fhs_pre_solicitation_notice_of_intent.pdf

Pre-solicitation Non-competitive Notice of Intent Synopsis

Type: Pre-Solicitation Notice Number: 75N92024R0245 Title: Framingham Heart Study (FHS) Classification Code: A – Research & Development NAICS Code: 541715, Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology).

Is this a Recovery and Reinvestment Act Action: No Posted Date: January 29, 2024 Response Date: February 12, 2024 Primary Point of Contact: Elizabeth Bulger

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME).

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR subpart 6.302-1.

The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Boston University for the Framingham Heart Study (FHS). It is anticipated that one award will be made around February 2025 for a period of seven years. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITAION.

BACKGROUND AND PROGRAM OBJECTIVES

The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) plans to renew the Framingham Heart Study (FHS). This acquisition will continue the FHS from February 1, 2025 through January 31, 2032. The overall aim of this renewal is to continue the FHS as a scientific resource for the research community to expand knowledge about the determinants of health and disease in heart, lung, blood, and sleep disorders. The overall goals of this acquisition are to (1) enhance statistical power to perform analyses of predictors of clinical events; (2) study the progression of risk factors with aging; and (3) identify new risk factors or interactions between risk factors that inform disease pathophysiology and/or disease progression. The operational goals are to (1) continue retention, annual follow-up, and clinical event ascertainment of all FHS study participants; (2) maintain FHS data and biospecimen repositories and facilitate use of FHS data and biospecimens; and (3) conduct a limited clinical examination of the FHS participants as a platform for investigator-initiated ancillary studies.

The FHS is a long-term multigenerational study that aims to identify genetic and environmental factors influencing the development of cardiovascular and other diseases. Examination of over 5,000 residents of Framingham, Massachusetts was initiated in 1948 (this cohort is hereafter referred to as the “Original” participants). About two decades later, the offspring of the Original participants were recruited into the study (hereafter referred to as “Offspring”). This was followed about three decades later by the third generation of original Framingham participants (hereafter referred to as “Generation 3”). In 2003, the New Offspring Spouse (NOS) Cohort began, which enrolled spouses of the Offspring Cohort if they were also parents of Generation 3 participants, to improve statistical power for family studies. In 2009, two minority cohorts (Omni Groups 1 and 2), which had been initiated by study investigators and funded by NIH grants, were integrated into the FHS contract. The designs and timing of the Omni Groups 1 and 2 examinations match those of the Offspring and Generation 3 cohorts, respectively. Except for the Original cohort, each cohort has recently undergone repeat examinations approximately every 6 years.

The aims stated above will be accomplished through one contract by the National Heart, Lung, and Blood Institute (NHLBI). Study protocols will be refined by an Executive Committee.

It is anticipated that one Indefinite Delivery Indefinite Quantity (IDIQ) award with cost reimbursement Task Orders will be made in February 2025 for a period of seven years. The intent is to award Task Order 01 for a twelve (12) month base with five (5) twelve (12) month options for a total of 6 years, see anticipated schedule below.

Periods Anticipated Dates

Base February 1, 2025 – January 31, 2026

Option 1 February 1, 2026 – January 31, 2027

Option 2 February 1, 2027 – January 31, 2028

Option 3 February 1, 2028 – January 31, 2029

Option 4 February 1, 2029 – January 31, 2030

Option 5 February 1, 2030 – January 31, 2031

PROJECT REQUIREMENTS

Throughout the period of performance, the Contractor shall provide appropriate senior personnel with expertise in cardiovascular disease epidemiology, clinical cardiovascular disease, longitudinal studies management, biostatistics, and administrative management. The Contractor shall:

• Develop and maintain a data collection system to conduct event follow-up for morbidity and mortality of Original, Offspring, Generations 3, New Offspring Spouse, Omni 1, and Omni 2 participants.

• Investigate participants’ self-reported clinical events by collecting supporting medical records, death certificates, and other relevant materials; perform abstraction of data from such records required for ascertainment of events; and conduct expert review and classification thereof (the anticipated approximate number of participants expected to be alive in 2025 and thus followed up is approximately 6,000).

• Establish and maintain study databases, including updating the databases with data from newly ascertained events and ancillary studies both for internal use and external use, including for posting to BioData Catalyst (BDC) and other NIH repositories, such as database of Genotypes and Phenotypes (dbGaP), as appropriate.

• Establish and maintain the study’s biospecimen repository and coordinate approved distribution of biospecimens.

• Coordinate and participate collaboratively in study committees to provide a transparent committee process, open access to materials, clear policies for access to data and materials, and an approval process for projects (including research proposals and ancillary studies) that is fair and balanced (See Section IV below for details on committee structure).

• Perform administrative duties to support productive collaboration among study investigators.

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

• Establish and direct appropriate quality assurance and quality control programs.

• Conduct statistical analyses for quality assurance and quality control and, as funding allows, for scientific abstracts, presentations, and publications.

• Conduct a re-examination of FHS Offspring, Generations 3, New Offspring Spouse, Omni1, and Omni 2 participants.

• Develop and implement a procedure for reporting genetics results to FHS participants who have been found to have clinically actionable results from contract-supported testing and conduct the appropriate reporting.

• Perform activities related to study transition or closeout as directed by the NHLBI Project Office.

• Prepare and submit technical and financial reports.

• Work Cooperatively with all study investigators and staff, including the NHLBI intramural Framingham investigators, the NHLBI Project Office, and nay subcontractors and consultants in all relevant aspects of the study.

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 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 the FedConnect web portal (www.fedconnect.net) and reference the FedConnect Pre-solicitation Number 75N92024R0245.

The due date for receipt of statements is 12:00 p.m. Eastern Time on February 12, 2024.

Vendors can register with FedConnect athttps://www.fedconnect.net/FedConnect/default.htm.

Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.p df .

For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800 )899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting.

https://www.fedconnect.net/FedConnect/default.htm https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf

Pre-solicitation Non-competitive Notice of Intent Synopsis