Notice of Intent to Award Sole Source Order for Weanling Olive Baboons

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE ORDER AND NOT A REQUEST FOR QUOTATIONS. This contract action is for the acquisition of supplies for which the Government intends to solicit and negotiate with only one source under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1(b). The U. S. Food and Drug Administration (FDA) intends to award a sole source firm-fixed price purchase order to Southwest Foundation for Biomedical Research (SFBR), 8715 West Military Drive, San Antonio, TX 78227 for four (4) Olive baboon weanlings, 10-14 months of age, unvaccinated, and Bordetella-free. The associated North American Industry Classification System (NAICS) Code is 112990 All Other Animal Production, SB Size status: $.75 million. At the U. S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), research conducted within the Office of Vaccine Research and Review (OVRR), which is tightly associated with its regulatory duties, involves the evaluation of immune responses to B. pertussis infection and vaccination using the baboon model of pertussis. Pertussis is an acute, highly contagious, potentially life-threatening respiratory disease, caused by the Gram-negative bacterium Bordetella pertussis. The underlying factors leading to the failure of public health measures to control pertussis disease using currently licensed vaccines are poorly understood. A more complete understanding of this disease and of the mechanisms of vaccine-mediated protection is a critical public health need. Currently, the baboon model of pertussis developed in the laboratories at FDA-CBER is the only animal model of pertussis that recapitulates the disease as observed in human patients. CBER-OVRR currently requires four replacement (4) Olive baboon weanlings, 10-14 months of age, unvaccinated and Bordetella-free, for an ongoing vaccine study to validate findings and strengthen the current Pertussis model. The 16 baboons initially procured for the study were sourced from SFBR. In order to effectively compare the immunological and pathological outcomes between all of the groups in the study, the replacement baboons must match the genetics and colony exposures of the other twelve animals currently in the study. Baboons obtained from a different colony would destroy the scientific efficacy and integrity of data collected thus far. FDA will solicit and negotiate directly with Southwest Foundation for Biomedical Research and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, all responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. Interested parties must express their interest in writing on or before November 30, 2019 by 2:00 PM Central Standard Time (CST) in Jefferson, Arkansas, to Tim Walbert via email at timothy.walbert@fda.hhs.gov with the solicitation number FDA_SOL_1222201 referenced in the Subject line. If no responsive statements are received by the time and date stated above, an award will be made to Southwest Foundation for Biomedical Research.