The National Institutes of Health (NIH), National Institute on Aging (NIA), intends to negotiate, under authority of FAR 6.302-1, on a noncompetitive, sole source basis, with the Consiglio Nazionale delle Ricerche for the Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort (SardiNIA3) requirement. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This effort will be five years (12 months per year). The Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort (SardiNIA3) is in accordance with the authority 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Consiglio Nazionale delle Ricerche has continued to support the Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort activities related to data collection, data entry, verification, editing, transmittal and file management,and participation in the preparation of publications and public presentations of the results to qualified investigators. Consiglio Nazionale delle Ricerche has maintained access to over 6,000 participants enrolled in the SardiNIA study and has available precise testing equipment required for collecting core assessments of traits and genotyping; competency and experience with the data collection manuals, forms and procedures, data entry, management, verification and quality control, transfer, and tracking systems; and study-wide policies and procedures relevant to data usage and scientific productivity of the study. Further, all critical study components were developed, implemented, field-tested, and refined by the proposed Contractor in collaboration with the NIA over the course of the SardiNIA study. No other contractors could provide a comparable service in a timely and cost-efficient manner. In addition, successful follow-up of cohort participants required continued and regular contact established and maintained by the proposed contractor. The Contractor is also the sole proprietor of the specific version of the inventory management system developed for and used by the Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort; therefore, there is limited access to the data management system itself. The Consiglio Nazionale delle Ricerche thus has the unique capability to provide the required services to NIA for the Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort. The SardiNIA3 requirement (1) must be performed in Sardinia, Italy; (2) has limited data access due to Consiglio Nazionale Delle Ricerche being the sole proprietor of the specific version of the data management system; and (3) must comply with Section 508 of the Rehabilitation Act or the Electronic and Information Technology Accessibility Standards pertaining to 36 CFR 1194.21. The transfer of the data management system to another contractor (other than incumbent) would be disruptive to the project, requiring start up time to become familiar with over ten years of invaluable and irreplaceable data or cause unacceptable delays to the SardiNIA3 project; and would require duplication of cost to purchase and develop a new data management system. In summary, inherent risk of loss of over ten years of data collection, duplication of cost to the Government, and unacceptable delays in completing the project make competition unfeasible for this study. Background and Purpose of the Longitudinal Studies for Aging-Associated Conditions in a Sardinia Population Cohort: In keeping with its overall mission, it is incumbent on the National Institute on Aging (NIA) to discriminate epidemiological and genetic factors involved in the etiology of aging-associated deficits, in order to understand and intervene to prevent or alleviate them. An indispensable and major step forward has been the progressive development of phenotypic tests for conditions and their application to determining statistical ranges of phenotypes in "outbred" (that is, genetically relatively heterogeneous populations with considerable admixtures from outside populations added over time), to assess both comparable statistical factors and epidemiological and genetic factors in the especially favorable Sardinian population. During the ongoing 10-year contract, the incumbent contractor recruited over 6,100 subjects from a selected group of four towns in east-central Sardinia, and measured the traits for each subject. Genotyping of all participants was also completed that has provided the data for investigators to look for genetic factors associated with each trait. The infrastructure for the clinic and phenotypic testing has been stable, with stringent quality control, and the data are of correspondingly high quality. The SardiNIA3 envisages a study for additional years. A critical step in longitudinal studies would record data from a fourth visit of participants (AIM I); and transfer of the data (AIM II) would provide them for later use in a range of studies, A subsidiary Aim III would be to design the studies to maintain an expansion to study additional phenotypes. The study is designed to permit the estimation of individual trajectories of quantitative traits, which requires the measure of at least three points in time to avoid the bias resulting from "regression to the mean". Thus, because some of the most important age-related traits were measured starting only in the second follow-up visit, completing four visits is essential to maximize the scientific productivity of the data collected in the SardiNIA study. A further advantage is that, by collecting multiple measurements over time, one can improve the power of mapping studies. Specifically, by modeling the repeated measures of each trait, one can focus on the long-term component of the trait for each individual. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-SBSS-10-133 and HHS-NIH-NIDA(AG)-RDSS-10-133. The estimated contract award date will be on or about June 15, 2011.
