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The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data management, sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI provides an opportunity for existing HEAL Initiative awardees to increase data FAIR-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements from existing awards funded or supplemented by the HEAL Initiative or otherwise required to meet HEALs Public Access and Data Sharing Policy. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

This Notice of Special Interest (NOSI) provides an opportunity for clinical trials funded by the Helping to End Addiction Long-term (HEAL) initiative to address challenges of recruiting and engaging the diverse populations suffering from pain and opioid use disorder. NIH will support supplements to current HEAL awards that would either enhance their patient, community, and other stakeholder engagement efforts; improve diversity and inclusion among participants; or both, as appropriate for a particular study. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose. This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity of patient inclusion in HEAL clinical studies.

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI focuses on data discoverability, and provides an opportunity for existing HEAL Initiative awardees to increase data FAIR-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements only from existing awards funded or supplemented by the HEAL Initiative. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Centers are not eligible to apply. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

The purpose of this request for administrative supplements to current NIH-fundedstudies is to encourage clinical and translational research that will increase our understanding of the prevalence, psychological variables, and response to therapy in those individuals with multiple chronic overlapping pain conditions (COPCs). Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one pain disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the characteristics of overlapping pain conditions, the progression of these conditions, and therapeutic approaches best suited for treating individuals with COPCs. Research efforts in chronic pain conditions have focused on single disorders or types of pain such as neuropathic and inflammatory pain. These research efforts have generated a substantial body of information advancing our understanding of the underlying mechanisms of pain onset and development, the transition from acute to chronic pain, and therapeutic targets for treating acute and chronic pain. Over the past twenty years reports have documented the presence of more than one chronic pain condition in subjects with pain. Studies have identified overlap between a number of chronic pain conditions, including lower back pain, fibromyalgia (FM), vulvodynia, endometriosis, functional gastrointestinal disorders such as irritable bowel syndrome (IBS), temporomandibular joint disorder (TMD), migraine, tension headache, low back pain, and urologic chronic pelvic pain syndromes (UCPPS). These results suggest that chronic pain conditions may not be localized conditions but may share symptoms and mechanisms that involve a general central nervous system dysfunction as well as disorder-specific symptoms.

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

This Notice of Special Interest (NOSI) provides an opportunity for researchers funded by the Helping to End Addiction Long-Term (HEAL) initiative to devote more time for mentorship activities. The NIH defines a mentor as experienced scientist who can help guide the research of junior investigators and challenge them to develop independence as researchers. The objectives of mentoring include to enhancing a mentees approach to scientific investigation, developing their critical thinking and communication skills and assisting with their progression the research community. Mentoring responsibilities involve helping junior investigators defining research goals, supporting the achievement of those goals, and discussing and evaluating progress throughout training. A mentor should provide constructive and timely feedback, support training, networking and professional development opportunities, and acknowledge a mentees contribution to research. The award is intended to provide protected time for established investigators supported by the HEAL Initiative to simultaneously provide mentoring to junior investigators. The supplement is intended for investigators (principal investigators or co-investigators) who have a record of supervising and mentoring clinical pain researchers. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose.

This Notice of Special Interest (NOSI) provides an opportunity for clinical trials funded by the Helping to End Addiction Long-term (HEAL) initiative to address challenges of recruiting and engaging the diverse populations suffering from pain and opioid use disorder. NIH will support supplements to current HEAL awards that would either enhance their patient, community, and other stakeholder engagement efforts; improve diversity and inclusion among participants; or both, as appropriate for a particular study. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose. This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity of patient inclusion in HEAL clinical studies.

HEAL Initiative: Notice Special Interest NOSI) regarding Availability Administrative Supplements Support Strategies Reduce Stigma Pain Management Opioid Disorder OUD) Treatment Notice Number: NOT-OD-20-101 Key Dates Release Date: April 23, 2020 First Available Due Date: 29, 2020 Expiration Date: 30, 2020 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Office Behavioral Social Sciences Research OBSSR) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Division Program Coordination, Planning Strategic Initiatives, Office Disease Prevention ODP) Office Research Women's Health ORWH) Purpose Notice Special Interest NOSI) calls research stigma the context chronic pain management opioid or opioid disorder OUD). part NIH’s Helping End Addiction Long Term HEAL) Initiative, NIH support supplements current HEAL awards address challenges people affected the opioid crisis stigma, discrimination prejudice related chronic pain management the context opioid and/or opioid disorder its treatment. NOSI calls applications integrate incorporate stigma research ongoing HEAL funded chronic pain OUD studies order address stigma is occurring the context chronic pain and/or OUD. Because stigma research require large clinical community networks, supplement program designed leverage many networks already being developed through HEAL awards. supplement program not intended support research basic processes e.g. cultural attitudes) rather result strategies enable rapid implementation changes. total up 3.5 million available supplement existing HEAL grants cooperative agreements, up 1 year, evaluate strategies reduce stigma improve treatment, management services people chronic pain and/or OUD. Supplement requests not need address possible aspects stigma the context chronic pain or OUD, it encouraged appropriate consider piloting multi-layer, multicomponent interventions address stigma these contexts. Background 50 million adults the United States chronic daily pain. 19.6 million adults experience chronic pain interferes daily life work activities. Misuse addiction opioids, including prescription pain relievers, synthetic opioids such fentanyl, heroin become serious national health crisis. than130 people die every day an opioid-related drug overdose. Stigma be barrier treatment both people chronic pain the context being treated opioids also people OUD related painful conditions. Appropriate care needed address suffering people pain and/or OUD it critical address challenges associated stigma living these conditions, seeking care support pain management and/or recovery OUD. Stigma be barrier treatment both painful conditions substance abuse. Studies suggest people chronic pain are receiving who previously received opioid treatment face stigma their healthcare providers, family, friends, coworkers, health care system, society general. Stigma also major barrier implementation programs treatments chronic pain opioid disorder, such medication assisted treatment naloxone. People chronic pain problematic opioid report significant perceived stigma associated methadone buprenorphine treatment. Stigma also lead severe consequences people chronic pain long term opioid face acute opioid withdrawal due stigma. Chronic pain often stigmatized itself some approaches address opioid crisis led stigma related addictions be also applied people chronic pain. Stigma be challenge people pain and/or substance disorders, families, caregivers, clinicians. Reducing barriers care exist because stigma crucial care people for treatment effectiveness both chronic pain management and/or OUD. Research Objectives order effectively reduce stigma related the treatment chronic pain the context the opioid crisis and/or stigma related OUD, NIH encouraging submission applications supplements active grants provide evidence-based data inform strategies reduce stigma build resilience discrimination those chronic pain and/or OUD. High priority supplements will: Analyze strategies reduce stigma, discrimination prejudice related chronic pain management and/or OUD impact areas such prevention, management treatment access effectiveness recovery; existing psychometrically validated tools measure stigma only very compelling rationales, support development any new measurement tool. Research areas interest include: Prejudice care providers undermine treatment health QOL Strategies address stigma a variety contexts includes: among healthcare providers, workplace colleagues, emergency responders, family friends others; impact internalized anticipated stigma prevention, management, treatment recovery; adaption application existing theories health related stigma chronic pain and/or OUD reducing stigma; Rather the creation new measurement tools, use psychometrically validated measures stigma other populations e.g. HIV, mental illness) their application these populations. Analyses combinations approaches are known reduce discrimination prejudice a variety situations workplace- supervisors, colleagues; family friends, healthcare providers, emergency responders, community); Strategies address internalized stigma; Approaches build resilience discrimination prejudice these populations First stage development multicomponent approaches could expanded implemented large scale multicomponent research projects. Researchers find materials related the 2017 meeting: The Science Stigma Reduction that sponsored the National Institutes Health NIH) helpful. Description circumstances which administrative supplements available. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – Applications be accepted through 29 , 2020 , 5:00 PM local time applicant organization. NOSI expires May 30 , 2020 funding consideration, applicants must include ldquo;NOT-OD-20 101” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. parent award must active the application submitted. project budget periods must within currently approved project period the existing parent award. Applications non-responsive the terms this Notice be be considered this initiative. Review criteria, addition those described PA-18-591, include following: Does PI(s)/PD(s) expertise stigma, pain management and/or addiction appropriate the study stigma chronic pain opioid use? Does application propose engage people chronic pain and/or those OUD, providers, relevant stakeholders identifying key questions regarding stigma chronic pain management opioid and treatment? successful, does application the potential be implemented broadly Administrative supplement applications to PA-18-591 must the application form package the Competition ID contains ldquo;FORMS-F-ADMINSUPP”. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Investigators planning submit application response the NOSI strongly encouraged contact appropriate Institute Center contact listed the NOSI discuss proposed project the context the parent award. Questions specific this NOSI should sent the contact listed the NOSI. nbsp; Inquiries Please direct inquiries to: Wendy B. Smith, MA, PhD, BCBAssociate DirectorOffice Behavioral Social Sciences Research OBSSR)Tel: 301-435-3718Email: smithwe@mail.nih.gov Wendy Weber, N.D., PhD., MPHNational Center Complementary Integrative Health NCCIH)Tel: 301-402-1272Email: mailto:weberwj@mail.nih.gov Alexis Bakos, PhD., MPH., RN National Cancer Institute NCI)Tel: 240-276-6609Email: alexis.bakos@nih.gov Leslie K. Derr, Ph.D.National Institute Arthritis Musculoskeletal Skin Diseases NIAMS)Tel: 301-402-4735 Email: derrl@mail.nih.gov M. Aklin, Ph.D.National Institute Drug Abuse NIDA)Tel: 301-827-5909Email: aklinwm@nida.nih.gov Shelley Su, Ph.D.National Institute Drug Abuse NIDA)Tel: 301-402-3869Email: shelley.su@nih.gov Yolanda Vallejo, PhD.National Institute Dental Craniofacial Research NIDCR)Tel: 301-827-4655Email: Yolanda.Vallejo@nih.gov Paul L. Kimmel, MDNational Institute Diabetes Digestive Kidney Diseases NIDDK)Tel: 301-594-1409Email:  Kimmelp@mail.nih.gov Durga Mohapatra, Ph.D.National Institute Neurological Disorders Stroke NINDS)Tel: 301-827-7403Email: dp.mohapatra@nih.gov Jacqueline Lloyd, PhD, MSWOffice Disease Prevention ODP)Tel: 301-827-5559Email: lloydj2@nih.gov

Notice Special Interest Encourage Eligible NIH HEAL Initiative Awardees Apply Administrative Supplements Promote Training Clinical Research Pain Admin Supp – Clinical Trial Allowed) Notice Number: NOT-NS-20-044 Key Dates Release Date: April 10, 2020 First Available Due Date: 15, 2020 xpiration Date: July 31, 2020 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Center Complementary Integrative Health NCCIH) Office Strategic Coordination Common Fund) National Cancer Institute NCI) Purpose NIH Helping End Addiction Long TermSM (HEAL) Initiative aims improve our understanding, management treatment pain funding high quality scientific research this relatively understudied area medicine. the HEAL Initiative NIH meet long-term goals providing effective non-opioid options the treatment pain conditions innovative approaches treating opioid disorders, will necessary train new generation clinical pain researchers. Leveraging HEAL Initiative clinical research programs train novice researchers investigators new pain research the mechanics, techniques, best practices clinical pain research maximize impact HEAL funding both current future research endeavors. Increasing number individuals trained high quality clinical pain research a critical step toward ensuring highest impact HEAL, studies encompass broad range pain conditions have potential include, address needs of, positively impact diverse traditionally underserved patient populations. supplement existing HEAL clinical research awards intended allow exceptional graduate, post-doctoral e.g., MD, DO, DDS, PhD), early career individuals hereafter ldquo;candidates”) expand clinical pain research experience gain access the tools skills needed prepare for career clinical pain research. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – 15, 2020 July 1, 2020 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-NS-20-044” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one two years support only. Only existing awardees active HEAL Initiative Clinical Research Pain Management awards including EPPIC-Net, BACPAC, ERN, PRISM, HOPE programs) the HEAL associated Common Fund A2CPS program eligible apply. Applications supplement parent grants sites performing clinical studies be prioritized. project budget periods this supplement must within currently approved project period the parent award parent award must active not a cost extension the entire extent a supplement). A?dministrative supplement applications to PA-18-591 must the application form package the Competition ID contains ldquo;FORMS-E-ADMINSUPP”. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Research Strategy section the application limited 5 pages two additional sections/attachments, PD/PI statement a candidate statement required descriptions below). Research Strategy Research Experience Plan; 5 pages) Describe plan the candidate’s research under supplement is within scope the funded parent HEAL Initiative research project. Identify research-related experiences be new the candidate how experiences contribute the candidate’s development a clinical pain researcher enhance ability contribute a meaningful to both current future clinical pain research projects. Describe goals will achieved during supplement award period. Examples goals include gaining experience new methodologies, assessment pain management pain management techniques the research setting, recruiting study participants, acquiring and/or analyzing data, preparing manuscripts publication, applying independent research funding. the first sentence the Research Strategy, applicants requested state the parent grant awarded a HEAL Initiative award to identify specific FOA the parent grant e.g., RFA-NS-19-016) facilitate processing the supplement application. additional sections/attachments required should attached PDF documents the ldquo;Other Attachments” field. PD/PI Statement 1 page) Describe qualifications track record the PD/PI the parent grant supporting co-investigators, applicable) mentoring graduate post-doctoral trainees clinical pain research. addition, describe specific plans mentorship this candidate during proposed research experience. Candidate Statement 3 pages) candidate should describe prior research experience, clinical experience the assessment, management, treatment pain, their accomplishments. candidate should also describe short- long-term research-related goals the ways which additional research experiences outlined this supplemental application help to achieve goals. Award Budget HEAL Initiative provide support up 50,000K per year a maximum 2 years up eight awards FY2020 FY2021. Awards be used provide salary support the candidate and/or funding relevant travel coursework. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Applications non-responsive terms this NOSI be be considered the NOSI initiative nbsp; Inquiries Please direct inquiries to: Rebecca Hommer, MDNational Institute Neurological Disorders amp; StrokeTelephone: 301-827-2257 Email: rebecca.hommer@nih.gov