The NHLBI is offering a grant opportunity for phase II and beyond single-site clinical trials. This grant requires applications to align with the NHLBI research mission and meet NIH clinical trial definitions. Projects should demonstrate scientific rationale, operational plans, project management, subject recruitment strategies, and dissemination plans. Utilizing a milestone-driven approach, applicants must present a comprehensive plan for trial conduct and data sharing. For more details on NHLBI’s mission and priorities, visit their website. Closing date for applications is October 25, 2017.
Opportunity ID: 287496
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-405 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33) |
| 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: | Aug 15, 2016 |
| Last Updated Date: | Oct 25, 2017 |
| Original Closing Date for Applications: | Sep 13, 2019 |
| Current Closing Date for Applications: | Oct 25, 2017 |
| Archive Date: | Nov 24, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public housing authorities/Indian housing authorities |
| 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: | This Funding Opportunity Announcement (FOA) supports applications to develop and implement phase II and beyond investigator-initiated single-site clinical trials. Applications submitted to this FOA must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven mechanism of award. It is anticipated that applications will present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes the conduct of the trial, as well as plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-405.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 reissued as PAR-18-406 | Oct 25, 2017 | |
| Oct 25, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-405 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33) |
| 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: | Aug 15, 2016 |
| Last Updated Date: | Oct 25, 2017 |
| Original Closing Date for Applications: | Sep 13, 2019 |
| Current Closing Date for Applications: | Oct 25, 2017 |
| Archive Date: | Nov 24, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public housing authorities/Indian housing authorities |
| 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: | This Funding Opportunity Announcement (FOA) supports applications to develop and implement phase II and beyond investigator-initiated single-site clinical trials. Applications submitted to this FOA must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven mechanism of award. It is anticipated that applications will present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes the conduct of the trial, as well as plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-405.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-16-405 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33) |
| 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: | Oct 25, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 13, 2019 |
| Archive Date: | Oct 14, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses For profit organizations other than small businesses 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments Private institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports applications to develop and implement phase II and beyond investigator-initiated single-site clinical trials. Applications submitted to this FOA must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven mechanism of award. It is anticipated that applications will present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes the conduct of the trial, as well as plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-405.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 | PKG00226872 | Oct 10, 2016 | Oct 26, 2017 | View |
Package 1
Mandatory forms
287496 RR_SF424_2_0-2.0.pdf
287496 PHS398_CoverPageSupplement_3_0-3.0.pdf
287496 RR_OtherProjectInfo_1_3-1.3.pdf
287496 PerformanceSite_2_0-2.0.pdf
287496 RR_KeyPersonExpanded_2_0-2.0.pdf
287496 RR_Budget_1_3-1.3.pdf
287496 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
287496 RR_SubawardBudget30_1_3-1.3.pdf
287496 PHS_Inclusion_Enrollment_Report-1.0.pdf
287496 PHS_AssignmentRequestForm-1.0.pdf
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