Strong Heart Study (SHS) – New Cohort of Young Native American (NA) Adults

Introduction

This Sources Sought Notice is for interested small businesses.  This notice is NOT a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation is available at this time.  The purpose of this notice is to obtain information regarding:  (1) the availability and capability of qualified small business sources; (2) whether small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran- owned; woman-owned; or small disadvantaged; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.  The NAICS Code for this acquisition is 541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology).  Small business organizations must have their size status certified by the Small Business Administration.  An organization that is not considered a small business under NAICS code 541715 should not submit a response to this notice.

Background

The Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as Community Field Centers 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.  THIS NOTICE ADDRESSES THE EXPANSION COMPONENT FOR THE COMMUNITY FIELD CENTERS ONLY.  It is anticipated that up to five (5) awards may be made on or about August 2027 for a period of ten (10) years. 

The Strong Heart Study (SHS) is a 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.  The study’s main objective is to examine the etiology and natural history of cardiovascular disease in American Indians.  Overall, there have been seven (7) phases of the study, with each phase corresponding to a multi-year project period.

In Phase I, the original SHS recruited 4,549 participants without regard to disease status from 13 tribes and communities in three (3) geographic regions in the US:  Oklahoma (OK), Arizona (AZ), and North and South Dakota (DA).  The original cohort was comprised of 4,549 unrelated participants that were examined three (3) times from 1989 to 1999 (once each in Phases I through III).  The Strong Heart Family Study (SHFS) was initiated to complement the original SHS by investigating the heritability of CVD and its risk factors.  A pilot family study was successfully conducted in Phase III, with the full-scale SHFS study (with expanded participant recruitment) beginning in Phase IV.  A total of 3,790 participants from 94 multigenerational families were recruited in the full-scale SHFS and were examined twice (once each in Phases IV and V).  Phase VI was funded for the period from 2013 to 2018.  The current phase (Phase VII) is funded for the period from 2019 to 2027.  More information about the SHS can be found on the SHS website: https://strongheartstudy.org/.

Objectives

The objective of this proposed acquisition is to designate Clinical or Community 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.  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 ~4,000 young adult participants.  The clinic exam will follow 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 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 baseline exam will serve as a platform for qualified researchers to propose investigator-initiated ancillary studies via independent funding mechanisms to enhance the number of baseline exam components.  Centers will conduct community engagement activities and will serve as a resource for training new and early-stage investigators, especially NA researchers.  One of the major focus areas of the funding is to improve research capacity in the communities that participate.

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 new population-based cohort of the SHS include the following:

1. Establish a new cohort of ~4,000 young adults across all field center (FC) sites through the development of collaborative partnerships with Tribal communities and stakeholders.  There are no restrictions regarding Tribal affiliation of recruited participants.
2. Obtain Tribal reviews and approvals of planned research in the form of Tribal resolutions of support, Memoranda of Understanding, or equivalent documents.
3. Establishment of the Field Center (FC) staffing infrastructure, including activation of clinical community sites and empaneling a Community Advisory Board/Group.
4. Development of communication plans to conduct regular community engagement activities and events, promote health education and healthy behaviors and provide updates on study progress and outcomes.
5. Development and approval of standardized study protocols in collaboration with the Steering Committee (SC), including preparation of required consents (including Tribal and participant); harmonized clinic forms (including translations as needed); questionnaires to capture lifestyle and health behaviors; biospecimen collection, storage, and management; and plans for the analysis of blood and urine.
6. Conduct pilot studies to refine and optimize common protocols.
7. Successful conduct of baseline interview and examination of all recruited study participants (physical, clinical, demographic, nutritional, and behavioral).
8. Completion of quality control, quality assurance, and data harmonization activities in conjunction with the Coordinating Center (CC).
9. Annual follow-up contact with participants to update contact information and health status with a brief standardized questionnaire.
10. Work collaboratively with the Coordinating Center (CC) and the Steering Committee (SC) on post-exam activities, including:

1. Identifying and reporting clinical events (participant morbidity and mortality surveillance).
2. Development and distribution of findings from the exam in the form of lay summaries for the study participants; Tribal leaders and communities; and research manuscripts/publications for advancing policy and scientific knowledge.

1. Provide a platform for testing innovative hypotheses via ancillary studies funded by mechanisms outside of the study contracts.
2. Train the next generation of Native serving scientists.

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 August 2027.

Capability Statements – How to submit a response

Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer.  The capability statements must specifically address each project requirement separately. Additionally, the Capability Statement should include:  1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including computer equipment and software; 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 5) any other information considered relevant to this program.  The Capability Statement must not exceed 15 single-sided or 7.5 double-sided pages in length and use a 12-point font size minimum.  

Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration.  The Government requests that no proprietary or confidential business data be submitted in response to this notice.  However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only.  Capability Statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives.  Capability Statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive.  When submitting this information, please reference the Sources Sought Notice number 75N98026R00073.

Point of Contact

John Lear, Contracting Officer, Research and Development (R&D) NHLBI Branch, R&D and Professional Services – Division B, Office of Acquisition and Logistics Management (OALM), Office of the Director, NIH; Phone:  (301) 827-7716; E-mail:  john.lear@nih.gov

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.

Information Submission Instructions

Interested parties shall submit capability statements via electronic mail and must reference the Sources Sought Notice number 75N98026R00073 in the subject line of the e-mail submission.  

The due date for receipt of capability statements is 3:00 p.m. Eastern Standard Time (EST) on May 26, 2026.  All responses must be received by the specified due date and time in order to be considered.

Capability statements shall be submitted electronically to the designated Contracting Officer and Contract Specialist as follows:

John Lear, Contracting Officer:  john.lear@nih.gov

Melissa K. Ramos, Contract Specialist:  melissa.ramos@nih.gov

This notice does not obligate the Government to award a contract(s) or otherwise pay for the information provided in the response.  No proprietary, classified, confidential, or sensitive information should be included in your response.  The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.  Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.  Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to  respondents with respect to any information submitted.  After review of the responses received, pre-solicitation and solicitation notices may be published in SAM.gov.  However, responses to this notice will not be considered adequate responses to a solicitation/Request for Proposal (RFP).