SOLICITATION NOTICE
A -- Research and Development Sources Sought for the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Renewal
- Notice Date
- 7/28/2009
- 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
- PS-NHLBI-HV-10-23
- Point of Contact
- Jeffrey A Williams, Phone: (301) 435-0338
- E-Mail Address
-
williamsja2@nhlbi.nih.gov
(williamsja2@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health, intends to negotiate on a non-competitive basis with the incumbent contractor for the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Data Coordinating Center (the University of Alabama at Birmingham) for the renewal of the INTERMACS program. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement before we negotiate on a non-competitive basis in accordance with the statutory authority cited under FAR 6.302-1 and HHSAR 306-302-1. Background The NHLBI is interested in renewing the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) program contract for a data coordinating center to manage a registry of advanced heart failure patients receiving FDA-approved, durable, mechanical circulatory support devices (MCSDs). INTERMACS is a national registry created to advance the understanding and application of mechanical circulatory support in order to improve the mortality, morbidity, and quality of life of patients with advanced heart failure. It is a collaboration among NHLBI, FDA, CMS, clinicians, scientists, and industry. To date there are 96 centers participating and over 1700 patients enrolled in the registry. As many as 600,000 patients in the US have advanced heart failure, and the numbers are growing. Therapeutic approaches have changed little over the last few years and include: drugs, implantable cardioverter defibrillators, and pacemakers. Patients whose heart failure progresses to later stages of heart failure have options limited to medical management, transplantation or mechanical circulatory support device (MCSD) therapy. INTERMACS data 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. Purpose and Objectives The goal of the proposed program is to continue and expand data collection of advanced heart failure patients receiving mechanical circulatory support devices (MCSD) collected through the existing INTERMACS contract. This will provide detailed data on advanced heart failure patients treated with FDA-approved, durable MCSD devices throughout the United States. All patients receiving MCSDs at INTERMACS certified sites are entered into the registry database. Information on patient demographics, clinical and laboratory parameters, outcome measures, hospital and device performance, as well as blood and tissue samples are collected and stored. The program is supported by an INTERMACS Data Coordinating Center. Project Requirements 1.Develop and implement a business plan that integrates non-federal government support for the INTERMACS enterprise on an increasing scale so that at the end of five years the NHLBI contribution to maintain the registry would be significantly reduced. 2.Maintain and support the existing Steering Committee structure and function including: representation from the NHLBI Project Office, the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), a study chair designated by the NHLBI, the Data Coordinating Center (DCC) Principal Investigator, Co-investigators, and members from representative participating hospitals; and the current and future Subcommittees and their activities. 3.Provide travel arrangements for meetings to be held at least twice per year. And prepare and distribute minutes of these meeting. 4.Maintain and support certification and monitoring of hospital performance. 5.Maintain and support regulatory requirements for patient privacy and good clinical practices. 6.Serve as the repository for clinical data and provide oversight for the collection and processing of blood and/or tissue specimens. 7.Provide statistical analysis of the data. 8.Prepare and distribute quarterly reports for participating hospitals to include patient recruitment in various categories, status of follow-up data, data compliance and other data as agreed between the sites and the DCC. 9.Provide both standard and specialized quarterly data reports to the Federal partners (FDA, CMS and NHLBI). 10.Provide quarterly individualized industry data reports to collaborating companies. 11.Provide a semiannual and annual summary report of the Registry to the NHLBI. 12.Coordinate and support meetings and conference calls and prepare and distribute minutes of the meetings. 13.Plan and conduct an annual conference for Registry collaborators and other interested investigators to present and review MCSD registry data. 14.Prepare interim limited access data sets, consistent with NHLBI policies. Provide interim data sets to NHLBI approved investigators. 15.Provide a final consolidated copy of patient data in hard copy and computerized disc formats, along with the supporting documents. 16.Perform site visits with record audits to determine the accuracy of web-based data submitted and information contained in source documents. Develop a plan for monitoring of INTERMACS hospitals over the 5 year course of the contract. 17.Work with participating hospitals and investigators to prepare for publication abstracts and manuscripts resulting from the Registry. 18.Develop a plan for extending research collaborations beyond the current INTERMACS investigators. 19.Develop and implement a plan to expand the pediatric component of INTERMACS in collaboration with outside organizations and other NIH programs. 20.Develop and execute procedures to make INTERMACS data collection software and associated documentation transportable for future government use. 21.Provide a detailed plan with cost estimates for identifying, contacting, and re-consenting existing INTERMACS patients. The plan shall include regulatory support costs both at the DCC and sites, site coordinator time, and documentation of the process. 22.Conduct registry data collection for a sub-study of prospective ambulatory heart failure patients followed on optimal medical therapy for whom chronic heart failure limits both function and survival to a range where elective implantation of LVADs should offer meaningful benefit. Anticipated Period of Performance A cost reimbursement contract is anticipated with an award date on or about May 31, 2010 and a period of performance for five years. Capability Statement NHLBI is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform the research effort described under the Purposes and Objectives. At a minimum prospective Offerors must document capabilities in the following areas: 1. Demonstrate past experience in and current capability to perform in collaborative biomedical clinical projects. Specifically, prospective offerors must provide a description of previous multi-center clinical research projects including registries, in which the organization and proposed personnel have participated. Curriculum vitas of potential key personnel must be provided. 2. a)Training and 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. b) Document experience in the clinical application of MCSDs, including knowledge regarding MCSD design, implantation and patient/device outcomes. c) Document expertise in assessing Quality of Life issues including the economic impact of medical costs and lost wages. d) Document experience in assessing the adequacy of medical facilities and the support teams that serve patients presenting with end-stage heart failure and the federal quality requirements associated with this care. Curriculum vitas of potential key personnel must be provided. 3. Document training and experience in data processing and biostatistical analysis of large numbers of patient and device variables and the use of survival analysis and competing outcomes statistical approaches to clinical outcomes data. Document the availability of sufficient computer systems and personnel including computer programmers and data managers to support the current and expanded database. Curriculum vitas of potential key personnel must be provided. 4. Training and experience in regulatory medicine as it applies to data collection of registries and informed consent, HIPAA requirements, and Investigational Device Exemption trials. Curriculum vitas of potential key personnel must be provided. 5. Training and 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. Curriculum vitas of potential key personnel must be provided. 6. Familiarization with INTERMACS data elements, collection, policies, clinical sites and industry collaborations, and data safety and security practices. 7. Facilities available for receiving, processing, storing, and retrieving medical data accurately and efficiently and blood and/or tissue specimen handling and storage. 8. Demonstrate past experience in re-consenting participants under a multi-center clinical research project, including registries. Discuss previously used strategies to locate, contact and re-consent existing patients in a registry or multi-center trial including staffing necessary for such an action. Provide estimates from previous experience as to the delays and added cost burden related to preparation of regulatory documents, submission for additional IRB reviews, locating, contacting and re-consenting patients and transitioning a large database to a new Data Coordination Center. Estimate impact of the need to reconsent patients upon continuity of data collection, scientific rigor of the registry, and provide strategies to overcome missing and incomplete data. 9. Experience in running or establishing a business collaboration with the government and medical device industry to generate matching funding to support a collaborative clinical activity. Training and experience in developing business plans. We ask that the capability statement not exceed 30 single sided or 15 double sided pages in length and that you respond by restating items 1 through 8 above followed with your response to each item. The curriculum vitas are not counted as part of the page limitation. Please identify your size classification relative to North American Industry Classification System (NAICS) code of 541712 for this requirement. Include a statement whether or not you are a small business; HUBZone small business; service-disabled, veteran-owned small businesses; 8(a) small business; women-owned small business; or small disadvantaged business in order to assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. 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: Contracting Office Address: Jeffrey A. Williams, Contract Specialist, National Heart, Lung, and Blood Institute, NIH, DHHS Office of Acquisitions, DERA 6701 Rockledge Drive RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902 (For overnight deliveries use zip code 20817; no MSC is required.) Do not include budget information. When submitting this information, please refer to Research and Development (R&D) Pre-solicitation Notice PS-NHLBI-HV-10-23. Responses that do not adhere to these guidelines will not be considered. This notice will close fifteen calendar days after posting. Questions may be directed to the Contract Specialist, Jeffrey Williams, williamsja2@nhlbi.nih.gov, 301-435-0338. Disclaimer and Important Notes. 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. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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