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SOURCES SOUGHT NOTICE

Title: Resource for the Collection and Evaluation of Human Tissue, Cells, and Bio-fluids from Donors with an Epidemiologic Profile Refence No: 75N91024R00018

Introduction:

The Laboratory of Human Carcinogenesis (LHC) within the Division of the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) is requesting capability statements from eligible organizations. This notice is issued as part of market research to assess the availability and capability of any organization, excluding the incumbent (the University of Maryland), to meet the requirements as detailed below and in the attached draft Statement of Work (SOW).

Please note: This Sources Sought Notice is NOT a solicitation for proposals, proposal abstracts, or quotations. Its purpose is to gather information on the following:

1. The availability and capability of all qualified sources, including small and large businesses.

2. The potential for small business set-asides, including specific subcategories (e.g., HUBZone, service-disabled veteran-owned, 8(a), veteran-owned, woman-owned, or small disadvantaged businesses).

3. The size classification of interested organizations relative to the North American Industry Classification System (NAICS) code for this acquisition.

The information gathered will assist the government in determining the appropriate acquisition strategy, including the possibility of a set-aside. All interested and capable organizations (excluding the incumbent, the University of Maryland) operating under NAICS code 541715 should 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

Sources Sought Notice Page 2 of 5 controls, recruited from online advertisements. 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. Five (5) previous contracts have been awarded competitively. The current contract 75N91020C00007 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 9/21/2020.

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

Sources Sought Notice Page 3 of 5 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 all fresh tissue specimens on wet-ice within 3 hours after receiving the specimen from the pathologist; store frozen biological specimens at -80°C and deliver them to NCI as a bimonthly batch; 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 information.

3) 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.

Participants must be recruited from the Baltimore Metropolitan area and outlying regions of Maryland to maintain consistency with the previous enrollees. Compatibility with records from the University of Maryland Medical System and Baltimore Veterans’ Affairs Facilities for previously enrolled participants is critical.

The contract must ensure compatibility with existing data collections and resource continuity. Over the years, the contract has led to the development of a tissue repository in LHC. Older tissues in this repository are particularly valuable for tracking survival times through periodic searches using the National Death Index (https://www.cdc.gov/nchs/ndi/index.htm). These older tissues must be used judiciously to preserve this vital resource while continuing to recruit additional donors and tissues. The epidemiological data and questionnaires must integrate seamlessly with previously collected data.

4) Obtain and maintain ethical and legal approvals, including but not limited to Local

Institutional Review Board (IRB) approvals.

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Anticipated Period of Performance:

The Government anticipates extending the current Cost Reimbursement Level-of-Effort type contract with the University of Maryland for two years, and up to five years (consisting of up to five, one-year option periods) beginning on or about September 30, 2025, contingent upon no other organization(s) being identified as available and capable of performing these services.

However, if there are qualified and interested organization(s) who demonstrate the capability to perform the required services, the Government will consider the potential for competitive procurement, with a single Cost Reimbursement Level-of-Effort type contract award consisting of a one-year base plus six, one-year option periods beginning on or about September 30, 2027.

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 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, if any; 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 UEI 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 Notice must be submitted electronically (via email) to Whitney Monkam, Contract Specialist, at whitney.monkam@nih.gov in MS Word or Adobe Portable Document Format (PDF) by 3:00 PM, EST on February 18, 2025. 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.

mailto:whitney.monkam@nih.gov

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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.

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).