EXPIRED
August 13, 2020
NOT-AI-21-036 - Notice of Early Expiration of NOT-AI-20-065
PAR-21-083 - NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
National Institute of Allergy and Infectious Diseases (NIAID)
This Notice of Special Interest encourages cooperative agreement applications for implementation of investigator-initiated high-risk clinical trials, as defined by NIAID in PAR-21-083 and NOT-AI-16-084, that will augment ongoing and planned clinical trials of therapeutic and vaccine candidates directed against SARS-CoV-2 to evaluate:
Please note, studies evaluating behavioral interventions (e.g., impact of face masks, hand- washing, social distancing) and those focused on disinfecting surfaces and equipment are not responsive and will not be considered for this NOSI initiative.
Investigators interested in responding to this NOSI are strongly encouraged to submit a written request for prior consultation to the email address listed below prior to submission of an NIAID Clinical Trial Implementation (U01) Cooperative Agreement application in response to PAR-21-083 to discuss the proposed project in the context of the needs identified above. This request should be as succinct as possible and include the study title and a brief description of the study and product to be evaluated; study PI; primary institution and potential collaborating sites; industry partners, if applicable; and a cost estimate. As a reminder, per NIH policy, applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIAID staff listed below no later than 6 weeks before submission and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Application and Submission Information
Submit applications for this NOSI initiative to the following funding opportunity announcements (FOAs) or any reissues of this announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Application Due Dates |
September 14, 2020 |
AIDS Application Due Dates |
September 14, 2020 |
Scientific Merit Review |
Applications will be reviewed and awarded to meet the goals of this program. |
Advisory Council Review |
Not Applicable |
Earliest Start Date |
Applications will be reviewed and awarded to meet the goals of this program. |
Expiration Date |
March 15, 2021 |
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 not be considered for the NOSI initiative.
Scientific/Research Contact(s)
Sonnie Kim, M.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3287
NIAIDCOVIDIICTNOSI@mail.nih.gov