April 6, 2022
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
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)
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."
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.
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.
Institutional eligibility for this supplement program is limited to current grantees of the following NIGMS programs:
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
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:
NCI will accept applications in areas listed above.
NCI will accept assignment of applications that propose new clinical trials.
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:
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.
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:
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.
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:
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.
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:
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:
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 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.
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.
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.
For this announcement, ORWH is interested in:
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.
Applications that are not responsive to the terms of this Notice will be not be considered for this initiative.
Applications will be evaluated through a 2-step administrative review process:
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.