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Notice Availability Administrative Supplements the U.S.-JAPAN Brain Research Cooperative Program – U.S. Component Notice Number: NOT-NS-10-014 Update: following update relating this announcement been issued: June 5, 2014 - Issuance PA-14-249. Key Dates Release Date: 14, 2010 Receipt Date: September 15, 2010, 2011, 2012 Earliest Anticipated Start Date: February 1, 2011 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov/) National Cancer Institute NCI) http://www.nci.nih.gov) National Eye Institute NEI) http://www.nei.nih.gov) National Institute Aging NIA) http://www.nia.nih.gov) National Institute Biomedical Imaging Bioengineering NIBIB) http://www.nibib.nih.gov) Eunice Kennedy Shriver National Institute Child Health & Human Development NICHD) http://www.nichd.nih.gov) National Institute Drug Abuse NIDA) http://www.nida.nih.gov/) National Institute Deafness Other Communication Disorders NIDCD) http://www.nidcd.nih.gov/) National Institute Dental Craniofacial Research NIDCR) http://www.nidcr.nih.gov/) National Institute Environmental Health Sciences NIEHS), http://www.niehs.nih.gov) National Institute Mental Health NIMH) http://www.nimh.nih.gov/) Purpose National Institutes Health NIH) announces continuation the United States U.S.) component the U.S.-Japan Brain Research Cooperative Program BRCP).  administrative supplement program provide funds research projects supported the participating NIH Institutes. purpose the BRCP to promote scientist exchange, training, research collaborations between neuroscientists the U.S. Japan. U.S. component the BRCP supports following activities: 1) Visit U.S. scientists conduct collaborative research and/or acquire advanced research skills Japanese institutions, 2) Joint workshops exchange scientific information to foster collaborations. Background agreement Cooperation Research Development Science Technology” signed the President the United States the Prime Minister Japan May 1, 1980 has subsequently renewed extended.  Under umbrella this Agreement, NINDS the National Institute Physiological Sciences, Okazaki National Research Institutes, Japan, signed Memorandum Understanding a Brain Research Cooperative Program November 29, 2000.  Since inception 2002, U.S. component the BRCP successfully supported U.S. neuroscientists’ collaborative activities Japanese institutions international workshops the neurosciences.  Japanese component the BRCP been active since 2001.  Details the Japanese component the program available http://www.nips.ac.jp/jusnou/english/. Within funding guidelines the BRCP program, country supports own scientists participate the aforementioned activities.  Areas research interests the participating NIH Institutes NINDS supports basic, translational clinical research understand structure function the nervous system mechanisms underlying neurological disorders stroke. NCI leads national effort improve treatment primary metastatic brain tumors. active program both early translational research later phase clinical trials via specialized trial networks currently on-going. institute also supports basic science correlative science efforts CNS tumors. NEI supports basic, translational clinical research respect blinding eye diseases, visual disorders, preservation sight, mechanisms normal visual function, the special health problems requirements individuals impaired vision.  NEI also supports development new technologies, strategies, research tools can applied basic translational research will benefit vision health. NIA supports broad spectrum research training aimed a better understanding age-related normal pathological changes the structure function the nervous system how such changes affect behavior.  mission includes basic clinical studies the nervous system, clinical trials interventions therapeutic modalities, epidemiological research identify risk factors to establish prevalence incidence estimates pathologic conditions. mission NIBIB to improve human health leading development accelerating application biomedical technologies. NIBIB encourages submission proposals support development bioengineering biomedical imaging technologies. NICHD supports basic, clinical behavioral research the neurosciences, particularly the research relates normal abnormal nervous system development, reproduction,  promotion healthy development prevention disability, improving through rehabilitation health, function, quality life persons chronic physical and/or cognitive disabilities. NIDA supports basic, clinical, applied research the causes, consequences, prevention treatment drug abuse addiction. NIDCD encourages collaborative basic clinical biomedical bio-behavioral research the communication sciences hearing, balance, smell, taste, voice, speech language. NIDCR supports research molecular mechanisms regulating normal craniofacial development; genetic environmental influences abnormal craniofacial disorders; the etiology pathophysiology chronic pain orofacial tissues a focus the temporomandibular joint. NIEHS supports basic mechanistic human based studies the interplay environmental neurotoxicant exposure neuronal dysfunction across life span.  includes influence prenatal exposure both childhood adult dysfunction/disease well adult exposures the aging brain. NIMH supports integrated program basic clinical research biology, neuroscience, epidemiology, behavioral sciences well services research aimed developing assessing new approaches diagnose, prevent treat mental illness. Eligibility current announcement for supplements Research Project R01, R37, R21), Program Project P01), Center P50), Cooperative Agreement U01, U54) grants funded the participating NIH Institutes. 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. Activities Supported Travel Fund Travel Fund provides support the travel lodging expenses the U.S. scientist’s visit Japan.  total direct cost each Travel Fund request not exceed 15,000.  to 2,500 be used research supplies.  Funds the BRCP not used salary support the principal investigator PI), co-investigators, collaborators. visit the Japanese institution be performed the PI, co-investigator, postdoctoral fellow students work the collaborative project.  Support the Travel Fund be used one multiple trips.  Travel costs should exceed U.S. Government Foreign Per Diem Rate Japan http://www.state.gov/m/a/als/prdm/). duration the supplement one year.  supplement be carried over the next fiscal year, prior approval NIH program staff. Workshop Fund Workshop Fund provides partial support joint workshops.  total direct cost each Workshop Fund request not exceed 35,000.  support travel lodging expenses should exceed U.S. Government Per Diem Rates.  honorarium allowed.  Applicants encouraged obtain additional support other sources. component U.S. Japan) the BRCP support travel lodging expenses the joint-workshop participants their own country.  Applicants encouraged use Workshop Fund compensate travel lodging women underrepresented minority investigators, junior investigators, postdoctoral fellows, graduate students. the joint workshop to held Japan, Japanese component the BRCP support logistical meeting expenses.  the joint workshop to held the U.S., U.S. component the BRCP support logistical meeting expenses. Submitting Administrative Supplement Request be considered an administrative supplement, submit request the NINDS How Apply” section below), to Division Receipt Referral, Center Scientific Review. request must signed the authorized Business Official describe need additional funding the categorical costs. Requests under notice should the PHS 398 forms rev. 6/2009; available http://grants.nih.gov/grants/funding/phs398/phs398.html) include following elements the request packet. Font size restrictions apply designated within PHS398 rev. 6/2009) instructions. 1) Cover Letter - Citing Notice NOT-NS-10-014), 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 Name the program official the NIH Institute has agreed accept application 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 number title) should cited Box 2, the 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 summary” that the administrative supplement, the parent grant. Japanese collaborator(s) should noted under Performance Sites, along their institution(s). 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. section should include description the supplement's specific aims, including research design,  methods data analysis.  Describe relationship the supplement request the parent grant.  c) Budget the supplement a justification details items requested, including Facilities Administrative costs, personnel costs, supplies, travel other expenses.  Applicants must submit budget using same budget format was used the parent award. Any no-cost extension must in place before submission the revision application.  d) Biographical Sketch all new key personnel those are additions the supplemental project) MS Word  PDF . Letters commitment all participants should included section L Consultants) the Research Plan. e) Resources page(s) all key personnel f) Current grant support citing participating NIH Institute) g) 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).   h) Bibliography References Cited Section 5 the PHS 398 Research Plan) should included. i) PHS 398 Checklist Form MS Word  PDF Research Collaborations addition the items outlined the Submitting Administrative Supplement Request” section above, applications research collaboration/training must also include Research/Training Plan the project to exceed five pages).  Font size restrictions apply designated within PHS398 rev. 6/2009) instructions. Research Plans must include: Description the goals the collaborative research/training how research/training enhance research the NIH-supported parent grant Background significance the proposed research/training relevance the goals the BRCP the mission the participating NIH Institutes unique opportunities offered this collaboration/training, the reciprocal U.S. Japan) component the project should clearly delineated Research design methods Description the qualifications the Japanese host the research environment the host institution letter invitation the Japanese host Joint Workshops  Joint workshop applications should developed collaboratively both U.S. Japanese organizers.  addition the items outlined the Submitting Administrative Supplement Request” section above, U.S. applications Joint Workshops must also include workshop plan.  Font size restrictions apply designated within PHS398 rev. 6/2009) instructions. Workshop Plans must include: Importance the proposed workshop investigators the field the larger neuroscience community Relevance the workshop the goals the BRCP the mission the participating NIH Institutes Background anticipated outcomes Content: topics, sessions, list invited participants a tentative agenda Plans foster potential collaborations between U.S. Japanese participants Plans include participation junior investigators, women underrepresented minorities not within scope the meeting, explain why) proposed workshop location duration Organizing committee applicable) Plans disseminate information generated the proposed workshop the larger neuroscience community Reporting Within month the completion all collaborative research/training efforts workshops, U.S. supported investigators required submit final report the NIH, detailing following information: Project objectives Significance Results/findings including list publications, presentations, dissemination material research grant applications resulting the collaboration/training workshop Outcome collaboration/training workshop how benefits NIH supported research Plans continued collaboration the Japanese investigator(s) Selection Factors Administrative supplement requests be reviewed administratively the joint U.S.-Japan BRCP Review Committee Grants Management Staff. Awards be determined the selection factors listed below the availability funds. funding decisions final not subject appeal. 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 supplemental study. Significance the collaboration/training workshop Qualifications the U.S. applicant Japanese host Environment the Japanese host institution Relevance the proposed work the goals the BRCP to mission the participating NIH Institutes to Apply Applicants strongly encouraged contact respective Program Official listed this Notice prior the submission an administrative supplement application.  is reoccurring announcement.  Applications must received or before September 15th each participating year. not send applications the NIH Center Scientific Review.  Submit original, hard copy the request packet original signatures the authorized business official) the address listed below.  Applications also submitted electronically an e-mail attachment PDF format clearly visible signatures the PD/PI Authorized Organizational Representative AOR). Stacey D. Chambers, M.S. Office International Activities National Institute Neurological Disorders Stroke Neuroscience Center, Room 2179 6001 Executive Boulevard Rockville, MD 20852-9523   Phone: 301-496-0690 FAX: 301-480-1080 Email: chambers@ninds.nih.gov Inquiries Inquiries discussion plans responding this Notice strongly encouraged. contacting Program Staff, applicants should prepared discuss purpose, significance necessity their visit Japan how collaborative arrangement benefit NIH-supported research.  names contact information the Program Staff representing participating NIH Institutes listed below: Yuan Liu, Ph.D. Chief, Office International Activities National Institute Neurological Disorders Stroke 6001 Executive Blvd. NSC Room 2187 Bethesda, MD 20892-9523 USPS) Rockville, MD 20852 Courier) Phone: 301-496-0012 FAX: 301-480-2060 Email: liuyuan@ninds.nih.gov William C. Timmer, Ph.D. Program Director Cancer Therapy Evaluation Program Division Cancer Therapy Diagnosis National Cancer Institute 6130 Executive Boulevard, EPN Room 7009, MSC 7432 Bethesda, MD 20892-7432 Phone: 301-496-8866 FAX: 301-480-4663 Email: william.timmer@nih.gov Jerome R. Wujek, Ph.D. Research Resources Officer Division Extramural Research National Eye Institute National Institutes Health Suite 1300 5635 Fishers Lane, MSC 9300 Bethesda, MD  20892-9300 Phone:  301-451-2020 FAX:  301-402-0528 Email: wujekjer@nei.nih.gov Wen G. Chen, Ph.D.  Program Director Sensory Motor Disorders Aging Behavioral & Systems Neuroscience Branch Division Neuroscience National Institute Aging/NIH/DHHS 7201 Wisconsin Avenue Bethesda, MD  20892-9205 Phone:  301-496-9350 FAX:  301-496-1494 Email: chenw@nia.nih.gov John W. Haller, PhD Liaison International Activities National Institute Biomedical Imaging Bioengineering 6707 Democracy Blvd. Suite 200 Bethesda, MD 20892-5649 Phone: 301-451-4780 FAX: 301-480-1614 Email: hallerj@mail.nih.gov Nancy L. Shinowara, PhD Program Director, Spinal Cord Musculoskeletal Disorders Assistive Devices National Center Medical Rehabilitation Research National Institute Child Health Human Development 6100 Executive Blvd. Room 2A03 MSC7510 Bethesda, MD 20892-7510 courier delivery use: Rockville, MD 20852) Phone: 301-402-2242 FAX: 301-402-0832 Email: shinowan@mail.nih.gov Christine Colvis, Ph.D. Genetics & Molecular Neurobiology Research National Institute Drug Abuse 6001 Executive Blvd, Room 4282 Bethesda, MD 20892 Phone: 301-435-1323 FAX: 301-594-6043 Email: cc303v@nih.gov Barry Davis, Ph.D. Division Scientific Programs National Institute Deafness Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC-7180 Bethesda, MD  20892-7180 Phone: 301-402-3464 FAX: 301-402-6251 Email: Davisb1@nidcd.nih.gov Annette Kirshner, PhD Program Administrator Cells Organ Systems Pathobiology Branch Division Extramural Research Training National Institute Environmental Health Sciences Box 12233  KE 3020 MD K3-15 Research Triangle Park, NC 27713 Phone: 919-541-0488 FAX: 919-541-0462 Email: kirshner@niehs.nih.gov Margaret Grabb, Ph.D. National Institute Mental Health 6001 Executive Blvd., Room 7201 Mail Stop Code 9645 Bethesda, MD 20892 Phone: 301- 443-3563 FAX: 301-443-1731 Email: mgrabb@mail.nih.gov

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

Notice Availability NINDS Administrative Supplements Promote Global Health Research Notice Number: NOT-NS-10-019 Key Dates Release Date: 14, 2010 Receipt Date: July 16, 2010 Earliest Anticipated Start Date: September 17, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose National Institute Neurological Disorders Stroke NINDS) announces administrative supplement program promote global health research involving training capacity building low-to middle-income countries.  NINDS set aside 2 Million dollars Fiscal Year 2010 award approximately 25 administrative supplements.  Background mission the NINDS to reduce burden neurological disease ndash; burden borne every age group, every segment society, people over world.  achieve mission, NINDS supports basic, translational clinical research, research training the causes, prevention, diagnosis, treatment illness the nervous system.  Neurological disorders such epilepsy, neurodevelopmental delay, nervous system infections, traumatic brain injury constitute major sources disability the developing world.  recent years, prevalence stroke neurodegenerative disorders rising rapidly is becoming significant health burden low- middle-income countries.  However, global health research, training capacity building activities the developing world particularly low-income countries) inadequate meet region’s growing needs. advance global health research research capacity building neurological disorders stroke, NINDS encourages collaborations between NINDS-funded investigators investigators low- middle-income countries.  goal this supplement program to strengthen existing research research training to support capacity building the sustainability activities aimed lessening global impact neurological diseases stroke.  proposed studies must within scope the peer-reviewed activities specified within NINDS-supported parent award. Areas interests Proposed work should enhance research research training scope the parent project.  Potential topics include, are limited to: Enhance Global Health Research Collaboration Research Training Add new partners recruit local personnel will enhance parent research project Enhance training health research methodology Enhance training clinical research skills the adaptation skills tools local conditions Enhance training research ethics, engage discussions research ethics issues, particularly those contribute multi-cultural perspectives global health research Support travel foreign investigators low- middle-income countries the U.S. collaborators’ institution attend site-visits investigators meetings, and/or receive short-term research training Support travel foreign investigators low- middle-income countries attend international meetings present research results Support travel U.S. investigators the foreign collaborators’ site low- middle-income countries conduct collaborative research, to provide onsite research training Recruit local collaborators provide ldquo;training-the-trainers” research education Global Health Research Tool Development Develop locally relevant information, research, communication technologies designed support ongoing research Improve local research data collection infrastructure Develop improved translation cross-cultural validation research assessment tools Develop educational materials in-country physicians, clinicians health care workers Accelerate Pace Ongoing Global Health Research Increase sample size accelerate participant enrollment clinical trials other clinical research Coordinate and contribute NIH NINDS supported sample collection programs, e.g., NINDS Human Genetics DNA Cell Line Repository enhance sample collection diversity http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10) Improve data collection analysis, e.g., secondary tertiary analysis global health research data generate new hypotheses models Eligibility program provide administrative supplements NINDS-funded Research Projects R01, R37, R21), Cooperative Agreement Awards U01) either directly via least component address global health related research research training.  Parent awards must actively funded least through July 31, 2010 order be eligible.  Parent awards are under no-cost extension before July 31, 2010 not eligible. World Bank main criterion classifying gross national income GNI) be employed this program determine low- middle-income country eligibility. World Bank country income classification tables http://www.worldbank.org/data/countryclass.html).  Before submitting application an administrative supplement, grantees should communicate their Program Director(s) discuss planned application.  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, submit request writing the NINDS, to Division Receipt Referral, Center Scientific Review. request must signed the authorized Business Official describe need additional funding the categorical costs. Requests under notice should the PHS 398 forms rev. 6/2009; available http://grants.nih.gov/grants/funding/phs398/phs398.html) include following elements the request packet. Font size restrictions apply designated within PHS398 rev. 6/2009) instructions.) 1) Cover Letter - Citing Notice NOT-NS-10-019), 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 Separate title the collaborative activity should also provided this letter. nbsp;(If activity involves submission two independent administrative supplement requests, name, institution, NINDS grant number the collaborating PI should also provided, well the additional documents listed under ldquo;How Apply”) 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 number title) 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) one 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. section should include description the supplement's specific aims, including research design methods data analysis.  Describe relationship the supplement request the parent grant.  c) Budget the supplement a justification details items requested, including Facilities Administrative costs, personnel costs, supplies, travel other expenses.  Budget Funding Information below. d) Biographical Sketch all new key personnel those are additions the supplemental project) MS Word  PDF e) Resources page(s) new key personnel named the parent grant(s). f) 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).   g) PHS 398 Checklist Form MS Word  PDF Selection Factors Administrative supplement requests be reviewed administratively NINDS Program Grants management Staff.  Awards be determined the selection factors listed below the availability funds. nbsp;All funding decisions final not subject appeal. 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 supplemental study. Global health impact Innovation Potential enhance international research education low- middle income countries Added value the underlying activity the parent grant(s) its realistic scope, given one year commitment  Budget Funding Information FY 2010, 2 million dollars be available administrative supplements existing research projects, up 25 awards anticipated. Applicants request to 50,000 direct costs the one-year duration an administrative supplement under program.  least collaborating investigator must the Principal Investigator the NINDS supported parent grant.  PI use funds support: or collaborative activity including research research education the partner low- middle-income country, participation a collaborator/co-investigator their home institution, subcontract an outside investigator(s) support involvement the low- middle-income country. nbsp;The maximum direct cost request an individual NINDS grantee 50,000.  duration each award limited one year. 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. Facilities Administrative F&A) costs be paid the full, negotiated rate. Salary support the PI, co-investigators, collaborators not permitted.  Reporting the end the activity, supported investigators be required submit brief 1-2 pages) summary the progress research and/or research training, relevant publications, plans future collaborations.  Sharing any data, resource, tools training materials developed these funds should also described within summary. to Apply is one-time announcement.  Applications must received or before July 16, 2010.  not send applications the NIH Center Scientific Review.  Submit original, hard copy the request packet original signatures the authorized business official) the address listed below.  Applications also submitted electronically an e-mail attachment PDF format clearly visible signatures the PD/PI Authorized Organizational Representative AOR). nbsp;Collaborative activities involve than administrative supplement request associated different NINDS grants and, potentially, different institutions) should note clearly the e-mail communication.  these cases, only complete application should submitted along a separate cover letter, budget page justification, face page, any biosketches/letters/resource pages pertinent the additional site.  role each site should clearly delineated within body the application. Stacey D. Chambers, M.S. Office International Activities National Institute Neurological Disorders Stroke Neuroscience Center, Room 2179 6001 Executive Boulevard Rockville, MD 20852-9523 nbsp; Phone: 301-496-0690 FAX: 301-480-1080 Email: chambers@ninds.nih.gov Inquiries Applicants encouraged discuss plans responding this Notice phone e-mail.  Scientific inquiries should directed the NINDS Program Director oversees parent grant associated the administrative supplement request.  General inquiries this supplement program be directed to: Dr. Yuan Liu Chief, Office International Activities National Institute Neurological Disorders Stroke Neuroscience Center, Room 2187 6001 Executive Blvd Rockville, MD 20892 301- 496-0012 Email: liuyuan@ninds.nih.gov

Notice Changes NINDS Policy Support NIH Exploratory/Developmental Research Grant Program Parent R21) Notice Number: NOT-NS-10-017 Key Dates Release Date:  13, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose purpose this notice to announce changes NINDS policy support research via R21 grant mechanism. Policy Effective immediately, following guidance apply consideration R21 applications NINDS: NINDS continue accept applications investigator-initiated exploratory/developmental projects R21s) all program areas supported the Institute.  Previous NINDS language stated R21 proposals ldquo;limited those the potential truly ground-breaking impact”.  would to emphasize such impact, described the trans-NIH parent R21 announcement http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html), be achieved many different ways.  example, projects assess feasibility a novel area investigation, develop new techniques models, apply existing methodologies a new scientific area, etc. parent announcement additional examples). NINDS maintain existing policy not accepting unsolicited R21 applications include clinical trials other clinical studies potential therapies. nbsp;NINDS places high priority the development evaluation clinical interventions has established specific mechanisms supporting types proposals, http://www.ninds.nih.gov/funding/funding_announcements/Funding-Bins-Cli…).  R21 applications involve human subjects be submitted NINDS the proposals not testing efficacy a clinical intervention if safety monitoring study participants be performed appropriately within budgetary time constraints an R21.  information regarding specific programs contacts, please http://www.ninds.nih.gov/about_ninds/ninds_overview.htm. is important note analyses new investigator applications NINDS indicate the success rate R21 applicants lower for R01 applicants FY 2009 success rates NINDS R21 New Investigators: 11% vs.  NINDS R01 New Investigators: 19%).  Given current policy the NIH support New Investigator R01s success rates equivalent those established investigators submitting new Type 1) applications http://grants.nih.gov/grants/guide/notice-files/not-od-09-013.html), NINDS encourages New Investigators, in particular Early Stage Investigators http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html), apply R01 grants seeking first-time funding the NIH. nbsp; Inquiries Inquiries concerning policy should sent to: Anna Taylor, Ph.D. Division Extramural Research National Institute Neurological Disorders Stroke, NIH 6001 Executive Blvd., Rm. 3003 Bethesda, MD 20892 Telephone: 301) 496-9248 Fax: 301) 402-4370 Anna.Taylor@nih.gov

Request Information: Scientific Regulatory Issues be Explored an Upcoming Pluripotent Stem Cell Workshop involving NIH FDA Notice Number: NOT-NS-10-016 December 12, 2011 - Notice NOT-NS-12-004. Request Information: Scientific Regulatory Issues be Explored an Upcoming Pluripotent Stem Cell Workshop involving NIH FDA. Key Dates Release Date:    6, 2010 Response Due By:  July 16, 2010 Issued National Institutes Health NIH), http://www.nih.gov) Purpose National Institutes Health NIH) the Food Drug Administration FDA) proposing series workshops will engage broader research community regarding requirements necessary translation pluripotent stem cell-derived products the clinic. purpose this RFI to solicit information will useful developing first workshop will focus establishment pluripotent stem cell lines banks, manufacturing early phase clinical trials, manufacturing commercial production, characterization human stem cell-derived products. Background Human pluripotent stem cells the potential both self-renew differentiate specialized cell populations can used repair, replace, regenerate damaged tissue.  characteristics offer substantial promise development therapeutic products address unmet medical needs.  state stem cell science advancing rapidly research activities this area, including those directed clinical application, expected multiply the next few years.  pluripotent stem cells pose additional challenges therapeutic development beyond those encountered other types somatic cellular products? development effective therapeutic products derived pluripotent stem cells require ability demonstrate safety other characteristics the starting cell populations. addition, effective methods have be developed produce target cells choice consistently through execution controlled vitro differentiation protocols.  Finally, analytic test methods need be developed permit identification characterization the intended final cell type(s), well facilitate assessment additional non-target cells present the final product. test methods should possess sufficient precision ensure product safety anticipate possible effectiveness.  enable translation clinical research occur effectively, to increase coordination between research regulatory communities, National Institutes Health the Food Drug Administration proposing series workshops will engage broader research community regarding requirements necessary translation pluripotent stem cell-derived products the clinic.  first workshop focus establishment stem cell lines banks, covering safety regulatory issues related how original cell line derivation done the case embryonic stem cells, how cells reprogrammed the case iPS cells.  workshop expected address issues of  cell line generation banking, manufacturing early phase clinical trials academic industry perspectives), manufacturing commercial production, characterization human stem cell-derived products methods, limitations, current developments).  second workshop expected focus preclinical safety and  proof concept  testing, including, among topics, clinical relevance the animal models, selection cell dose levels, impact host microenvironment, cell fate post-administration.  third workshop expected focus clinical trial design including safety monitoring, immunogenicity, immunosuppressant and immune monitoring. Information Requested NIH seeking information will useful developing first workshop the series. Specifically, NIH seeking input the following five questions: challenges exist moving pluripotent cells the laboratory clinical trials? key questions posed pluripotent stem cell biology respect safety potential clinical effectiveness? you aware any laboratories, research institutions, companies countries have experience safety regulatory translational stem cell research can serve models discussion? can learned our experience other cell therapies is applicable products derived pluripotent stem cells? other questions should asked the workshop? Responses Responses should submitted via email nindsstemcell@mail.nih.gov, will accepted through July 16, 2010.  Inquiries Specific questions this RFI should directed the contact listed below: Susan Marino, PhD Office the Director National Institute Neurological Disorders Stroke National Institutes Health marinosw@ninds.nih.gov

Corrections NOT-NS-10-013, NINDS Announces Availability Funds Competitive Revision Applications Grand Challenge Optimal Cortical Control DARPA Revolutionizing Upper-Limb Prosthetics R01 R37)” Notice Number: NOT-NS-10-015 Key Dates Release Date: April 5, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose Notice corrects/clarifies three aspects NOT-NS-10-013: 1) frequency administrative reporting; 2) allowability PD/PI changes; 3) budget format applications requesting than 250,000. 1) Frequency administrative reporting release FY2 funds NIH DARPA program staff use annual progress report make administrative evaluation whether has sufficient progress merit release funds the second year. evaluation include site visits. 2) Change single PD/PI multiple PD/PIs Competitive revisions allow change the Multiple PD/PI team well a conversion a single PD/PI multiple PD/PI. Applicants must include multiple PD/PI Leadership Plan the revision application such changes being proposed. nbsp; See OER Multiple Principal Investigators Frequently Asked Questions http://grants.nih.gov/grants/multi_pi/faq.htm#d4. 3) Budget format Applications requesting than 250,000 required submit detailed budget, regardless the budget used the parent award. Upon submission Grants.Gov, warning message be generated, can ignored, the application move forward processing.  other aspects NOT-NS-10-013 remain unchanged. Inquiries Dr. Daofen Chen Dr. James Gnadt Program Directors Systems Cognitive Neuroscience National Institute Neurological Disorders Stroke Neuroscience Center 6001 Executive Blvd Rockville, MD 20892 301) 496-9964 Email: daofen.chen@nih.gov; gnadtjw@mail.nih.gov

Notice Change Expiration Date Program Announcement Bioengineering Research Partnerships PAR-07-352) Notice Number: NOT-EB-10-001 Key Dates Release Date:  March 30, 2010 Issued National Institute Biomedical Imaging Bioengineering NIBIB), http://www.nibib.nih.gov) National Cancer Institute NCI), http://www.nci.nih.gov) National Heart, Lung, Blood Institute NHLBI), http://www.nhlbi.nih.gov) National Human Genome Research Institute NHGRI), http://www.nhgri.nih.gov) National Institute Aging NIA), http://www.nia.nih.gov) National Institute Deafness Other Communication Disorders NIDCD), http://www.nidcd.nih.gov) National Institute Dental Craniofacial Research NIDCR), http://www.nidcr.nih.gov) National Institute Environmental Health Sciences NIEHS), http://www.niehs.nih.gov) National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov) Purpose purpose this Notice to extend Expiration Date PAR-07-352: Bioengineering Research Partnerships R01) until September 8, 2010. However, following institutes no longer participating: National Eye Institute NEI), http://www.nei.nih.gov) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), http://www.niams.nih.gov) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), http://www.nichd.nih.gov) National Institute Drug Abuse NIDA), http://www.nida.nih.gov) other aspects this announcement remain unchanged. Inquiries Inquiries concerning Notice directed to: Albert Lee, Ph.D. National Institute Biomedical Imaging Bioengineering National Institutes Health 6707 Democracy Blvd., Suite 200 Bethesda, MD 20892-5477 Phone: 301) 451-4781 Email:  alee@mail.nih.gov 

NINDS Announces Availability Funds Competitive Revision Applications Grand Challenge Optimal Cortical Control DARPA Revolutionizing Upper-Limb Prosthetics R01 R37) Notice Number: NOT-NS-10-013 Update: following update relating this announcement been issued: April 5, 2010 - Notice NOT-NS-10-015 Corrections NOT-NS-10-013, NINDS Announces Availability Funds Competitive Revision Applications Grand Challenge Optimal Cortical Control DARPA Revolutionizing Upper-Limb Prosthetics R01 R37). Key Dates Release Date: March 12, 2010 Application Due Date: 12, 2010 Earliest Anticipated Start Date: September 30, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose purpose this notice to encourage requests competitive revisions research projects currently funded NIH R01 R37 grant mechanisms, appropriate support research development a Grand Challenge achieving optimal electrocorticography ECoG) based cortical control the Revolutionizing Upper-limb Prosthetics 2009 developed the U.S. Defense Advanced Research Projects Agency DARPA).  Grand Challenge be achieve reaching grasping objects the DARPA Arms a subject’s natural work space, obtaining maximum cortical control can realized the highly anthropomorphic prosthetic arm hand. Background Device-based therapeutic approaches offer opportunities restoring neurological function through mechanical, electronic, neural interfacing technologies, complement cellular molecular strategies under development, their roles reducing burden disease injuries. DARPA Revolutionizing Upper-limb Prosthetics DARPA Arms) been developed response the urgent needs providing clinical care and improving life quality the recently injured war veterans.  Launched 2005 funded over 100 million, four-year component the program a 2009 deadline demonstrate modular upper-limb prosthetic where associated hardware software become available open-source, that specifications replace current confusion scattered prosthetic-arm designs a standard platform could incorporate current well the future 21st century technologies. the desired functions be anthropomorphically designed fit inside package has look, weight, strength, dexterity, natural movement, toughness an intact arm.  Led DEKA Inc., by Applied Physics Laboratory APL) the Johns Hopkins University, over 30 universities research institutions, more 300 investigators, participated the DARPA project.  is multidisciplinary collaboration areas mechatronics, neuroscience, neurology/neurosurgery, electrical engineering; signal processing, battery design, nanotechnology, robotics, cognitive behavioral sciences. of participating labs considered leading groups their respective fields.  of goals the DARPA Arm program to allow investigators explore neural sensorimotor integration feedback paradigms could incorporated the control the prosthetic arm upper-limb amputees, by patients paralysis-related disorders, such spinal cord injury SCI) stroke, regain purposeful movements functions. DARPA Arms designed be capable being controlled decoded neural signals. is expected rigorous comprehensive experimental tests optimal neural control animals humans be conducted, once electromechanic components completed. is also recognized investigators have scientific knowledge interests who also the appropriate experimental resources provide test platform identifying optimal neural control the DARPA arm mostly NIH-funded investigators. funding initiative intends capture unique opportunity providing NIH-supported expertise sensorimotor neurophysiology neural interface technology a scientific challenge developing demonstrating optimal cortical control paradigms these highly advanced anthropomorphically designed prosthetic arms.  Scope Objectives the Grand Challenge competitive revision up a maximum 2 years duration project period the competitive revision not extend beyond of parent” award) be limited currently active NIH projects focus studying cortical sensorimotor control functions awake humans non-human primates using defined motor behavioral paradigms the upper arm, and/or projects involve electrocorticographic ECoG) local field potential LFP) recordings awake humans.  parent projects should already the capability generating brain signals cortical areas, be decoded establishing interface neutral control an external device. goal to foster collaborative team efforts NIH-funded cortical neurophysiologists, neurosurgeons have significant experience ECoG LFP data collection awake humans. receive competitive revision funding, proposed revision projects should established IRB approval all invasive procedures humans.  collaborative team should the capability recording decoding broadband low high frequency cortical signals, capable interfacing the DARPA Arms optimal ECoG based cortical control. particular interest signals recorded multiple cortical sites in combination multiple modalities. intend seek most robust approach recording signals terms recording scale, duration, signal quality), most robust decoding algorithm, the smoothest, volitionally-controlled kinematic trajectories the full functional degrees freedom the arm hand. additional programmatic interest the potential role brain plasticity plays adaptive control dexterity using visual other sensory) feedback, once neural interfacing established. We expect Grand Challenge not only able identify implement best ECoG-based cortical control the DARPA Arms, will also reverse-translational generating important scientific questions further basic science research this program area. Progress be monitored NIH DARPA program staff through semi-annual reporting site-visiting, will evaluated administratively sufficient progress merit release funds the second year.  Funded projects be required present results evaluation NIH DARPA program staff a selected steering committee a dedicated workshop symposium, using video demo kinematic analysis cortical controlled DARPA arm hand movement.  resource sharing plan be required element the application.  Eligibility notice calls competitive revision applications active NIH Research Grants funded under R01 R37 grant mechanisms.  be eligible, parent” award which revision application based must active the time revision application submitted. project period the competitive revision not extend beyond of parent” award. a no-cost extension needed complete work be proposed the revision, no-cost extension must in place before application submitted.  proposed studies must within scope described the Scope Objectives the Grand Challenge” section above, i.e. peer-reviewed activities specified within active NIH parent award(s) include recording brain signals human non-human primates performing upper-limb motor tasks, and/or projects involve electrocorticographic ECoG) local field potential LFP) recordings awake humans.  all revision applications, Project Director/Principal Investigator PD/PI) must the same the PD/PI the parent award. revision applications multiple PD/PI parent awards, Contact PD/PI must the PD/PI listed the parent application. competitive revision does allow change the Multiple PD/PI team nor conversion a single PD/PI multiple PD/PIs. revision applications must submitted the sponsoring institution the PD/PI Contact PD/PI multi-PD/PI grants) listed the parent grant. Only revision request be submitted per PD/PI an NIH-funded parent project. NIH encourages participation individuals racial ethnic groups underrepresented biomedical behavioral research, individuals disabilities individuals disadvantaged backgrounds. Budget Funding Information NINDS intends commit to 3 million total costs per year FY 2010 FY 2011 fund to 4 competitive revisions response this announcement.  Funding competitive revisions existing parent” awards be available FY2010 FY 2011. Due the limited, two-year nature these funds, competitive revision applications be requested no than years; therefore scope budget the requested revision must reflect aims goals can accomplished within limited timeframe. Applicants must submit budget using same budget format was used the parent award. applicant request budget up 400,000 per year direct costs associated the proposed new work, addition the funds allowed purchasing DARPA Arms.  Applicants should budget 250,000 either DEKA arm www.dekaresearch.com) the APL arm www.jhuapl.edu/ourwork/biomed).  Device specifications interface details the DARPA Arms be obtained directly contacting DEKA APL, by contacting the NIH Program Director listed below.  DARPA currently negotiating prices these arms.  lower prices achieved, awards be reduced commensurately.  maximum duration each award be limited two years.  Facilities Administrative F&A) costs be paid the full, negotiated rate. Applicants should provide detailed budget justification personnel costs, supplies, other expenses.  revision award period cannot extend beyond original project end date the parent grant. Any no-cost extension must in place before submission the revision application. Although budget plans the NINDS provide support this program, awards pursuant this solicitation contingent upon availability funds the receipt a sufficient number meritorious applications. Application Review Process mission the NIH to support science pursuit knowledge the biology behavior living systems to apply knowledge extend healthy life reduce burdens illness disability. part this mission, applications submitted the NIH grants cooperative agreements support biomedical behavioral research evaluated scientific technical merit through NIH peer review system. funding considerations, revision applications be assigned the IC through the parent” grant funded.  Applications are complete be evaluated scientific technical merit appropriate scientific review group(s) convened the Center Scientific Review accordance NIH peer review procedures http://grants1.nih.gov/grants/peer/) using review criteria stated below. Applicants be notified regarding review outcome. part the scientific peer review, applications will: Undergo selection process which only those applications deemed have highest scientific technical merit, generally top half applications under review, be discussed assigned overall impact/priority score; Receive written critique; Receive second level review the appropriate national advisory council board. Overall Impact. Reviewers provide overall impact/priority score reflect assessment the likelihood the project exert sustained, powerful influence the research field(s) involved, consideration the standard review criteria, additional review criteria applicable the project proposed). review committee consider overall scientific merit the new work proposed, appropriateness the match between parent project the proposed work, the likelihood the project achieve goal the Grand Challenge.  reviewing revision application, committee consider scientific merit the new work proposed the appropriateness the proposed expansion the scope the project. the revision application relates a specific line investigation presented the original application was recommended approval the committee, the committee consider whether responses comments the previous scientific review group adequate whether substantial changes clearly evident. Additionally, committee consider feasibility accomplishing specific aims the revision application within requested project period. Scored Review Criteria. standard review criteria research grant applications cooperative agreements be used reviewers evaluating scientific technical merit all applications outlined this Notice: NOT-OD-09-025. Additional Review Criteria. applicable the project proposed, reviewers consider following additional items the determination scientific technical merit, will give separate scores these items: Protections Human Subjects; Inclusion Women, Children, Minorities; Vertebrate Animals; Biohazards. Additional Review Considerations. applicable the project proposed, reviewers address of following items, will give scores these items should consider in providing overall impact/priority score: Budget Period Support; Select Agent Research; Resource Sharing Plans. After peer review the application completed, PD/PI be able access or Summary Statement written critique) via NIH eRA Commons. Selection Process Applications submitted response this funding opportunity compete available funds all recommended applications. following be considered making funding decisions: Scientific technical merit the proposed project determined scientific peer review. Availability funds. Translational impact relevance the proposed project program priorities. Award Notices the application considered funding, NIH request just-in-time" information the applicant. details, applicants refer the NIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General. formal notification the form a Notice Award NoA) be provided the applicant organization. NoA signed the grants management officer the authorizing document. Once administrative programmatic issues been resolved, NoA be generated via email notification the awarding component the grantee business official. Terms Award awards be subject the standard NIH terms award. Selection an application award not authorization begin performance. Any costs incurred before receipt the NoA at recipient's risk. costs be reimbursed only the extent considered allowable pre-award costs. Section IV.5., Funding Restrictions.” resource sharing plan become part the terms conditions the award. Program Official one more the participating NIH Institutes Centers be assigned each funded application will assume responsibility normal stewardship the awards. NIH grant cooperative agreement awards include NIH Grants Policy Statement part the NoA. these terms award, the NIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General Part II: Terms Conditions NIH Grant Awards, Subpart B: Terms Conditions Specific Types Grants, Grantees, Activities. to Apply receipt date revision applications May 12, 2010. Applicants interested applying revision support must submit application through Grants.gov, using Funding Opportunity Announcement FOA) was used the parent grant. Or, this FOA no longer active, the Parent FOA matches program activity code) the award. activity code the prior submission referenced the Federal Identifier the SF 424 RR Cover page) must match activity code the FOA used the revision e.g., R01s will PA-10-067). Notice should mentioned the cover letter. Competitive revisions applications grants using activity code R37 Method Extend Research Time MERIT) Awards) should the Parent R01 FOA PA-10-067). NOTE: Applicants submitting R37 revision response the R01 Parent FOA receive following warning eSubmission: mechanism the prior submission referenced the Federal Identifier the SF 424 RR Cover page) does match mechanism the Funding Opportunity Announcement FOA).  Please check Federal Identifier provided your application ensure are including correct prior information the FOA ensure are submitting the correct opportunity.  application be processed there be delay referral.” Please ignore warning. ALL applications: Follow instructions noted below. Note: Font size restrictions apply designated within applicable SF424 R&R) Application the PHS398 application instructions. current NIH guideline page limitations should followed. Include Cover Letter cite Notice Number NOT-NS-10-013) title NINDS Announces Availability Funds Competitive Revision Applications Grand Challenge Optimal Cortical Control DARPA Revolutionizing Upper-Limb Prosthetics R01 R37)] the first sentence.   Provide one-page Introduction describes nature the revision how relates the scope the specific aims, research design, methods the current grant. Item 2.1, Introduction application, the PHS 398 Research Plan component provide information. body the application should contain sufficient information the original grant application allow evaluation the proposed revision relation the expertise approach the original application. Applicants must submit budget using same budget format was used the parent” award. Any budgetary changes the remainder the project period the current grant must discussed the Budget Justification. Any significant budgetary changes the remainder the project period the current grant must discussed the Budget Justification. Include following additional information the revision application: a) Specific Aims.  Summarize activities were included the parent” grant encompass those proposed the revision request. section should include description the revision’s specific aims, including research design methods data analysis. Describe relationship the revision request the parent” grant the impact the proposed work have the research field(s) involved. b) Research Strategy. research strategy section, limited 12 pages, should discuss the cortical neurophysiology expertise the existing research resource the current parent grant be leveraged synergized the expertise the collaborating neurosurgical team, address scientific technical issues the Grand Challenge. c) Budget.  budget format must the same that the parent grant. Budget the revision a justification details items requested, including Facilities Administrative costs a justification all personnel their role this project. budget provided the revision application must match budget provided the parent” application. instance, the parent” application submitted using Modular budget component, the revision application must also the Modular budget component. d) Biographical Sketch PD/PI all new Senior/Key Personnel those are additions the revision project). will need include updated biographical Sketch the PD/PI new Senior/Key Personnel, using forms, are available MS http://grants.nih.gov/grants/funding/phs398/biosketch.doc) PDF http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). is need repeat information previously provided other Senior/Key Personnel. 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 revision award being made. Any differences the involvement use human subjects specimens, use vertebrate animals, between administrative revision 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). electronic applications R01, R37): the SF424 R&R) Application Guide available at: ttp://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.doc  (MS 3.5 MB]) http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_V…; PDF 4.5 MB]). Inquiries Applicants are  encouraged discuss plans responding this Notice phone e-mail NINDS Program Directors listed below. Scientific inquiries also directed the NIH Program Directors oversee parent grant associated the competitive revision request.  Dr. Daofen Chen Dr. James Gnadt Program Directors Systems Cognitive Neuroscience National Institute Neurological Disorders Stroke Neuroscience Center 6001 Executive Blvd Rockville, MD 20892 301) 496-9964 Email: daofen.chen@nih.gov; gnadtjw@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcements Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) Research Centers Excellence U54) Notice Number: NOT-NS-10-011 Key Dates Release Date: March 5, 2010 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose nbsp; National Institute Neurological Disorders Stroke NINDS) intends issue Funding Opportunity Announcements FOAs) the spring 2010: ldquo;Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)” ldquo;Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01)”.  goal both initiatives to provide support translational research develop therapeutics reducing mortality morbidity caused acute exposures chemical threat agents. Chemical threats toxic chemicals could used a terrorist attack accidentally released industrial production, storage shipping.  scope the research supported within milestone-driven translational program includes target candidate identification characterization, through candidate optimization demonstration in vivo efficacy, through Investigational New Drug IND) submission clinical trials appropriate.   www.ninds.nih.gov/counteract a description the CounterACT program.  CounterACT research program utilize Research Centers Excellence U54) Cooperative Research Projects U01) support to 5 years translational research.  Chemical threats be covered include pulmonary agents e.g. chlorine, phosgene), toxic industrial chemicals e.g. cyanide, pesticides), chemical nerve agents e.g. sarin, VX), others.  NIH intends commit approximately 12 million per year Fiscal Years 2011, 2012, 2013 fund new and/or competing renewal U01 U54 awards.  Because nature scope the proposed research vary application application, is anticipated the size duration each award also vary. total amount awarded the number awards depend the number, quality, duration, costs the applications received.  is anticipated several NIH Institutes, including National Eye Institute NEI), National Institute Allergy Infectious Diseases NIAID), National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Institute Environmental Health Sciences NIEHS), the National Institute General Medical Sciences NIGMS), also participate this funding opportunity announcement.  notice being provided allow potential applicants sufficient time develop responsive projects.  APPLICATIONS NOT BEING REQUESTED THIS TIME. Inquiries Direct inquiries regarding Notice to: David A. Jett, Ph.D. Program Director, NIH CounterACT Research National Institutes Health, NINDS 6001 Executive Blvd. NSC, Room 2177, MSC 9527 Bethesda, MD 20892-9527 Telephone: 301-496-6035 Fax: 301-402-1501 jettd@ninds.nih.gov

NINDS Support M.D./Ph.D. Students Now the F31 Ruth L. Kirschstein National Research Service Award Mechanism Notice Number: NOT-NS-10-010 Key Dates Release Date:  March 4, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Background National Institute Neurological Disorders Stroke NINDS) considers training outstanding predoctoral M.D./Ph.D. students neuroscience research be critical the mission reducing burden neurological diseases. nbsp;For last 9 years, NINDS supported M.D./Ph.D. students the F30 Ruth Kirschstein National Research Service Award NRSA).  enhance support time devoted research training during M.D./Ph.D., NINDS now an F31 NRSA mechanism, PAR-10-091 http://grants.nih.gov/grants/guide/pa-files/PAR-10-091.html) specifically designed M.D./Ph.D. students, place the F30 mechanism. F31 mechanism M.D./Ph.D students being implemented NINDS support students starting early the research portion their training, eliminating requirement graduate research publications and/or preliminary data the grant review process. F31 applications M.D./Ph.D. students be reviewed an NINDS study section. Purpose NINDS remains firmly committed the support M.D./Ph.D. students. F31 NRSA fellowship provide individuals integrated M.D./Ph.D. programs up 5 years predoctoral NRSA support. nbsp;It differs the F30 mechanism that will provide support research leading the Ph.D. degree, not training is associated obtaining M.D. degree.  the change mechanism, NINDS instituting changes the review requirements will enhance ability students submit successful applications much earlier their M.D./Ph.D. training.  is suggested students submit F31 applications soon they chosen dissertation laboratory, could as early the end the medical school year prior the start full time dissertation research.  Taken together, changes preclude need preliminary data, increase support students during research years, potentially provide support immediately upon entering research laboratory. intent the NINDS to foster development independent M.D./Ph.D. investigators neuroscience advance Institute’s mission decrease burden neurological disorders.  High quality, creative research an essential element training a successful research career.  NINDS also regards development a comprehensive training plan outstanding mentoring critical a successful outcome.  Therefore, F31 FOA used NINDS support M.D./Ph.D. students places heavy emphasis only the opportunity doing high quality neuroscience research also the quality the overall training mentoring plan. nbsp;As described the funding opportunity announcement PAR-10-091), applicants should at least closely involved mentor an excellent track record training M.D./Ph.D. students should contact NINDS staff before preparing application ensure their research fits within NINDS mission. Applicants should sure reference correct program announcement applying fellowship support ensure proposals reviewed the appropriate NINDS study section. Inquiries Direct questions this Notice to: Stephen J. Korn, Ph.D. Director Training Career Development NIH/NINDS Neuroscience Center, Room 2186 6001 Executive Blvd MSC 9531 Bethesda, MD 20892-9531 E-mail: korns@ninds.nih.gov