CDC International Reagent Resource (CDC-IRR)

The Centers for Disease Control and Prevention (CDC) intends to issue a full and open competition Request for Proposal (RFP) to support National Center for Immunizations and Respiratory Diseases (NCIRD). This will be a follow-on requirement to a previous ten-year contract 200-2018-28045 entitled, "The CDC Influenza Reagent Resource (CDC-IRR)", which was awarded to American Type Culture Collection (ATCC), on September 26, 2008. It is anticipated that the resultant contract, renamed the "The CDC International Reagent Resource (CDC-IRR), will be cost-plus-fixed-fee and will have a period of performance of one hundred twenty (120) months. The applicable NAICS code is 541990. The RFP will be posted on FedBizOpps and is expected to be released on or about April 25, 2018. Interested parties are responsible for checking the website regularly for release of the RFP and for other procurement-related documents. TELEPHONE CALLS WILL NOT BE ACCEPTED. The information provided in this pre-solicitation is for information purposes only. If there are any differences in the information provided here and the actual solicitation when released, the information provided in the actual solicitation shall govern.

The contractor will produce or otherwise acquire, characterize, store and distribute CDC-furnished NCIRD pathogens and other reagents, including ancillary reagents critical to the performance of CDC-developed assays, and associated with influenza, non-influenza respiratory viruses and bacteria, and other vaccine preventable bacterial diseases as described in SOW. This includes live and inactivated viruses, bacteria, nucleic acids, antisera, proteins, cell lines, hybridomas, monoclonal antibodies.

The purpose of IRR reagents is to assist in characterization of viral and bacterial pathogens as part of CDC surveillance and emergency response activities to aid in the development, evaluation, validation and testing of diagnostic products, to support vaccine development, and to support other research activities that increase awareness, knowledge, and understanding of the public health issues related to these pathogens. The IRR inventory of viruses, bacteria and other reagents will be regularly updated during contract performance to ensure that the catalog reflects current circulating or novel pathogen strains relevant to the ongoing surveillance and research activities of CDC and its partner laboratories. The contractor will ensure that these reagents are available to the CDC, its public health laboratory partners, and researchers and developers for characterization of circulating and novel viruses and bacteria and ensure the ability to ramp up acquisition, production, and distribution activities to surge levels as may be needed to meet the needs of a public health emergency.

All reagents produced by the contractor or its subcontractors shall be in accordance with the format and quality specifications as described in SOW. These reagents will be added to the IRR's existing inventory of over 200,000 vials of viruses, antigens, antisera, cell lines, monoclonal antibodies, plasmids, and other genetic materials, and over 4,000 RT-PCR typing kits and panels. All IRR reagents will be manufactured according to a recognized national or international quality standard such as ISO 9001, US current good manufacturing practices, or comparable standards. Manufacturing batch records documenting all production processes and quality control testing for every lot shall be maintained by the contractor and available for CDC review upon request.

Upon approval from CDC, IRR reagents that have met all required quality specifications will be made available to registered persons and institutions through an electronic "storefront" website, www.internationalreagentresource.org to be provided by the government and maintained by the contractor. The contractor will receive and process reagent order requests from the IRR website via their internal ERP system and manage all shipping logistics to recipient laboratories. In fiscal year 2016, the IRR shipped around 13,000 reagents in 1,675 shipments, 88 percent of which were to domestic states and territories.