The NIDCR is offering a grant to support the planning and design of clinical trials or biomarker clinical validation studies. This grant will assist in developing essential documents and strategies for the subsequent clinical trial or biomarker clinical validation study, excluding data collection on efficacy or prospective data for trial rationale. Behavioral and social interventions may undergo pilot testing during the R34 phase. Applicants have until Jan 07, 2018, to submit their proposals for this grant.
Opportunity ID: 266048
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-346 |
| Funding Opportunity Title: | NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 4 |
| Posted Date: | Sep 19, 2014 |
| Last Updated Date: | May 15, 2017 |
| Original Closing Date for Applications: | Sep 07, 2017 |
| Current Closing Date for Applications: | Jan 07, 2018 |
| Archive Date: | Feb 06, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits that do not have 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) State governments Private institutions of higher education For profit organizations other than small businesses 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-346.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 the notice NOT-DE-17-009 | May 15, 2017 | |
| changing Close date back to previous date due to LIMIT-ERROR in package close date change | May 15, 2017 | |
| Updated Expiration date in accordance with NOT-DE-17-009 | May 12, 2017 | |
| May 12, 2017 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-346 |
| Funding Opportunity Title: | NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 4 |
| Posted Date: | Sep 19, 2014 |
| Last Updated Date: | May 15, 2017 |
| Original Closing Date for Applications: | Sep 07, 2017 |
| Current Closing Date for Applications: | Jan 07, 2018 |
| Archive Date: | Feb 06, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits that do not have 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) State governments Private institutions of higher education For profit organizations other than small businesses 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-346.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 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-346 |
| Funding Opportunity Title: | NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | May 15, 2017 |
| Last Updated Date: | May 12, 2017 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 07, 2017 |
| Archive Date: | Oct 07, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) County governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts For profit organizations other than small businesses State governments Public and State controlled institutions of higher education 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-346.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-14-346 |
| Funding Opportunity Title: | NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | May 12, 2017 |
| Last Updated Date: | May 12, 2017 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 07, 2018 |
| Archive Date: | Feb 06, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) County governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts For profit organizations other than small businesses State governments Public and State controlled institutions of higher education 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-346.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-14-346 |
| Funding Opportunity Title: | NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | May 12, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 07, 2017 |
| Archive Date: | Oct 08, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) County governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts For profit organizations other than small businesses State governments Public and State controlled institutions of higher education 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-346.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
There are no related documents on this grant.
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-C | FORMS-C | PKG00206423 | Oct 21, 2014 | May 07, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00222521 | Apr 17, 2016 | Jan 07, 2018 | View |
Package 1
Mandatory forms
266048 RR_SF424_2_0-2.0.pdf
266048 PHS398_ResearchPlan_2_0-2.0.pdf
266048 PHS398_CoverPageSupplement_2_0-2.0.pdf
266048 RR_KeyPersonExpanded_2_0-2.0.pdf
266048 RR_OtherProjectInfo_1_3-1.3.pdf
266048 PerformanceSite_2_0-2.0.pdf
Optional forms
266048 RR_SubawardBudget30_1_3-1.3.pdf
266048 PlannedReport-1.0.pdf
266048 PHS398_CumulativeInclusionReport-1.0.pdf
266048 PHS398_ModularBudget_1_2-1.2.pdf
266048 RR_Budget_1_3-1.3.pdf
Package 2
Mandatory forms
266048 RR_SF424_2_0-2.0.pdf
266048 PHS398_CoverPageSupplement_3_0-3.0.pdf
266048 RR_OtherProjectInfo_1_3-1.3.pdf
266048 PerformanceSite_2_0-2.0.pdf
266048 RR_KeyPersonExpanded_2_0-2.0.pdf
266048 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
266048 RR_Budget_1_3-1.3.pdf
266048 RR_SubawardBudget30_1_3-1.3.pdf
266048 PHS398_ModularBudget_1_2-1.2.pdf
266048 PHS_Inclusion_Enrollment_Report-1.0.pdf
266048 PHS_AssignmentRequestForm-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
