Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute of General Medical Sciences (NIGMS)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Purpose

The Office of Research on Women's Health (ORWH) and the National Institute of General Medical Sciences (NIGMS), along with the other participating NIH Institutes, Centers, and Offices (ICOs) announce the availability of administrative supplements to IDeA awards to expand research and research capacity in the IDeA states to address important issues of women’s health across the lifespan. The proposed research must be within the scope of the parent grant and must address at least one of the strategic goals of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women."

Background

ORWH is the Public Health Service office dedicated specifically to promote women's health research within and beyond the NIH scientific community. ORWH was established in September 1990 by Congressional mandate.Congress assigned a far-reaching leadership role for ORWH by mandating that ORWH serves as the focal point for coordinating women’s health research at the NIH. ORWH crafts and implements the Trans-NIH Strategic Plan for Women's Health Research in partnership with NIH ICs and co-funds research on the role of sex and gender on health, with the ultimate goal of advancing rigorous research relevant to the health of women. ORWH also collaborates with NIH ICs, the NIH Office of Extramural Research, and the NIH Office of Intramural Research to monitor adherence to NIH's Inclusion Policies for Research Involving Human Subjects, which ensure that women and minorities are represented in NIH-supported clinical research. ORWH's interdisciplinary research and career development initiatives stimulate research on sex and gender differences and provide career support to launch promising women's health researchers. These programs set the stage for improved health for women and their families and career opportunities and advancement for a diverse biomedical workforce.

The Institutional Development Award (IDeA) program is congressionally mandated and administered by NIGMS. It supports research and research capacity building in states that historically have had low levels of NIH funding through a variety of funding mechanisms. The IDeA program has been instrumental in increasing the pool of Early Stage Investigators (ESIs) from IDeA states who apply for NIH research project grants and in strengthening research infrastructure in those states.

Residents in IDeA states, especially those living in rural areas, often have less access to health care and suffer from poorer health outcomes, including health outcomes for women and children, than the average American. For example, several IDeA states are among the states with the highest maternal and infant mortality rates. These administrative supplements aim to increase research specifically directed at women’s health and health disparities and to expand the capacity of IDeA states to conduct women’s health research.

Research Objectives

This NOSI encourages a broad range of research addressing important issues of women’s health across the lifespan, with a special interest in maternal and infant morbidity and mortality, including their underlying causes.

Eligibility

Eligible Institutions

Institutional eligibility for this supplement program is limited to current grantees of the following NIGMS programs:

• The Centers of Biomedical Research Excellence (COBRE) program, which supports the establishment and development of biomedical and behavioral research centers at institutions in IDeA-eligible states.
• The IDeA Networks of Biomedical Research Excellence (INBRE) program, which supports a statewide biomedical research development network that partners research-intensive institutions with primarily undergraduate institutions, community colleges and tribally controlled colleges and universities in IDeA-eligible states.
• The IDeA Networks for Clinical and Translational Research (IDeA-CTR), which supports the development and enhancement of statewide and interstate regional networks for clinical and translational research in IDeA-eligible states.

Eligible Individuals

• Program Director/Principal Investigator (PD/PI): The PDs/PIs of the parent awards remain the PDs/PIs of the administrative supplemental awards. However, they cannot serve as Project Leads for the proposed research, nor use the supplemental funds to support their own research programs.
• Project Leads: Projects proposed in the application must be led by faculty investigators (or equivalent) at the grantee or partner institutions of the parent awards. For collaborative projects, this eligibility requirement applies to all co-Project Leads.

Number of Applications

Only one supplement request per COBRE, INBRE, or IDeA-CTR award will be accepted for each NOSI due date.

Institute, Center, and Office (ICO)-Specific Research Interests

NCI

The National Cancer Institute (NCI) is interested in supporting research on cancer causes, prevention, and treatment that addresses important issues of women’s health. Areas of interest include, but are not limited to, the following:

• Fundamental mechanisms of cancer initiation, progression, and metastasis
• Population-level determinants of cancer occurrence and outcomes
• Cancer prevention, early detection, and screening
• Cancer diagnosis, prognosis, treatment response and resistance, and patient management
• Assessment of new anticancer agents, radiation treatments, surgical methods
• Cancer-focused imaging approaches
• Cancer care delivery and implementation science
• Cancer health disparities

NCI will accept applications in areas listed above.

NCI will accept assignment of applications that propose new clinical trials.

NCCIH

The mission of the National Center for Complementary and Integrative Health (NCCIH) is to determine, through rigorous scientific investigation, the fundamental mechanisms, usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. For purposes of this FOA, NCCIH is interested in research investigating complementary and integrative health approaches to improve maternal health outcomes. Natural products include botanicals, probiotics/microbials, naturally-derived peptides, dietary supplements, and special diets. Mind-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.

Areas of programmatic interest to NCCIH include, but are not limited to, the following:

• Studies to evaluate the utilization of complementary health approaches for managing symptoms such as perinatal and postpartum depression, stress, anxiety, pain, and sleep disturbance and assess their impact on maternal health outcomes
• Research on the use of complementary health approaches to support pregnant and parenting women with opioid use disorder
• Studies examining 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
• Research designed to investigate the influence of sex and gender on utilization of complementary health approaches to improve health outcomes among diverse populations, including gender diverse populations

NCCIH will accept projects proposing secondary analyses, observational studies, basic, and mechanistic studies (animal and human). NCCIH will not accept assignment of applications that propose new clinical trials. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). 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.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) supports basic, preclinical, translational, and clinical research that leads to improvement of heart, lung, blood, and sleep (HLBS) health outcomes for women. More details about the NHLBI mission, strategic vision, and research priorities can be found in the NHLBI Strategic Vision.

Research areas of particular interest to NHLBI for this NOSI include, but are not limited to:

• Addressing modifiable determinants of health disparities throughout women’s life course (including pregnancy and post-partum) as well as factors that contribute to optimal women’s and/or maternal health in underrepresented and underserved communities, particularly those in Tribal Nations and rural areas
• Impact of sex and hormones in HLBS conditions, (i.e., conditions with clinical presentation or higher prevalence in women, impact of hormonal changes throughout the life course, including physical changes during pregnancy which can worsen pre-existing HLBS conditions and introduce new symptoms)
• Identification of mechanisms underlying HLBS diseases and their risk throughout women’s life course and in women from different races/ethnicities/origins/heritage groups
• Identification of mechanisms underlying women’s resilience to certain HLBS diseases
• 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
• Studies on models of effective community engagement and health communication that can contribute to increased awareness and dissemination of scientific findings, especially in low income or underserved communities
• Development of approaches or feasibility studies for future interventions that target pregnancy-related HLBS disorders and/or underlying risk factors and assess their impact on maternal and long-term health status
• Research using artificial intelligence/machine learning modeling approaches to predict and diagnose the HLBS disorders throughout women’s life course including pregnancy and/or the post-partum period
• Identification of barriers to delivery of effective women/maternal health therapies and of implementation strategies to effectively address those barriers.

NEI

The National Eye Institute (NEI) is interested in supporting research in its programmatic areas (https://www.nei.nih.gov/grants-and-training) that addresses important issues of women’s health especially those focused on maternal and infant morbidity.

NIA

The National Institute on Aging (NIA) will accept applications for research projects in areas within the Institute's mission, including genetic, biological, behavioral, social, and economic research on aging. In addition, NIA encourages applications on Alzheimer’s disease (AD) and AD-related dementias (ADRD). The NIA website provides further information about the Institute’s mission and areas of research interest. A specific priority is understanding the environmental, sociocultural, behavioral and biological drivers of health inequities and disparities related to aging among older women, as outlined in NIA’s strategic directions for health disparities research and reflected within NIA’s Health Disparities framework. For additional scientific program information and for pre-application guidance, potential applicants are encouraged to contact the NIA Program Director whose portfolio covers the scientific topic of interest.

Specific areas of interest include:

• Research on mechanisms underlying differential rates of aging (e.g., the appearance of premature aging in pre- and post-menopausal women).
• The molecular and cellular mechanisms of aging leading to increased risk of disease in post-reproductive women and relevant animal models.
• Research that includes a mechanistic analysis of the intersection of sex and gender differences in the aging process with other social determinants of health.
• Life history studies of wild animal populations that can increase the understanding of the contribution of social environmental factors to sex differences in immune function, health, and aging.
• Research on how interpersonal relationships change during major life stage transitions for women, including the menopausal transition, transition to/from becoming a caregiver, etc., in ways that impact health and well-being.
• Research to elucidate the influence of complications during pregnancy, such as pre-eclampsia, gestational diabetes, on brain aging, Alzheimer’s disease, and Alzheimer’s disease related dementias.

NIBIB

NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.

NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005, "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

NICHD

The mission of the Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD) is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma, injury, and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan.

For this NOSI, NICHD seeks supplements addressing important issues in women’s health that are aligned with NICHD scientific priorities. Populations of high priority to NICHD include pregnant and lactating women as well as women of all ages with physical and/or intellectual disabilities. Areas of particular interest include, but are not limited to:

• How race/ethnicity (especially among American Indian/Alaska Native or Native Hawaiian/Other Pacific Islander populations), age, and other demographic characteristics; socioeconomic status; disability status; and nutrition relate to maternal morbidity and/or mortality and their causes.
• The incidence, diagnosis, and treatment of gynecologic disorders including uterine fibroids, endometriosis, adenomyosis, benign ovarian cysts, abnormal uterine bleeding, reproductive tract abnormalities, female pelvic floor disorders, and gynecologic pain.
• Studies of how menstruation and the menstrual cycle can affect, or be affected by, vaccination or medical therapies.
• The development of novel and effective pharmacotherapeutic strategies to improve clinical outcomes for women and mothers.
• The discovery or validation of biomarkers that predict adverse pregnancy outcomes or predict medication levels in breastmilk.
• Studies of maternal, neonatal, and infant outcomes of pregnancy in infertile couples, stratified by race/ethnicity and male/female factors, such as age, infertility cause (especially endometriosis and polycystic ovary syndrome), and/or infertility treatment.
• Studies of fertility status as a biomarker for women’s overall health.
• Studies of reproductive health, pregnancy, and parenting that address the specific needs of adolescent and adult women with physical and/or intellectual disabilities.
• The effects of violence and abuse on the health and development of girls and young-adult women and/or on girls' and women’s reproductive health, including but not limited to unintended pregnancy, pregnancy outcomes, and maternal morbidity and mortality.

NIDA

NIDA seeks to support research advancing women’s health and considering sex and gender as primary and interacting factors in substance use disorder (SUD), its comorbidities and risk states. A growing body of research across all domains, including basic, translational, clinical, and population-based, has revealed that SUD risk factors and SUD-relevant outcomes that vary by sex and gender. Topic areas of interest to NIDA in the context of women’s health and sex/gender factors include:

• Research focused on multidirectional interactions of risk factors and co-occurring morbidities that contribute to risk-outcome processes that disproportionally or uniquely impact the health of women and/or sexual minorities with SUD, or in the context of SUD risk. Of great interest are studies addressing how these processes vary across the lifespan, including the reproductive life cycle (premenarcheal, reproductive, premenopausal, early menopausal, late menopausal and menopause).
• Basic or translational research designed with the primary aim of examining sex and/or gender as biological, behavioral, or social variables, creating the potential to transform our understanding of the neurobehavioral and social mechanisms contributing to risk for, or resilience against, SUD consequences of substance use or SUD or recovery from, SUD. In this context, the study of gender as a more-than-binary construct is encouraged.
• Research on maternal/parental health and the prevention of morbidities related to or affecting pregnancy, childbirth, and post-partum health of the parent and parent-infant dyad, including but not limited to, research on integration of programs that span the perinatal continuum into early childhood to improve linkages to health care, relapse prevention and recovery management services among women with SUD.
• Research that examines the scalability and sustainability of small sets of evidence-based practices (EBPs) implemented to improve outcomes across the female or women's health continuum including obstetric care for people with SUD.

Studies can involve new data collection or secondary data analysis, or combination, but new clinical trials (i.e., that extend beyond the parent grant) or data collection outside the scope of the parent grant will not be supported. Regarding approach, priority will be placed on study design, but the completion of a fully powered study is not necessary. Proposals of innovative, well-designed pilot projects aimed at producing preliminary data, with estimations of effect sizes, to be used for a research project grant are encouraged. When appropriate, applicants should address how the data from the proposed study will made sharable and able to be harmonized with relevant existing data sets.

NIDCR

NIDCR is interested in supporting research in its programmatic areas that address mechanisms underlying the manifestations of sex- and gender-based differences in Dental, Oral, and Craniofacial (DOC)-related diseases and conditions across lifespan. These include, but are not limited to oral conditions such as Sjogren’s Disease, temporomandibular joint disorders, orofacial pain, high risk oral Human papillomavirus (HPV) infection and persistence, postmenopausal osteoporosis and periodontitis, oral health disparities and inequities in women. Specifically, NIDCR encourages studies aimed at understanding immune reactivity, genetic variation, environmental triggers, aging and geroscience, 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.

NIEHS

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. For this announcement, NIEHS is interested in supporting research that addresses or seeks to understand how exposures to toxic chemical and non-chemical environmental insults alter biologic processes that may be linked to disease in women, particularly maternal and infant mortality and morbidity. Equally important is research examining women’s health at the intersection of chemical, physical, built, and social environments. Examples of environmental exposures relevant to the mission of the NIEHS include, but are not limited to, industrial chemicals, e-waste, emerging and legacy endocrine-disrupting chemicals, indoor air pollutants from cooking and other sources, climate variability and the environmental impacts of natural and man-made disasters.

ODP

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and health equity and that include innovative and appropriate research design, measurement, and analysis methods. Furthermore, the ODP has a specific interest in projects that develop and/or test preventive interventions. For this NOSI, ODP is interested in supporting research to reduce maternal and infant morbidity and mortality, encourage the uptake of preventive interventions and services in rural and medically underserved communities, and promote health equity across the lifespan. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding.

ORWH

For this announcement, ORWH is interested in:

• Research that addresses women’s health issues across the lifespan with an emphasis on chronic diseases and comorbidities including but not limited to cardiovascular diseases, depression, obesity, dementia, endometriosis, intimate partners violence.
• In addition, ORWH is interested in research that addresses maternal and infant morbidity and mortality and their underlying causes affecting medically underserved women and living in rural areas.
• Research in digital health, including the use of mobile health apps, telemedicine, and data analytics to improve health systems access and delivery addressing women’s health disparities.

Specific Considerations

Before planning an application, potential applicants are strongly encouraged to contact the Program Director of an appropriate ICO to determine if the planned research fits within the ICO’s interest.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) October 17, 2022, October 17, 2023 and October 17, 2024 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-GM-22-005 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only.
• Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-20-272. Paper submissions and applications submitted as email attachments will be rejected without review.
• Requests can be for no more than $200,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts. As part of the budget justification, include a brief statement regarding currently available unobligated grant funds as well as expenditure plans to demonstrate the need for additional funds.
• Each request may include only one research project, which must be within the scope of the parent grant and appropriate for the duration of one year.
• The parent award must be active when the application is submitted (e.g., within the originally reviewed and approved project period), regardless of the time remaining on the current project.
• Research aims of new applications from parent awards that received supplemental funding under NOT-GM-20-017, NOT-GM-21-018 and/or this NOSI must be distinct from those previously funded.
• Project leads should be named as key personnel, but the contact PD/PI and any multi-PD/PIs must be the same as the parent award.
• The Research Strategy section of the application is limited to 6 pages and must clearly describe the significance of the project, its relevance to important issues of women’s health, and how it falls within the scope of the parent award.

Applications that are not responsive to the terms of this Notice will be not be considered for this initiative.

Review Process

Applications will be evaluated through a 2-step administrative review process:

1. NIGMS and ORWH will review the applications for responsiveness to the NOSI requirements.
2. Each participating ICO will assess the scientific merit of the application(s) that fall within their respective mission.

Applicants are strongly encouraged to notify the NIGMS contact listed below that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Crina Frincu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Regine A. Douthard, M.D., MPH
NIH Office of Research on Women’s Health Research (ORWH)
Email: [email protected]