Find Funding Opportunities

Notice Intent Publish Funding Opportunity Announcement Analytical Clinical Validation Biomarkers, Biomarker Signatures, Endpoints Pain Indications R61/R33) Notice Number:NOT-NS-18-074 Key Dates Release Date: July 23, 2018 Estimated Publication Date Funding Opportunity Announcement: 09/12/2018 First Estimated Application Due Date: 11/14/2018 Earliest Estimated Award Date: 06/01/2019 Earliest Estimated Start Date: 07/01/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS, other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) solicit applications research the analytical clinical validation biomarkers, biomarker signatures, endpoints pain indications. goal this FOA be support analytical clinical validation candidate biomarkers use the discovery development non-opiate alternatives the treatment pain conditions using retrospective and/or prospective methods. FOA assumes that: 1) candidate biomarker already identified, 2) assay technology already developed, 3) working hypothesis regarding context use in place. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published September 2018 an expected application due date November 2018. FOA utilize bi-phasic, milestone driven R61/R33 mechanism. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights biomarkers endpoints specific pain indications begin consider applying this new FOA. FOA support rigorous analytical clinical validation promising candidate biomarkers pain indications provide tools necessary the development non-opiate therapeutics the treatment pain conditions. biomarker a defined characteristic is measured an indicator normal biological processes, pathogenic processes responses an exposure intervention, including therapeutic interventions.  Biomarker modalities diverse, can include genetic, protein, cellular, metabolomic, imaging physiologic endpoints. endpoint an outcome event used objectively measure effect a therapeutic other intervention being studied.  precise definition an endpoint typically specifies type assessments made, timing those assessments, assessment tools used, possibly details, applicable, such how multiple assessments within individual to combined. scope this FOA does include discovery, will supported through another funding opportunity announcement supporting Discovery Biomarkers, Biomarker Signatures, Endpoints Pain Indications, will published shortly.   Rather, FOA supports Validation Phase biomarker endpoint development, where analytical validation the assay detection technology completed, along increasingly rigorous clinical validation. degree evidence required provide necessary confidence biomarker endpoint validation depends upon context use the biomarker endpoint. the context use moves research accepted utility clinical practice i.e., a diagnostic predictor therapeutic response), required degree validation evidence increased must include prospective, multi-site validation data. Multidisciplinary collaboration among scientific investigators, assay developers, clinicians, bioinformatics statistical experts, consultants, clinical laboratory staff must an integral part the application, investigators such expertise should also begin considering applying this FOA. Projects proposed this FOA also utilize multi-site design applicable, standardized data stewardship ensure data reusable accessible. Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD. National Institute Neurological Disorders Stroke 301-451-4551 mary.pelleymounter@nih.gov

Soliciting Feedback the BRAIN Initiative Notice Number: NOT-NS-18-075 Key Dates Release Date: July 23, 2018 Response Date: November 15, 2018 Related Announcements NOT-NS-19-041 Issued National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) 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 Request Information RFI) to solicit input how best accomplish ambitious vision the Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® set forth BRAIN 2025: Scientific Vision. NIH soliciting input all interested stakeholders, including members the scientific community, trainees, academic institutions, private sector, health professionals, professional societies, advocacy groups, patient communities, well other interested members the public. Background BRAIN Initiative aims develop new tools technologies understand manipulate networks cells the brain. BRAIN 2025: Scientific Vision serves the strategic plan the BRAIN Initiative NIH outlines overarching vision, seven high level scientific priorities, many specific goals. Designed be achieved over least decade, first five years BRAIN 2025 emphasizes development tools technology, the next five years shifts emphasis using tools make fundamental discoveries how brain circuits work what goes wrong disease. BRAIN Initiative well underway see  http://www.braininitiative.nih.gov ), we now approaching midpoint. this time, NIH seeking feedback the BRAIN Initiative's progress on opportunities moving forward given current state the science. NIH established new BRAIN Initiative Advisory Committee the NIH Director ACD) Working Group will provide scientific guidance the ACD how best continue accelerate ambitious vision the BRAIN Initiative. ACD-WG use responses this RFI, along information gathered through series public workshops, help inform discussions the BRAIN Initiative's progress potential updates the plan moving forward. Information Requested Please submit: Ideas new tools technologies have potential transform brain circuit research. Suggestions fundamental questions brain circuit function humans animal models could addressed new technologies. Considerations data sharing infrastructure policies. Areas topics research the ethical implications BRAIN Initiative-supported emerging neurotechnologies advancements their applications. Approaches disseminating new tools technologies well training broader neuroscience research community. Any topic relevant the strategic plan the BRAIN Initiative. to Submit Response assure consideration, responses must received November 15, 2018. Responses this RFI must submitted electronically using web-based form https://www.braininitiative.nih.gov/rfi.aspx via email BRAINFeedback@nih.gov  BRAIN RFI" the subject line. Responses this RFI voluntary. Any personal identifiers be removed responses compiled.  Individual feedback not provided any responder. Proprietary, classified, confidential, sensitive information should be included your response. This Request Information 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. Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Email: BRAINFeedback@nih.gov

Notice Change Requirements Interest Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Applications Directed Enhanced Pain Management Improved Treatments Opioid Misuse Addiction Notice Number: NOT-NS-18-076 Key Dates Release Date: July 23, 2018 Related Announcements PA-18-573 PA-18-574 PA-18-575 PA-18-576 PAR-18-617 PAR-18-618 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) Purpose purpose this Notice to inform potential SBIR STTR applicants areas special interest related the NIH Helping End Addiction Long-term HEAL) Initiative, effort speed scientific solutions stem national opioid public health crisis. National Institute Neurological Disorders Stroke NINDS) interested receiving applications directed improving pain treatment, including development new non-addictive medications devices objective pain measurement. addition, NINDS interested new screening tools models focused specifically pain development pain therapies. National Institute Drug Abuse NIDA) specifically interested receiving applications develop new approaches the prevention treatment opioid misuse, overdose addiction will help people opioid disorder OUD) achieve maintain meaningful sustained recovery. Notice also informs small business community a new requirement matching funds awarding grants through HEAL Initiative to for-profit applicant organizations. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Notice details matching/in-kind contribution requirement the HEAL Initiative how applies for-profit organizations apply to PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618, amends following sections of PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618 listed below. Part 2, Section I, Funding Opportunity Description Additional language: NIH Helping End Addiction Long-term HEAL) Initiative: The HEAL Initiative an NIH wide effort speed scientific solutions stem national opioid public health crisis. NIH interested receiving research related opioid addition, development opioid alternatives, pain management addiction treatment. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded through HEAL Initiative under PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618 must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Part 2, Section III, Cost Sharing Current language: FOA does require cost sharing defined the NIH Grants Policy Statement. Revised language: grantees a for-profit organization, FOA does require cost sharing research through HEAL Initiative related opioid addition, development opioid alternatives, pain management addiction treatment defined the NIH Grants Policy Statement.  information cost matching requirements in Section IV.2 R&R Modular Budget.  Part 2, Section IV, R&R Budget Current language: instructions the SF424 R&R) Application Guide must followed. Revised language: instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants funded through HEAL Initiative: Cost matching documented in-kind contributions required for-profit organizations funded through HEAL Initiative research related opioid addition, development opioid alternatives, pain management addiction treatment.  for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018.    Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement.  45 CFR 75.306 additional details. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred.  costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Part 2, Section IV, Letters Support Additional language: Letters Support: HEAL Initiative For-profit applicants research related opioid addition, development opioid alternatives, pain management addiction treatment seeking funding through HEAL Initiative must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.  Part 2, Section V, Budget Period Support Budget Period Support Additional language: Specific this FOA: research related opioid addition, development opioid alternatives, pain management addiction treatment seeking funding through HEAL Initiative: likely it the plans cost matching be adequate? Part 2, Section VI, Award Administration Information, Award Notices Additional language: Special award condition specific this FOA: grantee a for-profit organization funded through HEAL Initiative research related opioid addiction, development opioid alternatives, pain management addiction treatment under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.  45 CFR 75.306 additional details.   Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR. Part 2, Section VI, Reporting Current language: NIH requires SBIR/STTR grantees submit following reports within 90 days the end the grant budget period unless grantee under extension. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. Final RPPR (requirements recently changed - please the NOT-OD-17-085 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-085.html) Final Invention Statement Certification HHS 568) Annual Invention Utilization Reports Federal Financial Report FFR) – replaced Final Cash Transaction Report PSC 272) Phase II Data Collection Requirement Government Tech-Net Database Revised language: NIH requires SBIR/STTR grantees submit following reports within 90 days the end the grant budget period unless grantee under extension. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. Final RPPR (requirements recently changed - please the NOT-OD-17-085 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-085.html) Final Invention Statement Certification HHS 568) Annual Invention Utilization Reports Federal Financial Report FFR) (including Federal non-Federal share cost matching applicable) – replaced Final Cash Transaction Report PSC 272) Phase II Data Collection Requirement Government Tech-Net Database other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email: fertigs@ninds.nih.gov Elena Koustova, PhD, MBA National Institute Drug Abuse NIDA) Telephone: 301-496-8768  Email: koustovae@mail.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 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 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-18-012 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-18-021 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

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