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


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