Request Information RFI): Need Biologic Reagents, Imaging, Genetic Cognitive Behavioral Assessment Tools Facilitate Use Marmosets Biomedical Research Notice Number: NOT-AG-19-045 Key Dates Release Date: October 7, 2019 Related Announcements None Issued Office Research Infrastructure Programs ORIP) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Deafness other Communication Disorders NIDCD)? Purpose Request Information RFI) seeks input current challenges key bottlenecks the of marmosets animal models biomedical research. principal objectives include identification the needs species-specific biologic reagents, genetic behavioral analytic tools technologies, other crucial resources would advance use marmosets research facilitate translation modalities this organism. Background Nonhuman primates NHP) the closest evolutionary relatives humans, whom share anatomical, physiological, gene interactions features. common marmoset Callithrix jacchus) of increasing importance biomedical research worldwide. New World primate known cooperative social behavior, cognition, communication, potentially makes a good model organism help understand wide range human diseases. Marmosets smaller easier house rhesus macaques give birth twice year versus once every year two years, aiding multi-generational experiments. Because marmosets mature age quickly bigger monkeys, are potentially also good model organism study development aging. a nonhuman primate species several unique reproductive, physiological, and behavioral advantages, marmosets uniquely positioned accelerate progress biomedical research. Additionally, marmoset’s brain fewer gyri a macaque’s, making easier image record activity its surface. marmoset a research model enjoyed substantial growth over past decade largely through grass-roots, researcher-initiated projects. While ventures been remarkably productive, several bottlenecks must addressed the model reach full potential a keystone system addressing NIH’s stated goal enhance health, lengthen life, reduce illness disability humans. response the unprecedented growth demand marmosets following reports genome editing successful propagation transgenes marmoset offspring, NIH launched new initiatives cooperative agreements) expand number marmoset colonies to optimize housing, breeding, use research. NIH now seeking stakeholder feedback guide development priorities accelerate research using marmosets models human diseases to facilitate translation these findings human conditions treatment. Notice seeks solicit public comment the challenges, gap areas, bottlenecks experienced the marmoset research community. Feedback obtained through Notice other outreach efforts help inform development research infrastructure priorities biomedical research involving marmosets a model organism. Information Requested Stakeholder feedback requested any all, not limited to, following topics: Development distribution key biological reagents tools would facilitate use marmosets animal models accelerate translation results Types tools biomarkers facilitate physiological behavioral studies marmosets reference genome sequence annotation expected be available the research community soon--will be sufficient? Identified needs relation improving genetic diversity, animal husbandry, diet, shipping animals between sites Information other key areas where NIH facilitate research using marmosets Submitting Response comments must submitted via email text as attached electronic document. Please address response to manuel.moro@nih.gov by October 23, 2019. Include Notice number the subject line. Response this RFI voluntary. Responders free address any all categories listed above. submitted information be reviewed NIH staff. request for information planning purposes only should be construed a solicitation as obligation the part the Federal Government. NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. However, responses the RFI be reflected future funding opportunity announcements. information provided be analyzed may aggregated presentations reports. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: Manuel H. Moro, DVM, MPH, PhD, Dipl ACVPM Program Director Division Aging Biology National Institute Aging NIA) Telephone: 301-480-1796 Email: manuel.moro@nih.gov

Notice NINDS's Participation NOT-DE-19-013 Clarifications Regarding Institutional Eligibility PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed)" Notice Number: NOT-NS-20-011 Key Dates Release Date: September 27, 2019 Related Announcements NOT-DE-19-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to announce National Institute Neurological Disorder Stroke's participation NOT-DE-19-013 Clarifications Regarding Institutional Eligibility PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed)". following section been updated reflect participation NINDS this Notice. Currently Reads: Issued by: National Institute Dental Craniofacial Research NIDCR) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) Modified Read: Issued by: National Institute Dental Craniofacial Research NIDCR) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) other aspects this notice remain same. Inquiries Please direct inquiries to: Letitia Weigand, Ph.D.National Institute Neurological Disorders Stroke NINDS)301-496-4188 letitia.weigand@nih.gov

The purpose of this notice is to inform applicants that there will be a change in Resource Sharing Plans for RFA-EB-18-003 "HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)" (See changes in bold italics below). Currently Reads: Part 2. Full Text of Announcement Section V. Application Review Information Resource Sharing Plans Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3) Genomic Data Sharing Plan (GDS). Modified to Read: Resource Sharing Plans Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3) Genomic Data Sharing Plan (GDS); and (4) HEAL Data Sharing https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access data-sharing-policy. All other aspects of this FOA remain unchanged.

Notice Intent Publish Funding Opportunity Announcement Data Harmonization, Curation Secondary Analysis Existing Clinical Datasets R61/R33 Clinical Trial Allowed) Notice Number: NOT-NS-19-071 Key Dates Release Date: September 16, 2019 Estimated Publication Date Funding Opportunity Announcement: November 01, 2019 First Estimated Application Due Date: March 16, 2020 Earliest Estimated Award Date: September 16, 2020 Earliest Estimated Start Date: September 30, 2020 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Request Applications RFA) solicit applications research will promote discovery / validation scientific clinically-relevant hypotheses secondary analysis existing clinical datasets samples, sourced two more multi-site clinical studies i.e., clinical trials, natural history studies, comparative effectiveness studies). Proposals within scope this announcement include projects focused clinical research areas are within NINDS mission go beyond scope the individual clinical studies being included harmonization, curation analyses. Notice being provided allow potential applicants sufficient time develop meaningful collaborations, confirm data accessibility, develop appropriate projects. RFA expected be published fall 2019 an expected application due date spring 2020. RFA utilize R61/R33 activity code. Details the planned RFA provided below. first phase R61) expected support initial harmonization curation the datasets the second phase R33) support analyses address proposed research objectives. Details the planned RFA provided below. Research Initiative Details RFA for secondary curation analysis existing datasets two more multi-site clinical studies’ datasets. Studies include datasets ongoing studies; however, RFA not support collection new data. RFA use R61/R33 phased mechanism provide multi-year funding both harmonization curation phase R61) the analyses phase R33). Applicants should provide sufficient information demonstrating feasibility obtaining access the datasets, taking consideration data sharing policies described the original studies, including scope the informed consents, local regional privacy regulations. this phased mechanism, funding the second phase R33) be dependent upon meeting Go/No-Go criteria the end the first phase. The Go/No-Go Criteria must describe clear quantitative curation standards necessary enable analyses the second phase R33). Notice encourages investigators form collaborative teams include clinical subject matter expertise, statisticians bioinformaticians/data scientists begin consider applying this new RFA. Teams must include investigators involved the original data acquisition part the investigative team as consultants. Trainees young investigators also highly encouraged be included the investigative team. Examples potential research topics include, are limited to: Validation diagnostic and/or prognostic models outcome Comparative effectiveness hypotheses Mediation analyses biological, cultural environmental factors affect treatment response course disease Evaluation biomarker validity including clinical outcome assessments COAs)), new populations and/or new context use Discovery validation multi-domain clinical and/or biological measures diagnosis, prognosis and/or treatment response using existing genetic biological samples along clinical physiological assessments Extended characterization validation natural history disease course Novel methods improving patient stratification Examples research this RFA not support include: Studies using non-human animal models Studies using data a single clinical research study Multiple single-site clinical research studies Studies harmonization, curation, analysis where primary data source Electronic Health Record EHR) data Studies harmonization, curation, analysis where primary data source metadata EHRs ensure maximal value the project, applicants this RFA be expected include open-source cataloging the processes tools used harmonization, curation, analysis, well data sharing plans include information any controlled-access requirements the curated datasets. Investigators strongly encouraged use open-source software, analytic tools, programming languages promote interoperability well reproducibility. Investigators encouraged make of existing resources, tools training the NIH’s BD2K Centers https://commonfund.nih.gov/bd2k/centers), such as: Center Expanded Data Annotation Retrieval CEDAR) provides computational ecosystem development, evaluation, use, refinement biomedical metadata; https://more.metadatacenter.org/tools-training Center Causal Discovery CCD) develops computational methods known causal discovery algorithms can used discover causal relationships a combination observational data, experimental data, prior knowledge; https://www.ccd.pitt.edu/tools/ Big Data Discovery Science BDDS) provides software tools data resources developed the management, manipulation, mining large-scale biomedical data along education training resources; https://bd2k.ini.usc.edu/tools/. Proposals expected include plans harmonize data available NINDS Common Data Elements CDEs; https://www.commondataelements.ninds.nih.gov/#page=Default) both outcome non-outcome variables. CDISC standards https://www.cdisc.org/) should also incorporated where applicable. Funding Information Estimated Total Funding 1,500,000 direct costs per year Expected Number Awards 3 Estimated Award Ceiling Applicants should propose budgets required conduct work proposed. 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) Indian/Native American Tribal Government Federally Recognized) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) Applications not being solicited this time.  Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov Carol Taylor-Burds, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-1447 carol.taylor-burds@nih.gov