RFA-HL-26-002: NHLBI Outstanding Investigator Award (OIA) (R35 Clinical Trial Optional)

RFA-HL-26-002: NHLBI Outstanding Investigator Award (OIA) (R35 Clinical Trial Optional)

The National Heart, Lung, and Blood Institute (NHLBI) uses the Outstanding Investigator Award (OIA) to support an established investigator’s research program rather than a single narrowly defined project. The award is an R35 mechanism. It is intended for experienced Program Directors/Principal Investigators (PDs/PIs) with a substantial NHLBI record and a credible prospect of making major contributions to heart, lung, blood, and sleep (HLBS) research.

The official notice lists a new-application deadline of February 19, 2027. Applications are due by 5:00 PM local time of the applicant organization. The notice also lists scientific merit review in July 2027, advisory council review in October 2027, an earliest start date in December 2027, and an expiration date of April 29, 2027. Those dates belong to the published 2027 cycle; they are not a promise that an award will be made or that a later cycle will follow.

Opportunity at a glance

The request ceiling is not an automatic award amount. NHLBI determines the final funding level in view of peer review, NHLBAC recommendations, the investigator’s current NHLBI support, the proposed program’s needs, expected productivity, and available funds. The notice says NHLBI intends to commit up to $20 million per year in total costs for new awards across this OIA notice and its companion NOFO in Fiscal Years 2026, 2027, and 2028.

What the OIA is designed to support

An OIA application should explain a sustained line of inquiry and the scientific opportunities it may open, not present a fixed list of short-term aims as if it were a conventional project grant. NHLBI describes the award as a stable and flexible source of support that can let an investigator pursue new directions as the work develops. The research must remain within the NHLBI mission, but the program is not tied to predefined specific aims after the award is made.

That flexibility has portfolio consequences. NHLBI expects the OIA to become the primary, and most likely sole, source of NHLBI funding on individual research grants for the recipient. Existing individual research project grants are expected to be relinquished when the OIA is awarded, subject to the provisions in the notice. Separate categories can remain eligible, including research-resource grants, contracts, cooperative agreements, training and workforce-development grants, permitted SBIR/STTR or conference grants, program project or center grants, and certain supplements. Applicants should examine their own support portfolio and discuss questions with NHLBI staff before submission.

The award is therefore a fit for a researcher who can show both a strong record and a clear reason that long-term, flexible support will improve the program. A narrow proposal that reads like a request for one experiment will not communicate the purpose of the mechanism. The research strategy should connect prior accomplishments, important HLBS questions, possible directions, and the investigator’s ability to change course when evidence or new opportunities warrant it.

Who can apply

Eligibility is intentionally narrow and is determined by NHLBI after applications are received on the intended due date. Only a single PD/PI may apply; applications with multiple PDs/PIs will not be accepted. The PD/PI must meet one of the two primary funding-status routes:

1. The PD/PI is currently in the sixth or seventh year of support on an NHLBI R35 award; or
2. The PD/PI is currently PD/PI on at least two NHLBI R01-equivalent awards. For this notice, R01-equivalent means R01, DP1, or DP2.

For the second route, at least one of the qualifying awards must be a single-PD/PI award, must not be in a no-cost extension, and must not be an NIH-defined clinical trial unless it is a mechanistic clinical trial as defined by the notice. The additional qualifying award or awards can be multiple-PD/PI awards, can be in a first no-cost extension, and can be NIH-defined clinical trials.

The PD/PI must commit six person months to the OIA throughout the award. NHLBI describes that as 50% effort on a full-year appointment, 66.67% on a nine-month appointment, or 100% on a six-month appointment. Teaching, administrative, and clinical duties do not count toward the research-effort calculation. The PD/PI must also have received continuous R01-equivalent support from NHLBI as a PD/PI for at least the prior four Federal Fiscal Years. For the 2027 submission cycle, the notice defines that continuous-support period as having active eligible NHLBI support in each Federal Fiscal Year beginning in FY 2024.

The eligible-organization list is broad and includes higher education institutions, nonprofits, for-profit organizations, small businesses, governments, eligible federal agencies, U.S. territories or possessions, independent school districts, public housing authorities, tribal organizations, faith-based or community-based organizations, and regional organizations. Non-domestic organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. A foreign component may be allowed under NIH policy, but this NOFO does not allow foreign subawards or subcontracts. That distinction matters: an international scientific collaboration is not the same as paying a foreign subrecipient from this award.

Budget and project period

Applicants may request up to $700,000 in direct costs per year and may request no more than seven years of support. NHLBI encourages a well-justified request rather than an automatic request for the ceiling. The budget should match the scale of the research program, the investigator’s effort, the resources needed to pursue the proposed directions, and the current NHLBI support that the OIA may replace.

The application package may contain a 10-year detailed budget form, but this notice still limits the request to seven years. Applicants should not treat that form as permission to request a longer project period. The number of awards and the actual amount available depend on appropriations and the number of applications that NHLBI considers meritorious.

Application materials and format

The application package must be accessed through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace. The applicant then uses eRA Commons to track the submission. The organization and PD/PI should start registrations well before the deadline: the notice warns that registration can take six weeks or more, and an eRA Commons account can take up to two weeks. The organization must have active SAM, eRA Commons, and Grants.gov registrations before submission. The PD/PI must have an eRA Commons account and must link the personal profile to a valid ORCID ID.

The Research Plan has important OIA-specific instructions. Specific Aims should not be used and are not required. The Research Strategy should instead cover:

• the HLBS research area, important gaps or challenges, and why the work could have a major future effect;
• the overall vision, conceptual framework, and general strategies for sustaining the research program;
• the importance of the questions, how the program could evolve, and how risks and challenges will be handled;
• why the area will remain important within the NHLBI mission; and
• how the OIA’s flexibility, level of effort, and longer funding period will benefit the program.

A detailed experimental plan is not expected. Preliminary data are not required, although limited data may be included when needed to establish the feasibility of a new direction or unfamiliar method. A proposed program can continue the investigator’s existing work or move into a new line of research; a substantial change should be explained along with the investigator’s preparation for that direction.

The application must include a Letter of Support from the institution’s Authorized Organizational Representative (AOR), no more than two pages. Missing the letter makes the application non-responsive and it will not proceed to peer review. The letter must state the six-person-month commitment, identify the two qualifying NHLBI R01-equivalent awards or the qualifying R35 award, show substantial institutional commitment such as salary support, protected time, space, or resources, and acknowledge that most NHLBI research awards must be relinquished if the OIA is awarded.

The PD/PI’s biographical sketch should address creativity, consistent productivity, significant scientific impact, rigorous and reproducible research, transparent reporting, flexibility, and adaptability. It should explain intellectual and technical contributions to publications, contributions since becoming an independent investigator, and mentoring experience. Current and pending support must include all ongoing projects and pending applications, even when the PD/PI receives no salary support. List NHLBI grants first, then other NIH grants, then other support; include total award amounts for the full award period and person months per year.

Applicants must follow the NIH Research (R) Instructions and all applicable page limits. Resource-sharing requirements apply. A Data Management and Sharing Plan is required when the NIH-funded or conducted research will generate scientific data. If human subjects or an NIH-defined clinical trial is involved, the appropriate human-subjects and clinical-trial forms must be included. The Appendix is limited; the notice does not allow publications or other material there except blank questionnaires or blank surveys.

Submission and review checklist

Before submission, an eligible investigator should confirm the following:

1. The funding-status route is documented, including the required current NHLBI awards and four-year continuity.
2. The application names one PD/PI and includes the required six person-month commitment.
3. The organization’s SAM, eRA Commons, and Grants.gov registrations are active, and the PD/PI’s ORCID is linked to eRA Commons.
4. The research program is within the NHLBI mission and does not contain a non-mechanistic Phase I, II, III, or T4 clinical trial.
5. The Research Strategy uses the OIA format and does not submit Specific Aims.
6. The AOR letter is complete, signed through the institutional process, and no longer than two pages.
7. Current and pending support, resource-sharing materials, the Data Management and Sharing Plan when required, and human-subjects or clinical-trial forms are complete.
8. The application is submitted through ASSIST, institutional system-to-system submission, or Grants.gov Workspace and is visible in eRA Commons before the deadline.

Applicants should submit early enough to inspect the application in eRA Commons and correct errors. The notice states that a changed or corrected application must reach Grants.gov by the deadline; a corrected submission after the deadline is late. The applicant is responsible for viewing the application before the due time and confirming a successful submission.

How NHLBI reviews the program

Reviewers consider the standard NIH scientific and technical merit criteria, with OIA-specific attention to the investigator’s record and future program. They look for important prior contributions, outstanding HLBS productivity, and the potential to continue influencing the field at a high level. They also consider whether the proposed program is broad and ambitious enough, whether it addresses a meaningful HLBS challenge, whether it could advance or transform the field, and whether the investigator has shown rigorous research, transparent reporting, mentoring, and professional service appropriate to career stage.

The application competes with all other recommended applications submitted to the NOFO. After peer review, recommended applications receive a second level of review by the National Heart, Lung, and Blood Advisory Council. Final decisions also reflect NHLBI priorities, portfolio balance, scientific gaps, public-health impact, the needs of special or understudied populations, overlap with existing support, and available funds.

This page describes the announced 2027 cycle. The official NIH Guide notice remains the controlling source for the deadline, eligibility rules, award terms, application forms, and any later update. Applicants should read the complete notice and the NIH application instructions before preparing a submission.