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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 20, 2015 FBO #4957
SOLICITATION NOTICE

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

Notice Date
6/18/2015
 
Notice Type
Presolicitation
 
NAICS
541720 — Research and Development in the Social Sciences and Humanities
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
 
ZIP Code
20892-9661
 
Solicitation Number
HHS-NIH-NIDA(AG)-RFP-15-010
 
Archive Date
8/1/2015
 
Point of Contact
Kim Stapleton, Phone: (301) 443-3775, Yvette Brown, Phone: 301 443-2696
 
E-Mail Address
kimberlee.stapleton@nih.gov, Yvette.Brown@nih.gov
(kimberlee.stapleton@nih.gov, Yvette.Brown@nih.gov)
 
Small Business Set-Aside
N/A
 
Description
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 project entitled Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort (SardiNIA4). 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 statements and 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 for a one year base period and four one-year option periods. The SardiNIA4 study is in accordance with the authority 41 U.S.C. 253(c)(1), as set forth in FAR 6.301-1(a)(2). The proposed contractor possesses all the elements critical for performing the tasks detailed in the Statement of Work, including access to participants enrolled in the SardiNIA study and availability of the required resources for study. Further all critical components have been developed, implemented, field-tested, and refined by the proposed contractor in collaboration with the NIA over the course of the SardiNIA study. No other contractor could provide a comparable service in a timely and cost efficient manner. In addition, successful follow-up with participants requires continued and regular contact that has been established and maintained by the proposed contractor. It is essential for optimal performance of this contract that there are no disruption in work performance and that smooth continuation of the SardiNIA project be maintained as can be provided by the incumbent, Consiglio Nazionale delle Ricerche. The Consiglio Nazionale delle Ricerche thus has the unique capability to provide the required services to NIA for the Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort study. The SardiNIA4 requirement (1) must be performed in Sardinia, Italy in order to use the original Sardinia population cohort for the purpose of maintaining participant cooperation and study follow-up; and (2) has limited data access due to the Consiglio Nazionale delle Ricerche having sole proprietorship of the data management system that was created and has been used since the inception of the study. While the Consiglio Nazionale delle Ricerche developed the data management system and is the sole proprietor, the data developed for this study is Government owned. Therefore, the transfer of the data management system to another contractor (other than incumbent) would be disruptive to the project requiring stat up time to become familiar with over fourteen years of invaluable and irreplaceable data, cause unacceptable delays to the SardiNIA project and require duplication of cost to purchase and develop a system. In summary, inherent risk of loss of fourteen years of data collection, unacceptable delays, and duplication of costs to the Government in completing this project make competition unfeasible for this study. The background and purpose of 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. 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 SardiNIA4 contract envisages a study for five 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". This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-RDSS-15-010 and HHS-NIH-NIDA(AG)-SBSS-15-010. The anticipated contract award date is May 1, 2016.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-RFP-15-010/listing.html)
 
Place of Performance
Address: Sardinia, Italy
 
Record
SN03769258-W 20150620/150618235320-234cdef046d27e4f6964e26d0bf041b0 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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