Inactive

This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regar... This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institute on Aging (NIA) has a need for a project entitled, “Genetic and epidemiological factors for age-related traits and diseases in the Sardinian population (SardiNIA5)”, to analyze both epidemiological and genetic factors in aging-related traits and conditions. We propose to extend an ongoing longitudinal study (SardiNIA) and add new traits based on the unique ‘founder’ population of Sardinia. This proposed SardiNIA5 project is a continued need of the SardiNIA study under Contract No. HHSN271201100005C, with a primary focus on a genetic analysis of Alzheimer/dementia based an all-island case control study (AIM I) and also encompassing an additional follow-up period to carry out sixth visits for the maximum number as possible of current FIA cohort participants (AIM II). Starting in 2001, the Project examined ~6,000 individuals from 4 geographically clustered towns in the mountainous region of Ogliastra in central/eastern Sardinia. The Project now includes up to 5 visits from >7,000 individuals at a clinic in the town of Lanusei. This core group is herein referred to as the “SardiNIA Lanusei cohort”. The study, now in its 19th year, has collected longitudinal information from up to 10,000 participants on >800 age-related quantitative traits (‘endophenotypes’ or ‘quantitative risk-related genetic or environmental factors’), as well as >200 dichotomous traits (including major diseases and disease risk factors). The use of quantitative traits permits high resolution of the genetic studies, with the full spectrum of genetic variation identified via genomic DNA sequencing. Increasingly, trait values and trends can be assessed for the degree to which they can diagnose or predict outcomes – i.e., for their values as markers or intrinsic cues for what happens during aging, linking the proposed work to the NIA Strategic Goals. Purpose and Objectives: The Mediterranean island of Sardinia is unique for the presence of 1,500,000 individuals who show a relatively high continuity with the first founders who inhabited the island in prehistoric times. As a consequence of its ancient and complex demography, this population shows an excellent representation of genetic variation in Europe but also exhibits an enrichment of genetic variants that are very rare elsewhere. In addition, Sardinia is unique in the world in affording 1,500,000 relatively inter-related individuals, equivalent to an immense family, who have had a relatively constant environment in stable settlements for a very long time. It thus represents a model population that allows a better understanding of the role of genetic variation of human health. Project requirements: In the performance of the Tasks specified for each AIM, the Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of the Statement of Work (SOW). According to Government rules, the Contractor shall establish and implement appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of sensitive data, including personal protected identification, and government information and/or equipment. The following are goals to satisfy NIA’s objective fully for each AIM: For AIM I: To characterize clinical brain disease and endo-phenotype, genetic traits, and environmental correlates underlying clinical disease on up to 8000 AD dementia cases and 8,000 controls broadly frequency matched by 5-year age and sex strata. To achieve this, the Contractor shall: Design and conduct a Pilot Study (Pilot-AD) to develop a protocol and Electronic Medical Record (EMR) for assessing and recording data on AD cases and controls, as defined by standard research and clinical practice criteria. The pilot will aim to include a sample that largely reflects ‘typical’ late-age AD cases that have been clinically observed in the past few years. An Electronic Medical Record will be developed to provide participant data already collected by the Sardinian Health Care system, as well as newly collected data important to classify cases and controls. Design and conduct a large case-control (AD C-C) study to identify, characterize (as described above), and genotype up to 8000 cases and 8000 controls. Identify and characterize the cases and controls by other endophenotypes relevant to sub-typing dementia and understanding the causes of AD. Develop Ancillary Studies to: Assess the reliability and validity of state-of-the-art blood-based biomarkers of neurodegeneration. Characterize the cases and controls using a battery of standard biochemical serum components, consistent with the protocol for the established SardiNIA Lanusei cohort as described in AIM 2. Identify MRI /PET imaging signatures of neurodegeneration and vascular disease on up to 1000 participants, whose characteristics will be guided by emerging research questions Study brain structure and functional characteristics, as measured in the AD C-C, in association with longitudinal trajectories of traits collected in the deeply phenotyped individuals in the SardiNIA Lanusei cohort. Provide a database in electronic form that includes EMR and ancillary study data collected as a part of the pilot and case-control study For AIM II: I. Determine values for the specified range of phenotypes in the established SardiNIA Lanusei cohort from the founder population of Sardinia, completing a sixth visit for as many of the 7,000+ recruited participants as possible f/or 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. Anticipated period of performance: One (1) 12-month base period and Four (4) 12-month option periods Capability statement /information sought. Offerors that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. 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, administrative structure, and the institutional support to perform the functions of a collaborative epidemiology study, including high retention of study participants and regular follow-up health records for contacts for clinical events, identification and conduct of a multi-site clinic examination, and operational and scientific coordination; (3) facilities and equipment available to perform the required tasks; (4) evidence of ability to analyze data from longitudinal epidemiologic studies and publish results in peer reviewed journals, and a proven track record of collaboration with other research programs; (5) demonstrated ability to effectively manage both administrative and financial aspects of a contract to promote and support an integrated data collection effort; (6) the small business status of the firm under NAICS Code 541720. Evaluation of the capability statements shall be based on the technical capabilities listed above. Each technical point (criterion) will be weighted equally. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All responses to this notice must be submitted electronically to the Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Karen Mahon, Contracting Officer, at e-mail address Karen.Mahon@nih.gov. The response must be received on or before June 2, 2020, 10:00 am, Eastern Time. “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 presolicitation 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).”