Notice_of_Intent_1.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N94024Q00103 Solicitation Type: Sole Source (Non-Competitive) Title: NICHD: Services: Mouse Ssb (p.I17S) Conditional Knockin Project (ES) -

C57BL/6N

NAICS / Size Standard: 325414 / 1,250 Employees

Introduction

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. The National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to small business Cyagen Biomodels LLC to create a mouse Ssb conditional knockin model in C57BL/6NCya mice.

Background Information

The lab needs custom methodology-based generation of a genetic-engineered mouse containing a single mutation in the gene encoding the La/SSB protein. This is provided through the accelerated ES-cell based methodology for conditional mouse model generation known as TurboKnockout. This TurboKnockout service can provide a conditional knockout, reporter knockin and humanization mouse model as fast as 6 months.

Purpose and Objectives

The lab needs to create a mouse Ssb conditional knockin model in C57BL/6NCya mice. This is required to create mouse model for pathogenic diagnosis of first genetic disease attributed to mutation in the human gene encoding the La/SSB gene.

Period of Performance

The period of performance is one year from award.

Contractor Requirements

The contractor needs to perform the following as part of the Mouse Ssb (p.I17S) Conditional Knockin Project:

• BACs purchased from CHORI; Turnaround time 4-6 weeks.

• Gene Synthesis - 3’arm complex sequence; Turnaround time 1-2 weeks.

• TurboKnockout Conditional Knockin - Vector Construction to produce TurboKnockout Gene

Targeting Vector Report; Design and construction of TurboKnockout knockin vector after client approval of Cyagen proposed TurboKnockout gene targeting strategy; Turnaround time 8-14 weeks.

• TurboKnockout Conditional Knockin - Targeting in ES Cells; produce a correctly targeted and verified ES Cell Genotyping Report; TurboKnockout Vector will be purified, linearized, and electroporated into ES cells. ES cells are subjected to drug selection, screened by long range PCR, and verified for correct gene targeting by Southern blot; Turnaround time 8-14 weeks.

• TurboKnockout Conditional Knockin - Karyotype ES Cells; Chromosome counting is performed to ensure ES cells have the correct number of chromosomes; Turnaround time 1-2 weeks.

• TurboKnockout Conditional Knockin - Mouse Generation to produce a minimum of 3 TurboKnockout heterozygous mutant mice; Turnaround time 8-12 weeks.

• Handling for one rodent crate.

Sole Source Justification

This TurboKnockout service provided by small business Cyagen Biomodels LLC can provide a conditional knockout, reporter knockin, and humanization mouse model as fast as 6 months. This proprietary gene targeting method is enabled by two innovations: (1) A super competent ES cell line that generates 100% ESC-derived founder mice rather than chimeras, eliminating the need to screen for germline transmission. (2) A selection cassette on the targeting construct capable of removing itself after ES cell targeting without the need to breed to Flp deleter mice. These innovations eliminate two generations of breeding, shortening production time by 5-6 months as compared to industry standard. Cyagen Biomodels LLC provides an associated guarantee covering TurboKnockout based projects ensuring that a minimum of three (3) germline transmitting heterozygous mice will be delivered upon project completion.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the detector listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services, is applicable. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through

(v) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services applies to this acquisition.

FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services applies to this acquisition.

Additional Information

The North American Industry Classification System (NAICS) Code is 325414 and the Small Business Size Standard is 1,250 Employees. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2024-05 effective April 22, 2024.

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by May 14, 2024 12:00 PM ET and must reference solicitation number.

75N94024Q00103. Responses shall be submitted electronically to nicole.freid@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:nicole.freid@nih.gov