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Notice Change Allowable Appendix Materials PAR-17-312 NINDS Neuroscience Development Advancing Careers a Diverse Research Workforce R25)" Notice Number: NOT-NS-19-048 Key Dates Release Date: March 20, 2019 Related Announcements PAR-17-312 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change allowable Appendix Materials in PAR-17-312, NINDS Neuroscience Development Advancing Careers a Diverse Research Workforce R25)" update required information the Research Performance Progress Report RPPR). Appendix Currently Reads: not the Appendix circumvent page limits. Follow instructions the Appendix described the SF424 R&R) Application Guide. Modified Read: not the Appendix circumvent page limits. Follow instructions the Appendix described the SF424 R&R) Application Guide; any instructions provided here in addition the SF424 R&R) Application Guide instructions. Appendix meant provide additional details the following topics, not meant substitute clear descriptions the body the application. not include items than allowable materials described below, doing will result administrative withdrawal the application noncompliance. summary sheet listing the items included the Appendix be included the first Appendix attachment. following allowable Appendix materials: Evaluation Assessment Instruments. Applicants provide blank surveys, rubrics, and/or forms used a) document monitor trainee progress b) determine whether program its environment effective, inclusive, safe, supportive. Research Education Outcomes 4 pages).The application provide information table form outcomes subsequent educational/career progress appropriate career stage about recent past 5 years) participants including participants a pilot program) the pool potential applicants, such as: Aggregate number demographic characteristics participants Educational level participants Successful completion an undergraduate graduate degree neuroscience neuroscience-related field Subsequent enrollment an advanced degree program neuroscience neuroscience-related program Subsequent authorship scientific publications scientific presentations outside conferences a biomedical field Subsequent participation a formal research training career development program a neuroscience field Subsequent participation research a neuroscience field Subsequent employment promotion a research research-related biomedical field Subsequent independent research grant support NIH another source Participating Faculty 3 pages).The application may provide following information table form participating faculty: Faculty information: name, degree(s), academic rank, primary department program, research interest, training role i.e., PD/PI, preceptor, executive committee member, committee member, other) Mentoring record undergraduates, predoctorates, postdoctorates the last 10 years: number currently training, graduated/completed training, continued research related careers Applications exceed number allowed appendices the page limitation any the allowed materials be considered noncompliant will be reviewed. 3. Reporting Currently Reads: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually. Continuation support not provided until required forms submitted accepted. Programs involve participants should report education the responsible conduct research complete a Training Diversity Report, accordance the RPPR Instruction Guide. Modified Read: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually. When submitting RPPRs, funded programs expected provide evidence accomplishing research education objectives results the proposed evaluation plan. Continuation support not provided until required forms submitted accepted. Programs involve participants should report education the responsible conduct research complete a Training Diversity Report, accordance the RPPR Instruction Guide. other aspects this FOA remain same. Inquiries Please direct inquiries to: Lauren Ullrich PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7964 Email: lauren.ullrich@nih.gov

Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research Notice Number: NOT-NS-19-045 Key Dates Release Date: March 15, 2019 Response Date: 1, 2019 per NOT-NS-19-057 ) Related Announcements NOT-NS-19-057 Issued National Institute Neurological Disorders Stroke NINDS) Purpose 2018 National Institute Neurological Disorders Stroke NINDS) formed Working Group the National Advisory Neurological Disorders Stroke NANDS) Council focused how best advance research myalgic encephalomyelitis chronic fatigue syndrome ME/CFS). Working Group, composed scientists, clinicians, representatives non-governmental organizations NGOs), individuals ME/CFS, charged with: identifying gaps opportunities ME/CFS research, considering unique opportunities NIH-supported ME/CFS research attract train pipeline new young investigators, identifying potential approaches enhance ongoing research collaboration communication between NGOs, individuals ME/CFS, researchers, federal agencies support research ME/CFS. NANDS Council Working Group ME/CFS soliciting input approaches strategies address charge the Working Group will the responses this Request Information RFI) help inform discussions how advance research ME/CFS. Information Requested NIH soliciting input all interested stakeholders, including researchers, health care providers, individuals ME/CFS, patient advocates health advocacy organizations, scientific professional organizations, federal agencies, well other interested members the public. Organizations strongly encouraged submit single response reflects views their organization membership a whole. Optional: Please indicate you a researcher, health care provider, individual ME/CFS, patient advocate, other interested party. you submitting response behalf an organization membership a whole, please indicate name your organization. Please provide perspective any all the following issues related the Working Group's charge: most compelling ME/CFS research needs. Strategies overcoming scientific challenges barriers progress ME/CFS research. Potential research resources, tools, and/or materials could help advance ME/CFS research enable early career investigators senior investigators new the ME/CFS field more easily conduct research. Relevant considerations strategies clinical ME/CFS research, including development validation data standards outcome measures. Overcoming challenges barriers establishing career ME/CFS research early career investigators those new the field. Approaches strengthen research career training ME/CFS investigators. Identifying related scientific areas may relevant ME/CFS strategies establishing collaborations experts those areas help advance ME/CFS research. Approaches reduce barriers prevent individuals ME/CFS participating research. example, might logistical challenges, such difficulty traveling a study site, might because an unwillingness undergo certain types research protocols. Strategies increasing ME/CFS research collaboration communication between relevant stakeholders. approaches may improve overall field ME/CFS research.   Responses be accepted through April 15 , 2019 . Responses voluntary may submitted anonymously. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. Responses be shared publicly an NIH website. Please not include any personally identifiable other information you not wish make public. proprietary, classified, confidential, sensitive information should included your response. request for information planning purposes only should be construed a solicitation as obligation the part the United States Government. NIH not any awards based responses this RFI pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Andrew Breeden, PhDNational Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1917Email: andrew.breeden@nih.gov  Vicky Whittemore, PhD National Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1917Email: vicky.whittemore@nih.gov

Notice a Parallel Funding Opportunity Announcement the Canadian Institutes Health Research – Institute Neurosciences, Mental Health Addiction CIHR-INMHA) Notice Number: NOT-NS-19-049 Key Dates Release Date: March 14, 2019 Related Announcements RFA-NS-19-022 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD)National Institute Neurological Disorders Stroke NINDS) Purpose February 7, 2019, NIH issued following Funding Opportunity Announcement FOA): RFA-NS-19-022, Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW) U54 Clinical Trial Allowed) programmatic goals compatible, parallel funding a research program have positive synergistic effects the level scope research leveraging interests investments all involved agencies. Toward such goals, Canadian Institutes Health Research - Institute Neurosciences, Mental Health Addiction CIHR-INMHA) establish a parallel funding program to support single research project conducted Canadian research institutes facilities Canadian investigators, within PCS-EMA CWOW RFA-NS-19-022) selected funding NINDS NICHD. CIHR-INMHA expects provide to 250,000 Canadian dollars) per year this funding opportunity. CIHR-INMHA funding expected to supplant the equivalent amount funds the PCS-EMA CWOW’s award budget provided NIH will change total amount direct costs available, detailed RFA-NS-19-022. funding opportunity published the CIHR website by March 14, 2019. participate the CIHR-INMHA parallel funding opportunity, applications RFA-NS-19-022 a Canadian-based research component must also submit parallel abbreviated application CIHR-INMHA details requested support the Canadian component the PCS-EMA CWOW the CIHR website details). Canadian component must an integrated part a Research Project/s an application RFA-NS-19-022. PCS-EMA CWOW applications, or without Canadian Component, be reviewed using standard NIH panel review process. such, PCS-EMA CWOW application be reviewed accordance the review criteria outlined RFA-NS-19-022. Funds CIHR-INMHA only applicable the CWOW selected funding NINDS NICHD. NINDS, NICHD CIHR intend fund future years their respective components the awarded CWOW based the availability appropriations applicable policies. the extent permissible under applicable laws, regulations policies, Canadian research team expected function participate all the PCS-EMA CWOW activities, including involvement the CWOW’s leadership committees teleconferences, annual semi-annual meetings, publications, any additional PCS-EMA CWOW endeavors. applicable rules regulations under Freedom Information Act 5 USC552) Canadian Privacy Act be followed. NIH Data Sharing Policies outlined in NOT-OD-03-032 apply well TBI Clinical Research sharing policies outlined in NOT-NS-17-029. Inquiries Please direct inquiries to: Patrick Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1447 Email: psfb@mail.nih.gov

Notice Information: Clinical Trials Explore Non-Addictive Therapeutics Pain Conditions under Early Phase Pain Investigation Clinical Network EPPIC-Net) Notice Number: NOT-NS-19-043 Key Dates Release Date: March 13, 2019 Related Announcements RFA-NS-19-023 RFA-NS-19-024 RFA-NS-19-025 NOT-NS-19-075 Issued National Institute Neurological Disorders Stroke NINDS) Purpose April 2018, NIH launched HEAL Helping End Addiction Long-term) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. major goal the HEAL Initiative to spur development effective, non-addictive treatments reduce burden illness due pain to reduce risk addiction. Over past 2 years, NIH gathered input experts the U.S. Food Drug Administration FDA), academia, the private sector identify key gaps opportunities the development new treatments pain. Through consultations, NIH identified need a sophisticated clinical trial network design execute innovative early phase trials promising non-addictive pain therapies well-characterized patient cohorts pain conditions high unmet need. Early Phase Pain Investigation Clinical Network EPPIC-Net) EPPIC-Net seeks to improve treatment acute chronic pain reduce reliance opioids accelerating early phase testing non-addictive pharmacologic device strategies industry academic investigators alleviating pain. NIH broad input the appropriate NIH Advisory Council reach to industry academia interventions be tested EPPIC-Net. will lower burden early phase clinical testing provide strong evidence guide decisions proceeding later phase trials a pain indication. a continually learning network, EPPIC-Net researchers provide needed knowledge clinical populations, biomarkers, innovative means testing therapies the research community the singular goal accelerating process making effective therapies pain available the public reducing reliance opioids. goals the clinical trials EPPIC-Net to: Test new treatments early-stage trials using therapeutic candidates (“assets” encompassing small molecules, biologics, devices) Go/No-Go criteria inform decisions move toward efficacy trials regulatory approval. Test new treatments early-stage trials using assets help establish a specific therapeutic pathway holds promise a next generation device, small molecule biologic. Validate biomarkers utility tests target engagement proof principle could used enable accelerate discovery, development, approval new, non-addictive pain therapies. Develop test innovative clinical trial paradigms establish best means testing variety pain therapies. Establish well-characterized patient cohorts specific pain conditions outcome measures utility early-stage trials. Continuously learn experience engineer ever-improved early phase testing new pain therapies over time. scientific focus the clinical trials EPPIC-Net open all pain conditions. research infrastructure EPPIC-Net be established through previously published funding opportunities RFA-NS-19-023, RFA-NS-19-024, RFA-NS-19-025) will composed a Clinical Coordinating Center CCC), Data Coordinating Center DCC), regional Clinical Hubs linked clinical sites. Application Process Clinical Trials EPPIC-Net Stage 1. Asset submission review: Applicants submit preliminary information their drug device (“asset”), target condition population, available preclinical early phase clinical drug/device data proposed study design through template. Interested applicants visit www.ninds.nih.gov/EPPICNet for information to alerted asset application templates made available. objective review process be used select high ranking applications. high-ranking applications proceed the next stage. Stage 2. Development review a detailed dossier”: Successful applicants stage 1 be invited develop more detailed proposal (“dossier”) will submitted a second objective review process. high-ranking proposals proceed the next stage. Stage 3. Protocol development, research site selection, implementation: Successful applicants work the investigators EPPIC-Net develop tailored clinical trial protocol, will receive final round objective review. protocols be subject final approval NIH then funded through Other Transaction OT) mechanism. use Other Transaction Authority enable NIH rapidly initiate clinical trials EPPIC-Net adapt new knowledge technologies emerge. Inquiries Please direct inquiries to: Barbara I. Karp, M.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0150 E-mail: karpb@ninds.nih.gov

Notice Change Key Date PAR-19-170 Progression Markers Cognitive Impairment Parkinson's Disease Dementia R01 Clinical Trial Allowed)" Notice Number: NOT-NS-19-046 Key Dates Release Date: March 11, 2019 Related Announcements PAR-19-170 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Advisory Council Review Date PAR-19-170 Progression Markers Cognitive Impairment Parkinson's Disease Dementia R01 Clinical Trial Allowed)". Advisory Council Review Date change August 2019 to October 2019. Currently Reads: Part 1. Overview Key Dates Advisory Council Review August 2019 Modified Read: Part 1. Overview Key Dates Advisory Council Review October 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Debra Babcock, PhD, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dbabcock@mail.nih.gov

Notice Change Key Date PAR-19-167 Development Validation Advanced Mammalian Models Alzheimer's Disease-Related Dementias ADRD) R61/R33 Clinical Trial Allowed)" Notice Number: NOT-NS-19-047 Key Dates Release Date: March 11, 2019 Related Announcements PAR-19-167 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Advisory Council Review Date PAR-19-167 Development Validation Advanced Mammalian Models Alzheimer's Disease-Related Dementias ADRD) R61/R33 Clinical Trial Allowed)". Advisory Council Review Date change August 2019 to October 2019. Currently Reads: Part 1. Overview Key Dates Advisory Council Review August 2019 Modified Read: Part 1. Overview Key Dates Advisory Council Review October 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Amelie Gubitz, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email:gubitza@ninds.nih.gov

Notice Changes RFA-AI-19-002 HIV/AIDS Clinical Trials Networks Statistical Data Management Centers UM1 Clinical Trial Required)" Notice Number: NOT-AI-19-051 Key Dates Release Date: March 11, 2019 Related Announcements RFA-AI-19-002 Issued National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants two changes to RFA-AI-19-002 "HIV/AIDS Clinical Trials Networks Statistical Data Management Centers UM1 Clinical Trial Required)". Notice removes specific text Part 2. Section and Part 2. Section IV. Part 2: Full Text Announcement Section I. Funding Opportunity Description Statistical Data Management Center Specific Responsibilities Data Collection Management Funding Opportunity Announcement FOA) currently reads: SDMC provides, maintains, supports updates commercial off-the-shelf COTS) clinical trial management systems include electronic data capture EDC) are interoperable the laboratory information management systems LIMS). systems provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network including CTUs/CRSs Protocol-Specific sites. Both clinical trial management systems laboratory information management systems must 21CFR part 11 ICH E6 compliant. DAIDS reserves right audit vendors their sub-contractors. needed, SDMC interfaces, integrates adapts information system(s) be interoperable NIAID systems. SDMC supports collecting, storing providing data accordance regulatory requirements defined FDA ICH collaborating other DAIDS-affiliated SDMCs the development data elements do currently exist within CDISC. SDMC provides specific capabilities including: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. EDC system must interoperable fully integrated that data various sources be merged yield generalizable results. system provides targeted source data verification. SDMC establish procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies. Electronic Health Record EHR) Systems used SDMC ensure interoperability the EHR data the EDC system maintain record EHR systems used each clinical research site status data sharing agreements. SDMC provides timely data access, statistical analysis reports for: Safety Oversight, the Safety Oversight committees. Clinical research site protocol-specific reports: Provide reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS its IC partners purposes clinical monitoring. Funding Opportunity Announcement FOA) modified read without italicized language above: SDMC provides, maintains, supports updates commercial off-the-shelf COTS) clinical trial management systems include electronic data capture EDC) are interoperable the laboratory information management systems LIMS). systems provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network including CTUs/CRSs Protocol-Specific sites. Both clinical trial management systems laboratory information management systems must 21CFR part 11 ICH E6 compliant. DAIDS reserves right audit vendors their sub-contractors. needed, SDMC interfaces, integrates adapts information system(s) be interoperable NIAID systems. SDMC supports collecting, storing providing data accordance regulatory requirements defined FDA ICH collaborating other DAIDS-affiliated SDMCs the development data elements do currently exist within CDISC. SDMC provides specific capabilities including: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. EDC system must interoperable fully integrated that data various sources be merged yield generalizable results. system provides targeted source data verification. SDMC establish procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies. SDMC provides timely data access, statistical analysis reports for: Safety Oversight, the Safety Oversight committees. Clinical research site protocol-specific reports: Provide reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS its IC partners purposes clinical monitoring. Section IV. Application Submission Information 2. Content Form Application Submission Sub-section B. Data Collection Management Funding Opportunity Announcement FOA) currently reads: Describe clinical trial management systems how will provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network research agenda being supported including CTUs/CRSs Protocol-Specific sites. Describe nature type data be collected, how data taken together address overall goals objectives network clinical studies the network will supported. Describe policies procedures interfacing, integrating or adapting information system(s) interact clinical research management systems such NIAID N-CRMS other information systems components specified NIAID. Describe capabilities for: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. interoperable fully integrated electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant Title 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. targeted source data verification. Describe procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies Describe process timelines reports, data access statistical analysis Safety Oversight, the Safety Oversight committees. Clinical research site protocol specific reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS purposes clinical monitoring. Determining co-enrollment protocol status reports. Describe procedures interoperability the EHR data the EDC system Electronic Health Record EHR) Systems used. Describe documentation maintain a record EHR systems used each clinical research site. Describe procedures compliance with NIAID DAIDS policies, regulations procedures. Describe procedures used guide software development including project planning, requirements definition, system design, implementation, integration testing, deployment, maintenance, system retirement. Describe validation processes. Describe efforts establish processes methods common architecture the clinical research community including defining technical standards, identifying security requirements, identifying integrating existing resources, promoting use clinical research data are machine readable that adhere the FAIR findable, accessible, interoperable, re-useable) principles. Describe implementation use validated data collection systems, forms formats, identify any innovations adapting database systems structures accommodate various clinical site, laboratory collaborator needs. Address compliance 21 CFR 11, HIPAA, ability support data interchange standards. Describe alignment workflow systems. Describe system subject randomization procedures strict maintenance blinding throughout studies. Describe procedures used study randomization, randomization systems supported web-based allocation, touch tone allocation, permuted block allocation, etc.), procedures verification validation eligibility prior randomization. Describe integration your randomization system the workflow ability generate protocol status reports. Describe system capabilities the validated laboratory information management system track specimens. Describe the SDMC support Good Data Practices. Describe efforts develop implement standard uniform protocols data collection e.g., Common Data Elements CDE]). Outline process timeline the SDMC prepare the implementation an individual study including electronic Case Report Form eCRFs), protocol-specific site-specific randomization data entry screens, other study-related materials needed. Describe plans shift current data collection management practices address changes regulatory requirements opportunities provided information technology advances any advantage may over existing methodologies. Describe project management system forecasting timelines protocols the need provide data management, collection, retrieval data. Include process ongoing tracking planned versus actual milestones. Describe plans communications and the LOC means adjusting resources needed meet agreed upon protocol schedules. Funding Opportunity Announcement FOA) modified read without italicized language above: Describe clinical trial management systems how will provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network research agenda being supported including CTUs/CRSs Protocol-Specific sites. Describe nature type data be collected, how data taken together address overall goals objectives network clinical studies the network will supported. Describe policies procedures interfacing, integrating or adapting information system(s) interact clinical research management systems such NIAID N-CRMS other information systems components specified NIAID. Describe capabilities for: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. interoperable fully integrated electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant Title 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. targeted source data verification. Describe procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies Describe process timelines reports, data access statistical analysis Safety Oversight, the Safety Oversight committees. Clinical research site protocol specific reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS purposes clinical monitoring. Determining co-enrollment protocol status reports. Describe procedures compliance with NIAID DAIDS policies, regulations procedures. Describe procedures used guide software development including project planning, requirements definition, system design, implementation, integration testing, deployment, maintenance, system retirement. Describe validation processes. Describe efforts establish processes methods common architecture the clinical research community including defining technical standards, identifying security requirements, identifying integrating existing resources, promoting use clinical research data are machine readable that adhere the FAIR findable, accessible, interoperable, re-useable) principles. Describe implementation use validated data collection systems, forms formats, identify any innovations adapting database systems structures accommodate various clinical site, laboratory collaborator needs. Address compliance 21 CFR 11, HIPAA, ability support data interchange standards. Describe alignment workflow systems. Describe system subject randomization procedures strict maintenance blinding throughout studies. Describe procedures used study randomization, randomization systems supported web-based allocation, touch tone allocation, permuted block allocation, etc.), procedures verification validation eligibility prior randomization. Describe integration your randomization system the workflow ability generate protocol status reports. Describe system capabilities the validated laboratory information management system track specimens. Describe the SDMC support Good Data Practices. Describe efforts develop implement standard uniform protocols data collection e.g., Common Data Elements CDE]). Outline process timeline the SDMC prepare the implementation an individual study including electronic Case Report Form eCRFs), protocol-specific site-specific randomization data entry screens, other study-related materials needed. Describe plans shift current data collection management practices address changes regulatory requirements opportunities provided information technology advances any advantage may over existing methodologies. Describe project management system forecasting timelines protocols the need provide data management, collection, retrieval data. Include process ongoing tracking planned versus actual milestones. Describe plans communications and the LOC means adjusting resources needed meet agreed upon protocol schedules. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Phillip Renzullo, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3041 Email:prenzullo@niaid.nih.gov

Notice Extend Expiration Date RFA-NS-19-010 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed)" Notice Number: NOT-NS-19-040 Key Dates Release Date: March 7, 2019 Related Announcements RFA-NS-19-010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants the expiration Date RFA-NS-19-010 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed)" be extended one council round changes shown inbold italicsbelow). additional due date been added this FOA,June 4, 2019.. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes 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. AIDS Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes AIDS AIDS-related 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 March 2019 June 2019 Advisory Council Review 2019 August 2019 Earliest Start Date June 2019 September 2019 Expiration Date March 7, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019, March 6, 2019, andJune 4, 2019by 5:00PM local time applicant organization. Alltypes 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. AIDS Application Due Date(s) January 9, 2019, March 6, 2019, andJune 4, 2019by 5:00PM local time applicant organization. Alltypes AIDS AIDS-related 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 March 2019, June 2019,October 2019 Advisory Council Review 2010, August 2019,August 2019 Earliest Start Date June 2019, September 2019,February 2020 Expiration Date June 5, 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Charles Cywin, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email:charles.cywin@nih.gov

Notice Extend Expiration Date RFA-NS-19-020 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 Clinical Trial Allowed)" Notice Number: NOT-NS-19-042 Key Dates Release Date: March 7, 2019 Related Announcements RFA-NS-19-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants the expiration Date RFA-NS-19-020 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 Clinical Trial Allowed)" be extended one council round changes shown in bold italics below). FOA been modified add additional due date of June 4, 2019. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes 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. AIDS Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. All types AIDS AIDS-related 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 March 2019 June 2019 Advisory Council Review 2010 August 2019 Earliest Start Date June 2019 September 2019 Expiration Date March 7, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019, March 6, 2019, and June 4, 2019, 5:00PM 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. AIDS Apllication Due Date(s) January 9, 2019, March 6, 2019, and June 4, 2019, 5:00PM local time applicant organization. All types AIDS AIDS-related 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 March 2019, June 2019, October 2019 Advisory Council Review 2010, August 2019, August 2019 Earliest Start Date June 2019, September 2019, February 2020 Expiration Date June 5, 2019 other aspects this FOA remain same.  Inquiries Please direct inquiries to: Charles Cywin, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: charles.cywin@nih.gov

Notice Removal Matching Requirements RFA-NS-18-046 Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)” Notice Number: NOT-NS-19-037 Key Dates Release Date: March 6, 2019 Related Announcements RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions for RFA-NS-18-046 “Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)”. will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  Notice only applies the November 25, 2019 application due date subsequent application due dates. Currently Reads: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. grantees a for-profit organization, FOA does require cost sharing, defined the NIH Grants Policy Statement. information cost matching requirements in Section IV.2 R&R Modular Budget. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. grantees a for-profit organization, FOA does not-require cost sharing. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget:  instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA.  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. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget:  instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. For-profit applicants 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.  Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. Currently Reads: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research.  Specific this FOA: likely it the plans cost matching be adequate? Modified Read: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Currently Reads: Section VI. Award Administration Information 3. Reporting multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. final Research Performance Progress Report F-RPPR), invention statement, the expenditure data portion the Federal Financial Report, including Federal non-Federal share cost matching, required closeout an award, described the NIH Grants Policy Statement. Special award condition specific this FOA: grantee a for-profit organization funded 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. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. Modified Read: Section VI. Award Administration Information 3. Reporting multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: mary.pelleymounter@nih.gov