SOLICITATION NOTICE
B -- Generation of induced pluripotent stem cells (iPSCs) for the functional analysis of Type 2 Diabetes (T2D)
- Notice Date
- 8/30/2016
- Notice Type
- Presolicitation
- NAICS
- 813212
— Voluntary Health Organizations
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(HG)-2016-288-DM
- Archive Date
- 9/21/2016
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 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 Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to New York Stem Cell Foundation, Inc., 1995 Broadway Suite 600, New York, New York 10023-5850 to provide the following for NHGRI: Procurement: 1. Generation of 50 iPSC lines from NIH/NHGRI Type 2 Diabetes Fusion Study, fibroblast cell lines Background: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. The Medical Genomics and Metabolic Genetics Branch/Molecular Genetics Section Investigators use a broad range of tools to understand how health and disease are related to genetic, genomic and metabolic variation. Investigators study a broad spectrum of disorders, from common diseases associated with common variants to the rarest diseases associated with uncommon, sometimes unique variants. Scientific Investigators sometimes study disorders that are not inherited at all, which are due to somatic mosaicism-a difference in genetic composition among cells in an individual. Additionally also study how the genome influences normal metabolic processes. MGMGB investigators apply tools ranging from high-throughput biology to clinical and animal research. A unifying theme in their research is that the human is the most complex, fascin MGMGB investigators use the rich resources and technologies of the Human Genome Project to develop more sophisticated ways of understanding pathophysiology, diagnosis and treatment of disease.ating and important system in which one can study the effects of heritable variation. For the past 20 years the Finnish US Investigation of NIDDM (FUSION) genetics project has been investigating the genetic basis of type 2 diabetes (T2D) in the Finnish population. After successful completion of the genome-wide association study the FUSION study initiated a program of translational research to investigate the functional consequences of genetic variation associated with T2D. The Tissue Biopsy Study initiated collection of frozen skeletal muscle and adipose tissue from T2D subjects and normal controls subjects to correlate the gene expression differences between disease states in the T2D associated loci in order to implicate the correct gene responsible for the underlying pathology of T2D. The FUSION Study performed integrated analysis of genetic association and chromatin structural analysis in T2D related tissues with gene expression in these biopsies to identify the potential causal variant responsible for T2D related pathology. The ability to differentiate iPSCs into representative cells of tissues relevant to T2D allows for the functional analysis of causal variants in molecular and metabolic pathways affected by the disease state. This capability enables functional analysis of the T2D associated variants identifying mechanisms responsible for the pathology of T2D and leads to the ability to perturb the system with exposure to high and low glucose or cellular stress to identify new drug targets and test potential therapeutics. Purpose and Objectives: The purpose of this procurement is to obtain induced pluripotent stem cells (iPSCs) to advance the study of the functional basis of genetic variants associated with type 2 diabetes (T2D). With the provision of iPSCs FUSION investigators will be able to differentiate these cells with the genetic background of our well characterized subjects into tissues of interest such as but not restricted to pancreatic beta cells, representing pancreatic islets; adipocytes, representing fat tissue; hepatocytes, representing liver tissue, myocytes, representing skeletal muscle, and neuronal cells. With the capability of differentiating iPSCs FUSION investigators can perform functional analysis of genes associated with T2D in cell lines relevant to the biology of T2D that are characteristic of the tissues involved in the disease examining the differential effect of the genetic make-up of the original subjects on the function of the associated gene in that particular tissue type. Contractor's Requirement : • The Contractor will conduct generation of induced pluripotent stem cells (iPSCs) from 50 subject fibroblast cell lines provided by the FUSION project by the New York Stem Cell Foundation (NYSCF). The Government's minimum requirements are as follows: • The Contractor will present sufficient capacity to generate 50 iPSC lines in 6-9 months. • The Contractor will perform quality control for mycoplasma detection and sterility of input cell line resource. • The Contractor will monitor genomic integrity, stability and identity throughout the iPSC generation protocol. • The Contractor will generate iPSC through established mRNA transfection mechanism in a parallel manner for multiple fibroblast cell lines in order to enhance reproducibility. • The Contractor will be able to enrich iPSC cells generated from non-reprogrammed cells. • The Contractor will generate multiple pools for each cell line. • The Contractor will characterize iPSC cell lines by markers for pluripotency as well as early differentiation to establish quality of iPSC. • The Contractor will test differentiation potential of iPSC lines by in vitro methods and by gene expression to screen for efficiency of differentiation into three germ layers, endoderm, mesoderm, and ectoderm. • The Contractor will provide documentation of the process of generating the cell lines as well as the raw data supporting the process upon request. • The Contractor will provide monthly written reports and quarterly conference call updates throughout the generation of the iPSC lines. Period of Performance : Base Year: 12-Months Upon Award Statutory Authority : The acquisition is conducted under the statutory authorities justifying this sole-source acquisition are 41 U.S.C. 253(c)(1), and FAR 6.302-1(b)(1). The services required are available only from one responsible source based on unique capabilities. Additional Information : Industry Classification (NAICS) Code is 813212, Voluntary Health Organization and the small business size standard is $27.5M. The acquisition is being conducted under FAR Part 13.5, 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) 05-89-1, August 15, 2016. Closing Statement : This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. The determination by the Government to award a purchase order on a sole source on competitive basis for the procurement of Generation of 50 iPSC lines from NIH/NHGRI Type 2 Diabetes Fusion Study, fibroblast cell lines to New York Stem Cell Foundation, Inc., based upon Market Research conducted: only one response was received on the sources sought synopsis published in the FedBizOpps which was New York Stem Cell Foundation Inc. seeking small businesses under [HHS-NIH-NHLBI-CSB-2016-266-DM], posted August 17, 2016. An SBA Dynamic search was conducted and received no results for small businesses. An Interagency Contract Directory Portal search was conducted and received no additional small business or any agency results. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received no later than 7:30 a.m. Eastern Standard Time (EST), September 6, 2016; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-288-DM, may be submitted to the National, Heart, Lung and Blood Institute, COAC Services Branch, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2016-288-DM/listing.html)
- Place of Performance
- Address: NIH and Contractor's Location, United States
- Record
- SN04248558-W 20160901/160831000844-077643ed560cbb7a39deac92b3552c7c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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