Plain-English explanation
HHS-NIH11 offers this federal opportunity for work related to Health, Human Services, Youth Development. Organizations serving National should verify the requirements below before committing proposal time.
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A grant from HHS-NIH11
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant
HHS-NIH11 offers this federal opportunity for work related to Health, Human Services, Youth Development. Organizations serving National should verify the requirements below before committing proposal time.
Start here · Eligibility
Check whether your organization qualifies
Answer 5 focused questions in about 60 seconds before investing time in the application.
Take Eligibility Quiz2 source-confirmed criteria · No signupReview criteria
Potential award
Up to $1,515,000
Time remaining
137 days
Application load
Moderate effort
Best next move
Take the eligibility quiz
Apply
Verified against the source on 8/23/2026
01
Start here
Confirm eligibility
Check your fit in about 60 seconds.
Eligibility requirementsQuestion 1 of 5
About 60 seconds totalConfirmed criterion
Does your organization have the required nonprofit status?
What does this mean?
Eligible nonprofits are named in the source requirements.
Review supporting source ↗Select an answer to continue
No signup · Answers stay in this browser session
This is an explainable self-assessment, not a win probability or legal determination. Hard eligibility conflicts are never averaged against softer program-fit signals. Always verify the official notice.
Optional Review source criteria and citations
Geography
Nationwide availability is inferred from the catalog record; confirm the official notice.
Review source ↗Registrations
SAM.gov and Grants.gov registration may be required; confirm in the notice.
Review source ↗02
Grant-writer assessment
Understand the opportunity
Start with the practical interpretation. Open the complete source narrative when you need the underlying detail.
What the funder is trying to accomplish
A specific statement of funder intent has not yet been editorially reviewed. Use the official description and program priorities as the controlling source.
Strong-fit project signals
Projects should demonstrate a direct, substantive connection to Health, Human Services, Youth Development. This is directional guidance, not an eligibility determination.
What reviewers may prioritize
Review criteria have not yet been captured. Do not assume general best practices replace the scoring criteria in the official notice.
Source dossier Read the full official program description
Source-backed synopsisRead the complete official description ↗
What this grant funds
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.
03
Decision economics
Size the opportunity
Use the source facts below to judge whether the likely return justifies the application effort.
- Award range
- Up to $1,515,000
- Total program funding
- Not specified
- Expected awards
- Not specified
- Geography
- National
- Cost share
- Not indicated
- Assistance listing
- Not specified
Mission alignment
Compare your program with Health, Human Services, Youth Development.
Geographic fit
National
04
Working plan
Build the application
The generated milestones are planning aids. Only the official notice establishes required dates.
Requirements captured
- Other requirements
- 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.
- Submission system
- Grants.gov
- Attachments
- https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.html, PAR-25-025 Full Announcement Text
- Contact
- National Institutes of Health · grantsinfo@nih.gov · 301-402-2541
Official deadline
January 7, 2027
Moderate effort based on requirements currently captured.
Confirm eligibility, registrations, partners, and internal approval.
Finalize project design, outcomes, and supporting evidence.
Draft the narrative and detailed budget.
Complete compliance review and collect attachments.
Submit early and preserve the confirmation receipt.
05Past behaviorCompare historical awardsHistorical patterns provide context, but do not predict or guarantee future funding decisions.
No licensed historical awards are currently linked to this opportunity.
06Audit trailVerify the evidenceSee where the facts came from, when they were checked, and what has materially changed.
Source record
Source verified means the official record was successfully checked. It does not mean every eligibility or application field has been extracted.
- Verification
- verified
- Source
- grants gov
- Last checked
- 8/23/2026, 8:50:36 AM
- Content updated
- 8/23/2026, 8:50:38 AM
- Review
- Automated normalization; not yet expert-reviewed
Material changes
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Updated eligibility, eligibility details.
Verify before applying. Official funder documents control. Derived analysis and preparation dates should not replace the notice.
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Quick answersFrequently asked questionsGet concise answers about NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant.
Is NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant currently open?
Yes, based on the latest source record. The deadline is January 7, 2027, with 137 days remaining. Because funders can amend or extend notices, confirm the date and submission instructions on the official application page. The source was last checked 8/23/2026.
How much funding does NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant provide?
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant lists Up to $1,515,000 per award. The expected number of awards has not been captured, so the award range alone should not be treated as an estimate of competitiveness.
Who can apply to NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant?
State governments; Special district governments; County governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; For profit organizations other than small businesses; Small businesses; Public housing authorities/Indian housing authorities;… Applicants should still complete the eligibility quiz and verify every condition in the official notice; a general fit does not override exclusions or registration requirements.
Does NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant require matching funds?
No cost-share requirement is indicated in the captured source facts. Applicants should still verify the official budget instructions in case an amendment, program track, or specific cost category carries additional conditions.
What should I prepare before applying to NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) Grant?
Moderate effort is expected. The captured requirements include other requirements, submission system, attachments, contact. Start by confirming eligibility and registrations, then work backward from January 7, 2027 using the preparation plan above.