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Notice Correction Application Instructions RFA-HL-19-007: Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-591 Key Dates Release Date: February 13, 2018 Related Announcements RFA-HL-19-007 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-007 Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)." The purpose this Notice to alert scientific community an additional attachment required the application.  Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Correction Application Instructions RFA-HL-19-008: Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-592 Key Dates Release Date: February 13, 2018  (Rescinded March 21, 2018) Related Announcements RFA-HL-19-008 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-008 Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)". purpose this Notice to alert scientific community an additional attachment required the application. Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Change Key Dates PAR-17-001 Emerging Global Leader Award K43)" Notice Number: NOT-TW-18-003 Key Dates Release Date: February 08, 2018 Related Announcements PAR-17-001 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Research Women’s Health ORWH) Purpose purpose this Notice to alert scientific community a change the Key Dates for PAR-17-001 "Emerging Global Leader Award K43)".    Part 1. Overview Information Key Dates Currently reads: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017, March 2018, March 2019 Advisory Council Review: 2017, May 2018, 2019 Earliest Start Date: July 2017, July 2018, July 2019 Expiration Date: November 8, 2018 Modified read: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017; May 2018; March 2019 Advisory Council Review: 2017; August 2018; May 2019 Earliest Start Date: July 2017; September 2018; July 2019 Expiration Date: November 8, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christine Jessup Ph.D Fogarty International Center Telephone:301-496-1653 Email: Christine.Jessup@nih.gov

Notice Change Receipt Dates BRAIN Initiative: Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) Notice Number: NOT-EB-18-005 Key Dates Release Date: February 07, 2018 Related Announcements RFA-EB-17-005 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 purpose this Notice to change Application Due Dates BRAIN Initiative:  Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) RFA-EB-17-005) Currently reads: Application Due Date(s): December 15, 2017; October 17, 2018; October 17, 2019 Revised read: Application Due Dates(s): December 15, 2017; September 4, 2018; September 3, 2019 Currently reads: Scientific Merit Review: 2018, March 2019, March 2020 Revised read: Scientific Merit Review: 2018, February 2019, February 2020 Currently reads: Advisory Council Review: August 2018, August 2019, August 2020 Revised read: Advisory Council Review: August 2018, 2019, 2020 Inquiries Please direct inquiries to: Grace C.Y. Peng, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: BRAINTheoriesFOA@mail.nih.gov

Request Information RFI): Future Directions Research Fragile X Syndrome FMR1-Related Conditions Notice Number: NOT-HD-17-033 Key Dates Release Date: January 29, 2018   Related Announcements NOT-HD-20-009 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose Notice a time-sensitive Request Information RFI) part a trans-NIH effort update NIH Research Plan Fragile X Syndrome FMR1-related conditions. Background Fragile X syndrome FXS), results mutations the FMR1 gene the X-chromosome, the most commonly inherited form intellectual developmental disability. NIH supports conducts research the causes, mechanisms, diagnosis, treatment management Fragile X Syndrome FMR1-related conditions: Fragile X-Associated Tremor/Ataxia Syndrome FXTAS), Fragile X-Associated Primary Ovarian Insufficiency FXPOI) other conditions associated mutations the FMR1 gene. NIH also supports conducts research concomitant symptoms/conditions seen individuals these conditions.   input experts the field, NIH issued Research Plan Fragile X Syndrome Associated Disorders 2009, outlined series specific research goals objectives. Goal areas this research plan included: Pathophysiology pathogenic mechanisms Risk factors condition onset progression Screening diagnosis Treatments therapeutic interventions Quality life issues Impact families Research infrastructure detail goals specific FMR1-related conditions, well objectives within goal, be found the full report: https://www.nichd.nih.gov/publications/pages/pubs_details.aspx?from=&pu… Information Requested Request Information RFI) invites researchers academia industry, health care professionals, patient advocates, representatives health advocacy organizations, members scientific professional organizations, other interested members the public provide comments suggestions. welcome input includes, is limited to, following topics: Gaps/Challenges: Describe most critical existing gaps basic, translational, and/or clinical research Fragile X syndrome FMR1-related conditions.  are seeking input the conceptual, practical, technical challenges currently impeding progress these research areas, potential solutions these challenges.  Comments might include gaps are most practical pursue, and/or high-risk approaches could give highest potential short-term long-term payoffs.  also welcome feedback regarding specific challenges forming maintaining effective partnerships facilitate research progress.  Comments also address approaches have less fruitful should perhaps lower priorities future efforts. Priorities/New Directions: Describe most important priority areas new directions field should pursue over next 5-10 years make meaningful advances understanding treating FXS FMR1-related conditions. are soliciting input regarding areas most important patients, families, clinicians, researchers, and/or funding agencies. also welcome suggestions metrics/benchmarks be used measuring progress these priority areas, well identification new resources tools could a potentially transformative impact research clinical care. are also interested suggestions specific new partnerships collaborations respondents feel likely accelerate progress these areas. Significant Advances: Identify most significant recent scientific clinical advances related Fragile X syndrome FMR1-related conditions. may include advances address goals objectives the 2009 plan, well new perspectives captured the 2009 plan. to Submit Response ensure consideration, responses should submitted email fragilexplan@mail.nih.gov later Friday, March 2, 2018. Responses this RFI voluntary. Proprietary, classified, confidential, sensitive information should be included your response. will an electronic confirmation acknowledging receipt your response, may receive individual feedback. NICHD use information submitted response this RFI its discretion will provide comments any responder's submission. Government reserves right use any non-proprietary technical information any resultant solicitation(s). RFI for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. Inquiries Please direct inquiries to: Tracy King, MD, MPH Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-402-1822 Email: fragilexplan@mail.nih.gov issues specifically related this Request Information) Email: tracy.king@nih.gov other questions/information)

Notice Corrected Expiration Date PAR-16-112 Biomarkers Discovery Parkinsonism U01)" Notice Number: NOT-NS-18-038 Key Dates Release Date:   January 23, 2018 Related Announcements PAR-16-112 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice inform applicants the new expiration date PAR-16-112, quot;Biomarkers Discovery Parkinsonism U01)" January 24th, 2018.  NINDS plans reissue Funding Opportunity Announcement FOA) compliance FORMS-E. Part 1. Overview Information Key Dates Currently reads: Application Due Date(s) September 6, 2016; September 6, 2017; September 6, 2018 Modified read: Application Due Date(s) September 6, 2016; September 6, 2017 Currently reads: Expiration Date: September 7, 2018 Corrected read: Expiration Date: January 24, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Margaret Sutherland, PhD National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-5680 Email: sutherlandm@ninds.nih.gov

Notice Expiration PAR-17-145 NINDS Postdoctoral Mentored Career Development Award K01)" Notice Number: NOT-NS-18-034 Key Dates Release Date:   January 12, 2018 Related Announcements PAR-17-145 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice announces expiration PAR-17-145 quot;NINDS Postdoctoral Mentored Career Development Award K01) effective January 24, 2018.  notice also serves inform applicants NINDS plans reissue Funding Opportunity Announcement FOA) compliance FORMS-E. Part 1. Overview Key Dates Currently Reads: Application Due Date(s): April 4, 2017, standard dates April 4, 2017; June 12, 2017; October 12, 2017; February 12, 2018; June 12, 2018; October 12, 2018; February 12, 2019; June 12, 2019; October 12, 2019) Modified Read: Application Due Date(s): April 4, 2017, standard dates April 4, 2017; June 12, 2017; October 12, 2017) Currently Reads: Expiration Date: January 8, 2020 Modified Read: Expiration Date: January 24, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-4188 Email: korns@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) UT1/UT2 - Clinical Trial Required) Notice Number: NOT-HL-18-575 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-576 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute NHLBI) National Eye Institute NEI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) U.S. Food Drug Administration ( FDA)  Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support investigator-initiated clinical trials aimed furthering field regenerative medicine RM) using adult stem cells.  Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical interventions. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects use RM interventions and/or products demonstrated be ready advancing clinical trials. Applicants be encouraged include plans project management, subject recruitment retention, performance milestones, scientific conduct the trial, dissemination results.   Toward ends, NIH consider applications clinical trials involving adult stem cells the context generating supplementing necessary evidence clinical development, including support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent RMIP@nih.gov.   FOA utilize UT1/UT2 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stem cells support innate host healing mechanisms, treat disease, and/or restore function. Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical trials proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical trials also assessed according the following criteria:   RM interventions and/or products demonstrating readiness advancing clinical trials under IND/IDE application; Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related improved evaluation product quality, clinical safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products. Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Promote enhance mechanisms data standardization, curation, integration, sharing; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo. Matching Requirement Government requires least 1:1 recipient cost matching all federal funds awarded this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute ( NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) U43/U44 - Clinical Trial Allowed) Notice Number: NOT-HL-18-578 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-035 NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-577 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA) Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical applications. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects address critical issues product development relevant regulatory submissions. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness.    Toward ends, NIH consider applications clinical research involving adult stem cells the context generating supplementing necessary evidence clinical development, including submission a pre-Investigational New Drug IND) pre-Investigational New Device Exemption IDE) package; submission an IND/IDE application; to support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent to RMIP@nih.gov.   FOA utilize U43/U44 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). Of note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stems cells support innate host healing mechanisms, treat disease, and/or restore function. Funding be used, example, the appropriate chemistry, manufacturing, controls development support production such products clinical trials using good manufacturing practices GMP). Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical research projects proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria:   Does include a clinical trial (for clinical trial applications see NOT-HL-18-577); Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related product development. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical product development, clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Further development standards GMP adult stem cell-based RM products; Leverage extant cell production facilities product preparation qualification; Promote enhance mechanisms data standardization, curation, integration, sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.940, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) UG3/UH3 - Clinical Trial Required) Notice Number: NOT-HL-18-573 Key Dates Release Date: January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date:05/15/2018 Earliest Estimated Award Date:09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-031 NOT-HL-19-700 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA)  Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support investigator-initiated clinical trials aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical interventions. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects use RM interventions and/or products demonstrated be ready advancing clinical trials. Applicants be encouraged include plans project management, subject recruitment retention, performance milestones, scientific conduct the trial, dissemination results.   Toward ends, NIH consider applications clinical trials involving adult stem cells the context generating supplementing necessary evidence clinical development, including support such research conducted under authorized IND IDE.  Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent RMIP@nih.gov.   FOA utilize UG3/UH3 activity code employs bi-phasic, milestone-driven cooperative agreement mechanism award is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stem cells support innate host healing mechanisms, treat disease, and/or restore function. Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical trials proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical trials also assessed according the following criteria:   RM interventions and/or products demonstrating readiness advancing clinical trials under IND/IDE application; Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related improved evaluation product quality, clinical safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Promote enhance mechanisms data standardization, curation, integration, sharing; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching all federal funds awarded this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 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) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute ( NHLBI) 301-435-2152 RMIP@nih.gov