Inactive

This is a Small Businesses Sources Sought notice (SS). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) t... This is a Small Businesses Sources Sought notice (SS). 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 business; 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 that is 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. Background: 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. This Small Business Sources Sought (SBSS) is for information and planning purposes only and shall not be construed as an obligation on the part of NCI. 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. Offerors must be able to perform Task Areas 1, 7, and 8 and at least one other Task Area under Task Areas 2 through 6 in order to be considered capable of performing the SOW. NCI is seeking capability statements from all eligible small businesses concerns in performing the tasks/duties herein. Based on the responses received from this SBSS notice, the proposed project may be solicited as a Small Business Set-Aside. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought notice or the NCI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Project Requirements: Task Area 1: Kick-Off/Transition The Contractor shall work with previous DCEG support service contractors 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 DCEG for the period of the contract. Activities performed by the Contractor include but are not limited to: 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; provide detailed reports of the work completed within the period-of-performance; establish a method for data and knowledge transfer from incumbent contract, as required. Task Area 2: Field Preparation and Support Activities The Contractor shall perform all activities necessary to prepare for participant recruitment, follow-up, and biological specimen and data collections which may include medical record abstraction, electronic data linkage, questionnaires or interviews. Activities performed by the Contractor include, but are not limited to: providing detailed information for the effective planning and implementation of study protocols; methods development for the identification of study subjects and the feasibility of alternative sampling schemes; preparation of study materials (e.g., procedures manuals, training materials, data collection forms, coding manuals, data dictionaries, standard operating procedures, and study material translation for foreign studies); meet and comply with regulatory and administrative processes such as human subjects protection (e.g., obtain Institutional Review Board approval as required); and perform administrative, operational, and technical duties to support productive collaboration among NCI and contractor study personnel. Task Area 3: Study Management and Support Activities The Contractor shall implement and monitor study protocols for domestic and international field studies, comply with regulatory and administrative approval processes, such as human subjects protections, manage data, and coordinate biospecimen collections from study participants (e.g., blood, urine, tumor tissue, saliva), and environmental samples (workplace or general environment). Examples of activities involving biospecimen and environmental samples may include assisting DCEG investigators in writing study protocols and standard operating procedures, collecting samples (e.g., blood), conducting minimal processing of samples, and shipping and storing samples. DCEG activities include domestic and international studies with diverse study designs in epidemiology and genetics research that includes retrospective and prospective cohort studies, case-control studies, family studies, cross-sectional molecular epidemiologic studies, exposure assessment 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. Activities performed by the Contractor shall include but are not limited to: establishing procedures and providing support activities for collecting, processing, shipping, and storing data, biospecimens, and environmental samples; reporting on all irregularities, delays, losses, deteriorations, unplanned discrepancies, and inefficiencies connected with any data, biospecimen or environmental sample collection, handling, delivery, storage, or testing activity as soon as it becomes known to the Contractor; and providing computer programming, data processing, and data management for field, biospecimen, and clinical activities. Task Area 4: 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) performance of state-of-the-art molecular assays (e.g., testing of samples from a repository or collected under Task Area 3) and monitor laboratory performance; and 3) to prepare specimens for transport to testing laboratories by aliquotting, labeling and batching, as needed. Residual specimens will be sent to the NCI Central Repository for long-term storage. Task Area 5: Exposure Assessment The Contractor shall provide support to conduct exposure assessment in the context of epidemiologic studies relating workplace and general environmental exposures to disease risk, particularly cancer. These studies include retrospective assessment of historical exposures through industrial, environmental and questionnaire-based evaluations in case-control studies, cohort studies, and cross-sectional studies, and studies of early biologic effects and genetic susceptibility; on-site evaluation of exposures through real-time monitoring and the collection, storage, shipment, and tracking of domestic and international air, dermal, or bulk environmental samples and/or biospecimens (e.g., soil, archived tissues, milk, teeth, blood); remote collection of exposure measurements using sensors, mobile health-based and other technologies; the compilation of existing exposure measurements originally collected for regulatory or other external monitoring needs, or data derived through linkages to participants or geographic-based proxies; and the use of research tools developed for exposure assessment (e.g., human-like phantoms, computerized treatment planning programs, NCI-developed software). The Contractor shall provide support to DCEG using Geographic Information Systems (GIS) to develop exposure metrics in studies of the relationship between exposures and disease risk, particularly cancer, including locating, quality control checking, and management of multiple large environmental and geographic datasets; descriptive and spatial analyses for large epidemiology study populations; creation of publication quality cartography; customization of GIS and database routines including automation of these routines; documentation of study methods; and the creation and maintenance of project metadata. Task Area 6: Clinical Support Activities The Contractor shall provide support for clinical studies conducted in DCEG. Activities performed by the Contractor include but are not limited to: providing skilled nursing and cancer risk assessment/genetic counseling; and scheduling travel plans and admission to the NIH Clinical Center for participating individuals and their family members. Such skillsets and specialist support could be required either domestically or internationally and/or for multiple studies of varying complexity. Task Area 7: Quality Control The Contractor shall provide quality control of all aspects of data and specimen collection and management. Activities performed by the Contractor include but are not limited to: documenting each step in a specific study and maintaining all relevant material so that any aspect of a study may be reviewed and evaluated at any point in time; developing and using internal record-keeping procedures for assessing the progress and status of data collection, preparation (data editing and coding) and computer entry; and developing quality control procedures for the handling of biologic specimens and exposure assessment specific to the needs of each study. Task Area 8: Contract Transition-Out Plan In the event of a new Contractor, the Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within the first 90 days of contract award. At the direction of the COR, the Contractor shall develop a transition plan to transition all ongoing activities from the current contract and assume all responsibilities to conduct the ongoing management of data, systems and research operations. Prior to termination of this contract, the Contractor shall work with DCEG and any successor Contractor(s) to carry out transition activities. The incumbent Contractor shall affect a smooth, seamless transition of the management, operations, data, tools, resources, and other products generated through use of this contract to DCEG or any successor Contractor without prolonged interruption of the normal day-to-day operations. During the 90-day transition period, the incumbent Contractor shall continue to assume full responsibility for all essential activities, especially those that involve maintenance of existing study management. Sub-tasks include, but are not limited to: 1. Ensure that all documentation is current and available. 2. Submit a Final Transition Plan to the NCI COR. At a minimum the plan must address how software and information will be successfully transitioned to a subsequent Contractor or DCEG business owners. A draft of this transition plan is due to the NCI COR 120 calendar days prior to the completion date of the contract. The final plan is due at least 90 days prior to the completion date of the contract for final review and approval by the NCI COR. Anticipated Ordering Period: The anticipated ordering period for this potential multiple award indefinite delivery indefinite quantity acquisition is March 2022 – March 2025. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the aforementioned requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 20 pages (12-point font minimum), including all attachments, resumes, charts, etc.; and should include an outline of previous or similar projects performed. All responses 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. The Capability Statements must clearly document the following: A. Personnel: Understanding of the size, complexity, and public impact of this project, and an understanding that the entire proposed professional team should possess an expert depth of knowledge and documented experience in IRB, federal and other applicable regulations. B. Technical Approach: Understanding of the scope, purpose, and complexity of the project requirements above and the capability to perform the functions in an effective and efficient manner. There should be demonstration of the regulatory and operational understanding of the "why behind each sub-task. C. Corporation Experience and Management: Successful completion of similar contracts in support of similar projects, technically, administratively, and financially. D. Facilities and Equipment: Acceptable facilities and equipment to provide support to this project. Information Submission Instructions: All capability statements sent in response to this Small Business Sources Sought notice must be sent electronically (via email) to Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov and Rukshani Levy, Contracting Officer at rukshani.levy@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by Aptil 10, 2020; 2:00 PM Eastern. All responses must be received by the specified due date and time in order to be considered. Capability Statements received after that date and time will not 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 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.