PAR-21-082: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2021.
National Institutes of Health offered grants to small businesses. Applications closed on January 13, 2024.
From the official notice on Grants.gov, last changed January 14, 2021. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeU44
- Clinical trialsRequired
- Funded byNIAID
- Median yearly award$988,772
- Typical project length2 years
Projects funded under PAR-21-082 were run by National Institute of Allergy and Infectious Diseases (NIAID, 5 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read PAR-21-082 in the NIH Guide.
Other notices with this title
| Notice | Posted | Deadline | Status |
|---|---|---|---|
| PAR-24-099 | January 29, 2024 | Closed November 17, 2025 | Closed |
Key dates
| Posted | January 14, 2021 |
|---|---|
| Deadline | January 13, 2024 |
| Archived by Grants.gov | February 18, 2024 |
Who can apply
This opportunity was open to small businesses.
- Small businesses
Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Is this a realistic fit?
- Most of the program's money (67% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program.
Funded under PAR-21-082 so far
NIH funded 5 projects under PAR-21-082 in fiscal 2022 to 2026, at 5 institutions. The median yearly award was $988,772.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy | Moonlight Therapeutics, Inc. | 2026 | $999,927 |
| Phase 1 Clinical Trial to Assess the Pharmacokinetics, Safety and Tolerance of a Zanamivir Transdermal System in Healthy Subjects | TSRL, Inc. | 2026 | $999,298 |
| Bacterial Pneumonia Therapeutic Antibody Safety Trial | Trellis Bioscience, Inc. | 2026 | $998,879 |
| Targeting BCMA+ Cells with RNA-engineered CAR T cells to treat Lupus: A Phase 2 clinical study | Cartesian Therapeutics, Inc. | 2024 | $149,008 |
| PfSPZ Vaccine for Prevention of Plasmodium falciparum malaria | Sanaria, Inc. | 2022 | $988,772 |
Who has won Allergy and Infectious Diseases Research grants before
From fiscal 2021 to 2025, Allergy and Infectious Diseases Research (93.855) awarded $22 billion across 13,282 grant awards, an average of $1.6 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Fred Hutchinson Cancer Center | Washington | 85 | $938 million |
| Duke University | North Carolina | 230 | $781 million |
| University of California, Los Angeles | California | 138 | $745 million |
| The Johns Hopkins University | Maryland | 321 | $668 million |
| Emory University | Georgia | 282 | $650 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is PAR-21-082 still open?
No. It closed on January 13, 2024.
Who can apply for NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)?
National Institutes of Health accepted applications from small businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)?
Closed January 13, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.
Who has been funded under PAR-21-082?
NIH RePORTER lists 5 projects funded under PAR-21-082 in fiscal 2022 to 2026, at 5 institutions. The most were at Moonlight Therapeutics, Inc., TSRL, Inc., Trellis Bioscience, Inc.
Who has won Allergy and Infectious Diseases Research grants before?
The largest recipients over five fiscal years were Fred Hutchinson Cancer Center, Duke University, University of California, Los Angeles. The program made 13,282 awards worth $22 billion in that time.
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