Synopsis

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).
Response Date	Jun 02, 2027 12:00:00 AM EDT
Posting Date	Oct 31, 2024 12:00:00 AM EDT
Archive Date	Jul 08, 2027 12:00:00 AM EDT
Award Ceiling	N/a
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

County governments, Public and State controlled institutions of higher education, Special district governments, Small businesses, For profit organizations other than small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, City or township governments, Independent school districts, State governments, Private institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Native American tribal governments (Federally recognized)

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 not 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-25-211.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)

• 93.121: Oral Diseases and Disorders Research
• 93.213: Research and Training in Complementary and Integrative Health
• 93.313: NIH Office of Research on Women's Health
• 93.393: Cancer Cause and Prevention Research
• 93.866: Aging Research