Opportunity ID: 299629
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-547 |
| Funding Opportunity Title: | NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Dec 21, 2017 |
| Last Updated Date: | Mar 05, 2021 |
| Original Closing Date for Applications: | Jan 07, 2021 |
| Current Closing Date for Applications: | Mar 05, 2021 |
| Archive Date: | Apr 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $400,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 For profit organizations other than small businesses County governments City or township governments Native American tribal governments (Federally recognized) Private institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Small businesses Special district governments |
| 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; 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 not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The purpose of this Funding Opportunity Announcement (FOA) is to solicit UG3/UH3 phased cooperative agreement research applications to plan and implement clinical trials. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit the Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigators Brochure (or equivalent), if needed; the data management system and other tools for data collection and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial in the UH3 phase. The UG3 planning phase is not designed for the collection of preliminary data on the efficacy of the intervention (such as pre-clinical studies with animals), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals eligibility for participation in the future UH3 trial is allowed in the UG3 phase but not required. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial intended to assess safety and/or efficacy of various types of interventions. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-547.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 |
|---|---|---|
| Expired and Re-issued as PAR-21-160 | Mar 05, 2021 | |
| Updated expiration date in accordance with NOT-DE-20-037 | Dec 21, 2017 | |
| Dec 21, 2017 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-547 |
| Funding Opportunity Title: | NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Dec 21, 2017 |
| Last Updated Date: | Mar 05, 2021 |
| Original Closing Date for Applications: | Jan 07, 2021 |
| Current Closing Date for Applications: | Mar 05, 2021 |
| Archive Date: | Apr 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $400,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 For profit organizations other than small businesses County governments City or township governments Native American tribal governments (Federally recognized) Private institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Small businesses Special district governments |
| 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; 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 not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The purpose of this Funding Opportunity Announcement (FOA) is to solicit UG3/UH3 phased cooperative agreement research applications to plan and implement clinical trials. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit the Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigators Brochure (or equivalent), if needed; the data management system and other tools for data collection and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial in the UH3 phase. The UG3 planning phase is not designed for the collection of preliminary data on the efficacy of the intervention (such as pre-clinical studies with animals), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals eligibility for participation in the future UH3 trial is allowed in the UG3 phase but not required. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial intended to assess safety and/or efficacy of various types of interventions. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-547.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: | PAR-18-547 |
| Funding Opportunity Title: | NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 21, 2017 |
| Last Updated Date: | Nov 09, 2020 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 07, 2021 |
| Archive Date: | Jun 06, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $400,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) 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 State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education County governments Public housing authorities/Indian housing authorities Small businesses Independent school districts City or township governments 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; 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 not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The purpose of this Funding Opportunity Announcement (FOA) is to solicit UG3/UH3 phased cooperative agreement research applications to plan and implement clinical trials. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit the Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigators Brochure (or equivalent), if needed; the data management system and other tools for data collection and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial in the UH3 phase. The UG3 planning phase is not designed for the collection of preliminary data on the efficacy of the intervention (such as pre-clinical studies with animals), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals eligibility for participation in the future UH3 trial is allowed in the UG3 phase but not required. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial intended to assess safety and/or efficacy of various types of interventions. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-547.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: | PAR-18-547 |
| Funding Opportunity Title: | NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 21, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 07, 2021 |
| Archive Date: | Feb 12, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $400,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) 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 State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education County governments Public housing authorities/Indian housing authorities Small businesses Independent school districts City or township governments 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; 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 not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to solicit UG3/UH3 phased cooperative agreement research applications to plan and implement clinical trials. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit the Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigators Brochure (or equivalent), if needed; the data management system and other tools for data collection and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial in the UH3 phase. The UG3 planning phase is not designed for the collection of preliminary data on the efficacy of the intervention (such as pre-clinical studies with animals), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals eligibility for participation in the future UH3 trial is allowed in the UG3 phase but not required. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial intended to assess safety and/or efficacy of various types of interventions. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-547.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 | Package posted in error, do not use. Use revised form instead. | PKG00237226 | Jan 16, 2018 | Jan 17, 2018 | View | |
| FORMS-E-REVISED | Use for due dates on or before May 24, 2020 | PKG00237619 | Jan 23, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260431 | Jan 23, 2018 | Mar 12, 2021 | View |
Package 1
Mandatory forms
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Package 2
Mandatory forms
Optional forms
Package 3
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