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Notice Special Interest NOSI): Chimerism Marmosets other New World Primates Notice Number: NOT-MH-20-048 Key Dates Release Date: June 3, 2020 First Available Due Date: October 05, 2020 Expiration Date: January 08, 2022 Related Announcements PA-20-185 - NIH Research Project Grant Parent R01, Clinical Trial Allowed) PA-20-195 - NIH Exploratory/Developmental Research Grant Program Parent R21, Clinical Trial Allowed) Issued National Institute Mental Health NIMH) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institutes Health NIH) a special interest research project applications focusing understanding biological basis functional implications chimerism the common marmoset Callithrix jacchus) other callitrichid primates. interest applications focus the following areas: 1) stem cell exchange utero, extent molecular mechanisms associated the induction maintenance hematopoietic chimerism, the possibility somatic and/or germ line chimerism the adult animal; 2) development systems assays study cellular heterogeneity resulting chimerism potential intragenomic conflict within individual’s tissues; and, 3) understanding molecular cellular impact chimerism biological processes, including development, metabolism, cognition, social behavior, aging, immunological suppression reactivity, reproduction; well effects and mechanisms associated transplant tolerance. Background Nonhuman primates NHP) the closest evolutionary relatives humans, whom share anatomical, physiological, gene interaction features. common marmoset Callithrix jacchus) of increasing importance biomedical research worldwide, aided its small body size, shorter life span compared macaques, rapid reproductive maturation, making ideal genetic transgenerational research. New World primate also known cooperative social behavior, cognition, communication, potentially makes a good model organism contribute our understanding a wide range human biology diseases, are currently being extensively used study family interactions, hormonal development, reproduction, infectious diseases, neurodegenerative disorders age-related hearing loss. Marmosets obligate litter bearers most pregnancies resulting dizygotic twins show chimerism the blood other cells the hematopoietic lineage, a result in utero exchange stem cells through placental anastomoses during early development, process leads lifelong chimerism. Chimerism previously reported most marmoset tissues including skin, hair, brain, lung, blood, lymphatic tissues, muscle. However, recent quantitative studies indicate chimerism limited cells the hematopoietic lineage, that previous observation widespread tissue chimerism likely due blood lymphocyte infiltration those tissues, fibroblast cell lines chimeric individuals not chimeric. evolutionary functional consequences hematopoietic chimerism, is unique marmosets other callitrichid primates, currently unknown. is also known chimerism limits enhances use these animals models human physiology, health disorders. example, studies focused immune response the marmoset should cognizant the potential confounding effect chimeric lymphocytes. Therefore, this model reach full translational utility furthering our understanding human health diseases, is imperative we achieve better understanding the functional consequences chimerism its contributions health, behavior diseases New World primates. Research Objectives Applications response this NOSI should aligned the overall purpose, is improve our understanding the biological physiological significance chimerism this NHP model. Research areas include are limited to: stem cell exchange utero, extent molecular mechanisms/pathways associated the induction maintenance hematopoietic chimerism, mechanisms associated maintenance loss chimerism the bone marrow, blood, thymus, lymphoid tissues juveniles adults; the possibility somatic germ line chimerism the adult animal; development systems assays study cellular heterogeneity resulting chimerism; comparisons major histocompatibility complex genes proteins expressed dizygotic twin pairs; potential intragenomic conflict within individual’s tissues; understanding molecular cellular impact chimerism biological processes, including development, metabolism, cognition, social behavior, aging, immunological suppression reactivity, reproduction; medical interventions including organ cellular transplantation focus evaluation the immune response elicited a sibling twin third party donor organ e.g., kidney, heart, lung) cellular e.g., bone marrow islet) transplant mechanisms associated transplant tolerance rejection. Application Submission Information notice applies due dates or after October 5, 2020 subsequent receipt dates through January 8, 2022. Submit applications this initiative using of following funding opportunity announcements FOAs) any reissues these announcement through expiration date this notice PA-20-185: NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-20-195: NIH Exploratory/Developmental Research Grant Program Parent R21, Clinical Trial Allowed) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-MH-20-048” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Although NIMH NINDS not listed a Participating Organization all FOAs listed above, applications this initiative be accepted. Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) Abigail Soyombo, Ph.D., MBA National Institute Mental Health NIMH) Telephone: 301-827-7329 Email: abigail.soyombo@nih.gov Manuel Moro, DVM, Ph.D. National Institute Aging NIA) Telephone: 301-480-1796 Email: manuel.moro@nih.gov Julia Shaw, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3711 Email: julia.shaw@nih.gov Amy C. Lossie, PhD National Institute Drug Abuse NIDA) Telephone: 301) 827-6092 Email:amy.lossie@nih.gov James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:gnadtjw@ninds.nih.gov Peer Review Contact(s) Examine eRA Commons account review assignment contact information information appears weeks after submission due date). Financial/Grants Management Contact(s) Theresa Jarosik National Institute Mental Health NIMH) Telephone: 301-443-3858 Email: tjarosik@mail.nih.gov

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

The goals of this Funding Opportunity Announcement (FOA) are to stimulate further research on delineating the pathophysiology of HIV-1 associated CNS disease in the setting of chronic viral suppression and ART. In addition, FOA also encourages research studies to aid in the identification/ validation of biomarkers and pre-clinical targets with quantifiable readouts in domestic and international settings. Multidisciplinary research teams and collaborative alliances are encouraged but not required.

This Funding Opportunity Announcement (FOA) invites research grant applications studying mechanisms of HIV-1 persistence and eradication strategies specifically focused on the central nervous system (CNS) in the context of viral suppression. Basic and translational research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required

Reissue of RFA-NS-18-032. The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased flexibility to Program Directors (PDs) /Principal Investigators (PIs) whose records of research achievement demonstrate their ability to make major contributions to neuroscience. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PI's recent NINDS support (Part 2, Section II) This greater funding stability will provide eligible investigators at nearly all career stages increased freedom and flexibility, allowing them to be more adventurous in their research, take greater risks, embark upon research that breaks new ground, undertake research projects that require a longer timeframe, and/or extend previous discoveries in new directions. Research supported through the RPA must be within the scope of the NINDS mission (http://www.ninds.nih.gov/about_ninds/mission.htm). Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center will not be considered through this program. Other anticipated benefits of the RPA include: A more stable funding environment, facilitating the pursuit of longer-term research goals; Flexible funding, enabling investigators to pursue research opportunities as they arise, not tied to specific aims; Reduced time spent writing grant applications and managing multiple grant awards, thereby allowing investigators to spend more time conducting and overseeing research; and More time for PDs/PIsto mentor junior scientists. Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined here as R00, R01, R37, R56, DP1 or DP2 awards), and who have had an active R01 equivalent grant from NINDS in each of the past 5 years, with no more than one of those years in a no cost extension.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research.