A--National Gene Vector Biorepository (NGVB)
ID: 75N92025R00003Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NHLBIBETHESDA, MD, 20892, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH RESEARCH AND TRAINING; APPLIED RESEARCH (AN22)

Original Source

https://sam.gov/opp/032d1191d9064d9fb5e7bc284eaa5214/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for the National Gene Vector Biorepository (NGVB) to support gene therapy research for the National Heart, Lung, and Blood Institute (NHLBI). The contract aims to provide essential resources and services, including administrative management, core laboratory activities, and compliance with FDA regulations and Good Laboratory Practices (GLP). This initiative is crucial for advancing gene therapy capabilities and ensuring the proper archiving of biological specimens and development of assays. Proposals must be submitted by January 10, 2025, and should include detailed technical and business plans, with specific formatting guidelines and a budget submission required. For further inquiries, interested parties can contact Ethan J. Mueller at ethan.mueller@nih.gov or +1 301 496 2153.

    Point(s) of Contact
    MUELLER, ETHAN J
    +1 301 496 2153
    ethan.mueller@nih.gov
    Files
    Title
    Posted
    Att-15-Breakdown-Proposed-Costs_2.xlsx
    The provided document serves as a guideline for organizations preparing cost proposals in response to federal government RFPs. It includes essential instructions on how to utilize an Excel spreadsheet designed for organizing and presenting direct labor, fringe benefits, overhead costs, materials, supplies, and travel expenses across seven contract periods. Organizations must accurately enter current payroll information for proposed personnel, with specific sections for tracking either hourly or percent of effort labor. The document emphasizes the importance of supporting documentation for proposed costs and encourages modifications to the spreadsheet to accommodate differing organizational structures. It also highlights the significance of indirect rates—such as fringe benefits and overhead costs—and notes resources for organizations that do not have negotiated rates. Overall, this document aims to streamline the proposal process, enabling efficient reviews and awards while ensuring compliance with government standards. The inclusion of detailed instructions for documenting costs underlines the crucial nature of precision and transparency in federal contracting.
    Att-18-SFLLL_1_2_P-V12b_2.pdf
    The provided document appears to be an inaccessible PDF related to federal and state/local RFPs and grants. Due to technical limitations, specific content cannot be reviewed or summarized. However, such a document typically serves to outline funding opportunities for projects that align with government initiatives. The main focus would generally include guidelines for application processes, eligibility criteria, project objectives, and funding amounts available. Additionally, key details might involve deadlines, reporting requirements, and evaluation criteria for applicants seeking federal or state support. Understanding these elements is essential for entities looking to engage in government-funded projects, as they are crucial in ensuring compliance and maximizing opportunities for funding.
    Attachment_11_-_Pre-sol-notice_1.doc
    The National Heart, Lung, and Blood Institute (NHLBI) released a Pre-Solicitation Notice for RFP No. 75N92025R00003 that invites a contractor to support the National Gene Vector Biorepository (NGVB) program over a five-year period. The NGVB provides essential resources for translational gene therapy research, offering services that enable compliance with FDA regulations. Its offerings include a reagent repository, pharmacology and toxicology resources, analysis of clinical trial specimens, and archiving services. The contractor will be responsible for a range of tasks, such as archiving over 20,000 clinical specimens under Good Laboratory Practices (GLP), developing necessary assays for clinical testing, and maintaining a user-friendly web-based catalogue for gene therapy reagents. The announcement emphasizes that this is not a contract solicitation but rather a notice of intent to issue one, with RFP details anticipated to be available on November 22, 2024. This initiative signifies the government’s commitment to advancing gene therapy research aligned with FDA requirements while enhancing the portfolio of services provided by the NGVB.
    Attachments_-_all_RFP.pdf
    The document outlines the National Gene Vector Biorepository (NGVB) initiative, aimed at supporting gene therapy research under the National Heart, Lung, and Blood Institute (NHLBI). The primary objectives of this contract include providing resources for gene therapy vector construction, adhering to FDA regulations for specimen archiving, and conducting essential testing services to ensure compliance during clinical trials. The Statement of Work (SOW) delineates two key task areas. Task Area A focuses on administrative responsibilities, including managing communication, service requests, and compliance with regulatory standards. It stipulates the creation of a comprehensive Manual of Procedures and requires the development of a public-facing website to facilitate information sharing with researchers. Task Area B emphasizes core laboratory activities such as archiving biological specimens from clinical studies and developing assays for testing protocols necessary for FDA approval. Proposals must be submitted via email by January 10, 2025, using specified formats and naming conventions. The document also mandates a structured delivery schedule for reporting and outlines security measures, record management practices, and compliance with Section 508 accessibility standards. This initiative reflects the federal commitment to advancing gene therapy research while ensuring robust operational frameworks and regulatory compliance.
    Attachments_Revised_-_RFP_2.pdf
    The National Gene Vector Biorepository (NGVB) aims to support gene therapy research for the National Heart, Lung, and Blood Institute (NHLBI) by providing essential resources and services. The initiative focuses on administrative management and core laboratory activities, ensuring compliance with FDA regulations and Good Laboratory Practices (GLP). Key responsibilities include archiving biological specimens, developing assays, and maintaining a reagent repository. Proposals for the NGVB contract must include detailed technical and business plans, submitted via specified email addresses by January 10, 2025. The offerors are required to follow guidelines for document formatting and submission organization. An essential component is the development of a Manual of Procedures, which outlines administrative tasks, management of scientific inquiries, and stakeholder engagement through an External Advisory Board. The proposal must also adhere to data management regulations, privacy requirements, and accessibility standards in compliance with Section 508. Regular reporting, including monthly invoices and progress reports, ensures transparency and accountability in the contract's execution. The NGVB seeks to enhance gene therapy capabilities while fostering compliance with applicable health regulations.
    Q_A_-_RFP_75N92025R00003_2.pdf
    The document pertains to Solicitation 75N92025R00003 for the National Gene Vector Biorepository (NGVB). It addresses various inquiries related to proposal submissions for IDIQ contracts involving core administrative tasks and laboratory activities. The proposal deadline is set for January 10, 2025, with specific formatting guidelines outlined: a maximum of 30 pages for the technical proposal, and appendices limited to 50 pages. Offerors are required to present separate proposals for designated task areas, with no submissions needed for the overarching IDIQ contract. The government seeks a cost-reimbursement contract for issued task orders, clarifying that both task areas must be included in proposals. Additionally, it answers logistical concerns regarding document organization, clarifications about cost breakdowns, and the handling of sensitive data and reports, including compliance with FDA regulations. The importance of maintaining an accurate roster of personnel involved is stressed due to accessing sensitive systems. The document emphasizes the relevance of the Gene Therapy Resource Program and the necessity for a budget submission as part of the contract process. This solicitation outlines vital expectations and requirements for prospective offerors in the context of federal contracts aimed at advancing gene vector research and biorepository operations.
    Sol_75N92025R00003.pdf
    The National Institutes of Health (NIH) seeks proposals for the National Gene Vector Biorepository (NGVB) initiative, a critical resource for gene therapy research within the National Heart, Lung, and Blood Institute. The contract, set for a term from June 18, 2025, to June 17, 2030, involves collecting, archiving, and storing over 20,000 biospecimens and providing services necessary for compliance with FDA regulations. This Indefinite Delivery Indefinite Quantity (IDIQ) contract establishes minimum and maximum ordering quantities ($50,000 to $7,000,000) for cost-reimbursement tasks. Key deliverables include monthly and semi-annual reporting, managing assay development, and maintenance of specimen storage under Good Laboratory Practice (GLP) standards. Contractors must adhere to stringent security measures, ensuring infallible protection of sensitive data and compliance with federal requirements. Proposal submissions are due by January 10, 2025, with pre-proposal questions accepted until December 12, 2024. This initiative represents NIH's commitment to enhancing resources for gene therapy, ensuring compliance, and supporting clinical trial infrastructures while promoting the advancement of biomedical research.
    Lifecycle
    Title
    Type
    A--National Gene Vector Biorepository
    Special Notice
    National Gene Vector Biorepository
    Solicitation
    A--National Gene Vector Biorepository (NGVB)
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