REGARDS DNA Extraction and Quantification

Statement of Work (SOW) / Performance Work Statement (PWS)

The objective is to perform large-scale DNA extraction for over 12,000 samples from the Reasons for Geographic and Racial Difference in Stroke (REGARDS) project to support a genome-wide association study (GWAS).

• Execute DNA extraction following the Qiagen Puregene DNA Purification Kit protocol.

• Select 12,000 samples from the REGARDS repository and evaluate frozen packed cell availability.

• Pull samples from the repository in batches.

• Perform manual DNA extraction using Qiagen reagents.

• Quantify DNA using PICO green.

• Create cryovials of DNA for the REGARDS repository.

• Create a tracking inventory for the DNA samples.

• Prepare at least 1 ug of DNA per sample at a concentration of 50 ng/uL or greater.

• Ship prepared DNA to CARD facilities.

• Provide expertise and execute extraction, quantification, storage, shipping, handling, and plating of DNA samples.

• Deliver extracted DNA samples to CARD.

• Provide DNA quantification results to the Government.

• Identify any samples for which extraction failed.

• Submit quarterly progress reports detailing DNA extraction status, timelines for future extractions, and any encountered problems and their resolutions.

• Period of Performance: July 1, 2026 – June 30, 2029

• Place of Performance: Contractor's work site. Travel for contractor employees will not be necessary.

• Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities.

• Contractor will provide a dedicated project manager.

• Contractor shall comply with Section 508 of the Rehabilitation Act.

Notice of Intent to Sole Source

This document is a Notice of Intent to Sole Source, not a request for competitive proposals. 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 firm-fixed-price contract to the University of Vermont Laboratory for Clinical Biochemistry Research for 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. Specific tasks include:

• Evaluating frozen packed cell sample availability.

• Selecting and pulling samples from the repository.

• Performing manual DNA extraction using the Qiagen Puregene DNA Purification Kit.

• Performing DNA quantification using PicoGreen.

• Creating cryovials of DNA and maintaining tracking inventory.

• Preparing samples at a concentration of 50 ng/uL or greater.

• Shipping extracted DNA samples to CARD facilities.

• Providing DNA quantification results.

• Identifying samples with extraction failures.

• Contract Type: Firm-fixed-price.

• Anticipated Period of Performance: July 1, 2026, through June 30, 2029.

This is not a solicitation. However, interested sources may submit a capability statement demonstrating their ability to meet the requirement. Responses must clearly demonstrate capability to provide access to 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 (June 23, 2026, 11:00 AM Eastern Time) will be considered.

• Original Set Aside: N/A.

• The acquisition is being conducted under the statutory authority of 41 U.S.C. 3304(a)(1) and FAR 6.302-1 (Only One Responsible Source).

• The University of Vermont Laboratory for Clinical Biochemistry Research is identified as the only known source capable due to its design and leadership of the biosample collection, maintenance of the repository, role as the central analysis laboratory, and custody/access to proprietary biospecimens.

• No solicitation document is available.

• The Government will not reimburse respondents for costs associated with capability statement submissions.

• Attachments/Links: None at this time.

• Primary Point of Contact: Linda Smith, Contracting Officer (linda.smith2@nih.gov).

• Secondary Point of Contact: Danielle Tines, Procurement Technician (danielle.tines@nih.gov).