REGARDS DNA Extraction and Quantification

Title: Notice of Intent to Sole Source – REGARDS DNA Extraction and Quantification Notice ID: NIH-NOI-PCA-NIA-01601 Department/Ind. Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier: NATIONAL INSTITUTES OF HEALTH Office: NATIONAL INSTITUTE ON AGING Active Contract Opportunity Notice Type: Special Notice Original Published Date: June 11, 2026 Original Response Date: June 23, 2026, 11:00 AM Eastern Time Initiative: None Classification Original Set Aside: N/A Product Service Code: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets NAICS Code: 541380 – Testing Laboratories and Services Place of Performance Primary Place of Performance: University of Vermont Laboratory for Clinical Biochemistry Research Colchester Research Facility 360 South Park Drive, Room 224 Colchester, VT 05446 United States Description This is a Notice of Intent to Sole Source and is not a request for competitive proposals, quotations, or bids. The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute on Aging (NIA), Center for Alzheimer’s and Related Dementias (CARD), intends to negotiate and award a sole source firm-fixed-price contract to: University of Vermont Laboratory for Clinical Biochemistry Research Colchester Research Facility 360 South Park Drive, Room 224 Colchester, VT 05446 The purpose of this requirement is to obtain specialized laboratory support services for the Reasons for Geographic and Racial Difference in Stroke (REGARDS) project. The contractor shall perform DNA extraction, DNA quantification, repository handling, preparation, and shipment of extracted DNA samples for approximately 12,000 REGARDS participant biospecimens in support of a genome-wide association study (GWAS). The contractor shall: Evaluate frozen packed cell sample availability in the REGARDS repository; Select and pull samples from the repository in batches; Perform manual DNA extraction using the Qiagen Puregene DNA Purification Kit; Perform DNA quantification using PicoGreen; Create cryovials of DNA for the REGARDS repository; Create and maintain tracking inventory for extracted DNA samples; Prepare 1 ug or more DNA per sample at a concentration of 50 ng/uL or greater; Ship extracted DNA samples to CARD facilities; Provide DNA quantification results to the Government; and Identify any samples for which extraction failed. The anticipated period of performance is July 1, 2026 through June 30, 2029. The statutory authority for this sole source acquisition is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The University of Vermont Laboratory for Clinical Biochemistry Research is the only known source capable of meeting the Government’s requirement because it designed and led the biosample collection effort for the REGARDS study, maintains the REGARDS biosample repository, serves as the REGARDS central analysis laboratory, and has custody of and access to the proprietary, unique, and non-replaceable REGARDS participant biospecimens required for this effort. Although other commercial laboratories may provide general DNA extraction and quantification services, no other source is known to possess the proprietary REGARDS starting samples or repository access required to perform this requirement. This notice is not a solicitation. However, any responsible source that believes it is capable of meeting the Government’s requirement may submit a capability statement demonstrating its ability to satisfy the requirement described herein. Responses must clearly demonstrate the offeror’s capability to provide access to the proprietary REGARDS biospecimens and repository services, as well as the required DNA extraction, quantification, handling, and shipment services. All capability statements received by the response date and time will be considered by the Government. A determination by the Government not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. No solicitation document is available. The Government will not reimburse respondents for any costs associated with submission of capability statements. Attachments/Links None at this time. Contact Information Primary Point of Contact Linda Smith Contracting Officer linda.smith2@nih.gov Secondary Point of Contact Danielle Tines Procurement Technician danielle.tines@nih.gov