J&A_Approved_(FBO).pdf

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. NIH

b. Sponsoring organization. NIAID/DIR/CHI

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

a. Acquisition purpose and objectives.

The Center of Human Immunology (CHI) is involved in several different ongoing projects. In this order we have separated the needs based upon each individual project. As part of the research, the laboratory runs the SOMAscan assay platform.

CHI is involved in the continuation of several studies, each of which was previously run on the SOMAscan platform at CHI. CHl's current studies will expand on previous findings. The studies are as follows:

In the continuation of multi-variate proteomic analysis of the human immune system, this project studies the human immune system using a systems biology approach which will entail analyzing human blood and tissue products. To continue projects, CHI needs to order kits of human serum.

In the continuation of the Inter-strain Radiation Sensitivity study, this study's focus is to identify novel proteomic biomarkers of radiation exposure and will be conducted using several different murine strains. To continue the study, CHI needs to order samples of human serum.

In the continuation of the inCHIANTI study, we have developed and validated molecular model of multiple sclerosis (MS) severity, based on cerebrospinal fluid (CSF) biomarkers measured by Somalogic 1.3k platform. To continue projects, CHI needs to order plates of human serum and plates of human plasma.

In the continuation of biomarker discovery in muscular, these samples represent the entire time series collected from subjects' first visit compared to our previous trial that looked at only a subset of data collected. To continue projects CHI needs to order plates of human plasma.

In the continuation of the Proteomic Analysis to Identify Characteristics of PTSD, this study's focus is to identify proteomic alterations in serum samples from PTSD cases and age/gender/ethnicity-matches controls. To continue projects CHI needs to order plates of human serum and tissue/cells.

Thus, the Government is seeking to purchase the following SOMAScan High Throughput System (HTS) Reagents sold exclusively by Somal ogic:

6 HTS Assay Kits: Cells & Tissue

10 Diluent Tubes for cerebrospinal fluid (CSF)

21 HTS Assay Kits: Human Plasma

21 HTS Assay Kits: Human Serum

b. Project background. The requested kits are necessary to process collaborative samples to determine clinical results. The data generated from the HTS kits are then shared with collaborators. Only CHI has personnel that is adequately trained and the appropriate equipment; and therefore, capable of performing necessary tasks with the assays and evaluating the sample results. HTS kits are the mechanism for which samples are processed.

The requested products are exclusively manufactured by Somalogic. The kits are only compatible with the associated SOMAscan products, which only CHI has possession of. The contents of each kit vary based on the need determined by each collaborative project. Collaborators provide samples and CHI provides the tools necessary for processing. Each kit is specifically capable of investigating proteins from tissue, plasma, or serum samples.

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

a. Project title. SOMAscan HTS Assay Kits and Reagents.

b. Project description. The Government is seeking to purchase various HTS kits for the SOMAscan platform, along with 10 diluent tubes for CSF.

• Requirement type.

• Research & development (R&D)

• R & D support services

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

• Information technology (IT)

• Construction

• Architect-engineer (A & E) services 0 Design-build

• Other (specify): ________ _

• Type of action.

[BJ New requirement

• Follow-on

• Other (specify): ________ _

• Proposed contract/order type.

!El 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

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

[BJ This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1 - Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

• 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.

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

The research performed in the Center for Human Immunology (CHI) involves characterizing the protein expression in human fluid and tissue.

Previously, CHI has used a Luminex platform for proteomics, but now the laboratory installed a Somascan. In order to run the assay on the Somascan, CHI needs to order kits for protein detection. CHI has previously purchased these kits and needs to continue using the same kits to perform a reproducible assay. Therefore, CHI needs to order HTS kits. Based on the myriad of samples CHI will run, we will likely need to place several orders for kits.

Somalogic produces cutting edge technology to analyze a vast number of proteins in samples, more than any other technology available. Therefore, CHI can only order kits for its SOMAscan assay through Somalogic.

Somascan assay is an exclusive technology of Somalogic. This is a unique aptamer based protein detection that allows the scientists to detect 1310 analytes in sera or plasma.

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 pre-solic itation notice of the intent to sole-source this requirement was pub lished on FedBizOpps on August 14, 201 8, closing on August 24, 2018. No responses were received in response to the pre-solicitation notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. This is an acquisition under FAR Part 12, thus Certified Cost and Pricing Data is not required. See FAR 12.102(f).

The unique nature of the SOMAscan platform required a review of other multiplex assay platforms whose capabilities are significantly less than the platform at issue.

However, it should initially be noted that the kits at issue are being offered at the standard commercial price Somalogic offers to Government buyers. See NHLBl's HHSN268201700364A, HHSN268201700232A, and HHSN268201700153A for identical pricing - -

Two other vendors were surveyed for price reasonableness: QIAGEN's prices for Single-Analyte ELISArrayP0F 1 P Kits and Quantitative Proteomics Services (QPS), who use a GLP compliant Quantibody Multiplex ELISA platform to quantitatively detect up to 1000 human proteins.

Price reasonableness was conducted in comparing the capability of the SOMAscan platform to analyze over a thousand biomarkers against the price of the kits required for smaller platforms or assay services to analyze a similar numbe~omic biomarkers. The discovery price per sample from one vendor totaled--for biomarker discovery when contrasted to the SOMAscan platform. In another instance, using QPS to analyze a similar number of human proteins (1,000) would cost $1 ,000 per sample, whereas the SOMAscan platform can run up to 84 samples per day. If the Government were to instead use the Multiplex ELISA platform services QPS offers,P1 F 2 P it would be spending $84,000, as opposed to the Thus, the use of the kit over alternative would significant cost savings to the Government. Using these market analogs, we can determine that the price of - per kit offered by Somalogic is fair and reasonable.

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.

The contract specialist reviewed literature published by qualified organizations;

researched the field regarding market capabilities; reviewed FPDS and GovTribe for similar acquisition history; and reviewed the capabilities of other multiplex assay platforms and companies offering assay services to perform a price comparison. No responses were received in response to a pre-solicitation notice indicating the Government's intent to sole-source this requirement.

Somalogic has had forty-nine other contracts and purchase orders with the Food and Drug Administration, the National Institutes of Health, and the Center for Disease Control and Prevention. Furthermore, according to Govtribe.com, a reporting website for Government purchases, the HTS Assay Kit purchases reported indicated that the acquisition was sole-sourced to Somalogic or Somalogic was the only responsive vendor. The research further indicated that no resellers of the SOMAscan HTS kits exist. Additionally, the market research indicated that the SOMAscan platform is unique in its capabilities - other platforms and services do not have the proteomics technology to analyze biomarkers with the same level of detail and efficiency. While this has made it challenging to find market analogs for a price reasonableness comparison, it

1 Single-Analyte ELISArray Kits are designed to quantitatively measure the amount of an individual cytokine or chemokine in multiple samples using an ELISA. ELISA (enzyme-linked immunosorbent assay) is a plate-based assay technique designed for detecting and quantifying substances such as peptides, proteins, antibodies and hormones 2 Viewed simply from a cost-perspective; the logistic difficulties involved with using such a service rather than the SOMAscan is not addressed here.

t supports the determination that only one responsible source is capable of meeting the Government's requirement.

9. Any other facts supporting the use of other than full and open competition.

All facts supporting the use of other than full and open competition are detailed here.

10. Listing of sources, If any, that expressed, In writing, an Interest In the acquisition.

No other sources have expressed an interest In the proposed acquisition, even after publicizing a pre-solicitation notice of the intent to sole-source to FedBizOpps.

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 supplles or services. The kits being procured are specific to the SOMAscan platform and are proprietary to the original manufacturer of the platform. The competitive landscape will be revaluated should a subsequent need arise for the required items; however, it is possible that no resellers of the SOMAscan kits and reagents will be available.

12. Program office certification.

This Is to certify that the portions of this justification that have been developed by the undersigned program office personnel, Including supporting Information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer 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 the rationale and recommendation for approval is accurate and complete.

14. Chief of the Contracting Office and Head of the Contracting Activity s lgnature( s ).