SoleSource Synopsis_75N98026Q00751.pdf

PUBLIC NOTICE OF PROPOSED ACQUISITION

Office of Acquisitions, Office of Management

National Heart, Lung, and Blood Institute

(FAR Subparts 5.101(a)(2))

1. Announcement/Number: 75N98026Q00751

2. Post Date: 07/23/2026

3. Closing Response Date: 07/30/2026

4. Proposed Award Date: 09/22/2026 – 09/21/2027

5. Project Title: Research Coordinator Support Services for NHLBI Novel Structural Heart Intervention Protocols

6. Contracting Office: R&D and Professional Services - Division B, OALM Office of the Director, National Institutes of Health, 6701 Rockledge Drive, Rockledge Building 2, Suite 400, Bethesda, Maryland 20892-7902

7. Contact Point/Contracting Officer/Contract Specialist: John Lear - John.Lear@nih.gov / Andrew Dinh – Andrew.dinh@nih.gov

8. Acquisition Authority: This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2026-01.

9.

10. North American Classification System (NAICS) Code: 561990

11. Small business size standard: $16.5M

12. Classification Code: R499

13. Set-aside Status: None, this is a single-sole source (including brand-name) non-competitive action.

mailto:John.Lear@nih.gov mailto:Andrew.dinh@nih.gov

14. Description: The National Heart Lung and Blood Institute’s (NHLBI) Division of Intramural Research (DIR) has a long history of leveraging resources from partner institutions and medical centers throughout the world to carry out its ground-breaking research. Emory University is a long-time partner of the DIR currently supporting a number of on-going clinical protocols in the area of interventional cardiology.

NHLBI and Emory have entered into a Memorandum of Understanding to develop novel non-surgical catheter-based treatments for heart and valve disease. Emory has unique staff expertise, capabilities, and proven experience in implementing novel catheter-based therapies developed at NHLBI.

The purpose of this contract is to obtain Emory research coordinator support services for clinical research studies sponsored by NHLBI DIR enrolled at Emory University.

15. Statutory Authority:

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1

(b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13— Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

16. Single-sole Source (Including brand-name) Determination:

The determination by the Government to make a single-sole source (Including brand-name) award is based upon the market research conducted as prescribed in FAR Part 10—Market Research, specifically the results of the market research concluded: Emory University is the only source capable of fulfilling the requirements of this acquisition. Emory University is engaged in many long-term clinical trials on behalf of the NHLBI, and this acquisition is to support Emory University's ongoing work. Emory staff are the only physicians in the world capable of performing the investigational VINTAGE procedure. Emory physicians are the co-creators and highest volume operators in the SESAME procedure.

Transfer of this work from Emory University to another institution is not feasible and would greatly disrupt NHLBl's clinical trial network. Furthermore, Emory University will not allow a non-university employee to perform research coordinator support for Emory University's IRB-sponsored trials on-site. For these reasons, no other company or institution is capable of fulfilling the requirements of this acquisition.

17. Closing Statement:

This notice 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 and include:

unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. 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 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 July 30, 2026 at 3:00PM EST. Responses must be submitted via email to the Contract Specialist and Contracting Officer identified above.

“All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”

http://www.sam.gov/