Inactive

General Information Short Title: Request for study and data management services from the Male Breast Cancer Consortium in support of the Confluence project Document Type: Notice of Intent Solicitation... General Information Short Title: Request for study and data management services from the Male Breast Cancer Consortium in support of the Confluence project Document Type: Notice of Intent Solicitation Number: 75N91020R00057 Posted Date: 9/4/2020 Response Date: 9/11/2020 Classification Code: B599 – Special Studies/ Analysis - Other NAICS Code: 541990 – All other Professional, Scientific and Technical Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description: The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Intramural Research Program (IRP), Division of Cancer Epidemiology and Genetics (DCEG) intends to procure support services on a sole source basis from Queen’s University Belfast. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. Only one award will be made as a result of this solicitation. This will be awarded as a Non-Severable) firm fixed price type contract with two option periods. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND The Confluence Project is a research project funded by the National Cancer Institute (NCI) Intramural Research Program at the Division of Cancer Epidemiology and Genetics (DCEG) aiming to build a large research resource for the scientific community by 2020 to study the genetic architecture of breast cancer. This will be accomplished by the confluence of existing and new genome-wide genotyping data to be generated through this project. Queen’s University, Belfast is developing the Male Breast Cancer Consortium (MBCC), this will be the largest consortium of epidemiological and clinical studies dedicated to studying breast cancer among males, with detailed epidemiological, clinical/pathology, and survival/treatment data on study participants. In support of the Confluence project, support services are required from Queen’s University, Belfast in order to contact institutions with existing studies on male breast cancer to discuss the inclusion of their data in the Confluence project. The support services will include collecting study information and data, setting-up data transfer agreements, and performing data management, storage and access services. OBJECTIVE The primary objective of the Confluence project is to develop a large research resource by 2020 to uncover breast cancer genetics through genome-wide association studies (GWAS). The resource will include at least 300,000 breast cancer cases and 300,000 controls of different races/ethnicities. This will be accomplished by the confluence of existing GWAS and new genome-wide genotyping data to be generated through this project. Broad scientific aims that can be addressed through this resource include: To discover susceptibility loci and advance knowledge of etiology of breast cancer overall and by subtypes. To develop polygenic risk scores and integrate them with known risk factors for personalized risk assessment for breast cancer overall and by subtypes. To discover loci for breast cancer prognosis, long-term survival, response to treatment, and second breast cancer. As the MBCC is a large source of male breast cancer information for the Confluence Project, NCI is requesting support services from Queen’s University, Belfast to harmonize and manage male breast cancer data from the studies in the MBCC that are participating in the Confluence project. SCOPE Over the course of the contract, the contractor shall contact institution with existing studies on male breast cancer to discuss the inclusion of their data in the Confluence project, collect study information and data, setup data transfer agreements, and perform data management, storage and access services. The contractor will also assist NCI with developing a secure Cloud-hosted Data Platform. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The contractor must have data governance permissions for the MBCC data. Also, the contractor must have experience performing data harmonization on MBCC data as well as experience managing the data. Over the course of the contract, the contractor shall: Contact authors of eligible studies that include cases of male breast cancer to request that they participate in the Confluence project. The cases shall have genome-wide genotyping data or DNA samples available for genotyping. Collect study information from eligible studies, such as (but not limited to) Study name, investigator name, study design, country of study. Number of available subjects that have not been genotyped with a genome-wide array. This includes breast cancer cases and non-cases. Number of cases with pathology data from medical records, clinical follow up for recurrence, clinical follow up for second cancers, treatment information and tumor samples. Number of cases and non-cases with data on classical risk factors, mammographic breast density and germ line sequencing data. Number of cases and non-cases that have been genotyped with a genome-wide array Set up data transfer agreements with authors of the collaborating studies and assist the University of Cambridge and NCI in establishing material transfer agreements with the participating studies. Collect and harmonize data (e.g. core data, risk factors, pathology, treatment and survival) that is contributed to the Confluence project from studies with cases of male breast cancer. Identify eligible samples for genotyping and contact individual study centers. Manage data access after approval by the Data Access Coordinating Committee (DACC) for the male breast cancer studies. Work with NCI to evaluate feasibility and subsequent use of a secure Cloud-hosted Data Platform for data submission, management, access, documentation, harmonization and analyses by Queen’s University Belfast. Develop an alternative plan on how the contractor would provide efficient and secure data management, storage and access services through its Institution if the preferred Cloud-hosted Data Platform is not feasible. Four progress reports will be required from the contractor during the periods of performance. For each progress report the NCI will provide the contractor a template requesting specific updates regarding the deliverables of progress reports that will be completed by the contractor to inform NCI of progress on deliverables. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on September 11, 2020. All responses and questions must be emailed to David Romley, Contract Specialist via electronic mail at david.romley@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91020R00057 on all correspondence.