75N95024R00040- Presolicitation Notice.pdf

RFP Number: 75N95024R00040

Project Title: Scientific Management and Support to the National Institute of Mental Health (NIMH)

Repository and Genomics Resource (NRGR)

PRE-SOLICITATION NOTICE OF INTENT

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION

NOTICE OF A PROPOSED CONTRACT ACTION.

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA) on behalf of the National

Institute of Mental Health (NIMH) intends to award a single Cost Reimbursement, Level of Effort, research and development (R&D) contract for Scientific Management and Support to the National

Institute of Mental Health Repository and Genomics Resource (NRGR).

EXTENT OF COMPETITION

This acquisition is proposed to be solicited under full and open competition with no set-aside restrictions.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and PRODUCT SERVICE CODE

The intended procurement is classified under NAICS Code 541714 - Research and Development in

Biotechnology (except Nanobiotechnology); with a Size Standard of 1,000 employees.

The intended PSC Code is AN12 – Health R&D Services; Health care services; Applied Research.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal

Acquisition Circular that is current at the time the solicitation is posted, which is currently (FAC) 2024-05 with an effective date of May 22, 2024.

This acquisition is conducted under the procedures as prescribed in FAR Subpart 15—Contracting by

Negotiation at an amount exceeding the simplified acquisition threshold inclusive of options.

DESCRIPTION OF REQUIREMENT

The National Institute of Mental Health Repository and Genomics Resource (NRGR) is a centralized national biorepository funded by the National Institutes of Health (NIH). NRGR provides to the research community DNA, RNA, cell lines, and other biospecimens from large collections of individuals with psychiatric illness along with neurotypical controls. NRGR provides basic demographic and diagnostic data for all biospecimens and genotype, DNA sequence, and gene expression data associated with a subset of biospecimens.

Purpose and Objectives

The purpose of this acquisition is to obtain services to sustain, enhance, and enrich NRGR for genetic and cellular studies of psychiatric disorders to facilitate and accelerate the scientific understanding of the genetic risk architecture and basic biology underlying mental disorders. This effort is expected to involve a functionally integrated, multi-disciplinary team that will continue to manage broad sharing of biospecimens and data resources through a single, centralized, national resource to advance basic and translational research in the genetics of mental disorders.

Project requirements

The Contractor shall provide research sources and services for genetic studies to the scientific community and acquire brains from deceased donors with diverse neurodevelopmental, neurological, and neuropsychiatric disorders, as well as individuals with no known brain disorders. The Contractor must have a demonstrated capacity to store and distribute the existing collection of biospecimens and associated data (including metadata such as phenotypic data), as well as receive, store, and distribute newly acquired biospecimens and associated data (including metadata and phenotypic data).

Biospecimens include but are not limited to: human-derived saliva, blood, cerebrospinal fluid (CSF), DNA, RNA, plasma, biopsied materials, fibroblast cell lines (FCLs), lymphoblastoid cell lines (LCLs), cryopreserved lymphocytes (CPLs), and induced pluripotent stem cell lines (iPSCs).

The existing NRGR collection encompasses over 3.5 million biospecimens, including: 1.4 million LCLs in

1.8 mL glass ampules or plastic cryovials; 300,000 CPLs in 1.8 mL plastic cryovials; 66,000 iPSCs in 1.8 mL plastic cryovials; 1 million aliquots of DNA and 100,000 aliquots of RNA in both tubes and 96-well plates;

750,000 samples of blood plasma; 7,000 urine samples; 40,000 whole blood; and 2,000 saliva samples.

On average, NRGR currently receives and processes a minimum of 25,000 biospecimens per year, including: 750 saliva samples, 15,000 blood samples, 2,000 DNA samples, 25 FCLs, and 60 iPSC lines.

Annually, NRGR currently distributes over 15,000 biospecimens. In 2023, NRGR received and banked 67 externally produced iPSC lines and generated 15 iPSC lines for NIMH investigators, and these numbers are expected to grow.

The following are the specific areas of scientific expertise as required by NRGR:

1. Molecular biology, with a primary focus on the Epstein-Barr virus transformation of lymphocytes from fresh blood samples received from national and international sites to create contaminant-free cell lines, and the extraction of high-quality DNA from these cell lines. Additional molecular biology expertise is required in extraction of nucleic acids (DNA and RNA) directly from blood with quality control procedures to assure the integrity and competence of the products in modern genetic assays.

2. Tissue and cell culture, with a primary focus on initial isolation, scale-up culture, and banking of primary cells from diverse types of tissue samples (e.g., skin punches, hair follicles, olfactory epithelial biopsies).

3. Developmental and stem cell biology, with expertise in reprogramming, pluripotent stem cell culture, gene editing, cryopreservation, banking, reconstitution, and differentiation of iPSCs with comprehensive quality control capabilities at each step.

4. Laboratory information management including receipt of orders and distribution of biologicals with computerized-based inventory management and storage facilities with monitored and alarmed low temperature storage and fail-safe procedures in place.

5. Psychiatric clinical data curation, standardization, and harmonization, with a comprehensive knowledge of cross-disorder phenotypic dimensions.

6. Computer and information sciences to maintain query of clinical data in NRGR and NIMH Data

Archive (NDA; https://nda.nih.gov/) databases, provide tools to support NIH Program tasks associated with registering and monitoring studies, track research outcomes that results from

NRGR biospecimens and data, and develop systems to support approving and tracking researcher access to samples and the integration of data with other repositories.

Period of Performance

The anticipated period of performance for this requirement is one (1), 12-month base period and four

(4), 12-month option periods.

CLOSING STATEMENT

Solicitation No. 75N95024R00040 is anticipated to be issued on or about August 27, 2024, and proposals will be tentatively due within 30 days after the solicitation release date.

The Points of Contact are Sarah Adan, Contract Specialist at sarah.adan@nih.gov and Valerie Whipple, Contracting Officer at valerie.whipple@nih.gov.

https://nda.nih.gov/ mailto:sarah.adan@nih.gov mailto:valerie.whipple@nih.gov