D_SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

DNA methylation sequencing using the Illumina MethylationEPIC array for Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) participants.

Statement of Need and Purpose:

Investigators in the HANDLS study require DNA methylation sequencing to examine whether changes in DNA methylation patterns in African Americans and whites contribute to observed health disparities in obesity and chronic kidney disease. A contract is required because the Government does not have available facilities or personnel to perform this work.

Background Information and Objective:

Health disparities in age-related chronic conditions such as obesity and chronic kidney disease (CKD) are well documented. Importantly, obesity and CKD have been linked to accelerated aging, the risk for age-associated conditions at younger ages than usual. Although epigenetics may contribute to observed health disparities, there are limited studies in the racial and ethnic minority populations most affected by obesity and CKD. The objective of this work is to examine health disparities associated with obesity and CKD through DNA methylation sequencing using the Illumina MethylationEPIC array to investigate the contributions of epigenomics to the disproportionate burden of disease incidence, prevalence, morbidity, and mortality in minority groups within the United States.

Period of Performance:

September 1, 2021 to August 31, 2022

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:

HANDLS investigators require DNA methylation sequencing data on 549 study participants plus 11 contractor-supplied technical controls using the Illumina MethylationEPIC array. The Contractor shall perform sample quality and quantity control metrics, bisulfite conversion of DNA samples, DNA methylation quantification using the Illumina MethylationEPIC array and provide the data in the following electronic data file formats: intensity data file (.IDAT), comma separated values (.CSV), and Excel spreadsheet(.xls). The contractor shall confirm genomic DNA quantity and quality by performing DNA concentration measurements using PicoGreen quantification-based methods and volume checks. The contractor shall perform bisulfite conversion for all samples. The contractor shall sequence the bisulfite-converted sample using the Illumina MethylationEPIC array that covers over 850,000 CpG sites. The contractor shall perform primary analyses of the sequencing data including but not limited to performing quality control and calculating the assay percentage of each probe. The contractor shall provide written summaries and documentation of the methods used to perform the DNA methylation sequencing pipeline.

The contractor shall supply the DNA methylation sequencing data in a mutually acceptable electronic format that preserves study participants’ confidentiality. Following data delivery and upon request by the Government, the contractor shall participate in Government laboratory staff meetings to provide technical consultations as needed.

GOVERNMENT RESPONSIBILITIES

The Government shall provide genomic DNA samples (with a minimum concentration as determined by the contractor) to the contractor for quality control metrics, bisulfite conversion, and sequencing. The Government will load the genomic DNA samples on government-provided 96-well plates.

DELIVERY OR DELIVERABLES

The contractor will provide the following deliverables:

• A report on the concentration of all genomic DNA samples

• A report on the genomic DNA sample integrity and purity

• A summary report outlining any problems from sample quality control metrics

• Eleven (11) control samples to be run with the government-provided samples

• Bisulfite conversion for all samples

• Electronic sequencing data in a mutually agreed upon device that shall contain the raw sequencing data in the intensity data file (.IDAT) format, post-sequencing quality control files analyzed using GenomeStudio, and sample sheet with experiment information in the .xls or .CSV format. These electronic data files will be securely transferred to a portable disk drive and delivered to the Government at the NIH Biomedical Research Center.

• Upon the Government’s request, written summaries and documentation of all methods and parameters used to perform the DNA methylation sequencing pipeline

• Upon the Government’s request, attend staff meetings and provide technical consultations as needed

REPORTING REQUIREMENTS

N/A

OTHER CONSIDERATIONS

Travel:

Travel is not required.

Key Personnel:

N/A

Information System Security Plan:

Data Rights:

The National Institute on Aging (NIA) shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, data updates and statistical results. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.”

FAR clause 52.227-14, “Rights in Data-General, is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

N/A

Confidentiality of Information: