Notice Number: NOT-DE-20-022

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."

NOT-DE-20-020, Notice of National Institute of Dental and Craniofacial Research (NIDCR) Participation in PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

NOT-DE-20-023 Notice of Special Interest (NOSI): Infrastructure Access for Research on Coronavirus Disease 2019 (COVID-19) Conducted in the National Dental Practice-Based Research Network

NOT-DE-20-024 Notice of Additional Receipt Dates for PAR-DE-20-073 National Dental Practice-Based Research Network Infrastructure Access (X01 Clinical Trial Not Allowed)

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

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

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). 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. These topics include prevention of SARS-COV-2 transmission and improvements in the detection and diagnosis of COVID-19; as well as acquisition of a more robust understanding of SARS-CoV-2 pathogenesis. Further, topics addressing influence and interaction of sex (a biological variable) and gender (a social construct), race and ethnicity, and those addressing questions about risk, prevention, and health outcomes are also of interest.

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.

ACE2 serves as major receptor for SARS-CoV-2. ACE2 is expressed in many organs vulnerable to SARS-CoV-2 infection. RNA profiling studies reveal that ACE2 is expressed in oral mucosa and is highly enriched in the epithelial cells of the tongue. The correlation of ACE2 expression with SARS-CoV-2 colonization of oral/nasal tissues, local infection of oral/nasal epithelia, viral replication, and viral shedding into oral fluids/nasal secretions is unexplored. To minimize entry of SARS-CoV-2 into oral/nasal epithelium, approaches are urgently needed to reduce ACE2 expression in oral/nasal tissues or block SARS-CoV-2-ACE2 interactions. Further, research on sex, race, ethnic, and age-based differences in ACE2 expression and its interaction with SARS-CoV-2 is also required. This work will be instrumental in developing therapeutic approaches for limiting COVID-19 onset and progression through oral/nasal routes.

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 order to contain 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

• Improvement of accuracy and level of detection of saliva-based point-of-care screening and rapid detection tests, to reduce false positives and false negatives, and development of home/self-tests, for SARS-CoV-2 virus or antibodies to improve triage and early disease management strategies

• Examination of the role of oral/nasal microbiota and ACE2 receptor on SARS-CoV-2 infectivity and carriage in oral fluids and nasal secretions, as gateways to the spread of infection into the respiratory tract via proof of principle studies

• Pilot testing of existing therapeutic modulators of oral microbiota that may limit infectivity of SARS-CoV-2

• Performance of research conducted within the National Dental Practice-Based Research Network (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 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.

Submit applications for this initiative in response to one of the following funding opportunity announcement (FOA) or the subsequent reissued equivalent through the expiration date of this notice:

• PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

• PA-18-935: Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

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-20-022 (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 non-responsive to terms of this NOSI will be not be considered.

• Eligible mechanisms include R42, R44, SB1, K01, K08, K23, K25, K99/R00, R01, R15, R37, U01, U19, and UH3.

• Requests are expected not to exceed $150,000 in total direct costs; strong compelling justification is needed to exceed this cap. In either case, total direct costs requested may not exceed the direct cost amount of the current year’s award. Maximum direct costs are exclusive of consortium/contractual Facilities and Administrative (F&A) costs.

• Requests are limited to one year of support.

• The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.

• The Research Strategy section of the application is limited to 6 pages.

• 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.

• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-F-ADMINSUPP . Competitive revision applications to PA-18-935 must use the application form package with the Competition ID that contains NOT-DE-20-022." The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

• Potential applicants are strongly encouraged to contact the Program Official listed in the Notice of Grant Award of the parent project to discuss responsiveness and appropriate mechanism before submission and to facilitate efficient processing of the request.

Inquiries