Request for study and data management services from the Male Breast Cancer Consortium in support of the Confluence project
SOURCES SOUGHT NOTICE: Request for study and data management services from the Male Breast Cancer Consortium in support of the Confluence project Notice Number: 75N91021R00024 Issued By: National Canc... SOURCES SOUGHT NOTICE: Request for study and data management services from the Male Breast Cancer Consortium in support of the Confluence project Notice Number: 75N91021R00024 Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: February 26, 2021 by 12:00PM EST 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 purpose of this Sources Sought Notice is to identify qualified Small Business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses 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. This requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of $15 million. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). 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 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. 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 2021 for studying 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 institutions 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, conduct data management, and provide 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. The contractor must also have experience performing data harmonization and data management of the MBCC data that will be contributed to Confluence. Over the course of the contract, the contractor shall: Contact eligible studies that include cases of male breast cancer for participation in the Confluence project. 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 collaborating studies and assist the University of Cambridge and NCI in establishing material transfer agreements with 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 on the deliverables in the progress reports. These reports will be completed by the contractor to inform NCI of its progress on deliverables. TYPE OF ORDER This will be issued as a Non-Severable Firm-Fixed Price Purchase Order. PERIOD OF PERFORMANCE The period of performance shall be for a 12-month base period with one (1) 12-month option period. Base Period: April 1, 2021 – March 31, 2022 Option Period One: April 1, 2022 – March 31, 2023 PLACE OF PERFORMANCE Centre for Cancer Research and Cell Biology Queen’s University Belfast Room 01.003 - CCRCB University Road, Belfast, BT7 1NN, Northern Ireland, United Kingdom REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The NCI (Dr. Montserrat Garcia-Closas) will provide to the contractor a template requesting detailed information on the progress of deliverables that must be completed by the contractor. The contractor will be required to complete a progress report approximately every three months during the a 12-month contract period. The progress reports shall be returned to the technical points of contact (TCPs) Dr. Montserrat Garcia-Closas (montserrat.garcia-closas@nih.gov) and Dr. Thomas Ahearn (Thomas.ahearn@nih.gov) within 2-weeks of receiving progress report template. All written deliverable products shall be submitted in draft format for review, comment and approved by Dr. Montserrat Garcia-Closas. Progress reports will request information specifically about, or related to, the deliverables listed in the below table. Final copies of approved drafts shall be delivered to the COR within five (5) business days after receipt of the Government’s comments. All deliverables shall be sent electronically (Microsoft Word or Excel 2013, unless approved by the COR) per the following deliverable schedule: DELIVERABLE DELIVERABLE DESCRIPTION DUE DATE BASE PERIOD Base Period - Draft Progress Report #1 Draft Progress Report #1 shall respond to the request from the Technical Point of Contact (TPC) and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Base Period - Final Progress Report #1 Final Progress Report #1 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Base Period - Draft Progress Report #2 Draft Progress Report #2 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Base Period - Final Progress Report #2 Final Progress Report #2 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Base Period - Draft Progress Report #3 Draft Progress Report #3 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Base Period - Final Progress Report #3 Final Progress Report #3 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Base Period - Draft Progress Report #4 Draft Progress Report #4 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Base Period - Final Progress Report #4 Final Progress Report #4 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. OPTION PERIOD 1 Option Period 1 - Draft Progress Report #1 Draft Progress Report #1 shall respond to the request from the Technical Point of Contact (TPC) and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Option Period 1 - Final Progress Report #1 Final Progress Report #1 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Option Period 1 - Draft Progress Report #2 Draft Progress Report #2 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Option Period 1 - Final Progress Report #2 Final Progress Report #2 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Option Period 1 - Draft Progress Report #3 Draft Progress Report #3 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Option Period 1 - Final Progress Report #3 Final Progress Report #3 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. Option Period 1 - Draft Progress Report #4 Draft Progress Report #4 shall respond to the request from the TPC and provide information specifically related to the tasks listed under section 4.1 to 4.8. The draft report is subject to TPC review and commentary. The Contractor shall perform subsequent edits until the draft is approved by the TPC 2-weeks after initial request from TPC. Subsequent comments on the draft must be addressed within 2-weeks of receipt from TPC Option Period 1 - Final Progress Report #4 Final Progress Report #4 shall reflect all changes, edits and comments made by the TPC. The final version of the report shall be the version that received TPC approval. 5-business days after TPC approval of finalized draft. How to Submit a Response: Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12-point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern’s name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Organizations shall demonstrate 1.) Technical Approach 2.) Personnel Requirements and Organizational Experience. Due Date: Capability statements are due no later than February 26, 2021 by 12:00PM EST Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and emailed to David.Romley@nih.gov. A determination by the Government not to compete this 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) at Beta.SAM.gov. No collect calls will be accepted. Please reference number 75N91021R00024 on all correspondence. 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. After a review of the responses received, a RFQ may be published in beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: David Romley at David.Romley@nih.gov. 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.
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