Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort (SardiNIA4)

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." INTRODUCTION/BACKGROUND The National Institute on Aging (NIA) has a need for a project entitled, "Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort (SardiNIA4)". The SardiNIA4 project is a continued need of the SardiNIA study under Contract No. HHSN271201100005C encompassing an additional follow-up period to carry out fifth visits for the maximum number of participants that are possible. The primary study will facilitate the achievement of three major goals of the longitudinal study. First, with a fifth visit, the data become accurate enough to correct for measurement noise ("Type 1 error") and determine the trajectory (rate of change) of traits. This will permit corresponding analyses of genetic factors that affect changes as well as absolute levels of traits such as blood pressure. Second, the Outcome Study reaches the point where the genetic risk factors inferred for traits can be assessed for diagnostic and prognostic value for aging-related conditions and diseases. Third, newly added measures, as specified in the Tasks, will add scope to analyses of the effects of genetic factors on aging. The AIMS include: AIM I: Performance of all data collection activities for Tasks 1-5 (A-C) of the SOW; AIM II: Performance of data entry, verification, editing, transmittal and file management contained in Tasks 1-5 (D-G); and AIM III: Participation in the preparation of publications and public presentations on the results of the study, and design the studies to maintain expansion for additional phenotypes and longitudinal studies. In keeping with its overall mission, it is incumbent on the 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. Examining the genetics of aging-associated conditions such as cardiovascular problems and osteoporosis is especially difficult because 1) they are "late-onset" conditions, affecting older individuals; and 2) they are "complex traits", with a number of genes contributing more or less to tipping the balance toward a phenotype or disease in one or another person. As one aid to analyses, attention has increasingly focused on the promise of "founder populations" that arise from a delimited group living in a defined region, in this case, Sardinia, for many centuries with minimal admixture from outside populations. The high degree of relatedness in such a population helps in modern non-parametric analyses to localize and refine the localization of those genes. The Sardinian population is one of the few that is both numerous and accessible enough, and one of the most extreme in its relative homogeneity. The attractiveness of Sardinia for study is increased by the concentration on an especially isolated cluster of four (4) towns in east-central Sardinia, Ogliastra, for the core studies; and in addition, for targeted case: control studies, the entire island population of 1,500,000 provides a recruitment base for a wide range of diseases. The program examines phenotypes for which NIA expertise and test instruments are well developed, and which represent important aging-related conditions. The study has been scoring >200 dichotomized traits (smoking, etc.) and over 300 quantitative traits ("endophenotypes" or "quantitative risk-related genetic or environmental factors") that can be scored on a continuous scale. The traits of particular interest include a range of cardiovascular risk factors; kidney and lung function tests; anthropometric measurements; blood test values; and facets of personality and cognition. The primary SardiNIA study has been ongoing since June 15, 2001. This study has recruited over 7,000 subjects and measured the traits for each subject. Genotyping and genome sequencing of all participants was also completed that has provided the data for investigators to look for genetic factors associated with each trait. We note that the advantages of the inter-related population have included the ability to sequence the genomes of 2,000 individuals at relatively low coverage and impute the results on the genomes of 5,000 other family members who had been genotyped inexpensively with a framework set of markers. Thus, we recovered the genomic sequence information for >7,000 individuals for an investment that, using conventional whole genome sequencing strategies, would have allowed deep sequencing of only 160-180 genomes. The infrastructure for the clinic and phenotypic testing has been stable, with stringent quality control, and the data are of correspondingly high quality. The sample cohort numbers (ages 22-102) absorb over 60% of the population of the towns, organized into over 1,000 families who are all locally born. This sample is large enough and interrelated enough to infer highly significant estimates of genetic heritability for traits, with the bulk of genetic diversity seen across Europe along with millions of DNA variants that are rare or non-existent elsewhere but have increased to relatively high levels on the island; another advantage for genetic studies. With this cohort, repeated visits to the testing center for repeated tests and additional tests, including bone-density and frailty measures, echocardiography, and blood pressure variability, has been done. Fourth visits will be completed within the tenure of SardiNIA3. The SardiNIA4 contract envisages a study for 5 additional years. A critical step in longitudinal studies would record data from a fifth 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 five points in time to deal with "noisy" traits like blood pressure and avoid the bias resulting from "regression to the mean". Based on the proposed studies, the information recovered could facilitate ulterior analyses of age-related trends and the molecular nature of gene variations that are significant factors for traits of particular interest, and stabilize a platform for the possible extension of studies to other phenotypes and further longitudinal studies. SCOPE AND REQUIREMENTS The specific objective is to extend the longitudinal study of trends in quantitative trait values with a fifth clinic visit for the participants in the study. The Contractor shall be responsible for coordination of the data collection, including recruitment and scheduling of study participants, administration and scoring of tests for each trait and data entry and transfer. The Contractor shall provide maintenance of equipment; provide personnel, supervising their performance in the administration and scoring of the tests; and be responsible for computer entry and data transfer of the test data to the Contracting Officer's Representative (COR). The Contractor shall continue the data acquisition for the additional years with an assured intent for continuity of Contractor leadership and staff. In addition, the Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of the Statement of Work (SOW). The Contractor shall establish and implement appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of sensitive Government information, data, and/or equipment. The following are three goals to satisfy NIA's objective fully: I. Determine values for the specified range of phenotypes, including specified new traits, in the established cohort from the founder population of Sardinia, completing a fourth visit for as many of the 7,000+ recruited participants as possible for the required tasks. II. Provide the data (values) for all traits in electronic form and reports as specified, in order to support derived analyses and publications. III. Design the studies for later expansion of successful efforts to additional phenotypes and outcome studies in the founder population. REPORTS/DELIVERABLES: The following reports will be required: (1) Annual Report; (2) Annual Clinical Research Study Population Report; and (3) Final Report. ANTICIPATED PERIOD OF PERFORMANCE: The anticipated period of performance is five (5) years beginning on or about May 1, 2016. OTHER IMPORTANT CONSIDERATIONS: (1) The Government is expected to use procedures in FAR Part 15, contracting by Negotiations; (2) The Contractor must perform services in Sardinia, Italy; (3) The contractor must use the data management system developed for and used for the SardNIA study. Because Consiglio Nazionale Delle Ricerche is the sole proprietor of this specific version, access to this data management system is limited; and (4) The Contractor must access participants enrolled in the SardiNIA study and availability of precise testing equipment required for collecting core assessments of traits and genotyping; competency and experience with 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. It is essential the Contractor provide optimal performance of services so there will be no discontinuity in work performance and that smooth continuation of the SardiNIA3 Project be maintained in SardiNIA4. CAPABILITY STATEMENT/INFORMATION SOUGHT: NIA is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS: Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 - x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than June 5, 2015 at 4:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to kimberlee.stapleton@nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Kim Stapleton, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).