Women's Health Research at NIH: Sex Differences and Implications for Translational Science (R21 Clinical Trial Required)

Women's Health Research at NIH: Sex Differences and Implications for Translational Science (R21 Clinical Trial Required) is sponsored by National Institutes of Health (NIH). Encourages exploratory clinical trials on sex differences to advance women's health.

Expired RFA-OD-19-013: Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations Office of Research on Women’s Health ( ORWH ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed below. ORWH may co-fund applications assigned to those Institutes/Centers.

National Institute on Aging ( NIA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Heart, Lung, and Blood Institute (NHLBI) Funding Opportunity Title Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) U54 Specialized Center- Cooperative Agreements August 08, 2022 - This RFA has been re-issued as RFA-OD-22-014 December 18, 2018 - Notice of Change to FOA (RFA-OD-19-013).

See Notice NOT-OD-19-044 . December 11, 2018 - NHLBI Announces Participation in RFA-OD-19-013. See Notice NOT-HL-18-669 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 313, 93.

866, 93. 846, 93. 279, 93.

847, 93. 242, 93. 273, 93.

113, 93. 233; 93. 837; 93.

838; 93. 839; 93. 840 Funding Opportunity Purpose and participating organizations and institutes seek applications for Specialized Centers of Research Excellence (SCORE) on Sex Differences.

The Centers of Excellence will support interdisciplinary approaches to advance translational research on sex differences. Each SCORE institution should develop a research agenda bridging basic and clinical research underlying a health issue that is pertinent to improving the health of women.

Open Date (Earliest Submission Date) New Date December 24, 2018 Letter of Intent Due Date(s) New Date December 24, 2018 New Date January 24, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) New Date January 25, 2019 per issuance of NOT-OD-19-044 .

(Original Expiration Date: January 11, 2019 ) ** ELECTRONIC APPLICATION SUBMISSION REQUIRED** NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants. gov to NIH.

Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description This Funding Opportunity Announcement (FOA) from the Office of Research on Women's Health ( ORWH ) invites applications for Specialized Centers of Research Excellence (SCORE) on Sex Differences. Each SCORE will serve as a National resource focused on translational research at multiple levels of analysis to identify the role of biological sex differences on the health of women.

Centers of Excellence will also serve as vital hubs for education and dissemination of innovative sex-based and informed translational research methods and best practices. In addition, they will provide leadership in the development and promotion of standards and policies for the consideration of sex differences in biomedical research.

The contributions of biological sex can assist in understanding the diversity of health outcomes, and this knowledge can be applied to the development of the next generation of interventions and medical treatments leading to improvements in women's health. It is expected that SCORE Centers will: Develop or strengthen awardee institutions' programs that focus and sustain progress on a key area in women's health research.

Provide intellectual leadership and innovation to advance research that elucidates the role of sex differences on the health of men and Facilitate and develop novel interdisciplinary research Stimulate incorporation of emerging technologies, methods and scientific advances into research designs as appropriate; Provide research career enhancement opportunities in sex Stimulate translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on findings Collaborate with other SCOREs on projects such as integrating data systems, supporting multi-center observational studies; Interface where possible with other NIH-funded programs and Leverage institutional resources.

The ORWH serves as a focal point for women's health research at the National Institutes of Health ( NIH ). The ORWH works in partnership with the NIH Institutes, Centers and Offices, as well as with federal agencies, including the Food and Drug Administration, to ensure that women's health research is an integral part of the scientific framework throughout the scientific community.

The Specialized Centers of Research (SCOR) program, a predecessor to the Specialized Centers of Research Excellence (SCORE) program represented by this FOA, was first announced by ORWH (in partnership with the FDA) in 2002 to support research to understand and explore the continuous interaction between sex and gender, human health that is determined by both biology and expression of gender.

Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. The consideration of these variables and comparisons of males and females are critical to the accurate interpretation, validation, and generalization of research findings in biomedical research.

Sex and gender may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes. Sex-based comparisons in research may also ensure that findings are applicable to both women and men.

The SCOR specialized centers were thus established to 1) expedite interdisciplinary development and application of new knowledge to human diseases that affect women, 2) learn more about etiology of these diseases, and 3) foster improved approaches to treatment and prevention.

The SCOR program represents an innovative interdisciplinary research program focusing on sex differences and major medical conditions affecting women in the U.S., and supports established scientists at centers across the country who conduct ground breaking research that integrates basic, clinical, and behavioral research approaches to incorporate sex differences.

ORWH committed $10 million initially to fund 9-10 Specialized Centers (P50 grants). Eleven centers were co-funded with the help of a number of NIH IC partners and the U.S. Food and Drug Administration.

To date, a total of 32 SCORs have been funded with an investment of over $132 million providing support at 21 US An outcome evaluation of the SCOR program, completed in 2017 found the SCOR program to be fully successful in accomplishing its stated goals. Moreover, the SCOR program goals were on the leading edge of the need for renewed focus on research on sex differences.

In a 2014 Nature commentary , NIH leadership called attention to a lack of knowledge about the influence of biological sex in preclinical research. In particular, an overreliance on male animals and cells in basic and preclinical research may obscure key sex differences that could guide clinical studies.

Inadequate specification of the sex of cells, inadequate inclusion of female animals in experiments, and inadequate analysis and reporting of data by sex, may also contribute to irreproducibility of preclinical biomedical research.

Additional information can be found in the article " Studying both sexes: a guiding principle for biomedicine " published by Dr. Janine Clayton in FASEB To advance the consideration of sex and other biological variables, NIH adopted a new policy in January 25, 2016, "Enhancing Reproducibility through Rigor and Transparency" ( NOT-OD-15-103 ), which mandated that investigators provide scientific justification of Sex as a Biological Variable (SABV).

NOT-OD-15-102 provides specific guidance regarding SABV. The ORWH SCOR program then, has been at the forefront of sex differences research and SCOR investigators have made seminal contributions to the study of sex differences that affect women's health.

With this FOA, ORWH is leveraging 15 years of investment in the study of sex differences and building upon advances in the field by expanding the SCOR program to add the expectation of excellence with the establishment of the Specialized Centers of Research Guided by current research, as well as the input we received from the evaluation and from stakeholders, the next generation SCORE program will have an enhanced focus on 1) translational science with the goal of translating biomedical discoveries into clinical applications that improve the health of women and 2) education, to disseminate innovative translational research methods and best practices; and provide leadership in the development and promotion of standards and policy for the consideration of sex differences Overview of Centers of Excellence The objective of the SCORE program is to expedite the development and application of new knowledge to human diseases that affect women, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention.

Applicants to this FOA should develop a translational research program in an area of research that considers sex differences underlying women's health issues. The translational science spectrum represents each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public.

The spectrum is not linear or unidirectional; each stage builds upon and informs the others. The path from the biological basis of health and disease to interventions that improve health, encompassing: Basic Research, Pre-Clinical Research, Clinical Research, Clinical Implementation, and Public Health.

For more information, please see Translational Science Spectrum on the National Center for Advancing Translational Science (NCATS) website.

SCORE applications can support: patient-oriented research, including epidemiological and behavioral studies or outcomes research or research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.

Excluded from this definition are in-vitro studies that utilize human tissues that cannot be linked to a living individual. Applicants proposing clinical trials should consult ORWH program staff prior to submission of their applications. With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary and collaborative approach.

Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes. SCORE applicants are expected to employ interdisciplinary research approaches, recognizing the complex interplay of factors that impact the health of women.

Collaborations among researchers in academia, private industry, and federal settings should be leveraged, as appropriate to advance the SCORE research program. Although the focus of the SCORE program is on sex differences, research programs are not required to have both male and female cohorts.

However, if female only research is proposed, the background section must include the current state of knowledge and review of the literature justifying that studies will include cohorts of women only, consistent with the NIH inclusion policy. This FOA allows applications for women's health research relevant to the mission of the participating NIH ICs (see below: Research Areas of Interest).

Prospective applicants are urged to consult with the Scientific/Research Contacts of the NIH early in the preparation of the Research Projects : required A SCORE program consists of at least three-individual, but interrelated, research projects, each with high scientific merit.

The overall program should have clear translational research objectives and, in the aggregate, be devoted to a specific major health area relevant to women's health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data. For the purposes of this FOA only Phase 0 or Phase I, Phase II may be supported.

SCORE Centers are strongly encouraged to establish collaborative clinical trial activities early in the development of projects that have clinical trials/studies as their goals. In addition, a SCORE program must have a Leadership Administrative core (LAC), and a Career Enhancement Core (CEC). Leadership Administrative Core (LAC) : required A Leadership Administrative Core (LAC) must be included for the SCORE program.

The LAC will (1) monitor, stimulate, evaluate, and report on the research projects and educational programs particularly with respect to the overall goals of the SCORE; and (2) provide Intellectual leadership in support of the activities of the SCORE consortium. The SCORE PD/PI or his/her designee will have overall responsibility for the LAC. Annual meetings of the SCORE Directors will be held.

Planning and execution of annual meetings will be shared between the ORWH, NIH ICs Program Staff, and the Steering Committee. By providing a focused and interactive agenda, the annual meeting fosters the initiation and maintenance of collaborative efforts and resource sharing among the Centers.

SCORE PD/PIs should budget funds for the PD/PI and one to -two designees to attend an annual Awarded SCOREs are expected to actively participate in the organization and programmatic objectives of a research consortium.

The goal of the consortium is to share expertise, research results and identify emergent issues, new research opportunities and establish research priorities and collaborations on conditions underlying women's health issues. The SCORE research consortium will also serve as a vehicle for collaborating on education and career enhancement initiatives and the promotion of diversity in the translational science workforce.

Career Enhancement Core (CEC) : required A Career Enhancement Core (CEC) must be proposed as part of this FOA. The goal of the CEC is to meet the career enhancement needs of translational science in the study of sex differences. As a required element of the SCORE, the CEC must be maintained throughout the entire term of the funding period.

Funds from this program may be used to support junior faculty or established investigators who wish to enhance or refocus their careers on translational research. Investigators supported by NIH career development award (K series) may also be eligible for support through this program. PDs/PIs are highly encouraged to support Early Stage Investigators and Early-Established Investigators through this Core.

Pilot studies and complementary education programs should provide opportunities in rigorous research methodologies and transparency in experimental design and reporting. The CEC should provide unique opportunities to understand women's health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data. This funding opportunity also seeks to facilitate educational opportunities of participants.

Participants from diverse backgrounds, underrepresented in the biomedical science are especially encouraged. Current estimates regarding the state of health of US women are variable, with many health, disease, mortality and morbidity outcomes differing significantly by race, ethnicity, and socioeconomic status.

Training a diverse biomedical workforce will enhance the scope of intellectual capacity brought to bear on intransigent issues of health and disease to positively affect the health of all women. Resource Support Core(s) (RSC) : optional SCORE applicants may propose one or more Resource Support Core(s) (RSC) to support two or more research projects, e.g., animal, pathology, and or informatics.

SCOREs may also find that their research goals would be facilitated by interactions with industry or the private sector, Pharma, or other federal agencies (e.g., CDC, FDA). It is expected that the sponsoring institution will provide resources in support of the SCORE application. Applicants should identify scientific, administrative, and financial support provided by the sponsoring department(s) and/or institutional official(s).

Examples of appropriate institutional commitment to the program include the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed career enhancement program, or other commitments essential to successful educational Consortium Steering Committee (CSC): The SCORE CSC is led by a Chair and an Executive Committee, who work with the ORWH and NIH IC Project Scientist(s) to achieve program goals.

The Chair's term is one year, to start and end at the annual Director's meeting. The Steering Committee Executive Committee will consist of past, current and rising Chairs. Each SCORE Director will be expected to participate on the Steering Committee for the duration of award.

Additional outside members from the research community may be added on an ad hoc basis to address emergent issues within the program. The ORWH and NIH IC Project Scientist(s) should be included as ex officio participants for all meetings and correspondence. Advisory Committees are a required component of a SCORE program.

Both External and Internal Advisory Committees provide critical evaluation of the progress of a Center and make recommendations to the Center in advance of NIH requests for information for programmatic review and evaluation or NIH site visits. The reports from Advisory Committees should be included in the Center's annual progress report. NIH officials reserve the right to perform a site visit(s) during the funding period.

The PD/PI should provide a plan for the appointment of Advisory Committees to monitor progress of the program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program.

Proposed Advisory Committee members need not be named in the application if it is new or resubmission; but for renewal applications, the Women's Health Research " Advancing Science for the Health of Women" highlights research priorities to improve the health of women.

The overarching themes of the determinants, evidence-based interventions, advancing women in biomedical research, innovative approaches, mentoring, networking, collaborations, and evaluations Research areas may encompass the etiology, pathogenesis and/or new treatments, diseases and conditions that affect women including studies on the various manifestations of disease.

The overall themes of proposed research projects, and associated cores must inform the etiology, pathogenesis and/or treatment of a condition underlying women's health. The centers funded under this initiative will be expected to participate in this consortium and to collaborate effectively with each other to maximize the chances of overall success of the program.

Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium. Each project is expected to comply with applicable consortium policies and procedures. In addition, the PD/PI(s) and designated individuals will be active members of the consortium, which meets on interim basis.

of Interest of Participating Institutes, Centers and Offices While applications submitted in response to this FOA may propose research in any disease or health area that falls within the broad areas of women's health research, there are also specific areas of interest to the NIH institutes, centers and offices that are participating in FOA.

National Institute on Aging (NIA) supports genetic, biological, clinical, behavioral, social, and economic research on Specific areas of interest for this FOA include: Sex and gender differences in health and disease at older ages; Sex differences in the basic biology of responses to interventions at older ages; Studies of sex differences and sex-specific aging of cognitive, emotional, sensory, and motor function, including Alzheimer's disease and Sex-specific responses to therapeutic interventions in elderly women, including those with comorbid conditions; Research on aging women with emphasis on prevention of frailty, promotion of healthy lifestyles, maintenance of independent living, self-management of symptoms, preservation of cognitive functions, and health-related quality of life; Demographic and economic studies of gender-specific health outcomes and well-being at older ages; Experimental models that can address sex differences across the New paradigms and approaches to study the impact of experience, hormones, developmental stage, and aging on sex differences in steroid hormone National Institute on Digestive Diseases and Kidney (NIDDK): Research areas must focus on priority interests within the mission of NIDDK.

Contact with program staff in NIDDK is highly recommended to ensure that your application would be considered.

Examples include benign conditions of the genitourinary tract; acute and chronic kidney disorders; chronic conditions of the digestive system with significant sex disparities; research focused on better understanding the natural history of dysglycemia in pregnancy and the postnatal long-term metabolic effects of dysglycemia in pregnancy in both mother and offspring; and sex differences in diabetes treatment outcomes.

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 differences in health and disease in response to environmental exposures; research on environmental exposures and sex and gender differences in fundamental biology across the lifespan; research focused on better understanding the role of environmental exposures and sex and gender differences 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) ( https://www. nimh. nih.

gov/about/strategic-planning-reports/strategic-research-priorities/index. shtml ) Studies of basic and translational research investigating sensitive periods (e.g., pre-puberty, puberty, reproductive years, menopause, later life) across the lifespan that may contribute to risk and resilience for developing mental illness.

Basic and translational research that explores sex differences in mechanisms responsible for vulnerability and resilience to social stressors. Studies that elucidate biological and environmental factors as well as mechanisms to prevent and/or cure mental illness. Studies of sex and gender differences in vulnerability to clinical course of psychiatric disorders.

Integrative neuroscience studies that examine sex differences in neural circuits that govern social, cognitive and emotional functions. Studies that examine mechanisms underlying mood disorders that impact women (e.g., perinatal depression) and determine whether these represent a subtype of mood disorders with distinct pathophysiological underpinnings.

Studies that foster collaboration (e.g., data sharing, technology transfer and dissemination) among investigators to advance sex differences research in mental illness.

Studies that incorporate, 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 sex differences 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 socio-demographically and culturally diverse populations.

NIMH supports hypothesis-driven mechanistic clinical trial studies in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and psychopathology of mental disorders and in HIV infection of the CNS.

The goal is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding mental health and mental disorders. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention for mental disorders.

NIMH supports biomarker studies that may provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses. The submitted studies are defined as clinical trials but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

These latter studies will not be accepted, but instead should seek the appropriate NIMH Clinical Trial FOA under which to submit. The NIMH Clinical Trial FOAs are listed on NIMH's Clinical Trials Funding Opportunity Announcements Web page . Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The issuing IC and partner components intend to commit an estimated total of $7. 5 million to fund 5 awards. Applicants may submit a budget for direct cost of up to $1.

0 million per year for five years. The total project period for an application submitted in response to this FOA may not exceed 5 years described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

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 must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors for early state investigators pursuing pilot projects through the Career Enhancement Core. Section IV.

Application and Submission Information A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.

gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants. gov will also be accepted.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (R&R) Application Guide , except where instructed in this