Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study – Expansion Cohort

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 the necessary steps to design a longitudinal cohort study within the Southern Plains region of the U.S. to serve as an expansion of the existing contract program titled “Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study cohort.  The National Heart, Lung, and Blood Institute (NHLBI) intends to expand the footprint of RURAL to increase representation of the U.S. rural population within the study.  This expansion cohort will identify up to four (4) rural counties in the Southern Plains region using rurality criteria comparable to the original cohort in the RURAL Heart and Lung study.  The selected counties should be demographically representative of the targeted area of the rural Southern Plains region, with enrollment targets that will enable valid inferences across key continuous and dichotomous factors of risk and resilience with respect to key population subgroups.  Where feasible, counties should be selected to mirror and enhance the ecological design of RURAL higher risk and lower risk counties with respect to cardiopulmonary outcomes; secure suitable mobile examination unit(s) (semi-trailer, customized RV, etc.) to conduct a clinical examination of participants that is comparable in scope to the baseline clinical examination conducted in the RURAL Original cohort; conduct cohort follow-up to ascertain health status and accrue cardiovascular and pulmonary events for the purpose of assessing progression from subclinical disease to clinical disease in a manner identical to the RURAL Original cohort; establish and maintain data and biospecimen repositories, enabling their use to test new ancillary study hypotheses (adding new ancillary study data and biospecimens as they become available); and engage the communities within the selected RURAL Expansion counties to facilitate recruitment and retention of study participants and to understand and work to improve the overall health of the communities.  THIS NOTICE ADDRESSES THE EXPANSION COHORT OF THE EXISTING RURAL HEART AND LUNG STUDY ONLY.  It is anticipated that one (1) award may be made on or about May 2027 for a period of four (4) years and four (4) months. 

The Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study was initially funded as a Cooperative Agreement (U01HL146382), with the first Notice of Award being issued on May 2, 2019.

The initial recruitment goal of the RURAL Heart and Lung Study (https://theruralstudy.org) was to enroll a cohort of 4,600 participants, ages 25-64, in the rural Southeastern U.S. to better understand the health of those living in rural, underserved communities.  The design of RURAL utilizes a mobile exam unit (MEU) to enroll and examine participants in six (6) high risk, and four (4) low risk, rural Southeastern counties in Alabama (AL), Mississippi (MS), Louisiana (LA), and Kentucky (KY).  Enrollment in MS (2 counties), LA (2 counties), and KY (4 counties) have an ecological paired design, in that rural counties at high risk for cardiopulmonary outcomes are paired with counties at lower risk based on county level demographic profiles.  In AL, both counties are at high risk as demographically similar lower risk counties were not found.  Key components of the baseline exam include the following:  anthropometry, biospecimen collection, behavioral/medical/demographic assessments, gated cardiac CT, inspiratory and expiratory chest CT, pulmonary function testing, Echocardiography, and an mHealth component that includes a smartphone with an embedded RURAL app, a Fitbit, and suite of questionnaires to comprehensively characterize Social Determinants of Health (SDoH).

The RURAL Heart and Lung Study was renewed in 2026 as a 5-year contract (Contract No. 75N98026D00018) to conduct a second comprehensive examination in previously enrolled participants, as well as prospectively follow participants through annual follow-up contacts and ascertainment of heart and lung events of clinical significance.

Objectives

The objective of this proposed acquisition is to designate a study coordinating center to provide the necessary expertise, solicit appropriate sub-awards, and manage relevant activities to carry out the necessary functions to achieve the overall objectives of the program.  

The scientific objectives are to:  (1) recruit and examine participants in rural, underserved areas in the U.S. Southern Plains region to further enhance understanding of risk factor progression or identify potential factors of resilience with respect to cardiopulmonary health; (2) provide sufficient statistical power to perform analyses of biological, social, and behavioral predictors of subclinical disease or risk factors within relevant population groups defined by sex and race and ethnicity; (3) study the progression of subclinical to clinical CVD and pulmonary complications; and (4) identify new risk factors or interactions among factors that inform disease pathophysiology.  

The operational goals are to:  (1) support the key study infrastructure including community level recruitment and retention for the optimizing participant clinical examinations, a data management center, support cohort follow-up and data collection on clinical events; (2) provide to the RURAL Expansion communities lay reports based on data collected during the expansion cohort baseline examination that summarize key findings to enhance awareness of health conditions, inform participants and communities of the relationship of risk factors to disease, and promote healthy behaviors; (3) provide for maintenance of a data repository (adding new ancillary study data as they become available) and biospecimen repositories and integration of data resources with the RURAL Original cohort baseline materials to facilitate their use to test new hypotheses; and (4) foster scientific collaborations in particular among early career investigators.

Project Requirements

The important overall technical requirements associated with this proposed acquisition for the expansion cohort of the existing RURAL Heart and Lung Study include the following:

1.   Develop and maintain a web-based data collection system and provide other services as necessary to enable regular follow-up contacts of participants through geocoded updates of addresses. (Task Area A)

2.    Conduct regular follow-up contacts with participants. (Task Area A)

3.   Develop and maintain a web-based data collection system and provide other services as necessary to investigate participant's self-report of clinical events by collecting supporting medical records, death certificates, and other relevant materials; perform abstraction of data from such records required for events ascertainment; and conduct expert review and classification thereof. (Task Area A)

4.    In collaboration with the program office, identify a minimum of two (2) and maximum of four (4) rural counties within the U.S. Southern Plains region using criteria comparable to the identification of the rural counties in the RURAL Original cohort study design. Population sampling within the identified counties should be broadly representative of the population groups of the targeted region.  Recruitment targets should permit comparisons of key cardiopulmonary risk or resilience factors by key demographic groups. (Task A)

5.   Procure appropriate mobile examination unit(s) for a clinical examination of enrolled participants.  Solicit proposals from potential vendors, establish criteria for evaluation of proposals and oversee the procurement process.  Secure insurance to provide reasonable coverage protecting from losses due to theft, weather related damage, and damage from unforeseen acts.  Ensure appropriate and reasonable liability insurance. Establish a maintenance program utilizing spare parts and local contractors to minimize any loss of time for participant examinations. (Task Areas A, B)    

6.    Design and implement appropriate quality assurance and quality control programs with particular attention to minimize manual entry of participant data. (Task Areas A, B)

7.   Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all supported Institutions, outside researchers, and collaborations with RURAL Original cohort investigators, and the NHLBI Project Office. (Task Area A)

8.   Establish and maintain study databases.  This shall include database activities as needed for recruitment and enrollment of expansion cohort participants, participant tracking and audit logs, recording and tracking participant informed consent, recording measures from participant survey responses, procedural tests performed on the mobile exam unit, and newly ascertained events, mHealth components, and ancillary studies both for internal use and for posting on BioData Catalyst (BDC) (https://biodatacatalyst.nhlbi.nih.gov/ ) and other NIH databases, such as dbGaP (http://www.ncbi.nlm.nih.gov/gap ), as appropriate and according to NIH/NHLBI applicable Data Sharing Policies (see https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing ). (Task Areas A, B, C)

9.    Maintain and support a biological specimen repository. (Task Areas A, B)

10. Coordinate and participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for access to data and materials, and an approval process for proposed manuscripts and ancillary studies that is fair and balanced. (See Appendix 2 below for details of the various study committees.) (Task Areas A, B)

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

12. Conduct statistical analyses and prepare scientific publications and presentations. (Task Areas A, B)

13. Provide statistical oversight and programming, and conduct analysis and data verification for collaborative publications with the RURAL Expansion investigators and the NHLBI Project Office. (Task Area A)

14. Prepare and submit technical and financial reports. (Task Area A)

15. Perform activities related to study closeout as directed by the NHLBI Project Office. (Task Area C)

16. Work cooperatively with all study investigators and staff, the NHLBI Project Office, and any subcontractors and consultants in all relevant aspects of the study. (Task Areas A, B, C)

17. Mentor early-stage investigators by providing formal and/or informal training opportunities for junior or less experienced investigators (assistant professors, fellows, and doctoral/medical students). (Task Area A)

Anticipated Period of Performance

The Government intends to negotiate one (1) contract award, for the potential period of four (4) years and four (4) months, with an approximate award date on or around May 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 75N98026R00074.

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 75N98026R00074 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 27, 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).