Nutrition Intervention Trial Biobank
Notice Type: Presolicitation Notice Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541 -- Professional, Scientific, and Technical Services/541990 -... Notice Type: Presolicitation Notice Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541 -- Professional, Scientific, and Technical Services/541990 -- All Other Professional, Scientific, and Technical Services Place of Performance: China Title: Nutrition Intervention Trial Biobank Background: The Nutrition Intervention Trials (NIT) cohort are a premier resource for studying the etiology of esophageal and gastric cancer in China. The trial and subsequent data and biorepositories were jointly conducted by the US National Cancer Institute and the Cancer Institute, Chinese Academy of Medical Sciences (now part of the National Cancer Center (NCC)). The trial portion of the study was conducted 1985-1991 and the study subjects have been under active surveillance from that date. A large biorepository of samples from the cohort subjects has been maintained at the NCC since collection from trial participants. This includes collections in 1985, 1991, 2000/2001 and other dates. In addition, the Early Detection of Esophageal Cancer (EDEC) project has produced a related collection of biosamples from early detection studies in and around Linxian through other collaborative projects. NCI intends to negotiate a contract with the Chinese Academy of Medical Science Cancer Hospital for the period of performance of a 12-month base period and four 12-month option periods. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source, Chinese Academy of Medical Science Cancer Hospital., under the authority of FAR 6.302-1. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Chinese Academy of Medical Science Cancer Hospital is the only responsible source, and no other supplies or services will satisfy agency requirements. The Chinese National Cancer Center (formerly Cancer Institute and Hospital; Chinese Academy of Medical Sciences) has already established the needed infrastructure and built-up extensive expertise for the project based on their previous years of successful performance. The contractor has successfully established and maintained the cohort data since 1985. The contractor has invested substantial time and resources in obtaining the necessary IRB approvals for this study from the Chinese government. Due to the effort put forth by the contractor, the Chinese government has designated the contractor to be the official institution devoted to these studies. As such, the contractor is the only institution who has access to the study population. The contractor is the sole source of the data and samples collected on these two important cohorts. Only through an active collaboration with this contractor can the NCI gain access to this valuable data and make productive use of it. No other such cohort exists and there is no other reasonable alternative to contracting directly with this contractor. Purpose and Objectives: The purpose of this requirement is to continue the maintenance of and access to the biosamples from the NIT and EDEC cohorts. 1. Maintain and upgrade biorepository of existing samples With input and guidance from the NCI, the Contractor shall maintain an inventory of biological samples in the Linxian biorepository. Maintain an accurate, complete, and up-to-date electronic master database file of existing human biological samples in the Linxian biorepository. The Contractor shall store, at -85 degrees Centigrade or room temperature, as appropriate, all existing biological samples collected during the Nutritional Intervention Trials (NIT) and Early Detection of Esophageal Cancer (EDEC) projects in the Linxian biorepository. The Contractor shall ensure freezers and ambient temperature in the freezer storage room for biological samples are monitored visually by staff and by electronic temperature monitoring (alarm systems) that allow for local and remote notifications of equipment problems. Temperature readings shall be recorded during each workday. The biorepository shall be equipped with fire and smoke alarms, and appropriate fire control equipment. Backup generators shall have the capacity to provide sufficient power to maintain the proper temperature of the mechanical freezers in the event of a partial or complete power failure. The generators shall be activated automatically within two minutes following a power failure or a voltage loss of 25 percent or more. Generators shall be tested at least quarterly. An emergency reserve source of liquid nitrogen shall be available to provide coolant for liquid nitrogen freezers ensuring there is a backup that can keep biological samples at a consistent temperature of -85 degrees centigrade. 2. Transfer of Biospecimens Only human biological samples from the NIT cohort and EDEC studies requested and approved by the COR shall be transferred from the Linxian biorepository to the NCI or other designated laboratory. All human biological samples transferred for processing shall be scheduled in advance, Monday through Friday, between the hours of 8 AM and 5 PM local time, except on Chinese Government holidays observed by The People’s Republic of China, and except in emergencies or exigent circumstances. The Contractor shall supply the appropriate transport service for the transfer of biological samples from the Linxian biorepository to other domestic laboratories as requested by the COR. The Contractor shall protect human biological samples from extreme temperatures by use of insulated containers or other acceptable means as needed. A portable liquid nitrogen container for transport of frozen samples shall also be used as needed. The Contractor shall transport all samples according to standards required by the International Air Transport Association (IATA) as well as any other applicable transportation requirements. The Contractor shall monitor shipments of human biological samples and track their progress in transit. Such monitoring activities shall be applicable to shipments from the Linxian biorepository to locations indicated by the COR. The Contractor shall initiate procedures for tracing shipments of human biological samples not received within eight (8) hours of the scheduled delivery time. This pertains to samples shipped from the biorepository and samples expected to be received at the processing laboratory. In such cases, the Contractor shall notify the COR by telephone and e-mail within 72 hours. Notification shall include the name of the study affected, number of samples and material type. 3. Consult with the COR and DCEG Investigators The Contractor shall consult with the COR as often as necessary concerning new and ongoing aspects of the work. In addition, the Contractor shall provide, within 72 hours, written responses to written data inquires generated by the COR in response to data received. 4. Preparation of Reports All reports in support of this project shall be provided electronically in database files. The Contractor shall ensure all written end-products (e.g., reports) are acceptable, complete, and in the proper format before transferring them to the COR or locations as designated by the COR. The Contractor shall prepare quarterly progress, annual and final reports that summarize the contract activities for the designated period as prescribed by the COR. Reports shall include a description of the services provided, the number of human biological samples processed, and a description of any problems encountered or other relevant comments. The Contractor shall provide a written report for any emergency affecting the status of biospecimens contained in the Contractor’s facility within 72 hours and daily thereafter. The report shall include details regarding the cause of the incident, steps taken to address the immediate needs, and recommendations for further actions needed to avoid similar incidents in the future. In the event of a shipment with damaged samples, the Contractor shall provide a written report for shipments that are received in a damaged condition, that describes the specimens and studies affected, a description of the finding and any follow-up action taken or needed within 72 hours. This applies to incoming shipments received in a damaged condition (e.g., broken biospecimen containers) or received at a recipient location in a damaged condition or when the research value of the biospecimens may have been compromised (e.g., thawed condition). Period of Performance: Base Period: 09/20/2022 – 09/19/2023 Option Period One (1): 09/20/2023 – 09/19/2024 Option Period Two (2): 09/20/2024 – 09/19/2025 Option Period Three (3): 09/20/2025 – 09/19/2026 Option Period Four (4): 09/20/2026 – 09/19/2027 The proposed contract action is for services for which the Government intends to solicit with one source, Chinese Academy of Medical Science Cancer Hospital, under authority FAR 6.302-1. Interested contractors may identify their interest and capability to respond to the requirement. This notice is not a request for competitive proposals. However, all capability statements received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition. Respondents should submit a tailored Capability Statement demonstrating the offerors’ qualifications, facilities, and experience. Capability statements must include the respondents’ DUNS number, organization name, address, and point of contact; and small business type(s). Sources are expected to have the necessary skills and tools to meet the requirements of this project. Interested organizations should submit a tailored capability statement for this requirement, not to exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All capability statements sent in response to this pre-solicitation notice must be submitted electronically (via email) to Thomas Conroy, Contracting Officer, at thomas.conroy@nih.gov . in MS Word or Adobe Portable Document Format (PDF). All responses must be received by October 11, 2021 by 10:00 AM EDT in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted.
Data sourced from SAM.gov.
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