SOURCES SOUGHT
A -- National Registry of Patients with Marfan Syndrome
- Notice Date
- 9/3/2004
- 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, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-SS-05-09
- Response Due
- 9/20/2004
- Archive Date
- 10/5/2004
- Point of Contact
- Craig Miron, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338, - Pamela Lew, Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
cm49x@nih.gov, pl116x@nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is interested in soliciting capability statements from qualified small business offerors for a possible small business set aside program. The program being considered is to establish a data coordinating center (DCC) to develop and maintain a registry of patients with Marfan Syndrome and other connective tissue disorders receiving treatment for aortic aneurysm, heart failure and other cardiovascular complications. The DCC will recruit 5 regional clinical centers which will collect and transmit to the DCC data, blood and tissue specimens on patients referred for treatment due to Marfan-related or other genetically-triggered cardiovascular complications. The DCC will collect and analyze clinical and laboratory data from RCCs on patients receiving treatment for aortic dilatation, aortic insufficiency, heart failure, or aortic valve repair. The registry will provide data about the RCCs and patient-care providers, treatment and patient characteristics, and outcomes in the hospital and in follow-up to researchers inside and outside the registry who are interested in advancing the fundamental understanding of aortic aneurysms or management of connective tissue disorder afflicted patients. An important capacity of the registry will be to collect family pedigrees and develop screening protocols for extended families. The registry will collect information on extra-cardiac complications of connective tissue disorders as well. It is estimated that 300 Marfan patients receive valvular surgery each year and that many more patients are being followed for aortic root disease and heart failure. The expected capacity for collection of new patient data and specimens is 1,000/year for a period of 4 years. Specifically, the DCC will: a) develop study protocols to collect data, blood and tissue samples, study policies, a manual of operations and study forms and informed consent documents in collaboration with a steering committee and the NHLBI, b) collect, format and store data, c) provide statistical analysis of the data and develop necessary software for this analysis, d) establish methods and procedures for tissue collection and storage, and e) facilitate interaction among the participating centers and provide administrative and logistical support for publication and dissemination of findings. At a minimum, prospective offerors must document capabilities in the following areas which would evidence the potential to successfully complete the work of the registry: 1) Experience and adequacy of time commitment of the professional, technical and administrative staff, as well as any proposed consultants, to collect, store, process and analyze patient data and tissue samples; experience in developing manuals of operations for the collection of data from clinical sites or patient registries; and monitoring quality, completeness and timeliness of submissions of data and specimens from multiple sites. 2) Experience in diagnosis and treatment of aortic aneurysmal disease and its complications; experience in surgical procedures for aortic root disease and evaluation of outcomes; experience in family genetics, molecular biology, imaging and in assessing quality of life and economic impact of medical costs and lost wages. Experience in assessing the adequacy of medical facilities and support teams that serve patients and in patient selection criteria and its impact on reducing adverse events. 3) Experience in developing plans for analyzing large numbers of clinical measures. 4) Experience in developing statistical designs for analysis of data. 5) Facilities available for receiving, processing, storing, and retrieving medical data and specimens accurately and efficiently, including any equipment to automate the processing of data forms. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the attention of the Contracting Officer at the above address. Three copies of the capabilities statement must be received at this address fifteen (15) days from the publication date of this Notice. When submitting this information, please reference Sources Sought Notice No. SS-NHLBI-HV-05-09. 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 concerns. The RFP will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NHLBI Website: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp. The North American Industry Classification System (NAICS) code is 541710 with a business size standard of 500 employees. Interested organizations submitting a capability statement are required to identify their size status.
- Record
- SN00665195-W 20040905/040903211806 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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