Datasets and Data Analysis Support for Studies of Environmental Exposures in a Case-Control Study of Childhood Cancer in Denmark

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) intends to procure, on a sole source basis, datasets and data analysis support from Danish Cancer Society Research Center, Strandboulevarden 49 DK2100 Copenhagen, Denmark. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed and made pursuant to FAR Part 13 for other than commercial items, and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 518210 and the business size standard is $35 million. 1.0 BACKGROUND The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) conducts studies of environmental and occupational exposures in relation to cancer risk. OEEB is conducting an analysis of environmental exposures in a population-based record-linkage case-control study within Denmark that utilizes the complete case ascertainment from the Danish childhood cancer registry and linkages to residential histories. OEEB will evaluate crop area near homes from national crop maps, locations of animal farms and animal counts, and wind data. The study will examine the associations between residential exposure to agricultural crops, pesticides, and animal production facilities in relation to risk of childhood cancers, adjusting for parental occupational exposures and other risk factors obtained previously for the study population. 2.0 OBJECTIVE The primary purpose of this Purchase Order is to obtain crop area, pesticide application, and animal counts and distance data for Danish residences for a case-control study of childhood cancer in Denmark. This research falls within the mission of the Epidemiology and Biostatistics Program within DCEG and specifically within the mission of OEEB. 3.0 SCOPE The Contractor shall perform linkages of the case-control study dataset to multiple environmental datasets. The Contractor shall prepare de-identified datasets with key questionnaire and registry variables from the case-control population (e.g., parental occupation, parental smoking status, family socioeconomic status, child's sex, age at diagnosis, place of birth, cryptorchidism diagnosis), environmental variables (e.g., crop area, pesticide application, animal counts by type), and information needed to estimate participant exposure to farms (e.g., distance from residence(s) to farm(s), wind direction). 4.0 CONTRACT REQUIREMENTS The contractor shall perform the following tasks: Task 4.1 Link estimates of environmental exposures based on geocoded residence locations and existing questionnaire/registry data for the Danish case-control study. The environmental exposures include the crop area, pesticide application, and animal counts by type. Task 4.2 Create analytic dataset from the Danish case-control study inclusive of all cancers diagnosed among children in Denmark ages 0-18 years, from 1996 to 2016 and provide datasets with a non-personally identifying (anonymized) residential identifier to NCI investigators. This dataset should include the environmental exposures described in Task 4.1 and existing questionnaire/registry data available for the study based on previous linkages, including parental occupation, parental smoking status, family socioeconomic status, child's sex, age at diagnosis, place of birth, and cryptorchidism diagnosis. Task 4.3 Provide a short report describing the linkage process, methods used to create the variables, and any problems or issues encountered in creating the dataset. Task 4.4 Provide ongoing support for questions about the data deliveries. 5.0 TYPE OF ORDER This is a firm fixed price purchase order for 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 the date of the award. 7.0 PLACE OF PERFORMANCE All work shall be performed at the Contractor's facility. 8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The government will request the complete case-control analytic file inclusive of environmental, questionnaire/registry, and cancer outcome data (generated in Task 4.2) over the period of performance. All written and electronic deliverable products shall be submitted in draft format for review, comment, and approval by the NCI Technical Point of Contact (TPOC). Final copies of approved drafts shall be delivered to the NCI TPC within ten (10) business days after receipt of the Government's comments. The contractor shall deliver to the government (NCI) electronic data files (databases) within 30 days of the dataset request during the period of performance. The contractor shall conduct the linkage of the environmental dataset variables to the study ID and provide the Government with the deidentified dataset within 30 days of receiving the environmental dataset/variables. Data will be provided in SAS-compatible format and will be sent to the NCI via a secure server. The Contractor shall provide a short final written report via email that describes the variables provided, the methods used, and any issues or details about the data. The Contractor shall also answer questions about the data deliveries through conference calls with NCI scientists. All deliverables shall be sent electronically (SAS datasets with documentation in Microsoft Word or Excel 2013, unless approved by the COR) per the following deliverable schedule: Deliverable #1: Datasets in SAS-compatible format (.txt, .csv, .sas7bdat, .dbf) with documentation/data dictionary (e.g., Proc Contents in Word or PDF format) sent via secure server. Due 30 days after the Government's request for dataset. Deliverable #2: Short report describing the linkage process, methods used to create the variables, and any problems or issues encountered in creating the dataset. Due 30 days after the Government's request for dataset. Deliverable #3: Ongoing support for questions about the data deliveries via conference calls. 8.1 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, Charles Rabkin, 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 9.0 UNIQUE QAULIFICATIONS OF THE CONTRACTOR Danish policy per the European Union General Data Protection Regulation (GDPR) does not allow residence location information to leave the country. Therefore, to preserve confidentiality, NCI requires this linkage to be done by Danish Cancer Society (DCS) staff/programmers. DCS is a Government entity within Denmark with access to - Statistics Denmark which is a repository for national registry information to be broadly used by Danish scientists and other stakeholders. DCS is the creator of the case-control dataset, in which cancer registry, birth registry, and other required information has already been compiled for use in epidemiologic analyses. DCS is the only known entity in the world in which the required case-control data resides and has the legal right to transfer the required datasets. The DCS and the department staff have the unique expertise and permissions to access the residential-level environmental data and link it to the Danish Childhood Cancer case-control study population. 10.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the above requirement, 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 enough detail to allow NCI to determine if the party can perform the requirement. All responses must be submitted via email to Adam Hernandez, Contracting Officer at contact@example.gov. Responses are due no later than 3:00 PM EST Monday, August 02, 2021 (08/02/2021). 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 determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out. Reference 75N91021Q00191 on all correspondence.