D. Attachment 1 - Statement of Work.pdf

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

STATEMENT OF WORK (SOW)

(SERVICES)

GENERAL INFORMATION

Title of Project:

Single Extracellular Vesicle Analysis from HANDLS participants

Statement of Need and Purpose:

The purpose of this acquisition is to purchase the single extracellular vesicle (EV) analysis service. The service includes EV sample preparation, imaging and analysis from Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) participants.

Background Information and Objective:

The DNA Repair Unit (DRU) hypothesizes that differences in extracellular vesicle (EV) morphology, size and cargo contribute to health disparities in age-related diseases. The DRU also hypothesizes that there will be different EV protein levels and morphology for participants who acquire chronic kidney disease in the HANDLS cohort. This analysis includes EV sample preparation and imaging on a Single-molecule localization microscopy (SMLM) system, computation of EV size and morphology, analysis the molecular profiles and differences of the EVs across different surfaces. The contractor will perform quality controls assessments. This specialized analysis is state of the art in the field and requires limited volumes of extracellular vesicles, which is critical since HANDLS plasma samples are limited and have high research significance.

Period of Performance:

The period of performance is from 12 months ARO (After Receipt of Order).

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 image and analyze plasma extracellular vesicles from 30 samples provided by the government. Specifically the contractor shall:

EV surface capture TMIX (CD9 + CD81 + CD63)

EV Sample imaging: EV sample preparation and imaging on an SMLM system

EV size and morphological analysis: EV size distributions will be computed for each sub-population and morphologies

EV quality assurance: Based on EV morphologies and noise signal produce a measure of quality of EVs

EV population analysis: Analyze the molecular profiles and differences of the EVs across the different surfaces

LEVEL OF EFFORT:

N/A

GOVERNMENT RESPONSIBILITIES

The government will provide the extracellular vesicle samples to the contractor.

DELIVERY OR DELIVERABLES

The contractor will provide the following deliverables in a mutually acceptable electronic format which preserves the security of the data (e.g., secure file transfer (sFTP)):

In-depth Analysis Reports and Comparative Study: Produce an in-depth analysis report with data visualizations and insights comparing EV samples between Pre- and Post- CKD across the entire sample, and between 3 subgroups: Race, Sex and Poverty

EV images: Selection of high resolution images of EVs will be provided

A description of the methods used appropriate for possible future publication

The contractor will make themselves available for a phone or video meeting to discuss the data and methods an answer any questions.

REPORTING REQUIREMENTS

Reporting requirements are not applicable.

OTHER CONSIDERATIONS

Travel:

Key Personnel:

Information System Security Plan:

Data Rights:

The National Institute on Aging 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:

Publications and Publicity:

Confidentiality of Information: