FDA Grant for Drug and Medical Device Development Tools for Substance Use Disorders

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The FDA is offering a grant to support the development of drug and medical device development tools for substance use disorders. This funding opportunity aims to advance tools for FDA qualification programs, ultimately speeding up the creation and regulatory approval of new therapies for SUD. The grant will fund research to address unmet needs in SUD biomedical product development, with the goal of bringing innovative treatments to SUD patients more efficiently. Application deadline is Nov 14, 2022.

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Opportunity ID: 341058

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: RFA-DA-23-019
Funding Opportunity Title:: Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expedite Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)
Opportunity Category:: Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity:: Education
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s):: 93.279 — Drug Abuse and Addiction Research Programs
Cost Sharing or Matching Requirement:: No
Version:: Synopsis 1
Posted Date:: Jun 10, 2022
Last Updated Date:: Jun 10, 2022
Original Closing Date for Applications:: Nov 14, 2022
Current Closing Date for Applications:: Nov 14, 2022
Archive Date:: Dec 20, 2022
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:: The purpose of this funding opportunity announcement (FOA) is to inspire and support research to advance the drug and device development tools for ultimate submission to DDT or MDDT tool qualification program within either FDAs CDER or CDRH. The funding will be used to further the development of tools that, once qualified, will be available to fill unmet needs in SUD biomedical product development. This FOA ultimately aims to bring innovative treatments to SUD patients faster.
Link to Additional Information::
Grantor Contact Information:: If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version Modification Description Updated Date
Synopsis 1 Jun 10, 2022

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:
Competition ID: FORMS-G
Competition Title: Use for due dates on or after January 25, 2022
Opportunity Package ID: PKG00274912
Opening Date: Oct 14, 2022
Closing Date: Nov 14, 2022
Agency Contact Information:: eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V5.0]
PHS 398 Cover Page Supplement [V5.0]
Research And Related Other Project Information [V1.4]
Project/Performance Site Location(s) [V4.0]
Research and Related Senior/Key Person Profile (Expanded) [V4.0]
Research & Related Budget [V3.0]
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0]
PHS 398 Research Plan [V4.0]
SBIR/STTR Information [V3.0]
PHS Human Subjects and Clinical Trials Information [V3.0]
optional_forms PHS Assignment Request Form [V3.0]

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Packages

Assistance Listings Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions Who Can Apply:
FORMS-G Use for due dates on or after January 25, 2022 PKG00274912 Oct 14, 2022 Nov 14, 2022 View eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ Organization Applicants

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