Statement of Work 75N95022Q00357.pdf

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

STATEMENT OF WORK FOR SERVICES

GENERAL INFORMATION

Title of Project:

HANDLS longitudinal homocysteine assays Statement of Need and Purpose:

Homocysteine is an intermediate metabolite produced by several physiological biochemical pathways. Homocysteine is a known toxic metabolite, particularly in the cardiovascular and nervous systems. Elevated levels of total homocysteine have been implicated as a significant risk for cardiovascular disease. There is also accumulating evidence that elevated total homocysteine is associated with accelerated age-associated cognitive decline and perhaps as a risk for Alzheimer’s disease. There is also evidence that elevated total homocysteine is associated with neuropathies in older adults.

It is known that men have generally greater homocysteine levels than women. It is also known that homocysteine increases with age in older adults. However, it is not known whether there are differences in homocysteine levels by age, sex, race, poverty status, and their interactions. Health disparities in cardiovascular disease and cognitive decline may be associated with differences in homocysteine levels over time.

Inadequate homocysteine metabolism is usually due to insufficient consumption of folate and B12. Fortunately, most causes of hyperhomocysteinemia are treatable by administering folate and B12 vitamin supplementation. However, it is unclear whether treatment is sufficiently adequate for everyone regardless of age, sex, race, or socioeconomic status.

Background Information and Objective:

The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study examines changes in health associated with disparities due to race and socioeconomic status.

Presently in the 7th wave of data collection, HANDLS established a longitudinal biomaterials bank of frozen blood serum and plasma for which participants have consented to further biological study in every wave in which they were examined. HANDLS has accumulated sufficient frozen samples to adequately address questions surrounding issues in health disparities associated with total homocysteine levels. These questions include, but are not limited to, examining changes over time in homocysteine levels by age, sex, race, poverty status, and their interactions; examining whether the relationships among B12, folate, and homocysteine levels are consistent regardless of age, sex, race, and poverty status; examining whether the risk for cardiovascular diseases such as hypertension, myocardial infarction, and stenotic blood vessels are associated with homocysteine regardless of age, sex, race, and poverty status; and examining the association of homocysteine with existing measures of neurological and brain health.

The objective of this requirement is to acquire the services of an established laboratory with a CLIA-approved method for assaying homocysteine in frozen blood samples. To avoid introducing biases in these assay levels, it is crucial to assay all the samples from all the waves using the same methodology and the same time. This avoids contaminating the data with "batch" effects in which there are statistical differences due to the assay method but not due to actual changes over time or due to differences to participants' demographic backgrounds.

Period of Performance:

September 23, 2022 – September 22, 2023

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:

A CLIA-approved clinical laboratory shall perform homocysteine assays on frozen blood provided by the Government.

Based on statistical considerations, the Government has determined that 2,500 samples are required to perform the purposes of this solicitation. This number of samples is based on considerations of statistical power for the envisioned longitudinal analyses.

GOVERNMENT RESPONSIBILITIES

The Government will supply frozen blood samples in sufficient quantity and in a manner mutually acceptable to the Contractor that is consistent with Federal requirements for shipment of biomaterials.

DELIVERY OR DELIVERABLES

The Contractor shall provide homocysteine values for all samples provided by the Government in an electronic file. In addition, the Contractor shall supply technical details demonstrating reliability and accuracy of the homocysteine assays performed including information on quality controls as well as information on methods to use in future publications. Following electronic data delivery and upon request by the Government, the Contractor shall participate in Government laboratory meetings to provide technical consultations as needed regarding the delivered data. The Contractor shall also return any remaining sample material to the Government that is consistent with Federal requirements for shipment of biomaterials.

REPORTING REQUIREMENTS

None required. The deliverables serve as the interim and final project reports.

OTHER CONSIDERATIONS

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.