Notice of Intent to Sole Source.doc

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Contract Type for the Procurement of BioVendor ELISA Kits for MxA analysis)-Sole Source. to Biovendor LLC., under Request for Quote RFQ-FDA-2021-1239093.

Notice of Intent to Sole Source to: BioVendor LLC.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Contract Type purchase order to BioVendor LLC., located at:

BioVendor, LLC

128 Bingham Rd, Suite 1300

Asheville, NC 28806

Tel: 828-575-9250

Toll-Free: 1800-404-7807

FAX: 828-575-9251

E-mail: infoUSA@BioVendor.com

Web: www.BioVendor.com FDA has a requirement to procure Mxa Elisa Kits from BioVendor Inc., under Request for Quote RFQ-FDA-2021-1239093, as a sole source acquisition. FDA is studying biomarker in an ongoing clinical research project. An enzyme-linked immunosorbent assay (ELISA) kit is needed for analysis of this biomarker. At the start of the project FDA compared the available MxA ELISA assay kits from different vendors and found that the kit from Biovendor provided the best linearity and sensitivity for the agency’s assay needs. As a result, FDA proceeded to validate the MxA assay using BioVendor ELISA kits and ran patient samples from patients in the clinical trial. Later, these kits were used for the method validation as per the FDA bioanalytical method validation guidance. FDA intend to purchase sufficient kits to analyze samples from the remaining patients on the clinical study. As part of this process, DARS needs to acquire the ELISA kits to support the analysis of study sample analysis: “RD194349200R Human MxA Protein ELISA (Biotin-labelled antibody) kits”. The kits are not available from any other vendor or on any Government purchase vehicles.

The associated NAICS Code is: 325413-In-Vitro Diagnostic Substance Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to BioVendor LLC., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 02/15/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov Template