Strong Heart Study (SHS) � Coordinating Center (CC)

Description

INTRODUCTION THIS SYNOPSIS IS A NON-COMPETITIVE NOTICE OF INTENT TO AWARD A MODIFICATION TO INCREASE THE INDEFINITE-DELIVERY/INDEFINITE-QUANTITY (IDIQ) CEILING OF CONTRACT NO. 75N92019D00027 AND EXTEND THE PERIOD OF PERFORMANCE BY NINE (9) MONTHS WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1), as set forth in RFO � Federal Acquisition Regulation (FAR) 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The National Heart, Lung, and Blood Institute (NHLBI) intends to award a modification to Indefinite-Delivery/Indefinite-Quantity (IDIQ) Contract No. 75N92019D00027, facilitating the requirements of the core study operational activities outlined in Task Area A of the Statement of Work (SOW), for the Strong Heart Study (SHS) � Coordinating Center (CC), without providing for full and open competition (including brand-name) to The University of Oklahoma Health Sciences Center (OUHSC). The IDIQ ceiling value for Contract No. 75N92019D00027 will be increased through a modification action to accommodate one (1) additional nine (9) month option period to continue core study operational activities outlined in the Statement of Work (SOW) for the Coordinating Center (CC). It is anticipated that the modification will be issued around January 2027. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. BACKGROUND AND PROGRAM OBJECTIVES The Strong Heart Study (SHS) is the largest, multi-center longitudinal observational epidemiological study of cardiovascular disease (CVD) in Native Americans / American Indians (AI/AN). The study�s primary objective is to examine the incidence and prevalence of CVD in this population, identify genetic, additional risk factors, assess co-morbidities of CVD and monitor morbidity and mortality. Initiated in 1989, the study recruited 4,549 unrelated individuals from 13 tribes and communities across three (3) US regions: Arizona (AZ); North and South Dakota (ND, SD); and Oklahoma (OK). Participants in the original cohort were recruited regardless of their disease status and underwent clinical examinations three (3) times between 1989 and 1999, once in each phase (I through III) of the study. In phase IV (beginning in 1998), a second cohort known as the Strong Heart Family Study (SHFS) was established adding 3,790 individuals from 94 multigenerational families from the original cohort. The SHFS aimed to complement the original SHS and to enhance understanding of the heritability of CVD and its risk factors in AI/AN populations. During phase V of the study, which concluded in 2009, participants received another clinical examination. During phase VI of the study (2013-2018), funding was focused on surveillance activities, data analysis, and infrastructure support. Currently, in phase VII (2019-2027), the SHS is funded for clinical examinations, surveillance activities, and community-based research. For more information about the SHS, please visit the SHS website: http://strongheart.ouhsc.edu/. PROJECT REQUIREMENTS This IDIQ contract supports The University of Oklahoma Health Sciences Center (OUHSC) Coordinating Center in providing administrative, data analytics, and management expertise for the SHS Field Centers as they maintain continued contact with and collect data from the SHS cohort to address new questions about the development and progression of clinical CVD and related conditions. The OUHSC Coordinating Center directly supports the SHS� ability to conduct novel epidemiologic research on CVD and related diseases in this cohort, serves as a resource to the scientific community for future research, promotes cardiovascular health in the local community, and encourages underrepresented minority students to pursue biomedical careers. The scientific objectives are to: (1) investigate the high risk of cardiovascular disease and related conditions in this special population; (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 data and biospecimen repositories to enable their use in the testing of new research hypotheses; (3) support the SHS Field Centers to conduct a limited clinical examination of the study participants as a platform for independently-funded ancillary study examination components; (4) support the SHS Field Centers in Tribal community engagement activities; and (5) support training of junior investigators, especially Native American Indian investigators. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also 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. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract modification action based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically in accordance with the instructions below. �All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.� Submission Instructions: Interested parties shall submit capability statements via electronic mail and must reference the Notice number 75N98026R00115 in the subject line of the e-mail submission. The due date for receipt of responses is 3:00 p.m. Eastern Standard Time (EST) on July 16, 2026. All responses must be received by the specified due date and time in order to be considered. Capability responses 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.