SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) – International Sites
- Notice Date
- 10/16/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HB-11-04
- Point of Contact
- Tara Knox, Phone: 301-402-0834, Allison M Stang, Phone: 301-435-0359
- E-Mail Address
-
knoxt@nhlbi.nih.gov, stanga@nhlbi.nih.gov
(knoxt@nhlbi.nih.gov, stanga@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of Health and Human Services (HHS) anticipates that Request for Proposals (RFP) No. NHLBI-HB-11-04 will be available on or about October 30, 2009. The solicitation will be for the International Sites for the program entitled ‘Recipient Epidemiology and Donor Evaluation Study-III (REDS-III).' It is anticipated that up to four awards will be made under full and open competition to U.S. blood centers collaborating with foreign blood centers/blood banks in low or middle income countries where HIV/AIDS is prevalent in January 2011 for a period of seven years. The goal of this highly structured, multicenter, 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. NHLBI plans to support one data coordinating center (DCC), one central laboratory, up to 4 domestic hubs, and up to 4 international collaborative programs involving U.S. investigators and investigators at international blood centers. This notice addresses the international hubs 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 REDS-III International program shall include epidemiologic and survey research as well as laboratory investigations. Clinical trials in potential recipients of blood products are NOT within the purview of the REDS-III program. A comprehensive longitudinal donation and donor database from each foreign collection site containing information on all donations collected during the period of the contract shall also be established to enable study investigators to address important blood safety issues. The research portfolios of the REDS-III Domestic and International programs will be fashioned in response to contemporary scientific questions that need to be addressed to advance blood transfusion safety in the U.S. and in countries where REDS-III international blood centers are located. The major objectives of the research in the REDS-III International program are: 1) assess and monitor the prevalence and incidence of HIV-1, HIV-2 and other existing as well as newly discovered infectious agents that pose a threat to blood safety; 2) assess risks of transfusion-transmitted infections; 3) assess the impact of existing and new blood donor screening methodologies on blood safety and availability; 4) evaluate characteristics and behaviors of blood donors including risk factors for acquiring HIV and other blood-borne agents; and 5) evaluate the donation process for ways to improve the safety and adequacy of the blood supply. Some studies may also address transfusion recipient safety concerns such as evaluating non-infectious transfusion risks (e.g., alloimmunization) and ways to reduce their occurrence. The domestic hubs and the international programs will be supported by a DCC responsible for overall coordination, communications, data management, and analytical/statistical support. The domestic hubs and the international programs will 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 infrastructure of the REDS-III international component shall consist of U.S. blood centers which have ongoing collaborative research arrangements with blood centers in low or middle income countries impacted by the HIV/AIDS epidemic. The blood centers participating in each international program must collect a total of at least 250,000 blood donations annually from at least three collaborating foreign collection sites. The foreign collection sites should be geographically dispersed and, whenever possible, be representative of the varying prevalence of HIV in the region(s)/country of interest. Each foreign blood collection site must collect a minimum of 25,000 donations annually. The infrastructure shall include a centralized data collection center (CCC) responsible for compiling donor/donation data and protocol specific data from participating blood centers within each country before being submitted to the REDS-III DCC. The offeror must meet the following three (3) mandatory qualification criteria at the time of receipt of proposal to be considered any further for award: 1.The offeror shall be a U.S. blood center, blood bank, or academic institution (henceforth referred to as a U.S. blood center) with an established collaborative program with a foreign blood center or blood bank in a low or middle income country where HIV/AIDS is prevalent. 2.The offeror shall provide evidence of scientific collaborations with proposed foreign site investigator(s) that could include participating in research project(s) in the foreign country, publications, and/or conducting training programs in the foreign country. 3.To ensure the statistical relevance of the resulting data, the offeror shall provide evidence (e.g., official institutional letter certifying the information) that the proposed foreign blood collection sites located in a low or middle income country collect a total of at least 250,000 blood donations per year from at least three collaborating foreign collection sites within the same country, and that each of the sites collects a minimum of 25,000 annual blood donation. Each U.S. Blood Center will perform the following program requirements: 1) Manage the REDS-III international sites scope of work and study protocols and ensure transmission of complete and accurate scientific data from the foreign blood collection sites (subcontracts) to the REDS-III DCC, in accordance with procedures set forth in the protocols and Manuals of Procedures; 2) Manage through foreign subcontracts the collection of a minimum of 250,000 blood donations annually from at least three collaborating and geographically dispersed foreign collection sites located in a low or middle income country affected by the AIDS epidemic. Each foreign blood collection site must collect a minimum of 25,000 donations annually; 3) Propose epidemiologic, survey, and/or laboratory studies that will advance blood transfusion safety in the country of interest; 4) U.S. blood center Principal Investigator shall serve as a member of the REDS-III Oversight Committee; 5) U.S. blood center and foreign investigators shall serve as members of the REDS-III country-specific International Steering Committee; 6) U.S. blood center and foreign collection sites shall participate in, coordinate, and successfully conduct the REDS-III research protocols that have been approved by the REDS-III country-specific International Steering Committee; 7) Oversee the establishment and the management of a Centralized Data Collection Center (CCC); 8) Translate all materials to appropriate languages or dialects, or to English, as appropriate; 9) Oversee the collection, processing, testing, and storage of biospecimens by the foreign blood collection sites as required by study protocols; 10) In collaboration with the REDS-III central laboratory and the DCC, the U.S. blood center shall oversee the shipment of specific biospecimens of research interest to the U.S. for laboratory testing which for technical or financial reasons is better accomplished at the central laboratory (or at another US testing facility subcontracted by the central laboratory); 11) Administer approved surveys and ensure that the foreign blood collection sites incorporate study protocols into blood center operations, contact participants, distribute questionnaires, collect and process data, address donor inquiries, and provide data to the CCC; 12) Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the international site Investigators and staff are members; and 13) obtain all necessary governmental, administrative, and regulatory approvals to ensure participation in and successful completion of all studies included in the REDS-III country-specific research portfolio. This announcement is not a request for proposals (RFP). Although up to four awards are anticipated, the Government is not committed to award a contract pursuant to this announcement. The RFP will be available on the FedBizOpps web page at www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. It is also the offerors' responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. The RFP will contain all the information and details to allow potential offerors to prepare and submit a contract proposal. This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541712. Subcontracting opportunities are anticipated during the course of this contract award. All responsible sources may submit a proposal, which shall be considered by the NHLBI.
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