The Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the Research Coordinating Center as part of the renewal of the program entitled "Coronary Artery Risk Development in Young Adults (CARDIA) Study". The applicable NAICS Code is 541712 and the size standard is 500 employees. It is anticipated that one award will be made in July 2013 for a period of five years. CARDIA began in 1985 in four U.S. communities (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA). The original cohort (n=5,115) was selected to have approximately the same number of participants in subgroups of age (18-24 and 25-30), sex, race (black and white), and education (high school or less and more than high school) within each community. Seven additional examinations have been completed every 2-5 years, including a Year 25 examination completed in 2011. The objectives of the renewal of the CARDIA program are: (1) to perform a limited examination of the cohort to determine abnormalities in cardiac structure and function that exist in a community-based sample of mid-to-late middle-aged adults; to utilize novel measures to better understand myocardial dysfunction; to examine 25-year trajectories in cardiac structure and function; and to assess whether these abnormalities and trajectories differ between white and black adults; (2) to continue cohort follow-up for cardiovascular events, including heart failure, coronary heart disease, stroke, and atrial fibrillation; and (3) to provide a platform for ancillary studies particularly to the cohort examination, a training ground for new investigators, and support data sharing. These objectives will be accomplished through annual follow-up and a ninth (Year 30) examination of the existing cohort. NHLBI plans to support one (1) Research Coordinating Center, four (4) Field Centers, and one (1) Echocardiography Reading Center. THIS NOTICE ADDRESSES THE COORDINATING CENTER ONLY. The important overall technical requirements associated with this acquisition for CARDIA include the following: - Establish and manage laboratories, and other consultants and subcontracts, as necessary. - Coordinate development of the study protocol by the Steering Committee. - Oversee development of and coordinate Field Center staff training and certification and pilot testing. - Oversee central administrative aspects of participant recruitment/retention and participant satisfaction assurance. - Monitor implementation of the study protocol by the Field Centers, Reading Centers, and laboratories, in accordance with the study timelines. - Facilitate and coordinate the tracking of regular follow-up contact of participants. - Facilitate and coordinate the collection of data on clinical events and classification thereof. Provide a centralized abstractor to abstract event data from medical records, death certificates, and other relevant materials received from the Field Centers. - Perform administrative duties to support productive collaboration among the study centers and the NHLBI Project Office. - Maintain study databases. - Direct quality assurance and quality control programs. - Conduct statistical analyses for quality assurance, and scientific publications and presentations. - Create databases for investigators and the scientific community and support data sharing. - Contribute to new scientific developments within the study and work collaboratively with all centers to support early stage investigators in training. - Provide a plan for transition of responsibilities, data, and materials from the existing Coordinating Center to the new Offeror. - Formulate hypotheses/research questions, and propose and write manuscripts and ancillary studies to achieve the scientific goals of the study. Small business firms that have demonstrated experience in performing the tasks as articulated above are invited to submit capability statements. Capability statements must provide evidence of ability to perform and experience in performing the tasks described above and will be reviewed based on the following: (1) the professional qualifications of scientific and technical personnel in accordance with the above requirements; (2) demonstrated capacity of individuals and the institutional support to perform the functions of a Research Coordinating Center for a multi-center collaborative epidemiology study, including protocol development, operational and scientific coordination, and information processing; (3) facilities and equipment available for data collection and transfer to the Reading Centers, and the Coordinating Center; (4) evidence of the ability to assess and monitor quality control for data acquisition at the Field Centers; (5) evidence of ability to analyze data from longitudinal epidemiologic studies, and publish results in peer reviewed journals; and (6) the small business status of the firm under NAICS Code 541712. Evaluation of the capability statements shall be based on the technical capabilities listed above. Each technical point (criterion) will be weighted equally. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. The Government intends to negotiate one contract for the period of five years with an approximate award date of July 01, 2013. Firms responding to this notice shall provide capability statements (original and three copies) no later than 04:00 pm EST on the fifteenth (15th) calendar day from the date of this announcement to the address shown above. Your submission shall include the name and telephone number of a point of contact. Please reference this notice number. Electronic copies of capability statements will be accepted and shall be sent to Elizabeth Zoller, Contract Specialist (email address: elizabeth.zoller@nih.gov) and Cheryl Jennings, Contracting Officer (email address: cheryl.jennings@nih.gov).
