NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) by the National Institute on Deafness and Other Communication Disorders

This department is offering a planning grant to support the preparation of phase III clinical trials for the treatment or prevention of communication disorders. The grant aims to facilitate the development of a Manual of Procedures (MOP) essential for conducting definitive efficacy trials. Successful awardees may proceed to apply for Phase III Clinical Trials in Communication Disorders grants (U01). Applications should adhere to specific guidelines outlined by the NIDCD, emphasizing robust study design and execution. The closing date for this opportunity is February 4, 2015.

Opportunity ID: 154194

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General Information

Document Type::	Grants Notice
Funding Opportunity Number::	PAR-12-124
Funding Opportunity Title::	NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34)
Opportunity Category::	Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity::	Health
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s)::	93.173 — Research Related to Deafness and Communication Disorders
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 1
Posted Date::	Mar 16, 2012
Last Updated Date::
Original Closing Date for Applications::	Feb 04, 2015
Current Closing Date for Applications::	Feb 04, 2015
Archive Date::	Mar 07, 2015
Estimated Total Program Funding::
Award Ceiling::	$200,000
Award Floor::	$

Eligibility

Eligible Applicants::

Native American tribal governments (Federally recognized)

Additional Information on Eligibility::

Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name::	National Institutes of Health
Description::	The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting robust, well-designed, and well-executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between NIDCD project collaborator and investigator for a planning grant for phase III clinical trials of definitive efficacy. NIDCD Phase III Clinical Trials in Communication Disorders (U01) applications are accepted only from successful NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) awardees, unless NIDCD program staff agrees to accept a phase III clinical trial application from an investigator who has not used an NIDCD clinical trial planning grant first. The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) is used to gather information and prepare a Manual of Procedures (MOP) (see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP). NIDCD Phase III Clinical Trials in Communication Disorders (U01) (PAR-12-123) applications must include a complete detailed MOP in the appendix.
Link to Additional Information::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version	Modification Description	Updated Date
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:	93.173
Competition ID:	ADOBE-FORMS-B2
Competition Title:	ADOBE-FORMS-B2
Opportunity Package ID:	PKG00106732
Opening Date:	May 05, 2012
Closing Date:	Sep 24, 2013
Agency Contact Information::	Grants Info
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.1] PHS Cover Letter [V1.2]