SOURCES SOUGHT
A -- Liver Tissue and Cell Distribution System
- Notice Date
- 12/5/2016
- Notice Type
- Sources Sought
- 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-SBSS-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
- Purpose of this Announcement: This is a R&D Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The primary purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether there are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses, women-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. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set aside is possible or to identify potential sources for a full and open competition. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a North American Industry Classification System (NAICS) code of 541712 and the small business standard is 1,000 employees. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking an organization to continue supporting the Liver Tissue Cell and Distribution System (LTCDS). Background and Project Requirements: The mission of 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 not be available to researchers who work outside a liver transplant center. To support this need, NIDDK has established the Liver Tissue Cell Distribution System (LTCDS) 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) to provide 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 basic 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. Government supplied facilities include cryopreservation facilities and LTCDS IT systems. 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 biotech laboratory for further processing. 2. Technical tasks, focused primarily on the isolating, purifying, and preserving the liver tissue in a biotech 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; process financial accounting information; and track the production process. The system shall receive user requests; review and prioritize requests; maintain a fee schedule; receive and process payments; 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, cost information, 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. Anticipated period of performance: It is anticipated that the period of performance will be for five years beginning approximately June 2017. Capability Statement Requirements: The intention of this announcement is to survey the market for potential offerors among small businesses including veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business and women-owned small business concerns. No large businesses should respond to this announcement. Interested small businesses that believe they possess the capabilities to perform the project requirements described above must submit electronic copies of their capability statements to Usha Raman at ramanu2@mail.nih.gov Capability Statements should be received by the Contracting Officer by 1 pm EST Monday, December 19, 2016. Respondents must send capability statements via electronic submission only. Each response should include the following business information: • DUNS number. • Company Name. • Company Address. • Company Point of Contact, phone and Email address. • Whether the Organization has an approved accounting system, and if so, the agency that approved the system. • Company size and type (i.e., small business, 8(a), woman-owned, veteran owned, etc.) pursuant to the applicable NAICS code, as validated via the system for Award Management (SAM). All offerors must be registered on SAM at https://www.sam.gov The content of the capability statements shall be limited to fifteen pages describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) the capability to provide the required level of effort on a continuing and emerging needs basis; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to 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). Inquiries should be directed to: Ms. Usha Raman Contracting Officer Acquisition Services Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH 6710B Rockledge Drive; Room: 1161B MSC 7000 Bethesda MD 20892 Phone: 301-443-5228 Email: ramanu2@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NIDDK-SBSS-2017-5/listing.html)
- Place of Performance
- Address: To be determined., United States
- Record
- SN04343012-W 20161207/161205234550-66e47a0fd287bc15bc691d8824e7306d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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