SAM #FDA_7222026

FDA Sole Source Procurement for Harvard Longitudinal Survey Data Access and Analytic Support

This opportunity is a sole source procurement by the FDA Human Foods Program for access to proprietary longitudinal survey data from Harvard School of Public Health cohort studies. - Agency: U.S. Food and Drug Administration (FDA), Human Foods Program - Vendor/OEM: President and Fellows of Harvard College/Harvard School of Public Health - Studies included: Nurses’ Health Study (NHS), Nurses’ Health Study II (NHSII), Health Professionals Follow-Up Study (HPFS), Growing Up Today Study (GUTS), Growing Up Today Study 2 (GUTS2) - Purpose: Support FDA research on dietary, environmental exposures, and health outcomes - Services required: - Access to unique, proprietary longitudinal datasets - Data extraction and specialized analytic support - Co-authoring scientific publications - Monthly progress reports and kick-off meeting - Period of performance: Base Year FY26 (9/30/2026-9/29/2027), Option Year FY27 (9/30/2027-9/29/2028) - Sole source justification: Data is not available from other sources - No physical products or equipment; service-based procurement - Commercial opportunity: Limited to Harvard as sole provider, but similar cohort data providers may exist for future needs

Description

Cross-sectional data sets, such as derived from the National Health and Nutritional Examination Survey (NHANES), are readily available at no cost over the web, and analyses of such data sets can help suggest potential associations between dietary intake exposures and health outcomes. However, because cross- sectional surveys collect exposure and outcome data at the very same point in time, they cannot help us understand if exposures through routine dietary intake and other exposures related to regulated products preceded diagnosis of adverse health conditions.

Longitudinal data – often collected repeatedly from participants in prospective cohort studies conducted over several years – help to reveal relationships between dietary and environmental exposures and the development of health conditions over time. The FDA Human Foods Program (HFP)/Office of Surveillance Strategy and Risk Prioritization (OSSRP)/Division of Evaluation and Population Health Science (DEPHS)/Epidemiology and Medical Sciences Branch (EMSB) is interested in obtaining such longitudinal data from the ongoing President and Fellows of Harvard College/Harvard School of Public Health (HSPH) longitudinal studies:

Nurses’ Health Study original cohort (NHS: ~122,000 participants, since 1976) Nurses’ Health Study II (NHSII: ~116,000 participants, began in 1989) Health Professionals Follow-Up Study (HPFS: ~100,000 men, since 1986) Growing Up Today Study (GUTS: children of NHS participants, including 16,882 girls and boys; since 1996) Growing Up Today Study 2 (GUTS2: children of NHSII participants, including 10,923 girls and boys; since 2004)

Analyses of longitudinal data from these studies will help monitor diet and lifestyle risk factors, allow for scientific evaluation of potential causal links between these factors and chronic disease incidence, and enhance understanding of individual and intergenerational relationships between dietary intake, lifestyle exposures, and chronic conditions/long-term health effects throughout the lifespan, among parents and offspring, including evaluating grandmother-maternal-child outcomes. This information will help the FDA improve dietary policy and consumer education to protect and promote public health. Please see attched SOW.

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