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Notice Change Expiration Date Cancellation Final Three Receipt Dates RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)." Notice Number: NOT-NS-20-049 Key Dates Release Date: April 14, 2020 Related Announcements RFA-NS-19-018 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) 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 Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) 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. Purpose purpose this notice to inform interested applicants a change the expiration date cancellation the final three receipt dates RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)." Effective immediately, June 22, 2020, October 21, 2020, February 21, 2021 receipt dates been eliminated, the new expiration date this Funding Opportunity Announcement be April 16, 2020 earlier previously published). Changes the Key Dates section shown below. Part. 1 Overview Information Key Dates Currently Reads: Application Due Date(s) New Dates January 9, 2019, March 22, 2019, 20, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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. Scientific Merit Review New Dates April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review New Dates May 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date New Dates July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Expiration Date February 23, 2021 Modified Read: Application Due Date(s) New Dates January 9, 2019, March 22, 2019, 20, 2019, June 21, 2019, October 21, 2019, February 21, 2020 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. Scientific Merit Review New Dates April 2019, June 2019, June 2019, November 2019, March 2020, June 2020 Advisory Council Review New Dates May 2019, August 2019, August 2019, January 2020, 2020, August 2020 Earliest Start Date New Dates July 2019, October 2019, October 2019, March 2020, July 2020, October 2020 Expiration Date April 16, 2020 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Expiration Date RFA-EB-18-003 Notice Number: NOT-EB-20-009 Key Dates Release Date: April 14, 2020 Related Announcements RFA-EB-18-003 Issued National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) Purpose purpose this notice to inform interested applicants a change the expiration date cancellation the final three receipt dates RFA-EB-18-003 " HEAL Initiative: Translational Development Devices Treat Pain U18 Clinical Trial Allowed)." Effective immediately, June 22, 2020, October 21, 2020, February 21, 2021 receipt dates been eliminated, the new expiration date this Funding Opportunity Announcement be April 16, 2020 earlier previously published). Inquiries Please direct inquiries to: Michael B. Wolfson National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: Michael.Wolfson@nih.gov

Request Information RFI): Invitation Comment Updates NIH Research Plans Down Syndrome Notice Number: NOT-HD-20-013 Key Dates Release Date: April 13, 2020 Response Date: July 10, 2020 Related Announcements None Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) 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 Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Office The Director, National Institutes Health OD) Purpose Purpose Given rapidly evolving science this area, National Institutes Health NIH) recognizes need updating two current Down syndrome-related research plans invites comment the Down syndrome community update unify plans.Down Syndrome Directions: NIH Research Plan Down Syndromewas published 2014. recently, 2018, INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project released Research Plan address three major domains research - basic science, cohort building, clinical research. NIH proposes combine two plans one NIHINCLUDE Down SyndromeResearch Plan capture breadth research supported NIH Down syndrome. part this process, NIH welcomes comments the public concerning effectiveness the previous plans, advances since 2014, remaining research gaps, suggestions concerning new future research objectives. Background mission the NIH to seek fundamental knowledge the nature behavior living systems the application that knowledge enhance health, lengthen life, reduce illness disability. Research lifelong disorders, such Down syndrome, been fundamental part the NIHs mission over 60 years. Medical improvements societal changes extended life expectancy people this condition, the average lifespan a Caucasian Down syndrome doubled approximately 30 60 years over past 30 years; however, comparable data not exist racial ethnic minorities Down syndrome, whose average lifespan considerably lower. While intellectual disability the primary consequence having third copy chromosome 21 trisomy 21), people Down syndrome also higher risk the general population Alzheimers disease dementia, leukemia, autism, cataracts, celiac disease, congenital heart disease, sleep apnea, diabetes, other health conditions. the same time, people Down syndrome protected other health conditions such solid tumors myocardial infarction. INCLUDE project designed fill of knowledge gaps. first NIH Research Plan Down Syndrome published October 2007. was developed the Trans-NIH Down Syndrome Working Group, composed program scientists Institutes Centers across NIH, had charged coordinating ongoing research related Down syndrome to bolster new research efforts based identification the areas greatest scientific opportunity, especially they related the development future treatments. organizing research objectives groupings subject area timeframe, 2007 plan served inform Down syndrome community NIHs goals moving ahead this area fostered collaborations between NIH other agencies groups. 2014 plan,Down Syndrome Directions,was revised take account extensive input the Down syndrome community, particularly represented the Down Syndrome Consortium https://.downsyndrome.nih.gov), public-private partnership includes researchers, constituency organizations professional societies, individuals Down syndrome their families. plan included research goals five major areas: Pathophysiology Down Syndrome Disease Progression; Down Syndrome-Related Conditions: Diagnosis, Screening, Functional Measures; Treatment Management; Down Syndrome Aging; Research Infrastructure. details the research plan, see:https://www.nichd.nih.gov/sites/default/files/publications/pubs/Documen…. Congressional directive the fiscal year FY) 2018 Omnibus Appropriations legislation called a new trans-NIH research initiative critical health quality-of-life needs individuals Down syndrome. NIH launched INCLUDE project June 2018 support this initiative. primary focus to investigate conditions affect individuals Down syndrome the general population, such Alzheimers disease/dementia, leukemia, autism, cataracts, celiac disease, congenital heart disease, diabetes. FY 2018, NIH dedicated almost 23 million under new project through administrative supplements both Down syndrome-focused non-Down syndrome-focused grants. FY 2019, NIH provided 35 million new funding under Funding Opportunity Announcements https://www.nih.gov/include-project/funding). INCLUDE project, supported multiple NIH Institutes Centers, aims include people Down syndrome all aspects research, support dedicated basic science studies through opportunities participate existing future clinical trials. Importantly, INCLUDE project does represent entire sum NIH investments related Down syndrome. FY 2019, example, total 86 million. Congress provided 60 million INCLUDE FY 2020. INCLUDE projects goals summarized the following 3 components: Conduct targeted, high-risk, high-reward basic science studies chromosome 21 Assemble large study population individuals Down syndrome Include individuals Down syndrome existing future clinical trials further details, see:https://www.nih.gov/include-project/include-project-research-plan. Information Requested NIH interested soliciting comments suggestions a range stakeholders, including scientific community, people Down syndrome their families, constituency organizations, professional societies, regarding topics be included the revised, combined NIHINCLUDE Down SyndromeResearch Plan. Notice remain open until July 10, 2020. NIH interested responses the following topics: Whether any the objectives the 2014 NIH Research Plan Down Syndrome been achieved, full in part. Achievements date full in part) under INCLUDE project, whether any the goals its 2018 Research Plan been met. Seminal publications have resulted research Down syndrome supported NIH since 2014, including INCLUDE project. Revised research objectives aimed expediting research Down syndrome, including unmet needs basic, translational, clinical research, identifying whether is short- longer-term priority. Remaining research gaps addressed either 2014 NIH Research Plan Down Syndrome, the 2018 INCLUDE Research Plan, especially those can started completed within five- seven-year timeframe. Strategies disseminating evidence-based information NIH-supported research widely health care professionals families may caring people Down syndrome. Strategies facilitating collaborations, such public-private partnerships, expand scope number research objectives can addressed. Whether following overall structure the revised, combined NIH INCLUDE Down Syndrome Research Plan captures major goals NIH research efforts: Conducting basic science studies chromosome 21 areas highly relevant Down syndrome Conducting translational research, including connecting existing resources establishing cohort individuals Down syndrome study Including individuals Down syndrome existing future clinical trials, including individuals underrepresented racial ethnic minority groups, range functional abilities, underserved areas, including research co-occurring conditions Research Infrastructure including models study; DS-Connect: Down Syndrome Registryhttps://DSConnect.nih.gov) to Submit Response Responses be accepted until July 10, 2020. responses must submitted via email toDownSyndrome@mail.nih.gov. Please include notice number, NOT-OD-20-013, the subject line include complete contact information your response. submission be considered revising Research Plan. Confidential, personal, private identifiable information should be included part responses this RFI. anonymized summary the responses be posted the INCLUDE website:https://www.nih.gov/include-project. Inquiries Please direct inquiries to: Lisa Kaeser, JD Eunice Kennedy ShriverNational Institute Child Health Human Development NICHD) Email:DownSyndrome@mail.nih.gov

Notice Change Key Dates PAR-17-480 NINDS Renewal Awards SBIR Phase II Grants Phase IIB) Pre-Clinical Research R44)" Notice Number: NOT-NS-20-043 Key Dates Release Date: March 24, 2020 Related Announcements PAR-17-480 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the Key Dates PAR-17-480 NINDS Renewal Awards SBIR Phase II Grants Phase IIB) Pre-Clinical Research R44)". Funding Opportunity Announcement been extended one additional council round. following New Application Due Date been added: January 5, 2021. Currently Reads: Part 1. Overview Key Dates: Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. *** Note new SBIR/STTR Standard Due Dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date September 6, 2020 Modified Read: Part 1. Overview Key Dates: Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. *** Note new SBIR/STTR Standard Due Dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 6, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Emily Caporello, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1778 Email: Emily.caporello@nih.gov

Notice Change Key Dates PA-18-358 NINDS Exploratory Neuroscience Research Grant R21 - Clinical Trial Optional)" Notice Number: NOT-NS-20-042 Key Dates Release Date: March 12, 2020 Related Announcements PA-18-358 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the Key Dates PA-18-358 NINDS Exploratory Neuroscience Research Grant R21 - Clinical Trial Optional)" changes shown below italics). Funding Opportunity Announcement been extended one additional council round. dates been modified add following New Application Due Date: February 16, 2021, Resubmission date: March 16, 2021, AIDS application due date of May 7, 2021. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 8, 2021 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date 8, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Karrah BensonNational Institute Neurological Disorders Stroke NINDS) Karrah.Benson@nih.gov

Notice Change salary allowance K00 awardees NIH Blueprint Diversity Specialized Predoctoral Postdoctoral Advancement Neuroscience D-SPAN) Award F99/K00 Independent Clinical Trial Allowed) Notice Number: NOT-NS-20-040 Key Dates Release Date: March 9, 2020 Related Announcements RFA-NS-19-011 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) 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 purpose this notice to inform community the NIH Blueprint changing funding allowance F99/K00 applications RFA-NS-19-011. This change apply new continuing NIH Blueprint F99/K00 awards. Currently, NIH Blueprint provides to 50,000 salary plus fringe) during K00 phase. Effective new continuing K00 awards with FY 2020 funds (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-070.html), NIH Blueprint increase amount provided salary up 58,000, the following provisions unchanged: salary must consistent both the established salary structure the institution with salaries actually provided the institution its own funds other staff members equivalent qualifications, rank, responsibilities the department concerned. full-time, 12-month salaries not currently paid comparable staff members, salary proposed must appropriately related the existing salary structure. Inquiries Please direct inquiries to: Michelle Jones-London, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: jonesmiche@ninds.nih.gov

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

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

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

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