Inactive

NINDS Human Genetics Resource Center (2024)

Inactive

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 Dru... 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: 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. 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); Receiving, processing, storing, creating, tracking, cataloging, and distributing existing and new samples; Assuring appropriate patient informed consent and Institutional Review Board (IRB) approval for sample and data submission, and maintaining confidentiality of human subjects; Maintaining ongoing disease collection and adding new distinct disease entities or groups as specified by the NINDS; Maintaining flexibility to allow collection of extant samples and other types of special collections as approved by the NINDS; Maintaining flexibility to offer on-demand custom service related to providing cell cultures and DNA samples; 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; Culling samples based on sample condition and scientific needs to increase the value of the sample collection; Providing secure back-up systems for physical samples and associated electronic data, and a plan for disaster recovery; Providing and maintaining searchable web-based interfaces to display inventory, associated phenotypic data, and other data portal activities to support the NINDS repository functions; Creating and maintaining informatics and data management solutions to allow easy usability of the collection; Creating and maintaining web-based and other solutions to adequately display and allow searches of familial disorders, including pedigree structure; 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; Utilizing informatics solutions to dovetail and federate with databases and data management tools used by related projects; Conducting public outreach to increase awareness and facilitate use of the repository; and 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.

Inactive

Sources Sought Notice Solicitation Number: 75N95024R00002 Title: NINDS Human Genetics Resource Center Classification Code: A – Research & Development NAICS Code: 541715 -Research and Development in th... Sources Sought Notice Solicitation Number: 75N95024R00002 Title: NINDS Human Genetics Resource Center Classification Code: A – Research & Development NAICS Code: 541715 -Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) Description: This is a 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 qualified sources to perform a potential 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. Small businesses are encouraged to respond. Background: 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. To support and accelerate the discovery of genetic causes and risk factors for neurological disorders, particularly complex diseases with multiple phenotypes, NINDS conducts and funds longitudinal clinical research studies and trials. These studies have generated a collection of biological materials with associated de-identified phenotypic and clinical data from individuals affected by neurological disorders and from neurologically normal control individuals. The NINDS Human Genetics Center, also known as the NINDS DNA and Cell Line Repository (“the NINDS repository”) currently houses this collection of DNA samples, lymphoblastoid cell lines (LCL), and accompanying genotypic, phenotypic, clinical and pedigree data. Established in 2002, the NINDS repository contains DNA samples and LCL from more than fifty-two thousand well-phenotyped unique individuals. As an invaluable shared resource for the scientific community, the NINDS repository receives, stores and distributes well characterized, high-quality human cell lines and DNA for use in biomedical research. It ensures that contributions from research participants are maximally utilized and decreases duplicative sampling efforts. It also ensures that a standardized, useful dataset of demographic, other phenotypic, and genotypic data is managed and curated to allow sharing publicly via related resources, such as the NIH Database of Genotype and Phenotype (dbGaP). This contract re-competition builds upon this existing infrastructure of the NINDS repository and provides a state-of-the-art inventory system for the storage and distribution of the existing collection. The contract also receives, processes, stores, and catalogues biological samples from ongoing collections of the NINDS-approved studies to facilitate the goals and specific scientific aims of NINDS grantees and other scientists studying neurological disorders. The objective of this requirement is to continue services without interruption, including the growth of the sample numbers in some disease areas, the maintenance and curation of samples and data in the existing collection and the distribution of samples and data to qualified investigators at academic, non-profit, and for-profit institutions throughout the United States and abroad. To be deemed capable, a business must have a demonstrated track record of running a large established biobank; recognized expertise in human genetics and genomics, bioinformatics, cell culture, and molecular biology; and experience in managing a complex resource, including customer service and outreach. Specifically, a business must demonstrate the ability and related experience to: 1) Receive and process whole blood samples collected from affected subjects, their relatives, and controls for DNA extraction and lymphocyte isolation; 2) Manage and track administrative study documents, phenotypic and genotypic data; 3) Monitor human subject concerns compliance with federal and other human subject regulations, including a means of masking individual identities to ensure confidentiality; 4) Maintain flexibility to expand operations as needed to accomplish aims of related projects; 5) Provide rapidly, upon request, as well as routinely, cell lines and DNA samples as well as associated data to submitters and sample withdrawers; 6) Transfer the entire existing NINDS repository of DNA, cell lines and data to their organization in a manner that allows seamless access to the existing collection; 7) Provide adequate cold storage facilities and equipment for securing, processing, storing, tracking, cataloging, and distributing the existing collection of approximately 1.9 million aliquots of samples from over 52,000 individuals and associated complex phenotypic and genotypic data; 8) Develop a website, transfer the existing web-based system, and maintain and modify the website based on needs of the resource; 9) Develop, transfer, and maintain a database of all associated data and resources needed to manage the NINDS repository and associated user interface; and 10) Create informatics and data management solutions to allow easy usability of the collection and utilize informatics solutions to dovetail and federate with databases and data management tools used by related projects. Capability statement /information sought: Companies that believe they possess the capabilities to provide the required products or services must provide clear and convincing 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. Information must be provided in sufficient detail of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) current in-house capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and other management capability; and (e) examples of prior completed Government contracts, references, and other related information. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, address, and point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code, and any other information that may be helpful in developing or finalizing the acquisition requirements. Respondents are also encouraged to provide a general overview of the respondent’s opinions about the difficulty and/or feasibility of the potential requirement, and any other information regarding innovative ideas or concepts that may be applicable. Submission Instructions: The information submitted must be in an 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. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist, Sneha Singh, at sneha.singh@nih.gov. Facsimile responses are NOT accepted. The response must be received on or before November 1, 2023 at 10:00 a.m., Eastern 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).”