NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
ID: 347306Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/347306

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-23-162.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity titled "NIDCR Prospective Observational or Biomarker Validation Study" through a Cooperative Agreement (U01 Clinical Trial Not Allowed). This initiative aims to support investigator-initiated observational studies or biomarker validation that require the prospective collection of data and biospecimens, with a focus on enhancing oral health through rigorous scientific research. The funding opportunity is significant for advancing the understanding of dental diseases and conditions, emphasizing the need for strategic designs in data collection and analysis. Interested applicants, including various educational institutions and nonprofit organizations, must submit their proposals by June 5, 2025, with funding expected to expire on May 8, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-23-162-Full-Announcement.html
    PAR-23-162.html
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NIDCR Prospective Observational or Biomarker Validation Study" through a Cooperative Agreement (U01 Clinical Trial Not Allowed). This funding supports investigator-initiated observational studies or biomarker validation that necessitate prospective data and biospecimen collection. Key dates include application openings starting on May 5, 2023, and the last application due on June 5, 2025, with a funding expiration on May 8, 2026. Eligible applicants include higher education institutions, various nonprofit organizations, for-profit entities, and government agencies. The primary goal is to enhance oral health through clinical studies acquiring high-quality data. The emphasis is on rigorous scientific research that improves understanding of dental diseases and conditions. Studies should demonstrate strategic designs for robust data collection and analysis and may include longitudinal epidemiological studies or biomarker validation in clinical contexts. Applications must adhere to strict submission guidelines, including the submission of a Quality Management Plan and Data Management Plan. Importantly, clinical trial proposals will not be accepted under this funding opportunity. The rigorous review process will assess significance, innovation, and approach, with substantial agency involvement to ensure alignment with NIH priorities.
    Similar Opportunities
    NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement
    National Institutes of Health
    The National Institutes of Health (NIH) is announcing a forthcoming opportunity for a cooperative agreement focused on prospective observational or biomarker validation studies through the National Institute of Dental and Craniofacial Research (NIDCR). This initiative aims to solicit applications for studies that involve the prospective collection or continued analysis of data and biospecimens, with an emphasis on well-designed clinical studies that can enhance understanding and improve dental, oral, and craniofacial health. Such studies are crucial for assessing exposure and its relationship to disease development, as well as validating biomarkers for diagnosis and treatment response. While applications are not currently being accepted, interested investigators are encouraged to prepare collaborative proposals in anticipation of the opportunity, which is expected to be formally announced in November 2025, with a closing date for submissions in February 2026. For further inquiries, potential applicants can contact Dr. Lorena Baccaglini at lorena.baccaglini@nih.gov or by phone at 301-435-7908.
    NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NIDCR Drug, Biologic, Device, and Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement, designated as UG3/UH3. This initiative aims to support the planning and execution of clinical trials that enhance dental, oral, and craniofacial health, utilizing a two-phased approach: a one-year UG3 planning phase followed by a potential five-year UH3 implementation phase. Eligible applicants include higher education institutions, nonprofits, and local or state governments, with a focus on proposals that test FDA-regulated products and involve significant NIH engagement. Interested parties should note that the application deadline is January 6, 2028, and can find further details and contact information at grantsinfo@nih.gov or through the provided link to the full opportunity announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-057.html.
    Dental Primary Care Practice-Based Research Network: Clinical Trial or Observational Study Planning and Implementation Cooperative Agreement
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a cooperative agreement opportunity titled "Dental Primary Care Practice-Based Research Network: Clinical Trial or Observational Study Planning and Implementation." This initiative aims to support clinical trials and large observational studies conducted within a Dental Primary Care Practice-Based Research Network (PBRN), focusing on integrating oral health care into overall medical care, including screening for medical conditions and appropriate referrals. The opportunity is particularly relevant for oral health practitioners interested in utilizing the PBRN infrastructure for research, with an expected three awards anticipated. Interested applicants can reach out to Dena Fischer at dena.fischer@nih.gov or by phone at 301-594-4876 for further information. The estimated synopsis post date is March 2, 2026, with applications expected to close on September 7, 2026, and awards projected for April 30, 2027.
    Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the continuation or revision of clinical trials under the National Institute of Dental and Craniofacial Research (NIDCR) through a UH3 Exploratory/Developmental Cooperative Agreement. This initiative aims to support competing renewals or competitive revisions of ongoing clinical trials that focus on dental, oral, and craniofacial health, emphasizing the importance of structured data generation in advancing healthcare research. Eligible applicants include a wide range of institutions, such as public and private entities, nonprofits, and government organizations, with the application deadline set for January 6, 2028. Interested parties can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries regarding the application process.
    NIDCR Research Grants for Analyses of Existing Genomics Data (R01) (Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering research grants through the NIDCR Research Grants program aimed at analyzing existing genomic data related to human dental, oral, and craniofacial (DOC) health. The primary objective is to support innovative research projects that utilize statistical and computational methods to address significant biomedical questions, particularly focusing on oral health disparities and the pathogenesis of genetic variants. This funding opportunity encourages the use of publicly available genomic datasets while requiring experimental validation of results and adherence to NIH's data sharing policy. Interested applicants, including higher education institutions and nonprofits, must submit their proposals by May 7, 2026, and can find additional information and application guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov.
    NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" aimed at supporting the planning and implementation of clinical trials focused on behavioral and social interventions related to dental, oral, and craniofacial health. This initiative consists of a two-phase approach: the UG3 phase, which allows for up to two years of planning, and the UH3 phase, which can extend up to five years for clinical trial execution, contingent upon meeting specific scientific milestones. This grant is crucial for advancing research methodologies in dental and oral health, particularly in addressing health disparities, and is open to a diverse range of applicants, including higher education institutions and community organizations. Interested parties should note that the application deadline is January 6, 2028, with an award ceiling of $500,000, and can direct inquiries to grantsinfo@nih.gov for further information.
    NIDCR Research Grants for Analyses of Existing Genomics Data (R01) (Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NIDCR Research Grants for Analyses of Existing Genomics Data (R01)" aimed at supporting research projects that address human dental, oral, and craniofacial diseases through the analysis of existing genomic data. Applicants are encouraged to utilize innovative statistical, computational, and artificial intelligence methods to analyze publicly available datasets, with a focus on oral health disparities and identifying genetic intervention targets. This grant emphasizes the importance of advancing genomic research in oral health and is open to a wide range of eligible applicants, including higher education institutions and nonprofit organizations. The application deadline is May 7, 2026, and interested parties can find more information and contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-23-133.html.
    NIDCR Small Research Grants for Analyses of Existing Genomics Data (R03 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Dental and Craniofacial Research (NIDCR), has announced a funding opportunity for Small Research Grants (R03) aimed at analyzing existing genomic data related to dental, oral, and craniofacial health. This initiative encourages projects that utilize publicly available genomic data and advanced methodologies, focusing on oral health disparities and biological pathways to identify intervention targets. The grant supports projects with budgets up to $200,000 over two years, with applications due by May 7, 2026. Interested applicants can find more information and guidelines at the NIH Grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NIDCR Small Research Grants for Analyses of Existing Genomics Data (R03 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering small research grants (R03) through the NIDCR for the analysis of existing genomic data related to human dental, oral, and craniofacial biology. The primary objective is to support innovative research projects that utilize statistical and computational methodologies, including artificial intelligence and machine learning, to enhance understanding of diseases and conditions, with a particular emphasis on addressing oral health disparities. This funding opportunity allows for up to $200,000 in direct costs over a two-year period, with applications opening on January 16, 2025, and submissions due by 5 PM local time on May 7, 2026. Interested applicants can find more information and guidance by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-166.html.
    NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed), aimed at supporting early-stage researchers in oral, dental, and craniofacial research. This grant program is designed for new investigators who have not previously secured substantial NIH funding, encouraging them to conduct pilot studies and developmental research projects that will generate preliminary data for future R01 proposals. Eligible applicants include a variety of institutions, such as historically black colleges and universities, tribal colleges, and faith-based organizations, with each application able to request up to $200,000 for direct costs over a project duration of up to two years. Interested parties should note that the application deadline is January 7, 2028, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.