Open · 320 days left D National Institutes of Health

NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)

Funding
Not specified
Deadline
--
Days
--
Hrs
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Min
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Sec
Jan 07, 2027
Posted Dec 5, 2024 (442 days ago)
Closes Jan 7, 2027 (in 320 days)

Grant Details

Opportunity Number
PAR-25-025
CFDA / ALN
93.233, 93.837, 93.838, 93.839
Opportunity Category
Discretionary (D)
Funding Category
Health (HL)
Funding Instrument
Grant (G)
Cost Sharing
No Cost Sharing (No)

Eligibility

State governments (00) County governments (01) City or township governments (02) Special district governments (04) Independent school districts (05) Public and State controlled institutions of higher education (06) Native American tribal governments (Federally recognized) (07) Public housing authorities / Indian housing authorities (08) Native American tribal organizations (11) Nonprofits having a 501(c)(3) status with the IRS (12) Nonprofits without 501(c)(3) status (13) Private institutions of higher education (20) For-profit organizations other than small businesses (22) Small businesses (23) Others (25)

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.

Description

The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion NOFO which utilizes an R61/R33 phased approach.