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Notice Change Instructions NOT-OD-18-194 Notice Availability Administrative Supplements NIH Grants are Focused Down Syndrome Address Specific Down Syndrome Research Objectives Notice Number: NOT-OD-18-204 Key Dates Release Date: July 11, 2018 Related Announcements NOT-OD-18-194 PA-18-591 NOT-OD-18-195 : companion notice applications are currently focused Down syndrome Issued National Institutes Health NIH) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) 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 Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to update Award Project Period NOT-OD-18-194, quot;Notice Availability Administrative Supplements NIH Grants are Focused Down Syndrome Address Specific Down Syndrome Research Objectives." updated language clear confusion regarding eligibility grants a cost extension allowing those their first year a cost extension apply. addition, additional requirement been added the review criteria under quot;Review Process" being able complete work within approved project period the existing parent award.   Currently reads: Award Project Period quot;To eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) not in extension period. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018." Modified read: Award Project Period quot;To eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) be the first year a cost extension the time receipt the supplement request. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018." Currently reads: Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work relevant Down syndrome even though parent award not focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? Modified read: Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work relevant Down syndrome even though parent award not focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? 7. the work completed within approved project period the existing parent award? other aspects this Notice remain unchanged. Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Melissa A. Parisi, MD, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6880 Email: parisima@mail.nih.gov Anna E. Mazzucco, PhD National Institutes Health NIH) Telephone: 301-451-1220 Email: anna.mazzucco@nih.gov Malcolm A. Smith, MD, PhD National Cancer Institute NCI) Telephone: 240-276-6087 Email: Malcolm.Smith@nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-402-3793 Email: SchrammC@nhlbi.nih.gov Joy T. Boyer, BA National Human Genome Research Institute NHGRI) Telephone: 301-480-2247 Email: jb40m@nih.gov Laurie M. Ryan, PhD National Institute Aging NIA) Telephone: 301-496-9350 Email: ryanl@mail.nih.gov Frosso Voulgaropoulou, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3205 Email: fvoulgaropoulou@niaid.nih.gov Lana Shekim, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 Email: shekiml@nidcd.nih.gov Jason Wan, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-9898 Email: JasonWan@nidcr.nih.gov Ellen Leschek, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK ) Telephone: 301-402-8291 Email: LeschekE@EXTRA.NIDDK.NIH.GOV Jonathan A. Hollander, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email: jonathan.hollander@nih.gov Donna Krasnewich, MD, PhD National Institute General Medical Sciences NIGMS) Telephone: 301-594-0943 Email: dkras@nigms.nih.gov Lisa Gilotty, PhD National Institute Mental Health NIMH) Telephone: 301-443-3825 Email: gilottyl@mail.nih.gov Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov Rebekah S. Rasooly, PhD National Institute Nursing Research NINR) Telephone: 301-827-2599 Email: rr185i@nih.gov Nathan Stinson, Jr., PhD, MD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8704 Email: stinsonn@mail.nih.gov Robin Elizabeth Boineau, MD National Center Complementary Integrative Health NCCIH) Telephone: 301-435-6286 Email: Robin.Boineau@nih.gov nbsp;  Erica K. Rosemond, PhD National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email: Erica.Rosemond@nih.gov

Notice Change Instructions NOT-OD-18-195 Notice Availability Administrative Supplements NIH Grants Focused Down Syndrome Address Specific Down Syndrome Research Objectives" Notice Number: NOT-OD-18-203 Key Dates Release Date: July 11, 2018 Related Announcements NOT-OD-18-195 PA-18-591 NOT-OD-18-194: companion notice applications are currently focused Down syndrome Issued National Institutes Health NIH) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) 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 Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to update Award Project Period NOT-OD-18-195, quot;Notice Availability Administrative Supplements NIH Grants Focused Down Syndrome Address Specific Down Syndrome Research Objectives." updated language clear confusion regarding eligibility grants a cost extension allowing those their first year a cost extension apply. addition, additional requirement been added the review criteria under quot;Review Process" being able complete work within approved project period the existing parent award.   Currently reads: Award Project Period quot;To eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) not in extension period. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018." Modified read: Award Project Period quot;To eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) be the first year a cost extension the time receipt the supplement request. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018." Currently reads: Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work proposed the parent award focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? Modified read: Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work proposed the parent award focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? 7. the work completed within approved project period the existing parent award? other aspects this Notice remain unchanged. Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Melissa A. Parisi, MD, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6880 Email: parisima@mail.nih.gov Anna E. Mazzucco, PhD National Institutes Health NIH) Telephone: 301-451-1220 Email: anna.mazzucco@nih.gov Malcolm A. Smith, MD, PhD National Cancer Institute NCI) Telephone: 240-276-6087 Email: Malcolm.Smith@nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-402-3793 Email: SchrammC@nhlbi.nih.gov Joy T. Boyer, BA National Human Genome Research Institute NHGRI) Telephone: 301-480-2247 Email: jb40m@nih.gov Laurie M. Ryan, PhD National Institute Aging NIA) Telephone: 301-496-9350 Email: ryanl@mail.nih.gov Frosso Voulgaropoulou, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3205 Email: fvoulgaropoulou@niaid.nih.gov Lana Shekim, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 Email: shekiml@nidcd.nih.gov Jason Wan, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-9898 Email: JasonWan@nidcr.nih.gov Ellen Leschek, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK ) Telephone: 301-402-8291 Email: LeschekE@EXTRA.NIDDK.NIH.GOV Jonathan A. Hollander, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email: jonathan.hollander@nih.gov Donna Krasnewich, MD, PhD National Institute General Medical Sciences NIGMS) Telephone: 301-594-0943 Email: dkras@nigms.nih.gov Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov National Institute Nursing Research NINR) Rebekah S. Rasooly, PhD Telephone: 301-827-2599 Email: rr185i@nih.gov Nathan Stinson, Jr., PhD, MD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8704 Email: stinsonn@mail.nih.gov nbsp;  Erica K. Rosemond, PhD National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email: Erica.Rosemond@nih.gov

Notice Extend Expiration Date PAR-15-349 Health Disparities Alzheimer's Disease R01)" Notice Number: NOT-AG-18-016 Key Dates Release Date: June 26, 2018 Related Announcements PAR-15-349 Issued National Institute Aging NIA) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-15-349 quot;Health Disparities Alzheimer's Disease R01)" be extended one receipt cycle. FOA expires January 8, 2019. FOA been modified follows: Key Dates Currently reads: Expiration Date                      September 8, 2018 Modified read: Expiration Date                      January 8, 2019 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Cerise L. Elliott, Ph.D. National Institute Aging NIA) Telephone: 301-496-9350 Email:  elliottce@mail.nih.gov

Notice Clarification Submission Materials Related Communications the FDA RFA-NS-18-011 Translational Neural Devices UG3/UH3 Clinical Trial Required)" Notice Number: NOT-NS-18-063 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-011 Translational Neural Devices UG3/UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" Notice Number: NOT-NS-18-066 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-012 Translational Neural Devices U44 Clinical Trial Required)" Notice Number: NOT-NS-18-064 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-012 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-012 Translational Neural Devices U44 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the awa other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System" Notice Number: NOT-NS-18-067 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-023 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same.   Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3)" Notice Number: NOT-NS-18-065 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-021 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-021 BRAIN Initiative:  Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Request Information RFI): Evaluation the NIH Senator Paul D. Wellstone Muscular Dystrophy Research Centers Program Notice Number: NOT-AR-18-021 Key Dates Release Date: June 21, 2018 Related Announcements None Issued National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Heart, Lung, Blood Institute NHLBI) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose NIH assessing the Senator Paul D. Wellstone Muscular Dystrophy Research Centers Program (“Wellstone Centers”). over 15 years, Wellstone Centers program served a flagship program muscular dystrophy research the NIH. evaluation provide insights how Wellstone program be enhanced. part the process, NIH seeking written input through Request Information RFI) the muscular dystrophy research, healthcare, patient communities, well any interested parties. Background Wellstone Centers promote communication collaboration, develop share research resources, help train new researchers aspects muscular dystrophy. center conduct mixture basic research understand diseases, translational research turn basic research findings interventions patients, clinical studies understand the diseases affect patients to test interventions. Wellstone Centers program funded the National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), the Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), the National Institute Neurological Disorders Stroke NINDS), additional support the National Heart, Lung, Blood Institute NHLBI).  Information Requested NIH invites interested people have muscular dystrophy, health care providers, researchers, individuals organizations address following topics: Wellstone Centers program’s key accomplishments. Wellstone Centers greatest challenges. Research training resources shared the Wellstone Centers.  you utilized Wellstone Center resources, please share you became aware these resources your experience obtaining using them. Involvement research participants, families, health care providers, other muscular dystrophy community members Wellstone Center activities. most compelling research needs the muscular dystrophy field the Centers’ potential role addressing them. Additional opportunities advancing research muscular dystrophy within Wellstone Centers. to Submit Response may respond this RFI by entering input at https://wellstonemdcenters.nih.gov/niams-centers-programs-evaluation or writing to: WellstoneEval@mail.nih.gov. Responses be considered submitted later than August 10, 2018. Responses this RFI voluntary, will help inform NIH how strengthen improve Wellstone Centers program the future. Any personal identifiers e.g., names, addresses, email addresses, etc.) be removed responses compiled. Only de-identified comments be used. Proprietary, classified, confidential, sensitive information should be included your response. Federal Government reserves right use any non-proprietary technical information any resultant solicitation(s), summaries, other materials. RFI for information planning purposes only should be construed a policy, solicitation applications, an obligation the part the U.S. Government provide support any ideas identified response it. NIH not any awards based responses this RFI otherwise pay the preparation any information submitted for Government’s of information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. NIH looks forward your input we hope you share RFI your colleagues. Inquiries Please direct inquiries to: Jonelle K. Drugan, Ph.D., M.P.H. Wellstone Evaluation Working Group National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-496-8271 WellstoneEval@mail.nih.gov

Notice Availability Administrative Supplements NIH Grants are Focused Down Syndrome Address Specific Down Syndrome Research Objectives Notice Number: NOT-OD-18-194 Key Dates Release Date: June 20, 2018 Related Announcements NOT-OD-18-203 NOT-OD-18-204 PA-18-591 NOT-OD-18-195 Issued National Institutes Health NIH) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) 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 Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to solicit administrative supplement applications existing awards are currently focused Down syndrome research order accelerate scientific progress meet new NIH Down syndrome research objectives, described below. Please NOT-OD-18-195 a companion notice applications are currently focused Down syndrome. Down syndrome the most common genetic cause intellectual disability, most common autosomal trisomy, one the most visible universally recognized genetic syndromes. year are approximately 5300 babies born the United States Down syndrome. Within past 25 years, average lifespan a person Down syndrome doubled, 30 60 years. While people Down syndrome connected the common feature a complete partial copy chromosome 21 trisomy 21), are significant physical cognitive differences among them, indicating inter-individual variability exists. notice initiates new trans-NIH program support research commonly co-occurring conditions individuals Down syndrome are also seen the general population, such Alzheimer’s disease/dementia, autism, cataracts, celiac disease, congenital heart disease, immune system dysregulation, diabetes. is known the INCLUDE Project INvestigation Co-occurring conditions across Lifespan Understand Down syndromE). Information learned studying people Down syndrome also help us learn these conditions people without Down syndrome. Likewise, common complications aging, such coronary heart disease solid cancers, rarely seen individuals Down syndrome; warrants additional study. new research initiative expands of research objectives opportunities previously highlighted the 2014 Down Syndrome Directions: NIH Research Plan Down Syndrome. recent discoveries enhanced our understanding chromosome segregation chromosome silencing, identified certain proteins neurotropic factors involved brain development using mouse models, uncovered role interferons immune dysregulation, of have potential lead development novel therapies individuals Down syndrome, well broader applications. People Down syndrome often excluded clinical research, such trials potentially beneficial drugs therapeutics are used treat same condition the general population. is great value connecting people Down syndrome therapies could improve overall health quality life. there great interest the Down syndrome community participating clinical research, based experience NICHD’s DS-Connect®: Down Syndrome Registry,” https://DSConnect.nih.gov ), online survey tool introduces individuals Down syndrome their families research opportunities. Opportunities engage Down syndrome community research also facilitated the members the Down Syndrome Consortium, public-private partnership involving NIH Institutes Centers, advocacy groups, private foundations professional organizations, self-advocates families, sharing passion promoting research will benefit people Down syndrome. comprehensive clinical cohort study deep phenotyping exploration pan-‘omics permit identification biomarkers outcomes the co-occurring conditions Down syndrome. Coupled development a clinical trials readiness program, informed basic science discoveries, combination resources have great impact addressing health disparities exist people Down syndrome could also lead the development therapies improve outcomes those and without condition. Supplement applications be considered eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome: basic science studies, supplements should target areas science highest impact that likely translate new therapeutic approaches Down syndrome, even the parent award not focused Down syndrome. Topics emphasis include: chromosome silencing, immune system dysregulation, epigenetic/metabolomic/transcriptomic profiling model organisms/iPSCs/brain organoids, development novel model systems, development a molecular atlas cardiac other specimens. Supplements also support projects will inform other components, namely cohort study a clinical trials network. Component 2: Molecular snapshot Down syndrome through cohort study: goal to add Down syndrome cohort an existing cohort focused a condition commonly co-occurs Down syndrome, data collected a shared database using common data elements building the DS-Connect® patient registry. Supplements add comprehensive molecular i.e. pan-‘omics) analyses support existing infrastructure sample neuroimaging collection the Down syndrome population. Component 3: Inclusive clinical research individuals Down syndrome: Supplement requests leverage existing clinical trials infrastructure add new Down syndrome cohort an existing trial, start building Down syndrome-specific modules a future study, to test drugs therapies co-occurring conditions the Down syndrome population. particular interest ongoing clinical trials testing therapies common conditions such asthma sleep apnea occur people and without Down syndrome. encourage projects that: within scope the active parent award not currently focused Down syndrome could add Down syndrome cohort, module, model system great relevance Down syndrome Propose address of components listed under Down syndrome research objectives likely stimulate additional activity leading progress Down syndrome Address priority the IC issued parent award applicable--see below) Investigators should submit applications responses the parent active administrative supplement PA, Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html Supplements existing clinical trials allowed, addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing components 2 3 should encourage participants Down syndrome their caregivers register DS-Connect®: Down Syndrome Registry https://DSConnect.nih.gov). the parent award focused Down syndrome, NOT-OD-18-195 Before submitting supplement request, principal investigators strongly encouraged contact program officer the program contact the Institute, Center Office supporting parent award discuss whether proposed supplement within scope the INCLUDE Project the priorities the IC supporting parent award with any questions. Award Project Period be eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) not in extension period. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018. Budget Supplement budget requests cannot exceed 500,000 direct costs exclusive Facilities Administrative costs sub-contracts, 50% the direct costs the current parent award, whichever less. Requests must reflect actual needs the proposed project. Requests be one year support only. Modular categorical budgets permitted. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Submitting Application additional information, the parent program announcement Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591. part the application investigators should submit no than one-page abstract the proposed research shows relevance the INCLUDE project articulates component(s) any IC-specific priorities the supplement addressing. Applicants should begin supplement application abstract stating: application being submitted PA-18-591 accordance NOT-OD-18-194." Page Limits: NIH consider supplements a Research Strategy no than 6 pages, addition the abstract. Supplements should submitted electronically allowed parent mechanism. addition, applicants strongly encouraged notify program contact the institute is supporting parent award list below) an application been submitted response this FOA order facilitate efficient processing the request. Requests must received 5:00 PM Pacific Daylight Time P.D.T.) July 23, 2018 funding FY 2018. Institute, Center IC) Office-specific Instructions National Cancer Institute NCI): NCI priorities include following: Evaluation the genetic, epigenetic, epidemiologic factors associated trisomy 21 lead greatly increased risk childhood leukemias that lead the distinctive biological clinical behavior these leukemias. Evaluation the genetic, epigenetic, epidemiologic factors associated trisomy 21 lead reduced risk selected childhood adult solid tumors. Characterization the biological clinical factors drive development transient abnormal myelopoiesis TAM) its progression acute myeloid leukemia AML) children trisomy 21. Mining and/or generation omics datasets clinically annotated specimens Down syndrome acute lymphoblastic leukemia ALL) AML. Translational research associated completed/ongoing clinical trials identify prognostic factors e.g., minimal residual disease) can used reliably guide treatment children leukemia associated Down syndrome. National Eye Institute NEI): NEI interested supplementing existing grants have potential further understanding ocular pathologies frequently seen Down syndrome manifestations include, are limited to, cataract, amblyopia, strabismus refractive errors). Applications examining regulation dysregulation eye development Down syndrome also encouraged. Interested applicants advised contact NEI program officer prior submitting supplement application. National Heart, Lung, Blood Institute NHLBI): NHLBI priorities include following: Incorporation individuals Down syndrome existing disease cohorts clinical trials directed toward sleep apnea, congenital heart disease, pediatric pulmonary hypertension, adult cardiovascular disease. This include collection tissue blood specimens omics data generation analysis genomics, transcriptomics, metabolomics, etc.), imaging, computational modeling, expansion a clinical trial include number Down syndrome cases necessary provide sufficient statistical power stratification.  Studies encouraged leverage DS-Connect registry identify potential participants. Mining and/or generation omics datasets heart, lung, blood, sleep disorders functions genes chromosome 21 downstream genes chromosome 21. Characterization animal models the morphological events occurring early heart development give rise the specific forms congenital heart disease are primary cause death during first year life infants born Down syndrome. Characterization differentiation disease-related tissue types induced pluripotent stem cells derived cells individuals Down syndrome compared euploid iPSC cells. Identification potential risk resilience factors make individuals Down syndrome susceptible transient persistent blood disorders congenital heart disease protected adult cardiovascular disease. National Human Genome Research Institute NHGRI): NHGRI interested the following: Ethical, legal social implications ELSI) related preimplantation prenatal screening testing trisomy 21. Research how Down syndrome understood individuals, families, specific subgroups within society. National Institute Aging NIA): NIA interested the following: Epidemiologic, genomic, mechanistic research studies aiming understand molecular mechanism underlying interplay between aging neurodegeneration Down syndrome. Mechanisms resilience Down syndrome individuals remain free dementia the face Alzheimer's pathology. Understanding aspects brain aging individuals Down syndrome. Identification sensitive neuropsychological measures cognitive decline, imaging, blood-based, genetic biomarkers associated transition normal aging mild cognitive impairment clinical dementia adults Down syndrome. particular interest studies will generate make available high quality omics data can used downstream systems biology other predictive modeling efforts. National Institute Allergy Infectious Diseases NIAID): Addition research focused immune system dysregulation Down syndrome; molecular basis, impact health, including infections autoimmunity, intervention strategies. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): NICHD priorities include: Basic science studies focused chromosome silencing; white matter brain development; gene therapy prenatal therapy animal models can include component significant relevance Down syndrome; studies rodent models understand cognition, behavior, other aspects the phenotype across different stages development; development novel tools understanding basic biology Down syndrome, such well-characterized induced pluripotent cell lines, cell tissue repositories, new murine other rodent models can better replicate chromosome regions syntenic human chromosome 21 well reproduce complex neurobehavioral other phenotypic features Down syndrome, mechanisms link current model organism databases resources. Supplements will increase pool individuals Down syndrome cohort studies, deep phenotyping, biospecimen collection, omics studies, ultimately, clinical trials, such through enhancements recruitment, phenotyping services, biobanks supplements perform pan-'omics approaches readily available cohorts; supplements will recruit individuals IDeA states limited NIH funding ensure representation rural underserved areas; approaches capture priorities parents individuals Down syndrome; supplements facilitate linkages between pan-'omics data sets, patient-reported outcomes, electronic medical records, DS-Connect® facilitate data sharing, data mining, secondary uses; development validation sensitive, robust, reproducible outcome measures complex phenotypes such cognition behavior using tools such the NIH ToolBox; studies expand extend available biomarkers studies regression, aging, dementia adolescents adults Down syndrome; studies risk resilience co-occurring conditions Down syndrome. Studies add Down syndrome component an existing pharmacologic clinical trial a condition common Down syndrome for dosage efficacy not established this population; supplements existing clinical trial networks establish infrastructure necessary clinical trials those Down syndrome, including efforts link existing datasets add participants DS-Connect®; studies develop new therapeutics interventions people Down syndrome; supplements explore ethical, legal, social implications research populations reduced decisional capacity optimal methods obtaining informed consent those Down syndrome. National Institute Deafness Other Communication Disorders NIDCD): NIDCD priorities include: Better understanding the natural history communication disorders hearing, balance/vestibular, voice, speech, language, taste smell) throughout lifespan Down syndrome. Early identification clinical management communication disorders throughout lifespan individuals Down syndrome. National Institute Dental Craniofacial Research NIDCR): Oral health problems experienced individuals Down syndrome: malocclusion, increased caries, periodontal diseases advanced pain. Evidence-based evaluation treatment approaches individuals Down syndrome: orthodontic treatment warranted? are best approaches the treatment sleep apnea individuals Down syndrome? National Institute Diabetes Digestive Kidney Diseases NIDDK): NIDDK interested research focused Down syndrome obesity, urologic conditions, type 1 diabetes, autoimmune thyroid disease, other autoimmune diseases within purview NIDDK.   National Institute Environmental Health Sciences NIEHS): PD/PI must propose project has focus environmental exposures within NIEHS mission.  Environmental agents are considered primary interest NIEHS include:  industrial chemicals manufacturing byproducts, metals, pesticides, herbicides, air pollutants other inhaled toxicants, particulates fibers, fungal, bacterial biologically derived toxins. Investigators propose studies a primary focus NIEHS mission-relevant exposures encouraged consider inclusion other relevant environmental exposures e.g., periconceptional smoking) order assess role(s) cofactors/modifiers the risk protection associated the primary exposure(s). Applications propose laboratory-based studies using only model compounds i.e., those without potential human exposure) must provide clear, reasonable specific description to research the model compound lead a better understanding the mechanisms involved responses specific environmental agents are included the mission responsibility the NIEHS.  NIEHS priorities include following: Characterization how environmental exposures linked cognitive/dementia phenotypic variations observed individuals Down syndrome. Incorporation animal models explore toxicity environmental agents impact oxidative stress pathways can exacerbate Down syndrome symptomology. Exploration the genetic susceptibility environmental exposures influencing progression, onset, and/or severity the complex clinical outcomes individuals Down syndrome. Epidemiologic mechanistic research studies aiming understand contribution environmental exposures subsequent co-morbidities and/or health factors individuals Down syndrome. National Institute General Medical Sciences NIGMS): the NIGMS MIRA Maximizing Investigators’ Research Award) program provides support an investigator's overall program research within Institute’s mission, MIRA awardees not eligible this supplement program. National Institute Mental Health NIMH): NIMH supports translational research examining neurodevelopmental underpinnings psychopathology, well the onset, developmental trajectories, outcomes mental health conditions across lifespan, including depression, anxiety, psychosis. Research a dimensional perspective supported identify fundamental components span multiple disorders, such attention, executive function affective regulation, may involve developing and/or validating biological markers, developing and/or validating methods measures assess domains psychopathology, testing integrative models within longitudinal frameworks track trajectories risk protection. interest supplements add specific Down syndrome cohorts develop validated measures psychopathology these individuals, to elucidate onset, course functional outcomes, including risk resilience, individuals Down syndrome have comorbid psychopathology. NIMH also supports studies investigating whether various mental disorders such schizophrenia, bipolar disorder, major depressive disorder, PTSD) increase risks developing dementia excessive cognitive decline, speed rate the biological aging process.  of studies follow aging adults prospectively, most include protocols neuroimaging changes brain structure and/or function, for assessing molecular, cellular, neuroinflammatory, other factors important the biological aging process.  interest supplements include persons Down syndrome, thereby contribute usefully an understanding how Down syndrome often leads early-onset, Alzheimer-type dementia to accelerated biological aging.  Finally, NIMH interest discovery specific genetic variants within chromosome 21 critical region have specific effects comorbid diseases mental health outcomes. National Institute Neurological Disorders Stroke NINDS): NINDS priorities include following: Addition a Down syndrome component a basic research study related cognitive decline Alzheimer's disease; Understanding role aberrant neurotrophin signaling the cognitive behavioral characteristics Down syndrome; Development characterization animal models developmental delays, cognitive, dysfunction cognitive decline Down syndrome; Determine role white matter individuals Down syndrome. National Institute Nursing Research NINR): NINR priorities research co-occurring conditions across lifespan individuals Down syndrome include health promotion, disease prevention, health disparities, caregiving, management symptoms, self-management, genetics, epigenetics, palliative care needs care the end life. Topics special interest include integration biological behavioral sciences, application new technologies research questions, improving quality effectiveness interventions. National Institute Minority Health Health Disparities NIMHD): NIMHD priorities include inclusion individuals Down syndrome NIH-designated health disparity populations Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual gender minorities) existing clinical community-based studies sufficient number conduct meaningful subgroup analysis. Topics particular interest related individuals Down syndrome health disparity populations include are limited the following: Intersectional stigma discrimination their impact health healthcare utilization Coping strategies, social support, other protective factors related chronic disease risk outcomes Access and quality healthcare, including primary, specialty, behavioral health care transition child adult healthcare other service systems National Center Complementary Integrative Health NCCIH): NCCIH priorities include following: Understand use mind body approaches improve cognitive function for managing Down syndrome-associated health conditions e.g., chronic pain, anxiety disorders, etc.) Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work relevant Down syndrome even though parent award not focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Melissa A. Parisi, MD, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6880 Email: parisima@mail.nih.gov Anna E. Mazzucco, PhD National Institutes Health NIH) Telephone: 301-451-1220 Email: anna.mazzucco@nih.gov Malcolm A. Smith, MD, PhD National Cancer Institute NCI) Telephone: 240-276-6087 Email: Malcolm.Smith@nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-402-3793 Email: SchrammC@nhlbi.nih.gov Joy T. Boyer, BA National Human Genome Research Institute NHGRI) Telephone: 301-480-2247 Email: jb40m@nih.gov Laurie M. Ryan, PhD National Institute Aging NIA) Telephone: 301-496-9350 Email: ryanl@mail.nih.gov Frosso Voulgaropoulou, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3205 Email: fvoulgaropoulou@niaid.nih.gov Lana Shekim, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 Email: shekiml@nidcd.nih.gov Jason Wan, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-9898 Email: JasonWan@nidcr.nih.gov Ellen Leschek, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK ) Telephone: 301-402-8291 Email: LeschekE@EXTRA.NIDDK.NIH.GOV Jonathan A. Hollander, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email: jonathan.hollander@nih.gov Donna Krasnewich, MD, PhD National Institute General Medical Sciences NIGMS) Telephone: 301-594-0943 Email: dkras@nigms.nih.gov Lisa Gilotty, PhD National Institute Mental Health NIMH) Telephone: 301-443-3825 Email: gilottyl@mail.nih.gov Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov National Institute Nursing Research NINR) Rebekah S. Rasooly, PhD Telephone: 301-827-2599 Email: rr185i@nih.gov Nathan Stinson, Jr., PhD, MD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8704 Email: stinsonn@mail.nih.gov Robin Elizabeth Boineau, MD National Center Complementary Integrative Health NCCIH) Telephone: 301-435-6286 Email: Robin.Boineau@nih.gov    Erica K. Rosemond, PhD National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email: Erica.Rosemond@nih.gov