SOURCES SOUGHT
A -- Registry of Angioplasty Registries (ROAR)
- Notice Date
- 4/4/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NHLBI-HV-08-04
- Response Due
- 4/19/2007
- Archive Date
- 2/28/2008
- Description
- This Request for Information (RFI) issued by the National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), is intended to solicit information from qualified small business offerors to serve as a Data Coordinating Center (DCC) that shall collect and analyze data for approximately 100,000 post-stent patients. This RFI is for planning purposes only and shall not be construed as a Request of Proposal or as an obligation on the part of NHLBI to acquire any research and development studies. NHLBI does not intend to award a contract on the basis of this RFI nor pay for the information provided. No entitlement to payment of direct or indirect costs or charges will arise as a result of submission of responses to the RFI and NHLBI?s use of such information. The research proposed is for the establishment of a registry of data that shall be collected and analyzed from existing and on-going registries and clinical trials. The registry shall combine patient level data from high quality registries and clinical trial data sets of drug eluting stents (DESs) and bare metal stents (BMSs). Rates of long term success and of adverse events will be evaluated. Additional data shall be collected and utilized in analysis as participant registries continue to collect and transmit data to the DCC. The DCC shall: 1) provide biostatistical support for protocol development, including power and sample size calculations; 2) monitor collection and analysis of registry data; 3) provide administrative guidance, oversight, and support for the registry as a whole; 4) develop a manual of operations, registry forms and informed consent documents in collaboration with a Steering Committee and the NHLBI; 5) make travel arrangements and reimbursement for registry personnel; 6) coordinate, plan, make arrangements for, and participate in the Steering Committee meetings and its subcommittees; 7) prepare and distribute minutes of meetings; 8) establish and maintain the necessary hardware and software required to process, store and analyze registry data; 9) prepare and distribute periodic technical and statistical reports; 10) review, registry plans, procedures, activities, and data to ensure the scientific validity and clinical relevance of the registry; and 11) provide administrative and logistical support for publication and dissemination of findings. The DCC shall have experience in developing plans for analyzing large numbers of clinical measures from clinical trials and registry data sets. The DCC shall have experience integrating and analyzing data from different clinical trial and registry databases. The DCC shall provide adequate facilities available for receiving, processing, storing, and retrieving medical data efficiently, including the ability to automate the processing of data forms. Small businesses that believe they possess the capabilities necessary to undertake this study shall submit documentation of their capabilities to the Contracting Officer. The capability statement submitted shall include: 1) the total number of employees; 2) the professional qualifications of all technical personnel required to achieve the above objectives; 3) a description of general and specific facilities and available equipment, including computer equipment and software; and 4) an outline of previous registries and research projects in which the proposed personnel have participated in and any other information that is relevant to this program. RFI submissions shall not exceed 20 pages (text, graphic, tables, etc.). Interested small business organizations submitting a capability statement are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in response to this RFI. However, responses to this RFI that indicate that the information therein is propriety will be properly safeguarded for Government use only. Questions, concerns and responses should be emailed to Mr. Tirene Crowell at crowellt@nhlbi.nih.gov. Responses shall be submitted by 3PM Eastern Standard Time, April 19, 2007. Responses shall be submitted in Adobe Acrobat PDF format and include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. When submitting this information, please reference the solicitation notice number. Responses received after the due date may not be reviewed. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business organizations. The RFP will be available in FedBizOpps and electronically via the NHLBI Website.
- Record
- SN01266026-W 20070406/070404220453 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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