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PRESOLICITATION NOTICE

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA) on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate and award a contract for the NINDS Human Genetics Resource Center.

EXTENT OF COMPETITION

This acquisition will be competed as full and open with no set-aside restrictions.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) with a Size Standard of 1,000 employees.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-03 dated 02/23/2024.

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 all options.

DESCRIPTION OF REQUIREMENT

Project Description

NINDS Human Genetics Resource Center

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. 75N95024R00002, ENTITLED: “NINDS Human Genetics Resource Center” WILL BE ISSUED VIA SAM.gov ON OR ABOUT April 1, 2024.

The National Institute of Neurological Disorders and Stroke (NINDS) has the stated mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. The mission of the NINDS Human Genetics Resource Center, also known as the NINDS DNA and Cell Line Repository, is to encourage, support, and accelerate the discovery of genetic causes and risk factors for neurological disorders through broad sharing of de-identified human biological samples and clinical data across the research community.

The NINDS DNA and Cell Line Repository (hereinafter “NINDS repository”), established in 2002, receives, processes, curates, stores, and distributes biological samples and accompanying clinical and genotypic data to the scientific community. Currently, the NINDS repository contains DNA samples, lymphoblastoid cell lines (LCL), and DNA 96-well plates (panels) from more than 52,000 well phenotyped unique individuals diagnosed with various neurological disorders (including cerebrovascular diseases, dystonia, epilepsy, motor neuron diseases, Parkinsonism, or Tourette syndrome), as well as from neurologically normal controls. These biological samples and associated data are accessible to researchers from academia, industry, and non-profit organizations, aiming to maximize the utilization of contributions from research participants and reduce redundant sampling efforts. Furthermore, the repository ensures that a standardized dataset of demographic, phenotypic, and genotypic data is managed and curated to allow sharing publicly via related resources, such as the NIH Database of Genotypes and Phenotypes (dbGaP).

The Contractor shall receive, process, store, and distribute biological samples and associated phenotypic and genotypic data; manage and track all associated data and human subjects materials; act in an administrative, educational, and supportive role to multiple related projects; create informatics and data management solutions to allow easy usability of the collection; utilize informatics solutions to dovetail and federate with databases and data management tools used by related projects; and maintain flexibility to expand as needed to accomplish human genetics and genomic research aims for the NINDS.

The scope of the contract requirement includes:

1. Transferring collection (if necessary) of all existing biological samples, associated data, experimental protocols, and Standard Operating Procedures that compose the current NINDS repository, currently housed at Coriell Institute for Medical Research, in the event that a new contractor other than the incumbent should be awarded this follow-on contract. Information about the current NINDS repository collection can be found at https://www.coriell.org/1/NINDS.


2. Providing adequate cold storage facilities and equipment for securing, processing, storing, tracking, cataloging, and distributing biological samples, following Biospecimen Repository Best Practices, as defined by the International Society of Biological and Experimental Repositories (ISBER https://www.isber.org/page/BPR);


3. Receiving, processing, storing, creating, tracking, cataloging, and distributing existing and new samples;


4. Assuring appropriate patient informed consent and Institutional Review Board (IRB) approval for sample and data submission, and maintaining confidentiality of human subjects;


5. Maintaining ongoing disease collection and adding new distinct disease entities or groups as specified by the NINDS;


6. Maintaining flexibility to allow collection of extant samples and other types of special collections as approved by the NINDS;


7. Maintaining flexibility to offer on-demand custom service related to providing cell cultures and DNA samples;


8. Developing, performing, and maintaining Quality Assurance/Quality Control (QA/QC) Systems and procedures for the facility, operations, stored biological samples, shipping materials, and personnel in accordance with all applicable Federal, State, and local regulations;


9. Culling samples based on sample condition and scientific needs to increase the value of the sample collection;


10. Providing secure back-up systems for physical samples and associated electronic data, and a plan for disaster recovery;


11. Providing and maintaining searchable web-based interfaces to display inventory, associated phenotypic data, and other data portal activities to support the NINDS repository functions;


12. Creating and maintaining informatics and data management solutions to allow easy usability of the collection;


13. Creating and maintaining web-based and other solutions to adequately display and allow searches of familial disorders, including pedigree structure;


14. Creating and maintaining informatics solutions via collaboration with the NINDS and investigators, as well as other related projects (such as dbGaP) to allow broad sharing of data while protecting human subjects’ privacy;


15. Utilizing informatics solutions to dovetail and federate with databases and data management tools used by related projects;


16. Conducting public outreach to increase awareness and facilitate use of the repository; and


17. Developing and implementing a successful transfer-out to ensure proper safety and documentation of stored biological samples at the conclusion of the performance period or upon request by the NINDS.

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 following performance areas:

Performance Area 1: Transition of existing collection, including transfer of existing collection (if applicable)

Performance Area 2: Collection of new biological samples and the associated data

Performance Area 3: Management of biological samples, including processing, storing, tracking, and distributing samples

Performance Area 4: Management of electronic data, including sample data, web-based inventory, and project management system

Performance Area 5: Public outreach

Performance Area 6: Transfer-out of NINDS repository (option line item)

The NINDS anticipates awarding one (1) cost-reimbursement contract with a one-year base period, four (4) one-year option periods and one (1) six-month option period, for a total period of performance of five and a half years, if all option periods are exercised. There is no obligation for the NINDS to exercise any Option Period; NINDS may end the terms of the contract after the Base Period or after any Option Period. It is also anticipated that the award will be made in the fourth quarter of Fiscal Year 2024.

CLOSING STATEMENT

Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this pre-solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration.

This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. 75N95024R00002 will be available electronically and may be accessed through the SAM.gov, 15 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM.gov WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.

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