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Request for Information: Research Plan on Rehabilitation

NOT
Tuesday, April 23, 2019
Saturday, January 1, 2022
NOT-HD-19-006

Funding Opportunity Purpose

Request Information: Research Plan Rehabilitation Notice Number: NOT-HD-19-006 Key Dates Release Date: April 23, 2019 Response Date: June 17, 2019 Related Announcements NOT-HD-15-032 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Deafness Other Communication Disorders NIDCD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Purpose The Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Center Medical Rehabilitation Research inviting comments suggestions guide revision the Research Plan Rehabilitation behalf the Trans NIH Medical Rehabilitation Coordinating Committee. Background 2016, National Institutes Health published Research Plan Rehabilitation outlined priorities the Institutes Centers advance rehabilitation science https://www.nichd.nih.gov/sites/default/files/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf). Since time, NIH promoted multiple initiatives, workshops, funding opportunities aimed advancing priorities within research plan. Moreover, National Center Medical Rehabilitation Research the Eunice Kennedy Shriver National Institute Child Health Human Development presented annual updates the changes the portfolio following publication the research plan the National Advisory Board Medical Rehabilitation Research https://www.nichd.nih.gov/about/advisory/nabmrr). Information Requested NIH Medical Rehabilitation Coordinating Committee beginning update the research plan, required the 21st Century Cures Act 42 USC 285g-4), is seeking guidance the community stakeholders involved this research. Specifically, NIH requests feedback the following: community’s perception progress towards achieving priorities specified the research plan, Potential priorities areas research consider the update the research plan, Current priorities should retained continued, Emerging areas science will impact research plan rehabilitation, Potential focus areas concentrated work medical rehabilitation research. feedback garnered this request information be reported the 2019 meeting the National Advisory Board Medical Rehabilitation Research will incorporated the update the Research Plan Rehabilitation is planned 2021. to Submit Response comments must submitted electronically Rehabilitation1@mail.nih.gov. Responses longer 300 words Microsoft or PDF format) must received 11:59:59 ET) the response date noted above. Please indicate RFI Reponse" the subject line the email. You receive electronic confirmation acknowledging receipt your response. Responses this RFI voluntary. not include any proprietary, classified, confidential, trade secret, sensitive information your response. responses be reviewed NIH staff, individual feedback not provided any responder. U.S. Government use information submitted response this RFI its discretion. U.S. Government reserves right use any submitted information public NIH websites, reports, summaries the state the science, any possible resultant solicitation(s), grant(s), cooperative agreement(s), in development future funding opportunity announcements. RFI for information planning purposes only shall be construed a solicitation, grant, cooperative agreement, as obligation the part the Federal Government, NIH, individual NIH Institutes Centers provide support any ideas identified response it. Government not pay the preparation any information submitted for U.S. Government’s of such information. basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. Inquiries Please direct inquiries to: Alison N. Cernich, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-496-0295 Email: Rehabilitation1@nih.gov

Notice of Change to Key Dates for RFA-NS-18-014 "BRAIN Initiative: Targeted BRAIN Circuits Planning Projects - TargetedBCPP (R34 Clinical Trial Not Allowed)"

NOT
Thursday, April 18, 2019
Saturday, January 1, 2022
NOT-NS-19-034

Funding Opportunity Purpose

Notice Change Key Dates RFA-NS-18-014 BRAIN Initiative: Targeted BRAIN Circuits Planning Projects - TargetedBCPP R34 Clinical Trial Allowed)" Notice Number: NOT-NS-19-034 Key Dates Release Date: April 18, 2019 Related Announcements RFA-NS-18-014 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) Office Behavioral Social Sciences Research OBSSR) Office Research Women’s Health ORWH) Purpose purpose this Notice to inform applicants a change the Key Dates RFA-NS-18-014 Targeted BRAIN Circuits Planning Projects - TargetedBCPP R34 Clinical Trial Allowed)". Three new receipt dates been added the FOA: November 6, 2019, July 1, 2020,and November 10, 2020. Additionally, Peer Review Contact changed Alexei Kondratyev, Ph.D. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) March 15, 2018; July 17, 2018; July 15, 2019 Scientific Merit Review June 2018; October 2018; October 2019 Advisory Council Review August 2018; January 2019; January 2020 Earliest Start Date September 2018; April 2019; April 2020 Expiration Date July 16, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) March 15, 2018; July 17, 2018; July 15, 2019; November 6, 2019; July 1, 2020; November 10, 2020 Scientific Merit Review June 2018; October 2018; October 2019; February 2020; October 2020; February 2021 Advisory Council Review August 2018; January 2019; January 2020; May 2020; January 2021; 2021 Earliest Start Date September 2018; April 2019; April 2020; June 2020; February 2021; June 2021 Expiration Date November 10, 2021 Currently Reads: Section II. Award Information Funds Available Anticipated Number Awards BRAIN Initiative partner componentsintend commit estimated total 2.5M fund 10 awards. Modified Read: Section II. Award Information Funds Available Anticipated Number Awards BRAIN Initiative partner componentsintend commit estimated total 2.5M fund 10 awards for FY21.   Currently Reads: Section VII. Agency Contact(s) Scientific/Research Contact(s) James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:BRAINCircuits@NIH.GOV Peer Review Contact(s) Nick Gaiano, PhD Center Scientific Review CSR) Telephone: 301-435-1033 Email:nick.gaiano@nih.gov Modified Read: Section VII. Agency Contact(s) Scientific/Research Contact(s) Karen K David, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:BRAINCircuits@NIH.GOV Peer Review Contact(s) Alexei Kondratyev, Ph.D. Center Scientific Review CSR) Telephone: 301-465-1785 Email: alexei.kondratyev@nih.gov other aspects this FOA remain same. Inquiries Please direct inquiries to: Karen K David, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: BRAINCircuits@nih.gov

Notice of Special Interest for Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp Clinical Trial Optional)

NOT
Wednesday, April 17, 2019
Saturday, January 1, 2022
NOT-OD-19-102

Funding Opportunity Purpose

Notice Special Interest Administrative Supplements Research Sexual Gender Minority SGM) Populations Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-19-102 Key Dates Release Date: April 17, 2019 First Available Due Date: 18, 2019 Expiration Date: 19, 2019 Related Announcements PA 18-591 Issued Sexual Gender Minority Research Office SGMRO) National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) 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) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Purpose Purpose mission the NIH to seek fundamental knowledge the nature behavior living systems, the application that knowledge enhance health, lengthen life, reduce illness disability. NIH committed supporting research will increase scientific understanding the health wellbeing various population subpopulation groups study effectiveness evidence-based health interventions services individuals within those groups. NIH places high priority research populations appear have distinctive health risk profiles have received insufficient attention investigators. Supplement provides administrative support expand existing research focus sexual gender minority SGM) populations, include are limited to) lesbian, gay, bisexual, transgender people, individuals difference disorders sex development, sometimes referred as intersex. Basic, social, behavioral, clinical, translational, health services research relevant the missions the sponsoring Institutes, Centers Offices be proposed. Potential applicants also encouraged review recent portfolio analyses NIH-funded SGM research found at https://dpcpsi.nih.gov/sgmro/reports) identify gaps research may relevant this Notice Special Interest. . Background Institute Medicine IOM), the National Academy Medicine) report issued March 2011 http://www.nationalacademies.org/hmd/Reports/2011/The-Health-of-Lesbian-Gay-Bisexual-and-Transgender-People.aspx) stated, reference SGM health, the existing body evidence sparse, that substantial research needed." situation improved, there still need further research a range health-related issues. NIH encourages potential applicants read IOM report, a number specific issues raised discussed therein; however, readers should note this IOM report addresses most, not all, the populations within NIH's SGM definition. Recent data national health surveys targeted studies suggest prevalence rates some health conditions significantly higher among SGM populations for general population. Sexual gender minority" an umbrella term encompasses lesbian, gay, two-spirit, bisexual, transgender populations well those whose sexual orientation, gender identity expressions, reproductive development varies traditional, societal, cultural, physiological norms. includes individuals disorders differences sex development DSD), sometimes known intersex. NIH uses term SGM these populations well for individuals within them. However, applicants study subpopulations, and/or adopt classification frameworks terminologies appropriate proposed research such understudied populations. Although has an increase SGM-focused health research recent years, remains need further research the health these populations. Specific Areas Research Interest Notice Special Interestcalls research will enrich scientific understanding how sexual orientation, gender identity, and/or being born DSD/Intersex conditions relate health health risks, perceptions expectations health, health behaviors, barriers access health-related services. Appropriate topics/studies these supplements include, are limited to, those listed below: Addition SGM individuals a study either originally excluded or not enrolled enough SGM participants make any meaningful comparisons between groups; studies need have sufficient power allow meaningful comparisons Expansion an ongoing SGM study focused one group add another; sample sizes need be powered allow meaningful comparisons Expansion questionnaires administered any setting where is relevant address issues sexual attraction, sexual behavior, sexual identity, gender identity, and/or gender expression Assessment reliability validity measures relevant sexual attraction, sexual behavior, sexual identity, gender identity, non-binary sex. Methodological innovations improve recruitment retention SGM individuals any research initiative Ethical, legal, social science research the implications genetic other research findings SGM populations. Scope Support Administrative supplements be used meet increased costs are within scope the approved award, that unforeseen the new renewal application grant progress report non-competing continuation support submitted. Applicants should propose research that, successful, contribute a greater understanding the health wellbeing sexual gender minority communities. Clinical Trials cannot proposed be added grants do include clinical trial since would constitute change scope. IC-Specific Considerations Applicants strongly encouraged discuss proposed supplement project the IC Program Official the approved award prior submission a supplement application order ensure the proposed activity fits the scientific priorities the IC is within scope the approved award. In addition contact the IC Program Official the approved award, applicants strongly encouraged include Scientific/Research Contact listed in Section VII. Agency Contacts in communications. Section VIII. Information award authorities regulations. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – 18, 2019, 5:00 PM local time applicant organization. expiration date May 19, 2019. funding consideration, applicants must include NOT-OD-19-102” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. budget cannot exceed 100,000 total costs. Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Della White, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-827-6358 whitede@mail.nih.gov Liz Perruccio, PhD National Cancer Institute NCI) Telephone: 240-276-6178 Email: liz.perruccio@nih.gov Tina Gatlin, PhD National Human Genome Research Institute NHGRI) Telephone: 301-402-2851 Email: gatlincl@mail.nih.gov Brad Newsome, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-8170 Email: brad.newsome@nih.gov Melissa Gerald, PhD National Institute Aging NIA) Telephone: 301-451-4503 Email: geraldmel@mail.nih.gov Robert Freeman, PhD National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-8820 Email: rfreeman@mail.nih.gov Phillip Renzullo, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3041 Email: prenzullo@mail.nih.gov Heiyoung Park, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-3507 Email: Heiyoung.Park@nih.gov Jeffrey Schulden, PhD National Institute Drug Abuse NIDA) Telephone: 301-402-1526 Email: schuldenj@nida.nih.gov Alberto Rivera-Rentas, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-402-6251 Email: riverara@nidcd.nih.gov Melissa Riddle, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-451-3888 Email: riddleme@nidcr.nih.gov Tamara Bavendam, M.D. National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-594-4733 Email: tamara.bavendam@nih.gov Thaddeus Schug, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3319 Email: schugt2@mail.nih.gov Tamara Lewis-Johnson, PhD National Institute Mental Health NIMH) Telephone: 301-594-7963 Email: tl247e@nih.gov Jennifer Alvidrez, PhD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-9567 Email: jennifer.alvidrez@nih.gov Rebecca Henry, PhD, BSN, RN National Institute Nursing Research NINR) Telephone: 301-594-5976 Email: rebecca.henry@nih.gov Victoria Cargill, PhD Office Research Women’s Health ORWH) Telephone: 301-402-1770 Email: CargillV@od.nih.gov ICs without listed contact please reach to Program Officer listed the NoA the parent award.  

Notice of Intent to Publish the Reissuance of "RFA-NS-19-025" "HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)"

NOT
Thursday, April 11, 2019
Saturday, January 1, 2022
NOT-NS-19-051

Funding Opportunity Purpose

Notice Intent Publish Reissuance RFA-NS-19-025" HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers U24 Clinical Trial Allowed)" Notice Number: NOT-NS-19-051 Key Dates Release Date:April 11, 2019 Estimated Publication Date Funding Opportunity Announcement: April 22, 2019 First Estimated Application Due Date: June 03, 2019 Earliest Estimated Award Date: November 01, 2019 Earliest Estimated Start Date: December 01, 2019 Related Announcements RFA-NS-19-025 Issued National Institutes Health NIH) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke intends re-issue Funding Opportunity Announcement FOA) solicit additional applications regional clinical centers associated clinical research sites the Early Phase Pain Investigation Clinical Network EPPIC-Net). EPPIC-Net be charged executing early phase trials high impact the treatment patients acute chronic pain. regional clinical centers ("hubs" their linked clinical research sites ("spokes") conduct clinical trials concert a network Clinical Coordinating Center CCC) a Data Coordinating Center DCC). Approximately ten regional clinical center Hubs anticipated be funded. purpose this notice to allow potential Hub applicants sufficient time develop meaningful plans collaborations their linked clinical center spokes support their application. EPPIC-Net part the NIH Helping End Addiction Long-Term HEAL) Initiative. EPPIC-Net enable exploratory clinical trials investigational drugs biologics, investigational devices, natural products, surgical procedures the treatment specific types pain. Thesetrials validate biomarkers, provide proof concept, otherwise contribute the justification proceeding not proceeding a futurePhase 3 trial e.g., informing go/no-go decisions). Interventions trials within EPPIC-Net be solicited the national international scientific community. Interventions e.g. investigational drugs, devices biologics) studied within EPPIC-Net be provided companies academic institutions. populations be studied include those well-defined pain conditions with high unmet needs, example chronic neuropathic, inflammatory nociceptive pain disorders adult pediatric populations. EPPIC-Net focus Phase 2 trials is anticipated be able run many five Phase 2 trials concurrently, addition biomarker validation studies. EPPIC-Net infrastructure also include repository HEAL initiative data samples facilitate future research discovery. TheEPPIC-Net Hubs work the EPPIC-Net CCC, DCC other hubs selected particular studies. Hub envisioned a regional medical center is center excellence encompassing medical expertise neurology, anesthesiology, rheumatology, obstetrics/gynecology, pediatrics, orthopedics, physical medicine, gastroenterology, and/or subspecialties providing care patients pain. Hub willenroll patients along its network 2-10 research spokes will additionally provide scientific leadership administrative oversight its multiple spokes. notice informs clinical centers excellence the forthcoming solicitation applications EPPIC-Net hubs. Research Initiative Details Hub must a flexible network Spokes. principal function the Spokes to provide access a sufficiently large patient population support trial enrollment. Spokes should selected increase access patients a particular pain disease pain syndrome, encompass patients underserved communities, and/or complement Hub providing access specific research clinical expertise. each clinical trial, Hub be expected assemble network 2-10 Spokes specifically tailored the needs that particular trial. Since requirements each clinical trial vary, identity configuration Spokes be unique each trial. Therefore, Hub should relationships a number potential Spokes the ability add Spokes appropriate the study. demonstrate ability attract Spokes, applicant requested identify, the time application, five Spokes committed participation at least clinical trial.Since five initial Spokes unlikely be able meet possible future clinical trial requirements, Hub need incorporate plan mechanism recruiting additional Spokes needed. 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) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time.  Inquiries Please direct inquiries to: Barbara I. Karp, M.D.National Institute Neurological Disorders Stroke NINDS)301-496-0150karpb@ninds.nih.gov

Notice of Change to Key Dates for RFA-EB-18-003 "HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)"

NOT
Wednesday, April 10, 2019
Saturday, January 1, 2022
NOT-NS-19-056

Funding Opportunity Purpose

Notice Change Key Dates RFA-EB-18-003 HEAL Initiative: Translational Development Devices Treat Pain U18 Clinical Trial Allowed)" Notice Number: NOT-NS-19-056 Key Dates Release Date: April 10, 2019 Related Announcements RFA-EB-18-003 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose purpose this notice to change Key Dates in RFA-EB-18-003 "HEAL Initiative: Translational Development Devices Treat Pain U18 Clinical Trial Allowed)". Specifically, additional receipt date has added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) March 22, 2019, June 20, 2019, October 22, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 22, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read:  Application Due Date(s) March 22, 2019, May 20, 2019 , June 20, 2019, October 22, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 22, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   Scientific Merit Review June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michael B. Wolfson National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email:Michael.Wolfson@nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice of Change to Key Dates for RFA-NS-19-016 "HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)"

NOT
Wednesday, April 10, 2019
Saturday, January 1, 2022
NOT-NS-19-053

Funding Opportunity Purpose

Notice Change Key Dates RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)" Notice Number: NOT-NS-19-053 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-016 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-016 "HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read: Application Due Date(s) January 9, 2019, March 22, 2019, May 20, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice of Change to Key Dates for RFA-NS-19-017 "HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)"

NOT
Wednesday, April 10, 2019
Saturday, January 1, 2022
NOT-NS-19-054

Funding Opportunity Purpose

Notice Change Key Dates RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)" Notice Number: NOT-NS-19-054 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-017 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-017 "HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read: Application Due Date(s) January 9, 2019, March 22, 2019, May 2 0, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice of Change to Key Dates for RFA-NS-19-018 "HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)"

NOT
Wednesday, April 10, 2019
Saturday, January 1, 2022
NOT-NS-19-055

Funding Opportunity Purpose

Notice Change Key Dates RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)" Notice Number: NOT-NS-19-055 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-018 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-018 "HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read:  Application Due Date(s) January 9, 2019, March 22, 2019, May 20, 2019 , June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   Scientific Merit Review April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice of Correction to Application Types Allowed for RFA-NS-19-017 "HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)"

NOT
Wednesday, April 10, 2019
Saturday, January 1, 2022
NOT-NS-19-052

Funding Opportunity Purpose

Notice Correction Application Types Allowed RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)" Notice Number: NOT-NS-19-052 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform potential applicants a correction Application Types Allowed in response to RFA-NS-19-017 "HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)". Renewal Direct Phase II applications allowed this Funding Opportunity Announcement.  notice be effective the June 21, 2019 application due date subsequent due dates. following section of RFA-NS-19-017 has modified shown bold-italics below): Currently Reads: Section II. Award Information Funding Instrument: Cooperative Agreement: support mechanism used there be substantial Federal scientific programmatic involvement. Substantial involvement means that, after award, NIH scientific program staff assist, guide, coordinate, participate project activities. Section VI.2 additional information the substantial involvement this FOA. Application Types Allowed: Revision New Fast-Track) New Phase II* SBIR Direct Phase II Only) Renewal(Phase II* Direct Phase II allowed) Resubmission phases) The OER Glossary and SF424 R&R) Application Guide provide details these application types. Modified Read: Section II. Award Information Funding Instrument: Cooperative Agreement: support mechanism used there be substantial Federal scientific programmatic involvement. Substantial involvement means that, after award, NIH scientific program staff assist, guide, coordinate, participate project activities. Section VI.2 additional information the substantial involvement this FOA. Application Types Allowed: Revision New Fast-Track) New Phase II* SBIR Direct Phase II Only) Renewal (Phase II) Resubmission phases) The OER Glossary and SF424 R&R) Application Guide provide details these application types. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice of Change to Response Date for NOT-NS-19-045 " Request for Information: Soliciting Input on How Best to Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research"

NOT
Monday, April 8, 2019
Saturday, January 1, 2022
NOT-NS-19-057

Funding Opportunity Purpose

Notice Change Response Date NOT-NS-19-045 " Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research" Notice Number: NOT-NS-19-057 Key Dates Release Date: April 05, 2019 Related Announcements NOT-NS-19-045 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform respondents a change the response date NOT-NS-19-045 Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research." response date change April 15, 2019 May 1, 2019 changes appear in bold italics below). Currently Reads: Key Dates: Release Date: March 15, 2019 Response Date: April 15, 2019 Modified Read: Key Dates: Release Date: March 15, 2019 Response Date: May 1, 2019 Currently Reads: to Submit Response: Response this RFA must submitted electronically using web-based form at https://www.ninds.nih.gov/RFI-NANDS-ME-CFS Responses be accepted through April 15, 2019. Modified Read: to Submit Response: Response this RFA must submitted electronically using web-based form at https://www.ninds.nih.gov/RFI-NANDS-ME-CFS Responses be accepted through May 1, 2019. other aspects this notice remain unchanged. Inquiries Please direct inquiries to: Andrew Breeden, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email:andrew.breeden@nih.gov Vicky Whittemore, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email:vicky.whittemore@nih.gov

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