NINDS ADMINISTRATIVE SUPPLEMENTS: TESTING OF CANDIDATE DRUG TREATMENTS FOR
NEURODEGENERATION IN RODENT MODELS

RELEASE DATE:  March 4, 2003

NOTICE:  NOT-NS-03-003

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

The National Institute of Neurological Disorders and Stroke (NINDS) 
announces an administrative supplement program of up to $1 million in 
Fiscal Year 2003 to facilitate the testing of candidate drugs in rodent 
models of neurodegeneration.  This administrative supplement program is 
issued in response to recommendations from the NINDS Strategic Plan 
(http://www.ninds.nih.gov/about_ninds/strategic_plan.htm)
and the Parkinson's Disease Research Agenda 
(http://www.ninds.nih.gov/about_ninds/plans/nihparkinsons_agenda.htm).
The program is intended to facilitate the identification of new 
treatments for neurodegenerative disorders through evaluation of 
promising drugs 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 apply.  

This program is designed to support the testing of candidate therapies 
for chronic neurodegenerative disorders in rodent models.  The animal 
model of disease under study should have demonstrable value for drug 
testing, with mechanistic relevance to the disease of interest and 
reliable outcome measures.  Outcome measures may include behavioral 
changes, biochemical or histological measures, or survival.  The 
proposed drug(s) should have clearly demonstrated promise as treatments 
for neurodegeneration based on data from previous in vitro, animal or 
clinical testing.  In addition to testing the efficacy of individual 
drugs, an important goal of this program is to generate data that can 
be used to compare the promise of different drugs within a disease 
area.  This information will be valuable in prioritizing active 
compounds for clinical testing.  Therefore, at the outset of the 
program, NINDS will facilitate discussions among investigators who 
share a disease focus.  To the extent possible, these discussions will 
be aimed at reaching a consensus about testing protocols.   

It is acceptable to purchase commercial or institutional services to 
conduct the drug trials.  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.

DATA SHARING

At the end of the supplemental project period (one year from the award 
date of the supplement), the NINDS will arrange a meeting of the 
investigators funded under this program to present the results of the 
tests.  The goals of the meeting will be to discuss the relative 
effectiveness of compounds tested, define steps to clinical evaluation 
of effective compounds, and consider effective compounds for testing in 
other neurodegenerative disease models.  In their proposals, applicants 
should discuss their willingness to share their data, under 
confidentiality, within the group of investigators funded under this 
program.  This will be an important factor for review. 

HOW TO APPLY

Submission of requests should be made electronically.  Supplement 
requests should be submitted via Email to: drugtests@ninds.nih.gov with 
the Principal Investigator's name (last name, first name) and grant 
number (e.g., R01NS01234-05) on the subject line.  Per the NIH Guide 
Notice OD-00-009 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-00-009.html), the supplemental request must be submitted to the above 
e-mail address by an authorized business official at the grantee 
institution.  Electronic submission by the authorized institutional 
official is understood as an expression of institutional approval and 
indicates that all internal procedures have been properly completed.  
Include the following sections in an attached file in MSWord, 
WordPerfect, or PDF format:

1. A cover page citing this NOTICE and requesting an administrative 
supplement, including the PI name, grant number and title, amount 
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 the rodent model.  For P01s and P50s and 
U54s, the named PI must submit a request for a supplement to a 
subproject.

2. A letter (5-page limit) describing the project, including an 
abstract, a rationale for the choice of animal model and drug(s) and 
the design of the rodent trial.  The project description should include 
the information listed in the Review Criteria section below.  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.  

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

Applicants unable to submit an electronic application should submit a 
complete written application, signed by an authorized business official 
at their institution, to Dr. Jill Heemskerk at the address listed at 
the end of this notice.

REVIEW CRITERIA

Applications will be reviewed administratively, and it is expected that 
a resulting Supplemental Notice of Grant Award will be issued within 
three months of the receipt deadline.  All funding decisions are final 
and are not subject to appeal.  Review criteria will include the 
relevance of the rodent model to neurodegenerative disease, quality of 
the rationale for the selection of the drug, the scientific merit of 
the design of the rodent trial, and the willingness to share resulting 
data with other investigators funded under this program.  Applicants 
should provide the following information for consideration in review:

1. A brief description of the rodent model, including genotype, 
phenotype and background strain, and the relevance of the model to the 
neurodegenerative disease of interest.  List any relevant publications 
describing the construction of the model and its use in drug testing.

2. The rationale for the choice of drug and dose to be tested.  Provide 
information about the potency of the drug in experimental assays or 
clinical settings, and relate this to the expected achievable dose in 
the rodent model.  Describe how the dose and route of administration in 
the trial will be selected.

3. A description of the trial design including description of outcome 
measures and the rationale for their choice, positive and negative 
controls, and method for determining sample size.  Describe at what 
stage and with what frequency the drug will be administered.

4. A data-sharing plan that addresses the willingness of the 
investigator to share data with other investigators in the program 
under confidentiality at a conference to be held at the end of the 
supplement period.

BUDGET INFORMATION  

Supplements will be awarded as direct costs in modular amounts of 
$25,000 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 drug testing 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 
merit.

Receipt dates:          April 7, 2003       June 30, 2003
Earliest Award date:    June 9, 2003        August 29, 2003

INQUIRIES

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) 480-1080
Email: jill_heemskerk@ninds.nih.gov

Direct inquiries regarding fiscal matters to:

Dianna Jessee
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., NSC Room 3259
Bethesda, Maryland  20892 (USPS)
Rockville, MD  20852  (FedEx and other couriers)
Tel:  301-496-7416
Fax:  301-402-0219
Email:  jesseed@ninds.nih.gov


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