THIS IS A PRESOLICITATION NOTICE ONLY AND NOT A REQUEST FOR PROPOSAL (RFP). THE RFP WILL BE AVAILABLE AFTER THE CLOSING DATE OF THIS PRESOLICITATION NOTICE, WHICH IS 15 DAYS AFTER THE DATE OF THIS PRESOLICITATION NOTICE. The Blood Diseases and Resources Program of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is seeking potential sources to perform as the central laboratory for the program entitled - Recipient Epidemiology and Donor Evaluation Study - III (REDS-III). The applicable NAICS code is 541712 and the size standard is 500 employees. It is anticipated that one award will be made in January 2011 for a period of seven years. The objectives of the REDS-III program are to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S. affecting about five million recipients annually. This research program is not only critical to public health in the U.S. but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. NHLBI plans to support one data coordinating center, one central laboratory, up to four domestic hubs, and up to 4 international collaborative programs involving U.S. investigators and investigators at international blood centers. THIS NOTICE ADDRESSES THE CENTRAL LABORATORY ONLY The REDS-III program will target the following blood banking and transfusion medicine areas: 1) donor targeted strategies; 2) blood banking; 3) transfusion practices in adult patients; and 4) education and training. The goal of this highly structured, multi-center, donor-recipient epidemiology, laboratory, and clinical outcomes program is to advance public health by conducting critical research to improve transfusion practices and the safety and adequacy of the blood supply in the U.S. and in countries affected by the AIDS epidemic. The program will include large survey, epidemiological and laboratory investigations. Clinical trials in potential recipients of blood products are NOT within the purview of the REDS-III program. The research portfolios of the REDS-III Domestic and International programs will be fashioned in response to contemporary scientific questions which need to be addressed to advance blood transfusion safety in the U.S. and in countries where REDS-III international blood centers are located. It is expected that about one third of the studies conducted in the REDS-III Domestic program will address donor and/or donation safety and availability issues, and other blood banking questions; and that about two thirds of the investigations will address adult transfusion recipient safety concerns. Most studies performed in the international setting, however, are expected to address blood banking concerns including donor and/or donation safety and availability issues although a small number of studies might address transfusion recipient safety concerns. Comprehensive databases including information on donors and their donations/components (required for the Domestic and International programs), and on adult patients considered for, or receiving a transfusion (required for the Domestic program only) will enable study investigators with the necessary scientific and analytical expertise to address in a timely fashion, important scientific issues in blood banking and transfusion medicine. The domestic hubs and the international programs will be supported by a Data Coordinating Center (DCC) responsible for overall coordination, communications, data management, and analytical/statistical support. The domestic hubs and the international programs shall also be supported by a central laboratory, which will be responsible for the necessary infectious disease, molecular, genetic, immunological, hematological and other testing conducted in the U.S., and for serving as the REDS-III biospecimen repository. The Central Laboratory of the REDS-III Program shall be responsible for: 1) providing technical laboratory expertise and serving as an active participant in developing and prioritizing all REDS-III domestic and international research activities; 2) proposing, developing, and conducting laboratory-based research studies; 3) performing infectious disease, genetic, molecular, immunological, hematological or other processing and testing of biospecimens from all domestic hubs and international sites participating in RED-III epidemiological and laboratory studies according to protocol; 4) arranging and managing subcontracts with other laboratory testing facilities, as appropriate; and 5) serving as the REDS-III biospecimen repository. All responsible sources may submit a proposal which shall be considered by the National Heart, Lung, and Blood Institute (NHLBI).
