H_Redacted_-_Brand_Name_JOFOC.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Brand Name Project Title: U-PLEX and PathSeq Analysis of Plasma Samples from the CHRONOS Study

I. Identification of the agency and contracting activity

Requestors phone number:

Requestors email address:

Address of the requesting lab/office:

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

· Name of the previous contractor(s): _Meso Scale_______________________________

· Sequence number(s), if available: __HHSN272201800550P__________________________________

· Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: __________________ C. Total estimated dollar value of the requirement (including options, if applicable): $ D. Period of performance, inclusive of options: One year E. Project Background The vaccine Research Center (VRC) Develops a vaccine against human immunodeficiency virus (HIV); stimulates multi- disciplinary research from basic and clinical immunology and virology through vaccine design and production; integrates modern immunological science with a detailed understanding of the pathogenesis of HIV infection; develops immunogens and vectors and new approaches to vaccination; conducts research directed towards developing candidate HIV vaccines suitable for evaluation in large field trials for efficacy in blocking HIV including both laboratory and clinical research projects focused on developing vaccines to prevent HIV.

Paired plasma samples from the CHRONOS study will be analyzed to determine the circulating microbiome and the associated cytokine profile. To determine the circulating microbiome, RNA and DNA will be extracted, sequenced, and analyzed using the PathSeq pipeline. To determine the levels of 43 different plasma cytokines, U-PLEX analysis will be performed, and the U-PLEX Biomarker Assay Kit is essential for this. No other product currently exists that allows for the measurement of these 43 cytokines together in one assay and thus the U-PLEX Biomarker Assay Kit is essential for this project.

F. Description of the supplies or services to be purchased

To analyze 90 plasma samples, 3 sets of 5 U-PLEX plates will be required. Each U-PLEX plate is an ELISA-like assay that is able to measure 10 analytes at once in a sample. This biomarker contains 74 cyokines and chemokines, the LLODs range form 0.08 pg.mL to 278 pg/mL and allows for the measurement of these 43 cytokines together in one assay

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 1901(e)(2) and FAR Part 6.302-1: Brand Name

☐ 41 USC 501 and FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition

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

A. Describe why only the requested supply/service will meet the government’s needs

These custom U-PLEX kits from Meso Scale Diagnostics are the only product of its kind. To measure our desired 43 analytes in a 1mL plasma sample this kit is required. These kits have been used in the past for similar projects and changing reagents mid-experiment would introduce error.

B. Describe why only the proposed contractor is capable of providing the requested supply/service

No other company or vendor provides a comparable kit that allows for the measurement of these 43 cytokines together in one assay.

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

The price is determined to be fair and reasonable based on (provide a narrative describing how the determination was made and the rational for the determination):

VI. 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.

Requestor Certification

Contracting Officer Approval