H_J&A_open_market_Redacted.doc

Attachment C HHS Template and Instructions for a Justification for Other than Full and Open Competition

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS

b. Sponsoring organization. NIH, NIAID, VRC

c. Project Officer information.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this acquisition will support The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). The Facilities are located on the NIH Main Campus in Bethesda, Maryland. The Zephyr and Sciclone Workstations are needed to process samples for FDA vaccine testing submissions.

b. Project background.

Our mission here at the Vaccine Research Center (VRC) is to determine the immune correlates of protection against emerging infectious diseases. One of the specific aims of the Virus Persistence and Dynamics lab is to understand processes that determine the course of human diseases in which the immune system plays a central role in their pathogenesis and outcome. Our work in HIV infection in part involves analysis of the clonal composition of CD8 T cells that respond to HIV and the interaction with HIV quasispecies. Escape from adaptive T cell immunity through viral epitope mutation is a major obstacle to the development of vaccines that aim to elicit cellular immunity. We are thus investigating the molecular determinants of this phenomenon at the level of the T cell receptor–epitope contact interface, and defining structural motifs that govern the pace and pattern of epitope escape. The practical consequences of our findings suggest that vaccine strategies should elicit responding T cells that are qualitatively superior, in terms of clonotypic composition, to those elicited in natural infection.

This request is for the purchase of a ZEPHYR and Sciclone Workstations. These systems handle high output, multi-platform capabilities that will allow for the purification set up, and enzymatic reactions needed for library generation experiments all in one system. These are the only robotic systems in existence that are designed for labs that perform Next Generation Sequencing. Also, they are the only workstations on the market that meet the governments need at the VRC by separating pre- and post-PCR protocols.

The three needed functions that are specific to these systems are the pre-programing of all of the VRC’s post-PCR library construction steps that are included on the FDA approval paperwork. These steps include: Post PCR SPRI Purification, qPCR Setup (96 or 384 Well), LabChip GX Plate Transfer, Volume and/or Concentration Normalization (based on qPCR or LabChip GX Results) and Indexed Library Pooling. Second, these workstations can be used for our high-throughput processing of anywhere from 8-96 samples, through the steps (again listed in the FDA paperwork) required for Next Generation Sequencing Library Construction that include Enzyme Mastermix Additions, Isothermal Enzymatic Incubation and Bead Based (SPRI) Purification. The third function, is that these workstations come pre-configured with these specifications: 1-200ul 96 Channel High Volume Head (HVH), 12 Position Deck, Left Handed Offset Gripper for Plates and Lids, integrated 4-110° Thermal Locator, Integrated 4-70° Thermal Shaker and Maestro Control Software. These functions and preprogrammed calibrations are needed to ensure that new variables are not introduced that would cause variables. These variable would cause the VRC the loss of the vaccine FDA approval for human use.

The VRC currently is using the ZEPHYR and Sciclone systems on a daily basis. Equipment used by our core must stay the same to ensure that experimental results are not influenced by new variables. Any new variable would cause our entire core to shut down because each and every protocol that we run must be recalibrated to meet the specifications of the FDA testing result submissions. Using an instrument other than the ZEPHYR and Sciclone workstations would compromise experiments and prevent the interpretation of results. Continuing to use the ZEPHYR and Sciclone workstations will avoid introducing outside variables which would result in the corruption of our data results and circumvent a great financial loss to the federal government.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Purchase of a new ZEPHYR Robotic Sequencing System

b. Project description. Reference in the attached Bill of Materials (BOM)

· Requirement type.

( Research & development (R&D) ( R & D support services

( Support services (non-R&D) ( Supplies/equipment

( Information technology (IT) ( Construction ( Architect-engineer (A & E) services ( Design-build ( Other (specify): ____________________

· Type of action.

( New requirement ( Follow-on ( Other (specify): ______________________

· Proposed contract/order type.

( Firm-fixed-price ( Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ( Cost-plus-fixed-fee ( Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ( Time and materials ( Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ ( Other (specify): ___________ ( Completion Form ( Term form

· Acquisition identification number. AMBIS # 1857279, Federal Business Opportunities (FBO) RFQ-NIAID-B-1857279 c.

Total estimated dollar value and performance/delivery period. Dollar Value: $294,480.28. Estimated Delivery Date: September 25, 2017

4. Identification of the statutory authority permitting other than full and open competition.

( This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 41 USC 1901(e)(_2_) as set forth in Federal Acquisition Regulation (FAR) 13.501- _(a)_.

This acquisition will be a brand name Justification. To ensure that new variables are not introduced.

( This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

( This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. 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).

This Acquisition will be limited to Brand Name only and competed on FBO as an Request for Quotes (RFQ). The name of the purposed contract will be announced at award.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The VCR has selected the ZEPHR sequencing system based on these functions and preprogrammed calibrations are needed to ensure that new variables are not introduced that would cause variables that would cause the loss of the VRC’s vaccine FDA approval for human use.:

1.) Post PCR SPRI Purification,

· qPCR Setup (96 or 384 Well),

· LabChip GX Plate Transfer,

· Volume and/or Concentration Normalization (based on qPCR or LabChip GX Results)

· Indexed Library Pooling

2.) The ZEPHYR can be used for our high-throughput processing of anywhere from 8-96 samples. Through the steps required for Next Generation Sequencing Library Construction which include:

· Enzyme Mastermix Additions,

· Isothermal Enzymatic

· Incubation and Bead Based (SPRI) Purification 3.) This system comes pre-configured with these specs:

· 1-200ul 96 Channel High Volume Head (HVH),

· 12 Position Deck,

· Left Handed Offset Gripper for Plates and Lids,

· integrated 4-110° Thermal Locator,

· Integrated 4-70° Thermal Shaker and Maestro Control Software.

6.) Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A FedBizOpps RFQ notices will be publicized under FAR 5.201 with the publicizing and response time requirements of FAR Part 5.203(a)(2) referring the combine synopsis and solicitation procedures. Quotes will be obtained from FedBisOpps.gov, which is the Governments Point of Entry System. Market research indicates that two vendors are able to meet this requirement. Previous awards were made to Perkin Elmer and Government Scientific Source. This Brand Name justification will be published with the solicitation.

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

The price will be considered fair and reasonable through competitive quotes in response to FedBisOpps RFQ posting.

8.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted. During Market Research, these workstations were not found to be offered on any priority sources or existing contract mechanisms. While researching the open market I found that Perkin Elmer was the manufacturer of both workstations and their manufacturing plan is located in Massachusetts. Perkin Elmer is a large business. A review of previous awards for the workstations revealed that two vendors are found in the market place. Government Scientific Source and Perkin Elmer.

9.

Any other facts supporting the use of other than full and open competition. Since this RFQ will only be limiting the brand name of the equipment to be purchased, competition in the market place will reveal the best price and delivery time.

10.

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Although the acquisition should well cover the VRC’s need at this time it is possible that a replacement could be purchased in the future. Should that occur, the NIAD will search the market for the best price through competition not limiting the vendors only the equipment needed through a brand name justification.

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