NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study U01 Grant

The National Institute of Dental and Craniofacial Research (NIDCR) is offering a grant to support investigator-initiated clinical trials or biomarker evaluation studies in phases I-IV. This grant aims to facilitate the prospective collection of clinical outcomes and specimens. Applicants must have previously obtained an NIDCR Clinical Trial Planning award. Each proposed study requires a unique application with essential documents like a study protocol and Manual of Procedures. The grant adheres to NIH, FDA, and OHRP guidelines and will be awarded as a cooperative agreement. Application deadline is January 7, 2015.

Opportunity ID: 123213

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General Information

Document Type::	Grants Notice
Funding Opportunity Number::	PAR-11-339
Funding Opportunity Title::	NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01)
Opportunity Category::	Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity::	Health
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s)::	93.121 — Oral Diseases and Disorders Research
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 1
Posted Date::	Sep 16, 2011
Last Updated Date::
Original Closing Date for Applications::	Jan 07, 2015
Current Closing Date for Applications::	Jan 07, 2015
Archive Date::	Feb 07, 2015
Estimated Total Program Funding::
Award Ceiling::	$
Award Floor::	$

Eligibility

Eligible Applicants::

Public housing authorities/Indian housing authorities

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::	This FOA issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, will support investigator-initiated Phase I, II, III or IV clinical trial cooperative agreement applications or biomarker evaluation studies that require prospective collection of clinical outcomes and clinical specimens. All applicants must have received an NIDCR Clinical Trial Planning (R34) award to plan the proposed cooperative agreement study (see PAR-11-338 for information about NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grants). NIDCR may consider an exception. A unique application is required for each proposed study, and must include a final draft of the study protocol, a Manual of Procedures and other supporting materials such as the Investigators Brochure. These documents must meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. All awards will be made as cooperative agreements.
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:	93.121
Competition ID:	ADOBE-FORMS-B2
Competition Title:	ADOBE-FORMS-B2
Opportunity Package ID:	PKG00078831
Opening Date:	Oct 18, 2011
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]