Notice Availability Administrative Supplements Prepare Projects the Blueprint Neurotherapeutics Network Notice Number: NOT-NS-10-018 Key Dates Release Date: 14, 2010 Receipt Date: June 18, 2010 Earliest Anticipated Start Date: August 2, 2010 Issued National Institute Neurological Disorders Stroke NINDS),
http://www.ninds.nih.gov) National Institute Deafness Other Communication Disorders NIDCD),
http://www.nidcd.nih.gov) Purpose NINDS NIDCD established administrative supplement program enable NINDS NIDCD grantees prepare projects entry the Blueprint Neurotherapeutics Network
http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). NINDS plans award to 10 administrative supplements this purpose Fiscal Year 2010, the NIDCD plans award to 5. administrative supplement award be capped 50,000 direct costs. Background NIH Blueprint Neuroscience Research
http://neuroscienceblueprint.nih.gov/) released Request Applications solicit projects the Blueprint Neurotherapeutics Network RFA-NS-11-002
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-002.html) expects release second RFA the same purpose April 2011. goal the Blueprint Neurotherapeutics Network to develop new small molecule drugs will transform treatment nervous system diseases conditions. Successful applicants the network receive 1) funding support biological testing compounds during development 2) access technical, infrastructure, advisory resources. network support stages drug development beginning medicinal chemistry ending phase clinical testing. nbsp;To competitive the network, investigators should have: least small molecule compound strong evidence biological activity relevant the intended indication a starting point medicinal chemistry optimization. robust, moderate throughput assay biological activity suitable testing compounds generated an iterative medicinal chemistry effort. assay should capable providing robust dose-response data 20-40 compounds a 1-2 week cycle. Secondary bioassays models sufficient evaluate potential a drug candidate the intended indication. administrative supplement program intended help NINDS grantees meet above entry criteria the Blueprint Neurotherapeutics Network. APPLICATIONS ENTRY THE BLUEPRINT NEUROTHERAPEUTICS NETWORK NOT BEING ACCEPTED THIS TIME. Eligibility administrative supplement program targeted NINDS NIDCD grantees are interested participating the Blueprint Neurotherapeutics Network who not yet sufficient data prepare competitive application entry the network. Administrative supplements be used any the following activities: Development optimization primary secondary biological assays suitable testing compounds generated an iterative medicinal chemistry effort Prioritization chemical scaffolds being considered starting points medicinal chemistry Preliminary assessment structure-activity relationships SAR) Validation studies hits identified through high-throughput screening PK/toxicology studies identify liabilities address through medicinal chemistry activities may help prepare project the Blueprint Neurotherapeutics Network should discussed the relevant program contact below, prior submitting supplement application. NINDS NIDCD grantees plan submit application response the April 2010 Blueprint Neurotherapeutics Network RFA-NS-11-002
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-002.html) eligible apply administrative supplements. Receipt an administrative supplement not affect peer review an application submitted under RFA-NS-11-002. NINDS NIDCD grantees receive supplement are accepted the network 2010 must still the supplement funds originally intended; will enable project make best of network resources. Principal Investigators Research Project R01), Javits Award R37), Exploratory/Developmental R21), phase II SBIR R44), Phase II STTR R42), Program Project P01), Specialized Center P50 U54), Cooperative Agreement U01) grants funded NINDS NIDCD eligible apply administrative supplements. be eligible, parent grant must active, the research proposed the supplement must accomplished within competitive segment. proposed supplement MUST within general scope the peer-reviewed activities aims approved within parent grant. IMPORTANT: research proposed the NIH grantee the supplement application must within original scope the NIH-supported grant project. funding mechanism being used support program, administrative supplements, be used cover cost increases are associated achieving certain new research objectives long they within original scope the project. Any cost increases need result making modifications the project order take advantage opportunities would increase value the project consistent its originally approved objectives purposes. Submitting Administrative Supplement Request be considered an administrative supplement, please submit request writing the NINDS contacts listed How Apply, to Division Receipt Referral, Center Scientific Review. request must signed the authorized Business Official describe need additional funding the categorical costs. Applicants submit only supplement request per grant. Requests under notice should the PHS 398 forms rev. 11/2007; available
http://grants.nih.gov/grants/funding/phs398/phs398.html) include following elements the request packet. Font size restrictions apply designated within PHS398 rev. 4/2006) instructions.) 1) Cover Letter - Citing Notice NOT-NS-10-018), request an Administrative Supplement, the following information: Project Director/Principal Investigator PD/PI) name Parent grant number title Amount the requested supplement Name title the institutional official, Phone, email, address information both PD/PI institutional official. cover letter must signed the authorized organizational representative/institutional official. 2) PHS 398 Form Page 1 Face page) MS Word PDF title the project Box 1) should the title the parent award. Notice NOT-NS-10-018, ldquo;Notice Availability Administrative Supplements Prepare Projects the Blueprint Neurotherapeutics Network) should cited Box 2, the ldquo;yes” box should checked. Principal Investigator PI) must the same the PI the parent award. Multiple PI parent awards, Contact PI must the PI listed the supplement request, the supplement cannot change Multiple PI team. remaining items the face page should filled in accordance the PHS 398 application instructions. 3) PHS 398 Form page 2 MS Word PDF Note: project ldquo;summary” that the administrative supplement, the parent grant. 4) brief proposal describing project, including: a) 1-page introduction. b) Scope the overall project the anticipated contribution the requested supplement to exceed five pages). Provide brief description the scope the overall project which supplemental request based. Describe relationship the supplement request the parent grant. Provide brief description the drug development project would submitted the Network, including disease interest, intended molecular cellular target, compound(s) proposed development, assays disease models be used. Describe current status the drug development project how supplement enable to meet entry criteria the Network. section should include description the supplement's specific aims, including research design methods data analysis. This section should also indicate any additional drug development expertise required the supplement studies e.g., expertise assay optimization SAR analysis) be obtained. c) Budget the supplement a justification details items requested, including Facilities Administrative costs. Budget Funding Information below. d) Biographical Sketch all new key personnel those are additions the supplemental project) MS Word PDF nbsp; e) Human Subjects/ Vertebrate Animal documentation applicable). Include current Human Subjects/IRB Vertebrate Animals/IACUC approval letter, available. Otherwise, will required the time funding. appropriate IRB IACUC approvals must in place prior a supplement award being made. Any differences the involvement use human subjects specimens, use vertebrate animals, between administrative supplement activity the parent grant should noted. appropriate, details should provided the protection human subjects inclusion women, children, minorities. Additional guidance Human Subjects Research Vertebrate Animals provided under Part II the PHS 398 instructions
http://grants1.nih.gov/grants/funding/phs398/phs398.html). f) PHS 398 Checklist Form MS Word PDF Selection Factors Administrative supplement requests be reviewed administratively a committee NIH staff. Selection factors include following: Relevance the proposed activities the parent grant Adequate progress the parent grant appropriate the current stage the project Appropriate well-described plan accomplish goals within timeframe proposed Expertise the research team proposed conduct achieve goals the supplemental study potential the proposed work result a project suitable entry the Blueprint Neurotherapeutics Network. Budget Funding Information FY 2010, 750,000 be available administrative supplements existing NINDS research projects, 375,000 be available NIDCD projects. Applicants request to 50,000 direct costs. Supplements be requested one year may extend longer the parent grant. Applicants must submit budget using same budget format was used the parent award. nbsp;Any no-cost extension must in place before submission the revision application. Supplement funds be used reagents and/or personnel costs, including costs hiring drug development consultants. requests equipment be considered. to Apply is one-time announcement. Applications must received or before June 18, 2010. not send applications the NIH Center Scientific Review. Applicants should submit electronic copy an e-mail attachment PDF format
rebecca.farkas@nih.gov one original, hard copy the request packet original signatures the authorized business official) the following address : Tijuanna E. Decoster, MPA National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Boulevard, Room 3258 Bethesda, MD 20892-9525 EXPRESS/COURIER: Rockville, MD 20852 Inquiries Inquiries discussion plans responding this Notice strongly encouraged. NINDS Program Contact: Rebecca Farkas, Ph.D. National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Boulevard, Room 2229 Bethesda, MD 20892-9525 EXPRESS/COURIER: Rockville, MD 20852 301) 496-1779 Email:
rebecca.farkas@nih.gov NIDCD Program Contact: Nancy L. Freeman, Ph.D. Division Scientific Programs National Institute Deafness Other Communication Disorders National Institutes Health 6120 Executive Boulevard, Room 400C Bethesda, MD 20892 301) 402-3458
freemann@mail.nih.gov NINDS Grants Management Contact: Tijuanna E. Decoster, MPA National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Boulevard, Room 3258 Bethesda, MD 20892-9525 EXPRESS/COURIER: Rockville, MD 20852 301) 496-9231
decostert@mail.nih.gov NIDCD Grants Management Contact: Christopher Myers Division Extramural Activities National Institute Deafness Other Communication Disorders National Institutes Health 6120 Executive Boulevard, EPS 400B Bethesda, MD 20892 301) 435-0713
myersc@nidcd.nih.gov