SPECIAL NOTICE
Q -- Prospective Associations of Serum Trimethylamine N-oxide, Choline, L-carnitine, and Betaine with Colorectal Cancer
- Notice Date
- 8/18/2020 11:02:23 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH National Cancer Institute Rockville MD 20850 USA
- ZIP Code
- 20850
- Solicitation Number
- 75N91020Q00172
- Response Due
- 8/25/2020 12:00:00 PM
- Archive Date
- 09/09/2020
- 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, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) plans to procure, on a sole source basis, services for a targeted analysis of TMAO, choline, betaine, and l-carnitine in 1,893 samples (includes QCs) using liquid chromatography-mass spectrometry panels from Cleveland Clinic Lerner College of Medicine/CWRU at 9500 Euclid Ave Cleveland, OH, 44195-0001 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); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 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 U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) conducts intramural research in areas related to nutrition, metabolism and cancer which are aimed to understand how to reduce risk for cancer. �One of the programmatic focus areas of the MEB is understanding the role of the microbiome and metabolites in relation to cancer risk. � Colorectal cancer (CRC) is the second leading cause of cancer death in the United States among men and women combined. �There is strong evidence that the collective activity of the gut microbiota influences CRC risk. �Microbiome-CRC associations may be mediated through the bacteria�s metabolically active metabolites, including trimethylamine n-oxide (TMAO). �TMAO precursors include choline, l-carnitine, and betaine, which are also implicated in CRC risk. �The associations of these precursors with CRC may depend on their circulating distribution that is directed to be microbially metabolized to produce TMAO vs. to other pathways. �Few studies prospectively investigated associations of microbially-related metabolites with incident CRC, but they all suggested strong TMAO/TMAO precursor-CRC associations. �No studies were conducted measuring these metabolites collectively in relation to adenoma. 3.0�� �SCOPE The Contractor shall perform a targeted analysis of TMAO, choline, betaine, and l-carnitine in 1,893 samples, including QCs, using liquid chromatography-mass spectrometry panels.� The samples have been collected by NCI and will be delivered to the Contractor within 15 business days of award. The cost of the shipment to the Contractor shall not be included in the quote. Samples will be shipped overnight on dry ice via the NCI shipping service. A written manifest shall accompany each shipment. Samples will arrive in 2 batches, with an electronic manifest emailed to the Contractor in advance. The shipment tracking number will be sent via email to the Contractor once established. The Contractor shall provide the required measurements 3 months prior to the purchase order expiration date. The measurements (to be provided via Excel spreadsheet) shall be provided to the NCI Technical Point of Contact (TPOC) and reviewed to ensure completion and acceptable coefficients of variation. Contractor shall return residual samples to NCI using NCI-provided carrier. �Residual samples, in original tubes where possible, shall be shipped overnight on dry ice to the NCI biospecimen repository. The cost of return shipment shall not be included in the quote. The Contractor shall provide a shipment tracking number via email to the NCI once established. 3.1� � TASKS The Contractor shall: 3.1.1� � Store samples immediately upon receipt in -80 degrees C until ready for staging and assays.� 3.1.2� � Measure metabolites using the TMAO, choline, betaine, and l-carnitine Panel for 1,893 study samples. All analytical work performed by the Contractor shall be conducted under conditions of careful quality control and follow the industry standard quality control procedures. Note: NCI shall review the data for the blinded QC samples to assure that satisfactory reproducibility was provided prior to the return of final study data and residual samples to NCI. 3.1.3� � Provide final study data Excel workbook with quantification of targeted TMAO, choline, betaine, and l-carnitine using internal standards to NCI via email. 3.1.4� � Communicate to TPOC immediately via email or phone call if any issues occur.� 3.1.5� � Store residual serum samples in the Contractor�s laboratory at -80 degrees C in case repeat assays or elucidation studies are needed. �All residual specimens provided by NCI and all data generated shall remain the property of the U.S. Government and shall be returned to NCI in accordance with the deliverables table in section 8 below. 4.0�� �TYPE OF ORDER This is a firm fixed price purchase order.� 5.0�� �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. 6.0�� �PERIOD OF PERFORMANCE The anticipated period of performance shall be for 12 months from date of award.� 7.0�� �PLACE OF PERFORMANCE Services shall be performed at the Contractor�s facility. 8.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE �� Electronic deliverables shall be submitted in the form of PDF files or Excel workbooks for review and comment by the Government�s technical point of contact (TPOC) (TBD at award) for a review period not to exceed thirty (30) business days. Final copies of approved drafts shall be delivered to the TPOC within ten (10) business days after receipt of the Government�s comments. DELIVERABLE / DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS /�DUE DATE 1.�� �Final study data - Excel workbook with quantification of targeted TMAO, choline, betaine, and l-carnitine using internal standards. Due�3 months prior to purchase order expiration date. 2.�� �Final report� -� to be submitted to the TPOC� via PDF file. Due 3 months prior to purchase order expiration date. 3.�� �Return of residual samples - to be shipped to NCI at Frederick Central Repository: American Type Culture Collection (ATCC),�4600 Wedgewood Blvd. Suite H & K Frederick, MD 21703. Due by purchase order expiration date. 9.0�� �INSPECTION AND ACCEPTANCE Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with 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.� HHS guidance regarding accessibility of documents can be found at: http://www.hhs.gov/web/section-508/making-files-accessible/index.html;� Federal Government-wide guidance regarding accessibility of documents can be found at: https://www.section508.gov/best-practices, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF. 10.0� � INVOICE SUBMISSION / PAYMENT Payment shall be made upon receipt, review and acceptance of each deliverable in Section 8.0. Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH Office of Financial Management (OFM). Electronic Email Submission: The current national emergency and the need to protect Federal and Contractor staff has resulted in a change to NIH�s invoice submission process. Effective Wednesday, April 1, 2020, all NIH contractors/vendors invoices should be sent electronically via email to the NIH OFM and the NIH Contracting Officer (CO) using the electronic submission instructions contained in Attachment #1. Electronic invoice submission shall remain in effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this purchase order. In fiscal year 2014-2015, the Cleveland Clinic Lerner College of Medicine/CWRU measured TMAO, choline, betaine, and l-carnitine in a subset of the Alpha Tocopherol Beta Carotene (ATBC) study using these same assays, under purchase order #HHSN261201400277P. The coefficients of variation were low between all batches, indicating quality sample handling and measurement. It is crucial that DCEG/MEB are able to compare the results of the previous award to the findings under the resulting award. Thus, it is critical to use the same laboratory, equipment, assays, quality control approach, and data processing that was used under the previous award to ensure the scientific comparability of the new data with the previous data, and to pool these data for higher powered analyses. �Any deviation from the proposed acquisition strategy would result in the DCEG/MEB being unable to combine the results provided under the subsequent award with the results provided under the previous award #HHSN261201400277P, as the findings would not be scientifically comparable. This notice is not a request for competitive quotation. However, if any interested party, especially a small business, believes it can meet the above requirements, it may submit a proposal/quote/capability statement 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 must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Tuesday, August 25, 2020 (8/25/20). 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: 75N91020Q00172 on all correspondence.
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- Record
- SN05762616-F 20200820/200818230158 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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