Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

All applications to this 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)

Sexual & Gender Minority Research Office (SGMRO)

Funding Opportunity Title

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

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research.

Funding Opportunity Announcement (FOA) Number

RFA-OD-19-029

Companion Funding Opportunity

None

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

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 Strategic Plan for Women's Health Research "Advancing Science 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 and Centers across NIH.


Key Dates

 

Posted Date

September 27, 2019

Open Date (Earliest Submission Date)

October 25, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

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 non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s)

No late applications will be accepted for this Funding Opportunity Announcement

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 Opportunity Announcement

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.

Scientific Merit Review

February/March 2020; February/March 2021; February/March 2022

Advisory Council Review

May 2020; May 2021; May 2022

Earliest Start Date

July 2020; July 2021; July 2022

Expiration Date

November 27, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

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

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Purpose

    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 Strategic Plan for Women's Health Research "Advancing Science 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 and Centers across NIH.  

    Background

    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 Strategic Plan for Women's Health Research , which offered a vision in 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 however is limited. 

    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 of women today.

    With the implementation of the SABV Policy that went into effect (NOT-OD-15-102) 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.

    Research Objectives and Scope

    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 Strategic Plan for Women's Health Research

    For the purposes of this FOA, the following definitions are utilized to describe and differentiate sex and gender-based factors:

    Sex-based 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).     

    Gender-based 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).

    In order to be responsive to this FOA, application must address all of the following:

    (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 new 2019-2023 Trans-NIH Strategic Plan for Women's Health Research.

    The strategic plan for Goal 1 has the following objectives:

    1.1  Discover 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.

    1.2  Investigate 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 life.

    1.3  Identify 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.

    1.4  Promote 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.

    1.5  Expand 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:

    Health 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. 

    Life 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.

    Research Scope

    This FOA supports basic, preclinical, translational and clinical research investigations composed of teams who share expertise, knowledge, and skills in the following research formats:

    Interdisciplinary or 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-15-102NOT-OD-15-103NOT-OD-16-011NOT-OD-16-012.

    Areas of Interest of 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 Funding Opportunities instead). NCCIH will accept assignment of applications in the 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 FOA for their research.

    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/

    National Institute on Aging (NIA)

    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 Optional)".

    National Institute of Allergy and Infectious Diseases (NIAID) 

    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 infections
    • 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)

    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 use disorder.

    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 consumption.
    • Effects of sex and gender and their interaction on alcohol withdrawal and relapse.

    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)

    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.

    National 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 reviewed.

    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 outcomes.

    2. Intervention research to improve HIV prevention and treatment outcomes for transgender individuals that focuses on the influences of sex and gender.

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

    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 Research (NINR)

    The 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.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    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.

    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.

    Award Budget

    Application budgets may not exceed direct costs of $350,000 per year.  

    Award Project Period

    The total project period for an application submitted in response to this FOA may not exceed 4 years.

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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 Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • 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
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    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.

    Required Registrations

    Applicant Organizations

    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 possible. The NIH 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 submission.

    • Dun and Bradstreet 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.
    • o   NATO 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. 
    • eRA Commons - Applicants 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.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program 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.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    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 not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • 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
    1. Requesting an Application Package

    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 the SF424 (R&R) Application Guide, 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 review.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Rebecca DelCarmen-Wiggins, Ph.D.
    Telephone: 301-451-8689
    Email: rdelcarm@mail.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of 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 application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    R&R or Modular Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

    Research Strategy: Applicants must address all of the following:

    • Describe the inclusion of one or more sex-based variable(s): 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.
    • Describe the inclusion of one or more gender-based variable(s) such as 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.
    • Address the intersection of sex and gender: Include integrative discussions that address the intersection of sex and gender in the context of advancing a better understanding of health and disease. Studies relevant to understanding the intersection of sex and gender can include sex-based comparisons of gender-related variables.
    • Address one of the five objectives from Strategic Goal 1 of the new 2019-2023 Trans-NIH Strategic Plan for Women's Health Research.  The Trans-NIH Strategic Plan includes five major research priorities which provides an optimal and timely framework for this FOA.  These include research to:

    1.1    Discover biological differences between females and males.

    1.2  Investigate the influence of sex and gender on disease prevention, presentation, management, and outcomes. 

    1.3  Identify the immediate, mid-, and long-term effects of exposures on health and disease outcomes.

    1.4  Promote research that explores the influence of sex and gender on the connection between the mind and body, and its impact on health and disease.

    1.5  Expand research on female-specific conditions and diseases including reproductive stages, and maternal and gynecologic health.

    The strategic plan endorsed by the NIH Director in March 2019 is the result of a collective effort, based on input from periodic strategic planning working group meetings, guidance from the Advisory Council on Research on Women’s Health (ACRWH), and recommendations from the Coordinating Committee on Research on Women's Health (CCRWH), composed of representatives from the NIH Institutes and Centers For more information, applicants are encouraged to review the ORWH website.

    Resource 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.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    In order to expedite review, applicants are requested to notify the ORWH Program Officer, Dr. Rebecca DelCarmen-Wiggins at rdelcarm@mail.nih.gov, when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Specific to this FOA:

    Is there a clear justification for the sex-based and gender-based variables that will be included in the study?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? 

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? 

    Specific to this FOA:

    Are the research strategy, methodology and analyses, appropriate to address the intersection of sex and gender in the proposed project?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis
    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure? 

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Study Timeline

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    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; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Rebecca DelCarmen-Wiggins, Ph.D.
    Office of Research on Women's Health (ORWH)
    Telephone: 301-451-8689
    Email: rdelcarm@mail.nih.gov

    Susannah Allison, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone:  240-627-386
    Email:  allisonsu@mail.nih.gov

    Christopher Barnhart, Ph.D.
    Sexual and Gender Minority Research Office (SGMRO)
    Telephone: 301-761-5262
    Email: Christopher.barnhart@nih.gov

    Inna Belfer, M.D., Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone:  301-435-1573
    Email:  inna.belfer@nih.gov

    Abee Boyles, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3241
    Email: abee.boyles@nih.gov

    Juliane Caviston, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-5094
    Email:  juliane.caviston@nih.gov

    Preethi Chander, Ph.D.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone:  301-827-4620
    Email: preethi.chander@nih.gov

    Dena Fischer, D.D.S., M.S.D., M.S.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone:  301-594-4876
    Email: dena.fischer@nih.gov

    Melissa Gerald, Ph.D.
    National Institute of Aging
    Telephone:  301-451-4503
    Email:  Melissa.gerald@nih.gov

    Ivana Grakalic, Ph.D.
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone:  301-443-7600
    Email: igrakalic@mail.nih.gov

    Holly Moore, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone:  301-827-7376
    Email: holly.moore@nih.gov

    Kelli Oster
    National Institute of Nursing Research (NINR)
    Telephone: 301-594-2177
    Email: osterk@mail.nih.gov

    Thaddeus T Schug, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3319 
    Email: schugt@niehs.nih.gov

    Lillian Shum, Ph.D.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone:  301-594-0618
    Email:  ShumL@mail.nih.gov

    Jennifer Troyer, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-480-3565
    Email: troyerj@mail.nih.gov

    Della White, Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone:  301-827-6358
    Email:  della.white@nih.gov

    Sung Sug (Sarah) Yoon, RN, Ph.D.
    National Institute of Nursing Research (NINR)
    Telephone:  301-402-6959
    Email:  sungsug.yoon@nih.gov

     
    Peer Review Contact(s)

    Elaine Sierra-Rivera, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-435-1043
    Email: riverase@csr.nih.gov

    Financial/Grants Management Contact(s)

    John Bladen
    National Institute on Aging (NIA)
    Telephone: 301-402-7730
    Email:  jbladen@mail.nih.gov

    Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone:  301-594-3788
    Email:  scarow@mail.nih.gov

    Pamela Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301 480 1159
    Email: pfleming@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Deanna Ingersoll
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-402-0733
    E-mail: ingersolld@mail.nih.gov

    Aaron Nicholas
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3297 
    Email: nicholaa@niehs.nih.gov

    Kelli Oster
    National Institute of Nursing Research (NINR)
    Telephone: 301-594-2177
    Email: osterk@mail.nih.gov

    Diana Rutberg, M.B.A.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4798
    Email: rutbergd@mail.nih.gov

    Donna Sullivan
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2979
    Email: DSullivan@niaid.nih.gov

    Rita Sisco
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-2805
    Email: siscor@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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