Added: Aug 14, 2008 10:35 am
The National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH), is conducting a market survey to determine the availability and technical capability of small business organizations. The applicable NAICS code is 541712 and the size standard is 500 employees. Sources are sought that possess the capability to serve as an Administrative Coordinating Center (ACC) for a project entitled: Global Health Activities in Developing Countries to Combat Non-Communicable Chronic Cardiovascular and Pulmonary Diseases. This synopsis has been prepared to test the marketplace and determine if it is feasible to conduct this acquisition as a small business set-aside. The work to be performed is a new requirement. The contract is anticipated to be awarded on June 8, 2008 for a period of six years.
The purpose of this program is to combat non-communicable chronic cardiovascular and pulmonary disease (CVPD), in developing countries, by enabling clinical research infrastructure development and research training and by conducting research of new or improved approaches, programs, and measures to prevent or treat chronic CVPD. Program objectives are to develop research Centers of Excellence (COEs) with faculty and staff capable of conducting independent and/or collaborative research, as well as training future chronic CVPD investigators at the doctoral and postdoctoral levels. This program is expected to stimulate clinical, epidemiologic, health services and outcomes, health policy, translational, and behavioral research. The COEs, to be awarded in developing countries, will be awarded under a Broad Agency Announcement (BAA). Each COE will propose their own research study and/or clinical trial based on the technical objectives described above.
The Administrative Coordinating Center (ACC) will provide administrative support services for the program such as communications, information collection and tracking, cataloging of program tools, identification and assessment of outcome measures and program statistics, preparation of reports, and logistical meeting support as required by NHLBI in collaboration with the COE investigators/staff, Scientific Advisory Board, Data Safety and Monitoring Boards (DSMB), collaborating universities, global health organizations, non-government organizations, corporations, foundations, and other NIH Institutes and Centers. The ACC will facilitate the initiation and growth of the program.
The ACC will perform the following program requirements: 1.) Design and maintain a Manual of Operations describing all ACC activities including, but not limited to, timelines, coordination activities, data collection, data assembly, data storage, data security, data analysis, and reporting. 2.) Provide management and coordination of activities across the Centers of Excellence and act as a methodological resource to each Center, as needed, in the selection of appropriate and current research methods, research tools, and statistical measures pertaining to cardiovascular and pulmonary health promotion, disease prevention, and treatment of chronic non-communicable CVPD. Provide guidance to the Centers of Excellence pertaining to Human Subject issues (examples include, but are not limited to: protocols, informed consent, data safety and monitoring, and other human subject related issues) and Institutional Review Board (IRB)/Ethics Committee approvals. 3.) Create a comprehensive electronic database to track the activities and achievements of each Center of Excellence. The database shall enable disease and program specific queries across Centers of Excellence so that reports of the entire program s progress can be easily generated. 4.) Plan, develop, and maintain a program website. 5.) Provide organizational and logistical support and structure to the program s committees and subcommittees. Promote communication between the Centers of Excellence, NHLBI, Data and Safety Monitoring Boards (DSMBs), and a Scientific Advisory Board. Responsibilities shall include developing appropriate websites and calendars, arranging and scheduling meetings, collecting and distributing appropriate materials and reports to committee members on a timely basis prior to each meeting; taking, seeking approval for, editing, and distributing minutes, maintaining a central repository of minutes; and maintaining all other materials relating to committee functioning. 6.) Manage unanticipated problems and study related Adverse Events. 7.) Obtain ACC IRB approval of protocols, consents, and amendments for the COEs. 8.) Design and implement a plan for study close-out, analysis, and dissemination of program information. 9.) Assist in ensuring an orderly and efficient transition to any successor contractor. 10.) Create a public use dataset, and design and implement a plan for data sharing.
Small business firms that have experience in performing the tasks described above are invited to submit capability statements. Capability statements will be evaluated on the following: 1) evidence of the firm s status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) evidence of ability to perform and experience in performing the tasks described above; 3) qualifications and availability of personnel with experience in providing oversight of clinical cardiovascular and pulmonary research studies in developing countries. Personnel must have extensive cardiovascular and pulmonary research experience and leadership pertaining to epidemiology, health services systems research, and biostatistics. Personnel must have experience in the operation of an ACC for multi-center clinical research studies in developing countries and for soliciting cooperation from national and international centers. This includes expertise in non-infectious chronic disease prevention and control, creating and maintaining databases, data collection and management, and preparation of scientific reports. 4) Demonstrated successful participation by the firm in providing oversight to international clinical research sites including data collection, data aggregation, and oversight of site specific research human subjects policies and procedures, as well as providing oversight to NIH clinical research grants and contracts in developing countries. 5) Availability and adequacy of the firm s facility, equipment, and software to accomplish the project requirements.
Three (3) copies of the capability statement must be received at the address shown below by 3:30 pm local time on the fifteenth (15th) calendar day from the date of this announcement.
Lynn Furtaw, Contracting Officer, Office of Acquisitions, DERA
National Heart, Lung, and Blood Institute, NIH, DHHS
6701 Rockledge Drive, Rockledge II, Room 6126, MSC 7902
Bethesda, MD 20892-7902
For overnight deliveries use zip code 20817, no MSC is required.
Capability statements may also be emailed to lynn.furtaw@nih.gov. Include the name and telephone number of a point of contact and please reference this notice number. Capability statements received in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP).
