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Data coordinating services and support services for the study of environmental exposure to perfluorinated substances and cancer risk in California

General Information

Document Type:PRESOL
Posted Date:Sep 04, 2017
Category: Professional, Administrative and Management Support Services
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States

Description

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, USA. Description: National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB), plans to procure on a sole source basis data coordinating services and support services for the study of environmental exposure to perfluorinated substances and cancer risk in California from the Cancer Prevention Institute of California (CPIC), 2001 Center Street - Suite 700, Berkeley, CA 94704 USA. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated 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 541990 and the business size standard is $15.0M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is to be twelve (12) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Occupational and Environmental Epidemiology Branch (OEEB) conducts studies in the United States and abroad to identify and evaluate environmental and workplace exposures that may be associated with cancer risk. OEEBs mission is to combine epidemiology, quantitative exposure assessment, and molecular components into multi-disciplinary studies to provide insight into cancer etiology, chemical carcinogenesis, and mechanisms of action. Our main research areas include: • Industrial and Occupational Exposures • Environmental Exposures • Exposure Assessment Methods Per- and polyfluoroalkyl substances (PFAS) were once widely used in commercial and industrial applications. These compounds resist degradation in the environment, and are detectable in serum in ~98% of the U.S. population. One persistent PFAS, perfluorooctanoic acid (PFOA), is classified by the International Agency for Research on Cancer as a possible human carcinogen based on animal evidence of liver, testicular, and pancreatic tumors. However, many other PFAS with known toxicity have not been evaluated for carcinogenicity. In occupational studies, PFAS have been associated with non-malignant renal disease and risk of kidney cancer. Consumption of contaminated water was predictive of serum PFAS levels in the C8 Study of mid-Ohio Valley residents living near a manufacturing plant, where PFOA exposure was associated with increased risk of kidney and testicular cancers. The C8 Study of a uniquely exposed population is the only U.S. evaluation of environmental PFOA exposure and cancer risk to-date. No U.S. studies have investigated these relationships with PFAS other than PFOA. PFAS enter waterways via their manufacture, use, and disposal. Widespread PFAS contamination of U.S. drinking water supplies is documented, but PFAS are not currently regulated in public drinking water. A biomonitoring study in the California Teachers Study (CTS) cohort demonstrated exposure to multiple PFAS, and serum levels were higher in participants who lived in ZIP codes served by a public water supply with PFAS detections (Hurley et al., 2016). This was the first study to relate PFAS in drinking water with body burden in the general population. The ubiquity and persistence of PFAS exposures and intriguing but limited epidemiologic evidence of their carcinogenicity provides a strong rationale for further cancer studies. The Occupational and Environmental Epidemiology Branch (OEEB) in the Division of Cancer Epidemiology and Genetics (DCEG) in the National Cancer Institute (NCI) conducts studies of cancer and environmental exposures to drinking water contaminants. DCEG intends to investigate ingestion of PFAS in drinking water and cancer risk in the CTS, leveraging its large numbers of incident cancers, residence histories, and biologic samples. This project will lay the groundwork for studies of PFAS exposure through drinking water and cancer risk by developing a PFAS drinking water exposure assessment. To accomplish this, we plan to link participants historical residence locations with their drinking water source(s). We will develop a predictive model to estimate PFAS exposures from drinking water (e.g., water consumption, local PFAS point sources, source water characteristics) and will validate these estimates using participants serum measurements. This novel exposure assessment will set the foundation for future prospective analyses of PFAS and cancer risk. The purpose of this procurement is to support the development of a drinking water exposure assessment for a future study of PFAS and cancer risk among CTS participants. Based on published data in a subset of the CTS population (Hurley et al., 2016), the Government expects PFAS exposures are prevalent. This contract covers support to develop a PFAS exposure assessment that covers all eligible participants of the CTS, with improvement of exposure estimates through model development and incorporation of data from a follow-up survey of some study participants. The results of this study will increase the Governments understanding of the specific PFAS point sources and exposure duration and frequency that may explain the association between PFAS exposures and cancer risk in the general population. Contractor shall perform the following: TECHNICAL REQUIREMENTS: The Contractor shall be involved in the coordination of cohort data approvals, design of exposure assessment questions, the selection of CTS population to target for study, and the initiation of research activities. The specific tasks to be accomplished follow. The Contractor shall: 1. Provide data from a questionnaire about drinking water source and water consumption as part of a follow-up survey to the cohort; an online version is planned in spring 2017 and paper survey to follow. 2. Coordinate NCIs request to access cohort data and biologic measurements. This effort shall include support and guidance in preparation of the data request application. 3. Assist NCI researchers with identifying and obtaining local geographic and other datasets useful for exposure assessment, including exposure point sources, water distribution systems, and ancillary contaminant data. 4. Provide technical assistance for the development of exposure models, including consulting about existing datasets and interpretation of study results. 5. Prepare cohort data files for NCI. The data shall consist of essential variables from the records of the primary data, including those originally generated from the field and the analytical labs, data recorded in field and lab logbooks, as well as data obtained from other third-party investigators or collaborators and subcontracted laboratories (if applicable). All of the data shall be ultimately transformed into a universal electronic format, such as DBF (Database File) or delimited format readable with standard statistical analytic software packages such as SAS, STATA, or R. 6. Organize and participate in monthly teleconference meetings to evaluate project progress. GOVERNMENT RESPONSIBILITIES: Provide the necessary information to the Contractor in order for them to complete Sections C and E of this Statement of Work. REPORTING REQUIREMENTS AND DELIVERABLES: The Contractor shall deliver the following items within the Period of Performance stated in the order and as coordinated with the NCI Contracting Officers Representative: 1. A status update on the online implementation of the follow-up survey, including participation rates and completeness of response to water source questions. 2. Geocoded residence locations for CTS participants to allow development of exposure models. 3. Cohort data files in a universal electronic format, such as DBF (Database File) or delimited format compatible with standard statistical analytic software packages such as SAS, STATA, or R. A data codebook or other metadata shall be included. 4. Biological sample data of PFAS measurements, including both raw and cleaned datasets, in a universal electronic format, such as DBF (Database File) or delimited format compatible with standard statistical analytic software packages such as SAS, STATA, or R. 5. Lab data quality summary report in electronic format prepared in Microsoft Word software (.doc or.docx format). INSPECTION AND ACCEPTANCE CRITERIA: The deliverables will be reviewed by Government investigators involved in the study. The work will be evaluated with regard to the completeness of tasks set forth in this Statement of Work combined with specific scientific knowledge of the subject matter. The Government investigators will review the deliverables within 30 days of receipt. Within 30 days of completion of the review, the investigators will notify the Contractor as to the acceptability of the deliverable. REQUIRED APPROVALS: OMB - Exempt TEP - Not applicable NCI SSIRB - In progress PAYMENT: NET 30 days from date of invoice. Payment shall be made in quarterly increments after satisfactory completion and acceptance of the deliverables stated in Section E. The Contractor shall be paid after satisfactory completion and acceptance of work provided. Payment authorization requires submission and approval of invoice to the NCI COR and NIH OFM Commercial Accounts per the attached Invoice and Payment Provisions. A copy of each invoice should be mailed, faxed, or e-mailed to the NCI CORs contact information on the first page of the order. AWARD: The award will be firm-fixed price, and made in the aggregate. REFERENCES: Hurley S, Houtz E, Goldberg D, Wang M, Park J, Nelson DO, Reynolds P, Bernstein L, Anton-Culver H, Horn-Ross P, Petreas M. Preliminary Associations between the Detection of Perfluoroalkyl Acids (PFAAs) in Drinking Water and Serum Concentrations in a Sample of California Women. Env Sci Technol Lett. 2016; 3: 264-269. The services are provided by the Cancer Prevention Institute of California (CPIC). This NCI-funded study within the CTS cohort is being conducted across the state of California. The CPIC was selected for the current procurement without competition because it has extensive and unique experience in California drinking water data and PFAS that is not available from any other potential contract source. They are in a unique position to conduct the work because they are experts in the CTS, and initiated the original work in PFAS exposures in this cohort that led to the proposed study. The CTS is uniquely suited to this work because the CTS cohort resides across the state of California, where recently published data has indicated PFAS exposures are widespread. Specimens and data from the CTS were collected prospectively before the diagnosis of cancer, making them extremely valuable for research. Unlike many cohorts, the CTS also has fairly complete residential histories, which allows for adequate PFAS exposure assessment infeasible in other studies. Because they previously measured PFAS in serum for other projects, the CTS also already has these data available for epidemiologic analysis. The expertise of the CPIC collaborators and familiarity with the CTS and PFAS data is unique, and their geographic proximity to and familiarity with the study area also make the study feasible in a way not possible to alternative sources for this procurement. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 1:00PM EDT, on Sept. 14, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. 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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP72699-76 on all correspondence.

Original Point of Contact

POC Catherine Muir, Phone: (240) 276-5434

Place of Performance

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