65--36C10G18R0003 Biologics

Description

PRE-SOLICITATION NOTICE: The Department of Veterans Affairs (VA), Strategic Acquisition Center in Fredericksburg, Virginia intends to issue a solicitation for the procurement of various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes. These biologics and biological implants are to be used in various surgeries and medical procedures to treat, prevent, or diagnose diseases. Biologic implants will consist of Allograft and Xenograft tissue. Allografts are bone and soft tissue grafts taken from human cadavers of genetically non-identical member of the same species. Most human tissue and organ transplants are Allografts. Xenografts are bone and soft-tissue grafts taken from animals, typically pigs and cows. All products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128 only for Medical Products of Human Origin, such as Allografts, which is the global standard for the identification, labeling, and information transfer of medical products used in the VA. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel. The Government intends to issue a Request for Proposal (RFP) to establish multiple-award Indefinite Delivery Indefinite Quantity contracts. The anticipated period of performance is 1-year base with four 1-year option. The Government anticipates awarding up to 30 awards from the resulting solicitation. The Government intends to post the RFP to Federal Business Opportunities website at http://www.fbo.gov/ not later than 28 February 2018 that is changed from the previous notice of on or about 31 December 2018. The solicitation will remain open and continuous for 1-year with submission cut offs dates in May, August and November 2018 and February 2019 for proposals to be submitted for evaluation. Specific details will be included in the final solicitation. All responsible sources must be registered in the System for Award Management (SAM) under NAICS Code: 339113 Surgical Appliance and Supplies Manufacturing, 750 Employees database at the following website: https://www.sam.gov/portal/public/SAM/. No telephone or email requests for information will be taken at this time.