Synopsis

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.
Response Date	Jan 07, 2027 12:00:00 AM EST
Posting Date	Dec 05, 2024 12:00:00 AM EST
Archive Date	Feb 12, 2027 12:00:00 AM EST
Award Ceiling	1,515,000
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info 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 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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.html
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

• 93.233: National Center on Sleep Disorders Research
• 93.837: Cardiovascular Diseases Research
• 93.838: Lung Diseases Research
• 93.839: Blood Diseases and Resources Research