CDC International Reagent Resource (CDC-IRR)

The purpose of this amendment 0002 is to do the following:

1. Change the website uptime status percentage from 99.99% to 99.90% to reflect the generally recognized industry standard. See section C.IV.F.3(c) on page 25 of the attached revised solicitation.
2. As a result of this amendment, the receipt date for proposals is not extended. Proposals are due no later than 2:00 PM EST, on Monday, July 30, 2018.
3. All other sections of the RFP remain unchanged.

.

Added: Jul 10, 2018 2:59 pm The purpose of this amendment 0002 is to do the following:

1. Change the website uptime status percentage from 99.99% to 99.90% to reflect the generally recognized industry standard. See section C.IV.F.3(c) on page 25 of the attached revised solicitation.
2. As a result of this amendment, the receipt date for proposals is not extended. Proposals are due no later than 2:00 PM EST, on Monday, July 30, 2018.
3. All other sections of the RFP remain unchanged.

The purpose of this amendment 0001 is to do the following:

1. Provide answers to the questions submitted by offerors. See attached Amendment 0001 document. (MS Word & PDF format)
2. Based on the answers to questions, revise Sections B and C of the RFP 2018-N-67801R, and the Appendix B. See attached revised documents (Revised 2018-N-67801R_MS Word Format & PDF Format; and Revised IRR Appendix B_Quality Specifications).
3. As a result of this amendment, the receipt date for proposals is extended. Proposals are due no later than 2:00 PM EST, on Monday, July 30, 2018.

.

Added: Jul 02, 2018 2:05 pm The purpose of this amendment 0001 is to do the following:

1. Provide answers to the questions submitted by offerors. See attached Amendment 0001 document. (MS Word & PDF format)
2. Based on the answers to questions, revise Sections B and C of the RFP 2018-N-67801R, and the Appendix B. See attached revised documents (Revised 2018-N-67801R_MS Word Format & PDF Format; and Revised IRR Appendix B_Quality Specifications).
3. As a result of this amendment, the receipt date for proposals is extended. Proposals are due no later than 2:00 PM EST, on Monday, July 30, 2018.

The Solicitation Request for Proposal (RFP) 2018-N-67801R (RFP document in MS Word and PDF formats and Appendices A-H) is being added to this announcement and is attached.

The solicitation (RFP) response time will be 30 days. Interested parties must respond to the solicitation RFP in order to be considered for award of any resultant contract. Please note that all questions shall be received no later than 2:00pm, EST, Wednesday, June 27, 2018 in accordance with Section L.5 in the solicitation. All proposals should be received no later than 2:00pm, EST, Friday, July 13, 2018.

.

Added: Jun 13, 2018 2:26 pm

The Solicitation Request for Proposal (RFP) 2018-N-67801R (RFP document in MS Word and PDF formats and Appendices A-H) is being added to this announcement and is attached.

The solicitation (RFP) response time will be 30 days. Interested parties must respond to the solicitation RFP in order to be considered for award of any resultant contract. Please note that all questions shall be received no later than 2:00pm, EST, Wednesday, June 27, 2018 in accordance with Section L.5 in the solicitation. All proposals should be received no later than 2:00pm, EST, Friday, July 13, 2018.

The Government anticipates release of RFP on or before 06/13/2018.

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.

.

Added: May 29, 2018 3:27 pm The Government anticipates release of RFP on or before 06/13/2018.

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.