Translational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- RFA-AI-28-012
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Special District Governments
- Tribal Governments (Federally Recognized)
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- Other
- Higher Education Inst. (Private)
- County Governments
- Tribal Organizations (Not Federally Recognized)
- For Profit Organizations
- City/Township Governments
- Independent School Districts
- 501(c)(3) Nonprofits
- Small Businesses
- State Governments
- Public or Indian Housing Auth.
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), in partnership with the NIH Office of the Director and Office of AIDS Research, seeks applicants for a cooperative agreement to establish a consortium of Translational Centers Using Microphysiological Systems (MPS) for Infectious Diseases, with applications due January 29, 2027. Clinical trials are not permitted.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal governments (federally and non-federally recognized), special district governments, independent school districts, public or Indian housing authorities, eligible federal agencies, U.S. territories or possessions, faith-based or community-based organizations, and regional organizations. Foreign entities and foreign subawards or subcontracts are not eligible.
NIAID will commit $9 million for 5–7 awards; the NIH Office of Research Innovation, Validation, and Application will commit $4 million for 1–2 awards; and the Office of AIDS Research will commit $2 million for 1–2 awards. Maximum project period is 5 years. No cost share is specified.
The program aims to refine validated human tissue MPS models studying infectious diseases to a regulatory qualification level that promotes adoption by product developers and supports FDA acceptance. Centers must advance MPS platforms toward FDA pathways including the Drug Development Tools Qualification program and Fit-for-Purpose Initiative. Applicants must structure proposals around five required components: an Overall section (12-page limit), an Administrative Core (6-page limit), a Qualification Core (6-page limit), one to two Scientific Cores (6 pages each), and two to four Research Projects (12 pages each).
Applications are reviewed for scientific merit and program relevance. NIAID involvement is substantial, including quarterly conference calls, annual consortium meetings, and site visits. The opportunity is designated RFA-AI-28-012, activity code U54, with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.310 (Trans-NIH Research Support).
Synopsis
The purpose of this notice of funding opportunity (NOFO) is to support a consortium of Translational Centers using Microphysiological Systems (MPS) for Infectious Diseases (TCMID). Recent efforts in the MPS fields are moving towards validation and regulatory use but have not focused upon models studying infectious diseases and testing of medical interventions. The NIH and FDA have recently issued guidance and established initiatives for enhancing use of New Approach Methodologies (NAMs) in research and product development. This includes in vitro systems that allow scientists to model human disease and capture human variability and patient-specific characteristics that will accelerate safer treatments for patients while reducing costs and sparing use of laboratory animals. To meet this need, the Centers will refine well validated human tissue models studying infectious diseases to a level consistent with regulatory qualifications that will promote their adoption for use by product developers, supporting regulatory acceptance.
Eligibility
Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).
Files
| File | Type | Posted |
|---|---|---|
| PKG00294429.pdf | ||
| RFA-AI-28-012-Full-Announcement.html | HTML file |
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