sole source 8 18 2022 3 06 PM.pdf

August 18, 2022

Notice of Intent to Sole Source:

La Jolla Institute for Immunology

FDA-1255063

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to the La Jolla Institute for Immunology located at 9420 Athena Circle, La Jolla, CA 92037. 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 of ficers 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 examine duration of vaccine-mediated pertussis immunity in a controlled population. This project requires evaluation of immune responses in the lymph nodes of vaccinated baboons. The samples for this analysis must be collected in a manner that does not harm the animal or induce inf lammation. This project is being funded by NIH/DMID through an interagency agreement and was developed in collaboration with Dr. Shane Crotty at the La Jolla Institute for Immunology. Dr. Crotty is a pioneer in lymph node germinal center analysis and the world’s leading expert on T follicular helper cells. His research group developed the methodology required to conduct this analysis.

Purpose

The purpose of this solicitation is to contract for the analysis of lymph node fine needle aspirates from 48 baboons vaccinated with B. pertussis whole cell or acellular vaccines.

Requirements

The contractor(s) shall:

Oversee the collection of fine-needle aspirates from 36 unvaccinated and vaccinated baboons (12 unvaccinated, 12 aP-vaccinated and 12 wP-vaccinated).

Isolate cells from 168 lymph node aspirates.

Perform FACS analysis to phenotype germinal center B and TFH cells.

Perform FACS analysis to phenotype germinal center TFH activated cells (AIM analysis)

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