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Notice Change Application Types Allowed RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)" Notice Number: NOT-NS-19-072 Key Dates Release Date: June 28, 2019 Related Announcements RFA-NS-18-021 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Deafness Other Communication Disorders NIDCD) Purpose purpose this notice to inform applicants revision applications be accepted response RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)". Changes listed below bold italics). notice be effective the October 21, 2019 due date subsequent due dates. Currently Reads: Section II. Award Information Application Types Allowed? New Resubmission Modified Read: Section II. Award Information Application Types Allowed New Resubmission Revision 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 Correction Application Submission Information PAR-18-543 CREATE Bio Development Track: Nonclinical Early-Phase Clinical Development Biologics U44 Clinical Trial Optional)" Notice Number: NOT-NS-19-070 Key Dates Release Date: June 19, 2019 Related Announcements PAR-18-543 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants a correction the Application Submission Information for PAR-18-543 , CREATE Bio Development Track: Nonclinical Early-Phase Clinical Development Biologics U44 Clinical Trial Optional) ". Application Submission Information Section been modified include information was erroneously omitted. notice be effective the July 18, 2019 receipt date subsequent due dates. correction applies the sentence below written in bold italics) the Page Limitations Section IV.2. Content Form Application Submission. page limitations described the SF424 R&R) SBIR/STTR Application Guide the Table Page Limits must followed. sentence corrected read: page limitations described the SF424 R&R) SBIR/STTR Application Guide the Table Page Limits must followed. this specific FOA, Research Strategy section limited 30 pages. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Chris Boshoff, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: chris.boshoff@nih.gov

Notice Allow Requests Budget Increases NINDS Research Program Award R35) Notice Number: NOT-NS-19-058 Key Dates Release Date: June 12, 2019 Related Announcements RFA-NS-19-037 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform current future recipients the NINDS R35 Research Program Award RPA) the opportunity request budget increase based exceptional circumstances the year five 5) administrative review. RPA provides long-term support Principal Investigators PIs) consolidating NINDS research support a single funding vehicle up eight years a fixed level is generally commensurate the PI’s funding over prior four years. greater funding stability provides recipients increased freedom flexibility, allowing to more adventurous their research, take greater risks, embark upon research breaks new ground, undertake research projects require longer timeframe, and/or extend previous discoveries new directions. Under exceptional circumstances, will consider requests budget increases the year five administrative review capitalize groundbreaking scientific findings. Although RPA budget exceed 750K direct costs DC) per year, requests increases 50K DC increments, a maximum 150K DC, be considered discussed the NINDS Advisory Council. approved, increase extend the duration the award. evaluating proposed budget increase, factors NINDS consider include: 1) PI’s support including non-NIH non-Federal funding); 2) career stage the PI; 3) progress the research program during first four years the R35 award; 4) size the initial R35 award. PIs significant support generally receive budget increases. specific guidance be provided R35-funded investigators advance the Year 5 administrative review. Inquiries Please direct inquiries to: Anna Taylor, Ph.D. National Institute Neurological Disorders Stroke NINDS) / Division Extramural Activities DEA) Telephone: 301-827-3565 Email: Anna.Taylor@nih.gov

Notice Intent Publish Funding Opportunity Announcement NIH Blueprint Neuroscience Research Education Program Translational Devices R25) Notice Number: NOT-NS-19-068 Key Dates Release Date: June 12, 2019 Estimated Publication Date Funding Opportunity Announcement: August 16, 2019 First Estimated Application Due Date: December 16, 2019 Earliest Estimated Award Date: June 01, 2020 Earliest Estimated Start Date: July 01, 2020 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) 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 National Institute Neurological Disorders Stroke NINDS), other NIH Institutes Centers the NIH Blueprint Neuroscience Research consortium, intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications develop comprehensive set short courses draws lessons learned academia industry is aimed filling translational knowledge gap the academic investigator small business communities. courses should address unique challenges inherent developing translating novel devices diagnose treat nervous system disorders. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects anticipation the FOA. FOA expected be published the summer 2019 an expected application due date the winter 2019. FOA utilize R25 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights successful development translation medical devices diagnose treat nervous system disorders begin consider applying this new FOA. Applicants be encouraged develop creative education activities focused 1) steps required successful device development translation eg, animal model selection, good laboratory practices, quality systems, regulatory activities, clinical trial design, etc.), 2) common technical strategic challenges, 3) providing resources mentors each stage the process. education activities be expected address broad audience, including post-doctoral fellows, independent academic researchers, small business entrepreneurs. Applications be expected describe critical aspects of a program plan including, not limited to, course details, location, personnel, educational environment/facilities, recruitment diversity strategies. should also address to incorporate responsible conduct research ethical considerations developing translating devices, course evaluation methods, dissemination plans make course materials widely available. Funding Information Estimated Total Funding 250,000 direct costs Expected Number Awards 1 Estimated Award Ceiling 250,000 direct costs 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 Eligible Agencies the Federal Government Applications not being solicited this time. Inquiries Please direct inquiries to: Kari Ashmont, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-1779 kari.ashmont@nih.gov

Notice Change Key Dates PAR-18-710 Career Transition Award NINDS Intramural Clinician-Scientists K22 Clinical Trial Required)" Notice Number: NOT-NS-19-066 Key Dates Release Date: June 6, 2019 Related Announcements PAR-18-710 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the Key Dates PAR-18-710 Career Transition Award NINDS Intramural Clinician-Scientists K22 Clinical Trial Required)" changes shown bold italics below). Funding Opportunity Announcement been modified add following New Application Due dates: October 12, 2019, February 12, 2020; June 12, 2020; October 12, 2020; February 12, 2021; June 12, 2021 and resubmission application due dates: November 12, 2019; March 12, 2020; July 12, 2020; November 12, 2020; March 12, 2021; July 12, 2021. Currently Reads: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 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 Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date July 13, 2019 Modified Read: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date July 13, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Change Key Dates PAR-18-711 Career Transition Award NINDS Intramural Clinician-Scientists K22 Clinical Trial Allowed)" Notice Number: NOT-NS-19-067 Key Dates Release Date: June 6, 2019 Related Announcements PAR-18-711 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the Key Dates PAR-18-711 Career Transition Award NINDS Intramural Clinician-Scientists K22 Clinical Trial Allowed)" changes shown bold italics below). Funding Opportunity Announcement been modified add following New Application Due dates: October 12, 2019, February 12, 2020; June 12, 2020; October 12, 2020; February 12, 2021; June 12, 2021 and resubmission application due dates: November 12, 2019; March 12, 2020; July 12, 2020; November 12, 2020; March 12, 2021; July 12, 2021. Currently Reads: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 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 Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date July 13, 2019 Modified Read: Part 1. Overview Key Dates: Application Due Date(s) Standard dates , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date July 13, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Request Information RFI): NINDS Soliciting Input Enhancing Neuroscience Research Institutions Emerging Neuroscience Programs Notice Number: NOT-NS-19-059 Key Dates Release Date: 17, 2019 Response Date: June 17, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose recent years, explosion advanced neurotechnology led exciting new discoveries advances neuroscience. has also led a widening technology gap between leading neuroscience institutions, institutions emerging neuroscience programs. advances sophisticated approaches, technologies instrumentation neuroscience research increased need cost-effective access these resources through shared core facilities enhance quality science. purpose this Request Information RFI) to seek input the neuroscience community help define research resource needs institutions where growth neuroscience research programs limited the lack access specialized expertise, instruments services. Information Requested NINDS soliciting input researchers, institutional leadership, science administrators, research professional organizations, other interested members the neuroscience community, improving access research resources technology, instruments approaches) institutions emerging neuroscience programs. your response please indicate role the neuroscience community. you submitting response a researcher administrator/leader a research institution, please provide estimate the number program directors/principle investigators PI/PDs) engaged primarily neuroscience research your institution. you responding behalf a professional organization, please indicate name your organization. Please provide perspective the importance any all these research resources, their role fostering growth development emerging neuroscience research programs: Shared resource facility staff specialized expertise Basic shared resource facilities e.g., microscopy, animal behavior, etc.) Shared resource facilities advanced technologies e.g., Cryo EM, Light Sheet Microscopy, etc.) Training researchers specialized approaches techniques offered shared resource facilities please specify) to Submit Response Responses this RFI must submitted electronically. Responses be accepted through 06/17/2019. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. Responses be shared publicly an NIH website. Please not include any personally identifiable other information you not wish make public. proprietary, classified, confidential, sensitive information should included your response. request for information planning purposes only should be construed a solicitation as obligation the part the United States Government. NIH not any awards based responses this RFI pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Timothy LaVaute, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: research.resources@ninds.nih.gov

Request Information: Seeking Feedback Research Priorities SCI 2020: Launching Decade Disruption Spinal Cord Injury SCI) Research Notice Number: NOT-NS-19-060 Key Dates Release Date: 14, 2019 Response Date: July 30, 2019 Related Announcements None Issued National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Fogarty International Center FIC) Purpose spinal cord injury SCI) research community experienced great advances discovery research, technology development, promising clinical interventions the past decade. build upon advances maximize benefit persons SCI, NIH hosted conference February 12-13, 2019 titled ldquo;SCI 2020: Launching Decade Disruption Spinal Cord Injury Research”. purpose the conference to bring together broad range stakeholders including researchers, clinicians health care professionals, individuals SCI, industry partners, regulators, funding agency representatives break down existing communication silos. participants asked critically evaluate state the science, assess areas technological community readiness, build collaborations could change trajectory research clinical options people SCI. Six primary sessions featured brief presentations recent scientific advances critical research questions the future. Facilitators audience participation encouraged identify opportunities areas collaboration. North American Spinal Cord Injury Consortium other public members provided personal context individuals living SCI defining future research priorities. five final breakout sessions, stakeholders discussed identified key gaps priorities SCI research the next decade. open sessions both days the conference be viewed at https://videocast.nih.gov/summary.asp?live=30194&bhcp=1 and https://videocast.nih.gov/summary.asp?live=30198&bhcp=1. Information Requested: NIH Institutes above soliciting comments suggestions the top priorities identified the five SCI 2020 breakout sessions summarized below. collated responses be shared the public will included a meeting summary document prepared collaboration the Spinal Cord Injury Model Systems Knowledge Translation Center https://msktc.org/about). NIH Institutes encourage input all interested stakeholders, including researchers, clinicians health care providers, individuals SCI, patient advocates health advocacy organizations, scientific professional organizations, federal agencies, well other interested members the public. Responders this RFI also encouraged provide input how research research capacity building the priority areas be adopted low resource settings including low- middle-income countries. Organizations strongly encouraged submit single response reflects views their organization membership. Optional: Please indicate you a researcher, clinician health care provider, individual SCI, patient advocate, and/or interested party. you submitting response behalf an organization, please indicate name your organization. SCI 2020: Research Priorities: Theme A: Improve care SCI patients the acute trauma setting Develop optimized approach infrastructure managing acute SCI: Establish evidence-based medical guidelines improve care SCI the time injury, including on-site stabilization, transportation admittance the ER trauma center. Establish evidence-based medical guidelines improve care SCI inpatient settings until discharge. Evaluate differences care during early period weeks months) after injury contribute long-term outcomes. Define provide specialty clinical expertise needed sites provide acute trauma care SCI. Improve multi-directional education among clinicians, patients, family, community peers. Align preclinical studies clinical conditions: Optimize of preclinical biomarkers outcome measures clinical relevance. Define clinically-feasible intervention window promising therapeutic approaches. Theme B: Accelerate research development therapies repair, plasticity improved functional recovery post-acute chronic SCI Develop use state the art technologies transform way study plasticity, circuits repair human SCI, well animal models. Expand fundamental knowledge the cells, circuits responses interventions inform innovative combinatorial repair approaches using cutting edge tools technologies. Define specificity requirements axonal growth, synapse formation, cell replacement, pathway activity and/or reconstruction circuits support recovery all stages post-injury. Optimize efficiency the of data standards data-sharing opportunities bench bedside bedside bench including unpublished data). Theme C: Improve evidence for, implementation of, functional recovery neuromodulation use-dependent plasticity Encourage longitudinal treatment studies study designs are informed outcomes high priority individuals chronic SCI. Understand mechanisms action characterize variables predict responsiveness neuromodulation interventions both early post-acute chronic conditions. Facilitate data sharing aggregation enable data science research can inform clinical care improve cost effectiveness interventions target recovery. Utilize input individuals SCI identify are acceptable risk/benefit ratios clinical trials modeled around the FDA’s Patient Engagement efforts). Theme D: Improve knowledge the full range health impacts chronic SCI Employ multi-site multi-disciplinary studies, SCI consumer community input, preclinical evidence use common data elements to: Understand impact behavioral, lifestyle, environmental factors reduce morbidity mortality across lifespan people SCI, a special emphasis nutrition metabolism, activity/exercise, and lean/fat mass a biomarker obesity. Promote safe efficient care recovery bowel, bladder sexual function; understand infection systemic inflammation impact functions individuals SCI. Understand biology impact SCI systemic health emphasis stressors effect immune function, role sensory autonomic regulation, physical mental health outcomes. Theme E: Improve functional recovery after SCI assistive technology Demonstrate assistive devices be used promote independence improve recovery after discharge. Incorporate user input, comparative effectiveness research, data sharing strategies establish robust evidence adoption assistive technologies. Improve reliability stability devices tissue interfaces lower barriers adoption improve embodiment. Develop approaches assistive devices adapt changes physical developmental needs, abilities, priorities the user over lifespan. to Submit Response: Responses this RFI must submitted electronically. Responses be accepted through July 30, 2019. Responses voluntary may submitted anonymously. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. Responses be shared publicly an NIH website. Please not include any personally identifiable other information you not wish make public. proprietary, classified, confidential, sensitive information should included your response. request for information planning purposes only should be construed a solicitation as obligation the part the United States Government. NIH not any awards based responses this RFI pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Lyn Jakeman, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-827-5832 Email: lyn.jakeman@nih.gov Carol Taylor-Burds, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: carol.taylor-burds@nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative: Development Next Generation Human Brain Imaging Tools Technologies U01 Clinical Trial allowed) Notice Number: NOT-EB-19-011 Key Dates Release Date: 09, 2019 Estimated Publication Date Funding Opportunity Announcement: June 03, 2019 First Estimated Application Due Date: September 03, 2019 Earliest Estimated Award Date: 20, 2020 Earliest Estimated Start Date: July 01, 2020 Related Announcements RFA-EB-17-004 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose NIH Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative intends reissue RFA-EB-17-004, Development Next Generation Human Brain Imaging Tools Technologies U01 Clinical Trials Allowed), modifications. funding opportunity aims support full development entirely new next generation noninvasive human brain imaging tools methods will lead transformative advances our understanding the human brain. FOA seeks innovative applications are ready full-scale development breakthrough technologies the intention delivering working tools. FOA utilize U01 activity code. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. Notice encourages investigators expertise insights this area noninvasive human brain imaging technologies methods begin consider applying this new FOA. Research Initiative Details TBD Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD 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) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Eligible Agencies the Federal Government Applications not being solicited this time   Inquiries Please direct inquiries to: Shumin Wang, PhDNational Institute Biomedical Imaging Bioengineering NIBIB)shumin.wang@nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative: Proof Concept Development Early Stage Next Generation Human Brain Imaging R01 Clinical Trial Allowed) Notice Number: NOT-EB-19-010 Key Dates Release Date:May 09, 2019 Estimated Publication Date Funding Opportunity Announcement: June 03, 2019 First Estimated Application Due Date: September 03, 2019 Earliest Estimated Award Date: 20, 2020 Earliest Estimated Start Date: July 01, 2020 Related Announcements RFA-EB-17-003 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose NIH Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative intends reissue RFA-EB-17-003, Proof Concept Development Early Stage Next Generation Human Brain Imaging R01 Clinical Trials Allowed), modifications. funding opportunity aims support early stage development entirely new novel noninvasive human brain imaging technologies methods will lead transformative advances our understanding the human brain. FOA solicits unusually bold potentially transformative approaches supports small scale, proof concept development based exceptionally innovative, original and/or unconventional concepts. FOA utilize R01 activity code. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. Notice encourages investigators expertise insights this area noninvasive human brain imaging technologies methods begin consider applying this new FOA. Research Initiative Details TBD Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD 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) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Eligible Agencies the Federal Government Applications not being solicited this time.  Inquiries Please direct inquiries to: Shumin Wang, PhDNational Institute Biomedical Imaging Bioengineering NIBIB)301-594-9001shumin.wang@nih.gov