Synopsis

NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34). The U34 is designed to: 1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study. The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK. Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.
Response Date	Jun 10, 2027 12:00:00 AM EDT
Posting Date	Jan 10, 2025 12:00:00 AM EST
Archive Date	Jul 16, 2027 12:00:00 AM EDT
Award Ceiling	225,000
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

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

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-25-090.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)

• 93.847: Diabetes, Digestive, and Kidney Diseases Extramural Research