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Notice Intent Publish Request Applications a Clinical Coordinating Center establish Network Excellence Neuroscience Clinical Trials NEXT-CCC) U01) Notice Number:  NOT-NS-10-026 Key Dates Release Date:   September 7, 2010 Related Notices NOT-NS-10-025 NOT-NS-10-027 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends issue Request Applications RFA) U01 grant applications support a clinical coordinating center CCC) establish Network Excellence Neuroscience Clinical Trials NEXT). clinical research network develop conduct multiple early stage clinical trials research studies enable efficient testing the most promising therapies academia industry.  Examples include proof-of concept trials preparatory studies aimed validating biomarkers clinical outcomes neurological disorders including pediatric patients rare diseases. network provide robust, standardized, accessible infrastructure rapidly develop protocols will coordinate cadre specialist investigators implement studies efficiently. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  companion RFAs be concomitantly released, requesting U10 grant applications support clinical research sites NOT-NS-10-025] U01 grant applications support a data coordinating center DCC) NOT-NS-10-027]. Note the current planned RFAs establish collaborating Coordinating Centers Clinical Research Sites.  Separate FOAs be published the future invite applications Phase II clinical trials preparatory research studies will conducted within network. RFA expected be published fall 2010 an expected receipt date winter 2011. Clinical Coordinating Center RFA utilize U01 mechanism activity code. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details Notice encourages investigators expertise clinical trials consider applying this new RFA. Successful applicants the Clinical Coordinating Center U01) have proven track record successful clinical project management neuroscience trials including, not limited to: protocol development adherence GCP all regulatory requirements efficient contracting IRB procedures development implementation recruitment plans, safety monitoring reporting plans APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Petra Kaufmann, MD National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Blvd., Room 2116 Bethesda, MD 20892-9520 Express/Courier:  Rockville, MD 20852 Telephone: 301) 496-9135 Fax: 301) 401-5301 Email: Petra.Kaufman@nih.gov http://www.ninds.nih.gov/

Notice Intent Publish Request Applications a Data Coordinating Center establish Network Excellence Neuroscience Clinical Trials NEXT-DCC) U01) Notice Number:  NOT-NS-10-027 Key Dates Release Date:   September 7, 2010 Related Notices NOT-NS-10-025 NOT-NS-10-026 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends issue Request Applications RFA) U01 grant applications support a data coordinating center DCC) establish Network Excellence Neuroscience Clinical Trials NEXT). clinical research network develop conduct multiple early stage clinical trials research studies enable efficient testing the most promising therapies academia industry.  Examples include proof-of concept trials preparatory studies aimed validating biomarkers clinical outcomes neurological disorders including pediatric patients rare diseases. network provide robust, standardized, accessible infrastructure rapidly develop protocols will coordinate cadre specialist investigators implement studies efficiently. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  companion RFAs be concomitantly released, requesting U10 grant applications support clinical research sites NOT-NS-10-025] U01 grant applications support a clinical coordinating center CCC) NOT-NS-10-026].  Note the current planned RFAs establish collaborating Coordinating Centers Clinical Research Sites.  Separate FOAs be published the future invite applications Phase II clinical trials preparatory research studies will conducted within network. RFA expected be published fall 2010 an expected receipt date winter 2011. Data Coordinating Center RFA utilize U01 mechanism activity code. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details Notice encourages investigators expertise clinical trials consider applying this new RFA. Successful applicants the Data Management Center U01) have proven capability manage large clinical trials efficiently to provide statistical support.  Expertise activities including, not limited to, following expected: web-based data management multicenter clinical trials is compliant regulatory requirements data quality assurance data sharing including and/or development common data elements CDEs, http://www.commondataelements.ninds.nih.gov/) APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Petra Kaufmann, MD National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Blvd., Room 2116 Bethesda, MD 20892-9520 Express/Courier:  Rockville, MD 20852 Telephone: 301) 496-9135 Fax: 301) 401-5301 Email: Petra.Kaufman@nih.gov http://www.ninds.nih.gov/

Notice Intent Publish Request Applications a Parkinson Disease Biomarkers Identification Network Coordinating Center U01) Notice Number: NOT-NS-10-024 Key Dates Release Date:  August 3, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose National Institute Neurological Disorders Stroke NINDS) intends issue Request Applications RFA) grant applications support a data coordinating center DCC) clinical coordinating center CCC) focused initially the discovery validation biological markers Parkinson’s disease PD). nbsp;The NINDS convened conference May 2010 discuss current state biomarker development PD how development validation biomarkers most effectively fostered.  Based the insights recommendations provided the conference, effort being developed part the NINDS response the critical need biomarker development PD. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  RFA expected be published the Fall 2010 a receipt date early 2011.  RFA utilize U01 Cooperative Agreement Research Project funding mechanism. nbsp; Notice encourages investigators expertise Parkinson’s Disease begin consider applying this new RFA.  Additional expertise subject recruitment, clinical site identification, coordination standardized biospecimen collection, operation a public database standardized data collection dissemination also highly desirable. nbsp;One more separate FOAs be published invite discovery validation other biomarker projects be performed within network. APPLICATIONS NOT BEING SOLICITED THIS TIME.  Inquiries Interested parties contact: Katrina Gwinn MD National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Blvd Room 2143 Bethesda, MD  20892 Express/Courier: Rockville, MD  20852 Phone: 301) 496-5745 Fax: 301) 401-5301 Email: gwinnk@ninds.nih.gov

Request Information RFI): Tools Resources Neuroscience Research Notice Number: NOT-NS-10-023 Key Dates Release Date:  July 22, 2010 Response Due By: September 23, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose is time-sensitive Request Information RFI), purpose which to assess scientific needs opportunities tool resource development neuroscience neurology. Background NINDS-funded research resources support development dissemination tools, collections, service facilities advance basic, translational clinical neuroscience research http://www.ninds.nih.gov/research/scientific_resources/index_research.h… selected examples).  planning future investments research resources, NINDS soliciting input the neuroscience neurological disease research advocacy communities identify areas greatest need. Information Requested Identify areas research could accelerated the development specific research resources. Describe 2-3 highest priority tools resources needed capitalize scientific opportunities overcome obstacles progress research. Describe NINDS might best facilitate development these tools/resources. Name Institutional Affiliation Email address Responses Responses must submitted electronically using web-based form http://www.ninds.nih.gov/research/scientific_resources/rfi.htm, will accepted through 09/23/2010.  Responses individual questions voluntary may anonymous.  Proprietary, classified, confidential, sensitive information should be included your response.  Government reserves right use any non-proprietary technical information any resultant solicitation(s).  Request Information RFI) for information planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health NIH), and/or National Institute Neurological Disorders Stroke NINDS). NIH does intend award grant contract pay the preparation any information submitted for NIH’s of such information.  Respondents not notified the NIH evaluation the information received.  basis claims against NIH shall arise a result a response this request information the NIH’s of such information either part our evaluation process in developing specifications any subsequent announcement.  Responses be held confidential. nbsp;Proprietary information should be sent. Inquiries Specific questions this RFI should directed the contact listed below: Anna Taylor, PhD 6001 Executive Boulevard, Room 3303 Bethesda, MD 20892 Phone: 301) 496-9248 Email: taylorann@mail.nih.gov

Extension Expiration Date Additional Receipt Dates RFA AI-10-014: Ancillary Studies Immunomodulation Clinical Trials R01) Notice Number: NOT-AI-10-035 Key Dates Release Date:  June 28, 2010 Opening Date:   Thirty days prior Letter intent Date. Letters Intent Receipt Date(s): Thirty days prior application receipt date Application Due Date(s): September 9, 2010; December 9, 2010, March 9, 2011 Peer Review Date(s): approximately twelve weeks after receipt date Council Review Date(s): Special Electronic Council Earliest Anticipated Start Date(s): approximately 17 weeks after receipt Expiration Date: March 10, 2011 Issued National Institute Allergy Infectious Diseases NIAID) http://www.niaid.nih.gov) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) http://www.niams.nih.gov) National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) National Institute Diabetes Digestive Kidney Diseases NIDDK) http://www2.niddk.nih.gov) Purpose purpose this notice to extend expiration date RFA-AI-10-014 Ancillary Studies Immunomodulation Clinical Trials R01) March 10, 2011, to add following additional receipt dates: September 9, 2010; December 9, 2010; March 9, 2011. participating NIH Institutes intend commit approximately 2M FY2011 fund 4-5 new grants support ancillary immune mechanistic studies conjunction independently supported clinical trials immunomodulatory interventions immune system mediated diseases vaccine clinical trials non-HIV/AIDS infectious diseases. than changes noted above, aspects RFA-AI-10-014 remain unchanged. Inquiries encourage inquiries concerning funding opportunity welcome opportunity answer questions potential applicants. Inquiries fall three areas: scientific/research program), peer review, financial grants management issues. Interested parties contact: 1. Scientific/Research Contact(s): Annette L. Rothermel, Ph.D. Division Allergy, Immunology Transplantation National Institute Allergy Infectious Diseases Room 3020, MSC-6601 6610 Rockledge Drive Bethesda, MD 20892- 6601 Telephone: 301-496-7104 Fax: 301-480-1450 Email: arothermel@niaid.nih.gov   Yan Wang, M.D., Ph.D. Division Skin Rheumatic Diseases, Extramural Program National Institute Arthritis Musculoskeletal Skin Diseases Democracy Plaza, Suite 800, MSC-4872 6701 Democracy Boulevard Bethesda, MD 20892-4872 Phone: 301-594-5032 Fax: 301-480-1284 Email: wangy1@mail.nih.gov  Ursula Utz, Ph.D. Neural Environment Program National Institute Neurological Disorders Stroke Room 213, MSC-9521 6001 Executive Boulevard Bethesda, MD 20892-9521 Phone: 301-496-1431 FAX: 301-402-1501Email: utzu@ninds.nih.gov  Beena Akolkar, Ph.D. Division Diabetes, Endocrinology, Metabolic Diseases National Institute Diabetes Digestive Kidney Diseases Room 681, MSC-5460 6707 Democracy Boulevard Bethesda, MD 20892-5460 Phone: 301-594-8812 FAX: 301-480-3503 Email: akolkarb@niddk.nih.gov 2. Peer Review Contact(s): Paul Amstad, Ph.D. Division Extramural Activities National Institute Allergy Infectious Diseases Room 3121, MSC-7616 6700B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817 express mail) Telephone: 301-402-7098 Fax: 301-480-2408 Email: pamstad@niaid.nih.gov 3. Financial/Grants Management Contact(s): Victoria P. Connors Division Extramural Activities National Institute Allergy Infectious Diseases Room 2122, MSC-7614 6700 B Rockledge Drive Bethesda, MD 20892-7614 Phone: 301) 402-5065 Fax: 301) 493-0597 Email: vp14v@nih.gov  

Request Information: Scientific Collaborative Considerations Associated the NINDS Epilepsy Centers without Walls Program Notice Number: NOT-NS-10-020 Key Dates Release Date:  June 25, 2010 Response Due By:  August 6, 2010 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose National Institute Neurological Disorders amp; Stroke NINDS) considering issuing series Funding Opportunity Announcements FOAs) the NINDS Epilepsy Centers without Walls Program Promote Collaborative Research the Epilepsies, newly envisioned cooperative agreement program will engage epilepsy research community collaborations solve challenges related the Epilepsy Research Benchmarks http://www.ninds.nih.gov/research/epilepsyweb/2007_benchmarks.htm). purpose this Request Information RFI) to solicit input will help guide development this new program.  Background epilepsies a diverse group chronic neurological disorders characterized spontaneous, recurring seizures. Collectively, disorders estimated affect approximately 3 million Americans all ages ethnic groups, a lifetime risk age 80 3%. highest incidence epilepsy in early childhood, the population the fastest growing incidence the elderly. a majority people epilepsy, medicines and/or surgical interventions control seizures, yet seizures continue about one-third cases even the best available treatment, sometimes leading devastating consequences.  Moreover, anti-epileptic treatments adverse side effects, no effective interventions exist prevent development epilepsy those risk.  Beyond seizures, sudden unexplained death epilepsy SUDEP) comorbid conditions, such depression cognitive behavioral impairments, increasingly recognized part a broader spectrum problems associated epilepsy. NINDS the lead NIH Institute research the epilepsies has supported important contributions past recent advances.  However, challenges remain epilepsy research.  further accelerate progress toward goals no seizures, side effects, the prevention epilepsy those risk, NINDS implementing new initiatives epilepsy research, including NINDS Epilepsy Centers without Walls Program Promote Collaborative Research the Epilepsies. program support multicenter, multidisciplinary consortia solve specific research challenges will lead advances prevention, diagnosis, treatment the epilepsies related comorbidities. program bring together best investigators, regardless geographic location, is novel innovative approach harnessing best research address difficult needs a particular field. NINDS expects issue first a series Request Applications RFA) this program fall 2010.  first RFAs likely focus human epilepsy genetics animal models epileptogenesis pharmacoresistance translational drug development. RFA soliciting planning grant applications a Center without Walls Sudden Unexpected Death Epilepsy SUDEP) also anticipated fall 2010. Recent planned NINDS workshops these topics be source input the key challenges Centers without Walls program should address.  NINDS hold workshops the areas human epilepsy genetics animal models epileptogenesis pharmacoresistance late summer, 2010.  NINDS previously held workshop SUDEP November 2008.  summary the meeting, includes research priorities identified during proceedings, in preparation. first workshop focus the state the science current large scale epilepsy genetic efforts. workshop assess readiness broad collaboration a US-based consortium how remove barriers collaboration this area. is hoped consensus begin be reached topics such as: priorities, phenotyping standards, retroactive of samples data, informatics data systems issues, informed consent future studies, functional validation studies, data sharing publication policies.  second workshop expected focus animal models epileptogenesis pharmacoresistance suitable translational research studies. purpose this workshop to assess utility available models developing testing new therapies prevent epileptogenesis, modify course epilepsy, to control seizures conditions remain resistant currently available treatment options.  workshop explore relevance these models specific clinical populations i.e., people develop epilepsy after traumatic brain injury, stroke, prolonged status epilepticus, etc.), regulatory barriers trial design, validation requirements candidate criteria preclinical intervention studies.  Information Requested NINDS seeking information will useful developing upcoming workshops the Epilepsy Center without Walls solicitations. Specifically, NINDS requests input the following areas please note it not required address areas order respond; feel free focus those items which are most interested addressing): Challenges exist investigators institutions establishing effective, large-scale, geographically dispersed collaborations.  Unique challenges collaboration the areas human genetics, animal models epileptogenesis pharmacoresistance, and/or Sudden Unexpected Death Epilepsy SUDEP). Lessons learned collaborative experiences other disorders are applicable the epilepsies. your experience, approaches models fostering collaborative research find be most effective, why. Approaches models have worked well. Key questions are currently obstacles further progress human genetics, translation therapies epileptogenesis pharmacoresistant epilepsy, and/or SUDEP. questions that  should asked the upcoming workshops human epilepsy genetics animal models epileptogenesis pharmacoresistance.  Recent advances emerging research should included. topic areas should considered an Epilepsy Center without Walls solicitation future years. Responses Responses should submitted electronically via web-based form available http://www.ninds.nih.gov/research/epilepsyweb/feedback.htm. Replies individual questions optional, the site permit anonymous responses.  Responses be accepted through August 6, 2010.  Confidentiality Responses this RFI voluntary may anonymous.  Any identifiers e.g., names, institutions, e-mail addresses, etc) be removed responses compiled.  Only processed, anonymized results be shared internally scientific working groups convened the NIH, appropriate. Proprietary, classified, confidential, sensitive information should be included your response.  Government reserves right use any non-proprietary technical information any resultant solicitation(s).  RFI for information planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health NIH), and/or National Institute Neurological Disorders Stroke NINDS). NIH does intend award grant contract pay the preparation any information submitted for NIH’s of such information.  Respondents be notified the NIH evaluation the information received.  basis claims against NIH shall arise a result a response this request information the NIH’s of such information either part our evaluation process in developing specifications any subsequent announcement.  Responses be held confidential. Proprietary information should be sent. Inquiries Specific questions this RFI should directed the contact listed below: Brandy Fureman, PhD Program Director, Epilepsies National Institute Neurological Disorders Stroke National Institutes Health furemanb@ninds.nih.gov Phone: 301-496-1917

Notice Intent Publish Series Request Applications the NINDS Epilepsy Centers without Walls Program U54) Notice Number: NOT-NS-10-022 Key Dates Release Date:  June 25, 2010 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose NINDS announcing plans the Epilepsy Centers without Walls Program Promote Collaborative Research the Epilepsies.  program support multicenter, multidisciplinary consortia solve specific research challenges will lead advances prevention, diagnosis, treatment the epilepsies related comorbidities. program bring together best investigators, regardless geographic location, is novel innovative approach harnessing best research address difficult needs a particular field.  fall 2010, NINDS expects issue first a series Request Applications RFA) targeting specified challenges will support to five Centers without Walls, beginning FY2011 adding new center year.  Because nature scope the proposed research vary application application, is anticipated the size duration each award also vary.  Although actual support depend the scope a Center’s proposed goals, NINDS anticipates supporting Center up 3 million direct costs per year five years.  Progress toward measurable goals determine eligibility a single competitive renewal. NINDS currently working develop challenge topics be addressed the first Centers without Walls RFAs.  Toward end, NINDS hold workshops summer 2010 assess readiness broad collaboration research human epilepsy genetics, on model therapy development pharmacoresistant epilepsy the prevention epileptogenesis. addition, NINDS held workshop fall 2008 research needs opportunities sudden unexpected death epilepsy SUDEP).   three workshops provide important information the current state the science potential opportunities accelerate progress through collaborative approaches.         parallel this Notice Intent Publish, NINDS issuing Request Information: Scientific Collaborative Considerations Associated the NINDS Epilepsy Centers without Walls Program NOT-NS-10-020).  NINDS seeking information will useful developing upcoming workshops the Epilepsy Center without Walls solicitations. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Direct inquiries regarding Notice to: Brandy Fureman, PhD Program Director, Epilepsies National Institute Neurological Disorders Stroke National Institutes Health furemanb@ninds.nih.gov Phone: 301-496-1917

Notice Availability NINDS Administrative Supplements Promoting Optogenetics Applications Basic Translational Neuroscience Research Notice Number: NOT-NS-10-021 Key Dates Release Date:   June 11, 2010 Receipt Date:  July 16, 2010 Earliest Anticipated Start Date:  September 1, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose National Institute Neurological Disorders Stroke NINDS) announces availability one-time administrative supplements NINDS-funded grantees promote facilitate applications optogenetic techniques basic translational neuroscience research.  proposed studies must within scope the peer-reviewed activities specified the NINDS parent award.  Background Scope Interests ability simultaneously activate silence specific groups neurons real time, to record activities, a powerful approach cellular circuit level analysis nervous system function.  Optogenetics, rapidly developing technique uses hybrid genetics, virology fluorescence optics, allows neuroscientists manipulate activity selected cell populations living animals spatial temporal precision.  provides sophisticated approaches exploring neural underpinnings behavior.  technique begun yield important data, it widely believed broader utilization have major impacts cellular systems neuroscience, both basic science translational research applications.  research groups interested acquiring technology have undertaken first steps this process e.g., obtaining reagents required biosafety approvals), need additional hands-on experience order establish method within own labs. is also critical this stage engage systems neurophysiologists further development this new approach, because rigorous vivo studies needed validate data-generating tool under variety experimental conditions.  supplement program intended allow currently active NINDS PIs intend use optogentics short term supplemental funding will enable to add new technology their arsenals. supplement be specifically targeted parent projects focus basic translational neuroscience research using vivo experimental approaches mammalian animal models.  proposed studies must within scope the peer-reviewed activities specified the NINDS-supported parent award.  is expected the application demonstrates scientific technical readiness employing optogenetics work under current NINDS-funded projects. Specific research activities include, are limited to: Efforts develop refine techniques tools can enhance effectiveness optogenetic application, including targeting delivering approaches specific circuitry neuronal populations interest; Efforts address issues related safety efficiency the optogentics non-human primates; Developing conducting workshops courses disseminate technique to provide training the neuroscience community the most up-to-date optogenetic techniques; Acquisition equipment e.g. optics such blue/yellow lasers) supplies e.g. viral vectors, DNA, cell-specific promoters) employing optogentic techniques on-going funded projects; Research development further expanding optogenetic toolbox its applications. Eligibility program support administrative supplements Research Project R00 R01), conditional seven-year Javits award highly meritorious applications R37), Program Project P01 P50) awards NINDS grantees.  supplement be specifically targeted parent projects focus basic translational neuroscience research using in vivo experimental approach mammalian animal models.  Parent awards must actively funded through July 31, 2010 order be eligible.  Any no-cost extension must in place before submission the revision application. While grants will in no-cost extension period NCE beginning or after July 31, 2010) be considered support under supplement program, priority be given parent grants are active through September 30, 2011.  Only supplement request response this Notice be submitted per PI.  Parent grants have received NINDS administrative supplements FY2010 through programs than this Notice still considered. Before submitting application a collaborative 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 Institute/Center, 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-10-021), 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.  (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 to 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 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. new co-investigator(s) collaborator(s) should noted under performance sites, along their institution(s). 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. The applicant should note selection factors below), pay particular attention the degree readiness implementation the proposed work. 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 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.  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 Potential enhance research capability to generate new results and/or interdisciplinary research opportunities Demonstration the lab’s readiness implementing proposed technology, such having required biosafety measures place, reagent procurement/production lined up, collaborations/consultations explicitly indicated, supporting letters provided where appropriate. Budget Funding Information Applicants request to 50,000 direct costs the one-year duration an administrative supplement under program. two NINDS grantees submitting joint application, can request to 50,000 direct costs an administrative supplement each the independent grants.  maximum direct cost request a joint application cannot exceed 100,000; each individual PD/PI only participate one submission.  duration each award limited one year.  Applicants must submit budget using same budget format was used the parent award.  Facilities Administrative F&A) costs be paid the full, negotiated rate. Applicants should provide detailed budget justification personnel costs, supplies, other expenses.  Salary support the PI co-investigators not permitted can requested technicians, graduate students, postdoctoral associates, and/or research personnel.  Funds be used support collaborators optogentics expertise, including provision reagents such viral constructs transgenic mice.     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). 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. Dr. Janet National Institute Neurological Disorders Stroke Neuroscience Center, Room 2119 6001 Executive Blvd. Rockville, MD 20892 Email:  yh74k@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. Daofen Chen Program Director National Institute Neurological Disorders Stroke Neuroscience Center, Room 2176 6001 Executive Blvd Rockville, MD 20892 301) 496-9964 Email: daofen.chen@nih.gov

Request Information RFI): Sleep Disorders Research Plan Notice Number: NOT-HL-11-107 Key Dates Release Date: June 9, 2010 Response Date: July 2, 2010 Issued National Heart, Lung, Blood Institute NHLBI) www.nhlbi.nih.gov) National Institute Alcohol Abuse Alcoholism NIAAA) www.niaaa.nih.gov) National Institute Aging NIA) www.nia.nih.gov) National Cancer Institute http://www.cancer.gov/) Eunice Kennedy Shriver National Institute Child Health amp; Human Development NICHD) www.nichd.nih.gov) National Center Complementary Alternative Medicine NCCAM) www.nccam.nih.gov) National Center Research Resources NCRR) http://www.ncrr.nih.gov) National Institute Diabetes, Digestive Kidney Diseases NIDDK) www.niddk.nih.gov) National Institute Drug Abuse NIDA) www.nida.nih.gov) National Institute Mental Health NIMH) www.nimh.nih.gov) National Institute Neurological Disorders Stroke NINDS) www.ninds.nih.gov) National Institute Nursing Research NINR) http://www.ninr.nih.gov) Office Behavioral Social Sciences Research OBSSR) obssr.od.nih.gov) Office Research Women’s Health ORWH) orwh.od.nih.gov) Purpose NIH Revitalization Act 1993 42 USC Sec. 285b-7) calls the development a comprehensive plan identifies priorities respect sleep disorders research provides the coordination this research, the revision the plan appropriate.  last plan published 2003 www.nhlbi.nih.gov/health/prof/sleep/res_plan/) now undergoing revision.  Background Planning Process Overview Comments submitted response this RFI inform National Centers Sleep Disorders Research NCSDR) participating NIH Institutes Centers the public perspective need biomedical sleep disorders research.  summary public comments a preliminary NIH planning document be presented discussion the next meeting the Sleep Disorders Research Advisory Board SDRAB) August 27, 2010, NIH, Bethesda, MD, disseminated public comment the NCSDR website www.nhlbi.nih.gov/sleep).  plan be finalized a second public SDRAB meeting approximately 10 months later.  NCSDR coordinates revision process a Trans-NIH Sleep Research Coordinating Committee. strategic planning process aims achieve following objectives: identify potential scientific programmatic goals priorities participating NIH sleep circadian research programs during next five years. enhance research translation, community engagement, commitments toward improving sleep health. identify implementable strategies support specific scientific goals. Definition Sleep disorders research, the purposes this Request Information, defined the basic science sleep circadian biology it applies all tissues organs; function(s) sleep circadian biology development, across levels biological organization across lifespan;  basic behavioral pathophysiological implications sleep loss untreated sleep disorders; societal social science relationships between sleep health including socioeconomic, racial/ethnic, gender disparities; safety performance; role sleep psychiatric, alcohol, substance abuse disorders; sleep chronic disease conditions; need training researchers health care providers; the need training researchers health care providers; the need educate patients, communities, the general public sleep sleep disorders.  Information Requested Members the health scientific community large, state local government officials, patient advocates, public interest organizations, community-based organizations, industry stakeholders, the general public invited respond any all the items listed below.  Comments linking sleep disorder research public health challenges the mission individual NIH Institutes Centers participating this RFI also welcomed.  Research Challenges mdash; describe key gaps barriers the science sleep circadian biology. nbsp;Gaps related research opportunities be any level scientific inquiry including knowledge acquisition basic, discovery, applied research), knowledge validation clinical trials comparative effective research), knowledge transfer education dissemination research), new technology development.  possible, please elaborate the specific scientific opportunity, clinical public health importance, technical feasibility suitability NIH investment.   Potential Solutions mdash; describe you believe be most innovative research approaches address key research challenges stimulate sleep circadian biomedical research. Trans-disciplinary Research mdash; recent advances sleep circadian research potentially inform scientific endeavors policies intended achieve national health goals priorities.  Describe scientific advances opportunities could accomplished the transfer sleep circadian knowledge other domains be optimized.  Describe key translational opportunities be facilitated trans-disciplinary collaborations among basic scientists, behavioral social scientists, epidemiologists, clinicians, public heal programs community groups. would also appreciate insights the following areas: are key unresolved scientific issues must addressed order translate advances understanding molecular physiological basis sleep circadian biology research a better understanding clinical mechanism disease risk, improved approaches diagnosis, treatment, prevention disease? research needed inform state local governments, health care institutions, public interest organizations, communities, other stakeholders the needs children adults appropriate amounts sleep to address public health concerns? research questions of highest priority relation improving sleep health special populations?  might include minorities, elderly, children, pregnant women, individual low socioeconomic status. national local organizations should included the discussion future sleep circadian research activities supported the NIH?   issues sleep circadian biology research be integrated existing future global health initiatives? Responses is necessary respond all the questions listed above. Responses be accepted until July 2, 2010, via email to: NCSDR-RFI2010@spmail.nih.gov Please mark responses this RFI identifier NOT-HL-11-107.  each suggested high priority area adherence research, please provide brief background information, define challenge outline potential solution. nbsp;Reponses expected be longer approximately 1,000 words. Respondents receive automated email confirmation acknowledging receipt their response, will receive individualized feedback. Significance Public Health Sleep, nutrition physical activity, a critical determinant health well-being.  Adequate sleep necessary maintain resistance infection, support metabolism sugar prevent diabetes, perform our best the job in school, sustain vigilance necessary workplace driving safety.  Sleep disorders sleep restriction due lifestyle choices associated fatigue, psychological disturbances, decrements performance vigilance, compromising safety oneself others.  Sleep also basic requirement infant, child, adolescent health development recent evidence points toward long-term trends decreased sleep during first decades.  Further, sleep loss untreated sleep disorders influence basic patterns behavior stress family health interpersonal relationships.  Sleep timing duration coupled an array endocrine, metabolic neurological functions are critical the maintenance individual health well-being.  than 20% US adults report insufficient sleep rest least 15 of every 30 days. nbsp;Sleep disorders including insomnia, circadian phase disorder, restless legs syndrome relatively common present challenges detection, prevention, therapy, management.  Sleep disordered breathing sleep apnea) affects than 20 million US adults, if left untreated associated a 2-3 fold increased risk stroke mortality all causes.  Sleep health also pervasive challenge individuals chronic disabilities disorders cause pain fatigue such arthritis, kidney disease, HIV, depression.  elderly populations, medical mental health consequences untreated sleep disorders include sharply increase rates diminished health-related quality life, physical functional limitations, ability remain independent, an increased risk death any cause.  Confidentiality Responses this RFI voluntary may anonymous.  Any identifiers e.g., names, institutions, e-mail addresses, etc) be removed responses compiled.  Only processed, anonymized results be shared internally scientific working groups convened the NIH, appropriate. Proprietary, classified, confidential, sensitive information should be included your response.  Government reserves right use any non-proprietary technical information any resultant solicitation(s).  Request Information RFI) for information planning purposes only should be construed a solicitation as obligation the part the Federal Government, the National Institutes Health NIH). NIH does intend award grant contract pay the preparation any information submitted for NIH’s of such information.  Respondents be notified the NIH evaluation the information received.  basis claims against NIH shall arise a result a response this request information the NIH’s of such information either part our evaluation process in developing specifications any subsequent announcement.  Responses be held confidential. Proprietary information should be sent. Inquiries Interested parties contact: Michael Twery, Ph.D. Director, National Center Sleep Disorders Research Division Lung Diseases, NHLBI Rockledge Centre, Suite 10170 6701 Rockledge Drive Bethesda, Maryland 20895-7952 Phone: 301-435-0199 FAX: 301-480-3451 Email: TweryM@nhlbi.nih.gov

NINDS Policy the Award Continuation Investigator-Initiated Phase III Clinical Trials Notice Number: NOT-NS-10-009 Key Dates Release Date:  14, 2010 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) Purpose establish NINDS Policy a phase award process Investigator-Initiated cooperative agreement phase III Clinical Trial applications submitted under PAR-10-198. Background Because their comparatively large size long duration, Phase III clinical trials the most complex challenging trials design implement.  require extensive planning proactive oversight successful completion.  Despite careful planning, numerous factors often extend time needed complete Phase III trial, including delays start-up, regulatory approval, in enrollment trial participants.  Such delays result the large carry-over research dollars the need additional years complete trial.  Therefore, NINDS developed policy providing initial funding commitment 2-3 years the trial order establish feasibility before administrative decision made allow award the remaining budget years within scope the original council approved application.  Policy NINDS multi-center phase III clinical trials awarded under NINDS program announcement the submission Phase III multi-center clinical trials PAR-10-198) be given initial award 2 3 years order start-up trial establish performance feasibility.  Continuation the award past feasibility period be contingent upon demonstrated ability meet milestones indicating the trial be implemented planned.  Feasibility milestones be defined the start each trial will monitored closely the Institute-appointed Data Safety Monitoring Board DSMB) NINDS program officer. decision either continue the completion the trial to discontinue enrollment subjects the trial be based some all the following factors: 1) implementation feasibility i.e., ability start trial planned; 2) enrollment feasibility i.e., establishing acceptable enrollment rate at least 80% projected rate), 3) safety concerns i.e., recommendation the Data Safety Monitoring Committee continue trial), 4) applicable, interim analysis evaluating probability the trial be futile inconclusive; 5) criteria appropriate the individual trial. the end the feasibility period, administrative decision input the DSMB be by NINDS continue terminate trial. the trial approved continue, investigators be permitted complete non-competitive Type 4) extension application obtain remainder the funding project years specified budget the initial application below) order complete trial.  During extension period, NINDS, input the DSMB, regularly evaluate progress toward enrollment goals, work investigators improve enrollment, will terminate trials adequate progress not demonstrated example, falling below 50% the expected enrollment goal).  During both feasibility extension phase, funding be carefully monitored adjusted appropriately proportionately the rate performance the trial.  Should performance accelerate faster planned, NINDS adjust funding award keep pace the rate activities. after feasibility assessment at any point during initial competitive application is determined both additional project years additional money i.e., addition what approved funded the original competitive application) going be needed complete trial, NINDS determine whether completion the trial remains priority if so, investigators be permitted submit competitive renewal Type 2) application request additional funding project years needed complete trial.  Submission this type 2 application be planned prior the end the type 1 grant ensure continuity funding trial during peer review process.   Application following section describes process either Type 4 non-competitive) extension Type 2 competitive) renewal applications. Non-competitive Extension Type 4) Before end the pre-defined feasibility phase the award, Principal Investigator discuss the NINDS program officer status the trial the conditions the feasibility agreement.  it determined the trial an appropriate candidate extension, investigator be permitted submit extension application. nbsp;The application include following: 1. letter co-signed the Principal Investigator his/her Institution’s Business Official requesting additional years support; 2. PHS 398Application Face Page; 3. progress report summary the current budget period; 4. one-page research plan the additional years; 5. budget justification using Page EE the PHS 398 budget entire proposed remaining period support; including accounting funds awarded remaining unspent date). Competitive Renewal Type 2) it determined the trial an appropriate candidate continuation it determined additional money project years needed complete trial, investigator be permitted submit type 2 competitve renewal application. Standard submission dates be used. submission dates, http://grants1.nih.gov/grants/funding/submissionschedule.htm).   Inquiries Inquiries concerning policy should sent to: Scott Janis, Ph.D. Office Clinical Research National Institute Neurological Disorders Stroke Room 2170, MSC 9525 6001 Executive Blvd. Bethesda, MD 20892-9525 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email: janiss@ninds.nih.gov inquiries review issues contact: Chief, Scientific Review Branch National Institute Neurological Disorders Stroke Room 3201, MSC 9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Telephone: 301) 496-9223 Fax: 301) 402-0182 Email: nindsreview@ninds.nih.gov inquiries grants management issues contact: Ms. Tijuanna DeCoster, MPA Grants Management Officer National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 3258 Bethesda, MD 20892-9529 Telephone: 301) 496-9531 Fax:  301) 402-0219 Email:  decostert@ninds.nih.gov