Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)

Forecasted Federal grant Posted

Opportunity number
PAR-28-074
Agency
Applications expected due
Award size
Not on record

Opportunity facts

Expected posting
Assistance listings
Funding instrument
Grant
Category
  • Health
Eligible applicants
  • Non-501(c)(3) Nonprofits
  • Public or Indian Housing Auth.
  • County Governments
  • Small Businesses
  • Higher Education Inst. (Public)
  • Tribal Governments (Federally Recognized)
  • For Profit Organizations
  • Special District Governments
  • Higher Education Inst. (Private)
  • Tribal Organizations (Not Federally Recognized)
  • 501(c)(3) Nonprofits
  • City/Township Governments
  • State Governments
  • Other
  • Independent School Districts
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

The National Institutes of Health is forecasting a Notice of Funding Opportunity to solicit applications for early to definitive clinical trials, with no application submission date currently set. The R61/R33 activity code funds a bi-phasic, milestone-driven award structure: the R61 phase supports planning activities, and the R33 phase supports execution of a clinical trial, with a maximum project period of 7 years. This is a forecast notice only; applications are not being solicited at this time.

Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are eligible. Participating NIH Institutes, Centers, and Offices will determine alignment with their respective research missions. Eligible applicants include non-501(c)(3) and 501(c)(3) nonprofits, public and private higher education institutions, for-profit organizations, small businesses, tribal governments and organizations, state and local governments, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and non-domestic (foreign) entities. The opportunity will be funded under the Aging Research program (CFDA 93.866), though participating ICOs may extend beyond the National Institute on Aging.

The NIH encourages investigators with expertise in clinical trial planning, design, implementation, intervention development, and stakeholder engagement to develop collaborations and projects in advance of the NOFO publication. This notice provides potential applicants sufficient planning lead time. The source does not specify an award ceiling, award floor, expected number of awards, cost share requirements, or specific evaluation criteria unique to this R61/R33 initiative.

Forecast synopsis

The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose early to definitive clinical trials. Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are of interest to this initiative. The trials should align with the research mission of the participating Institutes, Centers, and Offices (ICOs) of the NIH.

The NOFO will utilize the R61/R33 activity code, a bi-phasic, milestone-driven award. The R61 phase provides support for planning activities, and the R33 phase provides support for a clinical trial, with a maximum project period of 7 years.

Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and relevant projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to consider applying for the NOFO.

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).

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