NICHD Exploratory/Developmental Research Grant is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-17-259: NICHD Exploratory/Developmental Research Grant (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title NICHD Exploratory/Developmental Research R21 Exploratory/Developmental Research Grant December 6, 2017 - This PA has been reissued as PA-18-482 .

Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018. - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. July 28, 2017 - NICHD will accept R21 exploratory/developmental research grant applications for clinical trials submitted in response to PA-17-259.

See Notice NOT-HD-17-018 . May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The NICHD Exploratory/Developmental Grant program supports exploratory and developmental research projects that fall within the NICHD mission by providing support for the early and conceptual stages of these projects.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date December 6, 2017 per issuance of PA-18-482 .

(Original Expiration Date: May 8, 2020) It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The NICHD Exploratory/Developmental Grant program supports exploratory and developmental research projects that fall within the NICHD mission by providing support for the early and conceptual stages of these projects.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. The evolution and vitality of the biomedical, behavioral, and clinical sciences require a constant infusion of new ideas, techniques, and points of view.

These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.

Through the NICHD Exploratory/Developmental Research Grant Program, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical, behavioral, and clinical research within the NICHD This program is intended to encourage new exploratory and developmental research projects.

For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research.

Another example could include the unique and innovative use of an existing methodology to explore a Areas of Research Interest Areas of research covered by the proposed R21 projects must fall within the scientific missions of the twelve Scientific Branches of the NICHD Division of Extramural Research (DER) or the National Center for Medical Rehabilitation Research (NCMRR).

Details about those scientific missions and program staff contacts may be found on the web pages for the DER scientific branches at: http://www. nichd. nih.

gov/about/org/der/branches/Pages/index. aspx and the NCMRR at: http://www. nichd.

nih. gov/about/org/ncmrr/Pages/overview. aspx .

Specific research priorities of DER branches and NCMRR are listed as follows. This FOA will not support clinical trials.

The Child Development and Behavior Branch (CDBB) mission is to support research focused on neurobiological, genetic, environmental, or social factors impacting developmental processes associated with behavior, cognition, learning (including reading, math and science learning and related disabilities), language, motor or social-emotional functioning or health status of infants, children, and young adults.

CDBB high priority research areas include but are not limited to the following topics: Bilingual and biliteracy development?

Measures of neurodevelopment Pediatric primary care behavioral and health promotion Psychosocial adjustment for individuals in high-risk environments School readiness skills in economically and socially Reading, writing, and mathematics CDBB low priority research areas for the R21 mechanism include: Human or animal model research focusing on a specific disease, organ system or disability that lacks a developmental focus or does not address underlying developmental processes.

CDBB supports primarily mammalian animal models and will not accept avian models if focused solely on vocal learning or language development and does not have a specific cognitive or brain development focus. Invertebrate models are not accepted.

Research using animal models to study maternal behavior without a specific focus on brain, immunologic, or neuroendocrine factors impacting maternal or offspring behavior or without a focus on mechanisms underlying offspring cognition, brain development or health. Research investigating factors affecting child or adolescent self- and/or peer management of chronic conditions.

Research focusing primarily on professional development training of teachers or administrative personnel at the elementary Research on couples relationship education, relationship/marriage therapy, or interventions related to couples relationship quality, marriage, or divorce. Couple therapy for infertility.

The Contraception Research Branch (CRB) mission is to develop and support research and research training programs in contraceptive discovery and development. Major research areas include studies of: new contraceptive methods; mechanisms of action and effects of contraceptive and reproductive hormones, drugs, devices, and procedures as well as optimal formulations and dosages of contraceptive agents.

CRB high priority research areas include but are not limited to the following topics: Developing new methods to deliver pharmacologic agents to the sites of gamete production, maturation, and/or function. Developing methods that prevent both fertility and the transmission of sexually transmitted infections.

Comprehensive identification, characterization and/or validation of potential non-steroidal male and female contraceptive Developing more efficient and/or predictive strategies or methods to validate potential contraceptive targets.

Characterizing testicular stem cells to identify targets for male Elucidating the mechanism of transport of drugs and/or drug like molecules across the blood-testis and/or blood-epididymal priority research areas for the R21 mechanism: Basic biological research with no reference or immediate relevance to contraceptive use or contraceptive method Research to use, develop, or test methods that utilize chemicals known to have toxic properties.

Research to develop contraceptive methods which propose the use of chemicals which cannot be developed into contraceptive methods due to existing intellectual property considerations.

Biology and Structural Variation Branch (DBSVB) mission is to support research focused on understanding the biological processes controlling normal embryonic development as well as the mechanisms underlying the susceptibility and etiology of structural birth defects.

Major program areas in the Branch include developmental genetics; systems developmental biology; early embryonic development and differentiation; biophysics/biomechanics of development; developmental neurobiology and neural crest differentiation; organogenesis; in vivo mechanisms of tissue/organ regeneration; stem cells and iPSCs; and structural birth defects.

DBSVB high priority research areas include but are not limited to the following topics: Novel, exploratory/developmental projects of high potential significance relevant to the research areas described in the Branch description [see website] Developing tools or new animal models for studying embryonic development or structural birth defects Projects using stem cells or iPSCs for understanding human embryonic development and birth defects Projects addressing the emerging area of developmental metabolomics as related to embryonic processes or the etiology of low priority research areas for the R21 mechanism: Basic cell biology and molecular biology projects addressing basic cellular processes that are not specifically related to embryonic development, such as cell cycle control, organelle biogenesis, membrane structure and function, protein processing, DNA replication, damage and repair, etc. Projects using stem cells or iPSCs to study disease in adults Developing plants or unicellular organisms, such as bacteria, archaea, protozoa, unicellular algae, and unicellular The Fertility and Infertility Branch (FIB) mission is to support research aimed at alleviating infertility, uncovering new pathways to control fertility, and expanding our fundamental understanding of processes that underlie human reproduction.

The interests of the branch include basic research that increases our knowledge base regarding fertility regulation and applying that knowledge to develop more effective strategies for the diagnosis, management and prevention of human conditions that compromise fertility, with the ultimate goal of promoting a better quality of life for all individuals.

FIB high priority research areas include but are not limited to the following topics: Studies of gamete quality and pre-placental processes as they relate to the etiology of early pregnancy loss. Studies on transgenerational epigenetic inheritance. Studies to investigate the relationship of fertility status to overall health and disease.

Genetic basis of idiopathic male and female fertility. Impact of nutrition and metabolism on fertility. Identification of biomarkers to study reproductive transitions.

Development of innovative technologies and model systems that can advance progress in reproductive biology and medicine. priority research areas for the R21 mechanism: Basic biology of meiosis with no reference or immediate relevance to fertility or reproduction. Cellular mechanisms of epigenetic regulation with no reference or immediate relevance to a reproductive phenotype or function.

Biology of ovarian and testicular cancer. Male urogenital tract studies with a specific focus on urology. Non-mammalian models of uterine function.

Examination of neuroendocrine signaling cascades in isolation from networks. couple therapy for infertility. The Gynecologic Health and Disease Branch (GHDB) mission is to support research related to gynecologic health throughout the reproductive lifespan.

The GHDB portfolio includes studies on endometriosis, adenomyosis, uterine fibroids, gynecologic pain syndromes (chronic pelvic pain, vulvodynia, and dysmenorrhea), and pelvic floor GHDB high priority research areas include but are not limited to the following topics: Research involving longitudinal studies that include relevant Delineating the genetic, cellular, molecular, environmental, and psychosocial factors underlying the etiology of chronic gynecologic pain syndromes.

Developing novel, non-hormonal pharmacologic treatments for Developing novel imaging methods and biomarkers for gynecologic Investigating the genome, epigenome, and/or transcriptome as they impact development, progression, and/or treatment response in gynecologic conditions. Investigating the role of endogenous stem cells in the etiology or treatment of gynecologic disorders.

Transdisciplinary research based on findings from diverse fields to advance basic and mechanistic understanding of gynecologic health and disease. GHDB low priority research areas for Studies focusing on interstitial cystitis, irritable bowel syndrome, incontinence (fecal or urinary) or sexual dysfunction due to causes other than pelvic floor disorders.

Research on general pain mechanisms or treatments that use female gynecologic pain only as a model, rather than more Studies investigating interventions for gynecologic disorders that are within the mission of other Institutes or Centers, such as alternative/complementary or cognitive behavioral therapies.

and Developmental Disabilities Branch (IDDB) mission is to support research that will improve the understanding, screening, and treatment of conditions associated with intellectual and developmental disabilities, including common and rare neuromuscular and neurodevelopmental disorders.

IDDB high priority research areas include but are not limited to the following topics: Interdisciplinary studies emphasizing the cellular, genetic, epigenetic, and environmental factors that contribute to the cognitive and behavioral manifestations of IDD, including (but not limited to) Down, Fragile X, and Rett syndromes, inborn errors of metabolism, and autism Research on one or more comorbid conditions of IDD, including but not limited to: disordered sleep, self-injurious behaviors, obesity, gastrointestinal dysfunction, seizures/epilepsy, attention deficit/hyperactivity disorder, anxiety, depression, psychosis, and other mental health Research on the development and/or implementation of new screening tests for the prenatal, newborn, and early childhood periods that assesses the efficiency and effectiveness of translating these tools into clinical care and the community setting.

Research establishing the validity of biomarkers and outcome measures for IDD symptoms, severity assessments, and treatments, especially outcomes targeting cognitive (including language), behavioral (adaptive or maladaptive), social, and medical issues.

Research examining transitional time periods of particular interest for IDD, including presymptomatic, adolescent to adulthood, middle adulthood to aging (prevalence of dementia in IDD populations), and causes of mortality in IDD.

Developing, disseminating, and implementing treatments for IDD that will impact clinical care and improve quality of life, including physiological, cognitive and behavioral manifestations, for those IDDB low priority research areas for Research that focuses on parent or family outcomes rather than outcomes of the individual with IDD. Research that focuses on fundamental mechanisms of genes with tangential relationship to IDD conditions.

Pediatric Infectious Disease Branch (MPIDB) mission is to support and conduct domestic and international research related to the epidemiology, diagnosis, clinical manifestations, pathogenesis, transmission, treatment, and prevention of HIV infection and its complications in infant, children, adolescents, and women (pregnant and non-pregnant), as well as HIV-associated co-infections (such as tuberculosis, hepatitis, and malaria) in children and pregnant women.

MPIDB also supports and conducts research on other significant infectious diseases, including: congenital infections, such as Zika virus and cytomegalovirus; tropical diseases, specifically those that affect children and pregnant women; emerging and re-emerging infectious diseases; and vaccine-preventable disease in infants, children, adolescents, and pregnant women. ?

research areas include but are not limited to the following topics: HIV: Cure/remission and reservoirs in infants and children. HIV: Prevention strategies in adolescents, including uptake of and adherence to HIV prevention modalities. HIV: Adverse pregnancy and infant outcomes.

Emerging and re-emerging infectious diseases. Impact of infections on developing nervous system. Understanding of the immune connection and communication between the pregnant women, placenta, and fetus, and the effects on infant immunity.

MPIDB low priority research areas for Basic biomedical research focused on neurocognitive dysfunction Research applications on HIV and other infectious diseases where the focus and/or impact on infants, children, adolescents, and pregnant women represent only a minority of the work proposed.

Research with multiple behavioral and/or biological outcomes that are of relevance to HIV (and/or specified infectious disease), where HIV (and/or the specified infectious disease) is not the focus.

and Pediatric Pharmacology and Therapeutics Branch (OPPTB) mission is to support basic, translational, and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceuticals, and to ensure centralization and coordination of research, clinical trials, and drug development activities for obstetric and pediatric populations.

Implementation of the Best Pharmaceuticals for Children Act (BPCA) activities at the NICHD is among the major activities for the Branch. OPPTB high priority research areas include but are not limited to the following topics: Developmental pharmacology and pathophysiology of pregnancy. New drug development and drug repurposing.

Novel alternative designs for pediatric and obstetric clinical Outcome measures and biomarkers for pediatric and obstetric Developmental pharmacogenomics, toxicogenomics and epigenomics. Pk, safety and efficacy of pharmaceuticals in pregnant/obese OPPTB low priority research areas for Pediatric cancer and pediatric cancer medication development is not within the priorities of our branch.

Applications in those areas should be directed to the National Cancer Institute unless they address information that can be generalized for non-cancerous conditions, e.g. identification of biomarkers that can be applied to non-cancerous conditions as well.

Diseases, disorders or conditions that are within the research mission of another NIH Institute/Center, unless information from the study can be applied directly to pediatric or obstetric populations.

Nutrition Branch (PGNB) mission is to support research on how nutrition promotes healthy growth and development; lactation and breastfeeding, including the interactions of breast milk and the microbiome, as well as the effects of breast milk's non-nutritive compounds (e.g., oligosaccharides and dipeptides) on enteric pathogens; the causes of obesity in childhood and sequelae of childhood obesity in adulthood; the genetic, nutritional, and hormonal antecedents of bone health and the origins of osteoporosis; the neuroendocrine basis of growth and the onset of puberty; and the development of the hypothalamo-pituitary adrenal, gonadal, and thyroid axes.?

PGNB high priority research areas include but are not limited to the following topics: Interaction of nutrients and the microbiome Antimicrobial activity of breast milk Attainment of peak bone mass and peak bone strength PGNB low priority research areas for Influence of physical environment on weight loss and Critical Illness Branch (PTCIB) mission is to support research focused on preventing, treating, and reducing all forms of childhood trauma, injury, and critical illness to enhance healthy outcomes across the continuum of care.

in Pediatric Trauma and Critical Illness Research: BUILDING THE FIELD ADVANCING THE SCIENCE, Action Agenda . PTCIB high priority research areas include but are not limited to the following topics: Pediatric critical care medicine, epidemiology, pathophysiology, prevention and management of critical illness. Ethical, translational, and applied research in pediatric Injury prevention, trauma and emergency care.

Psychological trauma, traumatic stress, violence and violence-related injury and child maltreatment. PTCIB low priority research areas for Studies of adolescent behavioral outcomes or developmental trajectories of post-injury outcomes.

Research on bullying, teen dating violence or interpersonal Studies in which the preponderance of the science is focused on child developmental/parenting processes and Studies examining mental illness or psychopathology as primary Studies in which the primary aim is understanding the Studies focused on chronic conditions unless the primary aim of the science is on treatment in the PICU or the prevention of a chronic condition from progressing to a critical illness.

Projects in which critical care is provided exclusively in the Studies of treatment in the emergency department that are not related to trauma or to severe, potentially life-threatening illness. Studies of chronic/long-term rehabilitation or rehabilitation related to a chronic condition.

The Population Dynamics Branch (PDB) mission is to support research and data collection in three areas: demography the scientific statistical study of human populations; population health research on human health, productivity, behavior, and development at the population level, using population representative samples or policy or natural experiments; and behavioral and social science research on reproductive health.

PDB high priority research areas include but are not limited to the following topics: Behavioral research on the use and non-use of contraception. Health and disease across the lifespan. Multi-level interactions and inputs to human health and development, including gene x environment interactions.

PDB low priority research areas for Relationship education, relationship/marriage therapy, or interventions related to relationship quality, marriage, or Couples communication except as it is related to unintended pregnancy, contraception, HIV/AIDS, and other sexually Couple therapy for infertility Attitudes towards hypothetical contraceptive method(s).

Medical interventions except those related to reproductive Secondary analysis of quantitative data from non-representative Collecting quantitative and qualitative data based on non-representative samples except as a feasibility study leading to population-representative data collection.

The Pregnancy and Perinatology Branch (PPB) mission is to support research to improve the health of women before, during, and after pregnancy, improve pregnancy outcomes and increase infant survival free from disease and disability. PPB high priority research areas include but are not limited to the following topics: Improving the health of women before, during and after pregnancy. Improving pregnancy outcomes.

PPB low priority research areas for Management of maternal behavioral dysfunction and psychiatric disorders; neurobiology of repair and regeneration during development; developmental immunology. Center for Medical Rehabilitation Research (NCMRR) mission is to foster development of scientific knowledge needed to enhance the health, productivity, independence, and quality-of-life of people with physical disabilities.

NCMRR high priority research areas include but are not limited to the following topics: Multimodal approaches promoting plasticity and sensorimotor function, particularly the combination of physical therapy with regenerative, pharmacological, or stimulation treatments.

Developing objective measures and biomarkers that may predict rehabilitation treatment response, monitor functional progress, and tailor interventions to the individual abilities, needs, and resources of the person with disabilities. Developing scalable strategies and technologies to monitor outcomes in real-world settings (e.g., home, community, workplace and school).

This approach includes the use of engineering and social-science to understand environmental supports and barriers, monitor individual participation, understand health service access, and support health and independence. Identifying, preventing, and treating key secondary conditions that are associated with physical impairments and disabilities.

Addressing key lifespan transitional issues, such as the physical and developmental transition from adolescence to early adulthood and functional independence. NCMRR low priority research areas for Studies focused primarily on pathophysiology. Continued development/refinement of existing technologies.

Development of animal models. Applications for Exploratory/Developmental Research Grant awards should include projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, are not appropriate for this FOA.

Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the NIH Small Research Grant Program .

VIII. Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single The maximum project period is two years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 PHS Human Subjects and Clinical Trials Information Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed. Delayed Onset Study: All instructions