Justification.pdf

Justification and Approval – Simplified Acquisition under $250,000

FACTS SUPPORTING A REQUEST TO ENTER INTO AN ACQUISITION USING OTHER THAN FULL

AND OPEN COMPETITION – SIMPLIFIED ACQUISITION (UNDER $250,000)

REQ no. 5460055 Requestor Cathy Geer Office Code Phone no. 301-503-1305

Introduction: Pursuant to Federal Acquisition Regulation 13.106-3(b)(3)(i), the following data is furnished to the Contracting Officer to support the requisitioning office’s request that the items/services identified on the above-mentioned Requisition be obtained using other than full and open competition. The requisitioning office understands that a contract may not be awarded on a sole source/brand name only basis unless the Contracting Officer approves Other than Full and Open Competition.

1. Identification of the Agency: HHS/NIH/NEI

2. Nature and or/Description of Action Being Approved. – Sole Source

3. Description of the supplies and services required to meet the Agency’s needs. Program area is requesting the purchase of Illumina NextSeq 550 and consumables in order to provide the laboratory with enhanced capabilities of next-generation sequencing, including panel-based DNA testing, whole exome sequencing, RNAseq, and other sequencing modalities. Proposed Contractor’s unique qualifications.

a. Proprietary data: When considering the various Next Generation Sequencing

(NGS) technologies, we considered DNA sample preparation time and cost, turn-around-time, sequence read-length, throughput, sequencing error rates, and the need to the OGL. After extensive literature and market research, we were not able to identify a meaningful DNA sequencing alternative to Illumina in terms of quality and costs. Illumina manufactures a range of sequencing instruments with different sequencing outputs. The NextSeq 550 instrument we are planning to acquire appears to offer the laboratory with the ideal throughput and still be cost-effective.

b. Brand Name: The Illumina NextSeq 550 sequencer produces short sequencing reads. The analysis of these short sequencing reads is supported widely by the scientific community with abundant open-source softwares. Most of the analysis software tools are available in BioWulf, the high performance computing at NIH.

Thus, obtaining the Illumina NextSeq sequencer will ensure us to obtain the highest scientific values.

4. Additional Supporting Facts.

• The Illumina Inc. is the sole manufacturer and retailer of the NextSeq sequencer.

• We researched other NGS sequencing technologies, including PacBio and Oxford

Nanopore sequencing technologies. PacBio or Nanopore's sequencers cannot provide the sequence needs of high sequencing accuracy at the cost level provided by the Illumina's NextSeq 550.

• NIH already has an IDIQ with Illumina. Beside the equipment, NEI will be heavily purchasing reagents from Illumina that is only compatible with this unit.

I hereby certify that the supporting data above forms the basis for this justification, is complete and accurate to the best of my knowledge and belief.

Certification by Requirements\Technical Personnel:

Elaine Estrella

I concur and approve this justification for other than full and open competition.

Contracting Officer Date