JA Over SAT - FAR Part 13 - SomaScan Kits_SIGNED_Redacted.pdf

projects as well as offering it to the greater NIH intramural community as a fee-for-service platform. In 2022, the CHI upgraded the SomaScan platform to the latest version, investing significant resources into new equipment, and weeks of work into operator training. SomaScan 7K HTS kits are the only kits compatible with the current platform. There is a current bona fide need for the requirements included in this acquisition.

This is a new acquisition. Recent NIAID purchases for SomaScan 7K Assay Kits have been non-competitive, open market, acquisitions.

Purchase Order: 75N93023P00505 Vendor: SomaLogic, Inc.

Award Date: 4/12/2023 Amount: $208,050.00

Purchase Order: 75N93022P01242 Vendor: SomaLogic, Inc.

Award Date: 9/21/2022 Amount: $554,800.00

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

a. Project title. SomaScan kits for Coronavirus Disease 2019 (COVID) Vaccine Allergy Reaction (COVAAR) Project

b. Project description. Procurement of nine (9) SomaLogic SomaScan7K Assay Kits for the National Institute of Allergy and Infectious Diseases (NIAID)’s Center for Human Immunology, Inflammation, and Autoimmunity (CHI) as follows:

Item Number

Description Quantity

1 SomaScan 7k Assay kits (Plasma, Serum Urine, Cerebral Spinal Fluid, Cell and Tissue Kits) (900-00020, 900-200021, 900-00026, 900- 00025, 900-00027)

c. 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. 2174911 Other acquisition identification number: NOI-NIAID-23-2174911

c. Total estimated dollar value and performance/delivery period. Total estimated dollar value of $312,075 with a delivery period of 08/14/2023 – 08/13/2024.

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.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) and 13.501(a).

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). SomaLogic, Inc., 2945 Wilderness Place, Boulder, CO 80301

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). SomaScan 7K HTS Kits are proprietary technology provided solely by SomaLogic, Inc. Assay qualification studies show that the SomaScan Assay performs with median sensitivity of 100 fM (limit of detection) and median coefficient of variation (CV) of approximately 5% across all analytes measured repeatedly in replicate runs of biospecimens. In addition, the overall detection range of the platform spans 8 logs of dynamic range in serum. The Assay provides high throughput (96 samples per plate), highly multiplexed (>7,000 analytes), rapid (<48-hour turnaround) results. No other kit or technology can measure as many analytes in serum as quickly, precisely, or with equally lower serum volume requirements.

Additionally, the SomaScan 7K HTS Kits have been used in ongoing, longitudinal studies at the CHI and as a fee-for-service for the intramural NIH community. The assay needs to have the same performance as those used in previous studies to promote continuity and limit variation and addition of new variables. This will ensure on-going research and experiments are not compromised with changing variables. Maintaining existing protocols is paramount to the success of on-going projects.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a Contract Opportunities (formerly known as 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-Solicitation (Notice of Intent to Sole Source) was publicized via Contract Opportunities/SAM.gov as required by FAR Subpart

5.2 under the following Record ID: NOI-NIAID-23-2174911. The notice announced the Government’s intent to obtain SomaLogic SomaScan 7X Assay Kits on a non-competitive basis. Responsible sources who could provide comparable products were provided an opportunity to respond with a capability statement. If a reasonable capability statement from another source was provided, the intent was then to post a Request for Quotations on a full and open competition basis. NIAID received no responses from the NOI.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price.

NIAID will consider the Independent Government Estimate, market research, comparison with similar items in the marketplace, and quoted prices found reasonable on previous purchase as determining factors for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of a purchase order.

7. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Three products of similar caliber were found through market research but did not meet NIAID’s requirements. General Service Administration’s (GSA) Federal Supply Schedules and GSA Advantage were considered but were unable to meet the requirement. Online searches also provided no suitable vendors as the product is unique to SomaLogic, Inc. In conclusion, the market research supports