Notice of Intent to Sole Source - Pigtail Macaques

NOTICE OF INTENT TO SOLE SOURCE. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC), Division of HIV Prevention, Laboratory Branch, hereby announces its intent to issue a sole source order/contract to University of Washington. The NAICS code for this acquisition is 112990, All other Animal Production, with a size standard in millions of dollars of $2.75. Purpose: To purchase 16 Female Pigtail macaques for pharmacokinetic and efficacy studies of antiretroviral prophylaxis by the Centers for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV Prevention, Laboratory Branch Scope Independently, and not as an agent of the Government, the contractor shall provide all necessary trained personnel, transport cages, equipment, and materials to provide and deliver safely and humanely 16 female pigtail macaques to the Centers for Disease Control and Prevention (CDC), NCHHSTP, DHP, Laboratory Branch. The contractor's facility must be licensed by the United States Department of Agriculture and accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). The contractor's facility must be in compliance with the Animal Welfare Act and Regulations (Title 9 Code of Federal Regulations part 1), The Guide for the Care and Use of Laboratory Animals, and other federal policies and guidance as applicable that provide national standards for the acquisition, transportation, housing, control, maintenance, handling, treatment, care, use and disposal of macaques. The contractor transport company also must be United States Department of Agriculture (USDA) licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2013 USDA regulations, the contractor shall provide a copy of their transport - contingency plan for review by the CDC Contracting Officer's Representative (COR), CDC technical advisor, and CDC veterinarians. The contractor shall maintain its nonhuman primates in complex social and physical environments (other than during diagnostic testing or as clinically necessary for treatment) to provide behaviorally and medically healthy macaques. The contractor shall provide detailed information on veterinary care and a description of any procedures that have been performed on the macaques. The contractor shall send records of macaques to the COR and CDC veterinarian and maintain a copy for at least 3-years beyond the time of delivery/acquisition. Tasks To Be Performed The contractor shall provide 16 Female Pigtail macaques, meeting the following specifications: Pigtail macaques must be between the ages of 4 and 13 years. The contractor shall provide proof of the date of birth for each primate to the COR. The contractor shall ensure that all pigtail macaques have tested negative for tuberculosis (TB), tested for the presence of a measles antibody titer, tested for Macacine alphaherpesvirus 1 (B virus) antibody, tested negative for antibodies to SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), tested negative to simian retrovirus (SRV type D) by polymerase chain reaction (PCR), and been tested for the presence of internal and external parasites (include the testing modality used for internal parasitism and macaques shall have tested negative for Trichuris spp.), and tested negative by PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia). The contractor shall ensure that the macaques shall not have participated in prior studies with, or been exposed to HIV, SIV, SHIV, or other retrovirus studies prior to purchase by CDC. All macaques must have a breeder's statement and/or Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) export permits and declaration forms available. This must be provided to the COR and CDC veterinarian for each macaque. Preference is for macaques that have been maintained in complex social and physical environments for behavioral and medical health. If animals have been single housed within 2yrs of consideration, additional information on length of single housing along with behavioral history and documentation of any observed or reported abnormal behaviors is required. All macaques shall have had no invasive surgical procedures except caesarian. Hysterectomized macaques are not acceptable. All macaques shall have been confirmed NOT to be pregnant at the time of selection or shipment. Note: CDC reserves the right to request further information based on the history of pathogens noted in macaque's medical records and reserves the right to deny the selection of macaques based on the medical history and/or diagnostic testing. Additional testing may be required for animals who lived in or currently live in areas with known endemic pathogens of clinical concern (e.g., Coccidioides, Burkholderia pseudomallei, Chagas). A determination by the Government not to compete this proposed action will be based on responses to this notice and is solely in the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov. This action is for services which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit quotations. This is not a request for competitive quotations; however, the Government will review any/all product, capabilities, and pricing information submitted prior to the closure of this notice. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any responses should be emailed to Stephanie Reid at qsi5@cdc.gov by 3:00 pm EST on 14 FEB 2024