NOI Sole Source ANSI ISO35001 License Agreement.pdf

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Notice of Intent to Sole Source - American National Standards Institute - ISO 35001:2019 License Agreement
Solicitation number
96317
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This is a Notice of Intent to award a sole source purchase order for an ISO 35001:2019 License Agreement. The Centers for Disease Control and Prevention (CDC), Division of Laboratory Systems, Quality and Safety Systems Branch intends to award a firm fixed-price purchase order to American National Standards Institute, Inc. (ANSI), located at 1180 Avenue of the Americas, 10th floor, New York, NY 10036. The ISO 35001:2019 Licensing Agreement is required to support the Biorisk Management Pilot (BMP) program, a collaborative initiative between the CDC and the Association of Public Health Laboratories (APHL) designed to help clinical and public health laboratories improve internal processes and reduce incidents, accidents, infections, and illnesses resulting from laboratory operations. ANSI is identified as the sole source capable of providing this licensing agreement, as it defines the process to identify, assess, control, and monitor risks associated with hazardous biological materials.

The procurement will be conducted as a simplified acquisition under FAR Part 12 for commercial products and services, with the NAICS code 541611 (Administrative Management and General Management Consulting Services). The solicitation is not a request for competitive quotations; however, the Government will review all capability statements received within 10 days of this notice issuance. Interested parties believing they can satisfy this requirement must submit a capability statement demonstrating their abilities via email to contract specialist Felipe Cardenas at tpp5@cdc.gov by March 9, 2026. The Government reserves the right to decide whether to compete this proposed contract based on responses received. No phone calls will be accepted.

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The Centers for Disease Control and Prevention (CDC), Division of Laboratory Systems (DLS), Office of Laboratory Systems and Response (OLSR), Quality and Safety Systems Branch

(QSSB), hereby announces its intent to issue a sole source award, firm fixed-price purchase order to American National Standards Institute, Inc. (ANSI), 1180 Avenue of the Americas, 10th floor, New York, NY 10036 for the purchase of an ISO35001:2019 License Agreement.

The QSSB has a cooperative agreement with the Association of Public Health Laboratories

(APHL) and collaboratively, have developed a Biorisk Management Pilot (BMP) program for clinical and public health laboratories. The BMP program offers clinical and public health laboratories the capability to improve internal processes; thereby reducing incidents, accidents, infections, and illnesses that may result from laboratory operations. The ISO35001:2019

Licensing Agreement is deemed necessary by the CDC because the licensing agreement defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. The American National Standards Institute, Inc. (ANSI) is the only source that can provide the ISO35001:2019 Licensing Agreement.

This contract action for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.103-1(b) and 41 U.S.C. 3304(a)(1).

The sole source procurement will be awarded as a simplified acquisition in accordance with FAR

Part 12 – Acquisition of Commercial Products and Commercial Supplies. The NAICS code for this request is 541611 - Administrative Management and General Management Consulting

Services.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS;

however, all responses received within 10 days of the issuance of this notice will be reviewed by the Government. 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. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability statement demonstrating their abilities to meet this requirement. Any response must be emailed to the contract specialist Felipe Cardenas at tpp5@cdc.gov by March 9, 2026. No phone calls will be accepted.

mailto:tpp5@cdc.gov

File details come from the government source that posted it. Updated .