SPECIAL NOTICE
R -- Professional Data Management Services to incorporate epidemiologic, genetic and clinical data from the African-Ancestry Breast Cancer Genetic Consortium (AABCG) into the Confluence Project
- Notice Date
- 8/9/2021 1:52:57 PM
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH National Cancer Institute Rockville MD 20850 USA
- ZIP Code
- 20850
- Solicitation Number
- 75N91021Q00216
- Response Due
- 8/16/2021 12:00:00 PM
- Archive Date
- 08/31/2021
- Point of Contact
- Megan Kisamore, Phone: 2402765261
- E-Mail Address
-
megan.kisamore@nih.gov
(megan.kisamore@nih.gov)
- Description
- 1.0�� �DESCRIPTION The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure services, on a sole source basis, from Vanderbilt University Medical Center, 1161 21st Ave S STE D3300 Mcn, Nashville, Tennessee 37232. 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 541990 and the small business size standard is $16.5 million. � 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 the African-Ancestry Breast Cancer Genetic Consortium (AABCG), a collaboration of epidemiological and clinical breast cancer studies that currently includes approximately 18,000 breast cancer patients and a similar number of controls. Incorporating data from the AABCG 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 the African-Ancestry Breast Cancer Genetic Consortium (AABCG) into the Confluence Project. Therefore, the NCI/DCEG requires professional data management services to enroll, manage, and govern the AABCG data that is being contributed to the Confluence Project. 3.0�� �SCOPE Under this purchase order, the Contractor shall establish and manage a data coordinating center (DCC) for the purpose of providing custodianship and governorship to AABCG data that are being contributed to the Confluence Project. To accomplish this, the Contractor shall contact and engage AABCG participating study institutions about participating in Confluence; establish data transfer agreements with study institutions for the purpose of sharing data with the Confluence project; collect, harmonize, and provide custodianship to AABCG data that is shared with the Confluence project; and organize the development of a Data Access Coordinating Committee (DACC) that is comprised of representatives from AABCG studies that are participating in Confluence. The Contractor shall assist NCI with providing access to AABCG data though a secure, Confluence Cloud-hosted Data Platform developed by NCI to facilitate the performing of data analyses approved by the AABCG DACC. The Contractor shall work with NCI to provide summary level data from AABCG studies 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�� �Contact all eligible breast cancer studies participating in the AABCG to engage them about participation in the Confluence Project. Eligible breast cancer cases and non-cases shall have genome-wide genotyping data or germline DNA samples available for genotyping. The Contractor shall confirm that all studies have the required ethical approval to participate in the Confluence Project. 4.2�� �Collect study information from eligible studies, including (at a minimum): � �o�� �Study name, investigator name, study design, and case and control definitions. � �o�� �Number of available subjects that have not been genotyped with a genome-wide�array. This includes breast cancer cases and non-cases. � �o�� �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. � �o�� �Number of cases and non-cases with data on classical risk factors, mammographic�breast density and germ line sequencing data. � �o�� �Number of cases and non-cases that have been genotyped with a genome-wide array. 4.3�� �Establish data transfer agreements with the AABCG participating study 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 AABCG DCC for the purpose of being disseminated to the Confluence Project. Prior to executing the data transfer agreements with the study institutions, the Contractor shall submit draft and final copies of the data transfer agreements to NCI for review and approval. The Contractor shall submit the draft copy to NCI no later than one (1) month after award; the final copy shall be submitted no later than two (2) months after award. 4.4�� �Collect and harmonize AABCG data according to the Confluence data dictionary that is being contributed to the Confluence Project from the collaborating AABCG studies. The Confluence data dictionary shall be provided to the Contractor at award. 4.5�� �Create and organize regular meetings of the AABCG Data Access Coordinating Committee (DACC) for the purpose of providing data governorship to the AABCG data being managed by the DCC and being contributed to the Confluence Project. Within four (4) months of award, the Contractor shall develop and submit to NCI for review and approval the draft guidelines for how the AABCG DACC will be created and operate; and, within six (6) months of award, the Contractor shall submit the final guidelines to NCI for review and approval. This will ensure that guidelines are consistent with those of other consortia participating in the Confluence Project to facilitate data sharing across all collaborating institutions. 4.6�� �Provide summary statistics of the AABCG 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 be run at the AABCG DCC to generate the summary statistics and make them accessible through the Confluence data platform. The program provided by NCI will only generate summary statistics for variables that are listed in the Confluence data dictionary (i.e., core, risk factor, survival, pathology, treatment, and mammographic density variables). Summary statistics of genotype data (including imputed genotypes) will not be generated by the summary statistics program provided by NCI. The Contractor shall ensure that the AABCG consortium summary statistics presented on the Confluence data platform are accurate and an up-to-date reflection of the Confluence data in the AABCG consortium.� 4.7�� �Assist NCI with providing access to AABCG data though a secure Cloud-hosted Data Platform developed by NCI. Provide efficient and secure data management, storage, and access services of the AABCG data that are being shared with Confluence through its Institution. 4.8�� �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 is 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 shall be twelve (12) months from the date of award.� 8.0�� �PLACE OF PERFORMANCE All work 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.� The NCI shall provide the Contractor with a template for progress reports that shall be completed by the Contractor and submitted to the NCI TPOC on a quarterly basis. In each progress report template, NCI will specify specific items, e.g. progress of tasks and deliverables, to be addressed by the Contractor prior to submission to the NCI for review. NCI shall provide each progress report template to the Contractor no later than eleven (11) business days prior to the date the Contractor is required to submit the completed report for NCI�s review.� 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. � DELIVERABLE� /� �DELIVERABLE DESCRIPTION� /� �DUE DATE #1 (Task 4.3): Unexecuted Data transfer agreement to be sent to all participating study institutions; electronically via PDF format. Draft Due: Within 1 month of award; Final Due: Within 2 months of award #2 (Task 4.5): Guidelines for how the AABCG DACC will be created and operate.�Draft Due: Within 4 months of award;�Final Due: Within 6 months of award #3 (Task 4.6): Summary statistics of the AABCG data being contributed to the secure cloud-hosted Confluence data platform.� Due: Monthly or as specified by the NCI TPOC to ensure summary statistics are accurate and are an up-to-date reflection of the Confluence data in AABCG.� #4 (Task 4.8):�Quarterly reports related to progress completed under tasks 4.1 � 4.7 and in coordination with the NCI TPOC. Due:�Quarterly 10.0�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR In order to perform the required services, the Contractor must be a member of the African-Ancestry Breast Cancer Genetic Consortium (AABCG) that has both access and detailed knowledge of the AABCG study data. Moreover, the Contractor must have experience with performing data harmonization and data management of the AABCG study data and establishing data agreements with AABCG study institutions allowing for the governing of AABCG data.� Vanderbilt University Medical Center (VUMC) is the lead of the AABCG; thus, the Contractor has detailed knowledge of and unique access to the AABCG data and extensive experience performing harmonizing and managing the AABCG data. As the lead of the AABCG, VUMC has previously established and currently holds active data agreements with AABCG studies, allowing for VUMC to govern and manage the AABCG data. No other institution has existing data agreements with AABCG studies. Therefore, the VUMC is uniquely qualified to perform the required services, and to provide access to the required AABCG data. Procuring the required services through another outlet would require the creation of a new breast cancer consortium, which would be detrimental to the study.� 11.0�� �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 Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Monday, August 16, 2021 (8/16/21). 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: 75N91021Q00216 on all correspondence.
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-
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- Record
- SN06089766-F 20210811/210809230118 (samdaily.us)
- Source
-
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