NINDS ADMINISTRATIVE SUPPLEMENTS: FDA-APPROVED COMPOUND SCREENS
FOR NEURODEGENERATION
Release Date: May 8, 2001
NOTICE: NOT-NS-01-009
National Institute of Neurological Disorders and Stroke
Huntington’s Disease Society of America
The ALS Association
The Hereditary Disease Foundation
The National Institute of Neurological Disorders and Stroke (NINDS),
The Huntington’s Disease Society of America (HDSA), and The Amyotrophic
Lateral Sclerosis Association (ALSA), and The Hereditary Disease Foundation
(HDF) announce an administrative supplement program of up to $1.3 million
in Fiscal Year 2001. The program is intended to facilitate drug screens
to identify new treatments for late onset neurodegenerative disorders
through evaluation of FDA-approved compounds in disease models used or
generated in ongoing, peer-reviewed, NINDS-funded projects. This
administrative supplement program is issued in response to recommendations
from the NINDS Strategic Plan
(http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm) and the
Parkinson’s Disease Research Agenda
(http://www.ninds.nih.gov/about_ninds/plans/nihparkinsons_agenda.htm).
Principal Investigators with Research Project (R01),
Exploratory/Development (R21), FIRST (R29), Phase II SBIR (R44),
Program Project (P01), and Specialized Center (P50 or U54) grants
funded by NINDS are eligible to apply. To be eligible, projects must
have a Project Period End Date of January 31, 2002 or later (a no cost
extension beyond that date does not confer eligibility).
Evidence should be presented that the disease model is directly related
to the design or goal of Specific Aims of the original research
project, without constituting an expansion of scope. Supplements are
one-time awards and will not extend to subsequent years.
This announcement is designed to encourage the testing of an extensive
and diverse FDA-approved compound collection in models of late onset
neurodegenerative disorders, including ALS, Huntington s, Parkinson’s
and Alzheimer’s Disease. The disease model should be practical for a
screen of approximately one thousand compounds in a maximum of six
months. This program is intended to broadly evaluate compounds having
demonstrated safety and efficacy as drugs. Testing of specific
compounds that have been identified in prior screens is outside the
scope of this announcement.
The purchase of services from commercial vendors or institutional
facilities to screen the investigator’s assay is acceptable. Requests
for salary may be included, in proportion to time directly devoted to
the supplemental project. These funds are not intended to support the
purchase of screening equipment.
Data Sharing: The evaluation of the therapeutic promise of identified
compounds can be dramatically facilitated by comparison with effect in
other neurodegeneration assays. Thus, an important goal of this program
is to facilitate the comparison of results across multiple assays.
Toward achieving this goal, the NINDS will assist investigators in
coordinating the results of screens funded under this program. This
coordination of data depends on the use of a standard set of compounds,
which has been designed for this project to include compounds of
particular interest as treatments for neurodegenerative disease. This
set of compounds, identified as the NINDS Custom Collection (NCC), is
available from MicroSource Discovery Systems, Inc. (860-350-8078).
Investigators will enter data into the database supplied by MicroSource
Discovery. To facilitate the exchange of information among
participating investigators, the NINDS will convene a workshop at the
end of the supplemental project period (six months from the award date
of the supplement). This will allow investigators to evaluate and
prioritize effective compounds for inclusion in clinical trials. In
their proposals, investigators should discuss their willingness to
screen the standard compound set and share their results within this
group, as this will be an important factor for review.
Funds Available: The NINDS intends to commit up to $1 million in FY
2001 to fund approximately 20 administrative supplements in response to
this announcement. HDSA, ALSA, and HDF each intend to commit up to
$100,000 in additional funds, and each will award approximately 2
supplements based on their own review of relevant applications. This
funding level is dependent upon the receipt of a sufficient number of
applications of high scientific merit that fit within the mission of the
NINDS, HDSA, ALSA, and HDF respectively. After NINDS review, investigators
will be contacted for permission to forward their applications to HDSA, ALSA,
or HDF as appropriate. Investigators funded by HDSA, ALSA, and HDF will be
encouraged to fully participate in the data sharing plan as outlined
above.
How to apply: Applicants are encouraged to contact Dr. Carlos Pena at
the number below prior to submitting a proposal. Submission of requests
should be made electronically. Send an Email message to:
Drugscreens@ninds.nih.gov with the PI"s name (last name, first name)
and grant number (e.g., R01NS01234-05) on the Subject line. Include
the following sections in an attached file in MSWord or WordPerfect
format only:
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 the PI and institutional official.
For P01s and P50s and U54s, the named PI must submit the request for a
supplement.
2) A letter (5-page limit) describing the project, including an
Abstract, a Description of the proposed assay to be tested and its
relationship to the original project Specific Aims, a description of
the strategy for testing 1000 compounds in this assay within six
months, a description of the proposed plan for data sharing, and a
budget with justifications.
3) Specific Aims of the original grant.
PIs should not submit a request electronically until the institutional
business office has reviewed and approved the request. Applicants
unable to submit an electronic application should submit a complete
written application addressed to Dr. Carlos Pena postmarked no later
than June 15, 2001.
In addition, an original letter summarizing the request, signed by the
PI and countersigned by an authorized institutional official, should be
submitted by mail postmarked no later than June 15, 2001. This letter
should include the information listed above. This is required for
issuance of an award, and should be sent to Dr. Carlos Pena at the
address listed at the end of this notice.
Budget information: Supplements will be awarded as TOTAL COSTS in
modular amounts of $25,000 and are one-time awards. Any Facilities and
Administrative (F&A) Costs should be included in the modular request,
and may not be added to it. For R01s, R21s, R29s and R44s, the maximum
request is $50,000. For P01s P50s and U54s, 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
screening will not be fully supported by the supplemental funds from
NINDS, the sources and amounts of additional funds should be specified.
Review procedure: Applications will be reviewed administratively.
Review criteria will include the relevance of the disease model to
neurodegenerative disease, the relevance of the disease model to the
Specific Aims of the parent grant, and the willingness to share
resulting data with other investigators funded under this program.
Receipt date: June 15, 2001
Earliest Award date: August 1, 2001
Inquiries:
A website with FAQ’s about the program has been provided at
http://www.ninds.nih.gov/funding/drug_screens.htm.
Direct inquiries regarding programmatic matters to:
Dr. Carlos Pena
Neurodegeneration Group
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd. NSC Room 2228
Bethesda, MD 20892 (USPS)
Rockville, MD 20852 (Courier and FedEx)
Tel: (301) 496-5680
Fax: (301) 480-1080
Email: penac@ninds.nih.gov
Direct inquiries regarding fiscal matters to:
Kimberly Pendleton
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., NSC Room 3260
Bethesda, Maryland 20892 (USPS)
Rockville, MD 20852 (Courier and FedEx)
Tel: 301-496-7480
Fax: 301-402-0219
Email: kp33e@nih.gov
Weekly TOC for this Announcement
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