CDER-2024-121580-Purchase of Reagents for Electrophysiology Studies

Notice of Intent to Sole Source Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a CDER-2024-121580 ss Purchase of Reagents for Electrophysiology Studies, Sole Source, under Request for Quote FDA-RFQ-CDER-2024-121580.

Notice of Intent to Sole Source to:

Alomone Labs Inc. 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 Firm Fixed Price (FFP) Purchase Order Type to Alomone Labs Inc., located at:

ALOMONE LABS Inc or Distributors/Retailers, Email: orders@quartzy.com; orders@zageno.com FDA requires Reagents for Electrophysiology Studies, Sole Source, under Request for Quote FDA-RFQ-CDER-2024-121580. This is a request for the procurement of Reagents for Electrophysiology Studies, and the items are solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

FDA already has considerable experience with ATX-II purchased from Alomone Labs (See https://www.ncbi.nlm.nih.gov/pubmed/29127493 for publication by the requesting division/laboratory). As the sources of drugs can impact experimental findings, ATX-II needs to be sole-sourced Alomone Labs Inc., to enable data comparison within the laboratory. The associated NAICS 424210-Drugs and Druggists' Sundries Merchant Wholesaler.

Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation. 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 Alomone Labs Inc., 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 01/15/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov