NOT-AI-20-051: Notice of Special Interest (NOSI): Select Research Areas for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)

Notice of Special Interest (NOSI): Select Research Areas for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)

Notice Number:

NOT-AI-20-051

Key Dates

Release Date:

May 19, 2020

First Available Due Date:

June 16, 2020

Expiration Date:

New Date - September 08, 2020 per issuance of NOT-AI-20-066 (Original Expiration Date - September 8, 2021)

Related Announcements

NOT-AI-20-066

PA-20-200 NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

NIAID is issuing this Notice of Special Interest (NOSI) to highlight the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) in select scientific areas using the following funding mechanisms:

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-19-272 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-19-270 - PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

This NOSI replaces NOT-AI-20-031, which was expired following the release of two FOAs that provide an expedited funding mechanism for research on SARS-CoV-2 and COVID-19 using the R01 and R21 funding mechanisms. Applicants interested in pursuing NIH funding support utilizing either of these mechanisms is encouraged to consider the following funding opportunities:

Emergency Awards: Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) (R01 Clinical Trial Not Allowed): https://grants.nih.gov/grants/guide/pa-files/PAR-20-178.html
Emergency Awards: Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) (R21 Clinical Trial Not Allowed): https://grants.nih.gov/grants/guide/pa-files/PAR-20-177.html

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus was identified as the causative agent of a global pandemic of viral pneumonia. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Many other aspects of viral pathogenesis, natural history, and host range are poorly understood. Given this, there is an urgent public health need to better understand the SARS-CoV-2/COVID-19.

Research Objectives

In order to rapidly improve our understanding and available control measures for SARS-CoV-2 and COVID-19, NIAID is encouraging the submission of applications to address the following research areas of interest:

Studies to understand critical aspects of viral infection, replication, pathogenesis, and transmission;
Studies on the evolution and emergence of SARS-CoV-2 viruses including the identification of factors that affect viral host-range and virulence;
Development of sensitive, specific, and rapid clinical diagnostic tests for SARS-CoV-2;
Development of SARS-COV-2 therapeutic candidates, especially broad-spectrum therapeutics against multiple coronavirus strains;
Identification and evaluation of the innate, cellular and humoral immune responses to SARS-CoV-2 infection, including, but not limited to: cross-reactive antibodies from individuals exposed to SARS-CoV-2 and other coronaviruses; viral epitopes critical for T cell activation or antibody binding and neutralization; immune-mediated pathology or host factors that might predispose to severe infection; and studies to examine duration of protection or the potential for reinfection; and
Development of SARS-CoV-2 vaccine candidates, including approaches for pan-coronavirus protection, that include emerging antigen design strategies, novel platforms or delivery approaches, adjuvants, or assessing cross-neutralization potential of SARS-CoV vaccine candidates.

Application and Submission Information

This notice applies to due dates on or after June 16, 2020 and subsequent receipt dates through September 8, 2021.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice:

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-19-272 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-19-270 - PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

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

For funding consideration, applicants must include "NOT-AI-20-051 (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.

Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

Funds awarded using appropriations provided by the The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 and The Coronavirus Aid, Relief, and Economic Security (CARES) Act will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Diane Post, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3348
Email: postd@niaid.nih.gov

Michael Minnicozzi, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3532
Email: minnicozzim@niaid.nih.gov

Martin Gutierrez
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:240-292-4844
Email: mgutierrez@niaid.nih.gov