MODIFICATION
R -- Upper Gastrointestinal (UGI) Cancer Prevention Studies
- Notice Date
- 2/16/2017
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SBSS-ETSB-1010-58
- Point of Contact
- Rosa M. Lopez, Phone: 2402765426, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
rosa.lopez@nih.gov, jill.johnson2@nih.gov
(rosa.lopez@nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Type of Notice: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: The Division of Cancer Epidemiology and Genetics (DCEG) began work in China because of the unique circumstances allowing scientific study of esophageal cancer. The extraordinary rates of disease in Linxian (20-25% of deaths are due to this disease) coupled with the numerous documented nutritional inadequacies made this a model environment to test the hypothesis that nutritional supplements could prevent cancer. Both esophageal squamous cell carcinoma (ESCC) and gastric cardia cancer (GCC) occur at epidemic rates in this population, share some etiologic risk factors, and prior to widespread use of endoscopy and biopsy, were diagnosed as a single disease referred to as "esophageal cancer" or "hard of swallowing disease". Enabled by the establishment of a cancer field station in Linxian by the Chinese in the late 1950s and the opening of China to the West in the 1970s, NCI initiated collaborative studies of esophageal cancer with the Cancer Institute of the Chinese Academy of Medical Sciences (CICAMS) in 1982. Pilot studies were followed by a case-control study and the Nutrition Intervention Trials (NITs). With the conclusion of the NIT interventions in 1991, attention turned to the etiology and the early detection of Upper Gastrointestinal (UGI) cancers, where studies were started in members of the trial cohorts as well as other high-risk and diseased subjects in Linxian. These studies have been conducted over the years through 2 separate but overlapping projects: the Nutrition Intervention Trials and Follow-up Study, and the Early Detection of Esophageal Cancer (EDEC) Project. These previously separate projects were combined into a single project to gather data and information related to participants of UGI cancer in Linxian. Purpose and Objectives: The purpose of this project is to continue providing support for the prevention and early detection of upper gastrointestinal (UGI) cancers. The objective of this project is to follow-up on strategies to reduce mortality from esophageal and gastric cancer in Linxian, China where rates of these cancers are the highest in the world. Project Requirements: Major tasks required of the successful contractor include the following: 1.Project Implementation Planning: •Complete and submit to the National Cancer Institute a written project plan for carrying out the requirements of the Statement of Work. The plan shall delineate the activities to be undertaken, including timelines and standard operating procedures for the continued vital status/cancer incidence follow-up of the previously-enrolled Linxian study participants and maintenance of the biorepository, to include a schedule for the replacement of aging equipment. The project plan shall address the development and implementation of Quality Assurance/Quality Control (QA/QC), quality control methods to assure high quality in the collection, preparation and review of vital status and cancer status information. The plans shall also address the development and implementation of QA/QC quality control methods to assure high quality in the processing and storage of human biological samples. •Complete and submit documents including Standard Operating Procedures (SOPs) and any other protocols pertaining to the handling, processing of vital status/cancer records and dissemination of human biological samples, plans for QA/QC, logs for human biological sample processing and shipments and any other relevant electronic records, as appropriate. 2.Maintain and upgrade biorepository of existing samples: •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. •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. •Upgrade biorepository infrastructure through the purchase of new freezers to replace aging equipment. •Ensure freezers and ambient temperature in the freezer storage room for biological samples are monitored visually by staff and also by electronic temperature monitoring (alarm systems) that allow for local and remote notifications of equipment problems. Temperature readings shall be recorded during each work day. •Ensure biorepository is equipped with fire and smoke alarms, and appropriate fire control equipment. •Ensure backup generators 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. •Ensure an emergency reserve source of liquid nitrogen is available to provide coolant for liquid nitrogen freezers. 3.Continue follow-up of participants previously enrolled in Linxian studies: •Follow-up NIT participants (n=32,902) and all prior participants in the EDEC Project (n=4,000) cohorts for vital and cancer endpoints. •Acquire and determine vital status and cancer status data on all NIT and EDEC by monthly checks of village doctor records and semi-annual checks of Linxian Cancer Registry records. •Locate and contact study participants, or family members of study participants, and hospitals to conduct personal interviews and collect and store centrally all available diagnostic materials for NIT and EDEC participants who have developed cancer or died with cancer. Contractor staff will travel to the participant's residence or other locations, if needed, to complete these tasks. •Develop and implement a Quality Assurance/Quality Control (QA/QC) program to monitor the performance of work in the collection, preparation, and review of vital status and cancer status information. •Review diagnostic materials and summarize all causes of mortality and all incident and mortal cancers diagnosed. Prepare and provide an error-free electronic database of diagnostic materials collected and centrally stored on participants identified as having cancer and other relevant information as specified by NCI. •Use applicable and common security practices for protecting data collected under the project. 4.Provide Endpoint files: •Provide to NCI cumulative endpoint data files for all Linxian studies annually to include all cumulative endpoints (all incident cancers, cancer deaths, and deaths from all other causes) identified through follow-up from the beginning of each of the Linxian studies up to and including the present. 5.Transfer of Biospecimens: •Supply the appropriate transport service for the transfer of biological samples from the Linxian biorepository to other domestic or international laboratories and the NCI for specified laboratory analyses. •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 must also be used as needed. •Transport samples in accordance with standards required by the Air Transport Association (IATA) as well as any other applicable transportation requirements. •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 NCI. •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. 6.Consult with COR and DCEG Investigators: •Consult with the COR as necessary and respond to written data inquiries generated in response to data received from China. 7.Preparation of Reports: •Prepare progress reports that summarize the contract activities for the designated period. Reports shall include NIT and EDEC participants' demographic information and outcome information, a description of the services provided, the number of human biological samples processed and a description of any problems encountered or other relevant comments. •Annually provide up-to-date data analysis files that contain all available covariate and endpoint data collected and adjudicated cumulatively since the start of each of the component studies within the various Linxian projects, including the NITs and EDEC (and EDEC substudies). •Prepare in collaboration with the COR, reports from study data for publication. •Notify the COR by phone and e-mail within 72 hours of any emergency affecting the status of the biospecimens contained in the Contractor's facility. The Contractor shall follow-up with a written report that includes 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. •Notify the COR within 72 hours of any incoming shipments received in a damaged condition (e.g., broken biospecimen containers) or received at a recipient location in a damaged condition or in the research value of the biospecimens may have been compromised (e.g., thawed condition). In such cases, the Contractor shall notify the COR by telephone and e-mail, followed by a written report that describes the specimens and studies affected, a description of the finding and any follow-up action taken or needed. Anticipated Period of Performance: The anticipated period of performance for this requirement is one year, with four one-year option periods. Capability Statement/Information Sought: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 pages (12-point font minimum), including all attachments, resumes, charts, etc., that clearly details the ability to perform the aspects of the notice described above. Capability Statement must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: All capability statements sent in response to Sources Sought notice must be submitted electronically (via email) to Rosa Lopez, Contracting Officer at rosa.lopez@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by February 22, 2017, 10:00 AM, Eastern Time. 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 the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure 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).
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