This NCCIH grant is for the purpose of establishing Clinical Coordinating Centers to lead and manage investigator-initiated multi-site clinical trials. These trials will investigate the effects of complementary and integrative mind and body interventions, which involve physical and/or psychological therapeutic inputs, within NCCIH’s designated high research priority areas. Applicants must submit a robust scientific rationale and a comprehensive operational plan, detailing project management, participant recruitment and retention, performance milestones, and dissemination strategies. The funding mechanism is a two-phase, milestone-driven UG3/UH3 cooperative agreement. A corresponding Data Coordinating Center application, outlining data analysis and management, must be submitted simultaneously for consideration.
Opportunity ID: 334149
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-243 |
| Funding Opportunity Title: | Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 14, 2021 |
| Last Updated Date: | Jun 14, 2021 |
| Original Closing Date for Applications: | Mar 11, 2024 |
| Current Closing Date for Applications: | Mar 11, 2024 |
| Archive Date: | Apr 16, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) City or township governments Private institutions of higher education Small businesses Public and State controlled 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated multi-site clinical trials (e.g. efficacy, effectiveness or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH designated areas of high research priority. Clinical Coordinating Centers should develop and implement the proposed fully powered multi-site clinical trial. The objective of a Clinical Coordinating Center application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this FOA will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-XX-XXX proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans). Applicants are encouraged to contact the appropriate the Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-243.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 334149 Full Announcement-PAR-21-243 -> PAR-21-243-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270472 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00267734 | Sep 20, 2021 | Jan 24, 2022 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278437 | Nov 15, 2022 | Mar 11, 2024 | View |
Package 1
Mandatory forms
334149 RR_SF424_5_0-5.0.pdf
334149 PHS398_CoverPageSupplement_5_0-5.0.pdf
334149 RR_OtherProjectInfo_1_4-1.4.pdf
334149 PerformanceSite_4_0-4.0.pdf
334149 RR_KeyPersonExpanded_4_0-4.0.pdf
334149 RR_Budget10_3_0-3.0.pdf
334149 PHS398_ResearchPlan_4_0-4.0.pdf
334149 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
334149 RR_SubawardBudget10_30_3_0-3.0.pdf
334149 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
334149 RR_SF424_2_0-2.0.pdf
334149 PHS398_CoverPageSupplement_5_0-5.0.pdf
334149 RR_OtherProjectInfo_1_4-1.4.pdf
334149 PerformanceSite_2_0-2.0.pdf
334149 RR_KeyPersonExpanded_2_0-2.0.pdf
334149 RR_Budget10_1_4-1.4.pdf
334149 PHS398_ResearchPlan_4_0-4.0.pdf
334149 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
334149 RR_SubawardBudget10_30_1_4-1.4.pdf
334149 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
334149 RR_SF424_5_0-5.0.pdf
334149 PHS398_CoverPageSupplement_5_0-5.0.pdf
334149 RR_OtherProjectInfo_1_4-1.4.pdf
334149 PerformanceSite_4_0-4.0.pdf
334149 RR_KeyPersonExpanded_4_0-4.0.pdf
334149 RR_Budget10_3_0-3.0.pdf
334149 PHS398_ResearchPlan_5_0-5.0.pdf
334149 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
334149 RR_SubawardBudget10_30_3_0-3.0.pdf
334149 PHS_AssignmentRequestForm_3_0-3.0.pdf
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