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CDC Open Call to Industry – Influenza A(H5) Diagnostic Test Development and Validation

ID: 75D301-24-CTI-00001 • Type: Special Notice

Description

Posted: June 24, 2024, 3:47 p.m. EDT

The Centers for Disease Control and Prevention (CDC) is initiating an open call for innovative solutions to meet the CDC's diagnostic test development needs.

This open Call to Industry is considered to have high potential for one or more agreements that may be accomplished via CDC's Other Transaction (OT) authority pursuant to 42 USC 242c. As such, assessment activities conducted in furtherance of an award or awards are considered competitive in the same manner as a Broad Agency Announcement (BAA) or Commercial Solutions Opening (CSO), and solutions will be assessed independently of one another primarily for technical merit. The procedures outlined in this open call are considered by CDC to satisfy the reasonable effort to obtain competition.

Solution Providers shall submit concept papers via email to mcrow@cdc.gov no later than 11:59 PM Eastern on Wednesday, June 26th, 2024 in order to be considered for further evaluation. The government does not anticipate the ability to consider late concept paper submissions.

Solution Providers are instructed to contact ONLY the CDC Office of Acquisition Services point(s) of contact notated in this announcement. Refer to the attachment(s) to this announcement for full details and instructions.

06/24/2024 Amendment: A Q&A document is provided which contains the government's responses to questions received from potential solutions providers. The deadline for concept paper submission is extended until 11:59 PM Eastern on Wednesday, June 26th, 2024.

Posted: June 12, 2024, 7:59 a.m. EDT
Posted: June 10, 2024, 10:56 p.m. EDT
Background
The Centers for Disease Control and Prevention (CDC) is initiating an open call for innovative solutions to meet the CDC's diagnostic test development needs. This open Call to Industry is considered to have high potential for one or more agreements that may be accomplished via CDC's Other Transaction (OT) authority pursuant to 42 USC 242c. As such, assessment activities conducted in furtherance of an award or awards are considered competitive in the same manner as a Broad Agency Announcement (BAA) or Commercial Solutions Opening (CSO), and solutions will be assessed independently of one another primarily for technical merit.

Work Details
CDC requires design and validation of a Laboratory Developed Test (LDT) ready for U.S. Food and Drug Administration (FDA) regulatory approval. The LDT must be a Nucleic Acid Amplification Test (NAAT) diagnostic kit capable of detecting and differentiating H5 from seasonal influenza subtypes. Upon regulatory approval, performers must be able to manufacture test kits to support testing of a baseline of 1,000,000 unique samples and the ability to scale-up manufacturing efficiently.

Period of Performance
Ideally, all tasks undertaken pursuant to negotiated agreement(s) will be fully completed between 11/01/2024 and 12/31/2024.

Overview

Response Deadline
June 26, 2024, 11:59 p.m. EDT (original: June 24, 2024, 11:59 p.m. EDT) Past Due
Posted
June 10, 2024, 10:56 p.m. EDT (updated: June 24, 2024, 3:47 p.m. EDT)
Set Aside
None
Place of Performance
Atlanta, GA 30322 United States
Source
SAM
Est. Value Range
Experimental
$5,000,000 - $20,000,000 (AI estimate)
On 6/10/24 Centers for Disease Control and Prevention issued Special Notice 75D301-24-CTI-00001 for CDC Open Call to Industry – Influenza A(H5) Diagnostic Test Development and Validation due 6/26/24.
Primary Contact
Name
Michael Crow   Profile
Phone
(770) 488-3208

Documents

Posted documents for Special Notice 75D301-24-CTI-00001

Question & Answer

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > CENTERS FOR DISEASE CONTROL AND PREVENTION > CDC OFFICE OF ACQUISITION SERVICES
FPDS Organization Code
7523-00254
Source Organization Code
100188028
Last Updated
July 11, 2024
Last Updated By
wyv2@cdc.gov
Archive Date
July 11, 2024