PR_24730_-Agilent_Technologies_signed_SSJ_for_FBO.pdf

Rev. 1/6/14

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $150,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Chronic Viral Diseases Branch (CVDB) Division of High Consequence Pathogens and Pathology (DHCPP) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Centers for Disease Control and Prevention Atlanta, GA 30329-4018

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch II Atlanta, Ga 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Human Papillomavirus (HPV) genome target enrichment assays using Agilent SureSelect Technology; includes custom design and production of RNA library baits representing all known HPV genomes, and hybridization reagents .

b. Procurement Request (PR) Number (if available): Click here to enter text.

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Agilent Technologies 2850 Centerville Road Wilmington, DE 19808 Ph # 1-800-227-9770; Fax 302-633-8953

Contact: Lynne Crowley (Ph # 919-215-3195);

lynne.crowley@agilent.com

b. Estimated Procurement Amount: $89,678.47 kpy3 Typewritten Text

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3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is:

These reagents and consumables are required for HPV whole genome sequencing using a highly multiplexed HPV target enrichment assay with Agilent Technologies bioinformatics support and SureSelect technology. The enriched/captured HPV genomic sequences are compatible with Illumina platform for subsequent deep sequencing and genotype calling. As part of this project, CDC will provide genomic sequences of all known HPV types and selected human genomic sequence areas to Agilent for the custom design and construction of RNA baits. Agilent will supply the custom RNA baits and other accompanying reagents for indexing of samples, hybridization and capture of enriched library pools. CDC will use the custom RNA baits and library preparation reagents to generate HPV whole genome and selected human genomic sequence data using a variety of samples collected from epidemiological studies, and to investigate the role of HPV in cervical cancers that are HPV negative by traditional assays targeting only portions of the HPV genome. This project requires Agilent to provide services and reagents spread over a period of one year beginning September 2018. The technology and services for design and construction of RNA baits (overlapping 120 mers) for target enrichment of genomes is only available from Agilent. CDC recommends the following delivery schedule for the custom RNA baits and other reagents from Agilent.

Delivery schedule to be coordinated with CDC prior to shipping:

September 5, 2018 (2 kits - G9621B, 2 kits - 5190-4817, 1 kit – 600679) October 24, 2018 (2 kits - G9621B, 2 kits - 5190-4817, 1 kit – 600679) January 9, 2019 (2 kits - G9621B, 2 kits - 5190-4817, 1 kit – 600679) March 6, 2019 (2 kits - G9621B, 2 kits - 5190-4817, 1 kit – 600679)

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency

Exclusive licensing agreements/Proprietary data

Brand name required

Industrial mobilization

Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency

Only One Source

Logical Follow Up

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

Only Agilent technology provides long (120 bases) RNA baits for genome enrichment. Secondly, only Agilent target enrichment technology provides minimal hybridization times (16 to 24 hours) as opposed to 2-3 days by other sources. Thirdly, only Agilent provides software for both up-front design of the RNA baits and genotype calling after sequencing the enriched targets. These together provide an efficient work-flow for highly multiplexed and specific target enrichment that is required for this project.

b. What other products/services were considered and why did they not meet the need?

No other products were considered since design and production of RNA based baits for custom target enrichment is provided only by Agilent Technology.

3. Program Office efforts to seek potential offerors:

Based on internet research, the program could not identify any vendors except Agilent Technology to offer long RNA based baits for HPV target enrichment for subsequent deep sequencing to determine HPV genotypes.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: COR, Niyai Johnson

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a date.

F. Contracting Office Certification:

Niyailieka

Johnson -S

Digitally signed by Niyailieka

Johnson -S

Date: 2018.05.24 13:21:20 -04'00'

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.

Nathan R.

Amador -S

Digitally signed by

Nathan R. Amador -S

Date: 2018.08.20

08:38:15 -04'00'