75N95024R00040 - Sources Sought Notice.pdf

RESEARCH AND DEVELOPMENT SOURCES SOUGHT NOTICE

1. Solicitation Number: 75N95024R00040

2. Title: Scientific Management and Support to the National Institute of Mental

Health (NIMH) Repository and Genomics Resource (NRGR)

3. Classification Code: A – Research & Development

4. NAICS Code: 541714 - Research and Development in Biotechnology (except

Nanobiotechnology)

5. Size Standard: 1,000 Employees

6. Description:

This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the

Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background:

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:

Qualified sources will be required to 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. Qualified sources 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.

Qualified sources should have the following 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.

Other Important Considerations

1. Protocols and standards at a minimum should meet those set forth in the NCI Best

Practices for Biospecimen Resources established by the Office of Biorepository and Biospecimen Research.

2. Section 508 compliance is applicable for all systems housing data.

3. Compliance with the NIH/Office for Human Research Protections (OHRP) guidelines and 45 CFR Part 46, to ensure that the Bank has undergone annual review by the Institutional Review Board (IRB).

4. Information Technology (IT) Security that can be compliant with the Federal

Information Security Modernization Act of 2014 (FISMA) moderate standard within the first contract year to ensure security of all data generated over the life of the contract.

5. Appropriate shipping licenses and permits from local, state, federal and international authorities for the safe import, storage, and distribution of biological https://nda.nih.gov/ specimens, according to current regulatory guidelines, will be required, as applicable.

6. Procedures and protocols for safe handling of potentially hazardous and infectious materials will be required.

Anticipated 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.

Capability statement /information sought:

Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA

Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program.

Responses should include specific information, including metrics (e.g. size of facility, staff, etc.), which address the following capabilities, based on prior experience:

1. The capacity, including a brief description of infrastructure (e.g., facilities, storage conditions) and procedures, to bank the existing NRGR collection as described above and provide services such as shipping, receiving, cataloguing, banking, and distributing new biospecimens from deidentified human subjects in the average quantities described above plus 20%.

2. The capacity to provide an adequate informatic infrastructure to support the ingress, maintenance, organization, integration, and controlled dissemination of the biospecimens and associated clinical, phenotypic, genetic, and other metadata. Not counting redundant copies, the NRGR collection currently includes

21 terabytes of data.

3. The capability to provide expert curation of data associated with biospecimens, including mental health clinical data.

4. The capability to process and perform quality control on received blood, cell or tissue samples and extract high-quality, well-characterized derived products (e.g., DNA), including a brief description of the protocols and infrastructure in place to support biospecimen receipt, quality control, and manipulation to generate derived products.

5. Capability including a brief description of standard operating procedures and previous experience using state-of-the-art reprogramming techniques to derive iPSCs from source cells (e.g., skin punches, fibroblasts, or peripheral blood mononuclear cells) and perform isogenic iPSC line genetic modification, with appropriate quality control.

6. Capability to provide timely technical and instructional support for all NRGR user groups and staff a user-friendly customer service interface like a helpdesk to provide support to biomedical researchers who submit samples, submit data, search for samples, have technical questions regarding the submission, or who need assistance with decisions on ordering.

Capability statements must also include the Company Name, Unique Entity ID from

SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry

Classification System (NAICS) Code, and size standards in accordance with the Small

Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

Submission Instructions:

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

All responses to this notice must be submitted electronically to the Contracting Officer.

Facsimile responses are NOT accepted.

The response must be submitted to Sarah Adan, Contract Specialist, at e-mail address sarah.adan@nih.gov and Valerie Whipple, Contracting Officer, at e-mail address valerie.whipple@nih.gov.

mailto:sarah.adan@nih.gov mailto:valerie.whipple@nih.gov

The response must be received on or before February 26, 2024, at 12:00 p.m. Eastern

Standard Time.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).