Notice of Special Interest (NOSI): Availability of Emergency Awards for Limited Clinical Trials to Evaluate Therapeutic and Vaccine Candidates Against SARS-CoV-2
Notice Number:
NOT-AI-20-065

Key Dates

Release Date:

August 13, 2020

First Available Due Date:
September 01, 2020
Expiration Date:
September 01, 2021

Related Announcements

PAR-18-633 - 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-18-633 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-18-633 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-18-633 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

    September 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

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)

Sonnie Kim, M.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3287
NIAIDCOVIDIICTNOSI@mail.nih.gov


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