A -- Retrovirus Epidemiology Donor Study - II (REDS-II)

The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), will issue RFP No. NHLBI-HB-04-16 on or about July 24, 2003. It is anticipated that one cost reimbursement completion contract will be awarded. The contractor shall serve as a Coordinating Center (CC) for a new five-year multicenter research program, Retrovirus Epidemiology Donor Study-II (REDS-II). The objectives of REDS-II are to conduct epidemiological, laboratory, and survey research on volunteer blood donors to ensure the safety and availability of the Nation's blood supply. This includes monitoring known blood-borne infectious agents, evaluating the impact of emerging pathogens, assessing the safety implications of changes in laboratory and/or blood donor screening protocols, and examining blood supply and availability issues. The Coordinating Center will be expected to: 1) collect monthly donation data from 6-8 participating blood centers (under separate contracts) representing a minimum of between 170,000 and 220,000 donations annually; 2) process survey forms for one or two major studies with an estimated 15,000 - 50,000 subjects each; and 3) process, manage, and analyze data from approximately four laboratory projects annually . REDS-II Coordinating Center responsibilities include, but are not limited to the following: 1) Coordinate and participate in development and finalization of study protocols, manuals of operation, and design of study forms. 2) Arrange Steering Committee and other key meetings; prepare and distribute agenda, reports, and minutes. 3) Develop and implement data collection procedures for epidemiologic and survey studies; perform all activities of a coordinating center; assure the quality of the study data submitted and stored; provide support and documentation for the OMB forms clearance process. 4) Train blood center staff. 5) Assure prompt accumulation, entry, and editing of study data. 6) Communicate with blood centers concerning missing, delayed, incomplete, or erroneous data. 7) Obtain and process laboratory test reports; coordinate compilation of data into a study database for subsequent statistical analysis; maintain record of studies conducted; compile and manage an inventory of specimens shipped and received by the central laboratory from the blood centers. 8) Prepare technical progress reports. 9) Interact with the Project Officer on issues relating to study design, study conduct, and data analysis. 10) Analyze all study data collected during REDS-II. 11) Complete analysis of final study data for delivery in SAS format. 12) Assist in preparation of scientific reports for publication and presentation. 13) Develop, implement, and update an approved automated information system security plan. This is NOT a Request for Proposals (RFP), and the Government is not committed to award a contract pursuant to this notice. RFP-NHLBI-HB-04-16, Retrovirus Epidemiology Donor Study -II (REDS-II) - Coordinating Center, will be available from the NHLBI Website at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on FedBizOpps at: http://fedbizopps.gov. No collect calls will be accepted.