NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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 diversity of health outcomes, and this knowledge can be applied to the development of the next generation of interventions and medical treatments leading to improvements in women's health.

It is expected that SCORE Centers will:

• Develop or strengthen awardee institutions' programs that focus and sustain progress on a key area in women's health research.
• Provide intellectual leadership and innovation to advance research that elucidates the role of sex differences on the health of men and women;
• 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 gender, human health that is determined by both biology and expression of gender. Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. The consideration of these variables and comparisons of males and females are critical to the accurate interpretation, validation, and generalization of research findings in biomedical research. Sex and gender may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes. Sex-based comparisons in research may also ensure that findings are applicable to both women and men. The SCOR specialized centers were thus established to 1) expedite interdisciplinary development and application of new knowledge to human diseases that affect women, 2) Learn more about etiology of these diseases, and 3) Foster improved approaches to treatment and prevention.

The SCOR program represents an innovative interdisciplinary research program focusing on sex differences and major medical conditions affecting women in the U.S., and supports established scientists at centers across the country who conduct ground breaking research that integrates basis, clinical, and behavioral research approaches to incorporate sex differences. ORWH committed $10 million initially to fund 9-10 Specialized Centers (P50 grants). Eleven centers were co-funded with the help of a number of NIH IC partners and the U.S. Food and Drug Administration. To date, a total of 32 SCORs have been funded with an investment of over $132 million providing support at 21 US institutions.

An outcome evaluation of the SCOR program, completed in 2017 found the SCOR program to be fully successful in accomplishing its stated goals. Moreover, the SCOR program goals were on the leading edge of the need for renewed focus on research on sex differences. In a 2014 Nature commentary, NIH leadership called attention to a lack of knowledge about the influence of biological sex in preclinical research. In particular, an overreliance on male animals and cells in basic and preclinical research may obscure key sex differences that could guide clinical studies. Inadequate specification of the sex of cells, inadequate inclusion of female animals in experiments, and inadequate analysis and reporting of data by sex, may also contribute to irreproducibility of preclinical biomedical research. Additional information can be found in the article "Studying both sexes: a guiding principle for biomedicine" published by Dr. Janine Clayton in FASEB J, 2016.

To advance the consideration of sex and other biological variables, NIH adopted a new policy in January 25, 2016, "Enhancing Reproducibility through Rigor and Transparency" (NOT-OD-15-103), which mandated that investigators provide scientific justification of Sex as a Biological Variable (SABV). NOT-OD-15-102 provides specific guidance regarding SABV.

The ORWH SCOR program then, has been at the forefront of sex differences research and SCOR investigators have made seminal contributions to the study of sex differences that affect women's health. With this FOA, ORWH is leveraging 15 years of investment in the study of sex differences and building upon advances in the field by expanding the SCOR program to add the expectation of excellence with the establishment of the Specialized Centers of Research Excellence (SCORE).

Guided by current research, as well as the input we received from the evaluation and from stakeholders, the next generation SCORE program will have an enhanced focus on 1) translational science with the goal of translating biomedical discoveries into clinical applications that improve the health of women and 2) education, to disseminate innovative translational research methods and best practices; and provide leadership in the development and promotion of standards and policy for the consideration of sex differences in biomedical research.

Overview of Centers of Excellence

The objective of the SCORE program is to expedite the development and application of new knowledge to human diseases that affect women, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention.

Applicants to this FOA should develop a translational research program in an area of research that considers sex differences underlying women's health issues. The translational science spectrum represents each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public. The spectrum is not linear or unidirectional; each stage builds upon and informs the others. The path from the biological basis of health and disease to interventions that improve health, encompassing: Basic Research, Pre-Clinical Research, Clinical Research, Clinical Implementation, and Public Health. For more information, please see Translational Science Spectrum on the National Center for Advancing Translational Science (NCATS) website. SCORE applications can support: patient-oriented research, including epidemiological and behavioral studies or outcomes research or research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in-vitro studies that utilize human tissues that cannot be linked to a living individual. Applicants proposing clinical trials should consult ORWH program staff prior to submission of their applications.

With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary and collaborative approach. Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes. SCORE applicants are expected to employ interdisciplinary research approaches, recognizing the complex interplay of factors that impact the health of women. Collaborations among researchers in academia, private industry, and federal settings should be leveraged, as appropriate to advance the SCORE research program. Although the focus of the SCORE program is on sex differences, research programs are not required to have both male and female cohorts. However, if female only research is proposed, the background section must include the current state of knowledge and review of the literature justifying that studies will include cohorts of women only, consistent with the NIH inclusion policy. This FOA allows applications for women's health research relevant to the mission of the participating NIH ICs (see below: Research Areas of Interest).

Prospective applicants are urged to consult with the Scientific/Research Contacts of the NIH early in the preparation of the application (see Section VII. Agency Contacts).

Research Projects: required

A SCORE program consists of at least three-individual, but interrelated, research projects, each with high scientific merit. The overall program should have clear translational research objectives and, in the aggregate, be devoted to a specific major health area relevant to women's health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data.

For the purposes of this FOA only Phase 0 or Phase I Phase II may be supported. SCORE Centers are strongly encouraged to establish collaborative clinical trial activities early in the development of projects that have clinical trials/studies as their goals.

In addition, a SCORE program must have a Leadership Administrative core (LAC), and a Career Enhancement Core (CEC).

Leadership Administrative Core (LAC): required

A Leadership Administrative Core (LAC) must be included for the SCORE program. The LAC will (1) monitor, stimulate, evaluate, and report on the research projects and educational programs particularly with respect to the overall goals of the SCORE; and (2) Provide Intellectual leadership in support of the activities of the SCORE consortium.

The SCORE PD/PI or his/her designee will have overall responsibility for the LAC.

Annual meetings of the SCORE Directors will be held. Planning and execution of annual meetings will be shared between the ORWH, NIH ICs Program Staff, and the Steering Committee. By providing a focused and interactive agenda, the annual meeting fosters the initiation and maintenance of collaborative efforts and resource sharing among the Centers. SCORE PD/PIs should budget funds for the DP/PI and one to -two designees to attend an annual two-day 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 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. Early Stage Investigators and Early-Established Investigators are highly encouraged to apply. Pilot studies and complementary education programs should provide opportunities in rigorous research methodologies and transparency in experimental design and reporting. The CEC should provide unique opportunities to understand women's health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data. This funding opportunity also seeks to facilitate educational opportunities of participants. Participants from diverse backgrounds, underrepresented in the biomedical science are especially encouraged. Current estimates regarding the state of health of US women are variable, with many health, disease, mortality and morbidity outcomes differing significantly by race, ethnicity, and socioeconomic status. Training a diverse biomedical workforce will enhance the scope of intellectual capacity brought to bear on intransigent issues of health and disease to positively affect the health of all women.

Resource Support Core(s) (RSC): optional

SCORE applicants may propose one or more Resource Support Core(s) (RSC) to support two or more research projects, e.g., animal, pathology, and or informatics. SCOREs may also find that their research goals would be facilitated by interactions with industry or the private sector, Pharma, or other federal agencies (e.g., CDC, FDA).

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 includes 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 and an Executive Committee, who work with the ORWH and NIH IC Project Scientist(s) to achieve program goals. The Chair's term is one year, to start and end at the annual Director's meeting. The Steering Committee Executive Committee will consist of past, current and rising Chairs. Each SCORE Director will be expected to participate on the Steering Committee for the duration of award. Additional outside members from the research community may be added on an ad hoc basis to address emergent issues within the program. The ORWH and NIH IC Project Scientist(s) should be included as ex officio participants for all meetings and correspondence.

SCORE Advisory Committees:

An Advisory Committee is not a required component of a SCORE program. However, Advisory Committees, external and/or internal can provide critical evaluation of the progress of a Center and make recommendations to the Center in advance of NIH requests for information for programmatic review and evaluation or NIH site visits. NIH officials reserve the right to perform a site visit(s) during the funding period.

If an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file "Advisory_Committee.pdf".

ORWH Areas of Interest

The ORWH Strategic Plan for Women's Health Research, "Moving Into the Future With New Dimensions and Strategies: A Vision for 2020 for Women's Health Research," highlights research priorities related to women's health. The overarching themes of the Strategic Plan important in this FOA include but are not limited to: lifespan; sex determinants; health disparities, and diversity.

Research areas may encompass the etiology, pathogenesis and/or new treatments, diseases and conditions that affect women including studies on the various manifestations of disease. The overall themes of proposed research projects, and associated cores must inform the etiology, pathogenesis and/or treatment of a condition underlying women's health.

The centers funded under this initiative will be expected to participate in this consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium. Each project is expected to comply with applicable consortium policies and procedures. In addition, the PD/PI(s) and designated individuals will be active members of the consortium, which meets on interim basis.

Areas of Interest of Participating Institutes, Centers and Offices

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

The National Institute on Aging 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 Digestive Diseases and Kidney: Research areas must focus on interests within the mission of NIDDK. Examples include benign, noninfectious conditions of the bladder and lower urinary 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, the treatment of gestational diabetes, and the postnatal long-term metabolic effects, and diabetes risk to the mother and offspring; and sex differences in diabetes risk, prevention, treatment, and complications.

National Institute of Environmental Health Sciences: 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 (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 stressors.
• Studies that elucidate biological and environmental factors as well as mechanisms to prevent and/or cure mental illness.
• Studies of sex and gender differences in vulnerability to clinical course of psychiatric disorders.
• Integrative neuroscience studies that examine sex differences in neural circuits that govern social, cognitive and emotional functions.
• Studies that examine mechanisms underlying mood disorders that impact women (e.g., perinatal depression) and determine whether these represent a subtype of mood disorders with distinct pathophysiological underpinnings.
• Studies that foster collaboration (e.g., data sharing, technology transfer and dissemination) among investigators to advance sex differences research in mental illness.
• Studies that incorporate, sex, age, race, social economic status (SES), culture and gender factors as a means to reduce health disparities and to ensure that effectiveness of diagnostic and therapeutic breakthroughs are equitable across all populations with mental illness.
• Studies on sex differences that further our understanding of how community engagement and health care system factors can contribute to improved treatment adherence, retention, and outcomes in mental health care specifically designed for, or modified for women across the life course, including sociodemographically and culturally diverse populations.

NIMH supports hypothesis-driven mechanistic clinical trial studies in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and psychopathology of mental disorders and in HIV infection of the CNS. The goal is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding mental health and mental disorders. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention for mental disorders. NIMH supports biomarker studies that may provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses. The submitted studies are defined as clinical trials but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions. These latter studies will not be accepted, but instead should seek the appropriate NIMH Clinical Trial FOA under which to submit. The NIMH Clinical Trial FOAs are listed on NIMH's Clinical Trials Funding Opportunity Announcements Web page.

See Section VIII. Other Informationfor award authorities and regulations.

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

Higher Education Institutions

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

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

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)

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)
• 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

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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will 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 NOT-OD-11-101).

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

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, i 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter 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)

National Institutes of Health (NIH)

6707 Democracy Boulevard, Suite 400

Bethesda, MD 20892-5484
Telephone: 301-402-1770
Fax: 301-402-1798
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages each
Leadership Administrative Core (LAC) Core (use for Administrative Core)	12 pages each
Research Project (use for Research Project)	12 pages each
Career Enhancement Core (CEC)	12 pages each
Research Support Core (RSC) ((use for Core)	12 pages each

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

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

When preparing your application in ASSIST, use Component Type 'Overall'.

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

Complete entire form.

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

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 should provide estimated percentages of funds budgeted in each Resource Core (REC) for each Research Project. The filename provided for each attachment will be the name used for the bookmark in the application image.

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.

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.

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.

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. A short video of not more than 25MB may be included into the application under preliminary studies or methods, or wherever it is most appropriate. Additional information on including video content in NIH applications can be found at (NOT-OD-12-141).

Renewal applications from existing SCOR 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 Resource Cores 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.

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

Appendix:

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 NIH-defined human subjects research, clinical research, and/or 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

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

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

When preparing your application in ASSIST, use Component Type 'Project.'

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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.

• 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 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.

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).

3) If an applicant wishes to provide a short video clip as part of the application, a hyperlink must not be included. A short video of not more than 25MB may be included in a CD and sent to the Scientific Review Officer. A few selected "still shots" from the video must be incorporated into the application under preliminary studies or methods, or wherever it is most appropriate, with clear references to the full video. Additional information on including video content in NIH applications can be found at (NOT-OD-12-141).

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. Appropriate documentation for the use of human specimens must be included as an "Other" 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 should 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:

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)

Use only for applications with due dates on or after January 25, 2018. defined human subjects research, clinical research, and/or 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

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

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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 Research Project's activities 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 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 studies 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)

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.

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, and with other SCOREs or other projects; and planning for collaborative activities, if merited.

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 Advisory Board (EAB). Active involvement of the EAB is required for yearly review of progress toward the SCORE goals by a board whose members are entirely external to the institution(s) of the proposed SCORE. The operating procedures of the EAB, including the frequency of its meetings and the methods for the identification of members should be specified; however, the names of potential EAB members should not be included in the application, and potential members should not be contacted until the SCORE is awarded. Renewal SCORE applications should provide the names and affiliations of current EAB members in Appendix materials. There is no set number of EAB members; however, there should be sufficient expertise represented among the members of the EAB to provide an adequate review of all the functions of the SCORE. EAB 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 EAB'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 advisory 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 advisory committee for the SCORE can be summarized here and more thoroughly in the LAC section.

Advisory panels include:

An External Advisory Board (EAB) consisting of experts, all of whom are not associated with the SCORE and the grantee institution(s), is mandatory and will meet on an interim basis to review the SCORE's progress and provide a written report to the SCORE Director, which is to be included in the Center's annual progress report; and

Other advisory panels are convened to assist in selecting candidates for REC support, including Pilot/Exploratory research support.

At least one-third of the members of these panels should be external to the SCORE and the grantee institution(s). Applicants should not name potential advisors or select advisors prior to peer review of the application.

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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information ( )

Use only for applications with due dates on or after January 25, 2018. defined human subjects research, clinical research, and/or 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

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

When preparing your application in ASSIST, use Component Type 'Career Enhancement'.

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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 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 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.

The budget should not exceed $150,000 (direct cost). Budget can be used to support research activities, such as seminars or pilot projects, participant salary, supplies, and one scientific meeting associated with a piolet project. CED 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.

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.

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 including pilot studies. 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.

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.

CEC participants supported must be eligible to apply for independent research grant support. Participants can receive support for a minimum of 1 year and a maximum of 3 years of consecutive funding.

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 CEC program. Special attention should be paid to the recruitment of underrepresented candidates for research educational opportunities development activities.

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 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-08-065. 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 information 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide,

PHS Human Subjects and Clinical Trials Information (CEC)

Use only for applications with due dates on or after January 25, 2018. defined human subjects research, clinical research, and/or 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

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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.

The budget may include a request of up to $100,000 (direct cost) to be used to support RSC activities. The indirect cost is reimbursed at 8% of the direct costs.

Note: The R&R Budget form included in many of the component studies 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)

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:

• Regular review of utilization of core resources by the other SCORE cores, and reallocation of resources within or among cores.
• 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.
• Preparation of administrative documents relating to the award.

Additional activities for which the RSC 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 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 administrative structure of the RSC, the administrative 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 activities of the RSC leader(s), and other RSC staff in carrying out SCORE functions. A crucial component of this description is the activities of the RSC leader in monitoring, stimulating, sustaining, evaluating, and reporting the SCORE's progress toward the overall goals of the SCORE.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide,

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (RSC)

Use only for applications with due dates on or after January 25, 2018. defined human subjects research, clinical research, and/or 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

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

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.

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.

This initiative is not subject to intergovernmental review.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the CSR Referral Office Elaine Sierra-Rivera, PhD, Center for Scientific Review by email at { [email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications proposing clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

• 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? Will the proposed program develop or utilize innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, 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?

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? Does the institution have an established research program in areas related to the SCORE theme?

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

• Does the SCORE application address sex differences that affect the health of women?
• Does the application focus on translational research approaches to address sex differences in an important area affecting health and disease of men and women?
• Does the SCORE contain both human and animal projects and are they conceptually linked?
• Does the application describe how the proposed Center of excellence will enhance the established research base of the host institution?
• Does the proposed SCORE encompass basic and clinical research into the scientific goals and research theme?
• Does the application adequately justify the need for a Center of Excellence as opposed to independent R01s?

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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

For research that involves human subjects but does not involve one of the six 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 six 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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children 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.

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.

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.

Not Applicable.

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

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

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 .

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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.

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.

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 grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

ORWH requires that program staff be notified of pilot awards made by SCORE to its investigators. This can be done at the time of the progress report, unless the pilot 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

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 "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, Project Scientist(s), 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.

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Gayle Lester, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: [email protected]

Rajeev K. Agarwal, Ph.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: [email protected]

Rebecca DelCarmen-Wiggins, Ph.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-451-8689
Email: [email protected]

Tamara Bavendam, MD, MS
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4733
Email: [email protected]

Andrew Bremer, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-7886
Email: [email protected]

Frank Hamilton, MD, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8877
Email: [email protected]

Thaddeus T Schug, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3319
Email: [email protected]

Ivana Grakalic, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7600
Email: [email protected]

Kate Nagy
National Institute on Aging (NIA)
Telephone: 301-496-3121
Email: [email protected]

Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: 301-594-7963
Email: [email protected]

Cora Lee Wetherington, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1319
Email: [email protected]

Elaine Sierra-Rivera, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1043
Email: [email protected]

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610
Email: [email protected]

Elizabeth Gutierrez
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8847
Email: [email protected]

Aaron Nicholas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3297
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

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.

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.