Notice Number: NOT-DE-20-023

Key Dates
Release Date: May 05, 2020

NOT-DE-20-025 "NIDCR Announces Availability of Frequently Asked Questions (FAQs) for Coronavirus Disease 2019 (COVID-19)-Related Notices of Special Interest (NOSI) NOT-DE-20-022 and NOT-DE-20-023."

PAR-20-073 National Dental Practice-Based Research Network Infrastructure Access (X01 Clinical Trial Not Allowed)

NOT-DE-20-024 Notice of Additional Receipt Dates for PAR-20-073

NOT-DE-20-022 Notice of Special Interest (NOSI): Availability of Urgent Competitive Revisions and Administrative Supplements for Coronavirus Disease 2019 (COVID-19) Research within the Mission of NIDCR

Issued by
National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

National Institute of Dental and Craniofacial Research (NIDCR) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19) conducted in the National Dental Practice-Based Research Network (PBRN). NIDCR will place a high priority on topics that would be of immediate and high impact to protect and ensure the safety of personnel and patients in dental practices, prevent SARS-CoV-2 transmission, and improve detection and diagnosis of COVID-19. Successful X01 applicants will be given access to the National Dental PBRN infrastructure to support an individual project. Successful applications will utilize the resources of and be funded through the National Dental PBRN Administrative and Resource Center and/or National Coordinating Center for study planning and implementation.

Background

New knowledge about SARS-CoV-2 transmissibility, stability on surfaces, viral particle size, and presence in saliva have catalyzed a need to consider how the practice of dentistry will be performed in the near and long-term future. Dental practice today involves close person-to-person contact and procedures that produce aerosols. Many practice environments are in non-hospital settings and utilize open-concept layouts. These characteristics markedly increase the potential for viral transmission via aerosols or droplets. The American Dental Association has urged dental offices to remain closed during the pandemic except for emergency care, and recent polls have indicated that over 95% of surveyed dentists have followed this recommendation. During this time, the lack of oral care may exacerbate existing oral health problems. Importantly, the practice of dentistry must transform in the presence of COVID-19 and prepare for future pandemics.

Research Objectives

Since the identification of the highly contagious and transmissible SARS-CoV-2 and its associated disease COVID-19, there arose a significant need to understand the pathogenesis, prevent transmission, and mitigate the impact of this disease. Health care personnel and other front-line professionals are particularly susceptible to aerosol or droplet virus transmission. The practice of dentistry must transform, with short-term modifications to address immediate needs, and impactful innovations to change dental practice to reduce the risk of virus transmission, especially in non-hospital settings. Additionally, the oral/nasal route serves as SARS-CoV-2 point of entry into the host and thus plays a pivotal role in viral spread and COVID-19 onset and progression. As such, limiting viral infectivity, replication, shedding, and load at the point of entry is crucial in containing COVID-19 progression and viral transmission.

NIDCR encourages submission of applications on the following topic areas of potentially immediate and high impact in combatting COVID-19.

• Modifications to dental practice and/or treatment space to prevent aerosol and droplet pathogen transmission

• Determination of the extent to which viral pathogens are transmitted via aerosol and droplet routes during treatment in dental settings

• Design and implementation of strategies to achieve the Center for Disease Control and Prevention (CDC) second-tier Transmission-Based Precautions in dental practice

• Implementation of disinfection processes to ensure treatment spaces and equipment are devoid of transmissible viral pathogens

• Development of interventions to protect health care workers, other front-line professionals, and patients from viral transmission

• Assessment of the impact of dental care delivery delays upon oral health needs and access to care, especially for vulnerable populations and those affected by health disparities

• Development or implementation of strategies to triage and manage patients with oral care needs, including via remote or virtual means

• Implementation of FDA-approved detection and screening tests for SARS-CoV-2 virus and antibodies to improve triage and early disease management strategies

Proposed research studies will be conducted in, utilize the resources of, and be funded through the National Dental PBRN, which supports clinical research studies in dental practices with dental practitioners and their consenting patients, as well as survey studies of practitioners and/or their patients. Potential applicants are strongly encouraged to contact NIDCR Scientific/Research staff to discuss the suitability of conducting the proposed study within the dental PBRN infrastructure and to review the process for potential grant applicants to interact with and utilize National Dental PBRN resources.

Application and Submission Information

Application due dates: June 1, 2020, and November 2, 2020, by 5:00 PM local time of applicant organization.

Applications in response to this NOSI must be submitted to the following FOA through the expiration date of this notice:

• PAR-20-073: National Dental Practice-Based Research Network Infrastructure Access (X01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the parent funding opportunity announcement must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DE-20-023 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

• Applications must use "FORMS-F" for application due dates on or after May 25, 2020.

• Applications non-responsive to the terms of this NOSI will be not be considered.

• Requests are limited to a one year project duration.

• Where applicable, provide details of appropriate biohazard management plans commensurate with the level of risk. Applications conducting research on the SARS-CoV-2 virus or specimens with possible SARS-CoV-2 infection must address protections against potential biohazards, including details on access to special facilities, e.g., Biosafety Level 3/4 (BSL3/4) laboratories.

• Potential applicants are strongly encouraged to contact NIDCR Scientific/Research staff to discuss the suitability of conducting the proposed study within the National Dental PBRN. In addition, given the exigency, Proposing a Study Idea to the National Dental PBRN before submitting an X01 application will help expedite the study, if selected.

Inquiries

Please direct all inquiries to:

Dena Fischer, DDS, MSD, MS
Center for Clinical Research
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: dena.fischer@nih.gov