sole source 8 18 2022 10 41 AM.pdf

August 18, 2022

Notice of Intent to Sole Source:

University of Texas Baboon Research Resource at MD Anderson

FDA-1254214

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to University of Texas, Baboon Research Resource at MD Anderson, located at 1515 Holcombe Blvd., Unit 207, Houston, Texas 77030.. 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

The purpose of this sole-source contract is to contract a study in which twelve baboons that have recovered from B. pertussis infection will be housed and followed for one year in order to assess duration of B. pertussis immune responses.

• The contractor(s) shall transport twelve convalescent baboons from FDA/CBER to MD Anderson.

• The animals shall be housed for one year in a manner that minimizes exposure to B. pertussis.

• Twice during the year, samples will be collected from the animals as follows:

1) Draw Blood a. 8 mls for PBMCs for evaluation of T-cell responses. PBMCs will be isolated on site, stimulated with HKBp or cocktail of antigens and incubated at 37OC in 5% CO2 for 72 hours. An aliquot of each culture supernatant will be analysed by Luminex for a 8-plex cytokine panel. The remaining supernatant will be frozen and shipped to CBER. Plasma will be frozen and sent to CBER for antigen ELISAs and banking for proteomics

b) 8 mls whole blood shipped fresh overnight to LJII for evaluation of memory responses in the periphery.

c) 0.5 mls for CBCs.

2) Collect bone marrow for evaluation of B-cell and T-cell memory. Ship fresh to FDA/ CBER overnight.

3) Collect BAL to quantify Tissue-resident memory cells (TRM) cells. Ship fresh overnight to FDA/ CBER.

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 after 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