Presol_Notice_SHS_Coordinating_Center_2.pdf

Pre-Solicitation Notice

Type: Pre-Solicitation Notice Number: 75N92026R00010 Title: Strong Heart Study (SHS) – Coordinating Center 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 a Coordinating Center to serve as part of the renewal of the program titled “Strong Heart Study”. This acquisition will designate a coordinating center to oversee new data collection from the existing cohort of participants and baseline data from newly recruited participants and maximize previously collected data and samples to address new questions about the development and progression of clinical cardiovascular disease and related conditions across the lifespan. The purpose of this announcement is to provide a Pre-solicitation Notice for the release of Solicitation No.

75N92026R00010. THIS NOTICE ADDRESSES THE COORDINATING CENTER 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 more than 35 years of follow-up. Data on risk factors; lifestyle (diet, physical activity, etc.); cardiac mailto:john.lear@nih.gov https://strongheartstudy.org/ 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 result in a single contract award for a Strong Heart Study Coordinating Center, with potential subcontracts, as needed, to accomplish the technical requirements for the expansion of the study. THIS PRE-SOLICITATION NOTICE ADDRESSES THE COORDINATING CENTER ONLY. It is anticipated that one (1) award may be made on or about November 15, 2027 for a period of ten (10) years.

Objectives The objective of this proposed acquisition is to designate a coordinating center to oversee new data collection and maximize previously collected data and samples, to address new questions about the development and progression of clinical CVD and related conditions across the lifespan.

The SHS renewal will continue novel epidemiologic research in CVD and related heart, lung, blood, and sleep diseases in Native American (NA) populations, serve as a resource to the scientific community for future research, promote HLBS health in NA communities, and encourage research capacity building in these communities.

The scientific objectives are to: (1) investigate the high risk of cardiovascular disease and related conditions in these populations; (2) enable investigations of new risk factors or interactions among factors that inform disease pathophysiology; and (3) enhance statistical power to perform analyses of predictors of clinical events. The operational objectives are to: (1) continue to foster scientific collaborations; (2) maintain the existing and new data and biospecimen repositories to enable their use in the testing of new research hypotheses; (3) support the SHS field centers to conduct limited clinical examinations of the Legacy Cohort study participants as a platform for independently-funded ancillary study examination components; (4) support the SHS field centers in recruitment, a limited clinical examination, and ascertainment activities of the New Cohort; (5) support the SHS field centers in Tribal/community engagement activities; (6) produce and disseminate research findings to scientific and lay communities; and (7) support training of junior investigators, especially NA investigators.

The focus for this requirement will be to identify clinical events among surviving Legacy Cohort SHS participants and participants recruited as part of the new expanded SHS study (New Cohort), and to support scientific collaborations and data analysis. There will also be an emphasis on Tribal/community engagement activities to communicate health information and promote participant and community satisfaction with the SHS. Support for two (2) basic follow-up examinations for the Legacy Cohort and one baseline examination of the New Cohort during the contract cycle will be included. The components of the basic core examinations will include the following: recruitment, informed consent, blood pressure and anthropometry measurements, phlebotomy and spot urine for key lab analytes (serum lipid profile, plasma glucose, whole blood HbA1c,serum albumin, and urinary creatinine and albumin) and sample storage for future research use, and questionnaires to update personal and medical history and questionnaires on sleep, social determinants of health and psychosocial factors, current medications use. Other measures may be included for the Legacy and New Cohorts based on community interests and feedback, given budgetary considerations.

Project Requirements

The important overall technical requirements associated with this proposed acquisition for the Strong Heart Study Coordinating Center include the following:

1. If necessary, perform an orderly, secure, and efficient transition of all SHS activities, data, documents and other materials, in collaboration with the incumbent Contractor. (Task Area A)

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

3. Obtain Tribal/community review and approval of Coordinating Center activities as required in the form of Tribal resolutions of support or equivalent documents. (Task Area A)

4. Facilitate meetings and communications among SHS collaborating investigators and staff, partnering communities, consultants, and the NHLBI Project Office as necessary throughout the contract period. (Task Area A)

5. Implement, distribute to all field centers, and maintain a data management system. (Task Area A)

6. Prepare documentation for data to be distributed to and used by approved investigators, per guidelines mutually approved by Tribal/community partners and NIH, and with appropriate protections for participant privacy and assuring that only qualified investigators have access.

(Task Area A)

7. Distribute research-ready data (after completion of data cleaning and QC) to SHS investigators and other approved users (e.g., non-SHS collaborating investigators with approved paper proposals). (Task Area A)

Ramos, Melissa (NIH/OD) [C] @Puggal, Mona (NIH/NHLBI) [E] Language needs to be refined.

8. Upon approval from Tribal/community partners and in cooperation with the NHLBI, prepare datasets and associated documentation for submission to an agreed upon repository. (Task Area A)

9. Comply with all relevant Tribal/community and NIH policies (applicable to all Task Areas).

10. Provide services, as necessary, to enable regular follow-up contacts of participants by Field

Centers. (Task Area A)

11. Provide services, as necessary, to enable abstraction of data from medical records, death certificates, other relevant materials; expert review of potential clinical events; and classification thereof. (Task Area A)

12. Obtain Medicare claims data for SHS cohort members who are Medicare-eligible to facilitate continuing surveillance efforts in the SHS. (Task Area A).

13. Coordinate the study’s quality control and assurance activities. (Task Area A)

14. Provide statistical oversight and programming, conduct statistical analyses, and prepare scientific publications and presentations. (Task Area A)

15. Participate in and support the SHS Publications and Presentations Committee. (Task Area A)

16. Submit abstracts and manuscript proposals for presentation and publication to Tribes and the

Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals. (Task Area A)

17. Arrange for and maintain biorepository services for existing and future SHS biological specimens. (Task Area A)

18. Establish and manage an image repository of previously collected and any future images. (Task

Area A)

19. Arrange for, attend, and manage meetings of an NHLBI-appointed Observational Studies

Monitoring Board (OSMB) as directed by the NHLBI Project Office. (Task Area A)

20. Perform administrative duties to support productive collaboration among the study personnel at all SHS centers, outside researchers’ collaborations with SHS, and the NHLBI Project Office.

21. Support activities to promote participant and Tribal/community satisfaction with the SHS. (Task

Area A)

22. 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)

23. Assist Field Centers in development and implementation of an annual short-term summer research immersion program (up to 3 weeks long) for high school students from participating Tribes/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)

24. Mentor and provide formal and/or informal training opportunities for at least twenty junior and early career investigators, fellows, and students. (Task Areas A)

25. Provide formal and/or informal training opportunities for at least twenty community members in the Coordinating Center’s geographic region regardless of whether affiliated with the study.

26. Provide technical support for data and/or biospecimen preparation and distribution activities for approved requests for research activities by community members, junior and early career investigators, fellows, and students. (Task Area A)

27. Support re-examination of SHS Legacy Cohort participants, including developing and maintaining a data collection system for Phase VIII and Phase IX. (Task Areas B and D)

28. Support recruitment and a clinical examination of a New Cohort, including developing and maintaining an electronic data collection system for a clinical exam. (Task Area C)

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

30. Prepare and submit technical and financial reports and monthly invoices. (Task Areas A, B, C, D, and E)

Anticipated Period of Performance

The Government intends to negotiate one (1) contract award, 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.