SPECIAL NOTICE
Q -- Metabolomic Profiles and Pancreatic Cancer Risk in Women�s Health Initiative
- Notice Date
- 3/27/2023 5:08:23 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
- 75N91023Q00052
- Response Due
- 4/3/2023 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 Metabolon Inc., 617 Davis Drive, Suite 100, Morrisville, NC 27560. 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 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 African-American (AA) 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 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 those who do 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 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. Utilizing a nested case-control design within the Women�s Health Initiative cohort, the Contractor shall examine the association between metabolomic and lipidomic blood concentrations and the risk of pancreatic cancer. �The Contractor shall measure metabolomic and lipidomic concentrations on 55 samples that are part of a nested case-control study of incident pancreatic cancer. � 4.0�� �PURCHASE ORDER REQUIREMENTS 4.1�� �TASKS Test results shall be delivered to the NCI Technical point of contact (TPOC) via encrypted email. �The data files shall be provided as Excel files. No personally identifiable information shall be included. The Contractor shall perform the following tasks: 4.1.1�� �Receive the samples that will be shipped on dry ice and store received samples immediately in -80 degrees Celsius until ready for assays. 4.1.2�� �Measure metabolites and lipids in 55 ethylenediaminetetraacetic acid (EDTA) plasma samples in the order specified by NCI using the DiscoveryHD4 and complex lipid panel (CLP). �Assay all batches and samples within the batches (n=36 samples per batch) in the order provided by the NCI. �Refreeze residual samples as soon as possible after metabolite and lipid measurement. 4.1.3�� �Conduct all analytical work performed under the conditions of careful quality control in accordance with the laboratory�s quality control procedures. �All Contractor internal quality control charts shall be provided to the NCI, at the completion of the work, for review of the data. �The NCI shall review the WHI blinded quality control samples embedded within the study samples to assure that satisfactory reproducibility is being provided. 4.1.4�� �Return residual samples to NCI repository. Send samples on Monday-Wednesday on dry ice to: Frederick National Laboratory for Cancer Research American Type Culture Collection (ATCC) 4600 Wedgewood Blvd, Suite H Frederick, Md 21703 301-732-8200 matthew.paschal@nih.gov 4.1.5�� �Notify the NCI TPOC immediately via e-mail or phone call if any unusual problems develop over the course of the project. � 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 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. DELIVERABLE RELATED TASK # DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE 4.1.2 - 4.1.3 Spreadsheet: ��� �Biochemical profiling report(s) ��� �Metabolites and lipids results� ��� �Data: measured metabolites and lipids in 55 EDTA plasma samples in the order specified by NCI using the DiscoveryHD4 and complex lipid panel (CLP) Chart: ��� �Analytical work performed in accordance with the laboratory�s quality control procedures No less than 30 days from the contract expiration date. 4.1.4 Residual samples returned to NCI Within 1 year of contract award The Contractor shall provide all personnel, labor, facilities, materials, and equipment necessary to perform the required tasks described in section 4 below. Utilizing a nested case-control design within the Women�s Health Initiative cohort, the Contractor shall examine the association between metabolomic and lipidomic blood concentrations and the risk of pancreatic cancer. �The Contractor shall measure metabolomic and lipidomic concentrations on 55 samples that are part of a nested case-control study of incident pancreatic cancer. � 10.0�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR Metabolon Inc. has conducted previous studies on pancreatic cancer cases and controls (funded under DoD award # W81XWH-22-1-1019) with NCI awards HHSN261201600682P, and HHSN261201700009I, that will be pooled with the results from this acquisition. If the same method and laboratory are not used to measure metabolites and lipids, then the Metabolic Epidemiology Branch (MEB) cannot combine the results from the earlier studies. The new results need to be combined with the results from these three previous studies mentioned above. The other 995 samples from WHI for this study along with the 5 samples from this same study will be measured by Metabolon using DoD award # W81XWH-22-1-1019. For scientific comparability, it is critical that the metabolomic and lipidomic profiles be carried out at Metabolon, Inc. It is critical that the samples are run using the Q-Exactive Mass-Spectrometry (MS) platform and Complex Lipid Panel to allow the Metabolic Epidemiology Branch (MEB) to combine this and a previous study. For scientific comparability, as discussed in section 5 above, it is critical that the metabolomic profiles be carried out by Metabolon, Inc. In addition, Metabolon has a comprehensive, extensive proprietary metabolite library that links metabolites peak that does not exist with other laboratories to the same extent. Therefore, is no known potential contractor, other than the proposed source, that can meet the Government�s requirements. 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 April 3, 2023, (4/03/2023). 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: 75N91023Q00052 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/0ad487baffcd4568a258f4528e1cba68/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06630688-F 20230329/230327230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |