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Notice NINDS Participation PA-18-688 Developmental Pharmacodynamics Models Drug Effects Pediatrics R01 Clinical Trial Optional) Notice Number: NOT-NS-18-049 Key Dates Release Date: March 6, 2018 Related Announcements PA-18-688 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participating PA-18-688 Developmental Pharmacodynamics Models Drug Effects Pediatrics R01 - Clinical Trial Optional)". following sections been updated reflect participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865, 93.242 Part 2. Full Text Announcement Section I. Funding Opportunity Description Scope NIMH Area Interest: The NIMH specifically interested clinical studies supporting establishment pharmacodynamic PD) markers psychopharmacologic drugs pediatric populations.  instance, study using EEG measure would change proportion an administered drug dose CNS PD marker drug action) be interest.  is expected studies include dose ranging PK/PD measures.  Age-dependent effects be interest well the inclusion comparator drugs. Using EEG PD example, is likely the EEG measures reflecting drug action be different grade school children vs adults.  Modified Read: Part 1. Overview Information Components Participating Organizations Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865, 93.242, 93.853 Part 2. Full Text Announcement Section I. Funding Opportunity Description Scope NIMH Area Interest:The NIMH specifically interested clinical studies supporting establishment pharmacodynamic PD) markers psychopharmacologic drugs pediatric populations.  instance, study using EEG measure would change proportion an administered drug dose CNS PD marker drug action) be interest.  is expected studies include dose ranging PK/PD measures.  Age-dependent effects be interest well the inclusion comparator drugs. Using EEG PD example, is likely the EEG measures reflecting drug action be different grade school children vs adults.  NINDS Area Interest: National Institute Neurological Disorders Stroke NINDS) encourages applications mission-relevant topics, particularly study pharmacodynamics treatments diseases affecting nervous system. Examples include are limited to) diseases conditions neonates e.g., seizures, hypoxic-ischemic injury, stroke, neuromuscular disorders) younger children e.g., headache, epilepsy, movement disorders, neuromuscular disorders, stroke, demyelinating disorders) where age-related PD not explored cannot extrapolated adult studies. Treatments rare diseases affecting CNS across pediatric age spectrum also interest. Only treatments have approved FDA use humans be considered. Pharmacodynamic studies experimental drugs seek support via PAR-15-071. Applications include clinical trials noted above); however, NINDS not accept applications seek answer specific questions safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions, preventive, therapeutic, services interventions e.g., phase I, phase II, phase III clinical trials). Such designs should submitted a clinical trial-specific funding announcement PAR-18-420 or PAR-18-422). Applicants strongly advised consult NINDS Scientific/Research staff prior submitting application human subjects determine appropriate funding opportunity. following contacts been added: Section VII. Agency Contacts Scientific/Research Contact(s) Adam L. Hartman, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 E-mail: adam.hartman@nih.gov Financial/Grants Management Contact(s) Tijuanna Decoster, Ph.D.  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9231 E-mail: tijuanna.decoster@nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Adam L. Hartman, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 E-mail: adam.hartman@nih.gov

Notice National Institute Neurological Disorders Stroke NINDS) IGNITE CREATE Bio Program Applications Directed Non-Addictive Pain Therapies Notice Number: NOT-NS-18-048 Key Dates Release Date: March 5, 2018 Related Announcements PAR-17-456 PAR-17-457 PAR-18-542 PAR-18-543 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Innovation Grants Nurture Initial Translational Efforts  (IGNITE) Cooperative Research Enable Advance Translational Enterprises Biologics CREATE Bio) program Funding Opportunity Announcements an area special interest.  NINDS like accelerate development pain treatments little no potential misuse addiction. IGNITE program contains suite early-stage therapy development funding programs is meant serve a feeder program later-stage therapy development programs. three IGNITE programs in following areas:  Assay Development Neurotherapeutic Agent Identification, Neurotherapeutic Agent Characterization In vivo Efficacy Studies, Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery.  of IGNITE programs like encourage applications related non-addictive therapies the treatment pain. CREATE Bio program interested receiving applications biotechnology products biologics-based therapies, broadly include modalities such peptides, proteins, oligonucleotides, gene therapies, cell therapies, novel emerging therapies directed optimizing developing non-addictive therapies the treatment pain.  CREATE Bio program includes following tracks:  Optimization Track supports optimization agents obtain clinical candidate appropriate entry to the Development Track. Development Track supports IND-enabling studies a clinical candidate projects expected achieve filing an Investigational New Drug IND) application the U.S. Food Drug Administration FDA), the end the funding period.  more advanced projects, optional small delayed-onset first human Phase clinical trial also proposed follow filing the IND package. Additionally, IGNITE CREATE Bio programs hold informational webinar potential applicants. webinar recommended investigators meet entry criteria the programs interest. webinar optional not required submission applications.   WEBINAR INFORMATION Informational Webinar the IGNITE CREATE Bio Programs a focus Non-Addictive Pain Therapies April 16, 2018 1:30 p.m.- 2:30 Eastern Time Please visit following link register the webinar: Link webinar registration button available the bottom the page. Inquiries Please direct inquiries to: Chris Boshoff, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: chris.boshoff@nih.gov Rebecca Roof, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:  Rebecca.Roof@nih.gov   Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov  

Notice Change Application Due Date RFA-NS-18-024 Lewy Body Dementia Center Without Walls CWOW) U54 Clinical Trial Allowed)" Notice Number: NOT-NS-18-047 Key Dates Release Date: February 28, 2018 Related Announcements RFA-NS-18-024 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) Purpose purpose this notice to inform interested applicants the Key Dates RFA-NS-18-024 Lewy Body Dementia Center Without Walls CWOW) U54 Clinical Trial Allowed)" been changed.  new application due date is April 30, 2018.  new expiration date is May 1, 2018. Key Dates Currently Reads:    Open Date March 17, 2018 Application Due Date(s) April 17, 2018, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date. Late applications not permitted response this FOA. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date April 18, 2018   Modified Read:   Open Date March 30, 2018 Application Due Date(s) April 30, 2018, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date. Late applications not permitted response this FOA. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date 1, 2018 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Debra Babcock, PhD, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dbabcock@mail.nih.gov

Notice Intent Reissue Funding Opportunity Announcement PA-15-354, SBIR Technology Transfer R43/R44)" Notice Number: NOT-NS-18-046 Key Dates Release Date: February 23, 2018 Estimated Publication Date Funding Opportunity Announcement: 03/01/2018 First Estimated Application Due Date: 09/01/2018 Earliest Estimated Award Date: 04/01/2019 Earliest Estimated Start Date: 04/01/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants NINDS plans reissue PA-15-354, SBIR Technology Transfer R43/R44)for compliance FORMS-E. FOA not allow clinical trials.   Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects.    FOA expected be published March 2018 the September 5th, 2018 due date. Research Initiative Details Funding Opportunity Announcement FOA) encourages Small Business Innovation Research SBIR) grant applications small business concerns SBCs) projects transfer technology of NIH intramural research labs the private sector. selected SBIR funding, SBC be granted royalty-free, non-exclusive patent license agreement internal research for term and within field use the SBIR award technologies held NIH the intent the SBC develop invention a commercial product benefit public. Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) 301-496-1779 fertigs@ninds.nih.gov

Notice National Institute Neurological Disorders Stroke NINDS) Interest Biomarkers Directed Pain Pain Therapies Notice Number: NOT-NS-18-043 Key Dates Release Date: February15, 2018 Related Announcements PAR-18-548 PAR-18-549 PAR-18-550 PAR-18-664 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Neuroscience Biomarker Program Funding Opportunity Announcements PAR-18-548, PAR-18-549, PAR-18-550 an area special interest. NINDS like encourage applications directed the analytical and/or clinical validation biomarkers associated pain pain therapies. Candidate biomarkers particular interest those can used stratify patients clinical trials, predict response a therapeutic, indicate target engagement.   Moreover, applications directed developing biomarkers associated pain pain therapies permitted include aims related biomarker discovery identification addition aims related analytical and/or clinical validation.   NINDS hold informational webinar the Neuroscience Biomarker Program potential applicants. webinar recommended investigators have identified candidate biomarkers are interested learning the NINDS funding opportunities supporting rigorous validation biomarkers a manner is consistent FDA guidelines.   webinar optional not required submission applications. Webinar Information Informational Webinar the Neuroscience Biomarker Program February 14, 2018 2:30 p.m.- 3:30 p.m. Eastern Time Please visit following link register the webinar: Link webinar registration button available the bottom the page. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: mary.pelleymounter@nih.gov   Victoria Smith, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: victoria.smith@ninds.nih.gov   Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Correction Application Instructions RFA-HL-19-007: Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-591 Key Dates Release Date: February 13, 2018 Related Announcements RFA-HL-19-007 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-007 Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)." The purpose this Notice to alert scientific community an additional attachment required the application.  Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Correction Application Instructions RFA-HL-19-008: Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-592 Key Dates Release Date: February 13, 2018  (Rescinded March 21, 2018) Related Announcements RFA-HL-19-008 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-008 Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)". purpose this Notice to alert scientific community an additional attachment required the application. Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Change Key Dates PAR-17-001 Emerging Global Leader Award K43)" Notice Number: NOT-TW-18-003 Key Dates Release Date: February 08, 2018 Related Announcements PAR-17-001 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Research Women’s Health ORWH) Purpose purpose this Notice to alert scientific community a change the Key Dates for PAR-17-001 "Emerging Global Leader Award K43)".    Part 1. Overview Information Key Dates Currently reads: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017, March 2018, March 2019 Advisory Council Review: 2017, May 2018, 2019 Earliest Start Date: July 2017, July 2018, July 2019 Expiration Date: November 8, 2018 Modified read: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017; May 2018; March 2019 Advisory Council Review: 2017; August 2018; May 2019 Earliest Start Date: July 2017; September 2018; July 2019 Expiration Date: November 8, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christine Jessup Ph.D Fogarty International Center Telephone:301-496-1653 Email: Christine.Jessup@nih.gov

Notice Change Receipt Dates BRAIN Initiative: Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) Notice Number: NOT-EB-18-005 Key Dates Release Date: February 07, 2018 Related Announcements RFA-EB-17-005 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to change Application Due Dates BRAIN Initiative:  Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) RFA-EB-17-005) Currently reads: Application Due Date(s): December 15, 2017; October 17, 2018; October 17, 2019 Revised read: Application Due Dates(s): December 15, 2017; September 4, 2018; September 3, 2019 Currently reads: Scientific Merit Review: 2018, March 2019, March 2020 Revised read: Scientific Merit Review: 2018, February 2019, February 2020 Currently reads: Advisory Council Review: August 2018, August 2019, August 2020 Revised read: Advisory Council Review: August 2018, 2019, 2020 Inquiries Please direct inquiries to: Grace C.Y. Peng, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: BRAINTheoriesFOA@mail.nih.gov

Request Information RFI): Future Directions Research Fragile X Syndrome FMR1-Related Conditions Notice Number: NOT-HD-17-033 Key Dates Release Date: January 29, 2018   Related Announcements NOT-HD-20-009 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose Notice a time-sensitive Request Information RFI) part a trans-NIH effort update NIH Research Plan Fragile X Syndrome FMR1-related conditions. Background Fragile X syndrome FXS), results mutations the FMR1 gene the X-chromosome, the most commonly inherited form intellectual developmental disability. NIH supports conducts research the causes, mechanisms, diagnosis, treatment management Fragile X Syndrome FMR1-related conditions: Fragile X-Associated Tremor/Ataxia Syndrome FXTAS), Fragile X-Associated Primary Ovarian Insufficiency FXPOI) other conditions associated mutations the FMR1 gene. NIH also supports conducts research concomitant symptoms/conditions seen individuals these conditions.   input experts the field, NIH issued Research Plan Fragile X Syndrome Associated Disorders 2009, outlined series specific research goals objectives. Goal areas this research plan included: Pathophysiology pathogenic mechanisms Risk factors condition onset progression Screening diagnosis Treatments therapeutic interventions Quality life issues Impact families Research infrastructure detail goals specific FMR1-related conditions, well objectives within goal, be found the full report: https://www.nichd.nih.gov/publications/pages/pubs_details.aspx?from=&pu… Information Requested Request Information RFI) invites researchers academia industry, health care professionals, patient advocates, representatives health advocacy organizations, members scientific professional organizations, other interested members the public provide comments suggestions. welcome input includes, is limited to, following topics: Gaps/Challenges: Describe most critical existing gaps basic, translational, and/or clinical research Fragile X syndrome FMR1-related conditions.  are seeking input the conceptual, practical, technical challenges currently impeding progress these research areas, potential solutions these challenges.  Comments might include gaps are most practical pursue, and/or high-risk approaches could give highest potential short-term long-term payoffs.  also welcome feedback regarding specific challenges forming maintaining effective partnerships facilitate research progress.  Comments also address approaches have less fruitful should perhaps lower priorities future efforts. Priorities/New Directions: Describe most important priority areas new directions field should pursue over next 5-10 years make meaningful advances understanding treating FXS FMR1-related conditions. are soliciting input regarding areas most important patients, families, clinicians, researchers, and/or funding agencies. also welcome suggestions metrics/benchmarks be used measuring progress these priority areas, well identification new resources tools could a potentially transformative impact research clinical care. are also interested suggestions specific new partnerships collaborations respondents feel likely accelerate progress these areas. Significant Advances: Identify most significant recent scientific clinical advances related Fragile X syndrome FMR1-related conditions. may include advances address goals objectives the 2009 plan, well new perspectives captured the 2009 plan. to Submit Response ensure consideration, responses should submitted email fragilexplan@mail.nih.gov later Friday, March 2, 2018. Responses this RFI voluntary. Proprietary, classified, confidential, sensitive information should be included your response. will an electronic confirmation acknowledging receipt your response, may receive individual feedback. NICHD use information submitted response this RFI its discretion will provide comments any responder's submission. Government reserves right use any non-proprietary technical information any resultant solicitation(s). RFI for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. Inquiries Please direct inquiries to: Tracy King, MD, MPH Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-402-1822 Email: fragilexplan@mail.nih.gov issues specifically related this Request Information) Email: tracy.king@nih.gov other questions/information)