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Notice NIH Pre-Application Webinar RFA-NS-20-028 HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required)". Notice Number: NOT-NS-20-027 Key Dates Release Date: February 6, 2020 Related Announcements RFA-NS-20-028 Issued National Institute Neurological Disorders Stroke NINDS) 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) Purpose NINDS, through Office Pain Policy Planning, conduct pre-application Webinar regarding Funding Opportunity Announcement FOA) HEAL Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3, Clinical Trial Required) Tuesday, February 11th, 2020 11 am Eastern Standard Time. webinar provide background information answers applicant questions regarding FOA, is part the NIH Helping End Addiction Long-term HEAL) Initiative. join webinar, follow link below: https://nih.webex.com/nih/onstage/g.php?MTID=e1852c2d4e9819aec053c25739… Participation this webinar, although encouraged, not required the submission an application response to RFA-NS-20-028. Inquiries Please direct inquiries to: Danielle Haney, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-827-8605 Email: danielle.haney@nih.gov Linda Porter, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-435-7572 Email: porterl@ninds.nih.gov Jane C. Atkinson, D.D.S. National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov

Notice Correction Open Date RFA-NS-19-043 BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed)" Notice Number: NOT-NS-20-037 Key Dates Release Date: Janaury 16, 2020 Related Announcements RFA-NS-19-043 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a correction the Open Date Earliest Submission Date) RFA-NS-19-043 "BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed)". Open Date Earliest Submission Date) January 9, 2020. Changes the FOA shown Bold Italics below. Currently Reads: Part 1. Overview Information Key Dates Open Date Earliest Submission Date) January 9, 2022 Modified Read: Part 1. Overview Information Key Dates Open Date Earliest Submission Date) January 9, 2020 other aspects this FOA remain same. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: BRAINDIVERSITYK99R00@nih.gov

Notice Data Sharing Policy Autism Data Notice Number: NOT-MH-20-010 Key Dates Release Date: January 13, 2020 Related Announcements NOT-MH-09-005 NOT-MH-19-033 Issued National Institute Mental Health NIMH) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) Purpose Widespread data sharing research communities adds significant value research accelerates pace discovery. NIMH Data Archive https://nda.nih.gov/, NDA) been established enable responsible sharing use data collected and human subjects the entire research community. Consistent authorities under 21st Century Cures Act, researchers are conducting autism research involving human subjects funded the Institutes participating this Notice required deposit raw analyzed data including, not limited to, clinical, genomic, imaging, phenotypic data) the NDA infrastructure. Unless NIH stipulates otherwise during negotiation the terms conditions a grant award, Notice applies all grant applications awards involve human subject research related autism are submitted after September 1, 2020 through Funding Opportunity Announcements FOAs)in the institutes participatingin notice also participants the FOA. Investigators applications assigned NIMH abide the data sharing timeline published NOT-MH-19-033. Notice does apply following types applications: Fellowship F) Research Career Development K) Training T) Small Business SBIR/STTR) Small Grants R03) Education R25) Notice updates replaces NOT-MH-09-005. Data were previously stored the National Database Autism Research referred in Notice been incorporated the NIMH Data Archive NDA). Non-NIH funded researchers human subjects data relevant autism welcome deposit data they willing adhere the archive’s data sharing terms conditions https://nda.nih.gov/contribute/contribute-data.html). data archive a rich source data can used a variety ways, including development preliminary data support application. Investigators strongly encouraged explore data the data dictionaries are available before submitting application. Resource Sharing Expectations Grant Applications NDA provides infrastructure support enable autism researchers deposit data to share data the research community. Prior applying a grant, investigators should review planning section the web site https://nda.nih.gov/contribute/contribute-data.html). Applicants strongly encouraged use clinical phenotypic data collection instruments/data dictionaries have already defined rather create new versions those data dictionaries. are several required data collection instruments, mostly related demographic sample information, must used all researchers data harmonization purposes https://nda.nih.gov/standards.html). Applicants should also plan collect data needed generate global unique identifiers GUIDs) each study subject https://nda.nih.gov/contribute/harmonization-standards.html#guid). Informed consent documents should describe study data be shared NDA the research community https://nda.nih.gov/contribute/contribute-data.html#infocon). necessary funds submitting data the NDA should included the requested budget. cost estimator https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.x…) available facilitate calculation these costs. Post-Award Data Management Data funded awards be submitted NDA every 6 months. Within 6 months the original award, awardees provide Data Submission Agreement signed the principal investigator an institutional business official. most cases, single NDA Collection containing data associated each grant award be established. Submitting data this Collection distinct sharing data the research community. Submitted data generally held a private enclave open only the awardee until data shared the research community. Data submission requires data undergo validations other quality control checks the data deposited. Performing checks improves reliability reproducibility the data. While general data sharing expectation for data be submitted every 6 months, researchers strongly encouraged use NDA validation tool https://nda.nih.gov/vt/) much frequently. Awardees strongly encouraged submit full study clinical trial protocol one exists, additional information each Collection. Data be shared the research community papers using data been accepted publication at end the award period including first cost extension), whichever occurs sooner. Applicants encouraged share basic demographic raw baseline data shortly after data submission encourage collaborations the research community. addition submitting data associated a grant award they collected, researchers expected separately submit NDA specific data was used each resulting publication creating NDA Study. NDA assigns digital object identifier each study, studies should created prior publication will only shared papers accepted publication. Creation these studies encourage rigor reproducibility https://nda.nih.gov/training/modules/study.html). Inquiries Please direct inquiries to: technical assistance data submission, please contact NDA help desk NDAHelp@mail.nih.gov). other inquiries please contact: Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone: 301-435-0778 Email: farberg@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement Blueprint Neurotherapeutics Network BPN): Small Molecule Drug Discovery Development Disorders the Nervous System U44 Clinical Trial Optional) Notice Number: NOT-NS-20-032 Key Dates Release Date: January 06, 2020 Estimated Publication Date Funding Opportunity Announcement: February 08, 2020 First Estimated Application Due Date: August 11, 2020 Earliest Estimated Award Date: February 16, 2021 Earliest Estimated Start Date: April 01, 2021 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose NIH announces intention reissue PAR-18-541 SBIR-eligible small businesses seeking support the Blueprint Neurotherapeutics Network BPN). Applicants encouraged utilize customized set contract resources, consultants the Blueprint Neurotherapeutics Network BPN) help advance neuroscience-focused drug discovery development projects the clinic. Notice provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA utilize U44 activity code. Details the planned FOA provided below. FOA expected be published February 2020 an expected application due date August 2020. Research Initiative Details facilitate drug discovery development the neuroscience community, NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov/) established Blueprint Neurotherapeutics Network BPN), collection contract service providers consultants extensive industry experience the areas pharmacology, medicinal chemistry, pharmacokinetics, toxicology, GMP synthesis, formulation development, Phase clinical safety testing. list consultants contract service providers be viewed http://neuroscienceblueprint.nih.gov/bpdrugs/bpn.htm. reissued Funding Opportunity Announcement FOA) encourage applications SBIR-eligible small businesses seeking funding through Fast-Track phased U44 cooperative agreement mechanism help advance drug discovery development projects the clinic. Applicants be encouraged build customized utilization BPN services their applications. be eligible the BPN, applicant must well-validated bioactive compound(s) hand; BPN does support screening hit compounds. Projects enter BPN during Discovery Development may seek support through phase I/first-in-human testing. Discovery involves iterative medicinal chemistry improve potency ADMET properties compounds, toward goal identifying clinical candidate. During Development, clinical candidate undergoes preclinical toxicology testing required an IND manufacturing, ultimately advancing phase I/first-in-human testing. BPN Development activities include chemical manufacturing controls CMC), formulation development, toxicology studies, regulatory support, phase I/first-in-human testing. NIH assemble customized Lead Development Team each project accepted the program. Lead Development Team typically be co-chaired the Program Director/Principal Investigator PD/PI) a consultant extensive industry expertise identified supported the NIH. Lead Development Team also include members the PD/PI's team, NIH-hired consultants additional expertise, NIH staff. Lead Development Team plan coordinate work supported the cooperative agreement award conducted BPN contractors. Discovery projects begin a U44 Phase award up two years. first 6-12 months be used complete any studies required meet Discovery Development entry criteria to engage Lead Development Team establishing detailed research plan, go/no-go milestones, all subsequent work. Applicants strongly encouraged consult NIH program staff plans an application being developed. Consultations include conference calls NIH program staff webinars. Early contact provides opportunity NIH program staff discuss program scope, entry criteria, goals, to provide information guidance how develop competitive application. It's recommended applicants contact NIH staff least 8 weeks before receipt date. additional information the BPN, please http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm Funding Information Estimated Total Funding Expected Number Awards TBD Estimated Award Ceiling Primary CFDA Numbers TBD nbsp; Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Charles Cywin, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-1779 Email: cywincl@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement Blueprint Neurotherapeutics Network BPN): Small Molecule Drug Discovery Development Disorders the Nervous System UG3/UH3 Clinical Trial Optional) Notice Number: NOT-NS-20-033 Key Dates Release Date: January 06, 2020 Estimated Publication Date Funding Opportunity Announcement: February 11, 2020 First Estimated Application Due Date: August 08, 2020 Earliest Estimated Award Date: February 01, 2021 Earliest Estimated Start Date: April 01, 2021 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose NIH announces intention reissue PAR-18-546 investigators seeking support the Blueprint Neurotherapeutics BPN) Network. Applicants be encouraged utilize customized set contract resources, consultants the BPN Network help advance neuroscience-focused drug discovery development projects the clinic. Notice provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA utilize UG3/UH3 activity code. Details the planned FOA provided below. FOA expected be published February 2020 an expected application due date August 2020. Research Initiative Details facilitate drug discovery development the neuroscience community, NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov/) established Blueprint Neurotherapeutics BPN) Network, collection contract service providers consultants extensive industry experience the areas pharmacology, medicinal chemistry, pharmacokinetics, toxicology, GMP synthesis, formulation development, Phase clinical safety testing. list consultants contract service providers be viewed http://neuroscienceblueprint.nih.gov/bpdrugs/bpn.htm. planned reissue Funding Opportunity Announcement FOA) encourage applications investigators seeking funding through UG3/UH3 phased cooperative agreement mechanism help advance drug discovery development projects the clinic. Applicants be encouraged build customized utilization BPN services their applications. be eligible the BPN, applicant must well-validated bioactive compound(s) hand; BPN does support screening hit compounds. Projects enter BPN during Discovery Development may seek support through phase I/first-in-human testing. Discovery involves iterative medicinal chemistry improve potency ADMET properties compounds, toward goal identifying clinical candidate. During Development, clinical candidate undergoes preclinical toxicology testing required an IND manufacturing, ultimately advancing phase I/first-in-human testing. BPN Development activities include chemical manufacturing controls CMC), formulation development, toxicology studies, regulatory support, phase I/first-in-human testing. NIH assemble customized Lead Development Team each project accepted the program. Lead Development Team typically be co-chaired the Program Director/Principal Investigator PD/PI) a consultant extensive industry expertise identified supported the NIH. Lead Development Team also include members the PD/PI's team, NIH-hired consultants additional expertise, NIH staff. Lead Development Team plan coordinate work supported the cooperative agreement award conducted BPN contractors. projects enter BPN begin a preparatory phase UG3) up one year, can used complete any studies required meet Discovery Development entry criteria to engage Lead Development Team establishing detailed research plan, go/no-go milestones, all subsequent work. Applicants strongly encouraged consult NIH program staff plans an application being developed. Consultations include conference calls NIH program staff webinars. Early contact provides opportunity NIH program staff discuss program scope, entry criteria, goals, to provide information guidance how develop competitive application. It's recommended applicants contact NIH staff least 8 weeks before receipt date. additional information the BPN, please http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm Funding Information Estimated Total Funding Expected Number Awards TBD Estimated Award Ceiling Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Charles Cywin, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-1779 Email: cywincl@ninds.nih.gov

Addition SBIR Direct-to-Phase II Program NINDS RFA-NS-18-012, Translational Neural Devices U44 Clinical Trial Required)" Notice Number: NOT-NS-20-034 Key Dates Release Date: January 6, 2020 Related Announcements RFA-NS-18-012 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Section 5106 the SBIR/STTR Reauthorization Act 2011 authorized NIH ‘issue Phase II award a small business concern did receive Phase award that research/research & development'. phase flexbility' called ‘Direct-to-Phase II’ SBIR award. original authority this provision expired 9/30/2017. Recent legislation P.L. 115-232 re-instated SBIR Direct Phase II provision through Fiscal Year 2022. SBIR Direct-to-Phase II authority not available the STTR program not available the CDC, FDA, ACL SBIR progams. such, NIH re-implementing SBIR Direct-to-Phase II program. prior program specific SBIR Direct-to-Phase II funding opportunity announcements FOAs). transition FORMS-E earlier year allows NIH track SBIR Direct-to-Phase II applications the Application level, there a new check-box the SBIR/STTR Information Form Direct Phase II. a result this, NIH does need issue separate SBIR Direct-to-Phase II FOAs before, can offer Direct-to-Phase II an allowable Application Type any SBIR FOA. NINDS therefore amending RFA-NS-18-012 allow SBIR Direct-to-Phase II submissions NIH strongly encourages small businesses contact appropriate Institute Center early their application planning process ensure technology of priority the Institute/Center following sections RFA-NS-18-012 changed follows: Part 2, Section II. Award Information Currently Reads: Application Types Allowed New Fast-Track) Resubmission Fast-Track) Revision Fast-Track) OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. Modified Read: Application Types Allowed New Fast-Track) New Phase II - Direct Phase II) Resubmission Direct Phase II, Fast-Track) Revision Direct Phase II, Fast-Track) OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Emily Caporello, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: Emily.caporello@nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: nick.langhals@nih.gov

Notice Change the Data Safety Monitoring Plan PAR-18-422 NINDS Efficacy Clinical Trials U01 Clinical Trial Required) Notice Number: NOT-NS-20-013 Key Dates Release Date: January 03, 2020 Related Announcements PAR-18-422 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to update instructions regarding Data Safety Monitoring Plan PAR-18-422. Currently reads: 3.3 Data Safety Monitoring Plan Applicants should refer the NINDS Guidelines Data Safety Monitoring Clinical Trials https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Lib…) developing DSMP. Modified read: 3.3 Data Safety Monitoring Plan Applicants should refer the NINDS Guidelines Data Safety Monitoring Clinical Trials https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Lib…) developing DSMP. Note these guidelines been updated include requirement an independent statistician report unblinded study analyses the Data Safety Monitoring Board. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Peter Gilbert, ScM National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0870 Email: pgilbert@nih.gov

Notice NINDS Participation PA-18-917 Developing Therapeutic Potential the Endocannabinoid System Pain Treatment R01 - Clinical Trial Optional)" Notice Number: NOT-NS-20-036 Key Dates Release Date: January 03, 2020 Related Announcements PA-18-917 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-917 Developing Therapeutic Potential the Endocannabinoid System Pain Treatment R01 - Clinical Trial Optional)". notice be effective the February 5, 2020 standard receipt date subsequent due dates. following italicized changes made indicate participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations National Institute Drug Abuse NIDA) National Cancer Institute NCI)) National Center Complementary Integrative Health NCCIH) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Aging NIA) Catalog Federal Domestic Assistance CFDA) Number(s) 93.279, 93.393, 93.213, 93.273, 93.865, 93.866 Part 2. Full Text Announcement Section I. Funding Opportunity Description addition the topics listed above, additional specific areas interest some the participating ICs outlined below. Applicants encouraged contact participating IC's Scientific/Research contact discuss submission gauge interest the participating institute. NIDA: Examine role various combinations potencies the main cannabinoids THC CBD) their effects modulating endocannabinoid system pain perception analgesia; effects long-term endocannabinoid system therapies addiction liability. NCI: role cannabinoids the endocannabinoid system the treatment tumor-related pain conditions, such metastatic bone pain, painful conditions arising the treatment cancer, such chemotherapy induced peripheral neuropathy, aromatase inhibitor arthralgias, radiation induced stomatitis. NCCIH: role naturally occurring phytocannabinoids their derivatives either alone in conjunction other complementary approaches e.g. natural products, mind-body programs) modulating biological neural systems associated pain perception analgesia relevant model organisms human subjects well the mechanisms underlying cannabinoid analgesic anti-inflammatory properties. NCCIH not fund research proposing efficacy effectiveness clinical trials through FOA please NCCIH Clinical Trial Funding Opportunities instead). Investigators strongly encouraged discuss research plans NCCIH program staff prior submitting application. NICHD: Characterization the cannabinoids endocannabinoid system potential targets treatment dysmenorrhea, vulvodynia, chronic pelvic pain due endometriosis other gynecologic disorders. Studies the role these systems the management spasticity, neuropathic pain, bone pain, musculoskeletal pain pain secondary other disabling conditions. Cannabinoids endocannabinoid system their therapeutic adverse effects pregnancy its outcomes. NIAAA: Alcohol abuse/dependence causes increased pain sensitivity neuropathic pain. role endocannabinoids mediating actions alcohol inducing regulating pain responses be primary interest. Modified Read: Part 1. Overview Information Components Participating Organizations National Institute Drug Abuse NIDA) National Cancer Institute NCI)) National Center Complementary Integrative Health NCCIH) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.279, 93.393, 93.213, 93.273, 93.853, 93.865, 93.866 Part 2. Full Text Announcement Section I. Funding Opportunity Description addition the topics listed above, additional specific areas interest some the participating ICs outlined below. Applicants encouraged contact participating IC's Scientific/Research contact discuss submission gauge interest the participating institute. NIDA: Examine role various combinations potencies the main cannabinoids THC CBD) their effects modulating endocannabinoid system pain perception analgesia; effects long-term endocannabinoid system therapies addiction liability. NCI: role cannabinoids the endocannabinoid system the treatment tumor-related pain conditions, such metastatic bone pain, painful conditions arising the treatment cancer, such chemotherapy induced peripheral neuropathy, aromatase inhibitor arthralgias, radiation induced stomatitis. NCCIH: role naturally occurring phytocannabinoids their derivatives either alone in conjunction other complementary approaches e.g. natural products, mind-body programs) modulating biological neural systems associated pain perception analgesia relevant model organisms human subjects well the mechanisms underlying cannabinoid analgesic anti-inflammatory properties. NCCIH not fund research proposing efficacy effectiveness clinical trials through FOA please NCCIH Clinical Trial Funding Opportunities instead). Investigators strongly encouraged discuss research plans NCCIH program staff prior submitting application. NICHD: Characterization the cannabinoids endocannabinoid system potential targets treatment dysmenorrhea, vulvodynia, chronic pelvic pain due endometriosis other gynecologic disorders. Studies the role these systems the management spasticity, neuropathic pain, bone pain, musculoskeletal pain pain secondary other disabling conditions. Cannabinoids endocannabinoid system their therapeutic adverse effects pregnancy its outcomes. NINDS: Interest exclusively focused the effect the endogenous cannabinoid system the neural mechanisms pain the transition acute chronic pain. NIAAA: Alcohol abuse/dependence causes increased pain sensitivity neuropathic pain. role endocannabinoids mediating actions alcohol inducing regulating pain responses be primary interest. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michael Oshinsky, PhD National Institute Neurological Disorders & Stroke NINDS) Telephone: 301-496-9964 Email:michael.oshinsky@nih.gov

Notice Intent Publish Funding Opportunity Announcement HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required) Notice Number: NOT-NS-20-020 Key Dates Release Date: December 26, 2019 Estimated Publication Date Funding Opportunity Announcement: January 20, 2020 First Estimated Application Due Date: March 24, 2020 Earliest Estimated Award Date: August 31, 2020 Earliest Estimated Start Date: August 31, 2020 Related Announcements None Issued National Institute Neurological Disorders Stroke ( NINDS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) intends publish re-issuance funding opportunity announcement RFA-NS-19-021 solicit applications clinical trial planning implementation generate evidence-based pain management best practices the of existing medications devices specific pain conditions. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. funding opportunity announcement expected be published December 2019 an expected application due date March 2020. Applicant organizations submit than application, provided application proposes distinct clinical trial. funding opportunity announcement utilize UG3/UH3 bi-phasic activity code. Research Initiative Details Most chronic pain management delivered the primary care settings where providers few evidence-based guidelines support clinical decisions. Acute pain management often delivered emergency departments, hospital settings dental clinics where reliance treatment opioids increases risks Opioid Disorder OUD). Adults pain due injury, neck back pain, abdominal pain headache up over 33 million ER visits per year. . Evidence best pain care practices these settings lacking, only acute pain relief, also prevention chronic pain OUD. addition, quality, precision pain care following surgical other procedures medications including opioids other pharmacological therapies devices provide more robust evidence base guide providers these settings, promote tailored acute pain care, reduce reliance opioids. re-release HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required) prioritize following areas interest generate evidence-based pain management best practices the of existing medications devices specific pain conditions. guidelines should of to providers primary care, emergency departments, dental clinics, hospital settings. pain conditions high priority are: pain management emergency departments, dental clinics, primary care hospitals; chronic overlapping pain conditions; best practices effective analgesics appropriate; pain management individuals risk or OUD; pain management those co-occurring mental health disorders; Non cancer pain management persons medical comorbidities Research testing behavioral interventions manage pain not considered high priority projects since several currently funded HEAL trials testing behavioral interventions pain management. Investigators wishing test effectiveness behavioral interventions should contact program officials individual ICs find appropriate FOA. Research testing software decision-making tools help providers patients determine most effective safe methods pharmacological device pain management allowed. Funding Information Estimated Total Funding 800,000 total costs FY2020; 2,000,000 total costs per year FY2021, FY2022, FY2023, FY2024 Expected Number Awards to 2. Estimated Award Ceiling to 500,000 direct cost the one-year UG3 phase up 1,000,000 per year direct cost the UH3 phase no than 4 years. Note the Trial Innovation Network provide infrastructure including data management system, clinical coordination, support trial document development such the manual procedures. costs should be included the UG3/UH3 budgets. 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) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Linda L. Porter, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-435-7572 porterl@ninds.nih.gov Jane C. Atkinson, DDS National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov

Notice Extend Expiration Date PA-18-141 Mechanisms, Models, Measurement, & Management Pain Research R01 Clinical Trial Optional)" Notice Number: NOT-NS-20-021 Key Dates Release Date: December 18, 2019 Related Announcements PA-18-141 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) 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 Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) Purpose purpose this notice to inform interested applicants a change the Key Dates PA-18-141 ""Mechanisms, Models, Measurement, & Management Pain Research R01 Clinical Trial Optional)". Four additional receipt dates been added changes shown bold italics below). Funding Opportunity Announcement been modified add following New Application due dates: February 5, 2020, June 5, 2020, October 5, 2020, February 5, 2021 new applications) March 5, 2020, July 5, 2020, November 5, 2020, and March 5, 2021 (renewal, resubmission, revision applications) AIDS Application Due Dates of May 7, 2020, September 7, 2020, January 7, 2021, and May 7, 2021. Currently Reads: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 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. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. All types AIDS AIDS-related 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 Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 8, 2020 Modified Read: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. Alltypes AIDS AIDS-related 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 Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date 8, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michael Oshinsky, PhD National Institute Neurological Disorders & Stroke NINDS) Telephone: 301-496-9964 Email:michael.oshinsky@nih.gov Martha Matocha, PhD National Institute Nursing Research NINR) Telephone: 301-594-2775 Email: matocham@mail.nih.gov