Attachment-SOW Reasons for Geographic and Racial Difference in Stroke (REGARDS).pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Reasons for Geographic and Racial Difference in Stroke (REGARDS)

Statement of Need and Purpose:

Large-scale DNA extraction capabilities are required for the Center for Alzheimer’s and Related Dementias (CARD) to execute genotyping of over 13,000 samples from the REGARDS project.

Background Information and Objective:

The Government has identified REGARDS, which is a national cohort study that enrolled 30,239 Black and White adults across the continental US in 2003-7 to understand stroke prevalence in the United States. The University of Vermont Laboratory for Clinical Biochemistry Research designed and led conduct of biosample collection, contains the biosample repository, and is the REGARDS central analysis laboratory. The Government intends to perform a genome-wide association study (GWAS) to better understand the genetic basis underlying stroke prevalence in the United States. Data from these studies will be made available through the Alzheimer’s Disease Work Bench (ADWB).

Period of Performance:

August 1, 2022 - July 31, 2024

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

Specific Requirements:

The Contractor shall complete DNA extraction following the protocol from the Qiagen Puregene DNA Purification Kit. The Contractor shall complete selection of the 14,333 samples to be extracted and evaluation of frozen packed cell sample availability in the REGARDS repository, followed by sample pull from the repository in batches. Additionally, the Contractor shall execute manual DNA extraction using Qiagen reagents. The Contractor shall also complete DNA quantification by PICO green. The Contractor shall be responsible for creation of cryovials of DNA for REGARDS repository, creation of tracking inventory for these DNA samples, and preparation of 1 ug or more DNA per sample at a concentration of 50 ng/uL or greater and shipment to CARD facilities.

LEVEL OF EFFORT:

The Contractor shall provide expertise and execute the extraction, quantification, storage, shipping, handling, and plating of DNA samples.

GOVERNMENT RESPONSIBILITIES

The Government will provide resources for genotyping data, data access to harmonized data within CARD, and data science resources.

DELIVERY OR DELIVERABLES

The Contractor shall provide extracted DNA samples to CARD after extraction has been completed. The Contractor shall also provide the DNA quantification results to the Government and identify any samples for which extraction failed.

REPORTING REQUIREMENTS

The Contractor shall provide a progress report quarterly during the contract period through email. The progress report shall include the number of samples that have had DNA extracted and timelines for when future samples are expected to be extracted. This report shall also include a description of any problems encountered and whether these issues were resolved.

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the Contractor’s work site. Travel for contractor employees will not be necessary.

Key Personnel:

Contractor will provide a dedicated project manager to the Government as a point of contact for the services.

Information System Security Plan:

Not Applicable

Data Rights:

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Confidentiality of Information: