SOLICITATION NOTICE
A -- Liver Tissue and Cell Distribution System (LTCDS)
- Notice Date
- 3/9/2017
- 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, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NIDDK-DDN-2017-5
- Point of Contact
- Usha Raman, Phone: 301-443-5228, Marlene T. Mireles, Phone: 301-443-7795
- E-Mail Address
-
ramanu2@mail.nih.gov, mirelesm@mail.nih.gov
(ramanu2@mail.nih.gov, mirelesm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Description: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), on behalf of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), plans to solicit proposals, through full and open competition procedures, from qualified organizations having the capability to support the Liver Tissue and Cell Distribution System (LTCDS), in order to facilitate the procurement, processing and distribution of liver tissues and cells to NIH funded investigators throughout the United States. The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support research on many of the most serious diseases affecting public health. The institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. Among these diseases are end-stage liver diseases. To understand the pathophysiology of these diseases, it is essential to provide researchers with access to liver tissue and cells from a variety of end-stage liver diseases, as well as normal livers. These specimens would generally not be available to researchers who work outside a liver transplant center. To support this need, NIDDK established the Liver Tissue Cell Distribution System (LTCDS) in 1986 to facilitate the procurement, processing and distribution of liver tissues and cells to investigators throughout the United States. The incumbent contractor is the University of Minnesota. The LTCDS provides to the scientific community human liver tissue collected from regional centers (with active liver transplant programs and human subjects approval), supplying portions of the resected pathologic liver for which the transplant is performed. Frozen or fresh tissue is available from other organizations for the usual forms of childhood and adult cirrhosis, fulminate liver failure, chronic rejection, and certain inborn errors of metabolism. In addition LTCDS provides "normal" human liver tissue (primarily frozen), slides, and tissue blocks, and rarely other liver cell types in culture. LTCDS is to serve as a resource for investigators to obtain human liver tissue for scientific investigation. This liver tissue system: 1. Collects portions of liver removed from liver transplant recipients at surgery. 2. Collects and provides normal liver tissue to investigators if the tissue from organ donations cannot be used for the recipient because of size, state of anoxia, etc. (a very rare event). 3. Develops and maintains the capacity to retrieve, preserve, and deliver available tissues in such condition as will be useful to investigators conducting biomedical research projects at institutions throughout the United States. 4. Provides normal human hepatocytes in culture. On average, each year, this system provides about 750 shipments of liver tissue (tissue, blocks and slides) and 150 shipments of hepatocytes (equivalent to about 7x10^9 hepatocytes). The NIDDK requires an organization to provide the infrastructure for procurement and distribution of liver tissues and cells from a variety of end-stage liver diseases and normal livers to scientific investigators. The requirement seeks to facilitate the distribution of discarded liver tissue to qualified investigators in order to stimulate research on liver diseases. Recipients of cells and tissue from diseased livers are primarily investigators whose projects have been vetted by the NIDDK grant process. Available supplies of isolated hepatocytes from normal liver currently dictate that these are provided only to investigators at the National Institutes of Health. The scope of the program is comprised of procuring, isolating, purifying, preserving and distributing donor liver tissue, as well as reporting on this process. Donor tissue shall include whole or sectioned human liver tissue that is normal or shows pathology from a variety of liver diseases. This tissue shall be processed into liver tissue blocks (frozen, paraffin embedded), hepatocytes suitable for cellular and molecular studies, and other preparations. To facilitate progress in liver research, to respond to the need of the investigators and to assess the evolution of the services, the contractor shall obtain periodic input from the scientific community regarding the provision of other liver specimens, particularly non-parenchyma cells. The requirement shall consist of the following tasks: 1. Clinical tasks, focused primarily on procuring donor tissue in a clinical setting. Specifically, the requirement shall include obtaining informed consent of organ donors; building a synopsis of donor's medical history and laboratory data; collecting whole or partial livers; and delivering this to a laboratory for further processing. 2. Technical tasks, focused primarily on isolating, purifying, and preserving the liver tissue in a laboratory setting. The primary objective for tissues prepared with cryopreservation or histology techniques is a preparation that clearly preserves characteristic structures and pathology. The primary objective for cells is to maintain a high rate of cell viability. 3. Order Management tasks, focusing primarily on distributing the tissue to basic investigators. The primary objective is to deliver specimens in excellent condition; and track the production process. The system shall receive user requests; review and prioritize requests; and communicate with investigators via a website and to form, and be guided by, an external Coordinating Committee. 4. Reporting tasks, focusing primarily on collecting, analyzing and reporting data on the tasks described above. Specifically, data shall be presented on demographics, metrics, quality control, inventories, transaction activity and benefits of the program, such as the citations of publications resulting from this service. These data shall be analyzed and presented in graphic form. The requirement includes the ability to customize data queries, export query results to spreadsheet applications and graphically summarize and print query results. This task shall support the Coordinating Committee's strategic decision-making by providing the following types of information: review of operating procedures, quality control procedures, tissue processing procedures, information storage and management procedures, and operating policies ensuring equitable access to contract services. A completion type cost-reimbursement contract using NAICS code 541712- Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology), is contemplated. On behalf of NIDDK, NICHD intends to award a contract on or about September 8, 2017, consisting of a base period and four 12 month option years. This acquisition is a competitive renewal of HHSN276201200017C, titled "Liver Tissue and Cell Distribution Systems (LTCDS)."FAR Part 15 procedures will be used to compete the procurement through full and open competition. It is anticipated that the Request for Proposals (RFP) will be released on or about March 31, 2017 on the FedBizzOpps website. RFP No. NIH-NIDDK-DDN-2017-5 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDDK anticipates an award date on or around September 8, 2017. NIDDK will consider proposals submitted by any responsible offeror. This announcement does not commit the Government to award a contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NIDDK-DDN-2017-5/listing.html)
- Record
- SN04430153-W 20170311/170309234954-a6040c43b53d5971c58cb60c6f2298b5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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