RFQ-Attachment1_Statement of Work-rev.pdf

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Neurodegenerative Disease Research – Whole Genome Sequencing
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75N95024Q00297-RFQ
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This document is a Statement of Work (SOW) and associated Request for Quotation (RFQ) for whole genome sequencing services required by the National Institute on Aging (NIA) for the NIH Intramural Center for Alzheimer's Disease and Related Dementias research program.

The SOW requires the contractor to provide whole genome sequencing of approximately 19,680 human samples over a 4-year period, with an initial base period of 300 samples and four 1-year option periods for additional sample quantities. Sequencing must be performed using Illumina NovaSeq6000 or NovaSeq X Plus platforms, with samples passing initial quality control measures. The contractor must provide the FASTQ raw data to a Google Cloud server within 10 weeks of sample acceptance. The contract will be awarded as a firm-fixed price purchase order, with technical capability, past performance, and price as the evaluation factors. The requirement is set aside for small businesses under NAICS code 621511 (Medical Laboratories), with a size standard of $41.5 million. Responses are due by 5:00 PM EDT on July 10, 2024.

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FAR Part 11—Describing Agency Needs

STATEMENT OF WORK

GENERAL INFORMATION

Neurodegenerative Disease Research – Whole Genome Sequencing

The NIH Intramural Center for Alzheimer’s Disease and Related Dementias is an ambitious program to genotype disease patients and controls around the world to further understand the genetic architecture of Alzheimer’s Disease and related dementias. There is much to learn about genetic risk factors and the path to further understanding requires working collaboratively and openly sharing data, processes, and results.

Whole genome sequencing of disease samples and controls will be fully characterized. Whole genome sequencing services are necessary for Center for Alzheimer’s Disease and Related Dementias to be successful in completing its research project’s aims.

Base Period: August 20, 2024 - August 19, 2025 (QTY of samples = 300) Option Period One: September 1, 2024 - August 31, 2025 (QTY of samples = 4795) Option Period Two: September 1, 2025 - August 31, 2026 (QTY of samples = 4795) Option Period Three: September 1, 2026 - August 31, 2027 (QTY of samples = 4795) Option Period Four: September 1, 2027 - August 31, 2028 (QTY of samples = 4795)

SCOPE OF WORK

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.

Whole genome sequencing of human samples (quantity as noted above) with 30x coverage for each sample. The contractor should target 30x samples; minimum 100Gb will be generated in case 30X coverage unmet from sample nature. Prior to the sequencing runs, libraries will need to be constructed using Illumina’s TruSeq DNA PCR-Free Library preparation kit (350bp). Sequencing shall be performed using the latest Illumina NovaSeq6000 S4 (2x150bp) or NovaSeq X Plus 25B (2x150bp) platform and other related instrumentation and software with 150bp paired-end sequencing method. Contractor shall provide FASTQ raw data to Google Cloud server. Data shall be provided 10 weeks after samples pass initial quality control (QC). QC processes must be completed by quantification with picogreen method using Victor X2 fluorometry, qualification with Agilent genomic DNA screentape. Samples with amount >1.0ug and DIN > 7.0 shall pass sample QC and move forward to library prep process.

Title of Project:

Background Information and Objective:

Statement of Need and Purpose:

Period of Performance:

General Requirements:

Specific Requirements:

Vendor must show evidence of Good Laboratory Practices (GLP) and must provide at least two (2) of the certifications and/or accreditations shown below:

• The vendor must be ISO 9001 certified based on quality management principles.

• The vendor must be cGLP certified which ensures current good laboratory practice regulations as defined by the FDA.

• The vendor must be CLIA certified which ensures that Clinical Laboratory Improvement

Amendments of 1988 are practiced.

• The vendor must maintain a CAP laboratory accreditation to ensure precise testing results.

LEVEL OF EFFORT

Contractor staff shall provide whole genome sequencing information by fastq raw data files. Files shall be reported thru Google Cloud Server, and communication regarding results shall be conducted via email.

GOVERNMENT RESPONSIBILITIES

A minimum of 500ng of deidentified, purified gDNA per sample will be submitted to the contractor as the starting material for which to process and sequence.

DELIVERY OR DELIVERABLES

Raw data in FASTQ format delivered by Google Cloud Server.

REPORTING REQUIREMENTS

The contractor shall provide documentation regarding Genomic DNA sequencing at the end of each period of performance.

TRAVEL

The principal place of performance is the contractor’s work site. No travel is necessary for this project, nor will any travel expense be reimbursed.

KEY PERSONNEL

The contractor shall provide a dedicated project manager to the government as a contact point for the services.

PUBLICATIONS AND PUBLICITY

The contractor shall not, nor is required to, publish any articles of data as a result of fulfilling this requirement.

Other Considerations:

CONFIDENTIALITY OF INFORMATION

Government will not be providing Contractor with confidential information of a personal nature about individuals. All data submitted by the Government to the Contractor for processing shall be de-identified.

DATA RIGHTS

The National Institute on Aging shall have unlimited rights to, and ownership of, all deliverables provided under this contract. The contractor shall not release or share data without government approval. The contractor shall not use data for scientific investigation and shall have no right to work with these data or publish using these data. FAR clause 52.227-14, Rights in Data—General, shall be applicable to any resulting contract.

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.

GENERAL INFORMATION
LEVEL OF EFFORT
GOVERNMENT RESPONSIBILITIES
DELIVERY OR DELIVERABLES
REPORTING REQUIREMENTS
TRAVEL
KEY PERSONNEL
PUBLICATIONS AND PUBLICITY
CONFIDENTIALITY OF INFORMATION
DATA RIGHTS
SECTION 508—ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

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