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Notice Intent Publish Funding Opportunity Announcement the NINDS Exploratory Grant Program Parkinson's Disease Research P20) Notice Number: NOT-NS-13-040 Update: following update relating this announcement been issued: 19, 2014 - Notice NOT-NS-14-033. Notice update information provided. October 24, 2013 - Notice NOT-NS-14-001. Notice Correct Anticipated Application Due Date. Key Dates Release Date: September 23, 2013   Estimated Publication Date Announcement: November 2013  First Estimated Application Due Date: January 2014  New Date April 2014 per NOT-NS-14-001) Earliest Estimated Award Date: July 2014  Earliest Estimated Start Date: July 2014 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose Parkinson's disease PD) a chronic, progressive movement disorder affects least half million people the United States, well the relatives friends care them. average age onset during sixth decade, although earlier onset also possible, the incidence PD expected increase the population ages. While significant research advances continue, full complexity PD etiology not yet evident. Moreover, currently available treatments primarily symptomatic, neither slow halt disease progression. Challenges posed the inherent complexity PD often best addressed multidisciplinary research teams working tandem surmount obstacles seize opportunities advance knowledge improve treatment. However, development an effective team, identification an optimal strategy collection preliminary data address particular challenge PD require dedicated time resources. Therefore, National Institute Neurological Disorders Stroke NINDS) solicit Exploratory Grant P20) applications proposing planning and initiation collaborative research activities advance PD research. goal this program to formalize collaborative structures establish foundation research discovery necessary address intransigent issues PD research, such successful exploratory studies lead a subsequent application support a collaborative, multidisciplinary NINDS Morris K. Udall Center Excellence P50). foster development innovative research collaborations, FOA provide support new projects, continuation projects have already initiated. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Fall 2013 an expected application due date January 2013. Research Initiative Details NINDS Exploratory Grant Program provide support collaborative, multidisciplinary groups plan future application elucidation, disease modification prevention Parkinson's disease. most compelling P20 applications address unifying theme pursue focused, consortium-based strategy develop research approach which near-term, significant progress be made. Collaborative teams include expertise required address critical gaps knowledge are barriers therapeutic translation research findings; collaborations between public private sector encouraged. Related activities include preliminary data generation, pilot feasibility studies other organizational activities necessary prepare full scale NINDS Udall Center application. Proposed pilot studies must defined within application. Proposals include any combination basic, translational clinical components required the planning a subsequent application. Interventional clinical trials not included this FOA. Applicants also expected address significance outcomes PD research treatment should subsequent full-scale Udall Center grant awarded. Successful applicants establish proof-of-concept” experimental framework could generalized organize subsequent research efforts meet specific challenges PD research. Applicants request maximum annual direct costs 300,000 per year, up three years. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov

Notice a Webinar Discuss Changes PAR-13-343 Network Excellence Neuroscience Clinical Trials NeuroNEXT) U01)" Notice Number: NOT-NS-13-041 Key Dates Release Date: September 23, 2013 Related Announcements PAR-13-343 Issued National Institute Neurological Disorders Stroke NINDS) Purpose webinar intended inform academic community the changes be found the revised Network Excellence Neuroscience Clinical Trials NeuroNEXT) U01 funding opportunity announcement PAR-13-343), reissued August 30, 2013. Time be allotted questions answers. NeuroNEXT designed increase efficiency clinical trials, facilitate patient recruitment retention, increase quality neuroscience clinical trials, to enable public-private partnerships. network includes multiple Clinical Sites, Clinical Coordinating Center CCC), one Data Coordinating Center DCC); listing the sites be found the NeuroNEXT website www.neuronext.org). clinical research network provides robust, standardized, accessible infrastructure facilitate rapid development implementation protocols neurological disorders affecting adult and/or pediatric populations. Webinar Information November 22, 2013 12:00PM - 1:00PM EST) Instructions joining webinar: 1. to link join webinar: https://www1.gotomeeting.com 2. will connected audio using computer's microphone speakers VoIP). headset recommended. Or, may select quot;Use Telephone" after joining webinar, using following information: Teleconference number: 1-702-489-0003 Access code: 999-883-025 Audio PIN: Shown after joining Webinar Inquiries Please direct inquiries to: Amanda Sibley, DPhil, MPH National Institute Neurological Disorders Stroke NINDS) Telephone: 301) 496-9135 Email: amanda.sibley@nih.gov Website: www.neuronext.org nbsp;

Request Information RFI) the Action Plan the Muscular Dystrophies Notice Number: NOT-NS-14-039 Key Dates Release Date: August 30, 2013   Response Date: December 20, 2013 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose NIH, together the Muscular Dystrophy Coordinating Committee MDCC), leading effort update Action Plan the Muscular Dystrophies, was released 2005.  help inform planning process, NIH the MDCC welcome comments the public regarding accomplishments since Plan’s approval, remaining opportunities, suggestions new research objectives. Background NIH’s mission to seek fundamental knowledge the nature behavior living systems the application that knowledge enhance health, lengthen life, reduce illness disability. National Institute Neurological Disorders Stroke NINDS), National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), the National Heart, Lung, Blood Institute NHLBI) fund majority muscular dystrophy-related research NIH work together coordinate muscular dystrophy research activities across NIH.  muscular dystrophies a group hereditary, progressive degenerative disorders causing weakness the skeletal voluntary muscles.  are different forms muscular dystrophy, differ their age onset, severity, pattern muscles other body systems affected.  Among provisions, Muscular Dystrophy Community Assistance, Research, Education Amendments 2001 MD-CARE Act, Public Law 107-84) established MDCC prompted series activities leading the development the Action Plan the Muscular Dystrophies.  Action Plan, developed input an MDCC Scientific Working Group, includes research objectives five areas: Mechanisms Muscular Dystrophy, Diagnosis Screening Muscular Dystrophy, Therapy Muscular Dystrophy, Living Muscular Dystrophy, Research Infrastructure Needs Muscular Dystrophy.  Through individual collaborative activities researchers, clinicians, stakeholders in  muscular dystrophy community, driven, part, the Action Plan, have significant advances understanding disease mechanisms, development new diagnostic tools reduce diagnostic odyssey affected individuals their families, evolution drug discovery development partnerships have advanced candidate therapeutics, improvements the care quality life affected individuals.  While type muscular dystrophy distinctive, has required disease-appropriate activities, has benefited a shared focus the muscular dystrophy community.  this time, are new challenges gaps require assessment progress a re-focus current needs. Information Requested NIH the MDCC invite muscular dystrophy research, advocacy, family communities provide comments their perspective progress toward objectives the Action Plan, on remaining opportunities.  NIH also welcomes suggestions modifications the existing research objectives, research objectives are longer needed, new objectives should considered the updated Action Plan.  collected comments be reviewed considered the MDCC an MDCC Scientific Working Group develop updated Action Plan.  to Submit Response Responses this RFI must submitted electronically using web-based format at: http://www.ninds.nih.gov/funding/RFI-MuscularDystrophies.htm. Responses be accepted until December 20, 2013.  Responses this RFI voluntary.  Submitted information not considered confidential.  Any personal identifiers be removed responses compiled. request for information planning purposes only should be construed a solicitation as obligation the part the Federal Government. NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. NIH use information submitted response this RFI its discretion will provide comments any responder’s submission. However, responses the RFI be reflected future funding opportunity announcements. information provided be analyzed may appear reports. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted.  proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: John D. Porter, Ph.D. Executive Secretary, Muscular Dystrophy Coordinating Committee National Institute Neurological Disorders Stroke Telephone: 301-496-5745 Email: mailto:porterjo@ninds.nih.gov nbsp;

Discontinuation PAR-12-097 Ancillary Studies PREDICT-HD U01)" Notice Number: NOT-NS-13-037 Key Dates Release Date: July 25, 2013 Effective Date:   August 15, 2013 Related Announcements PAR-12-097 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants NINDS discontinue PAR-12-097  "Ancillary Studies PREDICT-HD U01)". Applications not accepted NINDS this Funding Opportunity Announcement after August 14, 2013 Application Due Date. Inquiries Please direct inquiries to: Margaret Sutherland, Ph.D Program Director, National Institute Neurological Disorders Stroke 6001 Executive Blvd, Bethesda, MD 20892 Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov nbsp;

Discontinuation Participation NINDS PA-11-196 Mentored Quantitative Research Development Award K25)" Notice Number: NOT-NS-13-031 Key Dates Release Date: July 18, 2013 Related Announcements PA-11-196 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice informs potential applicants NINDS discontinue participation PA-11-196 quot;Mentored Quantitative Research Development Award Parent K25)." New applications not accepted NINDS this award after September 7, 2013. Resubmitted A1) applications not accepted after 7, 2014. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Office Training, Career Development, Workforce Diversity 6001 Executive Blvd, Room 2186 Bethesda, MD 20892 Telephone: 301) 496-4188 Email: korns@ninds.nih.gov nbsp;

Request Information RFI): Advancing Research Parkinson's Disease 2014 Notice Number: NOT-NS-13-035 Update: following update relating this announcement been issued: September 26, 2013 - Notice NOT-NS-13-042. Notice the Extension the Response Date. Key Dates Release Date: July 18, 2013 Response Due Date: September 30, 2013 Extended October 31, 2013 per NOT-NS-13-042) Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), part the National Institutes Health NIH), the primary federal agency responsible funding research Parkinson's Disease PD). January 6-7, 2014, NINDS sponsor public conference assess critical needs related opportunities advancing PD research treatment. purpose this time-sensitive Request Information RFI) to seek comprehensive perspective the most significant challenges highest priorities basic, translational clinical research PD. RFI intended gather information relevant conference planning should be construed a funding opportunity. Information Requested RFI intended solicit broad community perspective scientific opportunities outstanding needs research treatment PD. NINDS invites input stakeholders including not limited researchers academia industry, healthcare professionals, patient advocates advocacy organizations, scientific professional organizations, Federal agencies other interested members the public. Organizations encouraged submit single response reflects views the organization a whole. Responses be used inform 2014 NINDS PD conference. NINDS interested basic, translational clinical PD research, well interdisciplinary approaches span areas. Please provide perspectives the following topics: New and/or ongoing challenges opportunities PD research treatment breakthroughs. highest individual priority PD each the following: basic, translational clinical research; well the impact accomplishment stated priority areas have laboratory-based science, clinical trials, patient well-being public health. Specific elements needed address basic, translational clinical priorities to remove any related obstacles. Examples such elements might include are limited to: enhanced tools, technologies, research resources; novel combinations research team expertise collaboration; bioinformatics resources; infrastructure. to Submit Response ensure consideration, responses must received September 30, 2013 must submitted electronically using web-based format www.ninds.nih.gov/funding/RFI-PD.htm. web format provide confirmation response submission, respondents not receive individualized feedback. Responses this RFI voluntary may submitted anonymously. Please not include any personally identifiable other information you not wish make public. Proprietary, classified, confidential sensitive information should be included your response. Comments submitted be compiled discussion the upcoming January 2014 conference may appear related reports. Any personal identifiers names, e-mail addresses, etc.) be removed responses compiled. RFI for informational planning purposes only should be construed a solicitation as obligation the part the United States US) Government, NIH the NINDS provide support any ideas submitted response it. Please note the US Government, NIH NINDS not pay the preparation any information submitted, for use that information. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD Program Director, Neurodegeneration National Institute Neurological Disorders Stroke Email: sieberb@ninds.nih.gov

Notice Support Clinician-Scientists Supported NINDS Mentored Career Development K08 K23 Awards Attend Workshop Notice Number: NOT-NS-13-028 Key Dates Release Date: July 16, 2013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose year, NINDS the American Neurological Association ANA) sponsor workshop designed specifically clinician-scientists obtain Mentored Career Development Award K08 K23) NINDS. workshop also available clinician-scientists supported other mentored K awards, including K12 K99 awards. workshop organized run based the expectation participation have large, beneficial influence the success K awardees their pursuit a dual career outstanding clinicians independently funded research scientists. workshop been given annually over 10 years, evaluated updated annually has considered be very beneficial those have attended.  faculty this workshop includes senior NINDS staff, Chairs Neurology Departments, established clinician-scientists neurology clinician-scientists recently transitioned mentored K awards independent funding. workshop covers wide range topics, including grant writing, career development problem solving multiple issues pertinent this population. addition, workshop includes poster session significant opportunities attendees network among peers, leaders neurology research NINDS staff. NINDS/ANA workshop typically begins the Friday evening continues day the Saturday immediately preceding start the ANA annual meeting. NINDS K awardees invited attend workshop twice non-consecutive years) during 5 year K award period. is intended K awardees attend workshop during 1st 4th year the K award. However, is understood time conflicts arise, historically, K awardees attended during 2nd, 3rd and/or 5th year their awards. purpose this Notice to inform NINDS K awardees a change financial support provided their K awards, is intended facilitate attendance this workshop. Currently, mentored NINDS K awards include 50,000 per year research career development expenses. Effective June 1, 2013, new awards subsequent May, 2013 NINDS council, additional 1,000 per year be added the research cost budget, a total 51,000 per year. additional funding being provided the expectation K awardees use or of to attend NINDS-ANA sponsored workshop twice during first four years the K award. Starting K awards on after June 1, 2013, K awardees expected attend workshop twice, once during either 1st 2nd year the K award once during 3rd 4th year the K award not consecutive years). is highly recommended scholars attend during 1st 4th year, it understood that, due scheduling conflicts, timetable not always possible. Because much the emphasis the workshop preparation transition independent funding, should in process during 5th year, funds not provided attendance the workshop during 5th year the award. additional 5,000 over duration the award being provided specifically enable attendance the annual workshop. Consequently, K awardees have attended workshop twice during first 4 years their K award receive total 46,000 the year 5 research cost budget, will maintain research cost budget the K award an average 50,000 per year support research career development activities. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. Director Office Training, Career Development Workforce Diversity National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2153  Bethesda, Maryland 20892 Phone: 301- 496-4188 Email: korns@ninds.nih.gov Website: http://www.ninds.nih.gov/funding/areas/training_and_career_development/…

Notice Intent Publish Revised Funding Opportunity Announcement NeuroNEXT Clinical Trials U01) Notice Number: NOT-NS-13-036 Update: following update relating this announcement been issued: August 30, 2013 - Issuance PAR-13-343 NeuroNEXT Clinical Trials U01). Key Dates Release Date: July 16, 2013 Estimated Publication Date Announcement: September, 2013  First Estimated Application Due Date: December 2, 2013 Earliest Estimated Award Date: June, 2014 Earliest Estimated Start Date: July, 2014 Related Announcements PAR-11-343 NOT-NS-13-034 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS intends reissue PAR-11-343 solicit applications NeuroNEXT Clinical Trials U01). revised Funding Opportunity Announcement FOA) expected be published Fall 2013 an expected initial application due date December 2013. FOA utilize U01 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators begin consider applying this revised FOA. revised FOA encourage applications biomarker validation trials exploratory clinical trials drugs, biologics, surgical therapies devices may contribute the justification and provide data required design subsequent trial further evaluate intervention. Applications drugs biologics should provide compelling scientific evidence the investigational agent proposed study reach/act upon designated target that mechanism action such it be benefit ameliorating specific aspect the disease. Applications devices propose early traditional feasibility studies. Diseases chosen study should based the NINDS' strategic plan clinical research interests.  APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: D. Elizabeth McNeil, MD MSc National Institute Neurological Disorders & Stroke Telephone: 301-496-9135 Email: mcneilde@ninds.nih.gov  

Notice Intent Publish Funding Opportunity Announcement the NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50) Notice Number: NOT-NS-13-033 Key Dates Release Date: July 11, 2013 Estimated Publication Date Announcement: November, 2013  First Estimated Application Due Date: January, 2014  Earliest Estimated Award Date: July, 2014  Earliest Estimated Start Date: July, 2014  Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) continue Morris K. Udall Centers Excellence Parkinson's Disease Research program publishing Funding Opportunity Announcement FOA) new renewal applications. purpose this Notice to alert potential applicants to provide lead time the development responsive projects.  FOA utilize Specialized Center P50) activity code, will support spectrum basic, translational clinical research activities utilizing integrated, multidisciplinary approach a specific disease entity, Parkinson's Disease PD).   is anticipated this FOA be published autumn 2013 an expected application due date early winter 2014. Research Initiative Details NINDS intends solicit new renewal applications the Morris K. Udall Centers Excellence Parkinson’s Disease Research program, consortium specialized Centers work collaboratively well independently define causes and discover improved treatments this disease. Individual Centers establish unique, interdisciplinary programs optimize available expertise basic, translational clinical research required advance PD research. overall theme, proposed research projects integral cores each Center relate directly the etiology, pathogenesis treatment PD related parkinsonian disorders. considerable degree collaboration among investigators required achieve overarching objectives each Center. proposal must include least translational research project focusing the development therapeutics, diagnostics, clinical criteria will inform new approaches the treatment PD. Notably, Centers Excellence, Udall Centers serve regional national resources PD research. Successful applicants participate the network existing Udall Centers foster translation scientific findings novel treatments PD. Applicants request maximum annual direct costs 1,500,000. Full details be available the FOA. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD Program Director, Neurodegeneration Cluster Division Extramural Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 2223 Bethesda, MD 20892-9525 Telephone: 301) 496-5680 Email: sieberb@ninds.nih.gov

Discontinuation PAR-11-343 NeuroNEXT Clinical Trials U01)" Notice Number: NOT-NS-13-034 Update: following update relating this announcement been issued: July 16, 2013 - Notice NOT-NS-13-036. Notice Intent Publish Revised Funding Opportunity Announcement NeuroNEXT Clinical Trials U01). Key Dates Release Date: July 3, 2013 Related Announcements PAR-11-343 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants NINDS discontinue PAR-11-343 NeuroNEXT Clinical Trials U01). Applications not accepted NINDS this Funding Opportunity Announcement after August 3, 2013. Inquiries Please direct inquiries to: D. Elizabeth McNeil, MD, MSc National Institute Neurological Disorders Stroke Office Clinical Trials 6001 Executive Blvd, Room 2114 Bethesda, MD 20892 Telephone: 301) 496-4135 Email: mcneilde@ninds.nih.gov