Resource for the Collection and Evaluation of Human Tissue, Cells, and Bio-fluids from Donors with an Epidemiologic Profile

Added:Oct 16, 2019 1:27 pmSynopsis:The Laboratory of Human Carcinogenesis (LHC), Division of the Center for Cancer Research (CCR), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses. 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. This requirement is assigned the NAICS code 541715, and the size standard for such requirements is 1,000 employees. Capability statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of the capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.Background:The Resource for the Collection and Evaluation of Human Tissue, Cells, and Bio-fluids supports molecular epidemiology studies of human lung, breast, prostate, liver and pancreatic cancer, as well as, the molecular pathogenesis and translational studies of all these diseases. LHC studies the induction of cancer directly in human tissues and cells. This requires a reliable source of fresh, professionally obtained human specimens.The contract initially began as a pilot to obtain tissues for the experimental development of conditions to culture human specimens as organ and cellular tissues. The focus at that time was to obtain case-series cancer and adjacent uninvolved tissues from consented patients as they underwent surgery. Historically, cancer cases were obtained primarily from the Baltimore Veteran's Administration Hospital, the University of Maryland Medical Center, and Johns Hopkins University Hospital. Beginning in 1996, focus shifted to case-control studies which still included collection of material from cancer patients, and also healthy population-based controls, recruited from the Maryland Department of Motor Vehicles records. Population controls were recruited based on matching to the cancer cases by geographic location (Baltimore City, Maryland and surrounding selected counties), gender, and race.In addition to human tissues for research, the resource provides corresponding epidemiology profiles that include occupational histories, personal health history, family health history, smoking information, and exercise information via informed consent. Addition of medical record abstracts and pathological reports complete questionnaires. Personal Identifying Information is excluded when data or samples are delivered to the NIH. Further, the contract provides histology slides and histopathological interpretations by professionals. Unstained regular, standard and immuno-stained slides are made available for staining and interpretation in LHC. Four (4) previous contracts have been awarded competitively. The current contract HHSN261201500051C titled "Resource for the Collection and Evaluation of Human Tissues and Cells from Donors with an Epidemiology Profile" was awarded to University of Maryland on 9/28/2015.Purpose and Objective:The scope of this contract is to provide ongoing research to support molecular epidemiology studies of human lung, breast, liver and pancreas cancer and also provide human cancer and non-cancer tissue and primary cells for both in vitro and in vivo studies allowing the LHC to conduct studies.Project Requirements:The Contractor shall do the following:1) Identify and Recruit Cancer Cases and Population-Based Controls and Obtain Signed Informed Consent from Potential Participants:The contractor shall accrue a goal of up to: 100 lung cancer cases per year; 40 benign lung nodules from surgery cases per year; 200 low-dose computed tomography (LDCT) screened candidates per year; 100 primary hepatocellular liver carcinomas (HCC) cases per year; 150 chronic liver disease (CLD) cases per year; 100 primary pancreatic ductal adenocarcinoma cases per year; 50 chronic pancreatitis cases per year; 40 breast cancer patients scheduled for surgery per year; 225 normal population control subjects per year; and accrue cancer patients willing to participate in research but who do not qualify for specific aforementioned studies.2) Collect, Store, Process and De-identify Biological Specimens Transferred to the LHC:The contractor shall administer an NCI-developed interview to each participant for the collection of basic demographic information, smoking history, family history of cancer, medications, occupational history, for use in epidemiological studies. At the time of interview, the contractor shall: collect and store specimens (tissues, blood products, urine, nasal swabs, cheek swabs, etc.) from either cases or controls; collect when possible, from each case, non-adjacent normal and tumor tissues; prepare paraffin embedded tissues for tumor and non-involved tissue from all cancer cases; collect and process an oral mouthwash rinse for cheek cells if a blood-draw is not possible; collect and process two vacutainers for serum and up to four vacutainers for plasma and lymphocyte preparation from all participants; deliver fresh tissues on wet-ice within 3 hours after receiving the specimen from the pathologist; deliver frozen biological specimens that have been stored at ‐80°C to NCI as a batch bimonthly; characterize and histologically classify both cancerous and non‐cancerous solid tissues delivered to the NCI, and; ensure that the Information delivered to Government personnel will be void of any personally identifiable health information3) Collect, Store, Process, and De-identify Participant Interview Data:The contractor shall: provide an epidemiology profile from an NCI-developed questionnaire, administered by trained interviewers via informed consent from each participant; store and maintain the computerized profiles of the participants (without personal identifiers) in a secured tissue‐donor epidemiology database; provide secure storage of completed questionnaires and up‐to‐date security for all electronic data, especially of those data containing personal identifiers in the contractor's facility. Databases must be covered under a Federal Information Security Management Act Authority to Operate (FISMA ATO) Letter, and; prepare, request, and store data for selected cases in the study for survival searches per the National Death Index as required by the LHC investigators.4) Obtain and maintain ethical and legal approvals, including but not limited to Local Institutional Review Board (IRB) approvals.Anticipated Period of Performance:It is anticipated that one (1) Cost Reimbursement contract will be awarded with a one (1) year base plus four (4) one (1) year option periods beginning on or about September 30, 2020.Capability Statement/Information Sought:To be deemed capable of providing services that meet the LHC project requirements, please submit a written capability statement demonstrating your ability and experience to provide the requisite technical expertise, personnel, organizational experience and facilities. In addition, the Capability Statements must clearly demonstrate the ability to deliver non-frozen viable tissues to the NIH campus within three (3) hours of receiving them from the pathologist, at all times of the day. The offeror is required to provide their address and the distance from the LHC, CCR, NIH located at: 37 Convent Drive, Building 37, Rm 3054, Bethesda, MD 20892.Submission Information:Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 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 requirement described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address), as well as the eligible small business concerns name, point of contact, address and DUNS number. Responses will be reviewed only by NIH personnel and will be held in a confidential manner.All capability statements in response to this Sources Sought Noticemust be submitted electronically (via email) to Pooja Rathore, Contract Specialist, at pooja.rathore@nih.gov in MS Word or Adobe Portable Document Format (PDF) by 3:00 PM, EST on October 31, 2019. All responses must be received by the specified due date and time 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.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.