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The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a modification to contract 200-2019-04205 in accordance with... The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a modification to contract 200-2019-04205 in accordance with FAR 6.302-1 to American Type Culture Collection (ATCC), 10801 University Blvd, Manassas, VA 20110-2204, to fund the manufacture, acquisition, and distribution of increased quantities of laboratory reagents as necessary to meet anticipated demands of CDC-IRR approved laboratories to support continued measles and rubella surveillance worldwide. CDC-IRR approved laboratories in the Global Measles and Rubella Laboratory Network (GMRLN) support global measles and rubella surveillance and no longer have access to external funds to purchase and distribute the required laboratory supplies. Providing material through the CDC-IRR is now the only mechanism available to provide supplies to GMRLN. CDC Contract 200-2019-04205 with American Type Culture Collection (ATCC) currently provides for acquisition, storage and distribution of the materials that will be required to increase the reagents supplied to GMRLN for surveillance of measles and rubella worldwide. The existing contract also addresses important corollary issues associated with off-site cold or frozen storage of large quantities of laboratory reagents, order processing, and shipping logistics associated with a large-scale reagent distribution effort. Under the Influenza Division’s existing International Reagent Resource (IRR) contract, ATCC has built substantial infrastructure to support the purchase, storage, distribution and tracking of ancillary reagents to specifically support CDC diagnostic testing. The GMRLN’s projected needs for the anticipated ancillary reagent demand exceeds 2000 items over the next year. This volume of reagents will require substantial cold storage space and a robust inventory system to track receipt and distribution. ATCC’s repository facilities include 26,000 square feet of storage space, including 200+ liquid nitrogen tanks and mechanicals with multiple walk in freezers at +4°C, -20°C, and -80°C. Under the existing Influenza Division’s IRR contract, ATCC has developed an extensive tracking system specifically designed for monitoring pending and completed shipments of CDC reagents to CDC’s strategic laboratory partners in a manner that directly integrates with existing CDC databases. ATCC has built and now maintains an approved secure website for external laboratories partners to view available reagents and request support. The required reagents have also undergone laboratory validation testing in the GMRLN. Many deployments of CDC staff have taken place to support training for these specific reagents for use in the network. Re-training and re-validation of new reagents which may or may not be able to be procured in the various countries would be a time-consuming and arduous process, potentially halting all surveillance efforts and enabling the spread of a deadly disease. The ELISA kits that are currently marketed to the public have not undergone laboratory validation testing to ensure their optimization. Use of unvalidated kits would inhibit the ability to detect the virus in human samples. The immediate nature of the loss of procurement and distribution mechanism for the network is critical. Without the ability to move these diagnostic kits into the countries, surveillance for measles and rubella will plummet worldwide. The purchase and distribution of these reagents from an alternate vendor would require the development of an entirely new infrastructure to store the reagents in bulk (including refrigerated at 4-8°C), register recipient laboratories, receive orders, arrange shipping logistics, and report burn data. All of these mechanisms already exist with the current contract. Recreation of parallel processes would involve a significant duplication of cost, time, and staff labor. This would also delay the surveillance and outbreak response as these systems were being built and validated. ATCC is the only vendor able to meet the CDC’s requirement to distribute and store the materials required to meet the needs of global measles and rubella surveillance. ATCC is the only vendor able to meet the Government’s requirement immediately, without delay, additional validation testing or additional training, which will ensure continuity of surveillance for measles and rubella. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement which shall be considered by the agency. Please forward the capability statement information to Maria Shamburger, Contracting Officer, Reference 2020-04205 Centers for Disease Control, Office of Acquisition Services, ATTN: Maria Shamburger, heg9@cdc.gov. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, negotiations will be conducted with the American Type Culture Collection as the only source and a contract will be issued without any additional notices being posted.