Opportunity ID: 298668

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-18-703
Funding Opportunity Title: Early Stage Testing of Pharmacologic or Device -based Interventions for the Treatment of Mental Health Disorders (R33- Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Nov 14, 2017
Last Updated Date: Oct 14, 2020
Original Closing Date for Applications: Oct 15, 2018
Current Closing Date for Applications: Feb 18, 2021
Archive Date: Mar 20, 2021
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Special district governments
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
City or township governments
Public and State controlled institutions of higher education
Small businesses
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 (FOA) is to support the early stage testing of pharmacologic interventions with novel mechanisms of action or device-based interventions, for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g., schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder). Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase), prior to full diagnostic criteria being met. Ultimately, this FOA is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult and geriatric focused interventions are appropriate for this FOA. This R33 FOA supports single phased clinical trial awards. Applicants proposing high risk projects are encouraged to apply to the companion FOA, RFA-MH-18-702.

Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-703.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-MH-21-023 Oct 14, 2020
Updated expiration date in accordance with NOT-MH-18-044 Nov 14, 2017
Aug 31, 2018

DISPLAYING: Synopsis 3

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-18-703
Funding Opportunity Title: Early Stage Testing of Pharmacologic or Device -based Interventions for the Treatment of Mental Health Disorders (R33- Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Nov 14, 2017
Last Updated Date: Oct 14, 2020
Original Closing Date for Applications: Oct 15, 2018
Current Closing Date for Applications: Feb 18, 2021
Archive Date: Mar 20, 2021
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Special district governments
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
City or township governments
Public and State controlled institutions of higher education
Small businesses
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 (FOA) is to support the early stage testing of pharmacologic interventions with novel mechanisms of action or device-based interventions, for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g., schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder). Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase), prior to full diagnostic criteria being met. Ultimately, this FOA is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult and geriatric focused interventions are appropriate for this FOA. This R33 FOA supports single phased clinical trial awards. Applicants proposing high risk projects are encouraged to apply to the companion FOA, RFA-MH-18-702.

Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-703.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 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-18-703
Funding Opportunity Title: Early Stage Testing of Pharmacologic or Device -based Interventions for the Treatment of Mental Health Disorders (R33- Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Nov 14, 2017
Last Updated Date: Aug 31, 2018
Original Closing Date for Applications:
Current Closing Date for Applications: Oct 15, 2020
Archive Date: Nov 14, 2020
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Special district governments
Native American tribal governments (Federally recognized)
State governments
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
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
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than 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 (FOA) is to support the early stage testing of pharmacologic interventions with novel mechanisms of action or device-based interventions, for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g., schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder). Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase), prior to full diagnostic criteria being met. Ultimately, this FOA is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult and geriatric focused interventions are appropriate for this FOA. This R33 FOA supports single phased clinical trial awards. Applicants proposing high risk projects are encouraged to apply to the companion FOA, RFA-MH-18-702.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-703.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: RFA-MH-18-703
Funding Opportunity Title: Early Stage Testing of Pharmacologic or Device -based Interventions for the Treatment of Mental Health Disorders (R33- Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Aug 31, 2018
Last Updated Date:
Original Closing Date for Applications:
Current Closing Date for Applications: Oct 15, 2018
Archive Date: Nov 20, 2018
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Special district governments
Native American tribal governments (Federally recognized)
State governments
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
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
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than 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 (FOA) is to support the early stage testing of pharmacologic interventions with novel mechanisms of action or device-based interventions, for the treatment of symptoms or domains of altered functions in individuals with mental illness (e.g., schizophrenia, depression, autism, obsessive compulsive disorder, anxiety, bipolar disorder). Early intervention studies are also encouraged where symptoms of a disorder have been identified in subjects (a prodromal phase), prior to full diagnostic criteria being met. Ultimately, this FOA is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. Pediatric, adult and geriatric focused interventions are appropriate for this FOA. This R33 FOA supports single phased clinical trial awards. Applicants proposing high risk projects are encouraged to apply to the companion FOA, RFA-MH-18-702.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-703.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

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 PKG00236217 Jan 14, 2018 May 24, 2020 View
FORMS-F Use for due dates on or after May 25, 2020 PKG00260067 Jan 14, 2018 Feb 18, 2021 View

Package 1

Mandatory forms

298668 RR_SF424_2_0-2.0.pdf

298668 PHS398_CoverPageSupplement_4_0-4.0.pdf

298668 RR_OtherProjectInfo_1_4-1.4.pdf

298668 PerformanceSite_2_0-2.0.pdf

298668 RR_KeyPersonExpanded_2_0-2.0.pdf

298668 RR_Budget_1_4-1.4.pdf

298668 PHS398_ResearchPlan_4_0-4.0.pdf

Optional forms

298668 RR_SubawardBudget30_1_4-1.4.pdf

298668 PHS_AssignmentRequestForm_2_0-2.0.pdf

Package 2

Mandatory forms

298668 RR_SF424_2_0-2.0.pdf

298668 PHS398_CoverPageSupplement_5_0-5.0.pdf

298668 RR_OtherProjectInfo_1_4-1.4.pdf

298668 PerformanceSite_2_0-2.0.pdf

298668 RR_KeyPersonExpanded_2_0-2.0.pdf

298668 RR_Budget_1_4-1.4.pdf

298668 PHS398_ResearchPlan_4_0-4.0.pdf

298668 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf

Optional forms

298668 RR_SubawardBudget30_1_4-1.4.pdf

298668 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-09T20:07:34-05:00

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