Reagents and Consumables

Closed Pre-Solicitation Posted

Solicitation number
NIH-CC-OPC-25-000159
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland 20892, United States

Notice details come from SAM.gov. Updated .

About this opportunity

Paragraph 1:

The National Institutes of Health (NIH) Clinical Center intends to award a Firm-Fixed Price purchase order to Life Technologies Corporation on a sole source basis to procure various reagents and supplies needed for clinical patient care testing by the Department of Laboratory Medicine, Hematology Service. The reagents and consumables are proprietary to Life Technologies and specifically designed for use with the existing instruments in the Clinical Center. Due to regulatory requirements and rigorous validation testing, these are the only products that can meet the testing needs. The Government is accepting capability statements from interested parties by the due date of October 21, 2024, to determine if a competitive procurement is feasible.

Paragraph 2:

This acquisition is not set-aside. The purchase order shall not exceed the simplified acquisition threshold. Life Technologies Corporation is the current sole source provider for these proprietary reagents and supplies. The Government reserves the right to increase the quantities as needed. The North American Industry Classification System (NAICS) code for this acquisition is 325414 - Biological Product (except Diagnostic) Manufacturing, with a small business size standard of 1,250 employees.

Notice text

This is a Notice of Intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institute of Health, Clinical Center (CC) intends to award a Firm-Fixed price purchase order to LIFE TECHNOLOGIES CORPORATION, Grand Island, New York 14072-2028, on a sole source basis to procure various reagents and supplies from LIFE TECHNOLOGIES CORPORATION needed for clinical patient care testing by the Department of Laboratory Medicine, Hematology Service. The reagents and consumables requested are proprietary to Life Technologies Corporation and are designed specifically for use with the instruments already existing in the Clinical Center. The results derived from these reagents are critical to patient care, as they contribute to both the diagnosis and ongoing monitoring of hematological disorders, such as Myeloproliferative diseases, and provide essential data for monitoring chimerism levels following transplants.

Due to regulatory requirements and rigorous validation testing performed in the lab, these reagents and supplies are the only ones that can meet the needs of the testing conducted in the lab. Switching to a different supplier or system would require extensive re-validation of processes and instrumentation, which could result in delays to patient diagnostics, interruptions to research, and potentially inaccurate results. Any deviation from the protocol must be reported to the FDA for non-compliance. Life Technologies will deliver these reagents and consumable every 3 months in equal quantities as requested.

The product list and quantity are attached to this notice and titled - LIST OF SUPPLIES- 25-000159. The government reserves the right to increase quantities pursuant to FAR 52.217-6. The purchase order shall not exceed the simplified acquisition threshold.

This acquisition is being conducted under the authority of the FAR Subpart 13.106 -1(b)(i) allowing the Contracting Officer (CO) to solicit from one source.

The North American Industry Classification System (NAICS) code for this acquisition is 325414 with a small business standard size of 1,250 employees.

This notice of intent to award is not a request for competitive quotations. Interested concerns capable of providing the same products or services as described in this notice may submit a capability statement outlining their capabilities. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

Each response should include the following Business Information:

a. SAM UEI.

b. Company Name, address, POC, Phone and Email address

c. Current GSA Schedules or NAICS codes appropriate to this Award.

d. Type of Company (i.e., small business, 8(a), woman owned, HubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1

e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov or Malinda Dehner, dehnerm@cc.nih.gov by the due date and time marked in this notice.

Files

File Type Posted
LIST OF SUPPLIES-25-000159.docx DOCX document

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