NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.

Eligible applicants Small businesses; Native American tribal governments (Federally recognized); State governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Special district governments; For profit organizations other than small businesses; Independent school districts; City or township governments; Native American tribal organizations (other than Federally recognized tribal governments); Private 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; Public housing authorities/Indian housing authorities; Public and State controlled institutions of higher education

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 Organizations) 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.

Small businesses; Native American tribal governments (Federally recognized); State governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Special district governments; For profit organizations other than small businesses; Independent school districts; City or township governments; Native American tribal organizations (other than Federally recognized tribal governments); Private 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; Public housing authorities/Indian housing authorities; Public and State controlled institutions of higher education

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 Organizations) 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.

Retrieved from the official Grants.gov public API. Applicant types and additional eligibility are reproduced together; program-specific restrictions govern eligibility.