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

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

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

Notice Special Interest: Administrative Supplements Promote Expand the Research Development Medical Countermeasures Against Chemical Threats Notice Number: NOT-NS-20-030 Key Dates Release Date: January 6, 2020 First Available Due Date: February 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-029 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications existing awards are currently focused developing medical countermeasures MCMs) against chemical threats allow to expand research focus this critical field. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension. Application budgets limited no than amount the current award 125,000 total costs whichever lower) must reflect actual needs the proposed project. Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. scope research will supported this NOSI should consistent the following currently published funding opportunity announcements, PAR-18-721, PAR-19-030, PAR-19-040, including basic translational research through preclinical studies. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. Examples topics chemical agents interest include, are limited to: Pulmonary Agents Chlorine Phosgene): Development MCMs prevent treat lung damage including pulmonary edema fibrosis) resulting after exposure Pharmaceutical-based Agents Synthetic Opioids): Development MCMs treat life-threatening respiratory depression caused opioid intoxication. post-exposure treatments should quick-acting effective against variety opioids, e.g., fentanyl, carfentanil. NOT-NS-18-019 more details Vesicants Sulfur Mustard Lewisite): Development MCMs mitigate acute and/or long-term injuries resulting exposure the skin, eyes, mucous membranes vesicating agents. Specific areas interest include treating corneal neovascularization, fibrosis, mustard gas keratopathy. Cellular Respiration/Blood Agents Cyanide): Development MCMs treat acute poisoning. Antidotes should rapidly effective easily administered first responders Nerve Agents Organophosphorus OP) Pesticides: Development MCMs treat seizures either before after become refractory treatment benzodiazepines therapeutics promote neuronal survival other persistent effects after seizure termination. the federal monograph, Sarin: Potential Long-term Neurological Effects. are chemicals interest addition those listed above, Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent award the CounterACT Program Officer listed below) most relevant the supplement project well advance the receipt deadline determine responsiveness, programmatic interest, relevance. Applications propose research chemical threats are of interest the program not considered funding. 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 PA-18-591 must followed, the following additions Research Strategy part the application, include abstract the proposed research shows relevance developing chemical medical countermeasures. Summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent grant. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must also provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – February 3, 2020, April 1, 2020, June 1, 2020, August 3, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-NS-20-030” 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. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award the CounterACT Program Officer listed below) most relevant the supplemental project a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 125,000 total costs. Inquiries Please direct inquiries related the overall NIH CounterACT Program, neurological injury metabolic/blood research to: David A. Jett, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov questions related dermal/vesicant-induced injuries: Hung Tseng, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: tsengh@mail.nih.gov questions related ocular injury research: Houmam Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov questions related pulmonary injury research: Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov questions related pharmaceutical based agents: Kristopher Bough, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: boughk@nih.gov