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NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement

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Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The National Institute of Dental and Craniofacial Research (NIDCR), under the National Institutes of Health and Department of Health and Human Services, is issuing a Notice of Funding Opportunity (PAR-27-058) for prospective observational or biomarker validation studies. This solicitation utilizes the U01 cooperative agreement mechanism to support well-designed clinical studies that prospectively collect data and biospecimens to improve dental, oral, and craniofacial health. Eligible projects include prospective cohort or multi-site studies, post-trial follow-ups to assess long-term adverse events, and advanced analytical or clinical biomarker validation studies aimed at improving diagnosis, prognosis, and treatment response prediction. This opportunity is a reissue of PAR-25-239 and is intended for investigators with expertise in clinical research or biomarker validation. While the solicitation was posted on July 8, 2025, with specific application cycles extending through June 2029, it is noted that clinical trials are not allowed under this specific NOFO. The initiative is authorized under the Public Health Service Act and federal regulations to foster meaningful collaborations and robust data collection to advance the existing knowledge base in craniofacial health.

General Info

NIDCR U01 funding for prospective observational or biomarker validation studies in craniofacial health.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

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

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
Contacts
Lorena Baccaglini PhD National Institute of Dental and Craniofacial Research (NIDCR
contact@example.gov
+1 (555) 000-0000

Full Description

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The National Institute of Dental and Craniofacial Research (NIDCR) intends to reissue a Notice of Funding Opportunity (NOFO) to solicit applications for observational or biomarker validation studies that require prospective collection or continued analysis of data/biospecimens. Well-designed, adequately powered, and well-executed clinical studies that prospectively collect data and/or biospecimens have the potential to generate robust results and advance the knowledge base to improve dental, oral and craniofacial health. Longitudinal studies allow for exposure assessment and its relation to disease development. A biomarker validation study aims to confirm the utility of strong candidate biomarker measures or endpoints—supported by robust preliminary data—for diagnosis, prognosis, monitoring, and/or predicting response to treatment. Study design examples include prospective cohort or multi-site studies, post-trial follow-up of clinical trial participants to assess long-term adverse events, and advanced analytical or clinical biomarker validation studies. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical research or biomarker validation studies are encouraged to consider applying for this new NOFO. NIDCR is authorized to forecast this opportunity under the Public Health Service Act (42 U.S.C §§ 241 and 284) and federal regulations (42 CFR Part 52 and 2 CFR Part 200).

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