Single Extracellular Vesicle Analysis from HANDLS participants.

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Single Extracellular Vesicle Analysis from HANDLS participants (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95024Q00482 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Nanometrix, LTD, 26 Stanley Road, Oxford, OX4 1QZ, United Kingdom for the Single Extracellular Vesicle Analysis from HANDLS participants.

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, with effective date 05/22/2024. (iv) The associated NAICS code is 541380 - Testing Laboratories and Services and the small business size standard is $19.0 million.

This requirement is non-competitive with no set-aside restrictions. (v) This requirement is for the following services: Single Extracellular Vesicle Analysis from HANDLS participants. (vi) The DNA Repair Unit (DRU) hypothesizes that differences in extracellular vesicle (EV) morphology, size and cargo contribute to health disparities in age-related diseases.

The DRU also hypothesizes that there will be different EV protein levels and morphology for participants who acquire chronic kidney disease in the HANDLS cohort. This analysis includes EV sample preparation and imaging on a Single-molecule localization microscopy (SMLM) system, computation of EV size and morphology, analysis the molecular profiles and differences of the EVs across different surfaces. The contractor will perform quality controls assessments.

This specialized analysis is state of the art in the field and requires limited volumes of extracellular vesicles, which is critical since HANDLS plasma samples are limited and have high research significance. The contractor shall image and analyze plasma extracellular vesicles from 30 samples provided by the government.

Specifically the contractor shall: EV surface capture TMIX (CD9 + CD81 + CD63) EV Sample imaging: EV sample preparation and imaging on an SMLM system EV size and morphological analysis: EV size distributions will be computed for each sub-population and morphologies EV quality assurance: Based on EV morphologies and noise signal produce a measure of quality of EVs EV population analysis: Analyze the molecular profiles and differences of the EVs across the different surfaces See Attachment 1 - Statement of Work. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months ARO (After Receipt of Order). (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition.

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer.

In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer.

Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference:

FAR 52.204-7, System for Award Management (Oct 2018)

FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and Disclosures (Dec 2023)

FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023)

FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024)

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference:

FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the applicable provisions and submit completed copies as separate documents with their proposal.

FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (May 2024)

FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) NIH Invoice and Payment Provisions (Mar 2023) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024), with its offer.

If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria.

The price quote must include the price for the following line items: 1) Single Extracellular Vesicle Analysis from HANDLS participants. The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All quotations must be received by 12:00pm Eastern Daylight Time, on August 6, 2024, and reference Solicitation Number 75N95024Q00482. Responses must be submitted electronically to Michele Pastorek, Contracting Officer at michele.pastorek@nih.gov. Fax responses will not be accepted.