Find Funding Opportunities

Notice Pre-Application Information Webinar RFA-DA-19-029, RFA-DA-19-036, HEALthy Brain Child Development HEALthy BCD) Study Notice Number: NOT-DA-19-020 Key Dates Release Date: January 16, 2019 Related Announcements RFA-DA-19-029 RFA-DA-19-036 Issued National Institutes Health NIH) National Institute Drug Abuse NIDA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) Office Behavioral Social Sciences Research OBSSR) Office Research Women’s Health ORWH) Environmental Influences Child Health Outcomes Program ECHO) Purpose December 21, 2018, NIH issued following Funding Opportunity Announcements FOAs) RFA-DA-19-029 HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) Collaborative R34 Clinical Trial Allowed) RFA-DA-19-036 HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) R34 Clinical Trial Allowed) assist potential applicants the above referenced FOAs, Notice provides following information: pre-application information webinar potential HEALthy BCD applicants be provided February 6, 2019. HEALthy BCD Webinar Information Date: February 6, 2019 Time: 1:00-2:00 pm ET intent the pre-application webinar to provide overview the HEALthy BCD FOAs to address questions potential applicants. webinar optional not required application submission. webinar conclude before scheduled time depending the number questions. Additional information, including link register the webinar be posted at: https://www.drugabuse.gov/news-events/meetings-events/2019/02/pre-appli…. Following webinar, NIDA post slides presented during Webinar the same website.  Prospective applicants inquiries concerning FOA are unable participate the Webinar encouraged view summary questions answers after Webinar. FAQs FAQs be posted the same website a summary questions answers the webinar may updated additional questions answers without further notice.   Inquiries Please direct inquiries to: Gayathri J. Dowling, Ph.D. National Institute Drug Abuse NIDA) Email: babybrain@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls CWOW) U54 Clinical Trial Optional) Notice Number: NOT-NS-19-027 Key Dates Release Date:January 07, 2019 Estimated Publication Date Funding Opportunity Announcement: February 10, 2019 First Estimated Application Due Date: April 12, 2019 Earliest Estimated Award Date: October 01, 2019 Earliest Estimated Start Date: October 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications research discovering validating biological measures be used assessing, prognosing, monitoring recovery adolescents either clinically present or at risk developing prolonged/persistent concussive symptoms following exposure repetitive head impacts and/or concussion. biological measures should be incorporated risk stratification algorithms inform clinical care patient stratification future clinical trials. A key component this FOA be broad sharing clinical, neuroimaging, physiological, biospecimen data to further advance research the area persistent concussive symptoms early middle adolescent EMA; ages 11-17 years old) populations. Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects. FOA expected be published Winter 2019 an expected application due date Spring 2019. FOA utilize NIH Specialized Center Cooperative Agreement U54) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area Traumatic Brain Injury TBI) begin consider applying this new FOA. addition, collaborative investigations combining expertise pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, clinical outcomes research be encouraged, these investigators should also begin considering applying this application. FOA utilize U54 Cooperative Agreement Center Without Walls CWOW) mechanism will included multi-site, multidisciplinary, research teams work synergistically discover, characterize, validate combination biological measures prognosis and/or monitoring recovery persistent concussive symptoms enrollment multiple points care e.g., Emergency Departments, urgent care clinics, primary care, concussion/sports medicine clinics, other specialty clinics) participants a variety injury mechanisms e.g., falls, sports, abusive head trauma, automobile accidents). Biological measures are responsive include, are limited neuroimaging, electroencephalography, oculomotor control, vestibular function, measures auditory processing speech production, autonomic responses, metabolomics, proteomics, other biofluid-based assays. Applications' analysis plans also expected include potential mediating factors such medication the type amount post-injury treatment rehabilitation provided participants. U54 should include following:(1) Administrative Core management reporting, establishing milestones, organizing communications among sites, resolving disputes; 2) Data Coordinating Core will responsible data curation, quality, submission the Federal Interagency Traumatic Brain Injury Research FITBIR) informatics platform be able coordinate the NINDS biomarker repository BioSEND; 3) least three research projects will used address list research areas interest. Scientific projects be expected include both 1) discovery / internal validation, 2) external validation stage their project. the discovery stage, research project should focus discovery biological measures persistent concussive symptoms. Where feasible, project's biological measures should collected across research projects sites. During internal validation stage, projects be expected determine selectivity sensitivity a unique individual set biological measures assessing, prognosing, / monitoring persistent concussive symptoms an EMA population. external validation, of research projects should collect full set biological measures be validated determine selectivity sensitivity these measures across multiple sites in multiple clinical contexts. Following validation, risk stratification algorithm prognosing monitoring recovery persistent concussive symptoms an EMA population should developed. is expected the FOA require incorporation the NINDS Core TBI pediatric common data elements CDEs) appropriate Core CDEs the NINDS Sports Concussion CDE set. Additionally, FOA expected require use the NINDS CDEs both outcome non-outcome measures including, not limited demographics, medical injury history, history abusive injury, family history, medications, neuroimaging, rehabilitation strategy, standardized outcome assessments) described theNINDS CDE Project. FOA require data sharing schedule is consistent NINDS's TBI data submission policy NOT-NS-17-029. Further, ensure maximal value the project, data sharing plan require sharing a limited" clinical data set e.g., clinical assessment amp; outcome measures, symptom lists, mechanism injury, demographics, etc.) be available FITBIR a limited access public” state more 1-year after collection. FOA also expect all biological specimens be banked the NINDS BioSEND Biomarkers Repository. Note costs collection NOT included a component the NINDS BioSEND Biomarkers Repository award. Therefore, most costs the biospecimen banking borne the grantees utilizing resource seeNOT-NS-15-046) should budgeted in application. Funding Information Estimated Total Funding 2,000,000 direct costs Expected Number Awards NINDS intends fund to 1 award. 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) Indian/Native American Tribal Government Federally Recognized) Applications not being solicited this time.  nbsp; Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov

Notice Change Key Dates RFA-NS-19-021 HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required)" Notice Number: NOT-NS-19-028 Key Dates Release Date: January 2, 2019 Related Announcements RFA-NS-19-021 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Key Dates in RFA-NS-19-021 "HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required)". Specifically, first receipt date change February 1, 2019 to February 11, 2019. Currently Reads: Part 1. Overview Key Dates Open Date Earliest Submission Date) February 1, 2019 Application Due Date(s) February 1, 2019, 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. AIDS Application Due Date(s) February 1, 2019, 5:00 PM 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. Expiration Date February 2, 2019 Modified Read: Part 1. Overview Key Dates Open Date Earliest Submission Date) January 11, 2019 Application Due Date(s) February 11, 2019, 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) February 11, 2019, 5:00 PM 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. Expiration Date February 12, 2019 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Linda L. Porter, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-435-7572 Email:porterl@ninds.nih.gov

Notice Interest Advancing Research Acute Flaccid Myelitis Guillain-Barre Syndrome Notice Number: NOT-NS-19-029 Key Dates Release Date: December 20, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose recent increase cases a polio-like illness children called Acute Flaccid Myelitis AFM) drawn attention gaps understanding its causes treatment. Both AFM Guillain-Barre Syndrome GBS) rare neurological conditions characterized acute onset muscle weakness paralysis believed be triggered an infectious agent. Affected individuals lose ability walk disrupted breathing be life threatening. currently available treatments, recovery often incomplete resulting long-term neurological deficits. purpose this Notice to announce the National Institute Neurological Disorders Stroke NINDS), National Institute Allergy Infectious Diseases NIAID), the Eunice Kennedy ShriverNational Institutes Child Health Human Development NICHD) encourage new applications request supplements existing grants competitive revisions administrative supplements) support basic, translational, and/or clinical research the causes, diagnosis, prevention treatment AFM, GBS other acute neurological conditions muscle weakness/paralysis triggered infectious agents related immune responses. Applications should submitted through ldquo;parent” funding opportunity announcements FOAs), through existing FOAs supported NINDS, NIAID, NICHD. Areas programmatic interest include, are limited to: Identifying etiology these neurological conditions, including infectious agents, immunological factors, other genetic environmental susceptibility factors Understanding pathogenesis these neurological conditions the central peripheral nervous systems musculoskeletal system. might include natural history studies cases study acute disease long-term sequelae Characterizing immunologic landscape e.g., immune profiling, genome sequencing) among AFM- GBS-affected individuals determining relationship related immune responses disease Developing model systems e.g. animal, cell organ culture) study pathogenesis serve screening platforms more reliable diagnosis, prevention therapy development Diagnosing conditions, including infectious agent detection, serology, genetics, imaging- electrophysiology-based techniques Developing biomarkers diagnostic, prognostic, predictive pharmacodynamic/response) use preclinical therapy development clinical studies these conditions Developing treatments, including potential novel therapies drug/biologic repurposing Testing strategies the rehabilitation patients affected these conditions, including conventional novel modalities, intense physiotherapies, and/or assistive technologies. variety Parent institute-specific FOAs available applicants, including Research R), Cooperative Agreement U), Career Development K), Fellowship F) awards which NINDS, NIAID, NICHD participate NINDS funding opportunities https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities; NICHD funding opportunities ((https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs/par… active FOAs https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs). Interested applicants encouraged contact program staff listed below guidance selecting appropriate FOA. Inquiries Please direct inquiries to: Adam L. Hartman, M.D. National Institute Neurological Disorders amp; Stroke Neuroscience Center Telephone: 301-496-9135 Email: adam.hartman@nih.gov Bill G. Kapogiannis, M.D. Eunice Kennedy Shriver National Institutes Child Health Human Development Telephone: 301-402-0698 Email: kapogiannisb@mail.nih.gov Walla Dempsey, Ph.D. National Institute Allergy Infectious Diseases Telephone: 240-292-4197 E-mail: wdempsey@niaid.nih.gov

Notice update Application Types Allowed PAR-18-763 Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery R61/R33) Notice Number: NOT-NS-19-017 Key Dates Release Date: December 19, 2018 Related Announcements PAR-18-763 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to update Application Types Allowed PAR-18-763 Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery R61/R33 Clinical Trial Allowed) ".  Specifically, NINDS accept resubmission applications response this Funding Opportunity Announcement FOA) from PAR-18-763 and RFA-NS-16-013. Section II. Award Information Application Types Allowed Currently Reads: New Resubmission Revision The OER Glossary and SF424 R&R) Application Guide provide details these application types. Modified Read: New Resubmission (PAR-18-763 RFA-NS-16-013) Revision 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: Rebecca Roof, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:  Rebecca.Roof@nih.gov

Notice NINDS Participation NOT-AG-18-050 Notice Specify High-Priority Research Topic PAR-19-070" Notice Number: NOT-NS-19-025 Key Dates Release Date: December 13, 2018 Related Announcements NOT-AG-18-050 PAR-19-070 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, NOT-AG-18-050 Notice Specify High-Priority Research Topic PAR-19-070". following sections been updated reflect participation NINDS this Notice. Currently Reads: Issued National Institute Aging NIA) Modified Read: Issued National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) following contacts been added: Inquiries: Roderick Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov other aspects this notice remain unchanged. Inquiries Please direct inquiries to: Roderick Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov

Reinstatement NIH SBIR Direct-to-Phase II Authority Associated Updates PA-18-705 Notice Number: NOT-NS-19-023 Key Dates Release Date: December 12, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) Purpose Section 5106 the SBIR/STTR Reauthorization Act 2011 authorized NIH lsquo;issue Phase II award a small business concern did receive Phase award that research/research amp; development'. phase flexbility' called lsquo;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 following SBIR FOA allow SBIR Direct-to-Phase II submissions per below: PA-18-705 SBIR Technology Transfer R43/R44 Clinical Trial Allowed) NIH strongly encourages small businesses contact appropriate Institute Center early their application planning process ensure technology of priority the Institute/Center. updated SBIR/STTR Application Guide additional instructions SBIR Direct Phase II application preparation submission be posted November 26, 2018. following sections PA-18-705 changed follows: Part 2, Section I. Funding Opportunity Description following Components NOT accept SBIR Direct-to-Phase II submission: National Institute Nursing Research NINR) Part 2, Section II. Award Information Currently reads: Application Types Allowed New Phase I, Fast-Track) Renewal Phase II* Direct Phase IInotallowed) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision The OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. Modified to: Application Types Allowed New Phase I, Fast-Track) New Phase II - Direct Phase II) Renewal Phase II) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. other aspects these FOAs remain unchanged.   Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email: fertigs@ninds.nih.gov

HEAL Initiative: Notice Interest Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Applications Directed Enhanced Pain Management Improved Treatments Opioid Misuse Addiction Notice Number: NOT-NS-19-014 Key Dates Release Date: December 10, 2018 Related Announcements PA-18- 573 PA-18-574 PA-1 8 -575 PA-18-576 PAR-18-617 PAR-18-618 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) 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 Minority Health Health Disparities NIMHD) National Institute Nursing Research NINR) National Library Medicine NLM) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to rescind NOT-NS-18-076 and inform potential SBIR STTR applicants areas special interest related the NIH Helping End Addiction Long-term HEAL) Initiative , effort speed scientific solutions stem national opioid public health crisis. NIH Institutes Centers listed this notice interested receiving applications directed improving pain treatment, including development new non-addictive medications devices objective pain measurement. addition, NIH interested new screening tools models focused specifically pain development pain therapies. National Institute Drug Abuse NIDA) specifically interested receiving applications develop new approaches the prevention treatment opioid misuse, overdose addiction will help people opioid disorder OUD) achieve maintain meaningful sustained recovery.   Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email:  fertigs@ninds.nih.gov Elena Koustova, PhD, MBA National Institute Drug Abuse NIDA) Telephone: 301-496-8768  Email:  koustovae@mail.nih.gov

Notice Change Key Dates Change Matching Requirement Instructions RFA-NS-19-010 Optimization Non-Addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed)" Notice Number: NOT-NS-19-026 Key Dates Release Date: December 3, 2018 Related Announcements RFA-NS-19-010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Key Dates RFA-NS-19-010 Optimization Non-Addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed) to revise Matching Requirement Instructions. Specifically, first receipt date change January 4, 2019 toJanuary 9, 2019. Additionally, will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA). Currently Reads: Part 1. Overview Key Dates Open Date Earliest Submission Date) December 04, 2018 Application Due Date(s) January 4,2019 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 4, 2019and March 6, 2019, 5:00 PM 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. Modified Read: Part 1. Overview Key Dates Open Date Earliest Submission Date) December 9, 2018 Application Due Date(s) January 9, 2019and 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, 2019and March 6, 2019, 5:00 PM 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. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Implementation: program provides funding through UG3/UH3 cooperative agreement mechanism. a cooperative agreement, implementation involve participation NIH program staff the planning execution the therapy-directed projects. program envisioned a 5-year program two stages UG3 UH3. UG3 portion the award designed support optimization research two years. Our goal to fund 6-8 projects a limited budget the first 2 years during UG3 phase. Based the progress milestones, only limited number projects proceed the UH3 phase 3 years) the remainder the award period will include final optimization development leading IND-enabling studies, either through grant budget through additional contract resources outlined above. Matching Requirement: part the HEAL Initiative, FOA subject certain requirements for-profit applicant organizations. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contributionof federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018. applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributionsrequired under announcement. See45 CFR 75.306for additional details. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Implementation: program provides funding through UG3/UH3 cooperative agreement mechanism. a cooperative agreement, implementation involve participation NIH program staff the planning execution the therapy-directed projects. program envisioned a 5-year program two stages UG3 UH3. UG3 portion the award designed support optimization research two years. Our goal to fund 6-8 projects a limited budget the first 2 years during UG3 phase. Based the progress milestones, only limited number projects proceed the UH3 phase 3 years) the remainder the award period will include final optimization development leading IND-enabling studies, either through grant budget through additional contract resources outlined above. Currently Reads: Section III. Eligibility Information 2. Cost Sharing 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 theNIH Grants Policy Statement. 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. See45 CFR 75.306for 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. 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: an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration, data sharing , intellectual property must 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: an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration, data sharing , intellectual property must included. Currently Reads: Section VI. Award Administration Information 1. Award Notices Any application awarded response this FOA be subject terms conditions found theAward Conditions Information NIH Grantswebsite. includes any recent legislation policy applicable awards is highlighted this website. 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. See45 CFR 75.306for 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. Modified Read: Section VI. Award Administration Information 1. Award Notices Any application awarded response this FOA be subject terms conditions found theAward Conditions Information NIH Grantswebsite. includes any recent legislation policy applicable awards is highlighted this website. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Charles Cywin, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email:charles.cywin@nih.gov

Notice Intent Publish Funding Opportunity Announcement HEAL Pain Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required) Notice Number: NOT-NS-19-022 Key Dates Release Date:November 27, 2018 Estimated Publication Date Funding Opportunity Announcement: December 18, 2018 First Estimated Application Due Date: February 01, 2019 Earliest Estimated Award Date: June 01, 2019 Earliest Estimated Start Date: July 01, 2019 Related Announcements None Issued National Cancer Institute NCI) National Eye Institute NEI) National Institute Aging NIA) 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 Mental Health NIMH) National Institute Minority Health Health Disparities NIMHD) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Advancing Translational Sciences NCATS) National Center Complementary Integrative Health NCCIH) Office Behavioral Social Sciences Research OBSSR) Purpose April 2018, National Institutes Health NIH) launched HEAL Helping End Addiction Long-term) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. response this initiative, National Institute Neurologic Disorders Stroke the National Center Advancing Translational Sciences, partnership other NIH Institutes Offices, solicit applications propose clinical trials test comparative effectiveness existing therapies effectiveness novel approaches prevention management pain while reducing risk addiction. studies must address questions within mission research interests participating NIH Institutes Centers evaluate preventive strategies interventions including medications, biologics, procedures, medical assistive devices technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, delivery system strategies well controlled trials specific pain conditions. overall goal to inform clinicians the effectiveness interventions management strategies reduce opioid that improve functional outcomes reduce acute chronic pain associated many types diseases conditions, pain presenting a disease itself. Clinical trials be conducted within infrastructure the HEAL Pain Effectiveness Research Network. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published Winter 2018 an expected application due date early 2019 will utilize UG3/UH3 activity code. Details the planned FOA provided below. Research Initiative Details Description planned request applications RFA) support effectiveness clinical trials propose clinical trials test comparative effectiveness existing therapies effectiveness existing novel approaches prevention management pain while reducing risk addiction. overall goal to inform clinicians the effectiveness interventions management strategies reduce opioid that improve functional outcomes reduce pain across continuum acute chronic pain associated many types diseases conditions, pain presenting a disease itself.  Notice encourages investigators expertise area clinical research consider applying this planned FOA. Collaborative teams combining expertise pain management large clinical trials be crucial the success the studies.  planned initiative encourage UG3/UH3 phased cooperative research applications conduct efficient, large-scale effectiveness trials evaluate non-addictive therapies pain would reduce of opioids. Awards support one-year milestone-driven planning phase UG3), transition an implementation phase UH3) up four years, contingent meeting milestone feasibility requirements the planning phase. UG3/UH3 application must submitted a single application. Overview the HEAL Pain ERN Network Awardees be required conduct studies through NIH HEAL Pain Effectiveness Research Network HEAL Pain ERN), will dedicated pain clinical trial design expertise.  HEAL Pain ERN use infrastructure the NCATS Trial Innovation Network TIN) ( https://trialinnovationnetwork.org/ ) provide scientific guidance coordination the HEAL Pain ERN trials. TIN work the broad consortium Clinical Translational Science Awards CTSA) hubs ( https://ctsa.ncats.nih.gov/ ) other sites identified awardees implement studies. TIN investigators work UG3/UH3 awardees during planning implementation phases, will provide clinical coordination center CCC) services, data coordination center DCC) services, recruitment retention services, biostatistical support. Background Reducing burden pain nationwide a significant unmet need, individuals need safe, non-addictive treatments alleviate pain.  strength evidence the effectiveness current strategies currently used manage pain often low moderate CDC Guideline Prescribing Opioids Chronic Pain, AHRQ Noninvasive, Nonpharmacological Treatment Chronic Pain - Systematic Review). strategies include non-pharmacologic treatments specific chronic pain conditions, long-term opioid therapy different methods initiate titrate opioids.  studies also needed inform evidence-based non-opioid treatments the peri-operative setting . Federal Pain Research Strategy a long-term strategic plan guide federal agencies departments support pain research to advance science better understand pain improve pain care.  strategy includes several priority recommendations effectiveness research pain. further information these programs see:https://www.painconsortium.nih.gov/Funding_Research/Funding_Opportuniti…;   Research Objectives planned request applications clinical ldquo;effectiveness” research management pain ways reduce risk addiction. Effectiveness research defined the conduct synthesis research comparing benefits harms different interventions strategies prevent, treat monitor pain conditions ldquo;real world” settings. purpose this research to improve functional health outcomes developing disseminating evidence-based information patients, clinicians, other decision-makers, responding their expressed needs, which interventions most effective which patients under specific circumstances.  provide information, comparative effectiveness pain research must assess comprehensive array health-related outcomes diverse patient populations subgroups. Defined interventions be tested controlled trials include medications, biologics, procedures, medical assistive devices technologies, diagnostic testing, behavioral change, complementary approaches, rehabilitation strategies, integrated approaches, deliver system strategies.  planned request applications not accept applications propose testing interventions establish initial efficacy drugs, devices biologics approval the FDA. NIH Institutes, Centers Offices share goal alleviate pain through support clinical research develop evaluate interventions approaches alleviate pain ways reduce risk addiction. Applications interest include: Trials address weak evidence the efficacy different classes analgesics manage acute post-operative pain all populations after minor major surgical procedures; Trials establish methods translate efficacious non-opioid interventions management acute chronic pain conditions effective therapies can delivered successfully rural settings; Comparative effectiveness trials mind body approaches specific pain conditions, such low back pain, fibromyalgia, osteoarthritis headache. could include helping individuals manage pain and/or studies assess effective contributions family/caregivers managing pain; Trials prevent treat acute chronic nociceptive neuropathic pain clinical trials designed compare effectiveness non-opioid analgesics devices, either alone in novel combinations; Trials assess effectiveness interventions reduce pain disparities pain management health disparity populations; Trials determine effective interventions persistent pain older adults ways maximize function, minimize pain’s interference life, and/or mitigate pain treatment interactions underlying aging processes, co-occurring conditions, medications; Trials testing methods prevent manage persistent pain ways maximize function minimize pain’s interference life the following conditions: Gynecologic pain syndromes; Acute chronic cancer related pain syndromes caused the disease its treatment;  Pain associated diabetic neuropathy, Inflammatory Bowel Disease, pancreatitis, hepatitis, cholecystitis choledocholithiasis, Irritable Bowel Syndrome, functional abdominal pain other functional gastrointestinal disorders, urologic chronic pelvic pain syndrome, kidney stone disease; Pain associated temporomandibular joint disorders TMD), trigeminal neuropathies, burning mouth syndrome, oral cancer, dental pathologies. Chronic sickle cell disease pain. Acute chronic pain children. Acute chronic pain co-occurring mental health symptoms disorders. Trials testing clinical tools and/or interventions designed modify practitioner opioid prescribing behaviors; Funding Information Estimated Total Funding NIH intends fund approximately five awards, corresponding a total 13,800,000 total costs fiscal year 2019 25,800,000 total costs each fiscal year 2020 2023. Expected Number Awards 5 Estimated Award Ceiling TBD Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Linda Porter, Ph.D National Institute Neurological Disorders Stroke NINDS) 301-435-7572 porterl@ninds.nih.gov Institute contacts: Jane C. Atkinson, DDS National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov   Lanay Mudd, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-594-9346 Email: lanay.mudd@nih.gov   Diane St. Germain, RN, MS, CRNP National Cancer Institute NCI) Telephone: 240-276-7050 Email: dstgermain@mail.nih.gov   Lisa Onken, PhD National Institute Aging NIA) Telephone: 301-496-3136 Email: lisa.onken@nih.gov   Soundar Regunathan, PhD National Institute Alcohol Abuse Alcoholism National Institutes Health NIAAA) Telephone: 301-443-1192 Email: soundar.regunathan@nih.gov   Chuck Washabaugh, PhD National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5055 Email: washabac@mail.nih.gov   Susan Marden, PhD, RN National Center Medical Rehabilitation Research Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6838 Email: mardens@mail.nih.gov   Dena Fischer, DDS, MSD, MS National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4876 Email: dena.fischer@nih.gov   Jose Serrano MD, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-594-8871 Email: js362q@nih.gov   Eve E. Reider, PhD National Institute Mental Health NIMH) Telephone: 301-827-1496 Email: ereider@mail.nih.gov   Andrew Louden, PhD National Institute Minority Health Health Disparities NIMHD) Telephone: 301.594.9009 Email: Andrew.louden@nih.gov   Jeremy Brown, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-827-8375 Email: Jeremy.brown@nih.com   Lois A. Tully, PhD National Institute Nursing Research NINR) Telephone: 301-594-5968 Email: tullyla@mail.nih.gov