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Alzheimer's-focused administrative supplements NIH grants are focused Alzheimer's disease Notice Number: NOT-AG-18-039 Key Dates Release Date: November 26, 2018 Related Announcements NOT-AG-18-055 PA-18-591 Issued National Institute Aging NIA) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Purpose participating Institutes Centers ICs) inviting applications expand existing awards these ICs are currently focused Alzheimer’s disease its related dementias ADRD) allow to develop focus ADRD. Active awards project end dates FY 2020 later eligible. award not in terminal cost extension going no cost extension FY2019. Please note a few ICs limit cost extensions a non-competing year an award. that reason, is important contact staff the Institute supporting award planning duration the supplement request. administrative supplements work proposed needs be within scope the research training is already supported. Center awards resource awards most likely be able justify supplements they tend have broad content scope. research grants also qualify the current research on related topic such cognitive decline aging; caregiving; biology neurodegeneration; genetics; imaging; computational methods; pain perception; or biostatistical tools have application research Alzheimer’s its related dementias). part the application, investigators should submit abstract the proposed research shows relevance ADRD. work include pilot projects resource development. preparing submission, indicate it a response NOT-AG-18-039 Field 4.b the SF 424 form. Investigators should submit applications responses the parent active administrative supplement PA: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html. Electronic submissions are strongly preferred for funding opportunity. one the methods described in PA-18-591. Electronic submissions allow expedited administration review the applications. allow tracking applications received simple movement applications between Institutes - requirement this initiative. ASSIST system allows most complex awards submit supplement requests electronically. Individual requests be more 250,000 direct costs exclusive Facilities Administrative costs sub-contracts.  Though supplement requests not limited one per award, will consider substantial additional funding an award beyond scope the funded award. Requests must received February 26, 5:00 p.m. local time the applicant organization funding FY 2019. Institute-, Center-, Office-specific Instructions National Human Genome Research Institute: NHGRI collaboration NIA support supplements NHGRI grants to 500,000 direct cost, support research accomplishes NIA’s research goals described this notice. NHGRI support studies provide generalizable methods knowledge all three scientific areas genome sciences, genomic medicine genomics society. Work proposed supplements must fall within scope the aims the NHGRI grant be supplemented. Investigators encouraged contact NHGRI Scientific Program Officer the grant be supplemented before preparing application, discuss relevance the proposed research the parent grant to Institute's research priorities. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): NICHD particularly interested studies explore linkages between pregnancy complications such hypertension preeclampsia later development dementia; role head trauma brain injury the later development dementia the possible benefit rehabilitation interventions cognition gait/balance AD/ADRD; in significantly increased risk Alzheimer’s disease adults Down syndrome. Review Process IC conduct administrative reviews applications their IC separately. NIA make funds available at least ten awards each the participating ICs. Criteria: the work proposed within scope the active award? the work proposed focused Alzheimer’s disease its related dementias? the work likely stimulate additional activity leading progress ADRD? Inquiries Please direct inquiries to: Robin A. Barr National Institute Aging NIA) Telephone: 301-402-7715 Email: rb42h@nih.gov Paige Green National Cancer Institute NCI) Telephone: 240-276-6899 Email: paige.green@nih.gov Martha Flanders National Eye Institute NEI) Telephone: 301-451-2020 E-mail: Martha.flanders@nih.gov Jue Chen National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0550 Email: jue.chen@nih.gov Bettie Graham National Human Genome Research Institute NHGRI) Telephone: 301-496-7531 E-mail: grahambj@exchange.nih.gov Abraham Bautista National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-9737 E-mail: Bautista@mail.nih.gov Michael Minnicozzi National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3532 Email: minnicozzim@niaid.nih.gov CDR Robyn Bent National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-827-2272 Email: Robyn.Bent@nih.gov Randy King National Institute Biomedical Imaging Bioengineering NIBIB) Telephone:301-451-4780 E-mail: randy.king@nih.gov Melissa Parisi Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-496-1383 Email: parisima@mail.nih.gov Judith Cooper National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 E-mail: cooperj@nidcd.nih.gov Preethi Chander National Institute Dental Craniofacial Research NIDCR) Telephone: 301-827-4620 E-mail: Preethi.chander@nih.gov Luke Stoekel National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-741-9223 E-mail: luke.stoeckel@nih.gov Roger Little National Institute Drug Abuse NIDA) Telephone: 301-435-1315 Email: roger.little@nih.gov Jonathan Hollander National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 E-mail: jonathan.hollander@nih.gov Paula Flicker National Institute General Medical Sciences NIGMS) Telephone: 301-594-0943 Email: flickerp@nigms.nih.gov Jovier Evans National Institute Mental Health NIMH) Telephone: 301-443-1369 E-mail: jevans1@mail.nih.gov Roderick Corriveau National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 E-mail: roderick.corriveau@nih.gov Lois Tully National Institute Nursing Research NINR) Telephone: 301-594-5968 E-mail: lois.tully@nih.gov Adelaida Rosario National Institute Minority Health Health Disparities NIMHD) Telephone: 301-402-1366 E-mail: Adelaida.rosario@nih.gov Hua-Chuan Sim National Library Medicine NLM) Telephone: 301-594-4882 E-mail: simh@mail.nlm.nih.gov Marya Levintova Fogarty International Center FIC) Telephone: 301-496-1653 E-mail: levintovam@mail.nih.gov Dave Clark National Center Complementary Integrative Health NCCIH) Telephone: 301-827-1916 E-mail: dave.clark@nih.gov Oleg Mirochnitchenko Office Research Infrastructure Programs ORIP) Telephone: 301-435-0748 Email: oleg.mirochnitchenko@nih.gov

Notice NICHD, NIDA, NINDS NIAAA NIDDK Participation PAR-18-714-Academic Research Enhancement Award Undergraduate-Focused Institutions R15 Clinical Trial Allowed) Notice Number: NOT-HD-18-027 Key Dates Release Date: November 26, 2018 Related Announcements NOT-DK-19-005 PAR-18-714 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose purpose this Notice to inform potential applicants the Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Institute Drug Abuse NIDA), National Institute Neurological Disorders Stroke NINDS), National Institute Alcohol Abuse Alcoholism NIAAA), and National Institute Diabetes Digestive Kidney Diseases NIDDK)will participate, effective immediately, in PAR-18-714 Academic Research Enhancement Award Undergraduate-Focused Institutions R15 Clinical Trial Allowed). following changes been in PAR-18-714 to reflect participation these NIH entities this funding opportunity announcement FOA): Part 1. Overview Information Text been added to PAR-18-714 under of headings below) follows: Components Participating Organizations Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Diabetes Digestive Kidney Diseases NIDDK) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865, 93.273, 93.279, 93.847, 93.855 Part 2. Section I. Funding Opportunity Description Eunice Kennedy Shriver National Institute Child Health Human Development (NICHD) NICHD supports biological, behavioral, clinical research related conception pregnancy, normal abnormal development childhood, reproductive health, population dynamics across lifespan, rehabilitation medicine. https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas…. Research projects considered funding NICHD must fall within scientific missions the twelve Scientific Branches the NICHD Division Extramural Research DER) the National Center Medical Rehabilitation Research NCMRR).Information those scientific missions program staff contacts be found the web pages the DER scientific branches at: http://www.nichd.nih.gov/about/org/der/branches/Pages/index.aspxand NCMRR at: http://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. Potential applicants strongly encouraged read webpages any updates response recent scientific advances emerging public health topics. NICHD encourages applications address extramural program priorities will consider well research projects align one more those priorities making award decisions. detailed list NICHD high priority research areas be found https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas…. National Institute Drug Abuse (NIDA) projects should address critical issues neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, co-occurring opportunistic infections e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences substance abusing populations, medication development, other research areas relevant drug abuse. NIDA priorities further described the NIDA Strategic Plan see https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan) on NIDA Topics Interest webpage see https://www.drugabuse.gov/funding/funding-priorities/nida-topics-specia…). Applicants encouraged contact program official discuss proposed application. National Institute Neurological Disorders Stroke (NINDS) NINDS seeks fundamental knowledge the brain nervous system to that knowledge reduce burden neurological disease. NINDS supports basic, translational clinical research within specifically defined areas neuroscience. Research projects considered funding NINDS must fall within scientific research mission the Institute. Information the research mission program staff be found at: https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Program-Directors. National Institute Alcohol Abuse Alcoholism (NIAAA) NIAAA accept applications research projects areas within Institute's mission. NIAAA website https://www.niaaa.nih.gov/) provides information the institute mission https://www.niaaa.nih.gov/about-niaaa/our-work/mission-statement) areas research interest https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan). additional scientific program information for pre-application guidance, potential applicants encouraged contact NIAAA Extramural Research Program Staff whose portfolio covers scientific topic interest https://www.niaaa.nih.gov/research/extramural-research). National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Diabetes Digestive Kidney Diseases NIDDK) conducts supports medical research research training to disseminate science-based information diabetes other endocrine metabolic diseases; digestive diseases, nutritional disorders, obesity; kidney, urologic, hematologic diseases, improve people’s health quality life. Research projects considered funding NIDDK must fall within scientific research mission the Institute. Potential applicants encouraged contact NIDDK Extramural Research Program Staff whose portfolio covers scientific topic interest. Specific information our Research Programs & Contacts available https://www.niddk.nih.gov/research-funding/research-programs. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Mahua Mukhopadhyay, Ph.D. Phone: 301-435-6886 Email: mukhopam@mail.nih.gov National Institute Drug Abuse NIDA) Tracy Waldeck, Ph.D. Phone: 301-827-5844 Email: tracy.waldeck@nih.gov National Institute Neurological Disorders Stroke NINDS) Letitia Weigand, Ph.D. Phone: 301-496-4188 Email: letitia.weigand@nih.gov National Institute Alcohol Abuse Alcoholism NIAAA) Li Lin, Ph.D. Phone: 301-827-7749 Email: linli@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK) Karl F. Malik, Ph.D. Phone: 301-594-8843 Email: karl.malik@nih.gov Financial/Grants Management Contact(s) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Bryan S. Clark, M.B.A Phone: 301-435-6975 Email: clarkb1@mail.nih.gov National Institute Drug Abuse NIDA) Pam Fleming Phone: 301-480-1159 Email: pfleming@nida.nih.gov National Institute Neurological Disorders Stroke NINDS) Tijuanna Decoster, Ph.D. Phone: 301-496-9231 Email: decostert@ninds.nih.gov National Institute Alcohol Abuse Alcoholism NIAAA) Judy Fox Phone: 301-443-4704 Email: jfox@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK) Ms. Aretina Perry-Jones Phone: 301-594-8862 Email: ap19s@nih.gov other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Mahua Mukhopadhyay, Ph.D. Eunice Kennedy Shriver National Institutes Child Health Human Development NICHD) Phone: 301-435-6886 Email:  mukhopam@mail.nih.gov Tracy Waldeck, Ph.D. National Institute Drug Abuse NIDA) Phone: 301-827-5844 Email: tracy.waldeck@nih.gov Letitia Weigand, Ph.D. National Institute Neurological Disorders Stroke NINDS) Phone:  301-496-4188 Email:  letitia.weigand@nih.gov Li Lin, Ph.D. National Institute Alcohol Abuse Alcoholism NIAAA) Phone: 301-827-7749 Email:  linli@mail.nih.gov Karl F. Malik, Ph.D. National Institute Diabetes Digestive Kidney Diseases NIDDK) Phone: 301-594-8843 Email: karl.malik@nih.gov

Reinstatement NIH SBIR Direct-to-Phase II Authority Associated Updates NINDS associated SBIR FOAs Notice Number: NOT-NS-19-024 Key Dates Release Date: November 21, 2018 Related Announcements PAR-18-618 PAR-18-628 PAR-18-563 RFA-NS-18-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Section 5106 the SBIR/STTR Reauthorization Act 2011 authorized NIH lsquo;issue Phase II award a small business concern did receive Phase award that research/research amp; development'. phase flexbility' called lsquo;Direct-to-Phase II’ SBIR award. original authority this provision expired 9/30/2017. Recent legislation P.L. 115-232 re-instated SBIR Direct Phase II provision through Fiscal Year 2022. SBIR Direct-to-Phase II authority not available the STTR program not available the CDC, FDA, ACL SBIR progams. such, NIH re-implementing SBIR Direct-to-Phase II program. prior program specific SBIR Direct-to-Phase II funding opportunity announcements FOAs). transition FORMS-E earlier year allows NIH track SBIR Direct-to-Phase II applications the Application level, there a new check-box the SBIR/STTR Information Form Direct Phase II. a result this, NIH does need issue separate SBIR Direct-to-Phase II FOAs before, can offer Direct-to-Phase II an allowable Application Type any SBIR FOA. NINDS therefore amending targeted SBIR FOAs allow SBIR Direct-to-Phase II submissions per below: 1. PAR-18-618NINDS Exploratory Clinical Trials Small Business R44 Clinical Trial Required) 2. PAR-18-628 NeuroNEXT Small Business Innovation Clinical Trials U44 Clinical Trial Optional) 3. PAR-18-563 NIH StrokeNet Small Business Innovation Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention U44 - Clinical Trial Optional 4. RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required) NIH strongly encourages small businesses contact appropriate Institute Center early their application planning process ensure technology of priority the Institute/Center. updated SBIR/STTR Application Guide additional instructions SBIR Direct Phase II application preparation submission be posted November 26, 2018. following sections each FOA changed follows: Part 2, Section II. Award Information each these FOAs: PAR-18-618 PAR-18-628 , PAR-18-563 , RFA-NS-18-022 Currently Reads: Application Types Allowed New Phase I, Fast-Track) Renewal Phase II* Direct Phase II notallowed) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision The OER Glossary and SF424 R&R) SBIR/STTR Application Guide provide details these application types. Modified Read: Application Types Allowed New Phase I, Fast-Track) New Direct Phase II) Renewal Phase II) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision The OER Glossary and SF424 R&R) SBIR/STTR Application Guide provide details these application types. other aspects these FOAs remain unchanged.   Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email:fertigs@ninds.nih.gov

Notice Correction Key Dates RFA-NS-19-002 BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP U19 Clinical Trial Required)" Notice Number: NOT-NS-19-018 Key Dates Release Date: November 8, 2018 Related Announcements RFA-NS-19-002 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform potential applicants changes Advisory Council Review  Dates RFA-NS-19-002 BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP U19 Clinical Trial Required)". Part 1. Overview Information Key Dates Currently Reads: Advisory Council Review 2018, 2019 May 2020 Modified Read: Advisory Council Review 2019, 2020 and May 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: BRAINCircuits@nih.gov  

Notice Correction Key Dates RFA-NS-19-003 BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP U19 Clinical Trial Allowed)" Notice Number: NOT-NS-19-019 Key Dates Release Date: November 8, 2018 Related Announcements RFA-NS-19-003 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform potential applicants corrections the Council Review  Dates RFA-NS-19-003 BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP U19 Clinical Trial Allowed)". Part 1. Overview Information Key Dates Currently Reads: Advisory Council Review 2018, 2019 May 2020 Modified Read: Advisory Council Review 2019, 2020 and May 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: BRAINCircuits@nih.gov

Notice Clarification Language Project Characteristics PAR-18-549, Analytical Validation a Candidate Biomarker Neurological Disease U44 Clinical Trial Optional) Notice Number: NOT-NS-19-020 Key Dates Release Date: November 8, 2018 Related Announcements PAR-18-549 PAR-18-550 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify language bullet four the Project Characteristics section Part. 2. Section I, Funding Opportunity Description for PAR-18-549. Part 2. Full Text Announcement Section I. Funding Opportunity Description Project Characteristics Current Language bullet four: Applications this FOA should technologies already use soon be approved use clinical laboratories since is a technology development FOA. Revised Language bullet four: biomarker detection method must developed ready validation studies. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Clarification Language Project Characteristics PAR-18-550, Analytical Validation a Candidate Biomarker Neurological Disease U01 Clinical Trial Optional)e Notice Number: NOT-NS-19-021 Key Dates Release Date: November 8, 2018 Related Announcements PAR-18-549 PAR-18-550 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify language bullet four the Project Characteristics section Part. 2. Section I, Funding Opportunity Description for PAR-18-550 . Part 2. Full Text Announcement Section I. Funding Opportunity Description Project Characteristics Current Language bullet four: Applications this FOA should technologies already use soon be approved use clinical laboratories since is a technology development FOA. Revised Language bullet four: biomarker detection method must developed ready validation studies. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Changes RFA-AG-19-020 Clinical Trial Effects Statins Older Adults without Clinical Cardiovascular Disease U19 Clinical Trial Required)" Notice Number: NOT-AG-18-038 Key Dates Release Date: November 8, 2018 Related Announcements RFA-AG-19-020 Issued National Institute Aging NIA) National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose Notice being issued inform potential applicants changes RFA-AG-19-020 Clinical Trial Effects Statins Older Adults without Clinical Cardiovascular Disease U19 Clinical Trial Required)". NIA increasing funding contribution commitments NHLBI NINDS remaining same). a result, key dates, scope, funds available anticipated number awards, award budget, application instructions being revised described below. changes ensure the future clinical trial be sufficiently powered assess effects statins mild cognitive impairment dementia MCI+D) the study population defined the RFA. is anticipated achieving power require enrollment substantially than originally projected 17,000 participants. Having larger number participants important several reasons: larger number participants increase power the primary outcome will provide a greater power assess effects statins in a priori defined subgroups e.g. minorities, older age groups, participants frailty, etc.). larger sample size crucial assessing effects statins the important secondary outcomes MCI+D composite clinical cardiovascular disease events. narrower confidence intervals around hazard ratios treatment the larger sample provide, even no significant effect dementia MCI+D found, provide definitive evidence benefit lack benefit. larger sample size associated increase funding provide enhanced ascertainment MCI+D outcomes, further increasing power measuring effects MCI+D ensuring fewer events been missed. participants fail screening test not only referred a healthcare professional, they also contacted the study staff confirm diagnosis addition review the electronic health records. following revisions been to RFA-AG-19-020 revised text italicized): Part 1. Overview Information, Key Dates Open Date Earliest Submission Date): January 4, 2019 Letter Intent Due Date(s): January 4, 2019 Application Due Date(s): February 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications  allowed this funding opportunity announcement due this date. late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review: May 2019 Advisory Council Review: August 2019 Earliest Start Date: September 2019 Expiration Date: February 5, 2019 Part 2. Full Text Announcement, Section I. Funding Opportunity Description Scope Research Requested NIA, NHLBI NINDS request applications a pragmatic trial a network consortium health care delivery systems HCS), together cover most the geographic regions the United States, a data coordinating center assess overall risks benefits statins adults = 75 years without clinical cardiovascular disease. Specifically, proposed trial should designed to: conducted a real-life healthcare delivery system setting Introduction pragmatic clinical trials" Rethinking Clinical Trials: Living Textbook Pragmatic Trials"). broad inclusion criteria use minimization, stratification another technique ensure enrollment a high number women, minorities, participants frailty, mobility limitations, cognitive impairment, comorbidities very old adults. Test effects moderate- high-intensity statin legally marketed the US approved the FDA) vs placebo administered up five years a blinded fashion the health care providers members the HCS participating the trial). Test effects interventions the universal primary health outcome survival free dementia persistent physical disability. Test effects the intervention two co-secondary outcomes: 1) composite clinical CVD events acute myocardial infarction, ischemic stroke transient ischemic attack, heart failure, death attributed cardiovascular disease) 2) MCI+D 90% power detect risk reduction 15%. secondary composite cardiovascular outcome should include acute myocardial infarction, stroke, heart failure may include cardiovascular components such to death attributed cardiovascular disease, urgent revascularization, acute coronary syndrome requiring hospitalization. Characterization the type heart failure well stroke subtype should considered. Assess effects interventions exploratory outcomes, including not limited health-related quality life, muscle-related symptoms, incident diabetes, hospitalization any cause, medication adherence, major sources health care resource utilization. Ascertain outcomes a cost-efficient manner a high degree accuracy. sufficient power assess effects interventions high degree confidence. applicants strongly encouraged propose trial has 90% power assess effects interventions both primary secondary outcomes. Sample size calculations should designed accommodate high crossover rates between study treatment groups. Obtain biological samples at least 17,000 the participants that analysis biomarkers predictive harms benefits feasible the future. Periodically obtain sufficient number biological samples assess difference the serum LDL-cholesterol levels between two trial arms.   Include pre-specified analyses adequate power assess treatment risks benefits important subgroups e.g., men/women, older/younger, differing baseline health status, differing ethnicity). See Section VIII. Information for award authorities regulations. Part 2. Full Text Announcement, Section II. Award Information Funds Available Anticipated Number Awards: The number awards contingent upon NIH appropriations the submission a sufficient number meritorious applications. NIA intends commit to 6.0 million direct costs FY 2019 fund award. Across seven-year project period, issuing IC partner components intend commit estimated 60.2 million direct costs fund award. Award Budget: Application budgets cannot exceed 60.2 million direct costs across seven years need reflect actual needs the proposed project. Part 2. Full Text Announcement, Section IV. Application Submission Information PHS 398 Research Plan Overall) Specific Aims: Describe overall scientific objective the proposed trial; individual aims the proposed study; the individual components contribute these aims; the overall trial objective. For example, of aims propose  test effects moderate- high-intensity statin is legally marketed the US approved the FDA vs placebo the primary universal health outcome survival free dementia persistent physical disability on co-secondary outcomes: composite clinical CVD events acute myocardial infarction, ischemic stroke transient ischemic attack, heart failure, death attributed cardiovascular disease) MCI+D 90% power detect 15% effect. The secondary composite cardiovascular outcome should include acute myocardial infarction, stroke, heart failure may include cardiovascular components such to death attributed cardiovascular disease, urgent revascularization, acute coronary syndrome requiring hospitalization. Characterization the type heart failure well stroke subtype should considered. Exploratory outcomes, including not limited health-related quality life, muscle-related symptoms, incident diabetes, hospitalization any cause, medication adherence, major sources health care resource utilization also proposed.  Research Strategy: The scientific rationale need a clinical trial test proposed hypothesis intervention should well supported preliminary data, clinical and/or preclinical studies, information the literature and/or knowledge biological mechanisms. trials focusing clinical public health endpoints, need a trial testing safety, efficacy effectiveness an intervention could lead a change clinical practice, community behaviors health care policy should justified. trials focusing mechanistic, behavioral, physiological, biochemical, other biomedical endpoints, need a trial advance scientific understanding should also justified. Focus the project a whole address i) importance the problem the field the proposed trial addresses, ii) this trial improve scientific knowledge clinical practice geriatrics cardiology, iii) the preventive interventions target population be changed the proposed aims achieved. Describe preliminary data which trial based. applicants required include both description a table graph the overall project timeline key milestones. overall study timeline should include description key milestones need be met throughout lifecycle the clinical trial ensure success to advance through defined study phases described projects elsewhere this FOA. milestone defined a scheduled event the project timeline signifies completion a major project stage activity. Milestones must relevant, measurable, results-focused time-bound. applicants should clearly define justify selection the target population. is expected the study enroll adults 75 years age older without clinical cardiovascular disease. study should propose justify selection broad inclusion criteria use minimization, stratification another technique would result enrollment a high number women, minorities, participants frailty, mobility limitations, cognitive impairment, comorbidities very old adults applicants required justify proposed definitions the primary secondary outcomes their components. Selection definitions the exploratory outcomes, any, should also justified. plan should detail assumptions obtaining bio-specimens baseline at least 17,000 participants, in subset participants periodic intervals during trial the masked determination LDL cholesterol levels arm. PHS 398 Research Plan Vanguard Phase) Research Strategy: A one-year vanguard phase follow protocol refinement study start-up phase. Objectives this phase to demonstrate study's ability recruit retain participants; deliver intervention; ascertain adjudicate outcomes. Regarding outcomes, detailed description how primary composite study outcome two co-secondary outcomes -- composite clinical CVD events MCI+D -- be collected. Any validation studies the secondary cardiovascular outcome be initiated the characterization the types heart failure. During phase, study also confirm loss follow-up cross-over rates; primary secondary outcome event rates the control group the intercluster coefficient correlation used sample size power calculations. one more these differ the original estimate, investigators required amend power calculations. the end the vanguard phase, grantees should submit the DSMB review its semi-annual meeting report justifying transitioning the study implementation phase. NIA NHLBI consider DSMB's recommendations will the following criteria evaluate whether vanguard phase reached objectives the study should continue: actual recruitment rate not lower 75% the target. rates between 75% 90% the target, DSMB report should include plan describing detail and the recruitment goal be met within allocated study budget.  revised study power calculated based upon observed: a) loss follow-up cross over rates; b) primary secondary outcome event rates the control group; c) intercluster coefficient correlation; d) estimated final N not lower 85%. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sergei Romashkan, MD, Ph.D. National Institute Aging NIA) Telephone: 301-435-3047 Email: romashks@nia.nih.gov

Notice Change Key Dates RFA-NS-18-026 NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50 Clinical Trial Optional)" Notice Number: NOT-NS-19-015 Key Dates Release Date: November 7, 2018 Related Announcements RFA-NS-18-026 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change Key Dates RFA-NS-18-026 NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50 Clinical Trial Optional)".  Specifically, first receipt date change January 4, 2019 January 11, 2019. Part 1. Overview Key Dates Currently Reads: Open Date December 4, 2018 Application Due Date(s) January 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 5, 2019 Modified Read: Open Date December 11, 2018 Application Due Date(s) January 11, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 12, 2019 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov

Notice Change Key Dates RFA-NS-18-027 Exploratory Grant NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls P20 Clinical Trial Optional)" Notice Number: NOT-NS-19-016 Key Dates Release Date: November 7, 2018 Related Announcements RFA-NS-18-027 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change Key Dates RFA-NS-18-027 Exploratory Grant NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls P20 Clinical Trial Optional)."  Specifically, first receipt date change January 4, 2019 January 11, 2019. Part 1. Overview Key Dates Currently Reads: Open Date December 4, 2018 Application Due Date(s) January 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 5, 2019 Modified Read: Open Date December 11, 2018 Application Due Date(s) January 11, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 12, 2019   other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov