Research Opportunity Announcement (ROA): All of Us Biobank
ID: OTA-25-002Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH OFFICE OF THE DIRECTORBethesda, MD, 20892, USA

NAICS

Research and Development in the Social Sciences and Humanities (541720)

PSC

COMMUNITY & REGIONAL DEVELOPMENT R&D SVCS; AREA & REGIONAL DEVELOPMENT; EXPERIMENTAL DEVELOPMENT (AB23)

Original Source

https://sam.gov/opp/1b5960ec1026456aaf4f7271cae0afe5/view
Timeline
    Description

    The National Institutes of Health (NIH) is soliciting proposals through a Research Opportunity Announcement (ROA) for the All of Us Biobank, aimed at enhancing the collection, processing, and distribution of high-quality biospecimens from a diverse participant pool to support biomedical research. The initiative seeks to fund one award that will maintain existing biobank specimens and expand operations to support the collection and dissemination of diverse biospecimens, with a focus on innovative technologies and methods. This program is critical for advancing health research and improving health equity by collecting data from historically underrepresented groups, with anticipated funding ranging from $13 million to $50 million over a potential five-year period. Interested proposers must submit a Letter of Intent by December 9, 2024, and can direct inquiries to AllofUsDCDAwardRequirements@nih.gov.

    Point(s) of Contact
    All of Us DCD Award Requirements
    allofusdcdawardrequirements@nih.gov
    Files
    Title
    Posted
    All of Us Biobank - Amendment 1.pdf
    The National Institutes of Health (NIH) announced an amendment to the Research Opportunity Announcement (ROA) for the "All of Us Biobank" program, identified as OTA-25-002, issued on December 13, 2024. Key changes include revisions to the proposal format and key personnel requirements. The updated format allows for expanded NIH biosketches for key personnel, with a four-page limit for the Principal Investigator or Program Manager, and a two-page resume for other key personnel, which do not count toward the overall page limit. Changes to the key personnel section clarify that at least one Principal Investigator or Program Director, along with one Program Manager, are mandatory. Proposed levels of effort for key roles must also be included. Additionally, resources such as webinar slides and an FAQ document have been made available under the “Attachments/Links” section of the ROA. All other existing requirements of the ROA remain unchanged. This amendment is vital for guiding proposals related to the Biobank, fostering a robust research environment consistent with current standards and expectations.
    All of Us Biobank - Amendment 2 December 18 2024.pdf
    All of Us Biobank - FAQs.pdf
    The National Institutes of Health (NIH) has released a Frequently Asked Questions (FAQ) document regarding the Biobank Research Opportunity Announcement (ROA) as part of the All of Us Research Program. This document addresses inquiries from potential proposers concerning the requirements and submission guidelines for the ROA. Key points include that proposers can include newly hired directors in their Phase I submission, are permitted to submit Letters of Support (limited to three pages), and must compile all required documents in a single proposal via eRA ASSIST. Additionally, the document outlines current and future automation standards for biospecimen collection, emphasizing the importance of automation for processing high-volume samples, enhancing accuracy and efficiency, and the anticipated role of artificial intelligence in optimizing biobank operations. This FAQ serves as a vital resource for applicants navigating the grant process, demonstrating the NIH's commitment to transparency and support within federally funded research initiatives.
    All of Us Biobank - FAQs - 2 December 18 2024.pdf
    All of Us Biobank - ROA Webinar_Slides.pdf
    The "All of Us Research Program Research Opportunity Announcement (ROA) No. OTA-25-002" outlines a new initiative to enhance the All of Us Biobank, aimed at collecting and distributing high-quality biospecimens from a diverse participant pool to accelerate health research. The program seeks to enroll over 1 million participants reflecting U.S. diversity and aims to process and manage extensive biospecimen collections, focusing on blood, saliva, and urine. The ROA provides a comprehensive overview, including the program's mission, strategic goals, and success metrics, emphasizing participant engagement, data security, and quality management. The proposed program structure comprises teams for laboratory operations, biospecimen research development, logistics, and training. Phases guide competitors through proposal submission, evaluation, and potential endorsement. Additional details cover logistical planning for specimen collection, adherence to regulatory compliance, and sustainable practices for biobanking operations. With a budget scope ranging from $13 to $50 million, the initiative encourages innovation and infrastructure expansion, prioritizing diverse and sustainable research collaborations. This ROA serves to stimulate valuable partnerships and improve public health outcomes based on cutting-edge research practices.
    All of Us Biobank Appendix A- Terms and Conditions.pdf
    The document outlines an Other Transactions Agreement between the National Institutes of Health (NIH) and a recipient institution, focusing on support for the All of Us Research Program. This program aims to collect health data from over a million diverse individuals to advance research and healthcare customization. The document specifies the agreement's scope, defining the roles of the NIH and the recipient in both administration and management of the project. It establishes guidelines on funding, reporting requirements, data ownership, and rights to inventions and technologies developed under the agreement. Key components include obligations and payments, data rights, and procedures for managing disagreements or disputes. The NIH retains significant rights over the data collected and any inventions arising from the research, ensuring they can be utilized for governmental purposes without restrictions. The document emphasizes compliance with federal regulations throughout its provisions, including stipulations on human and animal subjects research. The agreement highlights NIH's commitment to enhancing health equity and improving understanding of health disparities through a collaborative, well-structured approach to ongoing research. This framework is vital for ensuring accountability and proper utilization of federal resources in advancing public health goals.
    All of Us Biobank Appendix B - Letter of Intent.pdf
    The document outlines the Intent to Submit Proposal Form for the All of Us Biobank initiative, referenced as ROA No.: OTA-25-002. Interested entities intending to submit proposals must provide specific information, including institutional name, address, contact details, and proposed staff details such as names and titles of Program Directors/Principal Investigators. Furthermore, it requires details of collaborating institutions and investigators, listing names, titles, and institutional affiliations of subrecipients or consultants involved in the project. The submission deadline for this letter of intent is set for December 9, 2024, at 10:00 AM Eastern Time. While the letter is non-binding and does not influence subsequent proposal evaluations, it assists the All of Us Research Program in determining potential review workloads for planning purposes. Interested applicants must send their completed forms via email to the specified address, ensuring the subject line includes the relevant ROA reference. This document serves as a crucial step in the government RFP process, facilitating the organization and assessment of proposals related to the All of Us Biobank research program, which aims to enhance health data collection and biomedical research.
    All of Us Biobank ROA.pdf
    The National Institutes of Health (NIH) has issued a Research Opportunity Announcement (ROA) for the All of Us Biobank under the All of Us Research Program, aiming to enhance the collection, processing, and distribution of high-quality biospecimens from a diverse cohort for biomedical research. The program seeks to enroll over 1 million participants, focusing on groups historically underrepresented in research. The ROA entails a competitive selection process in three phases: submission and evaluation of a technical proposal, demonstration of capabilities (invitation only), and negotiation for an Other Transactions (OT) award (invitation only). The anticipated funding for the initial award period could range between $13 million to $50 million, covering a year with options for four yearly renewals. Key responsibilities outlined include developing innovative biospecimen collection methods, maintaining robust logistics for biospecimen shipment, and ensuring comprehensive participant training. The Biobank will also expand its scope to support pediatric participants, implement reassessment processes for adult specimens, and enhance collaborations for ancillary studies. Overall, the program is designed to advance health research while upholding principles of diversity, transparency, and accessibility in research methodologies.
    Lifecycle
    Title
    Type
    Research Opportunity Announcement (ROA): All of Us Biobank
    Currently viewing
    Solicitation
    Similar Opportunities
    A--National Gene Vector Biorepository
    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 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.
    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.
    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.
    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.
    A--Biomedical Computing Support Services
    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 Biomedical Computing Support Services to assist in ongoing cancer research initiatives. The procurement aims to provide comprehensive computing services that facilitate the analysis of high-dimensional biomedical data, supporting both domestic and international studies within the Division of Cancer Epidemiology and Genetics (DCEG). This opportunity is critical for enhancing cancer research capabilities, with an estimated contract value ranging from $3,000 to $147 million over a performance period of five years, beginning September 16, 2025, with a potential five-year extension. Interested offerors must submit their proposals by January 6, 2025, and can direct inquiries to Antoinette C. Robinson at antoinette.robinson@nih.gov or by phone at +1 240 276 5823.
    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.
    Assay Kits for Lumipulse instrument
    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 assay kits for the Lumipulse instrument, aimed at quantifying specific biomarkers related to Alzheimer's Disease. The acquisition includes a total of 4,410 assays for biomarkers abeta42, abeta40, and pTau 217, which will be utilized in research involving stored samples from the Baltimore Longitudinal Study of Aging (BLSA) to assess cognitive decline and neurodegeneration. This procurement is critical for advancing Alzheimer’s research and will be awarded as a firm fixed-price purchase order, with quotations due by 5:00 p.m. Eastern Time on January 8, 2025. Interested vendors should contact Iris Merscher at iris.merscher@nih.gov for further details.
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing research and development of medical countermeasures against antimicrobial-resistant pathogens and viruses with pandemic potential. The BAA encompasses two primary research areas: the development of therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens, and the creation of direct-acting antivirals for viral families of pandemic potential. This initiative is critical for addressing public health challenges related to infectious diseases and enhancing biodefense capabilities. Proposals for Research Area 001 are due by February 21, 2025, while those for Research Area 002 are due by January 21, 2025. Interested parties can reach out to primary contact Swee L. Teo at teosl@niaid.nih.gov or 240-669-5173 for further information.
    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.
    Long Sequencing Kits
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) NIDA, is seeking qualified small businesses to provide Long Sequencing Kits as part of a Sources Sought notice. The primary objective of this procurement is to acquire kits that facilitate long read sequencing for analyzing biomarkers related to Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD), which are crucial for understanding disease progression and therapeutic efficacy. The kits must meet specific technical requirements, including compatibility with Nanopore PromethION 48 sequencers and the ability to generate substantial sequencing data in real-time. Interested parties must submit their capability statements to Andrea Clay at amcgee@nida.nih.gov by December 31, 2024, at 12:00 PM Eastern Time, as this notice is strictly for research and information purposes and does not obligate the government to award a contract.