SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study - III (REDS-III) - Data Coordinating Center
- Notice Date
- 10/9/2009
- 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
- NIH-NHLBI-HB-11-02
- Archive Date
- 11/7/2009
- Point of Contact
- Kathleen J. Marsden, Phone: (301) 435-0364, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
km66x@nih.gov, lynn.furtaw@nih.gov
(km66x@nih.gov, lynn.furtaw@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 (DHHS) anticipates that Request for Proposals (RFP) No. NHLBI-HB-11-02 will be available on or about October 23, 2009. The solicitation will be for the Data Coordinating Center for the program entitled “Recipient Epidemiology and Donor Evaluation Study – III (REDS-III)”. 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 DATA COORDINATING CENTER 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 shall be supported by a DCC which shall be 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 shall 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 Data Coordinating Center (DCC) shall compile donation and patient data from the domestic centers (i.e., hubs) in 1) a centralized cumulative donor/donation/component database; 2) a centralized cumulative patient database; and 3) a centralized cumulative linked donor-recipient database that shall link all information on donors and their donations/components to information on the patients who received these components. The hub Centralized Data Collection Center (CCC) shall provide to the DCC the links that shall allow for the data from the donors, their donations and components to be linked with data on the recipients who received them. It will be desirable that at least 20,000 RBC transfusion exposures occur per year at each hub’s participating hospitals/outpatient clinics. It would also be desirable, although not required, that the consortium of hospitals participating in the hub admitted the following minimum number of cross-matched adult patients each year at the following hospital services: 1) intensive care units: 1,000; 2) cardiac surgery, 1,000; 3) orthopedic surgery, 500; 4) oncology/cancer center, 1,000; and 5) trauma service, 1,000. Each hub’s blood center must collect at least 75,000 allogeneic blood donations per year. Analysis of all data compiled in the databases shall be conducted by the DCC. Additionally, the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated five large epidemiological and/or survey studies and about ten laboratory studies [which may or may not be component(s) of the large epidemiological studies] during the course of the domestic program. The DCC shall compile donor and donation data from each international site in a centralized cumulative donor/donation database and shall be responsible for providing all statistical/analytical support for the analysis of these data. 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 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. Analysis of all data compiled in the database shall be conducted by the DCC. Additionally, the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated three large epidemiological and/or survey studies and about three laboratory studies [which may or may not be component(s) of the large epidemiological studies] conducted at each of the REDS-III international collaborative programs. The DCC shall perform the following study requirements: 1) coordinate REDS-III activities and participate as a member of the Oversight and Steering Committees to develop and implement a coordinated plan to achieve program objectives; 2) develop and maintain operating procedures for the REDS-III program; 3) develop and maintain a public and private REDS-III website; 4) develop and finalize the protocols and associated Manuals of Operations for the cumulative centralized databases; 5) coordinate and participate in the development and finalization of REDS-III study protocols and develop corresponding Manuals of Operations; 6) provide all necessary data management and tracking systems; 7) track all REDS-III biospecimens and their associated data, and identify biospecimens for retrieval; 8) provide training sessions and conduct site visits, as appropriate; 9) provide biostatistical support during protocol development and analyze database and study data collected during REDS-III; 10) assist the Oversight Committee and Steering Committees in preparation of scientific reports for publication and presentation; 11) help coordinate and convene the REDS-III Observational Study Monitoring Board (OSMB), provide administrative and logistic support for OSMB meetings/calls, prepare and present data reports to the OSMB, and prepare minutes of the sessions; 12) coordinate and convene the REDS-III External Review Panel, assist the NHLBI COTR(s) with the selection and invitation of the External Review Panel, provide administrative and logistic support for the External Review Panel meetings, prepare minutes from External Panel sessions and coordinate and pay for External Review Panel members travel and honorarium; 13) prepare quarterly and annual technical reports; 14) interact with the COTR(s) on programmatic research activity issues; 15) At close-out of the study, or earlier as directed by the COTR(s), create public use data sets for each data collection activity with documentation; and 16) ensure an orderly transition of REDS-III resources to a successor contractor at contract expiration. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS (RFP) and 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 North American Industry Classification System (NAICS) code 541712 and the size standard is 500 employees. Subcontracting opportunities are anticipated during the course of this contract. All responsible sources may submit a proposal, which shall be considered by the NHLBI.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NIH-NHLBI-HB-11-02/listing.html)
- Record
- SN01983566-W 20091011/091009234737-d180b7943c7b3587e9f2197e6ed24712 (fbodaily.com)
- Source
-
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