A--National Gene Vector Biorepository
ID: 75N92025R00003Type: Special Notice
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/bbd55328d0b64566810c034268f87a24/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
    Currently viewing
    Special Notice
    National Gene Vector Biorepository
    Solicitation
    A--National Gene Vector Biorepository (NGVB)
    Presolicitation
    Similar Opportunities
    Genotyping Services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for genotyping services to analyze 1,500 DNA samples related to Alzheimer's Disease and Related Dementias research. The selected contractor will perform microarray genotyping using Illumina Infinium Global Diversity + Neurobooster Arrays, ensuring quality control and timely reporting of results to support the National Institute on Aging's objectives in advancing research in this critical area. Proposals must be submitted electronically by 11:00 A.M. Eastern on December 27, 2024, to Hashim Dasti at hashim.dasti@nih.gov, with the anticipated award being a firm fixed-price purchase order for a period of twelve months after receipt of order. Interested parties should ensure compliance with all applicable federal regulations and provide evidence of their capability to fulfill the requirements outlined in the solicitation.
    Single-plex NULISApcr Absolute Quantification Assay of HDGFL2 in Plasma Samples
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is soliciting proposals for the development of a single-plex NULISApcr absolute quantification assay to measure HDGFL2 levels in plasma samples, linked to TDP-43 dysfunction associated with Alzheimer’s Disease and Related Dementias (ADRD). The project aims to establish a biomarker for HDGFL2, which is crucial for advancing research and treatment in neurological disorders. The anticipated contract will be a firm fixed-price purchase order with a performance period of twelve months, and proposals must be submitted electronically to Emily Palombo at emily.palombo@nih.gov by 9:00 a.m. Eastern Daylight Time on December 23, 2024. Interested parties should ensure compliance with all relevant FAR provisions and include necessary certifications in their submissions.
    65--Illumina Reagents and Consumables
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), intends to award a non-competitive contract to Illumina, Inc. for the supply of "Illumina Reagents and Consumables" essential for various sequencing and genotyping systems. This procurement is driven by the unique operational needs of NIH-owned systems, as confirmed by market research indicating that only Illumina can provide the proprietary reagents necessary to maintain research integrity and support ongoing studies. The contract performance period is set from September 3, 2025, to September 2, 2030, and interested parties may submit capability statements for review by January 6, 2025; however, this is not a solicitation for proposals. For further inquiries, interested parties can contact Ethan J. Mueller at ethan.mueller@nih.gov or by phone at +1 301 496 2153.
    NHLBI Procurement Forecast - FY2025-Q1 & Q2
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), has issued a special notice regarding its procurement forecast for the first and second quarters of Fiscal Year 2025. This notice outlines anticipated contracting opportunities, including a variety of goods and services such as scientific support services, IT security, and specialized scientific equipment, with a focus on fostering small business participation. The forecast serves as a planning tool for potential vendors, indicating that while the projected procurements are subject to change, they are essential for supporting the NIH's mission in health research. Interested parties can find detailed information, including estimated dollar values and points of contact, in the attached document, with initial award dates ranging from late 2024 to mid-2025.
    NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Cancer Institute (NCI), has issued a Special Notice regarding a subcontract opportunity at the Frederick National Laboratory for Cancer Research (FNLCR) aimed at enhancing laboratory practices to meet Good Clinical Laboratory Practice (GCLP) standards. The primary objective is to engage a subcontractor to evaluate current laboratory operations, identify compliance gaps, and implement improvements related to sample management, data integrity, and overall laboratory quality standards. This initiative is crucial for ensuring the integrity of testing and data management, which will facilitate the approval of new vaccine recommendations and enhance the laboratory's quality management system. Interested parties should note that this notice is for informational purposes only, with responses treated as government property, and are encouraged to monitor SAM.gov for updates. The deadline for submissions is January 3, 2025, at noon EST, and inquiries can be directed to Jennifer Gnuschke at jennifer.gnuschke@nih.gov.
    The Role of Mitochondrial Genetic Variation in Dementia
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small business sources for a project titled "The Role of Mitochondrial Genetic Variation in Dementia." The objective of this procurement is to obtain laboratory analysis of mitochondrial genetic variation in brain tissue samples from dementia patients, which will aid in understanding the relationship between mitochondrial function and Alzheimer's disease. This initiative is crucial as it aims to explore potential pathways to dementia through the examination of mitochondrial DNA mutations and oxidative capacity in patient samples. Interested contractors must submit their responses by January 2, 2025, to Kevin Alvarez at kevin.alvarez@nih.gov, detailing their capabilities and business size status, as this opportunity is particularly focused on small businesses.
    NIAID Virology Quality Assurance
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for a comprehensive quality assurance program for virologic assays related to HIV and other viral pathogens. The objective is to ensure the validity and comparability of laboratory data through proficiency testing panels and real-time assay controls, which are critical for ongoing and future studies on infectious diseases. This program has been operational since 1988 and supports approximately 110 laboratories globally, emphasizing the importance of maintaining high standards in virologic testing. Proposals are expected to be submitted electronically via the NIAID electronic Contract Proposal Submission (eCPS) website, with the solicitation anticipated to be available on or about January 9, 2025. For further inquiries, interested parties can contact Shawnice Williams at shawnice.williams@nih.gov or Ashley Kinderdine at ashley.kinderdine@nih.gov.
    iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide iNDI ALFAtag cell lines for the iPSC Neurodegenerative Disease Initiative (iNDI) project. The primary objective of this procurement is to generate a collection of up to 230 genetically engineered isogenic cell lines related to Alzheimer's disease and related dementias, which will serve as a national cell repository for the scientific community. These cell lines will be utilized to characterize how genetic mutations affect disease-relevant cell types, with specific requirements for quality control and genetic validation processes. Interested vendors must submit their capability statements by December 27, 2024, at 12:00 PM Eastern Time, to Andrea Clay at amcgee@mail.nih.gov, and should include their company details and relevant qualifications.
    cDNA-PCR Sequencing Kits for long-read sequencing.
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for the procurement of cDNA-PCR Sequencing Kits for long-read sequencing, as part of a combined synopsis/solicitation. The primary objective is to acquire Promethion Flow Cell packs and sequencing kits to support high-throughput sequencing efforts aimed at advancing research on neurodegenerative diseases, particularly Alzheimer's disease. This procurement is crucial for the Center for Alzheimer’s Disease and Related Dementias (CARD) and is expected to facilitate the identification of causative genes and potential therapeutic targets. Interested vendors must submit their quotations by 5:00 p.m. Eastern Time on December 30, 2024, referencing Solicitation Number 75N95025Q00008, and can direct inquiries to Iris Merscher at iris.merscher@nih.gov or by phone at 301-827-2547.
    In Vivo Non-Invasive Optical Imaging Approaches for Biological Systems (UG3/UH3 Clinical Trials Not Allowed
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking innovative proposals for the development of In Vivo Non-Invasive Optical Imaging Approaches for Biological Systems. The initiative aims to address the challenges posed by light scattering in biological tissues, which currently limits the effectiveness of non-invasive optical imaging techniques in assessing tissue function and structure. This funding opportunity encourages the advancement of next-generation imaging technologies that can achieve deeper penetration and higher resolution in biological systems. Interested applicants should note that the application due date is March 7, 2025, by 5:00 PM local time, and are encouraged to submit a letter of intent by the same date. For further inquiries, contact Jonathan Pollock at jpollock@mail.nih.gov or Robert Bailey at rob.bailey@nih.gov.