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)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. Office of Research on Women's Health (ORWH) and the following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and 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
Reissue of RFA-OD-19-029
Related Notices

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
RFA-OD-22-028
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.313, 93.361, 93.121, 93.213, 93.113, 93.242, 93.866, 93.279, 93.273, 93.172, 93.837, 93.838, 93.839, 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 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
October 13, 2022
Open Date (Earliest Submission Date)
November 21, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 19, 2022 December 19, 2022 Not Applicable July 2023 August 2023 December 2023
November 22, 2023 November 22, 2023 Not Applicable March 2024 May 2024 July 2024
November 22, 2024 November 22, 2024 Not Applicable March 2025 May 2025 July 2025

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
November 23, 2024
Due Dates for E.O. 12372

December 19, 2022; November 22, 2023; November 22, 2024

Required Application Instructions

It is critical that applicants follow the instructions in 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 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 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 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 health 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 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 are influenced by both biologic sex factors and social constructs of gender. An increasing body of research suggests that there are diseases that are sex specific, or unique to women, more common in women, or characterized by differences in disease course in women. Research on the sex and gender factors that drive crucial differences in health outcomes between women, men, and gender diverse individuals however is limited.

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 current 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.

Sex and gender refer to separate but inextricably linked influences on 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 data. For example, the recent 2022 NASEM Report, “Measuring Sex, Gender Identity, and Sexual Orientation for the National Institutes of Health,” identifies sex as a multidimensional construct based on a cluster of anatomical and physiological traits that include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones.” Gender is defined as “ a multidimensional construct that links gender identity, which is a core element of a person’s individual identity; gender expression, which is how a person signals their gender to others through their behavior and appearance (such as hair style and clothing); and cultural expectations about social status, characteristics, and behavior that are associated with sex traits. (https://www.nationalacademies.org/our-work/measuring-sex-gender-identity-and-sexual-orientation-for-the-national-institutes-of-health).

Sex and gender are important considerations in many areas of research, including biomedical, 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 the social construct of gender, including gender-related norms, roles, power relations, and systems. Both biological and social influences need to be more fully integrated and elucidated in biomedical research; applying knowledge gained through rigorous consideration of sex and gender is key to the NIH mission to enhance health, lengthen life, and reduce illness. Sex and/or gender-based studies include the consideration of sex as a biological variable: biological 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).

With the implementation of the Sex as a Biological Variable (SABV) Policy (NOT-OD-15-102) in 2016, integral to the NIH initiative to enhance reproducibility through rigor and transparency (NOT-OD-15-103), as well as the 21st Century Cures Act that reinforces our efforts to advance women’s health, there has been a growing appreciation for the importance of sex influences on health and disease. With regard to gender, a growing body of empirical data provides clear evidence that women, men, and gender diverse individuals 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 lifespan. 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 influences are not well understood however, and many questions remain unanswered. Boys, for example, are more frequently diagnosed with Autism, but a better understanding of sex differences 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 our 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 2019-2023 Trans-NIH Strategic Plan for Women's Health Research.

To be responsive to this FOA, applications must address each of the following three variables, and their intersection, in the context of advancing a better understanding of health and disease and as relevant to the current research investigation:

(1) Sex-based variables: including but are not limited to anatomical and physiological traits that include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones, evaluation of sex as a biological variable; sex-based comparisons on conditions in females and males; or biomarkers.

(2) Gender-based variables: Including but not limited to social, environmental, cultural, and behavioral factors including gender identity, as an element of a person’s individual identity; or gender expression.

(3) One of the five objectives from Strategic Goal 1 of the 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.

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

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.

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. 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, culture, education, sexual orientation, gender expression or identity, , access to care, and quality of care. .

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 please see the following NIH Notices and publications: NOT-OD-15-102, “Consideration of Sex as a Biological Variable in NIH-funded Research” including NIH’s expectations for the consideration of sex as a biological variable as provided at the following website: https://orwh.od.nih.gov/sites/orwh/files/docs/NOT-OD-15-102_Guidance.pdf; https://www.nationalacademies.org/our-work/measuring-sex-gender-identity-and-sexual-orientation-for-the-national-institutes-of-health.

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 various 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 supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI is interested in supporting research to understand the mechanisms of the heart (and vascular), lung, hematologic (blood), and sleep (HLBS) diseases/disorders that present only in women, are more prevalent in women than in men or have a different presentation, manifestation, outcomes or treatment effects in women as compared with men as well as their interaction with the broader environment. NHLBI is interested in applications that include, but are not limited to, multidisciplinary approaches that are relevant across more than one HLBS areas. In addition, the NHLBI is especially interested in applications that address topics relevant to its Strategic Vision.


Specific areas of interest to NHLBI include, but are not limited to, the following:

  • Understanding the intersection of sex and gender in mechanisms of HLBS diseases and disorders or resilience of the entire spectrum of health/disease topics within NHLBI's mission/research priorities, and throughout women’s life-course (including pregnancy and postpartum), and in women from different races/ethnicities/origins/heritage groups.
  • The influence or interaction of environmental factors (including psychosocial, socioeconomic, and sociocultural determinants of health) in sex differences in mechanisms of HLBS diseases or disorders and/or resilience.
  • Mechanisms of disease of non-HLBS diseases and disorders with increased or exclusive HLBS manifestation in women.
  • Sex differences in HLBS diseases and disorders symptomatology, presentation, and long-term outcomes.
  • Clinical trials and need for models of effective engagement and retention of women from underrepresented groups as clinical trial participants

National Institute on Aging (NIA)

NIA is interested in supporting research relevant to sex as a biological variable in studies that align with the goals outlined in the National Institute on Aging’s Strategic Directions for Research, 2020-2025. NIA will consider meritorious applications that fall within the Institute’s pay line.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The mission of the NIAAA is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, treatment and recovery of alcohol-related problems, including alcohol use disorder and alcohol-associated organ damage, across the lifespan. NIAAA supports basic and/or translational research in a wide range of alcohol research scientific areas including genetics, neuroscience, epidemiology, prevention, and treatment. For clinical trials, the applicant should have an existing alcohol research clinical trial or a history of experience conducting clinical trials that examine alcohol-related outcomes.

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. NIAAA encourages the Alcohol Research Centers to recruit a diverse group of scientists to its study teams, including individuals from underrepresented groups (see, e.g., NOT-OD-20-031 (Notice of NIH's Interest in Diversity)). NIAAA is especially interested in recruitment efforts intended to generate interest from racial, ethnic and gender minorities and early-stage investigators.

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 and other alcohol-related health complications (e.g., alcohol-associated organ damage). NIAAA priorities are as follows:

  • lmpact of factors including stress and trauma across the lifespan and sleep on sex and gender leading to AUD 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 is interested in supporting research in its programmatic areas that address mechanisms underlying the manifestations of sex- and gender-based influences 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-21-014 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)

The National Institute of Mental Health (NIMH) will accept applications that reflect the mission and scientific priorities as identified in the strategic plan NIMH » The National Institute of Mental Health Strategic Plan (nih.gov). For the purposes of this RFA, the NIMH Division of Translational Research has a particular interest in:

  • Studies to better understand the interplay between gender affirming hormone therapy, gender identity and sex assigned at birth and how the interaction of those factors impact on mental illness (e.g., mood disorder, schizophrenia, suicidal thoughts and behavior, bipolar disorder).
  • Studies to increase knowledge about the intersection of sex and gender as risk/protective factors for trauma and violence and to identify target of actions for intervention development.
  • Studies that examine how sex and gender identity interact to influence the neurocircuitry of the brain and the resulting brain behavior.
  • Studies that elucidate the intersection of sex and gender and their effects on the trajectory of mental illness across the lifecourse (e.g., prepuberty, puberty, menopause, later life)
  • Studies that incorporate and examine the intersection of sex, age, race, social economic status (SES), culture and gender factors as a means to reduce health disparities and to ensure that effectiveness of diagnostic and therapeutic breakthroughs are equitable across all populations with mental illness.
  • Studies on the intersection of sex and gender influences that further our understanding of how community engagement and health care system factors can contribute to improved treatment adherence, retention, and outcomes in mental health care specifically designed for, or modified for women across the life course, including NIH defined health disparity populations (e.g., racial and ethnic groups), less privileged socioeconomic status (SES), underserved rural and sexual and gender minorities (SGM) and any populations that can be characterized by two or more of these descriptions.

The NIMH Division of AIDS Research 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

Clinical Trials Information

Applications proposing a clinical trial must contact the NIMH program staff listed on this announcement before an application will be accepted for review.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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
Renewal
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).

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 per receipt date. 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:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving 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)

Local 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)

Federal Government

  • 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.

  • 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.
    • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 instructions in 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:

Chyren Hunter, Ph.D.
Telephone: 301-496-7849
Email: Hunterc@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 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. 1.1 Discover biological differences between females and males.
  2. 1.2 Investigate the influence of sex and gender on disease prevention, presentation, management, and outcomes.
  3. 1.3 Identify the immediate, mid-, and long-term effects of exposures on health and disease outcomes.
  4. 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.
  5. 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.

The following modifications also apply:

  • 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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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. Chyren Hunter at Hunterc@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.

For this particular announcement, note the following:

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

For Renewals, the committee will consider the progress made in the last funding period.

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(s) convened by the NIH Center for Scientific Review (CSR), 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 will receive a written critique.

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.

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 recipient's business official.

Recipients 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: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

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.

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 and 2 CFR Part 200.206 “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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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)

Chyren Hunter, Ph.D.
Office of Research on Women's Health (ORWH)
Phone: 301-496-7849
Email: Hunterc@mail.nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Kate Nagy
National Institute on Aging (NIA)
Phone: none
E-mail: nagyk@mail.nih.gov

Marrah Elizabeth Lachowiczscroggins
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0222
E-mail: marrah.lachowicz-scroggins@nih.gov

Dena Fischer, DDS, MSD, MS
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4876
E-mail: dena.fischer@nih.gov

Preethi Chander
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-443-7230
E-mail: preethi.chander@nih.gov

Thaddeus Schug, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3319
E-mail: schugt2@mail.nih.gov

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

Ebony Madden, PhD
National Human Genome Research Institute (NHGRI)
Phone: 301-503-5620
Email: ebony.madden@nih.gov

Ivana Grakalic, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-7600
E-mail: ig33z@nih.gov

Keisher S Highsmith
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1984
E-mail: keisher.highsmith@nih.gov

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

Teri Senn, Ph.D. (HIV POC)
National Institute of Mental Health (NIMH)
Telephone: 301-761-7852
Email: teri.senn@nih.gov

Tamara Lewis Johnson, MPH, MBA (non-HIV POC)
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: tamara.lewisjohnson@nih.gov

Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

E. C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: e.melvin@nih.gov

Taryn Cobb
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-8025
E-mail: cobbt@mail.nih.gov

Diana Rutberg, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov

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

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

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

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@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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