NIDA Center for Genetic Studies

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from Small Business organizations to provide the Government a resource that can maintain and expand the NIDA Center for Genetic Studies, a repository to process, store, and distribute de-identified biological samples and clinical data. This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to maintain and expand the NIDA Center for Genetic Studies. The Contractor shall process, store, and distribute high-quality data files, documentation, and biological materials. Biological materials may include but may not be limited to the following items; cell lines, skin fibroblasts, DNA, RNA, serum, saliva, hair, urine, and fecal matter. Biological materials will be collected from individuals with substance use and addiction-related disorders and their relatives. The current repository contains over 74,000 samples. It is anticipated that there will be approximately 80,000 samples by the start of the contract. NIDA expects to receive a volume of approximately 10,000 samples over the course of the contract. Interested small business organizations must have the required capabilities and in-depth knowledge in the areas listed below. (1) Receiving de-identified data that includes, but is not limited to: clinical samples, diagnostic criteria, pedigree structure, environmental exposure information and other phenotypic data, along with blood samples or other bio materials (e.g. blood, cell lines, skin fibroblasts, DNA, RNA, serum, saliva, hair, urine, fecal matter) from research on the genetics of addiction and addiction vulnerability, which may include but not be limited to limited to Government funded grants and/or contracts; (2) Processing these data and materials to create databases, serum, DNA, RNA, and cell lines; (3) Distributing all data and materials in the NIDA Human Genetics Initiative to qualified investigators in the scientific community in a cost-effective manner; (4) Maintaining storage of data and biospecimens; (5) Performing microarray genotyping, as well as high-throughput DNA sequencing and/or RNA transcriptome sequencing on pre-existing and/or new de-identified biospecimens; (6) Supporting the creation of reprogrammed cellular derivatives, such as induced pluripotent stem cells (iPSCs) to facilitate the molecular and cellular study of brain development and addiction processes; (7) Creating a cyberinfrastructure that enables interoperability and full access to distributed data, software and other bioinformatics resources, as well as research summaries and outbound links for all addiction related studies available through the NIH database of Genotype and Phenotype (dbGaP) system; (8) Facilitating NIDA genetic studies data (both genotype and phenotype) being uploaded into NIH databases, such as BioSample and dbGaP. (9) Demonstrating experience (by lead investigators and support staff) in molecular genetic and molecular biology techniques, including microarray analyses, genomic sequencing, transcriptome analysis, creation of reprogrammed cellular derivatives (i.e., induced pluripotent stem cells, also known as iPSC), biological specimen processing, nucleic acid extraction, irradiated feeder technology, and dissemination, as well as preparation of pedigree files and files used to conduct statistical genetic analyses across a broad range of genetic/genomic questions that are suitable for publication in peer-reviewed journals. (10) Demonstrating expertise conducting quantitative genetic research on common, complex human disorders, including the analysis of data generated from genome-wide scans, as evidenced by publications in peer-reviewed scientific publications. (11) Creating comprehensive documentation and data libraries of phenotypic and genotypic databases. MANDATORY REQUIREMENTS: Capable small businesses must meet the following mandatory criteria: (1) Demonstrate an ability to safely process and store between 90,000 and 95,000 biospecimen samples; (2) Be eligible to receive a Certificate of Confidentiality. As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH supported research applicable to this Policy are required to establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of award. Recipients of Certificates are required to ensure that any investigator or institution not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate issued by this Policy, understand they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. In accordance with NIHGPS Chapter 15.2.1, recipients are also responsible for ensuring that any sub-recipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sensitive information protected by a Certificate issued by this Policy understand they are also subject to subsection 301(d) of the Public Health Service Act (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html). Furthermore, as a term and condition for award, prohibit the disclosure of the names of research participants or any information, documents, or biospecimens that contain identifiable, sensitive information collected or used in research by an investigator or institution with a Certificate. (3) State in writing that business entity/contractor agrees to and is committed to processing, generating, and widely distributing high-quality data files, documentation, and biological materials (e.g. cell lines, DNA, RNA, serum, urine samples, fecal samples) in an efficient and cost-effective manner for use in genetic analyses by qualified investigators in the scientific community; (4) Provide information on ability to obtain Clinical Laboratory Improvement Amendments (CLIA) certification for microarray platforms (i.e., smokescreen) (see: https://biorealmresearch.com/category/press-releases/ ); and (5) Be a co-signatory of the Distribution Agreement developed by NIDA http://www.drugabuse.gov/researchers/research-resources/genetics-researchresources/nida-distribution-agreement. Interested small business organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above. 2) Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of drug abuse research. 3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work. The Government will assess the appropriateness of professional and technical personnel classifications. The Government will consider any other specific and relevant information about this particular announcement that would improve our evaluation of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, contracts in which the organization performed equivalent tasks (Government and commercial); references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability; and awards or commendations. The established NAICS code is 541714: Research and Development in Biotechnology (except Nanobiotechnology). The U.S. Small Business Administration establishes a size standard for 541714 of 1,000 employees or fewer. All capability statements also should include the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if any (e.g., small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. Interested small business organizations that believe they possess the capability necessary to successfully undertake the work described above must submit capability statements to Josh Lazarus, whose contact information is below, NO LATER THAN 4:00 p.m. EST on 11/03/2017. NIDA will accept paper or electronic capability statements.