National Institutes of Health · Department of Health and Human Services
Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)
Key facts
- Deadline
- Due Jun 2, 2027 · 238 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Public college or university, Tribal organization, Special district (utility, fire, etc.), County government, Nonprofit with 501(c)(3), Larger business, City or town government, Tribal government, State government, Private college or university, School district, Nonprofit without 501(c)(3), Small business, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Hamilton County (nationwide program)
- No match required
- Past Tennessee awards on file: 358
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/eb435a48-9193-4424-bbe9-6ab11e6683ee · Printed from grantme.click/grants/a3a8efc9-bfbe-429b-a1d7-59a685c56be0
View on Grants.gov Add deadline to my calendar
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About this grant
The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions using a milestone-driven, biphasic award mechanism, R61/R33 Phased Innovation Award. Specifically, this NOFO solicits applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal of this NOFO is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses.
The first phase, funded by the R61, will providing for up to 2 years to identify unique host biological patterns (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with heterogeneity of probiotic clinical effects using observational or secondary data analysis studies. The second phase, funded under the R33, will support studies to assess the ability of the unique patterns determined in the R61 phase to detect the improvement of probiotic responsiveness in rigorously designed mechanistic studies in relevant animal models or in human subjects.
The combined R61/R33 should not exceed 5 years. Transition from the R61 to the R33 phase of the award will be administratively reviewed and will be determined based on successful completion of Transition Milestones that need to be clearly specified in the R61 phase application.
Support for a single phased award that does not need the R61 Exploratory phase is available in the companion (R33) NOFO, PAR-AT-24-XXX (TEMP-25413).
Who can apply, from the official notice
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 not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Your schedule, working back from the deadline
- Oct7
Check that your SAM.gov registration is active (or start it now)
Grants.gov: allow up to 10 business days for SAM registration, weeks or months if information isn't verified. It must be renewed every year. Grants.gov - May12
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - May26
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - May31
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Jun2
Deadline
From the funder.
Save this grant to put these dates in My grants and your private calendar.
Writing the need statement? Hamilton County facts with citations.
Who in Tennessee has won this program
75 awards to Tennessee groups in 5 counties since 1981 · 0 in Hamilton County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $39.5M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $37.5M | 2021 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $24.1M | 2011 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $18.6M | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $18.3M | 2019 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | $14.9M | 2015 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $14.4M spent that year | 2025 |
| St. Jude Children's Research Hospital, Inc. | Memphis, Shelby County | $14.2M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $14M | 2016 |
| Vanderbilt University | Nashville, Davidson County | $14M | 1997 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $11.1M | 1981 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $10M | 2025 |
Source: Federal Audit Clearinghouse, USAspending.gov. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through Tennessee Department of Education
This federal money also reaches local groups as pass-through grants. In Tennessee, Tennessee Department of Education passes it on: watch that agency for applications, not the federal agency. 283 pass-through grants on file · 0 in Hamilton County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Vermont & State Agricultural College | $4.4M | 2023 |
| University of Tennessee | Memphis, Shelby County | Virginia Polytechnic Institute & State University | $1.8M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of Michigan | $1.4M | 2024 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | The University of Texas Southwestern Medical Center | $1.4M | 2026 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Vanderbilt University | $1.3M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Health Research, Inc. | $1.3M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Texas Health Science Center at Houston | $1.2M | 2026 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $1M | 2026 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | Ohio State University, the | $1M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Texas Health Science Center at Houston | $993K | 2024 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $979K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Vanderbilt University | $965K | 2023 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Oral Diseases and Disorders Research, also called “Dental, Oral and Craniofacial Research.”
Program number 93.121 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
The primary criteria for evaluating grant applications include assessment of: (1) the scientific merit, significance and overall impact of the proposed study and its objectives; (2) the competency of the proposed investigator(s) to successfully pursue the project; (3) the innovation and novelty of the concepts, approaches, or methodologies; (4) the technical adequacy of the experimental design and approach; (5) the adequacy of the available proposed facilities and resources; (6) the necessity of the budget components requested in relation to the proposed project; and (7) the relevance and importance to the posted institute program objectives. Also evaluated, where applicable, but not scored are: (1) protections for human subjects; (2) inclusion of women, minorities, and children; (3) vertebrate animal welfare; and (4) adequate protection of research personnel and/or the environment, biosafety, biocontainment and the security of select agents; (5) resource sharing plans; (6) authentication of key biological and/or chemical resources, (7) budget and period of support. In addition, the following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: the potential of the proposed research for commercial application. Phase II grant applications will reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of...
Match
None required (federal program listing).
About the federal program
Research and Training in Complementary and Integrative Health, also called “National Center for Complementary and Integrative Health”
Program number 93.213 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant, training
How applications are judged
The major elements in evaluating proposals include assessments of: (1) the scientific merit innovation and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; (6) the relevance and importance to the announced program objectives and when applicable,and (7) the adequacy of assurances detailing the proposed means for safeguarding human or animal subjects. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed...
Match
None required (federal program listing).
About the federal program
NIH Office of Research on Women's Health, also called “(NIH/ORWH)”
Program number 93.313 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
In each year's official notice: read this year's.
Match
None required (federal program listing).
About the federal program
Cancer Cause and Prevention Research
Program number 93.393 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; 2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...
Match
None required (federal program listing).
About the federal program
Aging Research, also called “(Aging)”
Program number 93.866 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: the scientific merit and general significance of the proposed study and its objectives; the technical adequacy of the experimental design and approach; the competency of the proposed investigator or group to successfully pursue the project; the adequacy of the available and proposed facilities and resources; the necessity of the budget components requested in relation to the proposed project; and the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed...
Match
None required (federal program listing).