Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional)

The summary for the Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.
Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional): 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.
Federal Grant Title: Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional)
Federal Agency Name: National Institutes of Health (HHS-NIH11)
Grant Categories: Education Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-DA-20-015
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.279
CFDA Descriptions: Information not provided
Current Application Deadline: October 23rd, 2019
Original Application Deadline: October 23rd, 2019
Posted Date: June 25th, 2019
Creation Date: June 25th, 2019
Archive Date: November 28th, 2019
Total Program Funding:
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching: No
Last Updated: June 25th, 2019
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
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.
Link to Full Grant Announcement
http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-20-015.html
Grant Announcement Contact
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
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