SOLICITATION NOTICE
A -- NIDDK Biosample and Genetics Repositories
- Notice Date
- 3/24/2016
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIHNIDDKKUHASB201619
- Point of Contact
- Richard Bailey, Phone: 301.402.1139, Marlene T. Mireles, Phone: 301-443-7795
- E-Mail Address
-
Richard.Bailey@nih.gov, mirelesm@mail.nih.gov
(Richard.Bailey@nih.gov, mirelesm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) has a requirement to award a contract to serve as the "NIDDK Biosample - Genetics Repository". NIDDK conducts, supports, and coordinates research on many of most serious diseases affecting public health. The Institute supports clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The NIDDK Division of Kidney, Urologic, and Hematologic Diseases (KUH) provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs. The objective of this requirement is to continue the Biosample and Genetics Repositories in a highly efficient, rapid, and cost-effective manner in the performance of the respective task areas: The first component, Biosample Repository gathers, stores, and distributes biological samples from studies and works with investigators in new and ongoing studies as a real-time storage facility for archival samples. Many of the large clinical studies funded by the NIDDK collect biospecimens from subjects for analysis and future study. The collection of these patient and control samples from many different studies in a single repository is a valuable resource with which researchers can rapidly validate clinical hypotheses and algorithms for clinical decision. The collection is also advancing the development of prognostics, markers, and therapeutics for diseases related to the mission of the NIDDK. The repository stores and maintains biosamples under high quality conditions, and distributes them in an equitable and ethical manner. This facilitates sharing of NIDDK­supported resources, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in current collaborations, without excluding those who are established in their fields. It helps to ensure that research participants make a maximal contribution, and decreases duplicative sampling efforts. The tasks to be performed under the Biosample Repository include, but are not limited to the following: (a) Establish biospecimen preparation, shipping, receipt, and tracking systems for numerous individual multi-center clinical studies; (b) Maintain the confidentiality of subjects by removing all traditional personal identifiers from samples; (c) Establish one or more subcontracts for timely and cost-effective shipping of biosamples between multiple sites and the repository and for timely and cost-effective laboratory processing and/or testing of biosamples; (d) Store biosamples under optimal conditions to minimize loss, damage or contamination; (e) Distribute biosamples to qualified investigators granted access by the Contracting Officer's Representative (COR), including packaging, handling, and coordinating sample shipments to domestic and international sites; (f) Withdraw and destroy samples from the repository as proposed in writing by the COR; (g) Establish and maintain Quality Control (QC) and Quality Assurance (QA) programs; (h) Provide security and back-up systems and a plan for disaster recovery; (i) Maintain robust, flexible, high quality, secure information systems to allow detailed tracking of sample receipt, processing, storage and distribution, rapid retrieval of samples, storage of QA/QC information associated with the sample, and listing of investigators using the repository; (j) Collaborate with the COR, the External Advisory Committee and the Steering Committee. The second component, Genetics Repository receives and processes blood samples, generally from pediatric study participants, to allow genetic analyses, creates immortalized cell lines or cryopreserves nucleate cells for future immortalization, and prepares DNA from whole blood, cryopreserved cells and cell lines. The Genetics Repository will allow the continued storage, maintenance, and quality control, and equitable, ethical distribution of DNA and other resources important to the study of diseases under the mandate of the NIDDK. It facilitates sharing of resources, thus encouraging work by a broad group of investigators and perhaps, increasing the sample size and the resulting power of a study to identify the genetic determinants of a disease. It helps to ensure that research participants will be making a maximal contribution, and decreases duplicative sampling efforts. The tasks to be performed under the Genetics Repository include, but are not limited to the following: (a) Establish biospecimen preparation, shipping, receipt, and tracking systems for numerous individual multi-center clinical studies; (b) Maintain the confidentiality of subjects by removing all traditional personal identifiers from samples; (c) Establish one or more subcontracts for timely and cost-effective shipping of biosamples between multiple sites and the repository; (d) Create and store viable cell lines via Epstein-Barr virus transformation of lymphocytes from blood samples, with a success rate of 98% or greater and expanding the lymphoblastoid cell lines; (e) Receive and store lymphoblastoid cell lines prepared at other facilities and carry out quality control assessments; (f) Extract and store DNA from cell lines, whole blood and, with designated samples, separate the white blood cells (buffy coat) from the plasma of received blood samples; (g) Distribute cell lines and biosamples to investigators or other facilities as proposed by the COR, including arraying in a variety of formats, packaging, handling, and coordinating sample shipments to domestic and international sites; (h) Withdraw and destroy samples from the repository as proposed in writing by the COR; (i) Establish and maintain Quality Assurance (QA) and Quality Control (QC) programs; (j) Provide security and back-up systems and a plan for disaster recovery; (k) Maintain high quality, secure information systems to allow detailed tracking and reporting of sample receipt, processing, storage and distribution, rapid retrieval of samples, storage of QA/QC information associated with the sample, seamless interaction with the Database Repository, and listing of investigators using the repository; (l) Collaborate with the COR, customers, and the Steering Committee. A fixed price type contract using NAICS code 541712 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), is contemplated. NICHD intends to award a five year contract, with a base year plus four option years, beginning on or about September 1, 2016. FAR Part 15 procedures will be used to complete this procurement with full and open competition. The request for proposal is expected to be released on or about April 15, 2016 at the FedBizOpps website.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIHNIDDKKUHASB201619/listing.html)
- Record
- SN04061417-W 20160326/160324234632-a5e90fd8e5a2398c9d767d9c39b49d2b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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