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 Field Centers as part of the renewal of the program titled "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 four awards 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 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 FIELD CENTERS ONLY. The important overall technical requirements associated with this acquisition for CARDIA include the following: - Ensure that the protocol specifies comparability of repeat measures with those previously collected where trend analysis is planned. - Collaboration with other Field Centers and the Coordinating Center in the development of an informed consent template with common language for all Field Centers. - Recruit, obtain signed informed consent, and conduct the Year 30 examination for all available cohort survivors. - Provide for handling of collected blood and urine specimens including shipping to the Central Laboratory and long-term storage for future measurements of additional biomarkers. - Provide participants with referrals for follow-up of medically relevant abnormal findings within a local network of health care providers or institutions to which participants can be referred if indicated. - Contact all surviving CARDIA cohort members annually and develop a local plan to maintain an annual cohort retention rate as high as possible, but over 80% at a minimum. - Design and execute a plan to continue community relations to enhance communication of study progress and findings to study participants. - Use the system recommended or provided and maintained by the Coordinating Center for participant data entry and transfer from Field Centers to the Coordinating Center or Reading Centers. - Provide a plan for transition of responsibilities, data, and materials from the existing Field 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. Firms must be able to meet the Mandatory Qualification Criteria that offerors shall provide evidence that they can seek out and include a study goal of a minimum retention rate of 70% of the eligible cohort for an in-person examination and 80% for annual follow-ups throughout the proposed period of performance in the geographical areas of Birmingham, Chicago, Minneapolis, or Oakland. The annual follow-up contacts are performed by telephone. 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 Field 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 ability to analyze data from longitudinal epidemiologic studies, and publish results in peer reviewed journals; and (5) the small business status of the firm under NAICS Code 541712. Evaluation of the capability statements shall be based first on the Mandatory Qualification Criteria. Once it has been established that the Mandatory Qualification Criteria has been met, then the capability statement shall be evaluated on each of the technical points (criterion) 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 four contracts 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).
