SPECIAL NOTICE
Q -- Serum organochlorine insecticide levels and risk of aggressive prostate cancer in African men
- Notice Date
- 6/29/2023 8:35:14 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N91023Q00113
- Response Due
- 7/13/2023 12:00:00 PM
- Archive Date
- 07/28/2023
- 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 the Ecole Nationale V�t�rinaire, Agroalimentaire et de l�Alimentation Nantes Atlantique, 101, Route de Gachet, Nantes 44307. 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 Prostate cancer is a leading causes of cancer morbidity and mortality among men worldwide. Men of African descent have the highest rates of prostate cancer incidence and mortality, and the factors contributing to this disparity are not well understood. � Organochlorine insecticides (OCs) are a class of synthetic insecticides that are currently banned in most countries due to their slow degradation and ability to bioaccumulate. However, they are still used for agriculture in less developed regions and persist in the environment even where use has been curtailed. OCs are also used for mosquito control in areas such as Ghana where malaria is endemic. OCs have extremely long half lives and are detectable in human tissue and sera in nearly 100% of the general population, which has raised concerns over their impact on human health. OCs are hypothesized to increase risk of prostate and other hormone-related cancers via effects on immunosuppression, oxidative stress, and hormone disruption. Although some OCs have recently been classified by the International Agency for Research on Cancer (IARC) as carcinogenic (i.e., lindane, Group 1) or probably carcinogenic (i.e., dichlorodiphenyl-trichloroethane [DDT], Group 2A), there is insufficient evidence to link these carcinogens specifically to prostate cancer. In previous epidemiologic studies, chlordane and related compounds have been most consistently associated with prostate cancer risk, but results for other OCs have been inconsistent. Previous studies have also been conducted primarily in populations of European descent. There have not yet been any studies conducted in Africa, despite the detection of OCs in food sources in several African countries and the high burden of prostate cancer in this region. Furthermore, only one study population has included men of African ancestry; of note, this study reported positive associations between DDE and chlordecone and total and aggressive prostate cancer. The relationship between chlordecone exposure and aggressive prostate cancer is of particular interest, given the strong positive association previously reported in the French territories of Martinique and Guadeloupe and the need to replicate this association in other exposed populations. To address these gaps and elucidate the relationship between OC exposure and prostate cancer risk in men of African descent, the Occupational and Environmental Epidemiology Branch of the Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) proposes to measure serum OCs in prostate cancer cases and controls from the Ghana Prostate Study. 2.1�� �OBJECTIVE The primary objective of this study is to investigate associations between serum levels of organochlorine pesticides (OCs) and prostate cancer risk in a population of men from the Accra region of Ghana. According to previous pilot data collected by NCI, men from this region have high exposure to OCs, yet they have been significantly underrepresented in prior studies examining the health effects of OCs. Thus, NCI proposes to study the relationship between serum OC concentrations and prostate cancer among men enrolled in the Ghana Prostate Study between 2004-2012. NCI will first conduct a pilot study using 18 1 mL serum samples (from 15 unique Ghana Prostate Study participants, with 3 QC replicates). If the pilot results indicate detectable levels of priority OCs of interest (aldrin, heptachlor epoxyde cis, heptachlor epoxyde trans, dieldrin, chlordecone, chlordecone + metabolites), NCI will then conduct the full study using 182 0.5 mL serum samples (including 82 prostate cancer cases, 82 age-matched controls, and 18 QC replicates). For each sample, �NCI will request measurement of 29 OCs and OC metabolites and 19 polychlorinated biphenyls (PCBs) using gas chromatography with high-resolution mass spectrometry, and examine associations with total and high-grade prostate cancer. 3.0�� �SCOPE The Contractor shall quantify serum levels of 29 OCs and OC metabolites and 19 PCBs in 18 pilot samples from the Ghana Prostate Study, followed by 182 samples if the pilot results show detectable levels of priority OCs (aldrin, heptachlor epoxyde cis, heptachlor epoxyde trans, dieldrin, chlordecone, chlordecone + metabolites). The assays will be performed by LABERCA staff using gas chromatography coupled with high resolution mass spectrometry. 4.0�� �PURCHASE ORDER REQUIREMENTS The Contractor shall perform the following tasks: 4.1�� �Document the receipt of all serum samples in an MS Excel file with the unique ID of each sample. 4.2�� �Base Period 4.2.1�� �The tasks for the base period shall be completed within three (3) months from the date of the award. 4.2.2�� �Quantify serum concentrations for 18 pilot samples for 29 organochlorine pesticides and metabolites and 19 polychlorinated biphenyls using automated liquid-liquid extraction coupled to gas chromatography isotope dilution high-resolution mass spectrometry. 4.2.3�� �Record analysis results, test date, batching information, and quality control data (if applicable). 4.2.4�� �Provide NCI investigators with a copy of the analysis results upon completion. 4.3�� �Option Period 1 4.3.1�� �The option period is contingent on the pilot results. It shall be executed and completed within 9 months of the expiration date for the base period. 4.3.2�� �Quantify serum concentrations of the 182 remaining samples for 29 organochlorine pesticides and metabolites and 19 polychlorinated biphenyls using automated liquid-liquid extraction coupled to gas chromatography isotope dilution high resolution mass spectrometry if the pilot results show detectable levels of priority OCs (aldrin, heptachlor epoxyde cis, heptachlor epoxyde trans, dieldrin, chlordecone, chlordecone + metabolites). 4.3.3�� �Record analysis results, test date, batching information, and quality control data (if applicable). 4.3.4�� �Provide NCI investigators with a copy of the analysis results upon completion. 4.4�� �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: Base Period � (TBD) Three (3) months from date of award Option Period 1 � (TBD) Nine (9) months from the expiration date for the base period 8.0�� �PLACE OF PERFORMANCE The services 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 �� �DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS�� �DUE DATE Base Period: Serum OC and PCB concentrations for n=18 samples�� �Provide measurements of OCs and PCBs for each of the 18 submitted pilot samples.�� �2 months within execution of the base period Option 1: Serum OC and PCB concentrations for n=182 samples�� �Provide measurements of OCs and PCBs for each of the remaining 182 submitted samples.�� �8 months within execution of the option period 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 Laboratoire d�Etude des R�sidus et Contaminants dans les Aliments (LABERCA) has the unique and specialized experience and capability of measuring chlordecone, as well as other specific OCs of interest such as aldrin, heptachlor epoxyde cis, heptachlor epoxyde trans, and dieldrin that are not able to be measured by other labs. LABERCA is a joint research unit of the Nantes-Atlantic National College of Veterinary Medicine, Food Science and Engineering (ONIRIS) under the supervision of the French National Research Institute for Agriculture, Food, and Environment (INRAE). It is the French National Reference Laboratory for many classes of substances including dioxins, PCB-dl, PCB-ndl, PAH, Melamine, and livestock growth promoters. LABERCA has developed and validated analytic techniques for measuring serum concentrations of chlordecone, an organochlorine insecticide that is not included in other standard assays due to its atypical physico-chemical properties. Chlordecone is of great interest to our study due to prior work demonstrating a strong association between serum chlordecone concentrations and prostate cancer risk among men of African descent (Multigner et al., �Chlordecone exposure and risk of prostate cancer,� Journal of Clinical Oncology 2010). LABERCA is the only lab with validated assays for measuring chlordecone and all other priority OCs of interest to this study (aldrin, heptachlor epoxyde cis, heptachlor epoxyde trans, dieldrin) and is the only lab able to conduct all of these measurements using small volumes of serum (<1 mL), which is what is available for most participants from the Ghana Prostate Study. To include these OCs in our study of organochlorine pesticide exposures and prostate cancer risk, we must conduct our measurements at LABERCA, as LABERCA is the only lab capable of completing the requested work. 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 13, 2023, (7/13/2023). 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: 75N91023Q00113 on all correspondence.
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