NINDS Grant for Translational Research in Neurological Disorders

The National Institute of Neurological Disorders and Stroke (NINDS) is offering a grant to support preclinical development and testing of new therapies for neurological disorders. This grant aims to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should have therapeutic leads with strong biological rationale and in vivo proof-of-concept of efficacy. The grant supports preclinical optimization, IND, IDE, or FDA application submissions, and Phase 0 clinical trials. Excluded activities are early-stage therapeutic discovery, clinical research not specified, basic research, and disease mechanism studies. This milestone-driven program involves NINDS staff in project planning and monitoring.

Opportunity ID: 207674

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General Information

Document Type::	Grants Notice
Funding Opportunity Number::	PAR-13-022
Funding Opportunity Title::	NINDS Cooperative Program in Translational Research (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)::	93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 2
Posted Date::	Nov 19, 2012
Last Updated Date::	Feb 13, 2014
Original Closing Date for Applications::	Aug 20, 2014
Current Closing Date for Applications::	Feb 13, 2014
Archive Date::	Mar 13, 2014
Estimated Total Program Funding::
Award Ceiling::	$
Award Floor::	$

Eligibility

Eligible Applicants::

Public and State controlled institutions of higher education

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); 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 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 goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should include therapeutic leads, a strong biological rationale for the intended approach, and where available in vivo proof-of-concept of efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND), Investigational Device Exemption (IDE), 510(k), or 510(k) de novo application to the Food and Drug Administration (FDA) can be submitted during the project period. The program can also support Phase 0 clinical trials for small molecule drugs, proof-of-concept for biologics, or proof-of-concept/pilot clinical trials for therapeutic devices. The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, other than those specified above, basic research, and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS program staff in the development of the project plan and monitoring of research progress.
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 2	This funding opportunity is being closed and archived, per NOT-NS-14-013.	Feb 13, 2014
Synopsis 1

Package Status

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

Package No: 1

Assistance Listings:	93.853
Competition ID:	ADOBE-FORMS-B2
Competition Title:	Adobe-Forms-B2
Opportunity Package ID:	PKG00152890
Opening Date:	Jan 07, 2013
Closing Date:	Sep 24, 2013
Agency Contact Information::	eRA Commons Help Desk
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]