Key Dates

Related Announcements

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)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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:

• SARS-CoV-2 candidate vaccines
• non-vaccine biomedical prevention of SARS-CoV-2 infection and/or COVID-19
• therapeutic approaches to treat COVID-19

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.

• PAR-21-083 NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

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

• Applications will be accepted once a month, from 09/14/2020 through 09/14/2021 5:00PM local time of the applicant organization

• Application Due Dates	September 14, 2020 October 14, 2020 November 14, 2020 December 14, 2020 January 14, 2021 February 14, 2021 March 14, 2021 April 14, 2021 May 14, 2021 June 14, 2021 July 14, 2021 August 14, 2021 September 14, 2021
  AIDS Application Due Dates	September 14, 2020 October 14, 2020 November 14, 2020 December 14, 2020 January 14, 2021 February 14, 2021 March 14, 2021 April 14, 2021 May 14, 2021 June 14, 2021 July 14, 2021 August 14, 2021 September 14, 2021
  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

• For funding consideration, applicants must include NOT-AI-20-065 (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 NOSI 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 not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Sonnie Kim, M.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3287
[email protected]