Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)

Closed Posted

Opportunity number
RFA-HL-18-030
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Categories
  • Food and Nutrition
  • Health
Eligible applicants
  • Small Businesses
  • State Governments
  • Tribal Governments (Federally Recognized)
  • Non-501(c)(3) Nonprofits
  • 501(c)(3) Nonprofits
  • Other
  • For Profit Organizations
  • Independent School Districts
  • County Governments
  • Higher Education Inst. (Public)
  • Public or Indian Housing Auth.
  • City/Township Governments
  • Tribal Organizations (Not Federally Recognized)
  • Higher Education Inst. (Private)
  • Special District Governments
Full announcement

Opportunity details come from Grants.gov. Updated .

Synopsis

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

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 Institutions) 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 not allowed.

Files

File Type Posted
oppRFA-HL-18-030-cidFORMS-E-instructions.pdf PDF

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