Generation of Primary Fibroblast Cell Lines in Finland

INTRODUCTION: THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Teryveyden JA Hyvinvoinnin Laitos, P.O. Box 30, Helsinki, Finland 00271 to generate primary fibroblast cell lines. Procurement: 1. The Contractor shall generate primary fibroblast cell lines from 150 subjects in the FUSION study of "Type 2 Diabetes". BACKGROUND: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The National Human Genome Research Institute (NHGRI), The National Human Genome Research Institute (NHGRI), Genetic Technology Branch (GTB) Molecular Genetics Section is currently working on a generation of primary fibroblast cell lines project from Finnish subjects enrolled in NHGRI project: R01 DK062370-06A1: "Genetic analysis of type II diabetes in the Finnish population". This project has been developed over the past 16 years in collaboration with Teryveyden JA Hyvinvoinnin Laitos (THL) to discover the genetic basis of diabetes. THL clinical laboratory has existing IRB approval from Finland, phenotyping and DNA analysis of thousands of individuals living in Finland has been conducted. The object of this procurement is a part of a research project identifying genes for type 2 diabetes: FUSION - R01 DK062370-06A1. To identify genes increasing susceptibility to type 2 diabetes and to fine map these loci to identify the predisposing variants. To achieve this goal, NHGRI will obtain biological specimens and phenotype information and examine the correlation of mRNA expression with genotype and phenotype in a subset of FUSION samples. Expression studies based on muscle and adipose samples from a select group of highly informative study subjects are likely to be critical in functional genomics efforts to identify the predisposing genetic variant(s). The purpose of this substudy is to establish fibroblast cell lines from the collected skin samples. NHGRI require the cell lines from these specific subjects because they are part of a longitudinal study where the subjects are exact same persons for which NHGRI have an immense amount of medical history, genotype and phenotype information. The required clinical laboratory Teryveyden JA Hyvinvoinnin Laitos is uniquely qualified for the biopsy of skin samples and the generation of primary fibroblast cell lines. An approved well tested protocol for the collection, processing and shipping of the samples to NHGRI for analysis has been established with THL PERIOD OF PERFORMANCE May 2013 through January 31, 2014 DELIVERY Delivery of cell lines will be within 4 Weeks of receiving approved purchase order. All deliveries will be handled exclusively by TERVEYDEN JA HYVINVOINNIN LAITOS (THL) JUSTIFICATION TERVEYDEN JA HYVINVOINNIN LAITOS (THL) is the site for collection of the patient samples. THL is the only clinical laboratory approved under the IRB OH95-HG-N030 "Mapping Genes for Non-Insulin Dependent Diabetes Mellitus" for the contact and collection of samples from the Finnish Population. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source, only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology and the Small Business Size Standard is 500. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-66 (April 1, 2013). This requirement is under the SAT of $150,000.00. The determination by the Government to award a purchase order on a sole source on competitive basis for generation of primary fibroblast cell lines from 150 Finnish Subjects is a continuation of a previous order [HHSN268201100398P, September 8, 2011] issued for this requirement. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. This notice of intent is not a request for competitive proposals.