JOFOC__for_NOI_1746086_Sole_Source.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Project Title: Octect RED 96 System

I. 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

· Name of the previous contractor(s): ________________________________

· Sequence number(s), if available: ____________________________________

· Was the initial and any subsequent awards competed? ☐ Yes ☐ No B. AMBIS Sequence number for this requirement: 1746086 C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: from ___________ to ________________ E. Project Background The National Institute of Allergy and Infectious Diseases' (NIAID) Laboratory of Infectious Disease (LID), the Structural Informatics Unit (SIU) seeks to elucidate the molecular architecture of viral proteins and the roles that factors, such as pH environment and protein modification and variation, play in modulating structure-function, epitope display, and viral pathogenesis. The research program exploits 3D electron microscopy of viruses and protein complexes with antibodies to obtain structural information. Structural analyses are supported by other structural, biochemical, and immunological analyses in order to understand antigen-antibody interactions and aid in structure-assisted immunogenic design for infectious diseases. Our research program integrates structural and biochemical studies with bioinformatics to facilitate a collaborative synergy between these disciplines in the context of the focus of structure-function studies of viruses and viral proteins. A major focus is on the antigenicity, structure, and function of respiratory viruses, such as influenza.

F. Project Description The laboratory of Infectious Disease (LID, Structural Informatics Unit studies the structure of influenza viruses complexed with antibodies by electron microscopy. As such the characterization of the interactions of the antibodies with viruses and viral proteins with antibodies is a critical part of LID’s research and provides critical information to help understand how influenza vaccines work on influenza viruses and helps better understand the viruses and helps us produce better vaccines in our research. The Octect RED96 instrument will help conduct this research because it allows the characterization of the interactions between the antibodies with the viruses, viral proteins and vaccines. This equipment will aid the goal of developing better more effective vaccines and drugs to highly pathogenis influenza viruses. We require this brand because it is what we currently use and it is critical to maintain continuity. Changing brands at this point in our research could cause devastating delays and interfere with the success of our research. The Octect RED96 will satisfy the requirement to have a high through put instrument to measure antibody interactions with viruses and viral proteins. In order to carry out the requirements of high level structural studies there is a requirement for semi-automated high through put measurements of affinity, kinetics, and active protein concentration in a 93-well microplate format which is provided by the technology of the Octect RED96 instrument. This technology is required and is critical for maintaining continuity of our research. This acquisition is to replace our current out dated Octect instrument.

II. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

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) Fortei Bio Menlo Science & Technology Park 1360 Willow Road Menlo Park, CA 94025 B. Describe why only the requested supply/service will meet the government’s needs The Octet RED 96 instrument is a benchtop protein interaction system that is fluidics-free and based on the interferometry technology, which has the capability of analyzing 8 samples in parallel for affinity, kinetics or active protein concentration determination from samples in a 96-well microplate. This platform allows the measurement of the interaction between the viral proteins and antibodies and aid in identifying antigens for viral vaccines C. Describe why only the proposed contractor is capable of providing the requested supply/service Fortei Bio is the manufacturer of the required equipment and they are the only open market distributor for their products. They have one GSA authorized dealer, but their prices have been determined to be unreasonable and they are not authorized to quote on a trade-in order.

IV. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Price reasonableness will be determined through market research that will be documented to the file.

V. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.