D_Statement of Work.pdf

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK - SOW

GENERAL INFORMATION

Title of Project:

Multi-Center Assessment of Precision Nutrition Proteomic Biomarkers of Health and Aging in Clinical Biofluids – Proteomic Essays.

Statement of Need and Purpose:

The purpose of this requirement is to utilize a discovery-based proteomics platform in archived plasma samples collected in the Nutrition for Precision Health Study and examine individual responses to diet across the human lifespan.

Background Information and Objective:

Whether individual responses to different diets is affected by age has never been rigorously studied in a large study population in a highly controlled experimental design. Given the unique dietary needs of individuals depending on age, it is anticipated that molecular signatures of a dietary response, as well as the clinical outcomes, will vary depending on participant’s age and also depending on variables measured by other centers (i.e. the microbiome). Therefore, it will be critical to identify proteomic and multi-modal biomarkers that identify, predict, and evaluate response to diet. Previous data have identified proteomic signatures associated with healthy aging and senescence burden across the lifespan. Others have shown the lifestyle interventions, including both diet and exercise, can reduce markers of senescence burden and senescence-associated secretory phenotype (SASP) over a period of weeks. Therefore, the aim to utilize a proteomic platform to identify which diets can reduce molecular signatures of aging in 872 plasma samples from the Nutrition for Precision Health Study, and give the researchers insight into molecular signatures of dietary responses and outcomes.

Period of Performance:

The period of performance will be 08/30/23 – 07/31/2026.

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 – Perform discovery-based proteomic assays on approximately 872 human plasma samples from the Nutrition for Precision Health cohort to identify proteomic signatures that predict clinical responses to diet and dietary challenges across a span of ages. The contractor shall use the aptamer-based assay to measure levels of approximately 7,000 proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases. The assay should require approximately 100 microliters of plasma or serum and allow hundreds of assays to be run in apreallel 96-well plates. The contractor shall use a modified aptamer-based reagent comprised of synthetic single-stranded DNA sequences with protein-like appendages that bind to specific target proteins. The data will be combined with data previously analyzed with SomaLogic technology. Therefore, the single-stranded DNA SOMAmer reagent should then be quantifiable by hybridization to a custom DNA microarray containing probes complementary to the SOMAmer sequences.

LEVEL OF EFFORT:

Senior researcher or technical researcher.

GOVERNMENT RESPONSIBILITIES

The government shall provide adequate quantities of archived plasma samples to the contractor to enable the performance of the proteomic assays detailed above.

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files incuding quantitative measurement of all proteins assayed in the provided plasma samples and relevant quality control metrics (including specimen usage, assay coefficients of variation, assay success/failure rates, normalization process) as well as an electronic copy of a report summarizing the laboratory methods and technical specifications used.

REPORTING REQUIREMENTS

The contractor shall submit via e-mail as PDF or a MS Word document a progress report during the contract period. The progress report shall include tasks completed and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

The key personnel requirements for the senior or technical researcher are as follows:

• A Masters or PhD in a laboratory science field.

• Extensive experience in high throughput lab methods.

Information System Security Plan:

N/A

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables.

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 the contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW. However, all reports and deliverables shall be submitted electronically and, shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can befound at: https://www.hhs.gov/web/section-508/index.html and at: https://www.section508.gov/create/documents,"Create Accessible Documents."

Publications and Publicity:

N/A

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.