The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is offering a grant to small businesses to develop therapeutic agents for alcohol-related disorders. The grant supports Investigational New Drug (IND)-enabling studies to ensure the therapeutic candidate meets required qualifications for clinical applications. Successful projects will have an IND application submitted to the FDA by the end of the funding period. Early-phase clinical trials are supported but not mandatory. Closing date for applications is March 25, 2021.
Opportunity ID: 300042
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-580 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 -Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.273 — Alcohol Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 12, 2018 |
| Last Updated Date: | Jan 06, 2021 |
| Original Closing Date for Applications: | Dec 04, 2020 |
| Current Closing Date for Applications: | Mar 25, 2021 |
| Archive Date: | Apr 24, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA. An identified candidate, having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-580.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Updated expiration date in accordance with NOT-AA-20-026 | Jan 06, 2021 | |
| Jan 12, 2018 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-580 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 -Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.273 — Alcohol Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 12, 2018 |
| Last Updated Date: | Jan 06, 2021 |
| Original Closing Date for Applications: | Dec 04, 2020 |
| Current Closing Date for Applications: | Mar 25, 2021 |
| Archive Date: | Apr 24, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA. An identified candidate, having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-580.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-580 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 -Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.273 — Alcohol Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 12, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Dec 04, 2020 |
| Archive Date: | Jan 09, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA. An identified candidate, having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-580.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00237601 | Feb 27, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260459 | Feb 27, 2018 | Mar 25, 2021 | View |
Package 1
Mandatory forms
300042 RR_SF424_2_0-2.0.pdf
300042 PHS398_CoverPageSupplement_4_0-4.0.pdf
300042 RR_OtherProjectInfo_1_4-1.4.pdf
300042 PerformanceSite_2_0-2.0.pdf
300042 RR_KeyPersonExpanded_2_0-2.0.pdf
300042 RR_Budget_1_4-1.4.pdf
300042 RR_SubawardBudget30_1_4-1.4.pdf
300042 PHS398_ResearchPlan_4_0-4.0.pdf
300042 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
300042 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
300042 RR_SF424_2_0-2.0.pdf
300042 PHS398_CoverPageSupplement_5_0-5.0.pdf
300042 RR_OtherProjectInfo_1_4-1.4.pdf
300042 PerformanceSite_2_0-2.0.pdf
300042 RR_KeyPersonExpanded_2_0-2.0.pdf
300042 RR_Budget_1_4-1.4.pdf
300042 RR_SubawardBudget30_1_4-1.4.pdf
300042 PHS398_ResearchPlan_4_0-4.0.pdf
300042 SBIR_STTR_Information_1_3-1.3.pdf
300042 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
300042 PHS_AssignmentRequestForm_3_0-3.0.pdf
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