THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR COMPETITIVE PROPOSALS. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. THIS PRESOLITIATION NOTICE IS A CORRECTED COPY OF THE POSTING OF JANUARY 6, 2008. The Behavioral and Rehabilitation Technology Branch, National Center for Medical Rehabilitation Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health intends to negotiate a sole source contract with the Agenzia Regionale Sanita of the Regione Toscana, a component of the Regional Health Authority of Tuscany in Italy. The purpose of the contract is to create a rehabilitation research data resource entitled Community Assessment Rehabilitation Experiment (CARE). A pilot study to examine adaptive physical activity was initiated by the Istituto Superiore di Sanita as part of the research project "Obtaining Optimal Functional Recovery and Efficient Managed Care for the Chronic Stroke Population" within the framework of the 2003 Memorandum of Understanding between the U. S. Department of Health and Human Services and Italy's Ministry of Health. The study included a community intervention program that was initiated in the Tuscan Region by Dr. Francesco Benvenuti and Dr. Laura Tramonti. The program's impact included safety of the intervention, improvement of gait and balance function and reduction in participants' depression. Community access remains a key issue in translating research results of individuals with chronic conditions who have participated in an exercise regime. The pilot provided an important step in translating the growing evidence regarding the health benefits of exercise for stroke survivors into a sustainable community model that was safe, feasible and efficacious in improving walking speed, and community ambulation. The intervention program demonstrated it has the potential to improve health outcomes and reduce health care costs associated with chronic stroke in an aging population through reducing cardiovascular risk factors associated with a sedentary lifestyle. However, confirmation of the reduction of costs in health care will require implementation of a community intervention program on a large scale. There are approximately 2,500 individuals in the Tuscan Region who suffer a stroke annually who would be eligible to participate in an expanded study. The Regional Health System completed a pilot study with 40 individuals in the intervention group and 38 individuals in the control group; it will serve as a model to be expanded. The effort involves the leadership of several different Italian Governmental Health groups including: Office of Tuscana Predictive and Preventive Medicine (Andrea Leto); Technology Assessment Office (Alessandro Reggiani); Scuola Superiore Universitaria Sant" Anna of Pisa (Sabrina Nuti); and the Dipartimento Technologie e Salute (Velio Macellari) lead by Dr. Laura Tramonti, General Director of the Agenzia Regionale Sanita of the Region Toscana. The aforementioned components have worked with the Agenzia Regionale Sanita of the Regione Toscana and have the experience and necessary affiliations to obtain the data records needed to create the rehabilitation research database. They have completed a pilot study demonstrating applicable data management necessary to link the elements that are required to accomplish the rehabilitation data resource. In addition, the group has developed proprietary software to organize the data. The purpose of the proposed project is to expand this pilot into a computerized rehabilitation research data base that will link separate rehabilitation data components such as pre and post health measures of individuals with a chronic condition (e.g., stroke or back pain, etc.) participating in low cost interventions (e.g. adaptive physical activity) in the community with health services and drug utilization information. Expanded support from NICHD will include study components such as, 1) Establishment of a small Scientific Advisory Committee (SAC); 2) expansion of an existing computer based information system; 3) translation of a standardized outcome measure (e.g. SIS, PROMIS); 4) implementation of a telephone interview in the Tuscan region; 5) creation of a patient data file; and, 6) support for collaborative interactions for individuals with chronic conditions. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. The NICHD has determined that the Agenzia Regionale Sanita of the Regione Toscana in Italy is the only source that can develop a stroke rehabilitation data resource because of their organizational structure, clinical staff scientific expertise and data capability. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other furnished information must document access to a comparable cohort of stroke victims annually, ownership of a community physical activity intervention program, capacity to generate a de-identified patient record linking the various data elements, and capacity to analyze the data. If any interested party believes it can perform the above requirement, it may submit, within 45 days of publication of this notice, three (3) copies (plus an electronic copy to
[email protected]) to: Mrs. Lynn Salo, Contracting Officer, NICHD CMB, NIH, 6100 Executive Building, MSC 7510, Bethesda, Maryland 20892-7510 (or overnight courier: 6100 Executive Blvd., Rockville, Maryland 20852). Phone number: 301-435-6962 and FAX number: 301-402-3676. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Authority: 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1(a)(2)(i), HHSAR 306.302-1(a) (2) (i) b and c. No collect calls will be accepted.