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The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

The purpose of this FOA is to establish expert panels that will select genes and genomic variants associated with diseases or conditions of high priority to participating NIH Institutes and Centers (ICs) and systematically determine their clinical significance for diagnosis and treatment of these diseases or conditions. The Genomic Expert Curation Panels funded through this FOA are r?e?q?u?i?r?e?d to utilize the NHGRI Clinical Genomics Resource (ClinGen) and the NCBI ClinVar procedures, interfaces, tools and informatics infrastructure to determine the strength of evidence supporting the clinical significance of the selected genes and variants that will support development of clinical practice guidelines.

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management and reduce the use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to identify effective methods to improve the management of pain and reduce the need for opioid medications at the health care system level. This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care system; or implement health care system changes to improve adherence to evidence-based guidelines. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications that propose clinical trials to test the comparative effectiveness of existing pharmacological therapies or devices for prevention or management of pain while reducing risk of addiction. The studies must evaluate methods to manage specific pain conditions that are within the mission and research interests of participating NIH Institutes and Centers, and evaluate interventions including medications, biologics, medical and assistive devices or delivery system strategies in controlled trials. This FOA does not include testing behavioral interventions for management of pain. The overall goal is to inform clinicians about the effectiveness of pharmacological or device interventions or management strategies concerning use of these interventions that reduce opioid use, improve functional outcomes and reduce pain for diseases or conditions of interest. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.

This funding opportunity announcement is designed to support biomedical data repositories. Biomedical data repositories under this announcement should have the primary function to ingest, archive, preserve, manage, distribute, and make accessible the data related to a particular system or systems. Support for data curation must be limited to that which improves the efficiency and accessibility of data ingestion, management, and use and reuse by the user communities. Support for software and tool development must be limited to that which provides essential functions or significantly increases the efficiency of operation of the repository. Applications that have a significant focus on software and tool development are not appropriate for this activity.

This funding opportunity announcement is designed to support biomedical knowledgebases. Biomedical knowledgebases under this announcement should have the primary function to extract, accumulate, organize, annotate, and link growing bodies of information related to core datasets. Support for data curation should include efficient and effective methods of curation that scale to the needs of community and include semi-automated methods. Support for software and tool development must be limited to that which provides essential functions or significantly increases the efficiency of operation of the knowledgebase. Applications that have a significant focus on software and tool development are not appropriate for this activity.

Notice Special Interest NOSI): Administrative Supplement Continuity Biomedical Behavioral Research Among First-Time Recipients NIH Research Project Grant Awards Notice Number: NOT-OD-20-055 Key Dates Release Date: January 17, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 Issued Office The Director, National Institutes Health OD)National Eye Institute NEI)National Heart, Lung, Blood Institute NHLBI)National Human Genome Research Institute NHGRI)National Institute Aging NIA)National Institute Alcohol Abuse Alcoholism NIAAA)National Institute Allergy Infectious Diseases NIAID)National Insrtitute Arthritis Musculoskeletal Skin Diseases NIAMS)National Institute Biomedical Imaging Bioengineering NIBIB)National Institute Deafness Other Cormmunication Disorders NIDCD)National Institute Dental Craniofacial Research NIDCR)National Institute Diabetes Digestive Kidney Diseases NIDDK)National Institute Drug Abuse NIDA)National Institute Environmental Health Sciences NIEHS)National Institute General Medical Sciences NIGMS)National Institute Mental Health NIMH)National Institute Neurological Disorders Stroke NINDS)National Institute Nursing Research NINR)National Institute Minority Health Health Disparities NIMHD)National Library Medicine NLM)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. Office Behavioral Social Sciences Research OBSSR) Purpose overarching goal this pilot program to enhance retention investigators facing critical life events are transitioning the first renewal their first independent research project grant award to second new NIH research project grant award. Retention the first renewal continuous NIH research project grant support crucial sustaining both ongoing research NIH made investment and retaining diversity the biomedical research workforce. program supports at-risk investigators identified the NIH Next Generation Researchers Initiative seehttps://grants.nih.gov/ngri.htm). retention program seeks maintain productivity current first-time recipients eligible independent NIH research project grant awards are dealing a critical life event(s), such they remain competitive the first renewal their award for second research project grant award. retention supplements support transition K award independence, the companion NOSI. Background Investigators, especially women, leave science critical transition stages branching points their career for NIH-supported scientific workforce include transitions post-doctoral training faculty positions Heggeness et al., 2016,Acad Med,doi:10.1097/ACM.0000000000001209and Nikaj et al., 2019, FASEB Journal,doi:10.1096/fj.201800639) prior obtaining first R01 renewal Hechtman et al., 2018, PNAS,doi:10.1073/pnas.1800615115). rate R01/R01-equiv renewals potential impact the longevity an investigators research career Pohlhaus et al., 2011,Acad Med,doi:10.1097/ACM.0b013e31821836ff) remains gender disparity NIH funding should addressed. vulnerable career stages often parallel critical life events commonly contribute faculty attrition. Data NSF demonstrates among racial ethnic groups both biomedical scientists engineers, women far likely men cite family responsibilities a reason leaving work force https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). Pregnancy childbirth particular, appear be significant contributors the underemployment women scientists engineers given pregnancy impact research productivity Cech Blair-Loy 2018, Changing career trajectories new parents STEM;https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). demands childbirth subsequent primary caregiving responsibilities necessitate changes career goals alter researchers career trajectories, depriving scientific workforce an important source talent undermining NIHs investment promising avenues new research. Retaining investigators this critical transition point protect research investment already via parent NIH award enhance diversity the investigator pool. Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget request limited 1 year. Supplement budget requests cannot exceed 50,000/year direct costs, applicable F&A indirect) cost also requested. Budgets not exceed total direct costs the current parent award. Requests must reflect actual needs the proposed project. Categorical budgets permitted. Awards subject availability funds. Flexible of supplemental funds highly encouraged, may include all inclusive)computational services, supplies, equipment, supported effort additional scientific staff sustain PD/PIs research during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the program:DP1,DP2,DP5,R01,R00,R15,R21,R35,RF1, andU01and have qualifying critical life event. PD/PIs more one independent research project grant award ineligible this supplement. Qualifying Critical Life Events: PD/PI must demonstrate critical life event such childbirth adoption during parent grant project period; primary caregiving responsibilities an ailing spouse, partner, a member the immediate family. circumstances which critical life event pending is expected occur during project period, supplement period be submitted advance the event. supplements parent awards include multiple PDs/PIs, supplement be requested any the PDs/PIs accordance the existing leadership plan on behalf the PD/PI meets eligibility criteria) submitted the grantee institution the parent award. should noted for parent grant for administrative supplement, grantee the institution, the PD/PI. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)PA-18-591or subsequent reissued equivalent. Supplement requests must submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. . instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) Submission dates vary awarding IC.SeeTable IC-Specific Information, Requirements Staff Contactsfor details. funding consideration, applicants must include NOT-OD-20-055 without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Research Strategy section the application limited 6 pages. R&R Project Information form, the Attachments" field: Attach Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Attach Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicants return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the Institute supporting parent award SeeTable IC-Specific Information, Requirements Staff Contacts)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process IC conduct administrative reviews applications submitted their IC. ICs the parent grants support most meritorious applications submitted consideration, pending availability funds. Criteria: the work/activities proposed within scope the parent award? the progress the project prior the life event adequate? the administrative supplement increase preserve likelihood the project succeed, assist candidate complete research project submit timely renewal new research project grant application? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Melissa Ghim, PhD Office Research Womens Health ORWH) Division Program Coordination, Planning, Strategic Initiatives DPCPSI) Telephone: 301-496-7853 Email:melissa.ghim@nih.gov

The FOA invites applications that will apply computational approaches to the integration and analysis of clinical, genomic and transcriptomic data from the Accelerating Medicine Partnership in Parkinsons disease (AMP PD) to advance the identification of algorithms, biomarkers, and disease pathways related to the diagnosis, prognosis and progression of Parkinsons disease. Development of tools and workflows for data visualization and integration across data modalities and their application to AMP PD data are also supported.

This FOA invites applications for Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions (hereafter termed "Fragile X Centers"). Successful Centers will be composed of multidisciplinary teams of investigators collaborating to address specific research priorities identified in the Strategic Plan.

HEAL Initiative: Back Pain Consortium BACPAC) Research Program Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions. Notice Number: NOT-AR-20-016 Key Dates Release Date: January 15, 2020 First Available Due Date: March 13, 2020 Expiration Date: March 14, 2020 Related Announcements PA-18-935NOT-AR-20-015 Issued National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Purpose Notice Special Interest NOSI) calls research pain management the context opioid or opioid disorder OUD). particular, NIAMS interested providing data-driven evidence regarding effective mechanisms reducing reliance opioids while maintaining quality life. Funds Competitive Revisions active grants available part the NIH HEAL Helping End Addiction Long-termSM) Initiative awardees operate within Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM. Investigators active grants the area chronic pain and/or addiction encouraged apply. award two phases, one-year Planning Phase a to three year Research Project Phase. Background Back Pain the major form chronic pain among adults worldwide the most common, non-cancer reason opioid prescription the US. NIH HEAL InitiativeSM is trans-NIH initiative the aims improving treatments opioid misuse addiction; enhancing pain management, understanding biological underpinnings chronic pain accelerating discovery development non-addictive treatments pain. Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM, provides platform research the intersection pain management opioid or opioid disorder OUD). BACPAC a patient-centric translational research initiative, is taking biopsychosocial approach the study chronic low back pain cLBP) the need more effective personalized treatments. Research Objectives order effectively reduce reliance opioids the treatment chronic low back pain while maintaining quality life, NIAMS encouraging submission applications Competitive Revisions active grants provide evidence-based data inform clinical practice guidelines. Research areas interest include: Project Planning Phase - are key questions providers patients with respect opioid for managing chronic pain? Questions interest might patient-centric and/or provider-focused, e.g., is appropriate prescribe opioids chronic pain; someone already taking opioids pain management are most effective means reducing dependence; alternatives exist? Research Project Phase - Investigators should propose strategies test most effective means managing pain while reducing dependence opioids the intent informing clinical practice. Award Information NIAMS intends commit 320,000 FY2020, Planning Phase, 800,000 year the Research Project Phase, FY2021 through FY2023, fund to awards. Budget research project length should reflect project needs, the parent grant must active throughout duration the Competitive Revision. Awardees expected share data resources consistent the guidelines policies the NIH, NIH HEAL InitiativeSM, as developed the Steering Committee the BACPAC Research Program. Adherence these guidelines policies be required the terms conditions award. Application Submission Information Applications response this NOSI must submitted using following target funding opportunity: PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Eligible activity codes applications to PA-18-935 are dependent upon target Institute, Center, Office ICO). Table 1 lists activity codes will accepted each participating ICO. Table 1: Eligible Activity Codes Participating ICO Activity Code NIAMS NIBIB NINR NIMHD NICHD NIAAA NCATS NCCIH NIDA NINDS DP1 NIH Director’s Pioneer Award Yes Yes No No Yes Yes Yes P01 Research Program Projects No No No Yes Yes P41 Research Program Projects Centers Yes No No No No P50 Specialized Center Yes No No Yes Yes Yes R01 Research Project Grant Yes Yes Yes Yes Yes Yes Yes Yes Yes R35 Outstanding Investigator Award No No No No Yes R61 Phase 1 Exploratory/Developmental Grant Yes No No No Yes Yes Yes U01 Research Project – Cooperative Agreements Yes Yes Yes No Yes Yes Yes Yes Yes U18 Research Demonstration- Cooperative Agreements Yes Yes No No No Yes Yes U19 Research Program Cooperative Agreement Yes No Yes No Yes Yes U24 Resource-Related Research Projects – Cooperative Agreements Yes Yes No Yes Yes Yes Yes U54 Specialized Center- Cooperative Agreements Yes Yes Yes No Yes Yes Yes U2C Resource-Related Research Multi-Component Projects Centers Cooperative Agreements No No No No Yes UF1 Multi-Year Funded Research Project Cooperative Agreement No No No No Yes UG1 Clinical Research Cooperative Agreements-Single Project Yes No No No Yes Yes UH3 Exploratory/Developmental Phased Award Cooperative Agreement Yes Yes No No Yes Yes Yes Yes UM1 Multi-Component Research Project Cooperative Agreements No No No No Yes All instructions the SF424 R&R) Application Guide and PA-18-935 must followed, the following additions: Research Strategy section the application limited 12 pages. award project period the Competitive Revision must three four years, one year the Planning Phase two three years the Research Project Phase. deadline applications is March 13, 2020 5:00 PM local time of applicant organization. NOSI expires March 14, 2020. application submitted response this NOSI is received March 14, 2020 later, be withdrawn. Applications should must submitted PA-18-935, ldquo;Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement – Clinical Trial Optional)" using application forms package the Competition ID ldquo;NOT-AR-20-016-FORMS-E” IMPORTANT: funding consideration, applicants must designate NOT-AR-20-016 in Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. Applications non-responsive the terms this Notice be be considered this initiative. Review criteria, addition those described PA-18-935, include following: Does PI(s)/PD(s) expertise pain management and/or addiction appropriate the study low back pain opioid use? Does application propose engage patients, providers, relevant stakeholders identifying key questions regarding pain management opioid use, curtailment, alternatives opioids? successful, does application the potential inform clinical decision making? the PI(s)/PD(s) considered their work might interface or avail the BACPAC research program? 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 to bacpac-nih@mail.nih.gov. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. nbsp; Inquiries Please direct inquiries to: Scientific/Research Contact(s) Leslie K. Derr, Ph.D National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-402-4735 Email: derrl@mail.nih.gov Laura Kwako, PhDNational Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-451-8507 Email: laura.kwako@nih.gov Michael B. Wolfson, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: Michael.Wolfson@nih.gov Susan Marden PhD RN Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6838 Email: mardens@mail.nih.gov Shelley Su, PhD National Institute Drug Abuse NIDA) Telephone: 301-402-3869 Email: shelley.su@nih.gov Benyam Hailu, MD, MPH National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8696 Email: Benyam.Hailu@nih.gov Michael L. Oshinsky, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov D.P. Mohapatra, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dp.mohapatra@nih.gov Lois A. Tully, PhD National Institute Nursing Research NINR) Telephone: 301-594-5968 Email: tullyla@mail.nih.gov Lanay M. Mudd, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-594-9346 Email: Lanay.mudd@nih.gov Jane Atkinson, DDS National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov Lisa Begg, Dr.P.H., R.N.Office Research Women’s Health ORWH) Telephone: 301/496-3975 E-mail: beggl@od.nih.gov