SOURCES SOUGHT
A -- Medical Arm for Mechanically Assisted Circulatory Support (MEDAMACS) Registry
- Notice Date
- 5/1/2009
- 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
- SS-NHLBI-HV-09-22
- Point of Contact
- Jeffrey A Williams,, Phone: (301) 435-0340
- E-Mail Address
-
williamsja2@nhlbi.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health, is interested in soliciting capability statements from qualified small business offerors for a possible small business set aside program. Under consideration is the proposed program, Medical Arm for Mechanically Assisted Circulatory Support (MEDAMACS), a registry of advanced heart failure patients identified and followed in parallel to the patients receiving mechanical circulatory support devices collected through the existing Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)program. INTERMACS is a national registry of patients receiving mechanical circulatory support device (MCSD) therapy to treat advanced heart failure. It is a collaboration among NHLBI, FDA, CMS, clinicians, scientists, and industry. To date there are 94 centers participating and over 1500 patients enrolled in the registry. MEDAMACS will provide detailed data on advanced heart failure patients managed without device utilization. As many as 600,000 patients in the US have advanced heart failure, and the numbers are rising. Therapeutic approaches have changed little over the last few years and include: drugs, ICDS, and pacemakers. Patients, whose heart failure progresses to later stages of the disease, have options limited to medical management, transplantation or MCSD therapy. The MEDAMACS pilot data will provide a comparator to MCSD patient data collected through INTERMACS, serve to facilitate the refinement of patient selections to enhance clinical management with current devices, and guide and expedite clinical trials for new indications and/or new devices. Ambulatory heart failure patients will be identified at selected INTERMACS sites, enrolled and followed. The program will include Data Coordinating Center support, expert collaborators, and support for up to twelve INTERMACS clinical data collection sites and their collaborating cardiologists. It is anticipated that the MEDAMACS pilot will accumulate initial data sufficient to show feasibility for a future program. Data on approximately 40-50 consecutive consenting patients, from 8-10 sites to a total of 400 advanced heart failure patients, will be collected with patients followed-up at specified time points for up to 2 years. Specific patient eligibility criteria will be defined by an expert working group. The broad purpose of this registry pilot is to enable research to determine best medical practices for advancement of public health with respect to the use of standard and MCSD treatment of heart failure. The pilot registry utilizing the INTERMACS platform will: 1) Identify selected INTERMACS sites as collaborators; 2) Enroll prospectively a population of ambulatory patients followed on optimal medical therapy; for whom, chronic heart failure limits both function and survival to a range where elective implantation of left ventricular assist devices should offer meaningful benefit; 3) Establish expert working groups to develop data collection parameters and data elements for heart failure patients not receiving MCSDs; 4) Utilize standard methods consistent with INTERMACS processes to collect data and store patients’ clinical data including related costs; 5) Provide statistical analyses of the data and publish results; 6) Improve economic outcomes by identifying and optimizing factors affecting cost-effectiveness; 7) Guide and expedite clinical trial planning for new indications and/or new devices, including analyzing distribution of integrated functional survival endpoints to determine sample sizes for pivotal randomized trials; 8) Develop and advance a team of emerging clinical investigators in association with collaborating clinical sites. 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) Demonstrate past experience in and current capability to perform in collaborative biomedical clinical projects. Specifically, Offerors must provide a description of previous multi-center clinical research projects in which the organization and proposed personnel have participated; 2) Experience in and knowledge of cardiovascular and critical care medicine and the treatment of end-stage heart failure including the use of MCSDs as a treatment modality; 3) Experience in biostatistics, including survival analysis and computer systems include computer programmers and record analysts; 4) Experience in regulatory medicine as it applies to data collection of registries and informed consent and HIPAA requirements; 5) Experience with quality assurance and quality control, conducting site visits to assess site performance, and adherence to program procedures, timelines and program management and oversight; 6) Familiarization with INTERMACS data elements, collection, policies, and clinical sites; 7) Facilities available for receiving, processing, storing, and retrieving medical data accurately and efficiently. All responsible Small Businesses to include Small Disadvantaged, Women-Owned, Veteran-Owned, Service-Disabled Veteran-Owned, and HUBZone businesses, and Historically Black Colleges, University’s, and Minority Institutions are encouraged to submit capability statements. We ask that the capability statement not exceed 20 single sided or 10 double sided pages in length. Three (3) copies of the capability statement must be received at the following address no later than 15 calendar days from the publication date of this notice. Do not include budget information. When submitting this information, please refer to Sources Sought Notice SS-NHLBI-HV-09-22. Responses that do not adhere to these guidelines will not be considered. This notice will close fifteen calendar days after posting This is not a Request for Proposals (RFP). No RFP is available. If the 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. When released, the RFP will be available on the Federal Business Opportunities website. Questions may be directed to the Contract Specialist, Jeffrey Williams, williamsja2@nhlbi.nih.gov, 301-435-0338. Jeffrey A. Williams, Contract Specialist, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6120, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817; no MSC is required. Contracting Office Address: Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902 Primary Point of Contact: Jeffrey A Williams, Contract Specialist williamsja2@nhlbi.nih.gov Phone: (301) 435-0338 Fax: (301) 480-3338
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