Pre-Solicitation Announcement-Lung Health Cohort.pdf

Pre-solicitation Notice

Type: Pre-Solicitation Notice Number: 75N92026R00008 Title: Study Coordinating Center for the Lung Health Cohort Study Classification Code: A – Research & Development NAICS Code: 541715, Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology).

Posted Date: April 16, 2026 Primary Point of Contact: Lynn Furtaw, Contracting Officer, Lynn.Furtaw@nih.gov

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6705 Rockledge Dr RKL2, Bethesda, MD, 20892-7902, United States

Introduction The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Study Coordinating Center (SCC) for The Lung Health Cohort Study. The purpose of this announcement is to provide a Pre-solicitation Notice for the release of Solicitation 75N92026R00008. THIS IS A SYNOPSIS. THIS IS

NOT A SOLICITATION.

Background Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States, yet the complexity and chronic nature of the disease have made it difficult to understand and treat. Thus far, pulmonary physicians and respiratory researchers define respiratory health as the absence of lung disease. This simplistic definition has limited the development of a robust approach to the prevention of lung disease. Because of the absence of adult life-course studies focused primarily on lung health, the intermediate phenotypes of impaired lung health (which exist on a continuum between ideal lung health and lung disease) have not been well-defined. There is a critical need to identify modifiable risk factors and biomarkers for impaired lung health that will allow clinicians to recognize impaired lung health and intervene before chronic lung disease develops. There has been a national level infrastructure of the American Lung Association’s (ALA) Airways Clinical Research Centers (ACRC) which has formed the first national cohort of adults focused on respiratory health.

The Lung Health Cohort (LHC) is a longitudinal study that will enroll up to 4,000 community-dwelling adults aged 25 -35 years from 17 metropolitan regions across the United States. The study was designed to examine a large cohort of healthy young adults to better define and characterize the constructs of “ideal” versus “impaired” lung health. The study is currently supported through a single NHLBI cooperative agreement (U01), first awarded in 2019 and expected to end in early 2027, which supports the LHC study coordinating center. The cooperative agreement supports study enrollment, data coordination, human subjects regulation, imaging oversight, environmental surveillance, and other functions.

Study procedures for the baseline visit include physical assessment, spirometry, chest computed mailto:Lynn.Furtaw@nih.gov tomography (CT) scan, accelerometry, and collection of nasal epithelial lining fluid, nasal epithelial cells, blood, and urine. Additionally, medically related participant questionnaires are being recorded such as sociodemographic characteristics, home address histories and exposures, work history and exposures, medical histories, lung health, and health behaviors and activity. While baseline visits are ongoing, the full cohort of 4,000 participants is expected to have been enrolled and complete a baseline visit by early 2027 under the current cooperative agreement.

Objectives The objective of this acquisition is to procure the services of a study coordinating center to support the continuation of LHC. The contractor shall complete a second in-person visit of the full LHC cohort, to be completed approximately five years after the baseline visit, as well as other data to be collected remotely, all to be conducted through the ACRC network. Data and biospecimens shall be assessed for quality, stored, analyzed, and distributed as appropriate. Finally, the study shall be managed in a manner consistent with NIH and NHLBI policies with oversight from a single Institutional Review Board (IRB) and an NHLBI-managed Observational Study Monitoring Board (OSMB). The objective of this contract is to exploit the unique characteristics of the LHC to clarify how potential factors might alter ideal lung health and increase risk for future diseases such as chronic obstructive pulmonary disease.

Project Requirements

Services to be performed include:

Task Area One – Program Management: The contractor shall facilitate the management of study personnel, data, and biospecimens to enable achievement of study goals.

1. Organize residential, school and occupational address histories, which will be used to enable geocoding. Geocodes will be used to link relevant exposure data to each participant, including such exposures as elemental carbon, organic carbon, nitrogen dioxide, atmospheric particulate matter, ozone, proximity to greenspace, census-tract level indicators of neighborhood socioeconomic position, and local daily temperature.

2. Evaluate the quality of CT scans collected during study visits. Analyze data of images collected during baseline and follow-up study visits.

3. Analyze LHC data to address the major scientific goals of the study, generate study manuscripts, and publish in peer-reviewed journals. Overall, this work is expected to result in at least one peer-reviewed publication per year throughout the contract period. Provide statistical analytical support to study investigators within limits of resources provided by the Data Coordinating Center (DCC).

4. Perform statistical analyses and power considerations.

5. Communicate with a designated and approved single IRB to obtain approval for the main study protocol and ancillary studies, as well as to report adverse events and other deviations as specified by NIH policies.

6. Schedule, plan, and organize annual meetings and ad hoc meetings as directed of an

Observational Study Monitoring Board (OSMB), consisting of between 4 and 7 members. Provide compensation to OSMB members. Provide expedited reporting to the OSMB of serious unexpected adverse events and unanticipated problems as defined and required by NHLBI policies. Provide annual reports to the OSMB of study progress, including enrollments and visit completions, adverse events, protocol deviations, data quality and timeliness, presentations, publications, and major study findings. (The NHLBI Adverse Event (AE) and Unanticipated Problem (UP) Reporting Policy describes the procedures for identifying, monitoring, and reporting adverse events and unanticipated problems (http://www.nhlbi.nih.gov/funding/policies/adverse.htm).

7. Oversee general study management using a Data Coordinating Center, and Imaging Core, an Environmental Core, and other study centers and cores, as approved by NHLBI.

8. Establish and manage committees as needed for study governance. These may be organized through the ACRC network.

9. Travel to and register for domestic and international scientific meetings to discuss and present study data.

10. Travel to conduct study site visits and training, as needed.

11. Oversee a data repository with quality control of study data. The data repository shall implement data science methods, standards, and defined metadata that are consistent with NHLBI recommendations.

12. Provide quality control checks of data submitted from the clinical centers, and work with the clinical centers to correct errors. Collect and store in the data repository newly collected data, including data from study Visits, long-tern follow up contacts, environmental monitoring, and biospecimen analyses. Incorporate ancillary study data into the contract study data according to NIH and NHLBI policies. Provide appropriate data quality control.

13. Maintain a biospecimen repository for Lung Health Cohort biospecimens. This repository will store biospecimens under conditions established by protocol to minimize degradation over time and will employ backup systems to ensure preservation of biospecimens in the event of power losses. Distribute biospecimens to investigators for approved ancillary studies.

14. Transport biospecimens to an NHLBI-approved biorepository upon study conclusion.

15. Comply with NHLBI Data Management and Sharing Policies, including the NHLBI

Supplement to the NIH Policy for Data Management and Sharing (this can be found at https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing). Compliance will involve regular deposition of all available cleaned study data and ancillary study data to an NHLBI-approved scientific data repository such as NHLBI’s BioData Catalyst. The schedule of data deposition will be mutually agreed upon by the contractor and NHLBI, but is expected to be approximately once per year. Data sets shall include documentation of data formats and study procedures.

16. Provide regular progress reports to NHLBI that include enrollment and retention rates of Lung Health Cohort participants, in person and telephonic visit completion rates, data completeness, data quality measures, numbers of manuscripts and publications, numbers of funded ancillary studies, and number of Early Stage Investigators funded to conduct ancillary studies.

http://www.nhlbi.nih.gov/funding/policies/adverse.htm).

https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing

17. Establish a study website that is 508-compliant within 6 months of contract award.Maintain and update the website throughout the contract period. The study website will include:

a. A description of the LHC study

b. A description of available data, how to request data, and how to propose ancillary studies.

c. A description of available biospecimens and the procedures for requesting and obtaining approval for obtaining biospecimens.

d. Links to any current study policies, as appropriate.

18. Comply with the NIH Public Access Policy To that end, the Contractor shall do so for any manuscript that arises from any direct funding from the contract. For more information, see NOTOD-08-033 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 08033.html) and the Public Access website (https://publicaccess.nih.gov/).

19. Comply with all other NHLBI and NIH policies.

Task Area Two – The contractor shall use the ACRC network to complete a five-year follow-up exam and remote follow-up data collection of the Lung Health Cohort.

1. Complete an in-clinic follow-up exam of up to 4000 Lung Health Cohort participants.

Visits will be scheduled approximately five years after each participant’s baseline visit.

This visit will be conducted according to an NHLBI-approved protocol and will include the key data listed below. Some subjects may refuse some aspects of the visit but may still be considered to have a complete visit. Study visits shall be conducted through the ACRC network and may include (as defined by NHLBI-approved protocol):

a. Physical assessment (e.g. height, weight, resting heart rate, blood pressure)

b. Spirometry

c. Pregnancy testing in participants of child-bearing potential

d. Chest CT scan (to be transferred to a central Imaging Core)

e. Questionnaires (including but not limited to: contact information, address history, demographics, lung health, substance use, environmental and occupational exposures, medication use, medical history, activity, sleep, social elements, nutrition)

f. Nasosorption strip collection

g. Nasal epithelial curettage

h. Phlebotomy

i. Urine collection

2. Process biospecimens collected at baseline exam (blood, nasal epithelial cells, and urine.)

Each sample will be labeled with a unique bar code that includes no health information but can be linked to the participant ID.

3. Ship biospecimens to ACRC study biorepository for long-term storage. Biospecimens collected under this contract will be the property of the United States Government.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08033.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08033.html https://publicaccess.nih.gov/

4. Collect data remotely on the full Cohort. Remote data collection will be according to an NHLBI-approved protocol and may include (as defined by NHLBI-approved protocol):

a. Home spirometry

b. Actigraphy monitoring

c. Activity log

d. Vaping log

5. Collect remote follow-up data on up to 4000 Lung Health Cohort participants every 3 to 6 months (up to four times a year) during which participants may be asked to (as defined by NHLBI-approved protocol):

a. Update contact information

b. Complete additional assessments related to topics from the in-person visit

c. Complete additional assessments related to health events

d. Schedule a coached at-home spirometry session, to be completed at a later date

6. Contact study participants via telephone or internet to collect additional information if deemed necessary by the approved study protocol or by NHLBI.

Anticipated Period of Performance The Government intends to negotiate an IDIQ contract for the potential period of six (6) years with an approximate award date of March 1, 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 will be available in SAM.gov no sooner than 15 calendar days of posting this notice.