Tuberculin Vials (PPD, BOVIS)

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), National Veterinary Services Laboratories (NVSL), has an upcoming requirement for Mycobacterium bovis Purified Protein Derivative (PPD) used in the bovine caudal fold test. Product is dispensed in 10ml, 5ml, and 1ml vials. A 5 year IDIQ contract is anticipated with an estimated requirement of 30,000 vials per year. Manufacturers must be licensed to produce this product by CVB. Product is used to test for bovine tuberculosis per requirements of the federal bovine tuberculosis eradication program. The PPD Tuberculin specified herein is required by the National Veterinary Services Laboratories (NVSL), Ames, Iowa, for use in determining whether animals are infected with bovine tuberculosis. The Mycobacterium bovis Purified Protein Derivative Tuberculin (Tuberculin, PPD, BOVIS, hereinafter referred to as PPD Tuberculin), must be of current production. In order to meet program requirements, the delivery requirements specified must be met. It is highly important that the PPD Tuberculin possess the maximum uniformity possible from the standpoint of specificity and potency. Therefore, exacting compliance with uniform methods and materials in preparing, storing, diluting, testing, bottling, and shipping is essential. Any facility that is not already licensed and/or inspected and approved by the USDA for production of PPD Tuberculin shall be inspected and accepted and have product tested and licensed before a contract can be awarded to them. The manufacturer of the tuberculin must have, or be able to obtain, a license for the manufacturing of tuberculin from the USDA Center for Veterinary Biologics (CVB). APHIS is seeking interested sources from all concerns that are capable of manufacturing the materials indicated. The draft Statement of Work (SOW) is attached. The North American Industry Classification System (NAICS) code is 325413 In-Vitro Diagnostic Substance Manufacturing, with a small business size standard of 500 employees. This is not a request for proposals, but instead market research to determine interested sources prior to issuing the solicitation. The purpose of this Sources Sought Notice is to obtain an indication of interest and to obtain capability information of those interested sources. A determination by the Government on the method of competing this requirement has not been established. The Government will not award a contract based on this Sources Sought Notice, the information received, nor reimburse participants for the information they provide. If you are an interested concern, please provide the following information: 1.) Business name and Point of Contact; 2.) DUNS number; 3.) Indication of business size (large or small), and small business status if applicable (ie. HUBZone or SDVOSB); and 4.) A brief Statement of Capability which demonstrates the ability to meet the requirements specified in the above and the statement of work (including licensing). E-mail responses are preferred and telephonic requests for information will not be honored. No requests for capability briefings will be honored as a result of this notice. Information provided will not be used as a part of any subsequent solicitation requirement. Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. A determination by the Government not to compete this proposed contract action based on this notice is solely within the discretion of the Government. Responses are due no later than 1:00 p.m., Central Time, on May 10, 2018, to the attention of Patricia M. Simon, Contract Specialist, via e-mail to patricia.m.simon@aphis.usda.gov