The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant (X01) to provide investigators with consultative support for planning innovative, late-phase (Phase II and beyond) clinical trials. This opportunity focuses on single or multi-site investigator-initiated trials addressing critical clinical questions within NHLBI’s mission. The grant aims to foster the development of feasible and well-designed studies that employ non-traditional clinical trial designs and incorporate statistical novelty or innovation. Awardees will utilize expert consultative services provided by the Innovative Clinical Trials Resource (ICTR) to refine their concepts. This initiative ensures high-quality planning for complex trials that push the boundaries of clinical research.
Opportunity ID: 293897
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-009 |
| Funding Opportunity Title: | Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 17, 2017 |
| Last Updated Date: | May 19, 2017 |
| Original Closing Date for Applications: | Jan 12, 2018 |
| Current Closing Date for Applications: | May 19, 2017 |
| Archive Date: | Jun 18, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township 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 State governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts |
| 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 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 purpose of this FOA is to provide access to a consultative resource for planning activities for late phase (phase II and beyond) single-site or multi-site investigator-initiated clinical trials that address critical clinical questions within the mission of the National Heart, Lung, and Blood Institute (NHLBI) and that require non-traditional clinical trial designs with the opportunity for statistical novelty and/or innovation. The FOA will support the development of feasible and well-designed clinical trials utilizing consultative services provided by the Innovative Clinical Trials Resource (ICTR) (N01). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-009.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-17-294 | May 19, 2017 | |
| May 19, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-009 |
| Funding Opportunity Title: | Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 17, 2017 |
| Last Updated Date: | May 19, 2017 |
| Original Closing Date for Applications: | Jan 12, 2018 |
| Current Closing Date for Applications: | May 19, 2017 |
| Archive Date: | Jun 18, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township 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 State governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts |
| 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 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 purpose of this FOA is to provide access to a consultative resource for planning activities for late phase (phase II and beyond) single-site or multi-site investigator-initiated clinical trials that address critical clinical questions within the mission of the National Heart, Lung, and Blood Institute (NHLBI) and that require non-traditional clinical trial designs with the opportunity for statistical novelty and/or innovation. The FOA will support the development of feasible and well-designed clinical trials utilizing consultative services provided by the Innovative Clinical Trials Resource (ICTR) (N01). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-009.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-HL-18-009 |
| Funding Opportunity Title: | Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 19, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 12, 2018 |
| Archive Date: | Feb 17, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) 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 State governments Private institutions of higher education Special district governments City or township governments Small businesses For profit organizations other than small businesses Independent school districts 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); 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 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 purpose of this FOA is to provide access to a consultative resource for planning activities for late phase (phase II and beyond) single-site or multi-site investigator-initiated clinical trials that address critical clinical questions within the mission of the National Heart, Lung, and Blood Institute (NHLBI) and that require non-traditional clinical trial designs with the opportunity for statistical novelty and/or innovation. The FOA will support the development of feasible and well-designed clinical trials utilizing consultative services provided by the Innovative Clinical Trials Resource (ICTR) (N01). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-009.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-D | Use for due dates on or after May 25, 2016 | PKG00232576 | May 19, 2017 | May 22, 2017 | View |
Package 1
Mandatory forms
293897 RR_SF424_2_0-2.0.pdf
293897 PHS398_CoverPageSupplement_3_0-3.0.pdf
293897 RR_OtherProjectInfo_1_3-1.3.pdf
293897 RR_KeyPersonExpanded_2_0-2.0.pdf
293897 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
293897 PHS_AssignmentRequestForm-1.0.pdf
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