President and Fellows of Harvard College/Harvard School of Public Health Continuing Access to Harvard Longitudinal Survey Data (HFP-OSSRP-26-C-3187; Periods of Performance: Base Year, FY26, 9/30/2026-9/29/2027;

Option Year 1, FY27, 9/30/2027-9/29/2028)

FDA HUMAN FOODS PROGRAM

STATEMENT OF WORK

Title: Continuing Access to Harvard Longitudinal Survey Data

1. Purpose

The purpose of this requirement is to acquire U.S. population longitudinal data and specialized analytic support to help address the U.S. Food and Drug Administration’s (FDA’s) needs for scientific evidence on dietary intake and other exposures related to regulated products, and health outcomes over time.

2. Background

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.

3. Objective or Base Year FY26 and Option Year FY27

The objective is to acquire and analyze adequately granular U.S. population longitudinal survey data to advance understanding of relationships between dietary intake and other exposures related to regulated products, and health outcomes, as in the activities described below and in other activities HFP identifies during the Base Year FY26 and Option Year FY27 to address emerging and changing public health needs and priorities.

The goals and expectations regarding this objective may include, but not be limited to addressing, the following questions and/or aims:

• For novel and dietary supplement products and/or ingredients that HFP identifies of concern, what are the usage patterns and behaviors, characteristics/factors, and outcomes by population subgroup (sex/age, including children, adolescents, young adults, and women of childbearing age) and potential intergenerational effects?

- What behaviors are associated with use of products of concern?

- What intake practices are associated with use of products in these categories? (Example:

can we determine what intake presents health issues: high, multiple, concomitant, potentially interacting?)

- What are the associations between maternal intake of products in these categories and pregnancy and offspring outcomes? (Examples: gestational diabetes, preeclampsia, pre-term birth, pregnancy loss at different intakes among users compared to non-users?)

- What is the association of grand-maternal lifestyle and dietary exposures during pregnancy with BMI and risk of being overweight or obese in offspring by adopting a three-generation study design?

- What are the differences in physiological, developmental, and biochemical outcomes between formula-fed, breast-fed infants, and mixed-fed infants, including details about formula type, volume of intake and relevant data?

- What are the associations between offspring growth, weight, and pubertal development trajectories among those born to mothers who use these products during pregnancy (at different intake levels) compared to non-users?

- What is the prevalence and incidence (where possible) of outcomes reported with use of products in these three categories?

- What are the kidney, liver, cardiovascular, allergies, and other outcomes of concern among users compared to non-users (prevalence and incidence where possible)?

- What are the products and outcomes of concern by sex/age, intake patterns, behaviors, and other population subgroup factors?

• For HFP-regulated product hazard and nutrient exposures (e.g., chemicals, toxic elements, and others, such as caffeine, sweeteners/sugars, fats, and pesticides) and for other emerging public health needs as HFP determines of priority to investigate, including but not limited to the following:

- What are the dietary intake patterns for consumption of foods containing exposures of interest by population subgroup (sex/age, including children, adolescents, young adults, and women of childbearing age)?

- What patterns of consumption of foods containing the exposures of interest are associated with higher vs. lower risk of cancers and other diseases over time, by population subgroup (sex/age, including children, adolescents, young adults, and women of childbearing age)?

- What other behaviors and exposures, including but not limited to tattooing and cosmetics use, modify or interact with exposures of interest through dietary intake?

- Among different population subgroups, are tattoo exposures related to health outcomes?

- How have intakes of hazardous exposures and protective nutrients (e.g., iron, selenium, zinc) changed over time by population subgroup?

- What are the associations between maternal hazardous and protective nutrient exposures and pregnancy outcomes? (Examples: gestational diabetes, preeclampsia, pre-term birth, pregnancy loss.)

- What are the associations between maternal hazardous and protective nutrient exposures and offspring outcomes? (Examples: offspring growth, weight, and pubertal development trajectories.)

- How has dietary intake related to allergy outcomes changed over time by population subgroup?

- What are the patterns and correlates of exposure and outcomes related to emerging products (such as, but not limited to, novel foods, probiotics, nootropics, and hallucinogens) among population subgroups (by sex/age, including children, adolescents, young adults, women of childbearing age, women during pregnancy)?

• For cannabidiol (CBD) and tetrahydrocannabinol (THC) (cannabis), the goals and expectations regarding the objective of this effort shall include, but not be limited to, addressing the following aims:

- Aim 1. Characterize participants who report using cannabis products: stratify by product type (CBD-only or THC-containing), demographics (age, locality, socioeconomic status), route of administration, diet, health conditions, physical activity, dietary supplement use, medications (including hormone replacement therapy), tobacco/alcohol use, cannabis product use patterns (frequency, route of administration, history), and other variables/outcomes as the data allow.

Compare demographics, route of administration, diet, health conditions, physical activity, dietary supplement use, medications (including hormone replacement therapy), tobacco/alcohol use, and other variables/outcomes as appropriate with participants who report no use of cannabis products (stratifying by never-users and previous-users as the data allow).

Investigate within-group differences by product type(s) used, frequency of use, route of administration, and history of cannabis use.

- Aim 2. Explore cannabis-related health effects, including measures of sleep health, mental health, memory, health condition prevalence, and other conditions and outcomes, and relationships between cannabis use/co-use with tobacco and temporal characteristics, by menopausal status (e.g., pre-, peri- post-menopause) as the data allow, including evaluating effects on natural onset of menopause.

- Aim 3. Explore cannabis-related health effects among reproductive-age women over 18 years, including measures of sleep health, mental health, memory, health condition prevalence, and other conditions and outcomes as the data allow, by cannabis use characteristics among reproductive-aged women.

The work to be accomplished will support HFP’s mission by providing scientific evidence to help inform decision making for policy matters and regulatory activity, as well as consumer health protection, promotion, and education. The tasks are consistent with established epidemiological science and methods.

The results will be used in collaboration with and in support of HFP nutrition, dietary supplement, food safety/security, education, and outreach staff and efforts.

4. Scope

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW).

5. Specific Tasks for Base Year FY26 and Option Year FY27 The same Specific Tasks 5.1 through 5.5 below shall be carried out for the Base Year FY26 and Option

Year FY27:

5.1. Task 1 – Kick-off Meeting

The Contractor shall conduct a kick-off meeting with the Contracting Officer Representative (COR) fourteen (14) business days from the effective date of award, including providing a project plan identifying specific research questions to be addressed for the year, milestones for each task, roles and responsibilities, and timeframes/deadlines.

5.2. Task 2 – Itemized Timelines/Monthly Progress Reports

The Contractor shall develop and provide monthly progress reports to include itemized timelines and budgets by research question (described in the Objectives section) to organize and track costs and progress, allowing time for iterative discussion and refinement by HFP staff members.

5.3. Task 3 – Questionnaire Data

The Contractor shall identify and extract questionnaire data available from HSPH prospective cohort studies relevant to each of the specific analyses pursued, including case data appropriate for the analyses and related exposure distributions (with power calculations).

5.4. Task 4 – Specialized Analytic Support

The Contractor shall provide specialized analytic support, including, but not limited to, advising on data handling and statistical approaches to optimally address each research question, as well as making available appropriate contractor personnel needed by HFP.

5.5. Task 5 – Co-author Summaries/Publications

The Contractor shall co-author summaries/publications/presentations on findings from analyses for publication after appropriate clearance.

6. Deliverables for Base Year FY26 and Option Year FY27

The same Deliverables shall be carried out for the Base Year FY26 and for Option Year FY27 if exercised. In addition to the deliverables listed in the table below, the Contractor shall engage in ongoing dialogue by telephone and email with the Project Officer and designated HFP members.

Deliverables Table for Base Year FY26 and Option Year FY27

Deliverable

SOW

Task

Deliverable Title Quantity Frequency Required Format Due Date Recipient

1 5.1 Kick-off meeting One kick-off meeting including project plan identifying specific research questions to be addressed for the year, milestones for each task, roles and responsibilities, and timeframes/deadlines

Once Contractor format acceptable

14 business days (2 weeks) from the start of the performance period for each year

PO/COR

2 5.2 Itemized timelines and budgets, with monthly reports for tracking progress and costs by each research question addressed, allowing time for iterative discussion and refinement by HFP staff members

1 per research question addressed

Monthly updates

Contractor format acceptable

30 business days (1 month) after date of award

PO/COR

3 5.3 Exposure, outcome, and other important questionnaire data determined appropriate from each prospective cohort by research question/aim

To be determined in consultation with

HFP

As analyses require

SAS or Excel acceptable

60 – 90 business days (2 to 3 months) after date of award

PO/COR

4 5.4 Specialized analytic support

To be determined in consultation with

HFP

As analyses require

Microsoft Word, SAS, and Microsoft Excel acceptable

4 – 7 months after date of award

PO/COR

5 5.5 Collaboration on development and co- authoring of summaries and/or publications with appropriate clearance by FDA/HFP and other appropriate FDA management

At least 1 per research question addressed

Monthly to bi-monthly

Microsoft Word and other media files acceptable as needed by publication format

8 – 12 months after date of award

PO/COR

7. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or

GFI)

N/A

8. Contractor-Provided Special Material Requirements

N/A

9. Security

In executing this contract, the Contractor shall hold a non-public position involving the lowest potential risk level with the lowest degree of adverse impact on the efficiency of the Agency. The Contractor shall not have access to Government-sensitive information or access to the FDA’s network and will not require undergoing the badging process.

10. Travel

The Contractor shall not perform local or long-distance travel to execute the contract.

11. Other Considerations

All publications generated by this project are the property of the FDA and shall not be disclosed to any third party without the Project Officer’s express written consent.

12. Place of Performance

The work described under the requirement shall be done at the contractor’s site.

13. Holidays and Government Closures

The Contractor is not required to provide services on the following Federal holidays or on any other day designated as a Federal holiday:

New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

In the event that the Federal government closes because of inclement weather, or by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or in the event that the Agency, the Center, or the building closes for administrative or safety reasons, the Contractor is not required to provide service. The Contractor shall not bill the Government for any hours not worked due to any closure.

14. Period of Performance

The period of performance is for one (1) Base Year and (1) Option Year, with the following Periods of Performance: Base Year, FY26 (9/30/2026 to 9/29/2027); Option Year 1, FY27 (9/30/2027 to 9/29/2028.

15. Points of Contact

Project Officer:

André O. Markon, PhD, MPH (T: 240.402.3738/734.846.3951/andre.markon@fda.hhs.gov) Epidemiology and Medical Sciences Branch Division of Evaluation and Population Health Sciences Office of Surveillance Strategy and Risk Prioritization Human Foods Program U.S. Food and Drug Administration 5001 Campus Drive Harvey W. Wiley Building (CPK1) Mail Code HFS-014 College Park, MD 20740-3835

16. Points of Contact

Contracting Officer Representative:

Beverly J. Wolpert, PhD, MS (T: 240.402.2113/828.974.1730/beverly.wolpert@fda.hhs.gov) Epidemiology and Medical Sciences Branch Division of Evaluation and Population Health Sciences Office of Surveillance Strategy and Risk Prioritization Human Foods Program U.S. Food and Drug Administration 5001 Campus Drive Harvey W. Wiley Building (CPK1) Mail Code HFS-014 College Park, MD 20740-3835