HFP-2025-129650 Notice of Intent.pdf

NOTICE OF INTENT TO SOLE SOURCE

In support of Project No: HFP-2025-129650

Date Posted: August 28, 2025

Response Date: September 2, 2025, 10:00 AM EST

Classification Code: 6640 -- Laboratory Equipment

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing;

with a Small Business Size Standard of 1000 Employees

The U.S. Food and Drug Administration, Office of Acquisitions and Grants Services, Facilities Support Branch, Human Foods Program (HFP), intends to award a sole source, firm fixed price purchase order to Steris Corporation 5960 Heisley Rd., Mentor, OH 44060, under the authority of FAR 8.405-6 (1) (B), Limiting Sources.

The U.S. Food and Drug Administration (FDA) New York Human and Animal Food Laboratory (NYHAFL) conducts sample analysis on human and animal foods. The BSL3 laboratory requires a fully functional autoclave to decontaminate all waste and any other materials being removed and discarded from the BSL3. The BSL3 autoclave must be maintained in a constant state of operation and must be repaired as needed. It is necessary that the autoclave be on a preventive maintenance plan that helps to reduce the risk of equipment failure and downtime and to maximize equipment uptime and proper function.

The BSL3 autoclave must be maintained as specified by the FDA certified methodology in accordance with our ISO 17025 laboratory accreditation. Having a preventive maintenance plan meets our ISO 17025 accreditation requirements while also ensuring a constant state of readiness in the event of a public health emergency that requires samples analysis in the BSL3. Without a fully operational and functioning autoclave, no work can be performed in the BSL3.

The justification for this sole source action is that the Government requires this preventative maintenance service contract for BSL3 autoclave. Steris Corporation is the only manufacturer for the service.

Competing this requirement would result in significant detrimental delays in fulfilling the agency’s requirement. Acquisition of this system is essential and attempting to introduce another vendor at this time could impact the entire research program.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part

8.405 requiring the dissemination of information on proposed contract actions. This notice is being distributed solely via the System for Awards Management website (www.SAM.gov). This is a notice of intent to award a sole-source contract and is not a request for competitive proposals.

Information received will be used solely to determine whether to conduct a competitive procurement. A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government.

All responses must include the following business information:

a. Unique Entity Identification (UEI) Number

b. Company Name, address, primary point of contact and their email and phone number

c. Type of company (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.)

as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.

All responsible sources, especially a small business, may submit a capability statement to Ms.

Erika Crawford at erika.crawford@fda.hhs.gov no later than 10:00 AM EST on Thursday, September 4, 2025. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to Steris Corporation.

http://www.sam.gov/ mailto:erika.crawford@fda.hhs.gov