Presol_Notice_SHS_New_Cohort.pdf

Pre-Solicitation Notice

Type: Pre-Solicitation Notice Number: 75N98026R00073 Title: Strong Heart Study (SHS) – New Cohort of Native American (NA) Adults Classification Code: A – Research & Development NAICS Code: 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology).

Posted Date: October 15, 2026 Response Date: October 30, 2026 Primary Point of Contact: Jonathan Lear, Contracting Officer, john.lear@nih.gov

Contracting Office Address Department of Health and Human Services, National Institutes of Health, Office of Acquisition and Logistics Management (OALM), Research and Development and Professional Services – Division B, 6701 Rockledge Drive, RKL2, Bethesda, MD 20817 UNITED STATES.

Introduction The National Heart, Lung, and Blood Institute (NHLBI) is seeking to designate Field Centers (FCs) to establish a new population-based cohort to address key population gaps in the health of Native Americans (NAs) and to enhance understanding of the leading causes and risks of heart, lung, blood, and sleep (HLBS) conditions in NA populations. This proposed acquisition represents a strategic expansion of the existing Strong Heart Study (SHS) program and its prior research infrastructure—rather than a continuation of existing efforts—to establish a new epidemiologic cohort that will ensure the long-term scientific viability, relevance, and continuity of the SHS research. The purpose of this announcement is to provide a Pre-solicitation Notice for the release of Solicitation No. 75N98026R00073. THIS NOTICE ADDRESSES THE EXPANSION COMPONENT

FOR THE FIELD CENTERS ONLY. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

Background The Strong Heart Study (SHS) is a long-running longitudinal observational study of two (2) combined cohorts followed prospectively: the original SHS cohort recruited in 1989 to 1991, and a Strong Heart Family Study (SHFS) cohort recruited in 1998 to 1999. The original and family cohorts together form the largest, multicenter, prospective epidemiological study of cardiovascular disease (CVD) in American Indians (AIs). The study’s main objective is to examine the etiology and natural history of cardiovascular disease in AIs.

Overall, there have been seven (7) phases of the study, with each phase corresponding to a multi-year project period. The current phase (Phase VII) is funded for the period from 2019 to 2027 and is comprised of a clinical exam, in addition to infrastructure support, morbidity and mortality surveillance, data analysis, and dissemination activities. More information about the SHS can be found on the SHS website: https://strongheartstudy.org/.

The SHS has collected deep phenotyping data from its participants over six (6) clinical exams and mailto:john.lear@nih.gov https://strongheartstudy.org/ more than 35 years of follow-up. Data on risk factors; lifestyle (diet, physical activity, etc.); cardiac structure and function; vascular, pulmonary and gall bladder function; CVD events; and causes of death are available for approved research and community use. Genetic data are also available for approved community and research use.

In addition to generating a wealth of data on CVD and other disorders in AIs, the SHS features many accomplishments. These include: 1) publication of more than 500 medical and scientific articles; 2) support for approximately 45 young AI investigators and students; 3) establishment of risk prediction algorithms and guidelines for use by Indian Health Service and other health care providers; 4) elucidation of the role of diabetes in CVD; 5) discovery of the importance of albuminuria as a marker for CVD in AIs; 6) identification of higher than expected prevalence of cardiac enlargement among AI youth; and 7) stimulation of a large number of independently funded ancillary studies (~25) that have greatly increased the understanding of a variety of risk factors for CVD. Also noteworthy are the high retention rates during the exams and the low levels of loss to follow-up. Participant contacts for surveillance of all deaths and all nonfatal CVD events have been continuous, with little loss to follow-up.

This proposed acquisition will designate up to five (5) contract awards for Field Centers (FCs) under the Strong Heart Study program, with potential subcontracts, as needed, to accomplish the technical requirements. THIS PRE-SOLICITATION NOTICE ADDRESSES THE EXPANSION COMPONENT FOR THE FIELD CENTERS ONLY. It is anticipated that up to (5) awards may be made on or about November 15, 2027, each for a period of ten (10) years.

Objectives The objective of this proposed acquisition is to designate multiple Field Centers (FCs) to establish a new population-based cohort to address key population research gaps in the health of Native Americans (NAs) and to enhance understanding of the leading causes and risks of heart, lung, blood, and sleep (HLBS) conditions in NA populations. The FCs shall collaborate with a separately procured Coordinating Center responsible for study coordination, data management, and statistical support. This cohort will enable the enrollment, initial examination, and follow-up activities of NA participants. The cohort will have an overall proposed target sample size across all sites of up to 5,000 NA participants, with preference for a younger generation cohort with the final age range agreed upon in partnership with participating communities and the NHLBI. The clinical exam will begin only after a phase of trust building and community engagement to determine the needs and interests of the community, including designing the recruitment and eligibility plans. The clinical exam will serve as a baseline for future phases of the study and is expected to include core elements as implemented in other National Heart, Lung, and Blood Institute (NHLBI) cohort studies.

The scientific objectives are to: (1) examine participants to identify and measure initial resilience and risk factors that inform disease pathophysiology and (2) provide a reference point to measure changes in future clinical examinations and to identify new exposures and to track disease progression. The operational objectives are to: (1) establish a cohort of NA adults, with no less than 1000 participants in each field site; (2) conduct a baseline clinical examination of enrolled participants; (3) establish field center/site infrastructure including activation of community sites; (4) support Tribal community engagement activities by fostering partnerships with community representatives and stakeholders, including Tribal leaders; (5) increase research capacity in Tribal communities and support training of junior investigators, especially NA investigators; (6) produce and disseminate research findings to scientific and lay communities; and (7) foster scientific collaborations by serving as a platform for independently-funded ancillary study examination components.

The new cohort will serve as a platform for in-depth ancillary studies that may be funded outside of the study contracts. These ancillary studies, if funded, will be operationally integrated into the main study, and the data will be shared across both types of studies, after data sharing policies are established and implemented. Data obtained from clinical exams and/or ancillary studies will be shared with qualified investigators through a defined process that encourages maximum data utilization but ensures data sovereignty and protects participant and Tribal community confidentiality. Tribal governance and decision-making processes will be prioritized within the design and conduct of research.

Awards made under this proposed acquisition will support a milestone-driven planning phase, including Tribal engagement activities. Proposals are also expected to include plans for project management, including participation in the development of common protocols, including those for participant recruitment, data collection, and follow-up contacts.

Project Requirements

The important overall technical requirements associated with this proposed acquisition for the Strong Heart Study New Cohort of NA Adults include the following:

1. Coordinate and attend a kick-off meeting, to be held virtually, with the NHLBI Project Office and the Contracting Office. (Task Area A)

2. Obtain Tribal/community reviews and approvals of the planned research in the form of resolutions of support, memoranda of understanding, or equivalent documents. (Task Area A)

3. Support community engagement activities by fostering partnerships with community representatives and stakeholders, including community leaders. (Task Area A)

4. In collaboration with the other Field Centers (FCs) and with approval of the Steering Committee, convene and maintain a Community Advisory Board (CAB). The CAB’s charge shall be to advise the study centers on aspects that impact participants and Tribal communities. (Task Area A)

5. Implement a program to support community-based pilot research projects that align with the scientific mission of the NHLBI. These pilot studies must be conducted within the Native communities of the Field Center. This will represent a non-severable Subtask to Task Area A and will be issued as four (4) task orders, each for an estimated period of performance of 2.5 years, for a total potential duration of 102 months for community-based pilot research projects to increase research capacity. (Task Area A, Subtask A1)

6. Develop and administer an annual short-term summer research immersion program (up to 3 weeks) for high school students from participating Tribal communities. This activity aligns with the NHLBI mission of strengthening community engagement, research capacity and implementation science capacity. This will represent a non-severable Subtask to Task Area A and will be issued as ten (10) task orders, each for an estimated period of performance of 12 months, for a total potential duration of 120 months. (Task Area A, Subtask A2)

7. Organize, attend, and manage one of five (5) Community Symposiums during the contract period for Tribal/community leaders and/or representatives. (Task Area A)

8. Provide formal and/or informal training opportunities for at least twenty junior and early career investigators, fellows, and students. (Task Area A)

9. Provide formal and/or informal training opportunities for at least twenty community members in the Field Center’s geographic region regardless of whether affiliated with the study. (Task Area A)

10. Participate collaboratively in the Steering Committee (SC) and other appropriate study committees to develop and implement a coordinated plan to achieve the study objectives.

(Task Area A)

11. Provide materials for and attend meetings of an NHLBI-appointed Observational Studies Monitoring Board (OSMB) as directed by the NHLBI Project Office. (Task Area A)

12. Participate actively in data analysis, presentation, and publication. (Task Area A)

13. Establish and implement morbidity and mortality surveillance policies and procedures. (Task

Area A)

14. Facilitate quality control and quality assurance programs in conjunction with the clinical exam and cohort follow-up, as well as with the appropriate committees. (All Task Areas)

15. Perform administrative, operational, and technical duties to support productive collaboration among the study personnel, outside researchers collaborating with the study (e.g., ancillary study investigators), and the NHLBI. Ensure that all web-based systems designed under this contract meet the requirements of Section 508 of the Rehabilitation Act. (All Task Areas)

16. Prepare and submit technical and other reports and monthly invoices. (All Task Areas)

17. Develop the study design, the protocol for the examination, and policies and procedures (such as recruitment, communication planning, and performance monitoring) for the baseline examination. (Task Area B)

18. Conduct staff training and certification and shall plan and coordinate pilot testing for the examination. (Task Area B)

19. Conduct a baseline examination of all recruited and enrolled participants. (Task Area B)

20. Work collaboratively with the Coordinating Center (CC) and the Steering Committee (SC) on post-exam activities. (Task Area B)

21. If deemed necessary by the Government, perform activities related to the study closeout or center transition activities. (Task Area C)

Anticipated Period of Performance

The Government intends to negotiate up to five (5) contract awards, for the potential period of ten

(10) years, with an approximate award date on or around November 15, 2027.

This is not a Request for Proposal (RFP), and the Government is not committed to award a contract pursuant to this announcement. The RFP is expected to be posted to the Government-wide Point of Entry at SAM.gov approximately 15 calendar days after the date of this notice.

This date is subject to change.