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FBO DAILY ISSUE OF AUGUST 17, 2011 FBO #3553
SOURCES SOUGHT

A -- The Osteoarthritis Initiative – Data Coordinating Center

Notice Date
8/15/2011
 
Notice Type
Sources Sought
 
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-CSB-SBSS-AR-2012-15-KB
 
Archive Date
9/3/2012
 
Point of Contact
Kelli T Broda, Phone: 301-435-0332, Kristiane E Cooper, Phone: 301-435-6674
 
E-Mail Address
brodak@mail.nih.gov, cooperke@nhlbi.nih.gov
(brodak@mail.nih.gov, cooperke@nhlbi.nih.gov)
 
Small Business Set-Aside
Total Small Business
 
Description
This is a sources sought synopsis. This is not a Request for Proposals. The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is conducting a market survey to assess the availability and technical capability of a small business to perform this requirement. The applicable NAICS Code is 541712 with a size standard of 500 employees. It is anticipated that one award will be made by July 2012 for a period of three years. The National Institute of Arthritis and Musculoskeletal and Skin Diseases is seeking a Data Coordinating Center to complete the follow up years of the Osteoarthritis Initiative (OAI). The OAI is a multi-center, longitudinal, prospective study of knee osteoarthritis (OA) that has developed a public domain research resource. This resource serves to facilitate our basic understanding of OA and as a resource for the development and evaluation of OA biomarkers as potential surrogate endpoints for disease onset and progression. The OAI has recruited and followed for approximately 6 years approximately 4,800 subjects at high risk for OA initiation and progression. The NIAMS requires a Data Coordinating Center to immediately develop, implement, and oversee the following activities at the four OAI Clinical Sites: (1) mail and telephone interviews/questionnaires to assess overall health, measure development of disability, and collect co-morbid conditions, (2) in clinic visits for entire cohort for imaging, specimen collection, interviews/questionnaires, physical measurements, and outcomes adjudication, and (3) maintain and update all data and images online with appropriate supporting data that is accessible to the research public. Capability Statements will be reviewed based upon the following criteria: 1. Evidence of the firm's status as a small business under NAICS code 541712 with a size standard of 500 employees. 2. Experience and expertise in clinical research in chronic diseases; demonstrated understanding of and experience with clinical and radiographic criteria for the diagnosis of OA; demonstrated expertise with the design, development, and implementation of clinical cohort studies in arthritis or studies of similar complexity; administration and interpretation of outcomes measures; and experience managing clinical studies. 3. Professional, technical, and administrative staff with experience pertinent to the development of a protocol and management of multi-center clinical study of arthritis or studies of similar complexity; demonstrated expertise in assessing outcome measures in arthritis, data collection, data monitoring, quality control, data analysis, and preparation of scientific reports and manuscripts; quality of associated radiology reading center; and experience in analysis and interpretation of medical data for purposes of ensuring subject safety. 4. Suitability of the proposed plan for sample data management, and data analysis and adequacy of the proposed methods of coordination, monitoring, and central management of all activities, and coordination of data collection. Capabilities for storage, on-site and off-site backup and posting of large amounts of clinical and imaging (8-15 terabytes) data. 5. Adequacy of the organizational and administrative structure of the proposed program and institutional commitment to the program; and availability and adequacy of the facilities and resources necessary for conducting study coordination, and data management and analysis, including computer hardware, software, and other equipment in order to successfully implement the requirements of the contract. If an interested small business believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must demonstrate the ability to perform the tasks as described above. All responses must be received in writing and must contain material in sufficient detail to allow the NHLBI to determine if the small business is capable of performing this requirement (responses should not exceed 20 pages including attachments). Responses providing insufficient information will not be considered. This is not a Request for Proposals (RFP), nor is an RFP available. Statements of capability must be received at the following address (or by email as a Word document or PDF) no later than 4:00 pm local time, August 30, 2011: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6213, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Kelli Broda, Contract Specialist, brodak@mail.nih.gov. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-SBSS-AR-2012-15-KB/listing.html)
 
Record
SN02534942-W 20110817/110815235616-afd02faaef89fb35269d443f9aa60cd4 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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