sole source 8 18 2022 10 58 AM.pdf

August 18, 2022

Notice of Intent to Sole Source:

University of Maryland, School of Medicine, Institute for Genome Sciences

FDA-1255045

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to the University of Maryland, School of Medicine, Institute for Genome Sciences located at 670 West Baltimore Street, Baltimore, MD 21201. In accordance with FAR Part 13.106- l(b), (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold.

(i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

The purpose of this notice is to inform the public that the Food and Drug Administration (FDA) anticipates issuing a purchase order.

MINIMUM REQUIREMENTS:

Specific Tasks/Deliverables

FDA/CBER is undertaking a study in baboons to evaluate immune responses in vaccinated animals following infection. The work covered in this requirement is extending a study already conducted to evaluate the immune responses in a large number of unvaccinated animals following infection. To enable co-analyses of both data sets, it is necessary to have this work performed by the same vendor using the same methods and equipment to reduce variables that would confound the analysis.

The purpose of this solicitation is to contract for RNA extraction, quality control assessment, library preparation and Illumina sequencing of 200 peripheral blood samples collected in PaxGene tubes.

Requirements

The contractor(s) shall:

Isolate RNA from 200 PaxGene samples.

Conduct quality control assessment on 200 samples Perform library preperation on 200 samples Perform Illumina sequencing of 200 samples. 50 million, paired end reads.

Provide sequencing data to FDA/CBER researchers

This notice is not a request for competitive proposals. However, any party that believes it can meet 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 University of Texas, Baboon Research Resource at MD Anderson within approximately ten (10) days af ter the date of this notice unless the Government determines that any other organization has the capability to meet this requirement .

Response Date: August 22rd

, 2022 by 2 PM EST. Please email responses to Howard Yablon – howard.yablon@fda.hhs.gov .

Signed By: Howard S. Yablon:

Contracting Officer mailto:howard.yablon@fda.hhs.gov