The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)

The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This funding opportunity encourages research across many scientific disciplines to examine how sex and gender factors intersect with health and disease.

Proposed investigations must include both sex and gender-related variables and address at least one of the five objectives from Strategic Goal 1 of The 2019–2023 Trans-NIH Strategic Plan for Women's Health Research.

Expired RFA-OD-19-029: The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional) 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 Office of Research on Women’s Health ( ORWH ) funding opportunity announcement should fall within the mission of the Institutes/Centers. ORWH and SGMRO may co-fund applications assigned to those Institutes/Centers.

National Center for Complementary and Integrative Health ( NCCIH ) National Human Genome Research Institute ( NHGRI ) National Institute on Aging ( NIA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute on Drug Abuse ( NIDA ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) Research Office ( SGMRO ) National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title of Sex and Gender Influences on Health and Disease (R01 Clinical R01 Research Project Grant October 13, 2022 - This RFA has been reissued as RFA-OD-22-028 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

See Notice NOT-OD-21-169 . August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 September 24, 2020 - Notice of NHLBI Participation in RFA-OD-19-029. See Notice NOT-HL-20-812 . September 15, 2020 - Notice of Change: Expansion of Research Scope of RFA-OD-19-029.

See Notice NOT-OD-20-168 . June 19, 2020 - Notice of Change to NIA-Specific Text in RFA-OD-19-029. See Notice NOT-AG-20-037 .

March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077 . Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 313, 93.

213, 93. 172, 93. 866, 93.

273, 93. 855, 93. 279, 93.

121, 93. 113, 93. 361, 93.

242, 93. 837, 93. 838, 93.

939, 93. 840, 93.

233 Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications on the influence and intersection of sex and gender in health and disease including: (1) research applications that examine sex and gender factors and their intersection in understanding health and disease; and (2) research that addresses one of the five objectives from Strategic Goal 1 of the new 2019-2023 Trans-NIH for the Health of Women."

The awards under this FOA will be administered by NIH ICs using funds that have been made available through the Office of Research on Women’s Health (ORWH) and the scientific partnering Institutes Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date November 25, 2019; November 25, 2020, November 26, 2021 All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on No late applications will be accepted for this Funding 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) November 25, 2019; November 25, 2020, November 26, 2021 All applications are due, 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 the listed date(s).

No late applications will be accepted for this Funding 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.

February/March 2020; February/March 2021; February/March May 2020; May 2021; May 2022 July 2020; July 2021; July 2022 It is critical that applicants follow the Research (R) Instructions in the SF424 (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 purpose of this Funding Opportunity Announcement (FOA) is to solicit R01 applications on the influence and intersection of sex and gender in health and disease including: (1) research applications that examine sex and gender factors and their intersection in understanding health and disease; and (2) research that addresses one of the five objectives from Strategic Goal 1 of the new 2019-2023 Trans-NIH the Health of Women.

" The awards under this FOA will be administered by NIH ICs using funds that have been made available through the Office of Research on Women’s Health (ORWH) and the scientific partnering Institutes and Centers across NIH.

The Office of Research on Women’s Health ( ORWH ) works in partnership with the NIH Institutes, Centers and Offices (ICOs), as well as with federal agencies and their offices to ensure that women's health research is an integral part of the larger scientific framework to enhance heath and treat disease.

The ORWH mission includes strengthening research relevant to diseases, disorders, and conditions that affect women and ensuring that research supported by NIH adequately addresses issues regarding women’s health.

The ORWH recently led the development of the 2019-2023 Trans-NIH which the biomedical research enterprise thoroughly integrates sex and gender influences so that every woman receives evidence-based disease prevention and treatment tailored to her own needs, circumstances, and goals. Within this strategic framework, this FOA focuses on the need to better understand the influence and intersection of sex and gender.

Research supported by this FOA seeks to stimulate research advances on the influence of sex and gender, lay the groundwork for innovative investigative approaches, and improve health care tailored to women of all ages and backgrounds. In the last decade, there has been growing recognition that, disease prevalence, course and outcomes in women and men are influenced by both biologic sex and gender.

An increasing body of research suggests that there are diseases that are unique to women, more common in women than in men, or characterized by differences in disease course in women compared with men. Research on the sex and gender factors that drive these crucial differences The Institute of Medicine (IOM) report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?"

( IOM Report, 2001 ) defines the term sex and gender. The terms are used to refer to separate but inextricably linked influences in health. The terms however are often conflated or used interchangeably.

Sex and gender are conceptually complex, and our understanding is likely to evolve with the availability of a more complete body of research. Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Sex and gender are distinct concepts, but in human health their influence is often inextricably linked and poorly understood.

With continuous interaction between sex and gender, human health is determined by both biological sex and gender expression and identity, so both influences need to be more fully integrated and elucidated in biomedical research. In 2015, ORWH convened a workshop titled, Improving the Health of Women in the United States (National Academies of Sciences, Engineering, and Medicine, 2016).

Results from the workshop revealed that many analyses of health data are not stratified by sex or gender, making it difficult to fully understand the health of women or to translate findings to provide evidence-based care.

In addition, many gaps in our understanding of diseases and conditions in women are the result of the continued overreliance on male models (e.g. animals, cells) and the historical overreliance on men as participants in clinical research.

Interdisciplinary approaches, routine sex-disaggregation of data, refined measurement tools, and integrative approaches were deemed critical to addressing the health challenges With the implementation of the SABV Policy that went into as part of the initiative to enhance Rigor and Reproducibility ( NOT-OD-15-103 ) in 2016, as well as the 21st Century Cures Act that reinforces our efforts to advance women’s health, there has been growing appreciation for the importance of sex and gender in health and disease.

A growing body of empirical data provides clear evidence that women and men have different risks for the onset, expression, course, pathophysiology, and treatment response in many disorders that occur at different stages of development and throughout the life span. For example, beginning in puberty, women are twice as likely as men to experience depression and this increased risk is likely related to both sex and gender influences.

These sex and gender influences are not well understood however, and many questions remain unanswered. A better understanding of this sex difference could lead to major advancements in the diagnosis or treatment of Autism Spectrum Disorder (ASD) in both males and females.

This announcement solicits research to target gaps in knowledge regarding the influence and intersection of sex and gender on disease conditions to improve understanding of the factors and mechanisms underlying sex differences in health.

The primary objectives of this announcement include: (1) research applications that examine sex and gender factors and their intersection in understanding health and disease; and (2) research that addresses one of the five objectives from Strategic Goal 1 of the new 2019-2023 Trans-NIH For the purposes of this FOA, the following definitions are utilized to describe and differentiate sex and gender-based factors: Factors : Biological variables defined by characteristics encoded in DNA, such as reproductive organs and other physiological and functional characteristics.

See NIH Guide Notice NOT-OD-15-102 ( https://grants. nih. gov/grants/guide/notice-files/not-od-15-102.

html ). Factors : Social, environmental, cultural, and behavioral factors including individual gender identity and the choices that influence a person’s self-identity and health (Clayton and Tannenbaum, 2016 https://jamanetwork. com/journals/jama/fullarticle/2577142 ).

order to be responsive to this FOA, application must address all of the (1) Include one or more sex-based variables, including but not limited to: evaluation of sex as a biological variable; sex-based comparisons on conditions in females and males; biologically based variables such as hormones, physical features, anatomy, or biomarkers.

(2) Include one or more gender-based variables, including but not limited to: assessment of psychosocial variables relevant to health conditions; measures of socially constructed roles, experiences, identities, or behaviors of girls, women, boys, men, or gender diverse people. (3) The intersection of sex and gender. (4) One of the five objectives from Strategic Goal 1 of the basic biological differences between females and males.

Studying female and male cells, organs, and biological systems is necessary to improve our understanding of the mechanisms by which sex influences health and disease. Research that examines the possible influences of sex on both normal biology and pathophysiology is critical.

Generating fundamental knowledge about female biology and scientifically meaningful sex differences in both normal and abnormal processes strengthens the foundation for the design of rigorous preclinical and clinical studies that account for sex as a biological variable, enhancing their relevance to the health of women. the influence of sex and gender on disease prevention, presentation, management, and outcomes.

Sex and gender factors and their intersection influence the course of many diseases, including risk and protective factors, presentation, treatment, and recovery. Gaps in knowledge about these influences remain for many illnesses and chronic diseases affecting women, including the effects of comorbidities.

Identifying meaningful effects of sex and gender on diseases and understanding how these influences affect the health of women will address sex- and gender-based disease burden, contribute to a more individualized approach to health care, promote disease prevention, and improve quality of the immediate, mid-, and long-term effects of exposures on health and disease outcomes.

Various types of exposures affect disease risk across different timescales, ranging from an immediate outcome at the time of exposure to a delayed outcome that becomes evident at a later stage in life. Exposures include, but are not limited to, factors such as the microbiome, exogenous hormones, environmental toxins, the built environment, and behavior-related exposures such as physical activity, sleep, and nutrition.

Additional exposures include social and psychological exposures such as stress and trauma across the life course; discrimination and stigma; caregiving; and factors linked to resilience, such as social support and family cohesion. Socioeconomic exposures such as poverty, family and community resources, educational attainment, and access to health care are also relevant to the health of women.

Identifying the effects of exposures can inform the use of preventive interventions to reduce disease risk and promote well-being. research that explores the influence of sex and gender on the connection between the mind and body, and its impact on health and disease. Research is needed to understand the mechanisms of mind and body connections, including their dysregulation, and their impact on behavior and cognition.

Such studies are particularly relevant to certain conditions that differentially affect women such as pain, depression, sleep disorders, obesity, cardiovascular disease, and metabolic disturbances. Investigating the relationship between mental and physical factors and health outcomes can help identify opportunities for prevention, mitigate disease risk, and manage disease progression.

research on female-specific conditions and diseases, including reproductive stages, and maternal and gynecologic health. There is a need for focused investigation of female reproductive health and illness, including menstruation (normal and dysfunctional), infertility, pregnancy, lactation, and menopause. Additionally, there is a need for increased attention to research gynecologic health and disease in women of all ages.

Maternal health is critically important to the health of a woman during pregnancy and throughout her life course, and for the health of her children. Because the maternal mortality rate in U.S. women is on the rise ( GBD 2015 Maternal Mortality Collaborators, 2016 ), particularly in women of color, investigation of disparities in mortality and morbidity related to pregnancy is needed.

In addition, applications submitted in response to this FOA are encouraged to consider: Disparities: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment.

Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, sexual orientation, gender expression or identity, effects of poverty, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies.

course/Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and the frail elderly.

Each of these factors may influence health, disease, lifestyle, treatment choices, and response to therapy.

This FOA supports basic, preclinical, translational and clinical research investigations composed of teams who share expertise, knowledge, and skills in the following research formats: transdisciplinary research that includes collaborations across a range of disciplines, including but not limited to, economics, medical anthropology, psychology, and demography to address research from a multi-disciplinary perspective that may address gaps in the fuller context of women's lives and the underlying common root causes of poorer health outcomes.

In addition to new, cross-cutting interdisciplinary research, studies that leverage existing funded cohorts and datasets for analyses of hypotheses related to sex and gender influences in health and disease are of high interest. Comparative analyses of existing samples/datasets/databases and/or data-mining and data curation to investigate the role of sex/gender are encouraged.

This FOA is designed to stimulate research that incorporates and/or enhances understanding of the influence of sex and gender and their intersectionality in health outcomes.

For further information on NIH's expectations about consideration of sex as a biological variable, and NIH's initiative to improve reproducibility through rigor and transparency, please see the following Notices published in the NIH Guide: NOT-OD-15-102 , NOT-OD-15-103 , NOT-OD-16-011 , NOT-OD-16-012 .

Participating Institutes, Centers and Offices The participating NIH ICOs below identify priority research approaches and specific topics within the scope of their institute’s scientific mission and consistent with their interests toward a better understanding of the intersection of sex and gender in health and disease.

The National Center for Complementary and Integrative Health (NCCIH) The mission of the National Center for Complementary and Integrative Health (NCCIH) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their role in improving health and health care.

For the purposes of this FOA, NCCIH is interested in research on the contributions of sex, gender, and the intersection of sex and gender on the mechanisms of action of complex interventions including various mind and body approaches and natural products.

NCCIH is also interested in research that investigates the influence of sex and gender on utilization of these approaches to improve health outcomes among diverse populations, including gender diverse populations. Natural products include botanicals, pre/probiotics, and products marketed as dietary supplements.

Mind and body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy.

NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial area of complementary and integrative health that do not propose clinical trials, such as observational, basic, and mechanistic (animal) studies.

Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate National Human Genome Research Institute (NHGRI) NHGRI will support the development of resources, approaches, and technologies that will accelerate genomic research on the structure of genomes, the biology of genomes, and the biology of disease; that will use genomics to advance the science of medicine; and that will incorporate genomics to improve the effectiveness of healthcare.

NHGRI will also support genomic research in several cross-cutting areas, including the ethical, legal and societal implications of genomics and genetics research, bioinformatics, technology development, and research training and career development. In general, NHGRI supports studies that provide generalizable methods and knowledge.

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application. The contact information for the three scientific programs are: Division of Genome Science: https://www.

genome. gov/27550609/division-of-genome-sciences-staff/ Division of Genomic Medicine: https://www. genome.

gov/27550610/division-of-genomic-medicine-staff/ Division of Genomics and Society: https://www. genome. gov/27550080/division-of-genomics-and-society/ The National Institute on Aging invites research that examines sex and gender factors and their intersections to improve understanding of health and disease in the context of Alzheimer s disease and related dementias.

Research in NIA applications must focus on a high-priority topic of interest specified in PAR-19-070 : "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial National Institute of Allergy and Infectious Diseases Areas of programmatic interest to NIAID include, but are not limited to, the following: Research on all areas of HIV infection, including developing and testing preventive HIV vaccines, and other non-vaccine biomedical prevention strategies such as systemic protecting long-acting post-exposure prophylaxis (PrEP) and Multipurpose Prevention Technologies [MPT], and new strategies for controlling or eliminating HIV infection and AIDS-associated opportunistic Basic and applied research to better understand, treat, and ultimately prevent other infectious, immunologic, and allergic diseases National Institute on Alcohol Abuse and Alcoholism NIAAA is interested in supporting basic, preclinical, translational and clinical research applications that will examine the influence of sex and gender on treatment, prevention, and management of alcohol NIAAA priorities are as follows: lmpact of factors including stress and trauma across the lifespan and sleep on sex and gender leading to alcohol use, addiction, or cessation of Effects of sex and gender and their interaction on alcohol The National Institute on Drug Abuse (NIDA) NIDA invites applications that investigate the intersection of sex and gender factors in vulnerability to substance use and addiction, its consequences, and treatment and prevention outcomes.

National Institute of Dental and Craniofacial Research NIDCR encourages applications that address mechanisms underlying the manifestations of sex- and gender-based differences in Dental, Oral, and Craniofacial (DOC)-related diseases and conditions.

Specifically, NIDCR encourages studies aimed at understanding immune reactivity, genetic variation, environmental triggers, aging, and hormonal changes as they affect sex- and gender-based differences. Further, NIDCR encourages clinical research studies that address the influence of sex and gender on oral disease prevention, diagnosis, and management, and studies that assess the influence of sex and gender on oral health outcomes.

Investigators proposing clinical trials must use NIDCR’s UG3/UH3 mechanism. Please see NOT-DE-18-014 for information about NIDCR’s clinical trials program. All applicants are strongly encouraged to discuss potential requests with the NIDCR Program Officer listed in the Scientific/Research Contacts .

Institute of Environmental Health Sciences (NIEHS) Research areas must focus on interests within the mission of NIEHS.

Examples include research on sex and gender influences in health and disease in response to environmental exposures; research on environmental exposures and sex and gender influences in fundamental biology across the lifespan; research focused on better understanding the role of environmental exposures and sex and gender influences in relation to pregnancy, reproductive disorders and disease, metabolic diseases, cancers, metabolic disease, cardiovascular disease, and other disease conditions.

National Institute of Mental Health (NIMH) NIMH will only accept HIV/AIDS applications. Mental health applications that do not study HIV/ AIDS are non-responsive and will not be Specific Areas of Research Interest for: High priority areas of research within this announcement include, but are not limited to, the following: 1.

Studies to better understand the interplay between gender affirming hormone therapy, gender identity, and sex at birth, and how interactions between those factors impact HIV prevention and treatment 2. Intervention research to improve HIV prevention and treatment outcomes for transgender individuals that focuses on the influences 3.

Studies to better understand the differential effects of sex and gender on neurocognitive outcomes among people living with 4.

Studies to understand how the interactive effects of sex and gender influence intersectional stigma, trauma/violence, mental health and, ultimately, HIV prevention or treatment outcomes National Institute of Nursing mission of the NINR is to promote and improve the health of individuals, families, and communities by supporting research that spans and integrates the behavioral and biological sciences, and that develops the scientific basis for clinical practice.

NINR supports research on a range of topics in women s health within NINR’s four areas of scientific focus: symptom science, wellness, self-management of chronic conditions, and end-of-life and palliative care research. NINR is especially interested in applications that propose research on sex/gender influences in HIV/AIDS research. 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 these application types.

Only those application types listed here are allowed Optional: Accepting applications that either propose or do not propose clinical trial(s) 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.

ORWH and partner components intend to commit an estimated total of $3 million to fund up to 7 awards. The number of awards depends on the size and scope of the most meritorious applications, scientific programmatic interest, and availability of funds. Application budgets may not exceed direct costs of $350,000 per year.

for an application submitted in response to this FOA may not exceed 4 years. Grants Policy Statement will apply to the applications submitted and awards made from 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: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o 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) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but all registrations must be in place by time of submission.

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 submit an application. 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 Investigator) 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 (R&R) Application Guide.

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 The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace 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 in