SOURCES SOUGHT
B -- Nutrition Intervention Trial Biobank
- Notice Date
- 7/22/2021 8:08:08 AM
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SBSS-ETSB-03
- Response Due
- 8/5/2021 12:00:00 AM
- Archive Date
- 08/20/2021
- Point of Contact
- Thomas Conroy, Rukshani Levy
- E-Mail Address
-
thomas.conroy@nih.gov, rukshani.levy@nih.gov
(thomas.conroy@nih.gov, rukshani.levy@nih.gov)
- Description
- Sources Sought Notice (SSN) Agency/Office: National Institutes of Health Location: National Cancer Institute, Office of Acquisitions Title: Nutrition Intervention Trial Biobank NAICS Code: 541990 -- All Other Professional, Scientific and Technical Services PSC:� B537 -- SPECIAL STUDIES/ANALYSIS- MEDICAL/HEALTH HHS-NIH-NCI-SBSS-ETSB-03 Type of Notice: This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information �regarding the availability and capability of all qualified sources to perform a potential requirement.� Your response to the information requested will assist the Government in determining the appropriate acquisition method. The NAICS code for this project is 541990. The small business size standard is $15.0M. �Background: The highest known worldwide rates of esophageal cancer occur in Linxian, China where the cumulative death rate from this cancer for residents up to age 75, exceeds 20%.�� Widespread deficiencies of multiple nutrients are considered the most likely cause, but consumption of pickled vegetables, moldy foods,� nitrosamines, and other unknown factors may play a role. Two double-blind, placebo-controlled randomized intervention studies were conducted previously by this contractor in Linxian to evaluate multiple vitamins/minerals in the prevention of esophageal and other cancers.� The Dysplasia Trial, one of the two studies, evaluated 3,318 persons with cytologic evidence of dysplasia where participants were supplemented for 6 years, while the other study, referred to as the General Population Trial, evaluated 29,584 participants who were supplemented for 5 years.� Biologic specimens (blood, toenails, cytology and histology specimens) were collected periodically throughout the trials. 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.� This includes collections in 1985, 1991, 2000/2001 and other dates.� A successful early detection and treatment program for esophageal and gastric cardia cancer requires a sensitive screening test to identify dysplasia and early cancer in asymptomatic people, confirmatory tests that accurately identify the location and extent of these neoplastic lesions, and treatment methods that cure dysplasia and cancer.� The Early Detection of Esophageal Cancer (EDEC) project was established to evaluate promising techniques in all of these areas, and has previously conducted studies of cytologic and molecular detection of esophageal and gastric cardia dysplasia and cancer, endoscopic localization of dysplasia and cancer, and endoscopic therapy of focal dysplasias and early cancers.� In addition, it has evaluated the ability of chemopreventive agents to cause regression of squamous dysplasias. Further, the EDEC project has produced a related collection of biosamples from early detection studies in and around Linxian through other collaborative projects. Purpose and Objectives: The Purpose of this requirement is to maintain an inventory of biological samples in the Linxian biorepository. The main objective is to maintain the biological samples and an accurate, complete, and up-to-date electronic master database file of existing human biological samples in the Linxian biorepository from the NIT Cohort and the EDEC Project and transfer biospecimens as appropriate to the other designated laboratories. A further objective of this requirement is to Consult with DCEG Investigators and the Contracting Officer�s Representative (COR) on all aspects of the Contract Effort. The final objective is to prepare all reports in database files as end products and deliver to the COR. Project Requirements: The Contractor shall furnish services, qualified personnel, material, equipment, including secure computers, and facilities, to provide support services to DCEG studies in the areas of receipt and processing of human biospecimens and temporary storage of biospecimens until they are ready to be included in research activities, and transfer to laboratory for testing. Tasks: The Contractor shall: 1.� Maintain and upgrade biorepository of existing samples With input and guidance from the NCI, the Contractor shall develop and 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 other designated laboratory as specified by the COR.� 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. 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 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 Contract Effort. 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). Anticipated Period of Performance: It is anticipated that single standalone contract will be awarded with a five (5) year period of performance beginning 09/16/2022.� Capability Statement/Information Sought: Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 5 single-sided pages (not 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. Information Submission Instructions: All capability statements sent in response to this Sources Sought notice must be sent electronically (via email) to Tom Conroy, Contracting Officer at thomas.conroy@nih.gov and Rukshani Levy, Contracting Officer at rukshani.levy@nih.gov@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by 08/05/2021 All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the 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.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/e2f2a610b1e44332a4df9fdf56e7f2e9/view)
- Place of Performance
- Address: Beijing, CHN
- Country: CHN
- Country: CHN
- Record
- SN06071128-F 20210724/210722230127 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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