SPECIAL NOTICE
B -- Request for data harmonization and management services of clinical trial data from European clinical trials participating in the Confluence project
- Notice Date
- 7/12/2023 6:12:53 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N91023Q00130
- Response Due
- 7/26/2023 12:00:00 PM
- Archive Date
- 08/10/2023
- Point of Contact
- Dana Summons, Phone: 2402765319
- E-Mail Address
-
dana.summons@nih.gov
(dana.summons@nih.gov)
- Description
- Contracting Office Address The Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Rockville, MD 20850, UNITED STATES 1.0�� �DESCRIPTION The Division of Cancer Epidemiology and Genetics (DCEG) plans to procure services, on a sole source basis, from Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis (NKI-AVL), Division of Molecular Pathology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541715 and the small business size standard is 1,000 employees. It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0�� �BACKGROUND The Confluence Project is a research project funded by the National Cancer Institute (NCI) Intramural Research Program under the U.S Department of Health and Human Services (HHS), National Institutes of Health (NIH), NCI, Division of Cancer Epidemiology and Genetics (DCEG). The Confluence Project aims to build a large research resource for the scientific community 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 the project.� The Confluence Project seeks to incorporate breast cancer data from European Clinical Trials that are collaborating with the European Clinical Trials Confluence Data Coordinating Center (DCC) Incorporating data from the Netherlands Cancer Institute (NKI) DCC will help researchers address the following scientific aims of the Confluence Project: 1.�� �To discover susceptibility loci and advance knowledge of etiology of breast cancer overall and by subtypes. 2.�� �To develop polygenic risk scores and integrate them with known risk factors for personalized risk assessment for breast cancer overall and by subtypes.� 3.�� �To discover loci for breast cancer prognosis, long-term survival, response to treatment, and second breast cancer.� 2.1�� �Objective The purpose of this acquisition is to incorporate epidemiologic, genetic, and clinical data from European Clinical Trials that are participating in the Confluence Project. Therefore, the NCI/DCEG requires professional data management services to enroll, manage, and govern this data for the Confluence Project. 3.0�� �SCOPE The Contractor shall collect, harmonize and manage clinical trial data being contributed to the Confluence project from European clinical trials. The Contractor shall assist NCI with developing a secure Cloud-hosted Data Platform. The Contractor shall work with NCI to provide summary-level data from European Clinical Trials contributed to Confluence that shall be accessible to researchers through the Confluence Cloud-hosted Data Platform. All data shall be coded and shall not have any personally identifiable information (PII) attached. 4.0�� �PURCHASE ORDER REQUIREMENTS The Contractor shall perform the following tasks: 4.1�� �Establish data transfer agreements with the European Clinical Trials institutions that will allow the Contractor to share data with the Confluence Project. These agreements shall establish the terms under which data shall be transferred to the NKI DCC for the purpose of being disseminated to the Confluence Project. 4.2�� �Collect and harmonize European Clinical Trials data according to the Confluence clinical trials data dictionary that is being contributed to the Confluence Project. The Confluence clinical trials data dictionary shall be provided to the Contractor at award. 4.3�� �Provide summary statistics of the European Clinical Trials data being contributed to Confluence to the secure Confluence cloud-hosted data platform. NCI shall provide a program (e.g. a R script) to the Contractor that shall generate the summary statistics and make them accessible through the Confluence data platform.� 4.4�� �The Contractor shall provide quarterly reports to the NCI technical point of contract (TPOC). Each report shall include specific updates, as directed by the NCI TPOC, regarding the progress of the required tasks and deliverables. 5.0�� �TYPE OF ORDER This will be issued as a firm fixed-price purchase order. 6.0�� �NON-SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0�� �PERIOD OF PERFORMANCE The period of performance is planned to be August 20, 2023, through August 19, 2024. 8.0�� �PLACE OF PERFORMANCE The services executed under this contract shall be performed at the Contractor�s facility. 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in a Microsoft-compatible format, such as Microsoft Excel or text file unless approved by the TPOC in accordance with the deliverable schedule below. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five (5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government�s comments. Reports are to be delivered to: (TBD) DELIVERABLE�� �DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS�� �DUE DATE #1 (Task 4.3)�� �Summary statistics of the European Clinical Trials data being contributed to the secure cloud-hosted Confluence data platform. �� �As needed to ensure summary statistics are accurate and are an up-to-date reflection of the Confluence data in being shared with the Confluence Project. Final summary statistics delivered no later than 30 days prior to the expiration of the contract. #2 (Task 4.4)�� �Quarterly reports related to progress completed under tasks 4.1 � 4.4 and in coordination with the NCI TPOC.�� �Quarterly 10.0�� � � INSPECTION AND ACCEPTANCE CRITERIA Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor. Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. � 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and- guidelines. Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov�s Create Accessible Digital Products. 11.0�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR The Contractor must be a member of the European Clinical Trials Confluence Data Coordinating Center (DCC). Moreover, the Contractor must have experience with performing data harmonization and data management for the Confluence Project.� Dr. Marjanka Schmidt at the Netherlands Cancer Institute (NKI) is the lead PI of the European Clinical Trials Confluence DCC, thus her group has detailed knowledge of the European Clinical Trials data that is being shared with the Confluence Project and extensive experience performing harmonizing and data management of this data. No other group/organization has access to the European Clinical Trials data that is being shared with Confluence. Therefore, the NKI has the unique and specific qualifications for performing the requested work. There is not another institution that meets these requirements. 12.0�� �SUBMISSION INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote for the Government to consider. The response 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. �All responses and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on July 26, 2023, (7/26/23). 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. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov. Reference: 75N91023Q00130 on all correspondence.
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SAM.gov Permalink
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- Record
- SN06745193-F 20230714/230712230039 (samdaily.us)
- Source
-
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