Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

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

National Heart, Lung, and Blood Institute (NHLBI)
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 on Drug Abuse (NIDA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-OD-19-013

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-OD-22-014

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.837, 93.838, 93.839, 93.840, 93.233, 93.866, 93.273, 93.846, 93.279, 93.847, 93.113, 93.242

Funding Opportunity Purpose

The ORWH 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.

Key Dates
Posted Date

August 1, 2022

Open Date (Earliest Submission Date)

August 30, 2022

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 30, 2022 and August 15, 2024

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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)

Not Applicable

Scientific Merit Review

October/November 2022 and October/November 2024

Advisory Council Review

May/June 2023 and January/February 2025

Earliest Start Date

July 2023 and May 2025

Expiration Date

August 16, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


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. 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. Table of Contents

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

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


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

      Purpose

      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 differences 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 health;
      • Facilitate and develop novel interdisciplinary research strategies;
      • Stimulate incorporation of emerging technologies, methods and scientific advances into research designs as appropriate;
      • Provide research career enhancement opportunities in sex differences research;
      • Stimulate translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on findings from basic research;
      • 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 centers; and
      • Leverage institutional resources.

      Background

      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/or gender, human health that is determined by both biology and expression of gender. With this FOA, ORWH is leveraging more than 15 years of investment in the study of sex differences. Please visit ORWH SCORE website for further information.

      Sex and/or gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Rigorous 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/or gender may also determine how health and disease processes differ between groups of women and across the sex and/or gender spectrums. Sex and/or gender based variables can inform the development and testing of preventive and therapeutic interventions.

      Current guidance to advance sex and/or gender based studies includes the consideration of:

      Sex-based comparisons in research may also ensure that findings are applicable to all. The SCORE 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 SCORE 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 specialized centers across the country who conduct ground breaking research that integrates basic, clinical, and behavioral research approaches to incorporate sex differences.

      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. NIH encourages applicants for the U54 SCORE programs to include a diverse group of scientists, including individuals from underrepresented groups as per NOT-OD-20-031 (Notice of NIH's Interest in Diversity). NIH especially encourages individuals from racial, and ethnic groups that have been shown to be underrepresented in health-related sciences on a national basis and individuals with disabilities and women to work with their institutions to apply. In addition, research teams should include investigators from various disciplines/departments and specialties.

      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, biospecimens 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 many factors that impact the health of women, such as sex and gender, race and ethnicity, and a host of other internal and external factors. Moreover, it is critical to consider these factors and their potential interactions across the life course.

      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 NOT-OD-02-001 (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm and NOT-OD-18-014). 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 application (see Section VII. Agency Contacts).

      Research Projects: required

      A SCORE program consists of individual, but interrelated, research projects, each with high scientific merit. The overall SCORE program should have clear translational research objectives and, in the aggregate, be devoted to a specific major health areas relevant to women's health and to incorporate sex as a biological variable (SABV, NOT-OD-15-102) when planning, analyzing, and reporting data.

      For the purposes of this FOA only Phase 0, Phase I, or Phase II Clinical Trials may be proposed.

      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 meeting.

      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 workforce 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 (ESI) (e.g., PD/PI within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an ESI) 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, including individuals from groups underrepresented in the biomedical sciences are especially encouraged (Notice of NIH's Interest in Diversity, NOT-OD-20-031). 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).

      Additional Considerations

      Institutional Support:

      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 opportunities.

      SCORE Consortium Steering Committee (CSC):

      The SCORE CSC is led by a Chair/Co-Chairs and an Executive Committee, who work with the ORWH and NIH IC Program Officer(s)to achieve program goals. The Chair's term is one year, to start and end at the annual SCORE meeting. The Steering Committee/Executive Committee will consist of past, current and rising Chairs. 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 Program Officer(s) should be included as ex officio participants for all meetings and correspondence.

      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.

      SCORE Evaluation Committees:

      Evaluation Committees are a required component of a SCORE program. Both External and Internal Evaluation Committees provide critical evaluation of the progress of a Center and makes recommendations in response to NIH requests for information for programmatic review and evaluation or NIH site visits. The reports from Evaluation 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 Evaluation 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 Evaluation Committee will evaluate the overall effectiveness of the program. Proposed Evaluation Committee members need not be named in the application if it is new or resubmission; but for renewal applications, the members must be named.

      ORWH Areas of Interest

      The new 2019-2023 Trans-NIH Strategic Plan for 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 Strategic Plan important in this FOA include but are not limited to: sex determinants, evidence-based interventions, advancing women in biomedical research, innovative approaches, mentoring, networking, collaborations, and evaluations of NIH investments.

      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. Research to improve the health of women needs comprehensive consideration of the many factors that influence women’s health, such as sex and gender, race and ethnicity, and a host of other internal and external factors. Moreover, it is critical to consider these factors and their potential interactions across the life course. 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.

      Areas of Interest of Participating Institutes, Centers and Offices (ICOs)

      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. Specifically:

      National Institute on Aging (NIA):

      NIA supports genetic, biological, clinical, behavioral, social, and economic research on aging.

      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 related dementias;
      • 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 lifespan and in aging;
      • New paradigms and approaches to study the impact of experience, hormones, developmental stage, and aging on sex differences in steroid hormone signaling.

      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 areas must focus on interests within the mission of NIAAA. Examples include:

      • 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 alcohol use disorder (AUD).
      • Basic and translational research that explores sex and gender differences in mechanisms responsible for vulnerability and resilience to social stressors as they relate to AUD.
      • Studies that foster collaboration such as data sharing, technology transfer and dissemination among investigators to advance sex differences research in AUD.
      • 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 and alcohol use interventions focused on women, girls, and families in high risk, socio-demographically and culturally diverse communities. "Socio-demographically and culturally diverse populations" refer to Health Disparity Populations as indicated by NIH (https://www.nimhd.nih.gov/about/overview/). NIH-designated U.S. health disparity populations include: American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, Native Hawaiians and other Pacific Islanders, Sexual and gender minorities, Socioeconomically disadvantaged populations, and Underserved rural populations.
      • Studies that examine sex differences in response to AUD treatment and that translate these findings into improved therapies and treatment outcomes among women and girls.
      • Dissemination and implementation research to identify best approaches to bringing women and girls-specific and relevant alcohol treatment and preventive interventions to population scale.

      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

      The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in basic biological, genetic, psychological, social, and behavioral studies that address sex and gender differences in health and diseases that are within NIAMS mission relevant clinical research areas. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. For the purposes of this FOA, NIAMS also 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 musculoskeletal and skin disorders. Such studies are mechanistic in nature, and they are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. The clinical trials seeking to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions will not be accepted by this FOA, but instead should be submitted to a NIAMS clinical trial specific FOA. A current list of active NIAMS clinical trials FOAs is available at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

      National Institute on Drug Abuse (NIDA)
      NIDA encourages research center grants focused on sex and/or gender differences in neurobiological and behavioral mechanisms underlying drug addiction, differential responses to addictive drugs, the impact of addiction on health, or in the efficacy of preventative and treatment strategies. NIDA Centers are expected to be scientifically innovative and provide the next generation of ideas and approaches. They should enable research that would not be possible without the climate, facilities and/or interactive research resources that a research center can uniquely provide. NIDA Research Centers are encouraged to include as key investigators, scientists across a range of career stages, from early-stage to established investigators and are expected to foster career development appropriate to the career stage, including timely opportunities for effective dissemination of research findings. Applicants should refer to PAR-22-133 (https://grants.nih.gov/grants/guide/pa-files/PAR-22-133.html). Consistent with NIH’s interest in advancing diversity in biomedical research (e.g. NOT-OD-20-031 and NOT-OD-22-019), applicants are strongly encouraged to form research teams that include individuals with varying perspectives and backgrounds, and academic and technical areas of expertise. Researchers with diverse backgrounds, including underrepresented racial and ethnic groups, persons with disabilities, and women are strongly encouraged to work with their institutions to apply to this Funding Opportunity Announcement. PAR-22-133 (https://grants.nih.gov/grants/guide/pa-files/PAR-22-133.html)

      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) has interest in:

      • 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 and environmental 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 mental illness.
      • 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, perimenopausal 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. Socio-demographically and culturally diverse populations refer to Health Disparity Populations as indicated by NIH (https://www.nimhd.nih.gov/about/overview/). NIH-designated U.S. health disparity populations include: American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, Native Hawaiians and other Pacific Islanders, Sexual and gender minorities, Socioeconomically disadvantaged populations, and Underserved rural 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.

      National Heart, Lung, and Blood Institute (NHLBI):

      The NHLBI is interested in supporting research to understand mechanisms of heart (and vascular), lung, hematologic (blood), and sleep (HLBS) disorders/diseases that present only in women, are more prevalent in women than in men, or have 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 area. 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:

      • Mechanisms of disease of HLBS diseases and disorders or resilience of the entire spectrum of health/disease topics within the NHLBI mission/research priorities, and throughout women’s life course (including pregnancy and post-partum), and in women from different races/ethnicities/origins/heritage groups.
      • Sex and gender differences in mechanisms of disease for HLBS diseases and disorders that need to be better understood.
      • 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.
      • Sex differences in response to therapies for HLBS diseases and disorders, including adverse events.
      • Sex differences in response to therapies for non-HLBS diseases and disorders but affecting HLBS organs and tissues.
      • Clinical trials and need for models of effective engagement and retention of women from underrepresented backgrounds.
      • Studies on models of both efficient and effective HLBS healthcare delivery to women across the life course, especially those from underserved populations or communities, and/or that promote HLBS healthcare equity for women from all race/ethnic/national/cultural/socioeconomic/geographic backgrounds.
      • 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.
      • Consideration of sex- and gender-specific challenges in the development of health policy and evidence-based guidelines resulting from translation and implementation research.
      • Career development needs (at any career stage) to promote mechanistic and clinical studies that investigate sex/gender differences in HLBS diseases, disorders or resilience.
      • Training needs (at any career stage) to promote studies on effective models of healthcare delivery, health policy, and implementation science.
      • Workforce development needs to increase recruitment of women as candidates for leadership positions and to create inclusive work environments.

      Contact with NHLBI program staff prior to submission is highly recommended. Engagement of patient advocates is encouraged, as appropriate.

      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

      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 for this FOA.

      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)

      Need help determining whether you are doing a clinical trial?

      Funds Available and Anticipated Number of Awards

      The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

      The issuing IC and partner components intend to commit an estimated total of $18 million to fund up to 11 awards inclusive of both receipt dates.

      Award Budget

      Applicants may submit a budget for a total cost of up to $1.5 million per year for five years.

      Award Project Period

      The total project period for an application submitted in response to this FOA may not exceed 5 years.

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

      Section III. Eligibility Information
      1. Eligible Applicants
      Eligible Organizations

      Higher Education Institutions

      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education

      The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

      o Hispanic-serving Institutions

      o Historically Black Colleges and Universities (HBCUs)

      o Tribally Controlled Colleges and Universities (TCCUs)

      o Alaska Native and Native Hawaiian Serving Institutions

      o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

      Nonprofits Other Than Institutions of Higher Education

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

      For-Profit Organizations

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

      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 Governments

      · 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.
        • o NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
        • o Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); 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.

      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).

      Faculty

      Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors for early stage investigators pursuing pilot projects through the Career Enhancement Core.

      Section IV. Application and Submission Information
      1. Requesting an Application Package

      The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

      2. Content and Form of Application Submission

      It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

      Rajeev K. Agarwal, Ph.D.
      Office of Research on Women's Health (ORWH)
      Telephone: 301-451-7058
      Fax: 301-402-1798
      Email: rajeev.agarwal@nih.gov

      Page Limitations

      Available Component Types

      Research Strategy/Program Plan Page Limits

      Overall

      12 pages each

      Project (use for Research Project)

      12 pages each

      Admin Core (use for Leadership Administrative Core - LAC)

      12 pages each

      Career Enhance Core (use for Career Enhancement Core - CEC)

      12 pages each

      Core (use for Research Support Core - RSC)

      12 pages each

      Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

      Instructions for the Submission of Multi-Component Applications

      The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

      The application should consist of the following components:

      • Overall: required, maximum of 1
      • Research Project: required, minimum of 3
      • Leadership Administrative Core (LAC): required, maximum of 1
      • Career Enhancement Core (CEC): required, maximum of 1
      • Resource Support Core (RSC): optional
      Overall Component

      When preparing your application, use Component Type ‘Overall’.

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

      SF424 (R&R) Cover (Overall)

      Complete entire form.

      PHS 398 Cover Page Supplement (Overall)

      Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

      Research & Related Other Project Information (Overall)

      Follow standard instructions.

      Facilities and Other Resources: Include information regarding the interrelationship of the SCORE to other activities in the applicant's institution (e.g., other relevant research centers and projects) and the extent of institutional, departmental, and interdepartmental cooperation. (A chart or diagram may be used.) In addition, describe the administrative relationships of the proposed SCORE to the institution. Include relevant issues relating to institutional commitment and settings.

      Information provided in this section should be limited to describing the resources and providing a description of all resources available for the entire SCORE.

      Other Attachments: Include a table titled "Resource Core Distribution to Research Projects." This table must provide estimated percentages of funds budgeted in each Research Support Core (RSC) for each Research Project. The filename provided for each attachment will be the name used for the bookmark in the application image.

      Project/Performance Site Location(s) (Overall)

      Enter primary site only.

      A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

      Research & Related Senior/Key Person Profile (Overall)

      Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

      A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

      Budget (Overall)

      The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

      A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

      PHS 398 Research Plan (Overall)

      Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

      Specific Aims:

      Briefly and succinctly discuss the objectives and goals of the SCORE application. Summarize the expected outcomes(s) of the SCORE, including the impact that the results of the proposed interdisciplinary/translational research will have on women's health.

      Research Strategy:

      Significance. Focusing on the SCORE, address (i) the importance of the problem or critical barrier in the field that the proposed SCORE addresses, (ii) how the proposed SCORE will improve scientific knowledge, technical capability, and/or clinical practice in one or more fields, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. Information on including video content in NIH applications can be found at Notice (NOT-OD-20-061).

      Renewal applications from existing SCORE sites may use this section to provide an overall progress report distinct from that provided in other sections of the application (with citations where appropriate). Tables of SCORE activities during the previous funding period can be presented here provided they fit within the page limits of this attachment.

      New proposed SCORE sites may use this section to present preliminary data or evidence of preparatory activities for establishing a SCORE.

      For renewals include the following additional information:

      Renewals. If Cores included in the prior period of support are not part of the current submission, describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support. Identify and justify any changes in research emphasis and level of funds requested. If the structure of Cores has changed, show the correspondence to the prior structure.

      Approach. Present the SCORE's overall strategy for serving as a National resource in its selected research area of focus. Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and research educational opportunities functions expected of a SCORE. Describe the specific activities that the SCORE will undertake to accomplish the goals and strategy described above, including how the different components of the SCORE will interact to help accomplish them, how the approaches of the Research Support Core (RSC) complement each other or are inter-dependent, the mechanisms to ensure coherence of the Center and maintenance of a translational focus, and the mechanisms to be used in assessing progress toward the SCORE's goals. Where appropriate, provide timelines and organizational charts. Reference the appropriate sections of this application that contain more detail.

      Innovation. Considering the SCORE, show how the proposed SCORE seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

      Vertebrate Animals:

      Describe the general principles and policies that will apply to the treatment of vertebrate animals in the SCORE. List the components in the application that involve vertebrate animals. Institutional Animal Care and Use Committee (IACUC) approval should be submitted as Just-In-Time information.

      Letters of Support:

      Place institutional letters of support for the SCORE in this section.

      Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

      All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

      Appendix:

      Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

      PHS Human Subjects and Clinical Trials Information (Overall)

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

      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 (Overall)

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

      Research Project

      When preparing your application, use Component Type ‘Project.’

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

      SF424 (R&R) Cover (Research Project)

      Complete only the following fields:

      • Applicant Information
      • Type of Applicant (optional)
      • Descriptive Title of Applicant’s Project
      • Proposed Project Start/Ending Dates
      PHS 398 Cover Page Supplement (Research Project)

      Enter Human Embryonic Stem Cells in each relevant component.

      Research & Related Other Project Information (Research Project)

      Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

      Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

      Project Narrative: State the relevance of the Research Project to public health.

      Project /Performance Site Location(s) (Research Project)

      List all performance sites that apply to the specific component.

      Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

      Research & Related Senior/Key Person Profile (Research Project)
      • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
      • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
      • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
      • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
      Budget (Research Project)

      Budget forms appropriate for the specific component will be included in the application package.

      Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

      PHS 398 Research Plan (Research Project)

      Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

      Specific Aims:

      Briefly, but succinctly, state the goals of the proposed Research Project, including the specific aims to be accomplished. Summarize the expected outcome(s), including the impact that the results of the Research Project will exert on women's health. List concisely the objectives of the Research Project, e.g., to test a stated hypothesis, to generate new hypotheses, to solve a specific problem that has yet been unsolved in the field, to challenge an existing paradigm or clinical practice, to address any critical barrier(s), or to develop innovative technologies, detection methods, or biomarkers appropriate for women's health.

      Research Strategy:

      Additional items to consider:

      1) Each research project must address SABV policy as described in Section I. Funding Opportunity Description.

      2) Provide clear and specific cross references to information in other sections of the application (such as the personal statement in the Biosketch; power calculations or recruitment and retention strategies for participants in clinical trials in the PHS Human Subjects-Clinical Trial Information form; or methods for derivation of animal strains or power calculations for animal experiments in the Vertebrate Animals attachment).

      All the proposed research projects should be integrated and synergized with each other to translate the findings towards the improvement of women's health.

      Describe the research strategy underlying women's health issues that will be pursued in the research project. The research strategy should include Significance, Innovation and Approach, including the Preliminary Studies (for New Projects) and Progress Report (for Renewal Applications). Describe the specific contribution that the project will have to the overall SCORE and its success. Start each section with the appropriate section heading.

      The experimental plan should be discussed in detail: the importance of the problem, how the proposed research project will improve scientific knowledge, technical know-how, or clinical practice; how the research project challenges and seeks to shift current research paradigm or clinical practice. Describe any novel theoretical concepts, approaches, methodologies, instrumentation, interventions to be developed and their benefits over existing procedures. Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project, including how the data will be collected, analyzed, and interpreted. Identify potential major challenges or problems that might be encountered in conducting the proposed research, and discuss how these would be addressed. Innovative approaches that will be developed or employed by the project should be highlighted and their impact briefly discussed.

      All specimens must include a plan for sample acquisition (if applicable), storage, preparation of material without duplicating information on the PHS Human Subjects and Clinical Trials Information form or Vertebrate Animals attachment. When collecting new samples, investigators are required to obtain consent for the sharing of samples and data. Detailed justification for use of archived samples and data must be provided.

      Letters of Support:

      Applicants must attach letters of support from the appropriate institutional official (University President, Dean, Director, Department Head, or equivalent) from all collaborating institutions to substantiate the institutions' commitment to the proposed plan. The letter of commitment from the host institution should address the integration and synergies between the institutional resources and those of the SCORE project. Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Also attach appropriate letters specific to the project detailing the nature and extent of participation.

      Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

      All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

      Appendix:

      Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

      PHS Human Subjects and Clinical Trials Information (Research Project)

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

      Leadership Administrative Core (LAC)

      When preparing your application, use Component Type ‘Admin Core’

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

      SF424 (R&R) Cover (Leadership Administrative Core - LAC)

      Complete only the following fields:

      • Applicant Information
      • Type of Applicant (optional)
      • Descriptive Title of Applicant’s Project
      • Proposed Project Start/Ending Dates

      PHS 398 Cover Page Supplement (Leadership Administrative Core - LAC)

      Enter Human Embryonic Stem Cells in each relevant component.

      Research & Related Other Project Information (Leadership Administrative Core - LAC)

      Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

      Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

      Project Narrative: State the relevance of the Leadership Administrative Core to public health.

      Project /Performance Site Location(s) (Leadership Administrative Core - LAC)

      List all performance sites that apply to the specific component.

      Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

      Research & Related Senior/Key Person Profile (Leadership Administrative Core - LAC)

      • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
      • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
      • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
      • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

      Budget (Leadership Administrative Core - LAC)

      Budget forms appropriate for the specific component will be included in the application package.

      The SCORE PD/PI (or at least one of the SCORE PD/PIs in multiple PD/PI application) is expected to serve as Core Lead of the Administrative Core with minimum effort of 0.6 Person Months (PM). If multiple PDs/PIs serve as co-Core Leads, each must devote a minimum effort of 0.6 PM. The minimum total effort for the PD/PI on a SCORE grant is 2.4 PM. If the SCORE application is submitted as a multiple PD/PI application, each PD/PI must commit a minimum of 2.4 PM. The minimum of 2.4 PM time commitment should be an aggregate of efforts in different components.

      Budgets are required for each consortium (subcontract) if they are part of the Administrative Core.

      The budget of the LAC should not exceed $150,000 (direct cost). This may include a request of up to $50,000 (direct cost) to be used to support LAC activities and parent institutions are encouraged to supplement this amount.

      Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

      PHS 398 Research Plan (Leadership Administrative Core - LAC)

      Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

      Specific Aims: Succinctly outline the list of specific objectives and goals of the LAC.

      Research Strategy:

      Significance: Describe the overall role of the LAC in the SCORE.

      Approach and Innovation: The LAC should conduct or organize the following activities:

      Regular review of utilization of core resources by the other SCORE cores, and reallocation of resources within or among cores. This will include the review of plans to incorporate scientists and trainees from diverse backgrounds and with different life experiences into various CEC activities, including planned courses, research experiences, and as pilot awardees.

      Assessment of scientific opportunities for new utilization of core resources, and planning to utilize them. One topic that should routinely be assessed is the potential for translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research, or studies to improve understanding of the mechanisms contributing to clinical or functional findings.

      Assessment of potential areas for collaboration among SCORE cores within the Center, with other SCOREs and/or with partnering institutions should be conducted by LAC, if merited.

      Additional activities may include organizing research planning meetings (including participants from other institutions) and support for invited scientific presentations, and travel expenses for SCORE staff to visit other SCOREs for collaborative projects.

      Review of proposed Pilot Studies by an independent panel or panels and review of salary support for junior faculty supported. The LAC may elect to convene a single panel or separate panels to conduct reviews of the above activities. Panels may meet in person or by teleconference. Ad hoc reviewers may be invited to participate in the panels to address specific projects in their areas of expertise.

      Constitution and convening of an External Evaluation Committee (EAC):

      Active involvement of the EAC is required for yearly review of progress toward the SCORE goals, including plans for diversity by a committee whose members are entirely external to the institution(s) of the proposed SCORE. A plan for diversity should include a description of ways that the SCORE is enhancing workforce diversity, including the recruitment of individuals from diverse backgrounds, including groups shown to be under-represented in the US biomedical, clinical, behavioral, and social science enterprise (NOT-OD-20-031). The operating procedures of the EAC, including the frequency of its meetings and the methods for the identification of members should be specified. However, the names of potential EAC members must not be included in the application, and potential members must not be contacted until the SCORE is awarded.

      Renewal SCORE applications must provide the names and affiliations of current EAC members. There is no set number of EAC members; however, there should be sufficient expertise represented among the members of the EAC to provide an adequate review of all the functions of the SCORE. EAC meetings can be held in person and/or by remote conferencing as appropriate to the needs and budget of the SCORE. A report of the EAC's annual review should be included in the yearly NIH progress report.

      Coordination of attendance of SCORE personnel at an annual SCORE Directors meeting:

      Participation of SCORE PD/PI and Center leadership at the annual scientific meeting is mandatory. A Research Core Leader or other principal may attend as appropriate for purposes of programmatic coordination and scientific exchange. The meeting is typically held in Bethesda, Maryland.

      Preparation of administrative documents relating to the award:

      Additional activities for which the LAC may provide support include research planning meetings (including participants from other institutions) and support for invited scientific presentations, and travel expenses for SCORE staff to visit other SCOREs for collaborative projects.

      Renewal applications from existing SCORE sites should use this section to present progress report information specific to the LAC. Newly proposed SCORE sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed LAC.

      Describe the administrative structure of the LAC, the administrative relationships between the LAC and all other SCORE components, and the ways in which they will interact to achieve the SCORE's goals and maintain quality of the SCORE. Describe the activities of the LAC leader(s), the Center Administrator, and other LAC staff in carrying out the LAC functions. A crucial component of this description is the activities of the LAC leader in monitoring, stimulating, sustaining, evaluating, and reporting the SCORE's progress toward the overall goals of the SCORE. Present plans to establish and operate SCORE evaluation panels, including criteria for selecting advisors, how they will be identified, the operating procedures of each panel, and the frequency of meetings. Information on the evaluation committee for the SCORE can be summarized here and more thoroughly in the LAC section.

      Letters of Support:

      Attach appropriate letters relevant to the Leadership Administrative Core detailing the nature and extent of participation.

      Resource Sharing Plan:

      Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

      All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

      Appendix:

      Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

      PHS Human Subjects and Clinical Trials Information (Leadership Administrative Core - LAC)

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

      Career Enhancement Core (CEC)

      When preparing your application, use Component Type ‘Career Enhance Core’

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

      SF424 (R&R) Cover (Career Enhancement Core - CEC)

      Complete only the following fields:

      • Applicant Information
      • Type of Applicant (optional)
      • Descriptive Title of Applicant’s Project
      • Proposed Project Start/Ending Dates

      PHS 398 Cover Page Supplement (Core or Project Name)

      Enter Human Embryonic Stem Cells in each relevant component.

      Research & Related Other Project Information (Career Enhancement Core - CEC)

      Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

      Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

      Project Narrative: State the relevance of the Career Enhancement Core activities to public health.

      Project /Performance Site Location(s) (Career Enhancement Core - CEC)

      List all performance sites that apply to the specific component.

      Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

      Research & Related Senior/Key Person Profile (Career Enhancement Core - CEC)

      • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
      • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
      • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
      • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

      Budget (Career Enhancement Core - CEC)

      Budget forms appropriate for the specific component will be included in the application package.

      The Career Enhancement Core (CEC) Lead is expected to serve as Core Lead with minimum effort of 0.6 Person Months (PM). If multiple PDs/PIs serve as co-Core Leads, each must devote a minimum effort of 0.6 PM.

      The CEC budget can be used to support research activities, such as seminars or pilot projects, participant salary, and support for partnerships with other institutions to enhance diversity as described below in the research strategy section. Supplies, and one scientific meeting associated with the pilot project can also be supported. CEC funds cannot be used for the purchase of any large equipment. A minimum of $50,000 direct costs per year must be proposed and maintained for CEC. Parent institutions often supplement this amount.

      Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

      PHS 398 Research Plan (Career Enhancement Core - CEC)

      Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

      Specific Aims: Describe the contribution of the CEC to the SCORE's overall goals. Describe how the proposed use of CEC funds for career enhancement activities.

      Describe how the CEC Leader(s) and other mentors will help implement the intended goals of the CEC.

      Research Strategy:

      The Research Strategy must include the following subsections:

      Outline the objectives of the CEC and the program activities that will be used to meet these objectives. Include information about planned courses, research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed program. Provide examples of pilot studies conducted as part of the CEC. Provide examples of pilot projects consistent with the research scope of the proposed SCORE program.

      Outline how scientists and trainees from diverse backgrounds and with different life experiences will be incorporated into various CEC activities, including planned courses, research experiences, and as pilot awardees. Partnerships between SCORE U54 programs and institutions that have a historical and current commitment to educating scientists from any of the populations shown to be underrepresented in biomedical research such as those groups identified in NOT-OD 20-031 (Notice of NIH's Interest in Diversity) are strongly encouraged, as these institutions are uniquely positioned to engage underrepresented groups in research.

      Core Leader(s). Describe arrangements for administration of the core. Provide evidence that the Core Leader(s) is/are actively engaged in research and/or teaching in areas related to the mission(s) of participating NIH ICs, and can organize, administer, monitor, and evaluate career enhancement activities. For programs proposing multiple Core Leaders, describe the complementary and integrated expertise of the Leaders, their leadership approach, and governance appropriate for the planned Program.

      Faculty. Describe how the Program Faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of participants proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and providing educational opportunities individuals at the proposed career stage(s). For any proposed Program Faculty lacking experience in providing research educational opportunities, describe a plan to ensure successful participant guidance by these individuals. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

      Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

      Candidates must be able to commit a minimum of 6-person months of full-time professional effort for career enhancement and research activities associated with the U54 SCORE program. Institutions are especially encouraged to recruit prospective candidates from groups underrepresented in the biomedical sciences for research educational opportunities development activities. CEC participants supported must be eligible to apply for independent grant support. Participants can receive support for a minimum of 1 year and a maximum of 3 years of consecutive funding.

      CEC participants receiving pilot funding through the CEC are encouraged to apply for individual mentored K awards (e.g., K01, K08, K23, K25); if successful, the CEC appointment would be terminated, and funding would be received from the new individual K award. CEC participants are also encouraged to work with their institutions, as applicable, to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-18-157. Former or current principal investigators on any NIH research project grant (this does not include NIH Small Grants (R03) or Exploratory/ Developmental (R21) grants or their equivalents), or project leaders on sub-projects of program project (P01) or center grants (e.g., P30, P50) are not eligible to apply as CEC participants.

      Up to three CEC participants may receive pilot funding in the first year. Describe the goals for each candidate's career progression by the end of the SCORE award period.

      Renewal applications from existing SCORE sites should use this section to present progress report specific to research cores. Newly proposed SCORE sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed CEC.

      Letters of Support: Attach appropriate letters relevant to the Career Enhancement Core detailing the nature and extent of participation

      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.

      Appendix:

      Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

      PHS Human Subjects and Clinical Trials Information (Career Enhancement Core - CEC)

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

      If you have FOA-specific instructions for any of the study record fields, add the field label and specific.

      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.

      Resource Support Core (RSC)

      When preparing your application, use Component Type ‘Core’

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

      SF424 (R&R) Cover (Resource Support Core - RSC)

      Complete only the following fields:

      • Applicant Information
      • Type of Applicant (optional)
      • Descriptive Title of Applicant’s Project
      • Proposed Project Start/Ending Dates

      PHS 398 Cover Page Supplement (Resource Support Core - RSC)

      Enter Human Embryonic Stem Cells in each relevant component.

      Research & Related Other Project Information (Resource Support Core - RSC)

      Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

      Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

      Project Narrative: State the relevance of the Research Project's activities to public health.

      Project /Performance Site Location(s) (Resource Support Core - RSC)

      List all performance sites that apply to the specific component.

      Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

      Research & Related Senior/Key Person Profile (Resource Support Core - RSC)

      • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
      • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
      • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
      • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

      Budget (Resource Support Core - RSC)

      Budget forms appropriate for the specific component will be included in the application package.

      Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

      PHS 398 Research Plan (Resource Support Core - RSC)

      Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

      Specific Aims: Succinctly outline the list of specific objectives and goals of the RSC.

      Research Strategy:

      Significance: Describe the overall role of the RSC in the SCORE.

      Approach and Innovation: The RSC should conduct or organize the following activities:

      • Assessment of scientific opportunities for new utilization of core resources, and planning to utilize them.
      • Assessment of potential areas for collaboration among SCORE cores within the Center, and with other SCOREs or other projects; and planning for collaborative activities, if merited.
      • It is expected that the RSC will leverage existing institutional resources in support of the core research objectives.

      Renewal applications from existing SCORE sites should use this section to present progress report specific to research cores. Newly proposed SCORE sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed RSC.

      Describe the structure of the RSC. This will include the relationships between the RSC and all other SCORE components, and the ways in which they will interact to achieve the SCORE's goals and maintain quality of the SCORE. Describe the knowledge, skills and abilities of the RSC leader(s), and other RSC staff in monitoring, evaluating, and reporting the SCORE's progress toward the overall goals of the SCORE program.

      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.

      Letters of Support: Attach appropriate letters relevant to the Resource Support Core detailing the nature and extent of participation.

      Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

      Appendix:

      Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

      PHS Human Subjects and Clinical Trials Information (Resource Support Core - RSC)

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

      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) using ASSIST or other electronic submission systems. 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.

      For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

      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) and component Project Leads must include their eRA Commons ID in the Credential field of 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.

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

      See more tips for avoiding common errors.

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

      Post Submission Materials

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

      Section V. Application Review Information
      1. Criteria

      Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

      In addition, for applications involving clinical trials:

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

      Overall Impact - Overall

      Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center 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 center proposed).

      Scored Review Criteria - Overall

      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 center that by its nature is not innovative may be essential to advance a field.

      Significance

      Does the center 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 center 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?

      In addition, for applications proposing 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 center? 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 proposing clinical trials

      With regard to the proposed leadership for the center, 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 proposing 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 center? Have 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 center 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?

      In addition, for applications proposing 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 proposing 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 - Overall

      As applicable for the center 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.

      Approach:

      • Does the application focus on translational research approaches to address sex and/or gender in health and disease as described in 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women"?
      • Does the SCORE contain both human and animal projects and are they conceptually linked?

      Environment:

      • Does the application describe how the proposed Center of Excellence will enhance the established research base of the host institution?

      Study Timeline

      Specific to applications proposing clinical research studies/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)?

      Career Enhancement

      • Does the proposed CEC clearly state its goals and objectives, including the career level of the potential pilot awardees, the content to be covered, and the intended outcomes?
      • Does the applicant make a compelling case for the proposed research education program as an effective educational vehicle?

      Specific to this FOA:

      After the review of the individual components of the application, an overall impact score will be assigned to the application. This score will reflect not only the individual quality of the projects, cores, and administration, but also how the proposed SCORE will bring together all these elements to host a productive program. The overall score may be higher or lower than the "average" of the descriptors based on the assessment of the synergy of the whole as compared to the individual components.

      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 center 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 review committee will consider the progress made in the last funding period.

      Revisions

      Not Applicable

      Additional Review Considerations - Overall

      As applicable for the center 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 .


      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 Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

      As part of the scientific peer review, all applications:

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

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

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

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

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

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

      Section VI. Award Administration Information
      1. Award Notices

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

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

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

      Prior Approval of Pilot Projects

      ORWH requires information on CEC activities of SCORE investigators. Outline how scientists and trainees from diverse backgrounds and with different life experiences will be incorporated into various CEC activities, including planned courses, research experiences, and as pilot awardees. Partnerships between SCORE U54 programs and institutions that have a historical and current commitment to educating scientists from any of the populations shown to be underrepresented in biomedical research such as those groups identified in NOT-OD 20-031 (Notice of NIH's Interest in Diversity) are strongly encouraged. Information should be provided at the time of the annual progress report, unless the pilot award involves a human intervention study funded by the SCORE, in which case a description of the study and plans for data and safety monitoring must be communicated to, and approved by NIH SCORE program staff prior to initiation of the study consistent with NIH human inclusion and clinical trials policy.

      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 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.

      Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

      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

      The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

      The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

      The PD(s)/PI(s) will have the primary responsibility for:

      • Leading the development of common measures and methods for assessing health behavior;
      • Developing and implementing a process to support the sharing of data with investigators within the Consortium as well as with qualified investigators who are not part of the Consortium or NIH;
      • Serving as voting members on the Steering Committee;
      • Participating in in-person scientific meetings once a year, and monthly teleconferences;
      • Providing information to the NIH Program Directors and NIH Project Scientists concerning progress by submitting annual progress reports in a standard format, and by providing additional information as needed; Hosting site visits to be conducted by NIH staff; Cooperating with NIH Project Scientists in the program evaluation process;
      • Providing information on awarded core including specific aims of pilot project(s) and how the project(s) contribute to the overall goals of the SCORE program.
      • Committing a minimum of 2.4-person-months effort per year to the award; and
      • Assuring that appropriate administrative and logistical support is provided to coordinate Consortium research activities (including but not limited to facilitating the formation of working groups, scheduling and coordinating logistics of teleconferences and in-person meetings, and approval and tracking of research projects).

      Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

      NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

      NIH Project Scientist(s) will have the following responsibilities:

      • Advising on the development of common measures and methods for the consideration of sex differences;
      • Participating in the development and conduct of trans-Consortium research as appropriate;
      • Collaborating with Consortium investigators in some shared activities, including co-authoring papers if appropriate;
      • Serving as members on the Steering Committee;
      • Participating in in-person scientific meetings once a year, and Steering Committee teleconferences, and working group and committee calls on a weekly, bi-monthly or as-needed basis;
      • Monitoring the operations of the U54 research projects, and making recommendations on overall project directions and allocations of project funds;
      • Reviewing the individual progress of the U54 research projects, as well as the progress of Consortium collaborations;
      • Assisting the Consortium awardees as a liaison in stimulating their broader interactions with other NIH programs to disseminate results and outcomes from the program and effectively leveraging existing NIH resources and infrastructures;
      • Evaluating the adherence of Consortium awardees to the approved data sharing plans and intellectual property plans; and
      • Conducting periodic site visits for of the SCORE research projects.
      • Additionally, Program Official (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.

      Areas of Joint Responsibility include:

      Steering Committee:

      The Steering Committee will serve as the operational governing board for the Consortium and will be chaired by the SCORE Project Scientists.

      The Steering Committee will be composed of the following voting members:

      • The PD(s)/PI(s) of the SCORE who will collectively have one vote
      • The NIH Program Directors who will collectively have one vote

      Key co-investigators and career enhancement awardees, in addition to the PD(s)/PI(s), are eligible to attend Steering

      Committee meetings:

      A SCORE PI selected by voting members will chair the Steering Committee on a rotating basis. The Steering Committee will convene shortly after funding to review draft policies and procedures to guide Consortium activities.

      The Steering Committee will meet at least monthly via teleconference or videoconference to share information on planning, study progress and challenges, preliminary results and analyses in progress. One of these meetings should occur during an annual meeting of SCORE PIs, key study investigators, and the respective NIH program staff.

      The Steering Committee will establish working groups and subgroups to address scientific and administrative issues and to implement Consortium policies and goals. See Terms and Conditions, Section VI.2 for additional information.

      Dispute Resolution:

      Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. The SCORE Project Scientist will engage a separate committee to address any disagreements that may arise in scientific or programmatic matters. Following receipt of formal and full documentation of alleged bias from the SCORE Steering committee, A Dispute Resolution Panel composed of three members will be convened. The panel will have three members: One Ex-officio, non-voting NIH Project Scientist, one NIH designee, e.g., a senior NIH program official from an IC not participating in the SCORE program and a third designee with expertise in the relevant area who is chosen by the other two. The committee will review the issue and recommend a remedy if bias is indicated. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

      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 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition 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: https://grants.nih.gov/support/index.html(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)

      Rajeev K. Agarwal, Ph.D.
      Office of Research on Women's Health (ORWH)
      Telephone: (301) 451-7058
      Email: rajeev.agarwal@nih.gov

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

      Kate Nagy
      National Institute on Aging (NIA)
      Phone: 301-451-8396
      E-mail: nagyk@mail.nih.gov

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

      Xincheng Zheng (Ted), M.D., Ph.D.
      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
      Tel: (301) 594-4953
      Email: zhengx4@mail.nih.gov

      Sunila Nair, PhD
      National Institute on Drug Abuse (NIDA)
      Telephone: 301-827-6832
      Email: sunila.nair@mail.nih.gov

      Christine Maric-Bilkan, Ph.D.
      National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
      Phone: (301) 435-0486
      E-mail: christine.maric-bilkan@nih.gov

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

      Tamara Lewis Johnson, M.P.H., M.B.A.
      National Institute of Mental Health (NIMH)
      Telephone: 301-594-7963
      Email: tamara.lewisjohnson@nih.gov

      Peer Review Contact(s)

      Elia Ortenberg, Ph.D.

      Center for Scientific Review (CSR)

      Telephone: 301-827-7189

      Email: elia.ortenberg@nih.gov

      Financial/Grants Management Contact(s)

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

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

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

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

      Krystle Nicholson
      National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
      Phone: 301-594-8860
      Email: nicholsonk@mail.nih.gov

      Aaron Nicholas
      National Institute of Environmental Health Sciences (NIEHS)
      Phone: 984-287-3297
      E-mail: nicholaa@mail.nih.gov

      Tamara Kees
      National Institute of Mental Health (NIMH)
      Telephone: 301-443-8811
      Email: tkees@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 and 2 CFR Part 200.

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Department of Health and Human Services (HHS) - Home Page
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and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.