Manufacture of live and inactivated viruses to support laboratory testing component for surveillance studies.

The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to American Type Culture Collection (ATCC ), 10801 University Blvd, Manassas, VA 20110 to manufacture live and inactivated viruses to support laboratory testing component for surveillance studies. CDC’s Influenza Division awarded the “CDC Influenza Reagent Contract (CDC-IRR)”, to contractor American Type Culture Collection (ATCC) in 2008 and a follow-on contract in 2018 to provide laboratory support to public health professionals as necessary to minimize the impact of an influenza pandemic on the health of Americans. CDC supported the manufacture of live and inactivated influenza viruses for global distribution in addition to CDC use for surveillance studies. Limitations arose due to the scope of the contract. Such limitations included a ceiling on antigens required to support the epidemiological studies that answer critical questions such as vaccine effectiveness and seroprevalence in specific populations. The limitations required the need to expand the quantity of live and inactivated viruses needed to support the laboratory testing component of the surveillance studies. CDC Subject Matter Experts (SMEs) supported the extensive technology transfer of viral propagation and inactivation protocols to ATCC over the past 12 years. The live and inactivated viruses have been used in testing to support many surveillance studies over the years. Currently the testing of samples in active surveillance studies has been halted due to the depletion of qualified live and inactivated viruses. The need to replenish the qualified live and inactivated viruses with similar quality of product is critical for results interpretation and data analysis. Introduction of products with varying qualities will result in discrepancies the data for numerous studies. Thus, the need for consistency in the qualified live and inactivated viruses production over different lots of product is required. Other offerors services were not considered because American Type Culture Collection (ATCC) is the only full-service facility that can provide the government solutions to NCIRD’s research needs while maintaining the same level of quality of previously manufactured products. Other potential offerors would require extensive technology transfer of protocols and technical support to provide the products needed to continue the current surveillance studies. 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 to Maria Shamburger, [email protected], Contracting Officer, Reference 2020-111720, Centers for Disease Control, Office of Acquisition Services, District at Chamblee, Building #2900, 2900 Woodcock Blvd, MS TCU-4, Atlanta, GA 30341. 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 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 ATCC, as the only source and a contract will be issued without any additional notices being posted.