Department of Health
and Human Services (HHS)
and Human Services (HHS)
May 21, 2021
PAR-21-082 - NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
National Institute of Allergy and Infectious Diseases (NIAID)
This Notice informs potential applicants of modifications to the Application Types Allowed for Funding Opportunity Announcement (FOA) PAR-21-082, “NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)”.
The following section of PAR-21-082 has been modified as indicated below and will apply starting with the September 13, 2021 receipt date:
Currently Reads:
Part 2. Section II. Award Information
Funding Instrument
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
Revision
New (Fast-Track)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB)
Renewal (Phase II)
New (SBIR Direct Phase II)
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the FOA.
Clinical Trial?
Required: Only accepting applications that propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget
NIAID will consider Phase I budget requests up to $300,000 total costs per year for up to 2 years (Fast-Track only); and Phase II or IIB budget requests up to $1,000,000 (total costs) per year for up to 3 years.
Budget requests must be very well justified. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Award Project Period
Durations up to 2 years for Phase I (for Fast Track applications) and up to 3 years for Phase II may be requested.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Modified to Read(changes shown inbold italics):
Part 2. Section II. Award Information
Funding Instrument
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
Revision
New (Fast-Track)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB)
Renewal (Phase II)
New (SBIR Direct Phase II)
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the FOA.
Clinical Trial?
Required: Only accepting applications that propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget
NIAID will consider Phase I budget requests up to $300,000 total costs per year for up to 2 years (Fast-Track only); and Phase II or IIB budget requests up to $1,000,000 (total costs) per year for up to 3 years.
Budget requests must be very well justified. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Award Project Period
Durations up to 2 years for Phase I (for Fast Track applications) and up to 3 years for Phase II may be requested.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
All other aspects of this FOA remain the same.
Natalia Kruchinin, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2919
Email:NIAIDU44@mail.nih.gov