and will also forfeit consistency with previous studies related to the ongoing research. Deviation from these qualified reagents will require substantial person-hours to recertify new reagents and will also forfeit consistency with previous studies related to the ongoing research. Development of panels for immunophenotyping by high-dimensional flow cytometry requires extensive and sophisticated testing of reagents. We tested several of these reagents from different companies and selected the best performing reagents. Often, the selection of reagents differs among vendors and many fluorochromes and reagents are only available from BD Biosciences. Based on these facts we decided to obtain reagents from BD Bioscience.