NIDDK Data Repository

NIDDK Data Repository This is a Small Business Sources 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 small businesses; veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman owned small businesses; or small disadvantaged small businesses; and (3) their size classification relative to the North Industrial Classification System (NAICS) code for the proposed acquisition. Your response 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. 1.0 BACKGROUND. Storing and allowing subsequent use of biological materials and associated data collected in clinical studies is one way for the NIDDK to meet its responsibility to maximize the value of these studies. The NIDDK's Central Repositories' collection of the biosamples and associated clinical, diagnostic, genotypic, pedigree structure and/or other data is a resource that advances the development of diagnostic and treatment tools for many diseases. The NIDDK Biosample and Genetics Repositories, which are separately supported, house biological materials collected in large clinical studies. The project described in this sources sought notice will be referred to herein as "The Data Repository," stores the data from these large studies, including data associated with the stored biosamples and acts as the Data Coordinating Center for the NIDDK Central Repositories. The Database Repository, acting as a central coordinating entity, facilitates efficient distribution of data and samples. As an archive and distributor of highly usable legacy datasets, the Repository also allows re-analysis of these data and, where relevant, of specific biosamples, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in the original funded studies. 2.0 PUROSE AND OBJECTIVES. The objective of this contract will be to continue the NIDDK Data Repository, in order to accomplish the following in a highly efficient, rapid, and cost-effective manner: i. Assist study coordinating centers and the NIDDK Biosample and Genetics Repository in setting up labeling systems to cross-reference samples and associated data. ii. Maintain a central inventory of samples kept at the NIDDK Biosample and Genetics Repositories, and provide inventory reporting structures for individual studies. The inventory must clearly indicate additions, subtractions, and up to date totals of all sample types. iii. Receive and test the validity of electronic databases from completed studies. iv. Maintain and distribute those databases, including administering review of access applications. v. Provide timely and informative analyses of databases in response to researcher inquiries. vi. Create and maintain a website for all of the NIDDK Central Repositories. vii. Carry out activities to advertise to the research community about the availability of samples and data. The information systems, consulting, and database archiving tasks outlined in this sources sought notice are highly technical, and require extensive experience, expertise, and long-term commitment. The data from each study represent the efforts of hundreds of investigators to improve the public health through biomedical research, and the voluntary participation of hundreds or thousands of patients and family members. The data and samples represent tax payer funded work by the National Institutes of Health and it is important that these be made available to qualified researchers for the public benefit. The data cannot be replaced without great expense and effort, and, therefore, it is essential that they be protected from loss, damage or misuse. The Contractor's project director must have extensive experience in successful database management. The Contractor's staff must be highly trained to work with, maintain, and analyze numerous databases, including those in Oracle and other DBMS's. Because all these studies contain data from human subjects, all staff must be familiar with human subjects protections and be sensitive to the bioethical issues involved in handling subject data. Finally, the Contractor must have a demonstrable long-term interest in providing these services, to ensure that there is continuity throughout the period of the contract. 3.0 PROJECT REQUIREMENTS. The tasks to be performed under the new requirement include, but are not limited to the following: (1) Receive and test the accuracy, completeness and validity of electronic databases of participant information from completed studies that include clinical, diagnostic, genotypic, pedigree structure and other data, along with supporting documentation. (2) Link phenotypic data to high-density genotyping data stored in the dbGAP (database of Genotype and Phenotype) or comparable database. (3) Consult with data coordinating centers (DCC's) from new and ongoing studies and with the NIDDK Genetics and Biosample Repositories to facilitate use of the NIDDK Central Repositories. (4) Work in a cooperative fashion with the Project Officer, the External Advisory Committee, and the Steering Committee. (5) Maintain the confidentiality of subjects by removing all traditional personal identifiers from data. (6) Provide timely and accurate analyses of databases regarding the availability of samples, including the determination of the feasibility of the repository to meet the needs of a research request, such as the number of samples available that meet specific criteria. (7) Maintain and distribute stored databases or selected portions of stored databases to qualified investigators granted access by the Project Officer. (8) Establish and maintain general Quality Control (QC) and Quality Assurance (QA) programs. (9) Provide security and back-up systems and a plan for disaster recovery. (10) Maintain a public forum, including a web site, as a resource for users of the repository, and as a tool for public education about the repository and its goals, including a list of publications resulting from use of repository samples. Anticipated period of performance. It is anticipated that the period of performance will be for five years beginning approximately July 2013. 4.0 CAPABILITY STATEMENT/INFORMATION SOUGHT. Respondents must submit a capability statement that demonstrates the potential offeror's qualification, experience, and expertise, specifically providing evidence for the following:(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. Interested offerors must submit five (5) hard copies of their capability statement. This should be limited to twenty five (25) pages. Each respondent should include their DUNS number, organization name, address, point of contact, and size and type of business (e.g.) 8(a), HUBZone, etc.) pursuant to the applicable NAICS code. No faxed or emailed capability statements will be accepted. The intention of this announcement is to survey the market for potential offerors. No large business should respond to this announcement. All interested small business including veteran-owned small business, service-disabled small business; HUBzone small business; small disadvantaged small business; and woman owned small business concerns must provide copies of their capability statement on or before November 27, 2012 at 12:00pm Eastern time to Mr. Richard Bailey, Contract Specialist, NIDDK Acquisitions Branch, Two Democracy Plaza, Suite 700W, 6707 Democracy Boulevard, MSC 5455, Bethesda, Maryland 20892-5455. If the response is hand-delivered or sent by express delivery service use Bethesda, Maryland 20817. General questions may be emailed to the following address: Richard Bailey, Contract Specialist, baileyrichard@mail.nih.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use the information provided by respondents for any purposes 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 qualifications to perform this work. Respondent 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).