SPECIAL NOTICE
Q -- Metabolomic Profiles and Pancreatic Cancer Risk in Women�s Health Initiative (WHI)
- Notice Date
- 3/1/2023 4:29:09 AM
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N91023Q00034
- Response Due
- 3/8/2023 12:00:00 PM
- Point of Contact
- Dana Summons, Contract Specialist, Phone: 2402765319
- E-Mail Address
-
dana.summons@nih.gov
(dana.summons@nih.gov)
- Description
- 1.0 DESCRIPTION The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Metabolic Epidemiology Branch (MEB), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure services, on a sole source basis, from the Fred Hutchinson Cancer Center, 1100 Fairview Ave N, Seattle, Washington 98109. 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 $19.5 million. It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0 BACKGROUND Pancreatic cancer is among the most fatal cancers and one�s whose incidence has been increasing in the United States (US) since the early 1990s. Although pancreatic cancer (PC) is relatively rare, it is the third leading cause for cancer mortality in the United States and is projected to become the second, surpassing colorectal cancer mortality by the year 2026. Within the US, PC is often noted for its relevance to cancer disparities, with Black men and women experiencing 30 to 40% higher incidence and mortality rates than their White counterparts. Most pancreatic cancers are ductal adenocarcinomas. Smoking, being overweight, having diabetes or chronic pancreatitis, heavy alcohol use, and a family history of pancreatic cancer might increase pancreatic cancer risk. Although long-term diabetes is a risk factor for pancreatic cancer, diabetes can also occur as a consequence of pancreatic cancer. Metabolomics is a high throughput method that involves the quantitative and qualitative study of a large number (e.g., 400-800) of small molecules (typically less than 1000 Daltons) in a biofluid. A metabolomic profile represents the collection of metabolites within a biological system and it reflects environmental and genetic factors, as well as the gut microflora which may play an important role in diet and metabolism. Lipids broadly correspond to an assorted group of hydrophobic molecules involved in a wide range of key biological functions in human metabolism, including cell membrane structure, energy storage, and signaling. The �lipidome� is a subset of the �metabolome� and a more complete lipid profile within a cell, tissue or organism. In this context, lipidomics has developed distinctly from metabolomics to target hydrophobic nonpolar compounds and to comprehensively identify and quantify a wide array of lipid molecular species. The Metabolic Epidemiology Branch (MEB), Division of Cancer Epidemiology and Genetics (DCEG), of the National Institutes of Health (NIH), National Cancer Institute (NCI) is conducting a prospective metabolomic and lipidomic association study with pancreatic cancer risk using prediagnostic blood samples from Women�s Health Initiative Study (WHI) participants who developed pancreatic cancer years later and from those who did not develop pancreatic cancer.� 2.1 OBJECTIVE Investigators in MEB require the measurement of metabolomic and lipidomic blood concentrations in prediagnostic EDTA-plasma samples from Women�s Health Initiative Cohort (WHI) participants in a nested-case control study of pancreatic cancer. The aims of the study are 1) To identify metabolites and lipid species and their systemic effects associated with pancreatic cancer and 2) to identify groups of metabolites associated with diabetes and examine their association with pancreatic cancer.� � 3.0 SCOPE The Contractor shall provide all personnel, labor, facilities, materials, and equipment necessary to perform the required tasks described in section 4 below. This purchase order includes services to examine the association between metabolomic and lipidomic blood concentrations and the risk of pancreatic cancer, by utilizing a nested case-control design within the WHI cohort. �The Contractor shall facilitate a nested case-control study of incident pancreatic cancer cases and controls (500 cases, 500 controls, 50 blinded replicate quality control (QC) samples, total 1050 samples).� 4.0 PURCHASE ORDER REQUIREMENTS 4.1�TASKS The Contractor shall perform the following tasks: 4.1.1 Select case, control and replicate quality control (QC) samples that will be part of the nested case control study per NCI�s specifications. Set up anonymized batching order documents and subject manifests and provide via electronic spreadsheet to NCI.� 4.1.2��� Pull never-thawed parent edetic acid and ethylenediaminetetraacetic acid (EDTA) plasma sample vials from the repository and send the samples on dry ice for daughter vial aliquoting.� 4.1.3��� Aliquot study and QC into 320 ul samples and batch samples. The case and control samples shall be aliquoted consecutively at the same time, using the same protocol. QC samples shall be handled in a consistent manner.� Samples shall be thawed using minimal time at room temperature (< 20 minutes) with immediate aliquoting and refreezing. The study samples shall be aliquoted in provided cryovial tubes and labeled with provided bar codes.� 4.1.4��� Conduct WHI-required measurement of cholesterol on QC samples and provide via electronic spreadsheet to NCI.� 4.1.5��� Send batched samples on dry ice in insulated shipping box and zip lock bag for metabolite and lipidomic measurement. 4.1.6��� After metabolomic and lipidomic metabolites are measured, create an analytic data set with the necessary covariates and send to NCI. The data set shall be sent via a data file with participant anonymous ids to allow NCI to download and merge with data files on the WHI website. All data shall be coded and shall not contain any personally identifiable information (PII). 4.1.7 �� Assist with data reporting as needed. 4.1.8��� Notify the NCI TPOC immediately via e-mail or phone call if any unusual issues develop over the course of the required tasks.� 4.2�� PROHIBITION AGAINST PERSONAL SERVICES The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government shall not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he or she is a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following the requirements of the Contract. 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 for twelve (12) months from the date of award. 8.0 PLACE OF PERFORMANCE All work shall be performed at the Contractor�s facilities.� 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. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE 4.1.1 Spread sheet: Ordering of case, matched control, and replicate quality control samples by batch Anonymized ordering of case, matched control, and quality control samples by batch within digital subject manifests. Format: Microsoft excel Within 90 calendar days of award 4.1.4 Spread sheet: Results from quality control total cholesterol measures conducted at the Advanced�Research�and Diagnostic Laboratory (ARDL) at the University of Minnesota. Format: Excel file� Within 120 calendar days of award. 4.1.6��� Analytic data set: Result of metabolite, lipidomic measures, merged with other covariate data. Format: Microsoft Excel No less than 30 days prior to the end of the contract award 10.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR Fred Hutchinson Cancer Center houses the WHI�s clinical coordinating center, which handles collection, management, and analysis of the WHI data.� The WHI Clinical Coordinating Center is necessary to support and facilitate all ancillary studies that use WHI study resources including data and biospecimens. The Fred Hutchinson Cancer Center, WHI Clinical Coordinating Center is the only Contractor with access to the WHI resources and samples to support ancillary studies. The WHI samples are the only source for these samples because other aspects of the proposed study have been funded to use WHI samples (DoD award # W81XWH-22-1-1019). Therefore, the research cannot be conducted without the WHI samples and the Fred Hutchinson Cancer Center, WHI Clinical Coordinating Center.� It is critical for Fred Hutchinson Cancer Center to perform this work. The Fred Hutchinson Cancer Center, WHI Clinical Coordinating Center has standardized protocols used on all studies that use WHI samples.� The WHI Clinical Coordinating Center will facilitate the nested case-control study of incident pancreatic cancer cases and controls (500 cases, 500 controls, 50 blinded replicate quality control (QC) samples, total 1050 samples).� In particular, the WHI Clinical Coordinating Center will select, aliquot, batch, obtain biochemical measurement, and facilitate linkage of data from pancreatic cancer case, control and replicate QC samples that will be part of the nested case control 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 the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on March 8, 2023, (3/08/2023). 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: 75N91023Q00034 on all correspondence.
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- Record
- SN06604922-F 20230303/230301230102 (samdaily.us)
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