Coffee Drinking and Mortality Among Never Smokers in the Pooling Project of Prospective Studies of Diet and Cancer (DCPP)

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), Metabolic Epidemiology Branch, plans to procure, on a sole source basis, from Harvard College President & Fellows, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115. 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 Coffee is one of the most widely and habitually consumed dietary items worldwide. Consequently, there is sustained scientific and public interest in how coffee consumption impacts human health. Studies have reported both positive and inverse associations of coffee with risk of cardiovascular disease, but they have generally reported inverse associations with risk of diabetes, Parkinson Disease, depression and certain cancers, including liver, colorectal, endometrial, melanoma, and nonmelanoma skin cancer. Still, it is the association of coffee drinking with mortality that is particularly relevant when considering public health impact and dietary guidance. In general, studies have observed inverse associations with all-cause mortality, and in 2015 the Scientific Report of the Dietary Advisory Committee concluded that moderate coffee consumption (3 to 5 cups per day) could be a part of a healthy diet. Yet several important questions that may impact dietary guidance remain unresolved. First, there is concern that coffee drinking may increase mortality among younger individuals. In 2013, a prospective study reported that coffee drinking was positively associated with mortality among individuals under the age of 55. Since most cohorts have included older populations and mortality rates are lower among younger age groups, few studies can replicate this finding. Second, existing studies have each had a limited number of cases among the highest consumption categories (e.g. ?6 cups/day) precluding stable risk estimates at the extreme end of the distribution particularly among never smokers who tend to drink less coffee. Coffee drinking and cigarette smoking are strongly positively correlated. Consequently, the impact of residual confounding is likely greater among the heaviest consumers. In the proposed study, we will limit our analytic population to never smokers to estimate the associations in the absence of residual confounding by smoking. Third, racial and ethnic minorities are largely under-represented in studies of coffee drinking and mortality. Given that patterns of coffee consumption vary considerably by race/ethnicity, it is important to assess associations in these subgroups. Fourth, only a few large cohort studies have considered causes of death beyond composite measures of cardiovascular disease and cancer. Finally, associations of coffee and morality risk have generally been similar by coffee type (e.g., caffeinated versus decaffeinated) and use of additives, but associations with cause-specific mortality have generally not been reported. The Pooling Project of Prospective Studies of Diet and Cancer (DCPP) provides an opportunity to examine these issues in a large population with adequate sample size for well-powered analyses in key subgroups, including younger individuals and underrepresented racial/ethnic subgroups. 2.1 Objective The primary objectives of this project are to: 1) Provide stable estimates of the mortality risks across the entire range of low, moderate, high and very high coffee intake in a large, diverse analytic sample of never smokers. 2) Assess whether coffee drinking is associated with pre-mature mortality. 3) Evaluate mortality risks in key subgroups including racial and ethnic population subgroups. 4) Explore associations of coffee drinking with mortality by type of coffee and use of common coffee additives. The Division of Cancer Epidemiology and Genetics (DCEG) will investigate associations of coffee drinking with all-cause and cause-specific mortality risk, including among key demographic subgroups. The Division of Cancer Epidemiology and Genetics anticipates that the consortium approach, which affords a large diverse sample of never smokers, will yield unusually accurate and precise risk estimates that will clarify the dose response relationship of coffee drinking with mortality and inform public health nutrition guidance. 3.0 SCOPE The Contractor will conduct the analysis - Coffee drinking and mortality among never smokers in the Pooling Project of Prospective Studies of Diet and Cancer (DCPP)". The Contractor shall be the leader of the DCPP and has full access to the data and harmonization code. In this role, the Contractor shall invite cohorts to participate in the project, harmonized coffee variables for participating cohorts, evaluate the availability of coffee additive data and harmonize coffee additive data currently in the DCPP database, harmonize mortality outcomes including all-cause mortality and leading causes of death, conduct pooled analyses to examine the associations between coffee consumption and all-cause and cause-specific mortality in never smokers and for key population subgroups. 4.0 CONTRACT REQUIREMENTS AND PERSONNEL QUALIFICATIONS The Contractor shall work with the NCI TPOC to supervise the analysis of DCPP data. An analyst on the Contractor's DCPP research team will conduct all analyses. Tasks 4.1 and 4.2 below will each cover 50% of the work. The Contractor shall perform the following tasks: 4.1 Access DCCP consortium data to harmonize variables and run all-cause mortality analyses 4.1.1 Harmonize coffee intake data across all cohorts to the same unit accounting for variation in dilution by preparation methods; 2. harmonize coffee additive variables across cohorts to common categories; 3. harmonize all-cause mortality outcomes; 4. incorporate demographic, dietary, and mortality data from Mexican Teachers Cohort and harmonize variables to align with DCPP (assuming data received within 3 months of PO start date); 5. conduct descriptive analyses including the generation of numbers and column percentages for categorical and medians and interquartile ranges for continuous variables; 6. conduct categorical, continuous, and spline analyses of total coffee and coffee types and all-cause mortality using multivariable Cox regression models to account for time to event; 7. conduct analyses of total coffee and premature (i.e., death before age 65 years) all-cause mortality using multivariable Cox regression models to account for time to event; 8. conduct analyses of total coffee and all-cause mortality, using multivariable Cox regression models, stratified by sex, BMI category, alcohol drinking, geographic region, and follow-up time, creating interaction variables and using likelihood ratio tests to test for effect modification. 4.2 Access DCCP consortium data to run cause-specific mortality analyses 4.2.1 Harmonize cause-specific mortality outcome data across all cohorts using common ICD 9/ICD 10 based definitions for major of causes of chronic disease death; 2. conduct analyses of total coffee and use of coffee additives and cause-specific mortality using multivariable Cox regression models; 3. technical review of manuscript prior to publication. 4.2.2 The Contractor must have full access to the DCCP data, expertise in DCPP variable harmonization, especially harmonization of dietary data, and be able to facilitate communication with participating cohort investigators. 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 will 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/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 order understand and are committed to following these requirements. 5.0 TYPE OF ORDER This is a firm fixed price purchase order. 6.0 PERIOD OF PERFORMANCE The period of performance shall be for 12 months from date of award. 7.0 PLACE OF PERFORMANCE The services will be performed at the Contractor's facility. 8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE 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 Technical Point of Contact (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 contract, 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 https://www.hhs.gov/web/section-508/additional-resources/index.html. Federal government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, 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. All written deliverable products shall be submitted in draft format for review, comment and approval by the TPOC. Final copies of approved drafts shall be delivered to the TPOC within five (5) business days after receipt of the Government's comments. All written draft and final deliverable products shall be submitted in electronic copy for review and comment. If requested, final deliverable products shall be submitted in an electronic format. Other quantities and formats may be submitted after prior approval from the TPOC. All deliverables shall be sent electronically (Microsoft Word, PDF, or Excel 2013, unless approved by the TPOC) per the following deliverable schedule: Reporting Requirements and Deliverables: The Contractor shall deliver the following items within the applicable Period of Performance/ stated deadlines in the order and as coordinated with the NCI Technical Point of Contact (TPOC). A monthly report shall be submitted to the TPOC, via an appropriate government email address to be provided to the Contractor, detailing activities with allocation of labor hours and identification of work products for the period. The NCI TPOC shall review and accept the monthly reports. Any deficiencies identified shall be corrected prior to the final approval, and before the end of the Period of Performance. If no comments or requests for revisions from the NCI TPOC are provided to the Contractor within 30 days of receipt of deliverables, the deliverables will be considered acceptable. If comments or requests for revisions from the NCI TPOC are provided to the Contractor, the Contractor will have 30 days to respond to comments an and/or provide revisions. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE #1 (Task 4.1) Tables (and figures if applicable) of demographics and all-cause mortality results and written description of methods for manuscript 4-8 months after award #1 (Task 4.2) Tables (and figures if applicable) of cause specific mortality results and written description of methods for manuscript 8-12 months after award 8.1 Approvals by the Technical Point of Contact All services delivered to the TPOC will be deemed to have been accepted 30 calendar days after date of delivery, except as otherwise specified in this purchase order, if written approval or disapproval has not been given within such period. The TPOC's approval or revision to the services delivered shall be within the general scope of work stated in this purchase order. TPOC: (TBD) 8.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR The vendor, Harvard T.H. Chan School of Public Health, is uniquely positioned to assure that the harmonization of coffee and mortality data and delivery of relative risk estimates for coffee and mortality in the consortium are consistent with prior research in the Pooling Project of Prospective Studies of Diet and Cancer (DCPP). The DCPP is a restricted access dataset, and only the vendor has full and direct access to the harmonized DCCP dataset, which has been built, updated, and maintained for over a decade using proprietary IP and SAS code. The vendor is the only group that has collected and harmonized individual level data on diet and mortality from >30 cohorts within the NCI Cohort Consortium Cohorts. Analyses have previously been conducted in the DCPP on coffee consumption and risk of colon, renal cell, and pancreatic cancer. This project will build upon the data harmonized for those projects and on the statistical analyses conducted as well as on work currently being undertaken for projects examining associations between coffee consumption and risk of bladder and stomach cancer. Conducting all these analyses within the same consortium using exposures and covariates that have been harmonized using proprietary codes across over 30 cohorts will provide compatibility and consistency with past and future studies evaluating the health effects of coffee consumption. Conducting this project within the DCPP also provides consistency in the harmonization of mortality outcomes and analytic approaches used in the consortium as other mortality projects have been approved or are being proposed to be conducted within the consortium. In summary, the vendor is uniquely qualified to carry out the proposed research and the only vendor that can ensure consistency with past and future research on coffee and health in the NCI Cohort Conosortium. 9.0 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 25, 2024, (7/25/24). 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: 6954986 on all correspondence.