R -- PROVIDE OPERATIONAL AND LOGISTICAL SUPPORT FOR NIH DATA SAFETY AND MONITORING BOARDS

Key Dates: Responses are due January 5, 2007.Responses are to be submitted to Valerie Pickett, Contracting Officer, Office of Logistics and Acquisition Operations (OLAO), 6011 Executive Boulevard, Suite 529G, Bethesda, MD 20892. You are encouraged to also submit an electronic response, if available to vp5v@nih.gov. Questions may be submitted via email to Valerie Pickett at vp5v@nih.gov. Fax inquiries should be sent to 301-435-6101. The National Institutes of Health (NIH) is seeking expressions of capability and interest from businesses and other organizations that may be capable of providing operational and logistical support for Data Safety and Monitoring Boards (DSMBs) comprised of scientific, statistical, ethical, and other experts assisting the NIH research institutes and centers (ICs) in monitoring the progress and safety of clinical trials. Services would be provided to the NIH Bethesda, Maryland campus and, potentially, to other locations across the United States. To date, many of these DSMBs have been managed and provided logistical support by individual ICs. NIH is exploring the feasibility of providing these management and support functions on an NIH-wide or IC-wide basis through one or more contracts. This RFI seeks preliminary information on the extent to which these services may be available in the market place. THERE IS NO SOLICITATION AT THIS TIME. This request is for capability information and does not constitute a request for proposals. Submission of any information in response to this RFI is purely voluntary; the Government assumes no financial responsibility for any costs incurred. The applicable North American Industry Classification System Code assigned to this requirement is 561110, Administrative Services. It is anticipated that if the Government moves forward with an acquisition it would be for one (1) 12-month period with four (4) 12 month options. Background: The NIH is the world leader in the funding of biomedical research. It consists of 27 Institutes and Centers (ICs) and the Office of the Director. The ICs differ in their mandated health missions and the areas of scientific research they support, but certain types of research and research infrastructure span many of their missions. Clinical research, which refers to research involving human subjects, is conducted by NIH in-house investigators employed by the ICs (the Intramural Research Program) and through grants, cooperative agreements, and contracts funded by the ICs. NIH policies require the inclusion of a data and safety monitoring plan in each protocol for clinical research. http://grants.nih.gov/grants/guide/notice-files/not98-084.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. The method and degree of monitoring needed is related to the degree of risk to the human subjects and the complexity of the trial. The NIH guidelines generally require monitoring in the form of DSMBs for Phase III clinical trials. For earlier trials (Phases I and II), DSMBs are generally considered appropriate if the study has multiple clinical sites, is blinded (masked) or involves particularly high risk interventions or vulnerable populations. The number of DSMBs in operation at any given time varies; in a recent count, 340 were operating at NIH with about 2000 members total. A DSMB?s length of service will depend on the clinical trial it is organized to monitor. The number of times a DSMB meets in a given year will vary depending on the complexity of the trial and the data being accrued. The length of individual DSMB meetings can range from several hours to a full day or more, and conference calls may occur between meetings with varying frequency. The tasks involved in the convening, management, and support of the NIH DSMBs are multifaceted and would need to be accomplished in close coordination with program staff from the IC and the principal investigator of the trial. The tasks include: (1) the identification, recruitment, and appointment of experts in a range of academic disciplines, including science, clinical care, statistics, and ethics based on NIH standards and guidance, and are expected to include conflict of interest reviews based on NIH standards to ensure that their advice is not biased by financial or professional conflicts of interest; (2) ensuring that the DSMB members are protected from legal liability through appropriate insurance; (3) the convening of meetings of the DSMB and all logistical support for those meetings, including arranging a conference room and processing travel and lodging; (4) ensuring that DSMB members have ready access to the trial design, data, and other factors pertinent to its safety, while safeguarding confidential information; and (5) designing and implementing mechanisms for obtaining clear analysis from the DSMB on the safety of the trial and for conveying that analysis promptly to the NIH. Adequate insurance coverage for DSMB members is of particular importance, and responses to this RFI should address this issue specifically, providing evidence of the coverage that is available and its potential cost. If your organization has the potential capacity to perform these contract services, please provide the following information in response to this RFI: (1) Organization name, address, e-mail address, website address and telephone number as well as business size and type of ownership for the organization; and (2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability and liability insurance availability for DSMB members. Organizations responding to this RFI should keep in mind that this is a market survey and that only focused and pertinent information is requested. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. Taking into account the magnitude of this professional recruitment effort, organizations should also address the capacity of their financial infrastructure to coordinate and deliver contract performance. No geographic restriction is anticipated, but if responding organizations are located outside the Washington, D.C. metropolitan area, they should indicate how the organization would coordinate with the agency program office(s) located in Bethesda, Maryland, to provide support to multiple sites and DSMBs. Responding firms should provide three (3) copies of a tailored capability statement to the above address no later than January 5, 2007. You are also encouraged to transmit an electronic version of your capability statement, if available, to the Contracting Officer at vp5v@nih.gov. This notice is being published in FedBizOpps to reach the widest possible audience and to gather current market information. The Government will evaluate the submissions and other available market information to ascertain market capacity to (1) potentially provide the administrative support services consistent in scope and scale with those described in this notice and otherwise anticipated; (2) potential capacity to secure and apply the full range of financial, human capital, and technical resources required to successfully perform those and similar requirements; (3) potential capability to implement a successful project management plan that includes compliance with tight program schedules, cost containment, meeting and tracking performance, hiring and retention of DSMB members, obtaining adequate insurance coverage to protect the members from personal liability, carrying out and managing all DSMB functions and risk mitigation; (4) potential to provide all necessary services under a performance based service acquisition contract. This market survey may or may not result in a solicitation. NIH may decide to continue its current practice.