The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is offering a grant through the Small Business Technology Transfer (STTR) program to support the development of therapeutic agents for alcohol-related disorders. This grant focuses on Investigational New Drug (IND)-enabling studies to prepare a therapeutic candidate for IND application submission to the FDA. While early-phase clinical trials are not required, successful projects should have an IND application in progress by the end of the funding period. Applicants should have a candidate with essential properties for clinical application, including bioactivity, stability, and efficacy.
Opportunity ID: 270520
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-073 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (UT2) |
| 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: | Dec 15, 2014 |
| Last Updated Date: | Feb 18, 2015 |
| Original Closing Date for Applications: | Dec 11, 2017 |
| Current Closing Date for Applications: | Feb 18, 2015 |
| Archive Date: | Mar 18, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following:Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;3.i. SBIR and STTR. Be a concern which is more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; ORii. SBIR-only. Be a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern; ORiii. SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.4. Has, including its affiliates, not more than 500 employees. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) ) directed to Small Business Technology Transfer(STTR) applicants is dedicated to 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 Small Business Technology Transfer (STTR) 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-15-073.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 |
|---|---|---|
| Modified the close date field in accordance with NOT-AA-15-008. | Feb 18, 2015 | |
| Feb 18, 2015 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-073 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (UT2) |
| 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: | Dec 15, 2014 |
| Last Updated Date: | Feb 18, 2015 |
| Original Closing Date for Applications: | Dec 11, 2017 |
| Current Closing Date for Applications: | Feb 18, 2015 |
| Archive Date: | Mar 18, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following:Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;3.i. SBIR and STTR. Be a concern which is more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; ORii. SBIR-only. Be a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern; ORiii. SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.4. Has, including its affiliates, not more than 500 employees. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) ) directed to Small Business Technology Transfer(STTR) applicants is dedicated to 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 Small Business Technology Transfer (STTR) 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-15-073.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-15-073 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (UT2) |
| 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: | Feb 18, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Dec 11, 2017 |
| Archive Date: | Jan 11, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) ) directed to Small Business Technology Transfer(STTR) applicants is dedicated to 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 Small Business Technology Transfer (STTR) 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-15-073.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-C | FORMS-C | PKG00210774 | Feb 09, 2015 | Feb 19, 2015 | View |
Package 1
Mandatory forms
270520 RR_SF424_2_0-2.0.pdf
270520 SBIR_STTR_Information_1_1-1.1.pdf
270520 RR_KeyPersonExpanded_2_0-2.0.pdf
270520 RR_OtherProjectInfo_1_3-1.3.pdf
270520 RR_Budget_1_3-1.3.pdf
270520 RR_SubawardBudget30_1_3-1.3.pdf
270520 PerformanceSite_2_0-2.0.pdf
270520 PHS398_ResearchPlan_2_0-2.0.pdf
270520 PHS398_CoverPageSupplement_2_0-2.0.pdf
Optional forms
270520 PlannedReport-1.0.pdf
270520 PHS398_CumulativeInclusionReport-1.0.pdf
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