This grant from the National Institutes of Health aims to support the development of Clinical Outcome Assessments (COAs) specifically for Substance Use Disorders (SUDs) to be qualified by the FDA as Drug Development Tools (DDTs). The goal is to create reliable and validated COAs, such as patient-reported outcomes (PRO) or clinician-reported outcomes (ClinRO), which could enhance the regulatory approval process for new treatments in SUDs. Applications may involve developing new COAs or optimizing existing ones for use in SUD clinical trials. Successful qualification of COAs as DDTs could ultimately improve the assessment of treatment outcomes in SUD clinical research.
Opportunity ID: 317503
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-20-015 |
| Funding Opportunity Title: | Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.279 — Drug Abuse and Addiction Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 25, 2019 |
| Last Updated Date: | Jun 25, 2019 |
| Original Closing Date for Applications: | Oct 23, 2019 |
| Current Closing Date for Applications: | Oct 23, 2019 |
| Archive Date: | Nov 28, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Small businesses City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this funding opportunity announcement is to support the development of Clinical Outcome Assessments (COAs) for Substance Use Disorders (SUDs) aiming to be qualified by the Food and Drug Administration (FDA) as Drug Development Tools (DDTs).The FDA qualification of a COA is based on a review of the evidence to support the conclusion that the COA is a “well-defined and reliable assessment of a targeted concept(s) in a specified context of use in adequate and well-controlled investigations”. Once qualified as a DDT, the COA will become a publicly available instrument and can be deployed within a specified context of use (COU) as a sensitive, reliable and validated instrument. COA can be a patient-reported outcome (PRO), a clinician-reported outcome (ClinRO), an observer-reported outcome (ObsRO) or a performance outcome (PerfO). Applications may focus on the creation and development of a new COA, or on modification/optimization of an existing COA. The final goal is to have FDA-qualified COA(s) measure(s) that would be acceptable to regulatory authorities when used in SUDs clinical trials. It is expected that such FDA-qualified COAs will have a potential to catalyze the regulatory approval path for new treatments. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-20-015.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 |
|---|---|---|
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 | FORMS-E | PKG00252329 | Sep 23, 2019 | Oct 23, 2019 | View |
Package 1
Mandatory forms
317503 RR_SF424_2_0-2.0.pdf
317503 PHS398_CoverPageSupplement_4_0-4.0.pdf
317503 RR_OtherProjectInfo_1_4-1.4.pdf
317503 PerformanceSite_2_0-2.0.pdf
317503 RR_KeyPersonExpanded_2_0-2.0.pdf
317503 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
317503 RR_Budget_1_4-1.4.pdf
317503 RR_SubawardBudget30_1_4-1.4.pdf
317503 PHS398_ModularBudget_1_2-1.2.pdf
317503 PHS_AssignmentRequestForm_2_0-2.0.pdf
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