AMBIS 2280298 JA for Over SAT.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. U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH)

b. Sponsoring organization. National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), Center for Human Immunology (CHI)

c. Project Officer information.

• Project Officer name. Benjamin Ryan

• Mailing address. Bldg. 10, Room 7N116, 10 Center Drive, Bethesda, MD 20892

• E-mail address. ryanb1@mail.nih.gov

• Telephone number. 301-761-6734

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

a. Acquisition purpose and objectives. The purpose of this acquisition is to purchase 15 SomaScan 7K and 11K assay kits for the Center for Human Immunology (CHI) for the ability to analyze clinical samples (serum, plasma, cell lysates, tissue homogenates, urine, and cerebrospinal fluid) with highly multiplexed analytes and high throughput proteins. The kits will be used to measure 11,000 proteins across 10 logs of concentration dynamic range in less than 150 uL of human biological samples with median %CV<5% across all analytes. Currently, there are numerous CHI projects and NIH fee-for-service customers from various institutes and centers in the NIH Intramural Research Program (IRP) that are awaiting their samples to be run on the platform for their clinical protocols.

b. Project background.

The CHI develops and applies systems biology approaches combining computation, modeling, and experimental data to study the immune system at the organismal, cellular, and molecular levels. The proteomic data generated from the samples that will be run on the assay from this acquisition will be coupled to information from orthogonal experimental techniques to uncover a systems immunology-based model of disease.

The government requires SomaScan 7K and 11K assay kits, manufactured by SomaLogic Operating Co. (SomaLogic), to measure

11,000 proteins across 10 logs of concentration dynamic range in <150 uL of human biological samples (Serum, Plasma, CSF, Urine, Cell Lysate, Tissue Homogenate, etc.) with median %CV <5% across all analytes. The data generated from the SomaScan 7K and 11K assay kits must be directly comparable to previously generated data that utilized the SomaScan 7K and 11K assay kits as many of the studies utilizing this requirement are continuations of longitudinal studies, and any differences in data comparability may result in detrimental impacts such as the creation of data artifacts that cannot be overcome as well as potential damage to study data integrity where remediation would not be possible.

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

a. Project title. Acquisition of SomaScan 7K and 11K Assay Kits

b. Project description.

Currently, the CHI performs systems biology research on several biological matrices using the SomaScan Assay system. The SomaScan Assay is performed using proprietary SomaScan assay kits on dedicated instrumentation that was previously purchased (SomaScan v4.1 Assay runs on a Tecan Fluent Liquid Handling platform) and is integrated into CHI’s laboratory infrastructure. It enables highly multiplexed (>11,000 analytes) and high throughput (96 samples per kit) analysis of 11,000 proteins in clinical samples (e.g. human serum, plasma, cell lysates, tissue homogenates, urine, and cerebrospinal fluid). These assay kits are needed for projects involving work for ongoing clinical trials and longitudinal studies where the efficacy of the therapy to the patients would be at risk without the kits. With the SomaScan assay kits, it would provide investigators across the NIH intramural research community access to a unique set of capture reagents called “Slow Off rate Modified Aptamers (SOMAmers)” to measure the relative abundance of proteins in a multitude of biological matrices including human serum, plasma, cerebrospinal fluid, urine as well as many others. The SomaScan kits are used to search for biomarker signatures in a variety of biomedical applications, such as those predicting patient outcomes or characterizing responses to interventions and therapies at the NIH. Moreover, the CHI has successfully harnessed this technology since 2014 for use on CHI projects, as well as offering it to the greater NIH intramural community through its Technology Partnership Program. The CHI is the only laboratory and center at the NIH that is authorized to purchase SomaScan assay kits as they have two trained and certified laboratory operators to run the SomaScan Assay so that investigators at other institutes and centers at the NIH can access this technology. Therefore, the acquisition of the SomaScan assay kits is critical as it will provide significant advancement in the information that can be extracted from these samples.

• 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 #2244738

c. Total estimated dollar value and performance/delivery period.

The performance period is estimated to be from 3/1/2026 to 6/30/2026 and the total estimated dollar value is $522,030

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.) 1901 as set forth in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii).

❑ 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 Operating Co. (SomaLogic) 2945 Wilderness Place, Boulder, CO 80301

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

The purpose of this acquisition is to procure 15 SomaScan 7K and 11K assay kits to run samples to generate proteomic data for various studies and projects for NIAID and other institutes and centers at the NIH on the existing SomaScan V4.1 Assay, which runs on a Tecan fluent liquid handling platform. These assay kits have been integrated into longitudinal studies and are required for the final step in those projects that have spanned across multiple years dating back to 2015. Moreover, they are critical for work on ongoing clinical trials as well. The assay kits are unique in that they can rapidly and simultaneously measure more than 11,000 low and highabundance proteins across 10 logs of dynamic range (concentration) with very high accuracy and reproducibility (median %CV of replicate measurements less than 5%) and low sample volume input requirements (less than 55uL). They enable highly multiplexed (greater than 11,000 analytes) and high throughput (96 samples per kit) analysis of 11,000 proteins in clinical samples (e.g., human serum, plasma, cell lysates, tissue homogenates, urine, cerebrospinal fluid, etc.). Other technologies in this field, including other affinity-based protein assays, targeted protein assays, or mass-spectrometry based proteomic detection assays and technologies can only do some, but not all, of the capabilities of the SomaScan Assay. Furthermore, alternative technologies measure fewer proteins than the SomaScan Assay, do not have the ability to detect low abundance proteins (e.g. cytokines) as is possible with the SomaScan Assay, require patient sample volumes that far exceed what is required with the SomaScan Assay and more sample volume than is available to be analyzed, have poorer reproducibility than the SomaScan Assay leading to nondetection of biological signal changes, have sample throughputs far lower than that of the SomaScan Assay leading to increased wait times, labor costs, and delayed results; and the cost to run samples is far greater with other technologies than to run them on the SomaScan Assay. In addition to being independently verified in peer-reviewed scientific papers, the capabilities of the SomaScan Assay have also been verified by direct testing in our lab, and is therefore, the reason why the SomaScan Assay was selected in our laboratory for this type of work. The proteomic data generated from the samples run on the assay from this acquisition will be coupled to information from orthogonal experimental techniques to uncover a systems immunology-based model of disease. The data generated from the assay kits must be directly comparable to previously generated data from utilization of the SomaScan 7K and 11K assay kits.

Many studies utilizing this requirement are continuations of longitudinal studies, and any differences in data comparability could create data artifacts that cannot be overcome as well as potentially damage study data integrity. If alternative technologies and kits, other than the existing SomaScan Assay and the proprietary SomaScan 7K and 11K assay kits, are used for this work, the samples previously analyzed with the SomaScan Assay may not be directly comparable to those analyzed on other platforms. This could necessitate significant costs and resources to re-analyze these samples. Furthermore, some of the previously analyzed samples have no remaining sample volume.

Additionally, alternative platforms may produce inferior, unreliable, and incomplete sample measurements, as well as the cost per sample analysis would be higher for the Government should alternative platforms be utilized.

SomaLogic is the only manufacturer that produces compatible kits for the SomaScan Assay technology that meets the needs of CHI. The SomaScan Assay Kits are designed to integrate exclusively with the existing equipment and software which are available only from SomaLogic. Adopting other technologies would entail substantial capital expenditure, potentially exceeding $1 million, and a significant amount of time to acquire the necessary dedicated instrumentation as CHI’s laboratory infrastructure is currently designed to process the SomaScan Assay specifically and the proprietary SomaScan assay kits. CHI has already invested in excess of $1.5 million on equipment to run the SomaScan Assay and certified two (2) laboratory operators to run the SomaScan Assay and kits, as required by SomaLogic to procure the kits. The SomaScan assay kits cannot be used independently from the SomaScan Assay system, nor can alternative kits be run on the SomaScan Assay system. If alternative platforms or kits were utilized, it could necessitate the Government to invest further financial resources and time that would delay the progress of the existing projects. Therefore, it is essential to procure the SomaScan assay kits from SomaLogic.

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. Explain the efforts taken (or to be taken) to solicit as many potential offerors as possible, particularly if the basis of the JOFOC is the authority cited in FAR 6.302-2 (i.e., unusual and compelling urgency) or 6.302-6 (i.e., national security.) (NOTE: Proposed acquisitions for other than full and open that are expected to exceed $25,000 must be announced in Federal Business Opportunities (FedBizOpps), whether or not a sources sought notice or other presolicitation notice was issued previously.)

Indicate whether a FedBizOpps notice will be published as required by FAR Subpart 5.2 and, if not, state the exception in FAR 5.202 that applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. Provide a statement, based on the specific circumstances and type of acquisition proposed, that reflects the steps the CO will take (including documentation) regarding the fairness and reasonableness of the cost/price of the contract/order prior to its award. The determination shall cite, at a minimum: (a) the type of cost or pricing information that will be obtained from the proposed contractor(s) and whether it will be certified – see FAR 15.406-2; (b) the type and extent of cost or price analysis anticipated; and (c) whether an audit will be performed.

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.

Describe the market research that was conducted and the results of that effort (see FAR Part 10). Examples of market research include: (a) issuing a sources sought announcement in FedBizOpps; (b) publishing a request for information in technical or scientific journals or business publications; (c) reviewing literature published by qualified organizations; (d) contacting knowledgeable acquisition and program officials in Government and industry regarding market capabilities;

and (e) convening a presolicitation conference to exchange information with the marketplace. If market research was not conducted, provide an explanation.

(NOTE: Issuing the FBO notice under Item 6. above does not, in and of itself, constitute market research.)

The program surveyed the field of proteomics to determine and verify that SomaLogic is the only vendor to manufacture SomaScan kits. This market research was performed through multiple methods. These methods include reviewing scientific literature including reviewing technical articles in major scientific publications. In addition, staff have been able to attend scientific conferences in the field of proteomics and had the ability to view presentations related to scientific results using SomaScan Kits. The last form of market research that was performed is related to data that has been generated at the NIH related to using SomaScan Kits to enable highly multiplexed (>11,000 analytes) and high throughput (96 samples per kit) analysis of 11,000 proteins in clinical samples

(serum, plasma, cell lysates, tissue homogenates, urine, and cerebrospinal fluid). It was determined SomaLogic is the only source that manufactures compatible kits that meets the requirement. The equipment and software are designed to integrate exclusively with

SomaScan Assay Kits, which are available only from SomaLogic.

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

CHI is the only laboratory or center at the NIH that is authorized to purchase SomaScan Assay Kits so that investigators across the intramural research community can access this technology at NIH. The CHI has invested, at great cost to the Government, in training and certifying two (2) laboratory operators to run SomaScan Assay kits (required by SomaLogic for authorization). Since 2014, data for approximately 10,000 samples has been generated using SomaScan assay kits at the CHI. CHI bioinformaticians have also created numerous webtools, databases, and analysis pipelines specific to the unique data generated at CHI using SomaScan Assay kits. Additionally, the CHI have invested greater than $1.5 million in specialized dedicated equipment and the training and certification of two (2) laboratory operators to operate the SomaScan Assay system with the proprietary SomaScan Assay Kits at CHI. Any attempt to use alternative kits or methods could void the warranty of the scientific equipment that is used to perform this experiment.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. List the sources, if any, that have expressed an interest, in writing, in the acquisition and provide an explanation of why they are not being considered. If no expressions of interest have been received, enter “No other sources have expressed an interest, in writing, in the proposed acquisition.”

Any responses, such as capability statements, received in response to a published notice (e.g., a sources sought notice or request for information), must be evaluated. Include all evaluations as an attachment to the JOFOC, along with the names of the individuals who participated in the review and a copy of the communication to each organization that responded. In addition, document any requests made to the CO by interested organizations for a copy of the solicitation or SOW with the following information: (a) the name of and contact information for the organization that submitted the request; (b) any communications with the requestor; and (c) the disposition of the request.

(NOTE: Normally, a JOFOC should be routed for review and approval after the FedBizOpps notice period (see Item 6.) has expired. However, in extenuating circumstances (e.g., when substantial administrative, funding, or technical delays or issues are anticipated or occur that could jeopardize timely review and approval of a JOFOC), a JOFOC that does not require Senior Procurement Executive (SPE) review and approval may be routed for review (but not approval) prior to completion of the synopsis period. The OPDIV HCA must provide prior written/electronic concurrence with such an action. In no event shall the justification be forwarded to the approving official before expiration of the synopsis period and before the results of any expressions of interest in the acquisition have been evaluated (other than requests for a copy of the solicitation) and documented. Further, a solicitation may only be released to an intended source after approval of a JOFOC.)

Not applicable

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. Provide a brief statement as to whether or not there are future plans to acquire the same type of supplies or services, e.g., further extensions or renewals by competitive or other means. If subsequent acquisitions are anticipated, cite actions taken, or anticipated, to avoid continued noncompetitive acquisition of the requirement in the future and a schedule for accomplishing those actions. (NOTE: This may involve recompeting a successor requirement at a logical juncture in the phasing of the project or “breaking out” segments of the requirement to facilitate competition, where feasible.) If no actions have been or will be undertaken to overcome barriers to competition for future acquisitions, so indicate and provide an explanation.

12. Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

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.

Official Name & Title Signature Date

Project Officer Benjamin Ryan, Scientific Program Manager, Center for Human Immunology, NIH

Project Officer’s

Immediate Supervisor

Head of the Sponsoring

Program Office

13. Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. [NOTE: The CO’s signed certification may serve as approval of a JOFOC over $100,000 but not exceeding $550,0001, depending on OPDIV procedures.)

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.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). The Chief of the Contracting Office (CCO), if applicable, and the HCA shall indicate review of, and concurrence with, any JOFOC over $550,0002 by providing the information required below and signing in the applicable block.

Official Name & Title Signature Date

Branch Chief, AMOB

Chief of the

Office

Head of the

1 This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(1) and 13.501(a)(2)(i). See HHSAR 306.304(a)(1) and 313.501(a)(2)(i) for additional information regarding CO approval of a JOFOC in this dollar range.

2 This review and concurrence requirement is applicable to the dollar ranges over $550,000 cited in the FAR, specifically: (i) over $550,000 but not exceeding $11.5 million; (ii) over $11.5 million but not exceeding $57 million; and (iii) over $57 million – see FAR 6.304(a)(2) through (4) and 13.501(a)(2)(ii) through (iv). See HHSAR 306.304 and 313.501(a)(1)(iii) for additional information regarding CCO/HCA review of and concurrence with a JOFOC in these dollar ranges. These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No.

2008-03, but are subject to change.

Activity

15. Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the JOFOC, shall complete the information required below and sign in the block provided as the approving official for any JOFOC over $550,000 but not exceeding $57 million3.

However, if the CA does not meet the requirements of FAR 6.304(a)(3)(ii) for a JOFOC over $11.5 million, but not exceeding $57 million, an individual other than the CA shall exercise the approval authority.

The signature of the CA, or that of an individual meeting FAR 6.304(a)(3)(ii) requirements for a JOFOC over $11.5 million, but not exceeding $57 million, shall serve as concurrence on any JOFOC over $57 million that requires the approval of the HHS SPE.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the JOFOC, shall complete the information required below and sign in the block provided as the approving official for any JOFOC over $57 million4.

Official Name & Title Signature Date

HHS Senior Procurement

Executive

3 This approval authority is applicable to the following dollar ranges cited in the FAR, specifically:

(i) over $550,000, but not exceeding $11.5 million; and (ii) over $11.5 million, but not exceeding $57 million – see FAR 6.304(a)(2) and (3) and 13.501(a)(2)(ii) and (iii). See HHSAR 306.304(a)(2) and (3) and 313.501(a)(ii) and (iii) for additional information regarding this approval authority, including when the CA does not meet the requirements of FAR 6.304(a)(3)(ii). These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No.

2008-03, but are subject to change.

4This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(4) and 13.501(a)(2)(iv). See HHSAR 306.304(a)(4) and 313.501(a)(2)(iv) for additional information regarding SPE approval of a JOFOC in this dollar range.