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." REQUIRED: THE CONTRACTOR WILL NEED TO HAVE AUTHORIZATION FROM THE NEW YORK STEM CELL FOUNDATION (NYSCF) PROJECT TITLE: Generation of induced pluripotent stem cells (iPSCs) for the functional analysis of Type 2 Diabetes (T2D) associated genes in the genetic background of subjects from the Finnish US Investigation of NIDDM (FUSION) genetics protocol study: (ZIA-000024). A. 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. B. 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. C. 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. D. Line Items : 1. Generation of 50 iPSC lines from NIH/NHGRI Type 2 Diabetes Fusion Study, fibroblast cell lines E. Anticipated Period of Performance : September 2016 to September 2017 F. Deliverables : • Cells can be delivered ~6-8 months post execution of agreement and delivery of starting material. • iPS cell lines with master bank from up to 2 polyclonal pools (6 vials per pool). Expansion to larger working banks possible. • Protocol for iPS cell line recovery; • Certificate of Analysis will be made available and will include results from mycoplasma and sterility tests, identity and karyotype data, plutipotency expression profile and differentiation capacity. Raw data can be made available upon request; • Monthly written progress report; and • Quarterly phone updates. G. Capability Statement /Information : Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of 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 similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, TIN or EIN Number, organization name, address, point of contact, and business size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 813212 Voluntary Health Organization and small business size standard is $27.5M. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. H. Closing Statement: All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Dorothy Maxwell, Contracting Officer, at
[email protected] in either MS Word or Adobe Portable Document Format (PDF), by August 23, 2016, 7:30 a.m.., EASTERN TIME under Solicitation Number: HHS-NIH-NHLBI-CSB-SBSS-(HG)-2016-266-DM. FAXES ARE NOT ACCEPTED. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "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)."