Pre_sol_Notice_Final_1.pdf

Pre-Solicitation Notice Page 1 of 3

SAM.GOV CONTRACT OPPORTUNITIES PRE-SOLICITATION NOTICE

NOTICE ID: 75N91023R00042

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A

SOLICITATION WILL BE ISSUED ON A LATER DATE.

Title: Childhood Cancer Data Initiative (CCDI): Research Molecular Characterization

BACKGROUND:

This is a new acquisition to support the research molecular characterization goals of the Childhood Cancer Data Initiative (CCDI) to improve diagnosis and treatment for childhood and adolescent and young adult (AYA) cancers.

The National Cancer Institute (NCI)’s Office of Data Sharing (ODS) of the Center for Biomedical Informatics and Information Technology (CBIIT) is coordinating with relevant NCI programs to support a new acquisition for building a CCDI research molecular characterization pipeline on biospecimens from childhood cancer patients in clinical trials and other studies to complement the clinical-grade data from the Molecular Characterization Initiative (MCI). Specimen sources may include the Children’s Oncology Group (COG) sites and associated sample processing facilities and other sites.

Research molecular characterization methods and platforms for consideration include three Service Areas specified at the level of bulk sample, subpopulation of cells, isolated organelles, and/or single cell/single nuclei.

REQUIREMENTS:

The NCI seeks a new acquisition to support research molecular characterization goals of the CCDI through full and open competition procedures under NAICS Code 541380 - Testing and Laboratories and Services, with the size standard of $19 Million.

The proposed contract will support the generation of childhood cancer multi-omics research data (including primary and derived data) that will be delivered to the CCDI data ecosystem. All data from this contract will be of research grade that does not require additional accreditation by the Clinical Laboratory Improvement Amendments (CLIA), although laboratories with CLIA certification are not excluded from competition.

The Contractor shall serve as the Research Characterization Laboratory(ies) capable of providing high-throughput and quality-controlled characterization/assay pipelines for comprehensive ‘omics characterizations of different childhood cancer types using validated methods, platforms, and proven data analysis pipelines.

The Contractor shall coordinate activities including, but not limited to, receiving biological specimens and/or molecular analytes such as DNA, RNA, proteins, and metabolites extracted or enriched from original specimens (e.g., tumor tissue, blood, plasma, saliva), isolating and enriching for subpopulations of cells, organelles, and/or

Pre-Solicitation Notice Page 2 of 3 analytes from specimens with their associated data from investigators/ institutions with access to these materials, and performing molecular profiling and delivering data to CCDI that will be used to advance the understanding of childhood cancer.

The molecular characterization for consideration may include the following activities at the level of bulk sample, isolated organelles, subpopulation of cells, and/or single cell/single nuclei:

• Whole Exome Sequencing (WES)

• Whole Genome Sequencing (WGS)

• Whole Genome Bisulfate Sequencing (WGBS)

• ATAQ Sequencing

• Methylation Arrays

• Transcriptome Sequencing (e.g., total RNA-seq)

• Additional molecular assays (e.g., miRNA analysis, circulating tumor DNA analysis, targeted off-the-shelf gene panels)

• Global proteomics and phosphoproteomics, surface-omics or additional PTM profiling

• Metabolomics Profiling

• Single-Cell DNA/RNA/methylation/protein analysis

Specimens to be provided to the Contractor for analysis may include fresh frozen tumor biopsy or resected tumor tissue, formalin-fixed paraffin-embedded (FFPE) tissue, bone marrow biopsy, whole blood, plasma, and serum that need extraction and purification, as well as analytes already processed from specimens such as extracted DNAs, RNAs, proteins and metabolites. In addition to characterization of tumor samples, characterization may also need to support germline analysis from normal tissue and/or blood in selected settings.

The resultant data will be deposited by the Contractor into CCDI data ecosystem. Data to be deposited include multiple molecular characterization data, specimen data, clinical data, metadata, or other summary reports, depending on the specific needs of the clinical trials and studies as primary and derived data required by CCDI in coordination with NCI’s ODS.

The NCI-required research characterization specifications may change based on changing scientific needs, incremental increase needs in sample throughput in the out years, available characterization options, and novel validated assays coming online. As a result, characterization laboratories shall implement changes expeditiously when NCI specifications change.

The awardee will be required to perform the following Service Areas:

Service Area 1: High-throughput DNA and RNA sequencing

• High-throughput DNA Sequencing

• High-throughput RNA Sequencing

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• Epigenomics with Array- or Sequencing-based Assays

Service Area 2: Comprehensive (mass spectrometry or MS-based) proteomic characterization

• Comprehensive (MS-based) global proteomic profiling

• Comprehensive (MS-based) posttranslational modification profiling to include phosphoproteomics at a minimum with additional modifications if applicable (e.g., acetylation, glycosylation, and ubiquitylation)

• Comprehensive (MS-based) cell-surface proteomic characterization

Service Area 3: Metabolomic profiling and relative quantitation

• Metabolite profiling may include identification and relative quantitation of metabolites and metabolic features.

ANTICIPATED PERIOD OF PERFORMANCE:

The NCI Office of Acquisitions intends to issue a solicitation for a Contractor to support molecular characterizations of pediatric and adolescent and young adult (AYA) cancer biospecimens as part of NCI’s CCDI. It is anticipated that one (1) firm-fixed-price type contract with an anticipated period of performance with a base period of one

(1) year and four (4), one-year option periods inclusive of additional optional quantities, may be awarded, with an anticipated start on or around January 31, 2025.

The RFP will be available electronically on or around May 1, 2024, and may be accessed through the Contract Opportunities at https://sam.gov/. PAPER COPIES OF

THIS SOLICITATION WILL NOT BE MADE AVAILABLE. IT IS THE

OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE

FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE

ENCOURAGE ALL RESPONSIBLE SMALL BUSINESSES TO SUBMIT A

PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY.

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.

Primary Point of Contact:

Julia Tilton Contract Specialist julia.tilton@nih.gov Phone: 240-276-5576

Secondary Point of Contact:

Erin Felent Contracting Officer erin.felent@nih.gov Phone: 240-858-3667