1_Brand_Name_JOFOC_1764165.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold Project Title: Acquisition of BigDye® Terminator v1.1 Cycle Sequencing Kit, 5000 reactions

I. Identification of the agency and contracting activity DHHS, NIH, NIAID, LID, RNA Virus Section Address of the requesting lab/office: 50 South Drive, Bldg 50 Room 6511, Bethesda, MD 20892

A. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) Type of action: (check the appropriate box) ☐ New requirement ☒ Follow-on

· Name of the previous contractor(s): Life Technologies

· Sequence number, if available: 1751050

· Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: 1764165 C. Total estimated dollar value of the requirement (including options, if applicable): $30,065.25 D. Period of performance, inclusive of options: from ___________ to ________________

E. Project Background: The Laboratory of Infectious Diseases (LID), RNA Virus Sections, has a long history of influenza vaccine development and identification of new agents of viral diseases. LID is noted for undertaking high-risk, high-reward programs that require extraordinary time and resource commitments, such as programs to develop vaccines for viral hepatitis, severe childhood respiratory diseases, and viral gastroenteritis. Clinical studies complement LID’s major areas of research, including testing candidate vaccines in clinical trials, a human challenge study with influenza to study pathogenesis and immune correlates for protection against the virus, and studies of severe virus infections in persons without known immune deficiency.

F. Project Description: The Laboratory of Infectious Disease (LID), RNA Virus Section focuses their research on developing vaccines for, respiratory viruses, hepatitis and flaviviruses. This order is to support the clinical trials for the new vaccines that are being developed. LID is requesting comprehensive sequence analysis of the complete transcriptome (RNA-Seq) of different bacterial strains. This is a multi-step process with distinct technical steps and bioinformatics analysis. The successful outcome of this RNA-Seq analysis will require critical ongoing communication with the service provider due to the customized nature of the procedure for different samples and individual research requirements.

G. Description of the supplies/services to be purchased BigDye® Terminator v1.1 Cycle Sequencing Kit, 5000 reactions CAT# 4337452

· This BigDye® Terminator v1.1 Cycle Sequencing Kit is designed for specialty applications that require optimal basecalling adjacent to the primer and for sequencing short PCR product templates with rapid electrophoresis run modules.

II. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source/Brand Name

☐ FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition/Brand Name Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) and FAR Part 6.302-2: Authorized or required by statute/Brand Name

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) Life Technologies, 5791 Van Allen Way, Carlsbad, CA 92008 Fisher Scientific, 300 Industry Drive, Pittsburgh, PA 15275

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs Our genetic analyzer is only compatible with BigDye® Terminator v1.1. The primary purpose of the LID is the development and characterization novel Paramyxovirus vaccine candidates. The Big Dye Terminator reagent will allows us to perform genome sequencing of established and newly developed virus vaccines candidates. The sequencing step is crucial for the identification of genomic mutations that can influence, positive or negatively, the efficacy of these vaccine candidates in vitro and in vivo platforms. It is critical that we use this specific sequencing kit, not only because it is the only one that is compatable with our genetic analyzer, but because it is critical to maintain continuity for the success of our research.

IV. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file. See Award Determination tab.

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.