75N95024Q00548

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 

The purpose of this acquisition is to procure AAV viral vector with EF1a promotor expressing a green fluorescent protein for the National Center for Advancing Translational Sciences (NCATS). 

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under 325414 – Biological Product (except diagnostic) Manufacturing with a Size Standard of 1,250 employees 

REGULATORY AUTHORITY 

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: 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, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-06 dated July 30, 2024.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

PaVeGT seeks to harness 3D tissue engineered models to test the safety and efficacy of AAV gene therapy in correcting rare genetic disorders. For propionic acidemia induced by PCCA deficiency, pathophysiology in the liver is significant. Therefore, we aim to develop a 3D model of hepatic propionic acidemia. Prior to studies in diseased models, a healthy model is needed to evaluate baseline functional levels (albumin, urea, PCCA expression, PCCA activity, etc) as well as vector uptake and dose variability in a 3D system. AAV9-EF1a-EGFP allows a simplified test for vector uptake and incorporation, with confirmation through imaging.

AAV9-EF1a-EGFP (VB2084) (2 mL)

Vector BioLabs

Vector BioSystems

          70600-L

AAV8-EF1a-EGFP (VB2084) (1 mL)

Vector BioLabs

Vector BioSystems

70600-L

Salient characteristics: Vector needs to be an AAV9 to mimic the vector being used for gene editing in the PaVeGT program; also testing an AAV8 which is known to have better incorporation in the liver. The promoter for the PaVeGT vector is EF1a, so for accurate testing purposes the same promotor is being used for dosing and uptake experiments. A fluorescent protein should be expressed upon vector incorporation for quantification; green fluorescent protein is being used in this case. They need to be ready to use and high titer.

Quantity: 2 mLs AAV9-EF1a-EGFP, 1 mL AAV8-EF1a-EGFP

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The essential characteristics of the AAV9-EF1a-EGFP and AAV8-EF1a-EGFP that limit the availability to a sole source are custom viral vectors of the AAV9 or AAV8 serotype relying on EF1a promotors to produce a fluorescent signal. We have been using the AAV’s produced from Vector Biolabs for related work and require same source for continuity of the experiments. 

Only this suggested source can furnish the requirements, to the exclusion of other sources, because the PaVeGT project has previously used this supplier to test AAV dosing, and we are completing an experiment that is a direct comparison. Because of this need, we are unable to change suppliers or risk having an additional variable complication in the experiment.

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The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Vector BioSystems, is the only vendor in the marketplace that can provide the services required by NCATS in the interest of continuity of science.

The intended source is:

Vector BioSystems

293 Great Valley Parkway, Malvern, PA 19355-1308

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. 

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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. 

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 ID (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.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95024Q00548 Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at 

giuliana.faller@nih.gov. U.S. Mail and fax responses will not be accepted.