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ForecastedResearch announcementOpportunity PAR-28-074

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

National Institutes of Health · Department of Health and Human Services

At a glance

Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required) is a forecasted federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). The agency's forecast estimates an application due date of July 31, 2027; forecast dates can change. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.866 (Aging Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

  1. Sep 29, 2026Forecast posted
  2. May 31, 2027 (est.)Full notice expectednext date
  3. Jul 31, 2027 (est.)Application deadline
  4. Apr 30, 2028 (est.)Est. award date
Posted
Sep 29, 2026
Est. close date
Jul 31, 2027
Est. award date
Apr 30, 2028
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
Not specified
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary
Fiscal year
FY2028

Typical awards for this program (SAM.gov listing for ALN 93.866, not this notice): Awards vary in range depending on the particular activity codes. Individual fellowships range from $23,376 to $57,504 and average about $46,000. Research grants have much larger ranges - from $75,000 to several million dollars. Average costs of research grants are around $400,000. All costs are shown on a single year basis. Awards may be for up to five years.

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (from the notice)

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).

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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. 

How to apply

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Assistance Listing

What is an ALN?

Reported obligations under ALN 93.866

Historical data · not a prediction
FY24$3.75B
FY25$3.78B
FY26$262M est.
Source: SAM.gov Assistance Listing 93.866. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

NIA Scientific Program Contact
NIA-NOFO-Scientific@nih.gov
Please contact via e-mail

Quick answers

Is “Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)” open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. The agency estimates posting the full notice around May 31, 2027. Forecast details and dates can change.

Who is eligible to apply for “Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)”?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How do I apply for “Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity PAR-28-074), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.