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Notification NINDS Programmatic Priorities Use the K24 Midcareer Investigator Award Patient-Oriented Research Award Notice Number: NOT-NS-09-016 Key Dates Release Date: August 12, 2009 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov) Purpose purpose this notice to notify investigators programmatic priorities NINDS the of K24 award PA-09-037). K24 award, used NINDS, provides protected time mid-career, clinician-scientists act research mentors to expand own patient-oriented research. is enormous need mentoring junior clinician-scientists order increase pipeline clinicians successful research careers. number applications NINDS junior clinicians Career Development K) awards sharply decreasing, enhanced, large scale mentoring efforts be way reverse trend. Moreover, established clinical researchers in excellent position attract junior PhD scientists clinically-relevant, disease-oriented research. addition support mentoring, K24 provides protected time established clinician-scientists, dedicate time mentoring, expand own research new areas opportunities arise. notice serves only clarify programmatic priorities NINDS, also invite mid-career investigators an established dedication research mentoring join this effort attract promote entry junior scientists clinically significant neuroscience research.  Summary NINDS K24 support programmatic mentoring effort, combined a plan expand applicant’s research. will be awarded exclusively support on-going research efforts for mentoring is limited one’s own research area laboratory. accordance NIH guidelines, K24 be used protect between 25% 50% the applicant’s time. is expected the focus the application the majority the applicant’s effort the K24 be devoted the mentoring program.  Characteristics mentoring efforts high programmatic priority NINDS mentoring effort should tied a program research training. Programmatic activities might include, 1) research training mentoring residents fellows, 2) programs draw PhD neuroscientists disease-oriented research, 3) advising department’s trainees junior investigators grant submission grant writing, 4) advising network trainees junior investigators navigating pursuing successful, clinically-oriented research career 5) development and coordination courses related clinical research neurobiology disease. Although population being mentored include members the applicant’s own research program, should consist primarily this cohort. applicant should a well-established, mid-career investigator combines exceptional research clinical skills. Although is generally considered be somebody the Associate Professor level, mid-career applicants the Full Professor level also welcome apply. Applicants must hold R01 equivalent funding be actively involved running robust research program. applicant’s research program be completely clinical, it consist disease-focused laboratory research a patient-oriented component.  applicant must endorsed the Department Chair fulfilling mentorship role proposed. Chair should acknowledge, a letter support, the applicant be considered department’s overall mentor, coordinator, the program described. example, applicant be designated the departmental mentor research training residents fellows. role might include oversight over NINDS R25 program support residents fellows neurology neurosurgery http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-09-001.html, see subsequent reissue), the department such award. is anticipated there be only K24 recipient any time per department, unless department large and/or multiple, substantial programmatic efforts require multiple overseeing mentors. Research support through K24 Whereas mentoring component the K24 of extremely high priority NINDS, is also critical the K24 awardee maintain enhance already vigorous research program. Consequently, portion the K24 effort should into expanding and/or enhancing applicant’s research. effort include adding new component an already existing research project it be directed towards new, highly significant research area. Ideally, effort help generate new data will open a new area research the applicant, it allow applicant obtain new research training is necessary remain the forefront a research area. Although K24 be used directly support research component, NINDS does require a new research area proposed. However, salary support requested conduct research, proposed research must different what currently supported. is expected applicants have significant research support outside the K24, typically R01 equivalent, at least 3 the 5 years this award. Evaluation progress Applicants strongly encouraged provide detailed set measurable goals are anticipated be achieved year the K24 award regard both mentoring research. Particularly regard the mentoring component, applicants should provide description the proposed outcome the K24 support the metric(s) which achievement this outcome be measured. example, applicants indicate many trainees be mentored, specifically activities trainees participate that not occur without K24, planned outcome this mentorship e.g. next career steps the trainees, individual grant applications, etc.), timeline which applicant expects submit new research grant applications, courses will developed how trainees expected participate, many PhD degree holders students transition disease-related research how will measured, etc. choice metrics activities up the applicant, there should a clear description expected outcomes the K24 support. the NINDS K24 not awarded At NINDS, K24 award not made solely the benefit the PI’s on-going research solely support mentoring directly related the PI’s on-going research projects. research effort the applicant, the mentoring postdoctoral fellows working the applicant, covered the research funding already obtained the applicant, is an appropriate justification obtaining K24 support. K24 award does support mentoring clinical training is solely awarded promote mentoring research. Financial support the K24 award supply salary fringe the PI support mentoring activities course development tuition], travel, etc.). the application proposes expansion research area, which is current R-type funding, support also requested the new research area. K24 support not provided pay mentee’s salaries work projects currently funded R-type research awards. level funding provided described the institute contact web page accessed through program announcement. 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

Extended Expiration Date Program Announcement Exploratory/Developmental Bioengineering Research Grants R21) Notice Number: NOT-EB-09-004 Key Dates Release Date:  August 12, 2009 Issued National Eye Institute NEI), http://www.nei.nih.gov/) National Human Genome Research Institute NHGRI), http://www.genome.gov)  National Institute Alcohol Abuse Alcoholism NIAAA), http://www.niaaa.nih.gov) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), http://www.niams.nih.gov) National Institute Biomedical Imaging Bioengineering NIBIB), http://www.nibib.nih.gov)  National Institute Deafness Communication Disorders NIDCD), http://www.nidcd.nih.gov)  National Institute Dental Craniofacial Research NIDCR), http://www.nidcr.nih.gov)  National Institute Drug Abuse NIDA), http://www.nida.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 PA-06-418: Exploratory/Developmental Bioengineering Research Grants R21) until January 8, 2010.  following Institutes no longer participating: National Cancer Institute NCI), http://www.nci.nih.gov) National Heart, Lung, Blood Institute NHLBI), http://www.nhlbi.nih.gov/) National Institute Aging NIA) http:///www.nia.nih.gov) National Institute Mental Health NIMH), http://www.nimh.nih.gov/) other aspects PA-06-418 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 

Change NINDS Policy Regarding Salary Support Individual Mentored Career Development K) Awards Applicants Receive R01 Notice Number: NOT-NS-09-015 Update: following update relating this announcement been issued: 18, 2012 - Notice NOT-NS-12-018. Change NINDS salary caps the K02, K08 K23 Career Development Awards. Key Dates Release Date: August 7, 2009 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov) Purpose purpose this notice to notify investigators a change salary support provided 5 year mentored K awards the applicant obtains NIH R01 during first 3 years the award. Awards affected this notice the NINDS K01, K08, K23 K25 K Kiosk). Current Policy Mentored K awards require commitment at least 75% full time professional effort 50% effort neurosurgeons) towards mentored K research project. NINDS currently provides salary support commensurate the requested effort, to maximum 85,000. Applicants not obtain salary support other federal grants until final years mentored K support NOT-OD-08-065). the final years the K award, the awardee obtains federal grant is NIH R01 equivalent, applicants 1) reduce effort the K award a minimum 50% 2) obtain salary support, commensurate committed effort, the R01 equivalent federal grant. NINDS encourages K awardees obtain R01 level funding soon possible after obtaining mentored K. Consequently, K awardees obtain R01 federal equivalent during first 3 years a 5 year mentored K award be unable fully support salary commensurate their effort. Change Policy ameliorate situation, NINDS instituting following policy, effective the beginning FY2010. NINDS eliminate salary cap those mentored K awards obtain R01 equivalent federal grant funding during first 3 years the mentored K award. Applicants within first 3 years a mentored K award, obtain R01 federal equivalent, obtain to 80% their institutional base salary, commensurate effort, long the R01 research project represents expansion the K award project. minimum 75% effort must still devoted the K award project during first 3 years K award support. level salary support continue all remaining years the K award, commensurate effort devoted the K award project. During final years the mentored K award, additional salary be obtained the awarded R01, from another R01, effort exceeding 80% level. appropriate desired, level effort the mentored K award be reduced a minimum 50% during last years the award. all times, salary obtained the K award cannot exceed which commensurate full time professional effort committed the K award research project. those initially obtain R01 federal equivalent support during final 2 years mentored K award, salary support the mentored K award continue be capped up 85,000. accordance present NIH policy, additional salary support also obtained the awarded R01 federal equivalent. Timing the change salary support after receipt an R01 federal equivalent Grant start dates determine the salary change go effect.  the R01 obtained during same fiscal year the mentored K award anniversary date, requested salary change be effective the start date the R01. the R01 obtained the fiscal year subsequent the most recent mentored K award anniversary date, requested salary change be effective the K award anniversary date during fiscal year coincides the R01 start date example, the K award anniversary date July 1 the R01 approved the subsequent October council, salary change go effect the following July 1). is incumbent upon K award recipient request change salary support a timely manner. request changes K award salary must made least month prior the end the fiscal year which are take effect. Otherwise, changes the K award cannot made until K award anniversary date the subsequent fiscal year. 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

Extension Amendment the Receipt Date RFA–AI-08-011, Ancillary Studies Immunomodulation Clinical Trials R01) Notice Number: NOT-AI-09-044 Key Dates Release Date: June 16, 2009 Receipt Date(s): July 9, 2009, September, 9, 2009, November 9, 2009, January 9, 2010 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://www.niddk.nih.gov) Purpose purpose this notice to:  extend expiration date RFA AI-08-011, Ancillary Studies Immunomodulation Clinical Trials R01), June 10, 2009 January 10, 2010 change receipt dates monthly every-other-month, beginning July 9, 2009 provide NIAMS, NINDS, NIDDK staff contact information under Scientific Research Contacts” participating NIH Institutes intend commit approximately 2M FY2010 fund 4-5 new grants support ancillary immune mechanistic studies conjunction independently supported clinical trials a) immunomodulatory interventions immune system mediated diseases b) vaccines non-HIV/AIDS infectious diseases. than changes noted above, aspects RFA–AI-08-011 remain unchanged. Inquiries Inquiries discussion plans responding RFA AI08-011 strongly encouraged. Interested parties contact: Annette L. Rothermel, Ph.D. Division Allergy, Immunology Transplantation National Institute Allergy Infectious Diseases 6610 Rockledge Drive Room 3020, MSC-6601 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 National Institute Health, DHHS Democracy Plaza, Suite 800 6701 Democracy Blvd, MSC 4872 Bethesda, MD 20892 Phone: 301-594-5032 Fax: 301-480-1284 Email: wangy1@mail.nih.gov Ursula Utz, Ph.D. Program Director National Institute Neurological Disorders Stroke Room 2134 6001 Executive Boulevard Bethesda, MD 20892-9521 Phone: 301-496-1431 FAX: 301-402-1501 Email: 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

Administrative Supplements Collaboration the NIH-funded NeuroMab Facility Generate Monoclonal Antibodies Studies the Developing Nervous System Notice Number: NOT-NS-09-014 Key Dates Release Date:  June 11, 2009    Receipt Date:  July 17, 2009 Earliest Anticipated Start Date: September 1, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov/) National Institute Mental Health NIMH) http://www.nimh.nih.gov) National Institute Deafness Other Communication Disorders NIDCD) http://www.nidcd.nih.gov) National Institute Alcohol Abuse Alcoholism NIAAA) http://www.niaaa.nih.gov/) National Institute Drug Abuse NIDA) http://www.nida.nih.gov) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) http://www.nichd.nih.gov) Purpose NINDS, NIMH, NIDCD, NIAAA, NIDA NICHD announce administrative supplement program 400,000 Fiscal Year 2009 provide funds NINDS, NIMH, NIDCD, NIAAA, NIDA NICHD-funded research projects provide resources the generation use monoclonal antibodies mAbs) useful the neurodevelopment community.  purpose this program to facilitate production new monoclonal antibodies NeuroMabs) targets high relevance studies the developing nervous systems animal models.  Background NeuroMab Facility established provide inexpensive, carefully verified monoclonal antibodies proteins the mammalian nervous system.  investigator-initiated antibody requests, facility enters a collaborative partnership which requesting investigator provide expertise reagents necessary the project.  a current list neurodevelopmental protein targets, click here.  Investigators suggest own protein targets provided suitable monoclonal antibodies these targets not exist.  of criteria consideration antibody requests the ability the collaborating investigator provide reagents the project, including immunogens purified protein immunogenic peptides), tagged cDNA expression constructs screening specificity testing monoclonal antibodies, positive control polyclonal antibodies available), knockout mouse tissue available).  Investigators encouraged participate screening resulting monoclonal antibodies facilitate selection the best clone(s).  resulting NeuroMabs be available low cost the neuroscience research community the NeuroMab Facility www.neuromab.org). Eligibility current announcement for administrative supplements participating IC-funded projects ($10K-$50K total costs, per project) design generation reagents antibody production validation, such immunogens e.g., fusion protein cDNA constructs purified fusion proteins), and/or tagged cDNA expression vectors antibody screening.  request include providing reagents multiple targets can include personnel costs.  requests equipment be considered.  Investigators Mentored Career Development K01, K08, K23, K25 K99/R00), Research Scientist K02 K24), Research Project R01 U01), Academic Research Enhancement R15), Exploratory/ Developmental R21), Phase II SBIR R44 U44), Program Project P01), Developing Center P20), Research Resource U24), Specialized Center P50 U54) grants eligible apply.  be eligible, projects must actively funded throughout fiscal year 2009.  Review criteria provided below.  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. Investigators strongly encouraged contact NeuroMab Facility neuromab@ucdavis.edu) advance submitting supplement request preliminary discussions immunogens other reagents needed screening specificity testing. Submitting Application Applications an administrative supplement under program should the PHS 398 form rev. 11/2007; available http://grants.nih.gov/grants/funding/phs398/phs398.html), must include following: 1) cover letter citing Notice including PI name, grant number title, amount the requested supplement, name title the institutional official, the phone, email, address information both PI institutional official.  P01s, P20s, P50s, U24s U54s, PI must submit request a supplement one more subprojects.  cover letter must signed the PI the institutional official. 2) Face page title the project Box 1) should the title the parent award. Notice number title) should cited Box 2, the ldquo;yes” box should checked. Subproject PIs P01, P20, P50 U54 awards eligible apply these supplements. remaining items the face page should filled according the PHS 398 application instructions. 3) Form page 2 Project Summary, Relevance, Performance Sites, Scientific/Key Personnel, Significant Contributors, Human Embryonic Stem Cells) PHS 398. project description that the administrative supplement, the parent grant. 4) Proposed budget the supplement a budget justification details items requested.  Supplements should range 10,000 50,000.  awards TOTAL COSTS.  Any Facilities amp; Administrative Costs indirect costs) should included the modular request, cannot requested addition the modular amounts.  all grant mechanisms maximum supplement 50,000. 5) Biographical Sketch the PI. 6) Research Plan the supplement, items 2-5 to exceed five pages.  Applicants should include justification each nervous system target, relationship each target the original project Specific Aims, a discussion the significance having newly monoclonal antibodies available.  research design section should include plans each target provide expertise, immunogens purified protein suggested peptide sequences), tagged cDNA expression constructs screening specificity testing hybridomas, positive control polyclonal antibodies available) knockout mouse tissue available).  Font size restrictions apply designated within PHS398 rev. 11/2007) instructions. Review Criteria Applications be reviewed administratively.  Review criteria include 1) completeness the reagent package(s) be provided, 2) expertise the investigators their ability produce obtain proposed reagents, 3) importance the proposed antibodies the goals the funded project for areas developmental neuroscience, particularly those high relevance program priorities the Blueprint ICs.  is anticipated supplements be awarded before end the fiscal year. nbsp;  Budget Information Supplements be in amounts 10,000 to 50,000 total costs.  all grant mechanisms maximum supplement 50,000 total costs. Requests include providing reagents multiple targets can include personnel costs.  requests equipment be considered. nbsp; to Apply is one-time announcement.  Applications must received or before receipt date indicated Key Dates).  not send applications the Center Scientific Review.  Applicants should submit electronic copy the application an e-mail attachment PDF format NINDSNeuroDevMabsupplements@ninds.nih.gov, one hard copy original signatures the PI institutional official) to: Randall R. Stewart, Ph.D. NOT-NS-09-014 National Institute Neurological Disorders Stroke National Institutes Health Neuroscience Center, Room 2136 6001 Executive Blvd. Bethesda, MD 20892-9523 courier delivery:  Rockville, MD 20852). Inquiries Inquiries should directed to: Randall R. Stewart, Ph.D. Program Director Channels, Synapses Circuits SBIR/STTR Program Coordinator National Institute Neurological Disorders Stroke National Institutes Health Neuroscience Center, Room 2135 6001 Executive Blvd. Bethesda, MD 20892-9523 courier delivery:  Rockville, MD 20852) Phone:  301-496-1917 Fax:  301-402-1501 E-mail:  stewartr@ninds.nih.gov Laurie S. Nadler, Ph.D. Chief, Neuropharmacology Program Division Neuroscience Basic Behavioral Science National Institute Mental Health, NIH 6001 Executive Blvd., Rm. 7184, MSC 9641 Bethesda, MD 20892-9641 Rockville, MD 20852 express courier service] Phone:  301-443-5288 Fax:  301-451-5615 E-mail:  lnadler@mail.nih.gov Barry Davis, Ph.D. Director, Taste Smell Program National Institute Deafness Other Communication Disorders 6120 Executive Blvd, Suite 400 Bethesda MD 20892-7180 Phone:  301-402-3464 Fax:  301-402-6251 Email:  Davisb1@nidcd.nih.gov Matthew Reilly, Ph.D. Program Director, Genetics amp; Proteomics Division Neuroscience amp; Behavior, NIAAA 5635 Fishers Lane Room 2065, MSC 9304 Bethesda, MD 20892-9304 Phone: 301-594-6228     Fax: 301-443-1650 E-mail:  reillymt@mail.nih.gov nbsp;Nancy S. Pilotte, Ph.D., Chief Functional Neuroscience Research Branch Division Basic Neuroscience Behavioral Research National Institute Drug Abuse 6001 Executive Boulevard Room 4282, MSC 9555 Bethesda, MD 20892-9555 courier delivery: Rockville, MD  20852 Phone:  301-435-1317 Fax:  301-594-6043 E-mail:  npilotte@nih.gov James N. Coulombe, Ph.D. Health Scientist Administrator Developmental Biology, Genetics Teratology Center Developmental Biology Pediatric Medicine National Institute Child Health Human Development RM 4B01, MSC 7510 6100 Executive Blvd Bethesda, MD 20892-7510 Phone: 301-451-1390 Fax: 301-480-0303 E-mail:  CoulombeJ@mail.nih.gov

Notice Intent Publish Request Applications RFA) the Morris K. Udall Centers Excellence Parkinson’s Disease Research P50) Notice Number: NOT-NS-09-009 Key Dates Release Date: 28, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose Background purpose this Notice to indicate intent issue Request Applications RFA), set-aside funds, continue Morris K. Udall Centers Excellence Parkinson’s Disease Research program. is also intended alert potential applicants, including existing Centers approaching competing renewal, the change the Funding Opportunity Announcement FOA) Program Announcement PAR) RFA. Finally, Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. previous Udall Center FOA http://grants.nih.gov/grants/guide/pa-files/PAR-06-058.html), expired May 8, 2009, not renewed. RFA expected be published the summer 2009 an anticipated application receipt date November 20, 2009. RFA, previous announcements, utilize Specialized Center Mechanism P50). Research Initiative Details goal the Udall Centers program to fund high quality, multidisciplinary synergistic Centers can rapidly advance innovative basic, translational clinical research improve understanding treatment Parkinson’s disease PD) related disorders. Centers perform state-of-the-art research PD, including examination underlying neurobiological neuropathological mechanisms, identification characterization candidate disease-associated genes, establishment improved PD models development testing potential therapeutics, the initiation novel avenues clinical research. Notice encourages established investigators proven expertise and/or novel insights PD related disorders consider applying through upcoming RFA. Applications Principal Investigators outside the PD field welcome their specific expertise provide novel approaches identification disease mechanism therapeutic targets. Udall Centers program utilizes Specialized Center P50) grant mechanism, is designed support spectrum basic, translational clinical research activities utilizing integrated, multidisciplinary approach a specific disease entity biomedical problem area. Centers Excellence, Udall Centers should serve regional national resources the study PD related parkinsonian disorders. overall theme the Center, proposed research projects scientific Cores should relate directly the etiology, pathogenesis treatment PD parkinsonian disorders. this critical juncture PD research in evolution the Udall Centers program, RFA solicit applications focused an identified area need: translation basic research clinical practice. While basic research and continue serve the foundation discovery, proposed Center must include least translational project. this purpose, translation defined pre-IND/IDE Investigational New Drug/Investigational Device Exemption) stage research potential therapeutic diagnostic candidates.  Inclusion an integrated clinical component encouraged. Responsive applications nbsp;demonstrate potential to: pursue rapid translation basic research clinical practice contribute unique knowledge results the Udall Centers program collaborate effectively existing Centers serve a local national resource PD research NINDS policy Udall Centers establishes following budget limits: new competing renewal applications request maximum annual direct costs 1,000,000; requested budget 1,500,000 permitted inclusion a clinical component. clinical component accompanying budget should clearly described specified. Full details be available the RFA. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries further information, please contact: Beth-Anne Sieber, PhD Program Director, Neurodegeneration Cluster Division Extramural Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 2192 Bethesda, MD 20892-9531 Phone: 301) 496-5680 Email: sieberb@ninds.nih.gov

Notice Response Date Extension Request Information Soliciting Input Current Approaches Developing Integrated Databases Advance Research Parkinson’s Disease NOT-NS-09-010) Notice Number: NOT-NS-09-013 Key Dates Release Date: 27, 2009 Response Due By: June 26, 2009 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov) Purpose purpose this Notice to inform potential responders NOT-NS-09-010 the response date submitting information been extended. new response date June 26, 2009. is time-sensitive RFI ascertain needs clinical databases linked biorepositories advance clinical translational research Parkinson’s disease. Responses this RFI be collected various Institute/Center staff assess best meet needs researchers the field will made available the public. Responses must submitted electronically using web-based form at: http://www.ninds.nih.gov/research/clinical_research/rfi.htm later June 26, 2009. Inquiries Specific questions this RFI should directed the contact listed below: Wendy R. Galpern, M.D., Ph.D. Program Director, Office Clinical Research NINDS / NIH 6001 Executive Blvd., Rm 2225 Bethesda, MD 20892 Phone: 301-496-9135 Fax: 301-480-1080 E-mail: galpernw@ninds.nih.gov

Notice Intent Publish Request Applications The Human Connectome Project U54) Notice Number: NOT-MH-09-010 Key Dates Release Date: nbsp;May 12, 2009 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) National Center Complementary Alternative Medicine NCCAM) http://nccam.nih.gov/) National Center Research Resources NCRR) http://www.ncrr.nih.gov/) National Eye Institute NEI) http://www.nei.nih.gov/) National Institute Aging NIA) http://www.nia.nih.gov/) National Institute Alcohol Abuse Alcoholism NIAAA) http://www.niaaa.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 Deafness Other Communication Disorders NIDCD) http://www.nidcd.nih.gov/) National Institute Dental Craniofacial Research NIDCR) http://www.nidcr.nih.gov/) National Institute Drug Abuse NIDA) http://www.nida.nih.gov/) National Institute Environmental Health Sciences NIEHS) http://www.niehs.nih.gov/) National Institute General Medical Sciences NIGMS) http://www.nigms.nih.gov/) National Institute Mental Health NIMH) http://www.nimh.nih.gov/) National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov/) National Institute Nursing Research NINR) http://www.ninr.nih.gov/) Office Behavioral Social Sciences Research OBSSR) http://obssr.od.nih.gov/) Purpose the Notice NIH Blueprint Neuroscience Research, comprising 16 Institutes, Centers Offices, announces forthcoming issuance a Request Applications RFA) The Human Connectome Project. NIH Blueprint Neuroscience Research plans fund award a project period five years a maximum 6 million per year total costs.  new RFA expected be published the NIH Guide Grants Contracts during summer 2009.  RFA support development sharing data knowledge the structural functional connectivity the human brain, will the cooperative agreement U54) mechanism subcontracts, appropriate. APPLICATIONS NOT BEING SOLICITED THIS TIME. However, Notice to encourage investigators appropriate backgrounds capabilities pro-actively plan submit applications response the forthcoming RFA. Overview the Initiative overall purpose this five year Human Connectome Project HCP) to develop share knowledge the structural functional connectivity the human brain.  purpose be pursued through following specific efforts:  Existing, cutting-edge, non-invasive imaging technologies be optimized combined acquire structural functional vivo data axonal projections neural connections brains hundreds healthy adults.  Demographic data data regarding sensory, motor, cognitive, emotional, social function also collected each subject, will DNA samples blood establish cell lines). Models better understand use data be developed. Connectivity patterns be linked existing architectonic data. Data models be public immediately via user-friendly system include tools query, organize, visualize analyze data.  Outreach activities be conducted engage educate research community the imaging tools, data, models, informatics tools.  After five years, specific efforts expected deliver:  1) set integrated, non-invasive imaging tools obtain connectivity data humans vivo, 2) gold-standard, quantitative set human connectivity data linked behavioral genetic data well to general, existing architectonic data, associated models, up hundreds healthy adult female male subjects, 3) Rapid, user-friendly dissemination connectivity data, models, tools the research community via outreach activities an informatics platform. Inquiries Complete information the training program be provided the RFA, is expected be published the NIH Guide Grants Contracts the Summer 2009.  Prospective applicants encouraged check NIH Guide Grants Contracts the RFA publication and/or subscribe the NIMHFUNDINGOPPS list serv receive emails recent NIMH publications the NIH Guide Grants Contracts. any additional inquiries, please contact: Michael Huerta, Ph.D. National Institute Mental Health 6001 Executive Boulevard, Room 7202, MSC 9645 Bethesda, MD  20892-9645 Telephone:  301) 443-1815 FAX:  301) 443-1731 Email:  mhuert1@mail.nih.gov

Request Information: Soliciting Input Current Approaches Developing Integrated Databases Advance Research Parkinson’s Disease Notice Number: NOT-NS-09-010 Update: following update relating this announcement been issued: 26, 2009 - Notice NOT-NS-09-013 Notice Response Date Extension. Key Dates Release Date: April 21, 2009   Response Due By: New Date June 26, 2009 per NOT-NS-09-013; Original Date: 22, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov Purpose is time-sensitive Request Information RFI) issued the National Institute Neurological Disorders Stroke.  information requested meant ascertain needs clinical databases linked biorepositories advance clinical translational research Parkinson’s disease. Institute envisions such effort serving data sharing data integration needs the wider research community including industry, non-profit Parkinson’s disease-related organizations, the research activities other NIH Institutes Federal agencies including Veterans Administration the Department Defense.  responses the RFI be collected various Institute staff assess best meet needs researchers the field will made available the public. Background NINDS committed facilitating collection sharing data biologic samples amongst clinical translational researchers Parkinson’s disease. Given advances technology the increasing types amounts data being collected, are interested implementing efficient methods data sharing.  Additionally, the efforts develop valid biomarkers the risk progression Parkinson’s disease expand, want ensure access biospecimens might facilitate major research advances.  RFI meant solicit input the greater extramural research community, scientific medical organizations, Federal Agencies, other interested parties well-versed establishing managing large databases repositories.  is meant solicit input the greater research community Parkinson’s disease how specific databases linked biorepositories advance effort discover better strategies treat and/or prevent Parkinson’s disease.  Responses this RFI be reviewed NINDS staff will help inform complement assessment the field the identification specific, achievable goals have potential advance transform field overall. RFI for planning purposes only, should be construed a solicitation applications proposals and/or an obligation any on part the United States Federal Government.  Information Requested mission NIH to support biomedical discoveries will improve health save lives. NIH committed data sharing seeks input the optimal approaches establishing managing large databases biospecimen repositories.  NINDS like input the following issues: Large databases: Describe key features enhance value utility a large clinical database use clinical translational researchers. Describe clinical, imaging, biologic/genetic, pathology data be linked most effectively. Identify considerations impact cost effectiveness data collection data sharing.   Identify are most important barriers must overcome enhance data sharing procedures how these barriers overcome. Identify technologies enhance functional utility a large clinical database. Repository biospecimens: Describe advantages a federated versus non-federated repository.  Describe the collection various biosamples Parkinson’s disease should organized optimize utility. General Information: Please identify nature your interest the area databases repositories i.e. you biomedical clinical researcher, member an advocacy community group, other?). you a member a particular advocacy professional organization, please indicate name the organization. you your organization involved Parkinson’s disease clinical research, please indicate features a large integrated database be useful your group organization.  Describe conditions need be met you your organization enter data such database. Within research, please indicate main area interest. Responses Responses must submitted electronically using web-based form http://www.ninds.nih.gov/research/clinical_research/rfi.htm, will accepted through 22, 2009.  Replies individual questions optional, the site permit anonymous responses.  information provided be analyzed may appear various reports.  Inquiries Specific questions this RFI should directed the contact listed below: Wendy R. Galpern, M.D., Ph.D.  Program Director, Office Clinical Research NINDS / NIH 6001 Executive Blvd., Rm 2225 Bethesda, MD 20892 Phone:  301-496-9135 Fax:  301-480-1080 E-mail:  galpernw@ninds.nih.gov

Request Comments the Proposed of Determination Exceptional Circumstances DEC) the NINDS Medicinal Chemistry Neurotherapeutics Program Notice Number: NOT-NS-09-008 Key Dates Release Date: March 27, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose National Institute Neurological Disorders Stroke NINDS) seeking public comment a proposed of Determination Exceptional Circumstances DEC), provided under Bayh-Dole Act, its new Medicinal Chemistry Neurotherapeutics Program MCNP). Background goal the NINDS MCNP to improve public health stimulating development new drugs neurological diseases. NINDS supported high-throughput screens basic research studies have led the discovery many small molecule compounds activity models neurological disease. of compounds might transformed drugs, chemical modifications improve potency pharmacological properties. However, biotechnology pharmaceutical companies hesitant invest the early development compounds rare diseases new targets, given concerns market success, budgets, associated risks. Academic researchers have identified promising compound rarely access medicinal chemistry services. MCNP intended overcome barriers. MCNP provide resources chemistry expertise transform small molecule compounds evidence bioactivity lead compounds sufficient potency, efficacy, drug-likeness begin preclinical studies required an investigational new drug application. Once projects ldquo;graduated” the MCNP, researchers take advantage other NIH resources, such the NINDS Translational Research Cooperative Program, NIH Rapid Access Interventional Development RAID) Pilot Program, funding agreements clinical trials advance drug leads through preclinical clinical testing.  Researchers also engage industry other non-government resources follow-up work. MCNP envisioned a collaborative effort between NINDS-contracted medicinal chemistry service facility academic industry researchers bioassays model neurological disorders bioactive small molecule compounds. Under MCNP, researchers Contributors) provide compounds the NINDS medicinal chemistry service facility Contractors) a starting point chemical optimization. Contractors design generate chemical analogs these starting compounds, the Contributors test chemical analogs their disease bioassays. results inform next round analog design development, so on, potentially dozens rounds. design new chemical analogs under MCNP generate new inventions. Bayh-Dole Act establishes rights obligations grantees contractors Subject Inventions—inventions are conceived first actually reduced practice the performance work under funding agreement the Federal Government. of goals the Bayh-Dole Act to incentivize commercialization Government-supported Subject Inventions. Under Bayh-Dole Act, Government contractors generally retain right elect title inventions by researchers a result their work performed under Government-supported agreement. Determination Exceptional Circumstances DEC) the Bayh-Dole Act directs ownership inventions by funding recipient the Government other party. Thus, without Determination Exceptional Circumstances, NINDS-contracted MCNP medicinal chemists retain right elect title/ownership inventions all new compounds they invent under funding agreement NINDS. Responses a NINDS-issued Request Information RFI) directed potential Contributors Contractors suggest allowing Contractors retain ownership the chemical analog patent rights actually impede further development commercialization new drugs. order develop good lead compounds, MCNP must attract promising, high quality starting compounds. Potential Contributors informed NINDS they participate the MCNP only they be assured full ownership patent rights all analogs generated their starting compounds. Most potential Contractors not express interest retaining ownership Subject Inventions directed the analogs their methods use. potential Contractors indicated their business model these particular circumstances be provide specific services a fee. PROPOSED INTELLECTUAL PROPERTY STRATEGY: the MCNP, NINDS considering Determination Exceptional Circumstances DEC), provided under Bayh-Dole Act.  DEC cover classes Subject Inventions: 1)     Subject Inventions directed analog compounds their methods use, NINDS medicinal chemistry Contractors be required offer first right assignment the Contributor. the Contributor declines offer assignment, NINDS dispose the invention rights NINDS determines be the best interests the program public health e.g., allow Contractor retain invention rights). 2)     Subject Inventions directed the methods manufacturing analog compounds, Contractor retain rights, the DEC require the Contractor grant agree negotiate licenses as enable research and commercialization the compounds. Rights all Subject Inventions be retained the Contractor pursuant the Bayh-Dole Act. Inquiries NINDS invites comments this strategy use a DEC the MCNP. Alternative strategies will encourage contribution chemical compounds the program be considered before final determination made regarding use a DEC. Please submit comments the attention Annette Carter, Contracting Officer the address below 4:00 PM Local Time April 17, 2009. Annette Carter, Contracting Officer National Institutes Health, NINDS R&D Contracts Management Branch 6001 Executive Blvd., Suite 3287 Bethesda, MD   20892-9531 via courier Rockville, MD  20852 Electronic submittal also accepted cartera@mail.nih.gov