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NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)

ID: PAR-25-343 • Type: Posted

Description

The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm.
Background
The National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health (NIH), is dedicated to advancing research aimed at effective interventions for communication disorders. This funding opportunity announcement (FOA) supports cooperative agreements between NIDCD Project Scientists and investigators to conduct clinical trials that require FDA oversight, aim to establish efficacy, or present higher risks to participants. The goal is to enhance interventions in clinical care through well-designed trials.

Grant Details
This funding opportunity supports investigator-initiated clinical trials in communication disorders, including hearing, balance, taste, smell, voice, speech, and language. Trials must meet at least one of the following criteria: require FDA oversight (e.g., IND or IDE applications), involve higher risks for participants (e.g., non-routine interventions or unlicensed products), or be pivotal Phase III clinical trials. Each application may propose only one clinical trial. Applications exceeding annual direct costs of $700,000 may also be considered under this FOA. The NIDCD will provide substantial involvement in project activities post-award.

Eligibility Requirements
Eligible applicants include higher education institutions (public and private), nonprofits, for-profit organizations (including small businesses), local/state/county governments, tribal governments, and federal agencies. Organizations from diverse backgrounds are encouraged to apply. Non-domestic entities are not eligible.

Period of Performance
The maximum project period is 5 years. Specific timelines will depend on the scope of the proposed project.

Grant Value
There is no limit on application budgets; however, they must reflect the actual needs of the proposed project. The total value of grants will depend on NIH appropriations and the number of meritorious applications received.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.173 - Research Related to Deafness and Communication Disorders
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 1/6/25 the National Institutes of Health posted grant opportunity PAR-25-343 for NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required). The grant will be issued under grant program 93.173 Research Related to Deafness and Communication Disorders.

Timing

Posted Date
Jan. 6, 2025, 12:00 a.m. EST
Closing Date
Oct. 18, 2027, 12:00 a.m. EDT Due in 878 Days
Last Updated
Jan. 6, 2025, 12:39 p.m. EST
Version
1
Archive Date
Nov. 23, 2027

Eligibility

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

Contacts

Contact
National Institutes of Health
Contact Email
grantsinfo@nih.gov
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-343.html
Additional Information Site
http://grants.nih.gov/grants/guide/pa-files/PAR-25-343.html

Documents

Posted documents for PAR-25-343

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