RELEASE DATE:  October 30, 2003

NOTICE: NOT-NS-04-001 

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) 
announces an administrative supplement program of up to $1 million in 
fiscal year 2004 to promote progress in pre-clinical neurological 
therapeutics development.  This administrative supplement program is 
issued in response to recommendations from the NINDS Strategic Plan 
(  The program 
is intended to facilitate the identification of new treatments for 
neurological disorders from candidate therapies identified or evaluated 
in ongoing, peer-reviewed projects.  Principal Investigators with 
Research Project (R01), Exploratory/Development (R21), Phase II SBIR 
(R44), Program Project (P01), Specialized Center (P50 or U54), and 
Cooperative Agreement (U01) grants funded by NINDS are eligible to 

The goal of this program is to open critical paths in pre-clinical 
therapeutics development by funding small, focused projects. Supported 
studies should be designed to demonstrate the promise of therapies to 
1) reduce the barriers to commercial development or 2) justify NIH 
funding for additional pre-clinical or clinical development. Thus, 
proposals should demonstrate both a sound rationale for the proposed 
project and a feasible plan to support further development of the 
candidate therapy. The proposed intervention(s) should have clearly 
demonstrated promise as treatments for neurological disease based on 
data from previous in vitro, animal or clinical testing. Highest 
funding priority will be given to studies that are specifically 
designed to support an IND application for clinical testing, and that 
form part of a well-developed plan for pursuing an IND.

Examples of studies to be funded under this program include:

o Studies to test the efficacy of highly promising interventions in 
animal disease models

o Pre-clinical safety, kinetic or metabolic studies of strongly 
supported therapeutic leads

o Chemical optimization of strongly supported therapeutic leads

o Screening of clinically approved drug collections in neurological 

Studies that are not encouraged under this announcement include early 
stage exploratory studies, such as model development or target 
validation. Clinical studies will not be supported under this 

It is acceptable to purchase commercial or institutional services to 
conduct the proposed studies.  Requests for salary may be included, in 
proportion to time directly devoted to the supplemental project. 

Evidence should be presented that the results of the supplemental 
assistance will enhance the pursuit of the Specific Aims of the 
original research project, without constituting an expansion of scope. 
Supplements are one-time awards and will not extend to subsequent 
budget periods.


Applicants should submit an original and five complete copies to Dr. 
Jill Heemskerk at the address listed at the end of this notice. The 
following sections should be included:

1. A cover page citing this NOTICE and including the following 
information: PI name, grant number and title, direct and indirect costs 
requested, name and title of the institutional official, and phone, 
email, and address information for both the PI and institutional 
official.  Document the approval from the Institutional Animal Care and 
Use Committee (IACUC) for any animal testing. For P01s and P50s and 
U54s, the named PI must submit a request for a supplement to a 

2. A description of the project (5-page limit), including:

o an abstract 
o a rationale for the candidate therapeutic
o the design of the proposed study
o the plans for further development following the supplemental study

The applicant should describe the relationship of the project to the 
Specific Aims of the parent grant.  Evidence should be presented that 
the results of the supplemental assistance will enhance the pursuit of 
the Specific Aims of the original research project without constituting 
an expansion of scope.

o human subjects
o vertebrate animals 

If research involving human subjects or vertebrate animals was 
previously approved as within the scope of the project, then include 
the corresponding information as in the PHS 398 Research Plan, sections 
e. Human Subjects and/or f. Vertebrate Animals for the supplemental 
project.  If human subjects and/or vertebrate animals were not 
previously approved, they cannot be added through this administrative 

3. A modular budget with appropriate justifications for requested 
direct costs and specifying Facilities and Administrative Costs.
4. Specific Aims of the original grant.


A one-page report that specifically addresses the results of the 
supplement will be required. It should be included as an addition to 
the progress report of the parent grant, submitted the year following 
the supplement award.


Applications will be reviewed administratively, and it is expected that 
a resulting Supplemental Notice of Grant Award will be issued within 
four months of the receipt deadline. All funding decisions are final 
and are not subject to appeal. 

Review criteria will include:

o the quality of the rationale for the candidate therapy 
o the scientific merit of the study design
o the feasibility of the plans for further development following 
supplemental study
o importance of the study in moving the candidate therapy toward the 


Supplements will be awarded as direct costs in modular amounts of 
$10,000 and are one-time awards. Any Facilities and Administrative 
(indirect) Costs should also be specified in the budget request. For 
R01s, R21s, and R44s, the maximum request for direct costs is $50,000.  
For P01s, P50s, U54s, and U01s, the maximum is $100,000.  Although the 
awarded budgets will be modular, applicants should provide a budget 
justification that details the budget items requested, including 
Facilities and Administrative costs.  If the planned study will not be 
fully supported by the supplemental funds from NINDS, the sources and 
amounts of additional funds should be specified. 

NINDS will commit $1 million in total costs to fund applications for 
supplements submitted in response to this Notice. Awards pursuant to 
this Notice are contingent upon the availability of funds and the 
receipt of a sufficient number of applications of high scientific 

Receipt dates:          January 30, 2004        April 30, 2004
Earliest Award date:    April 30, 2004          July 30, 2004


Direct inquiries regarding the program to:

Dr. Jill Heemskerk
Technology Development Group
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd. NSC Room 2229
Bethesda, MD 20892 (USPS)
Rockville, MD 20852  (FedEx and other couriers)
Tel: (301) 496-1779
Fax: (301) 402-1501

Direct inquiries regarding fiscal matters to:

Ken Bond
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., NSC Room 3246
Bethesda, Maryland 20892 (USPS)
Rockville, MD  20852  (FedEx and other couriers)
Tel:  301-496-9231
Fax:  301-402-0219

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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and Human Services (HHS) - Government Made Easy

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