Division of Cancer Epidemiology and Genetics (DCEG) Field and Biospecimen Support Services

** See Amendment 2 - The purpose of this amendment is to: 1) Provide responses to questions received; 2) revise Section M, Att 4, 11 and 15; and 3) revise Section I.4 to include FAR 52.223-99. ** See Amendment 1 - The purpose of this amendment is to clarify the due date for questions is Friday October 15, 2021. The Division of Cancer Epidemiology and Genetics (DCEG), NCI conducts broad-based, high quality, high impact epidemiologic and genetic research to uncover the causes of cancer in order to facilitate prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies and other appropriate bodies. The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, NIH, and the global research community. DCEG has approximately 150 scientists whose activities could potentially be supported by this acquisition. Previously services were solicited individually to support each branch. This acquisition will be division wide. Purpose and Objectives: The goal of this acquisition is to support field preparation, biospecimen collection, and clinical activities in support of, but not limited to, the ongoing epidemiology and genetic research programs, conducted in the Branches and Laboratories in DCEG which include large scale domestic and international studies with diverse study designs in epidemiology and genetics research including retrospective and cohort studies, case-control studies, family studies, and randomized clinical trials. These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies. The contractor(s) shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work as defined in the Statement of Work. The contractor(s) shall coordinate and integrate all activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts and consultants for task orders which will includes one or more of the task areas below and as defined in the Statement of Work. Offerors must propose services under Task Area A and under any one or more from task areas B through E. Project Requirements: Task Area A: Contract Transition-In/Out Transition In: Where applicable, the Contractor shall work with previous support service contractor(s) to ensure orderly transition of all contract activities and materials to establish the necessary integrated infrastructure and procedures for effective communication between the contractor and the Government for the period of the contract. Activities performed by the Contractor may include, but are not limited to participating at a kick-off meeting; providing a summary of capabilities to the Contracting Officers Representative (COR), establishing a consistent method of reporting that tracks labor hours for individual studies/project identifiers; establishing a method for data and knowledge transfer from incumbent Contractor, as required. Transition Out: Prior to expiration of a task order, the Contractor shall work with the Government and any successor Contractor(s) to carry out transition activities. The Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials. Task Area B: Field Preparation, Study Management, and Support Activities The Contractor shall perform all activities necessary to prepare for, and implement, participant recruitment, follow-up, and biospecimen and data collections for domestic and international field studies. Activities performed by the Contractor include but are not limited to: establishing procedures and providing support activities for collecting, processing, analyzing, shipping, and storing data, biospecimens, and environmental and other samples. The Contractor shall assist NCI with the preparation of study materials (e.g., procedures manuals, training materials, data collection forms, questionnaires, coding manuals, data dictionaries, standard operating procedures, and study material translation for foreign studies); performing data linkages from various sources such as National Death Index for status and tumor registries for cancer status; reviewing and extracting data from medical records; managing data and research study record storage; providing computer programming, data processing, and data management for the collection and curation of field, biospecimen, and clinical study data; ensuring compliance with regulatory and administrative processes such as human subjects protection (e.g., obtain Institutional Review Board approval as required); and performing administrative, operational, and technical duties to support productive collaboration between the Government and any relevant third party contractor personnel. Task Area C: Biospecimen Activities and Assay Support The Contractor will cover three general areas: 1) the procurement, storage and shipment of specimen collection supplies to international and domestic specimen collection sites; 2) specimen processing, performance of state-of-the-art molecular assays (e.g., testing of samples from a repository or collected under Task Area B) and monitoring laboratory performance; and 3) preparing specimens for transport to testing laboratories by aliquoting, labeling and batching, as needed. Task Area D: Exposure Assessment The Contractor shall provide support to conduct specialized exposure assessment in the context of epidemiologic studies. Examples of exposure measurement collection include, but are not limited to, occupational, environmental, and behavioral exposure (e.g. sleep, light, physical activity, travel). This could involve on-site evaluation through real-time monitoring (e.g. air pollutants); remote collection, linkage, and synthesizing of existing environmental and personal monitoring data and application of personal monitoring systems via wearable or other mobile technologies. The Contractor shall support the collection, storage, shipment, and tracking of specialized exposure data and/or biospecimens (e.g., soil, archived tissues, milk, teeth, blood); compile and integrate newly collected and existing exposure measurements originally collected for regulatory or other external monitoring needs, or data derived through linkages to participants or geographic-based proxies (e.g., Geographic Information Systems (GIS)); and use research tools developed for exposure assessment evaluation (e.g., human-like phantoms, computerized treatment planning programs, Government-developed software, polysomnography, double labeled water). The Contractor shall manage and support exposure equipment testing as needed. Additionally, the Contractor shall support development of IT infrastructure for data storage, access, and application of state-of-the-art modeling of relevant exposure metrics. Task Area E: Clinical Support Activities The Contractor shall provide support for clinical studies. Activities performed by the Contractor include but are not limited to providing support for cancer risk assessment/genetic counseling; and scheduling travel plans and admission to the NIH Clinical Center for participating individuals and their family members. These skillsets and specialist support also may be required both domestically and internationally and/or for multiple studies of varying complexity.