Cancer and Other Health Effects Following the Chernobyl Accident in Ukraine

Small Business Sources Sought Notice NIH-OD-OALM-SBSS-DivB-06222026-2 Classification Code: AN11- (R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)) NAICS Code: 541715- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) Title: Cancer and Other Health Effects Following the Chernobyl Accident in Ukraine Type of Notice: This is a Small Business Sources Sought notice (SBSS). This is NOT a solicitation for proposals, 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, women-owned small businesses, or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this project is 541715. The small business size standard is 1,000 employees. This Small Business Sources Sought notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The NCI does not intend to award a contract based on responses received nor otherwise pay for the preparation of any information submitted. The Capability Statements submitted in response to this notice should include an indication of current certified 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 business concern s name, point of contact, address, and UEI number. Background: The Chernobyl Research Program (CRP), Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is responsible for studies on radiation effects on cancer and other diseases. CRP/REB/DCEG develops, administers, and evaluates a contract-supported applied research program. The scientific projects of this procurement are to study cancer and other health effects in radiation-exposed populations in Ukraine for the Ukrainian Thyroid and Breast Cancer Projects, which are conducted by the State Institution V.P. Komisarenko Institute of Endocrinology and Metabolism of the National Academy of Medical Sciences of Ukraine (IEM). The study currently involves: (1) the Ukrainian-American cohort, established in the late 1990s and consisting of 13,204 individuals who were 18 years of age or younger at the time of the accident and resided in affected areas; (2) the Ukrainian cohort of persons exposed in utero, established in 2006 and consisting of 2,582 individuals; (3) the Chernobyl Tissue Bank (CTB), established in the early 2000s and including approximately 4,500 individuals diagnosed with thyroid cancer; and (4) the Women s Health Study (WHS), which includes women potentially exposed to Chernobyl fallout during pregnancy or lactation. The emphasis of this procurement is to conduct health effects studies in these cohorts and other potentially radiation-exposed populations in Ukraine. This Small Business Sources Sought notice is for information and planning purposes only and shall not be construed as an obligation on the part of the National Institutes of Health. Purpose and Objectives: The goal of this procurement is to conduct health effects studies in these cohorts and other potentially radiation-exposed populations in Ukraine. Project Requirements: General Requirements Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, needed to simultaneously manage concurrent, multiple, in country and international studies. The contractor shall: Update and verify the vital status and last known address of individuals who are participants of the NCI-leading studies using mail survey, the State Chernobyl Registry (SCR), the National Cancer Registry of Ukraine (NCRU), or other population rosters Contact individuals who are participants of the NCI-leading studies and collect biological specimens from individuals for whom these samples are not currently available at IEM (Kyiv, Ukraine). Perform all activities necessary to identify, select, and trace the study subjects who meet the NCI criteria for inclusion in studies and use the different sources of data, including but not limited to the SCR, NCRU, or other population rosters. Develop and establish a master database for data recorded on the studies and data forms, including but not limited to laboratory and clinical information, blood collection and processing form, medical examination forms, prior medical history form, laboratory blood examination form, hospitalization form, pathological examination form, and report on adverse medical event. Collect demographic, medical history, risk factor information, and data needed to reconstruct radiation doses to the thyroid gland and female breast by administration of questionnaire to study participants. The Contractor shall provide specialized skills, such as development of medical, risk factors, and dosimetry questionnaires and interviewers training. Manage and support the dosimetry data previously collected by the Contractor on measurements in soil, milk, thyroid, as well as the radiation doses previously estimated for the collaborating post-Chernobyl studies with NCI. Calculate radiation doses to the thyroid gland and female breast from different exposure pathways, including intake of 131I and short-lived radiotellurium and radioiodine isotopes received in April July 1986 as well as external doses from radionuclides deposited on the ground and ingestion of 134Cs and 137Cs received during post-accident period. Provide the comparison between the measured doses and the doses, which were calculated using dose reconstruction methodology, for a sample of the study subjects to validate consistency and accuracy of estimated doses and prepare the written description of the final methodology that was employed in the estimation of organ doses and associated uncertainties for individuals in each study. Maintain databases of the study population, including databases of demographic, medical history, and risk factor questionnaires created by means of double entry as well as dosimetry data. Link database of the study population with the National Cancer Registry of Ukraine and the Chernobyl State Registry of Ukraine. Manage the shipment of biological samples, including but not limited to, blood and thyroid tissue samples from Ukraine to the U.S. with obtaining appropriate government clearances for international shipping required for transferring biologic specimens and assure that they are appropriately cleared through customs. Provide a brief description (inventory) of collected data and samples which were provided directly to the NCI by the collaborating institutions. Provide local office staff, who are fluent in English, Ukrainian and Russian, on-site administrative and financial management and oversight of the studies conducted by collaborating institutions. Prepare and submit quarterly technical and financial reports as required, establishing a consistent method of invoicing and reporting that tracks labor hours to a study/project identifier and to the requestor, and provide detailed reports of the work completed within the period-of-performance. This method must be flexible to accommodate any changes to the Government s business needs that may occur in the future. Provide support to NCI with data preparation, cleaning, quality control, and analysis for preparation of scientific papers. Work cooperatively with the NCI on all relevant aspects of study development and execution to maximize cost-effectiveness and efficiency of the study. NCI will recommend the priority of the activities. Report to the NCI Contracting Officer s Representative (COR) any significant managerial issues or problems and provide alternatives for resolution of the problems. Anticipated Period of Performance: It is anticipated that one fixed-price contract will be awarded on or before June 15, 2027. The anticipated period of performance is July 1, 2027 to June 30, 2032, consisting of one 12-month base period and four 12-month option periods. Capability Statement/Information Sought: The Government encourages interested, qualified small business organizations to submit a tailored…