It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose

The Office of Research on Women's Health (ORWH) announces the availability of administrative supplements to support research highlighting the impact of sex/gender influences at the intersection of race/ethnicity and other social determinants in human health and illness, including preclinical, clinical and behavioral studies. The purpose of this FOA is to provide Administrative Supplements to active NIH parent grants for one year to address health disparities among women of populations in the US who are underrepresented, understudied and/or underreported in biomedical research. Combinations of one or more populations is also encouraged, e.g. socioeconomically disadvantaged sexual and gender minorities.

The proposed research must address an area specified within Goal 1 and 2 of the new 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women".

These goals focus on advancing rigorous research that is relevant to the health of women (Goal 1) and developing methods and leveraging data sources to consider sex and gender influences that enhance research for the health of women (Goal 2).

Projects should include a focus on one or more NIH-designated health disparities populations defined by Public Law 106-525, Minority and Health Disparities Research and Education Act of 2000, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders (https://www.gpo.gov/fdsys/pkg/PLAW-106publ525/pdf/PLAW-106publ525.pdf ) as well as socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities (SGM), transgender women and women who have undergone genital cutting and mutilation. Combinations of one or more of these populations is also encouraged.

Studies relevant to increasing the understanding of the interaction and intersection of sex/gender, race/ethnicity, biological factors and social determinants of health and disease includes multidisciplinary, interdisciplinary and transdisciplinary research that probes the intersections as well as the hierarchical influences of etiology, biology, pathophysiology, psychology and more across a number of disciplines and interventions in these understudied, underrepresented and underreported populations. Of interest also are those projects that highlight common root causes of these disparities and the common pathways for the manifestations of ill health and disease, including differential risk, risk exposure, resilience, morbidity, and mortality at the individual, community and/or national levels. The application may address other goals within the Trans-NIH Strategic plan as long as Goal 1 ad 2 are the primary scope of the proposed research.

Background

The establishment of policies for the inclusion of women and minorities in NIH-funded clinical research originates from the civil rights and women's health movements. Multiple federal task forces and working groups over the past 3 decades have informed and shaped NIH's biomedical research policy, including Federal statutes and guidance.

The Office of Research on Women's Health (ORWH) was established over 25 years ago and with the congressional passage of the NIH Revitalization Act of 1993 [Pub. L. No. 103-43, 107 Stat. 122 (June 10, 1993)], NIH received statutory requirements to follow regarding research on women's health. The NIH Revitalization Act also requires specific actions related to the inclusion of minorities, categories of racial and ethnic populations in the United States (US), as defined by the Office of Management and Budget (OMB) (https://orwh.od.nih.gov/sites/orwh/files/docs/NIH-Revitalization-Act-1993.pdf) latest revisions in 1997. OMB Directive 15 defines racial and ethnic category as follows: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and Hispanic/Latino American.

In 1994, NIH revised its inclusion policy to comply with the statute and reinforce its existing policies. These were the four major differences that resulted from that revision:

-That NIH ensure that women and minorities and their subpopulations be included in all clinical research;

-That women and minorities and their subpopulations be included in Phase III clinical trials designed such that valid analysis can be performed;

-That cost not be allowed as an acceptable reason for excluding these groups; and

-That NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies.

Genetically defined male and female alone do not characterize women and men, who are more fully characterized by both sex and gender, well highlighted and described in the Institute of Medicine (IOM) report, entitled "Exploring the Biological Contributions to Human Health: Does Sex Matter?" (2001). In this context, factors that contribute to biological sex differences include chromosomes and genes, reproduction and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by the environment and experience. Consideration of these variables and comparisons of males and females may be critical to the accurate interpretation and validation of research findings. 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.

ORWH encourages and supports biomedical research that serves the entirety of the population of women in the US. However abundant data exist that there is a disproportionate burden of disease in a significant subpopulation of women, including racial and ethnic minorities, immigrants, those living in poverty, and those in both rural and urban areas. These subpopulations are diverse and are not mutually exclusive. Women and girls in these subpopulations bear a disproportionate burden of health risks and conditions compared to the general US population but are often underrepresented and understudied in clinical and biomedical research and may be underreported in surveillance data for many reasons. Similarly, women with physical, intellectual and developmental, and/or sensory disabilities also are often underrepresented in biomedical research and thus by extension overlooked in the development and testing of subsequent interventions such research stimulates (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5104996/pdf/AJPH.2016.303448.pdf).

Women in sexual minority (including but not limited to transgender and intersex women) are underrepresented in biomedical research as well as in reporting data, missing unique opportunities to learn more about not only the differences among men and women, but also the effects of the hormonal milieu that differs from that expected based upon biologic sex alone. Estimates of the size of these populations have significantly increased over the past decade; although the past underrepresentation of these individuals in population-based surveys will likely result in a continued increase in the size of this population detected by future studies. Women who have experienced genital mutilation and cutting are also understudied, underrepresented and underreported. Although exact numbers are unknown, estimates are that the population of women at risk for this practice, based upon prevalence estimates among immigrants from countries where this is practiced has increased over 400%. The short, mid and long-term consequences of this practice on physical and psychological development, as well as the impact upon reproductive outcomes is significant but understudied. Evidence based guidelines for the management of these consequences are lacking.

Another consideration is the ongoing shift in the US demographics. This historic demographic shift in the US population will greatly impact society and public health. By 2043 it is predicted that the majority of the US population will be persons of color ("racial and ethnic minorities"). This new majority will be 53.4% of the nation by 2050. Women of color are projected to increase in number from 57 million in 2010 to 107 million in 2050, from 36 percent to 53 percent of the total US female population. In 2014 ORWH published "The Women of Color Health Data Book, 4th edition" (https://orwh.od.nih.gov/sites/orwh/files/docs/WoC-Databook-FINAL.pdf), which consists of US Government sourced, population-based health and disease data disaggregated by sex/gender and race/ethnicity. The data book highlights the historical, cultural and socio-geo-demographic factors that influence the health status of women of color. This increase in subpopulations that are currently understudied and underreported are the same segments of the US population that will bear a disproportionate burden of health risk, poorer health and disease prevalence.

Aggregate data from NIH sponsored studies shows that there has been an increase in enrollment of both women and minorities in biomedical research, and data suggest that minority women enrollment (in the US) is stable. However, gaps in the knowledge of how, why and through what mechanisms biological factors and the social determinants of health intersect, interact and modulate poor health outcomes and disease to create differential outcomes across a range of populations remains unclear.

Moreover, current estimates regarding the state of health of US women are variable, with many health, disease, mortality and morbidity outcomes differing significantly by age, race, ethnicity and sexual orientation. Therefore, further research exploring not only the common roots or etiology of disease, but also the intersection of the factors and influences that affect the individual as well as their community, across the lifespan is needed. Focus upon the individual health disparities while ignoring the effects of community health upon a range of factors from risk of disease (e.g. epigenetic) to disease development (e.g. lack of safe open spaces for activity and the development of obesity) or the long term mental and physical consequences of early genital trauma leads to incomplete understandings of the interplay of these factors, as well as the key intersections for successful and effective interventions. Findings from such research can provide a framework from which greater understanding of the complex interplay of physiology, psychology, biology and environment can inform biomedical interventions, clinical management, disease detection and prevention strategies, disease risk reduction and more in diverse groups of women. The intent of this supplement program is to encourage and support interdisciplinary research that can positively affect the health of all women regardless of race/ethnicity, cultural background, physical/mental disability and socioeconomic status. This interdisciplinary research can include collaborations across a range of disciplines including but not limited to economics, medical anthropology, psychology, sociology and demography to address research areas in the fuller context of women's lives and the underlying common root causes of poorer health outcomes.

Specific Areas of Research Interest

This FOA will consider research supplements that include:

-Primary and secondary data analysis and reporting of sex/gender-based data and race/ethnicity data, and the intersection of the two in clinical research, including subgroup analyses of existing data to examine clinical differences among women of diverse racial and ethnic backgrounds, women in sexual and gender minority, women with physical, intellectual and developmental, and/or sensory disabilities.

-Develop and refine methodologies to enhance and increase the recruitment and retention of women underrepresented in clinical research.

-Evaluation of recruitment, enrollment and retention interventions utilized in studies addressing the "under-enrollment" of various sub-populations of women in a current parent clinical research study (recruitment and retention methods).

-Evaluation of increased community-based communications or cultural/sub-population knowledge of researchers in research study design.

-Primary or secondary data analysis of sex/gender and racial/ethnicity influences and/or barriers to increased enrollment (sample size increase to obtain meaningful comparative data) when a known or unexpected difference or trend in populations is seen during the parent study.

-Develop methods and data sources that provide attention to meaningful aspects of the cultural context of women's lives, from the woman's perspective.

-Develop new measures, statistical approaches, and sampling methods in small samples to include understudied sub-population groups of women.

Areas of scientific interest include but are not limited to the study of subjects of diverse populations, and the comparison of their outcomes in the following general areas:

-Sensitivity and specificity of biomarkers, screening, diagnosis of disease risk, prognosis or benefit of treatment

-The effect of violence, including intimate partner violence across the lifespan, including elder abuse, abuse during pregnancy and its subsequent impact upon the infant/child.

-The role of limited access to health care on care seeking behavior and outcomes in geographically isolated populations of understudied and underrepresented women.

-Maternal mortality and morbidity including the impact of substance use and its associated stigma on maternal health and outcomes.

-Disparities in reproductive health, gynecologic conditions, including treatments and outcomes.

-Chronic diseases that demonstrate disparities in specific communities of women.

-Health and disease conditions where data regarding the epidemiology or the outcomes are known in populations or sub-populations of women in the US is sparse or limited.

-Exposure assessments and disease outcomes in understudied populations.

-Evidence based interventions to improve outcomes in women who have experienced gender based violence.

Interdisciplinary and transdisciplinary areas of scientific interest include but are not limited to:

--Studies that explore the intersections of many factors such education, income, culture, built environment as examples: on health outcomes and risk for poor health outcomes in diverse populations of women. including women often overlooked including women with intellectual and/or developmental disabilities, women who experienced genital cutting and mutilation.

-Studies that explore the intersection of trauma, substance abuse and its social stigma upon health outcomes across the life course.

-Studies that further our understanding of the mutable causes of disparities in HIV risk, presentation for care, care engagement, linkage to care and treatment adherence for female, transgender or intersex individuals across the lifespan.

-Studies that further our understanding of the influence alone or in combination of exogenous factors such as stigma, racism, classicism, residential segregation, historical trauma (as examples) upon risk for disease, disease progression, health care engagement and retention, and disease morbidity and mortality.

-Studies that further our understanding of resilience, socioecological frameworks and cultural/community contexts and their role in disease prevention, intervention and progression.

Applicants are strongly encouraged to discuss their proposed supplement project with the Program Official of the parent grant before submission of an administrative supplement application in order to ensure that the work proposed in the supplement is within the scope of the parent grant

See Section VIII. Other Information for 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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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)

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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 not 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

Applicants must prepare applications using current forms in accordance with the Application Guide.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed,

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Research Strategy including a summary or abstract of the funded parent award or project.
• If applicable, attach documents indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

• Checklist: Select Revision in the Type of Application field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Victoria A Cargill, M.D., M.S.C.E.

Office of Research on Women's Health (ORWH), NIH

6707 Democracy Blvd, Suite 400

Bethesda, MD 20892

PHS Human Subjects and Clinical Trials Information

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.

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 electronic 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.

Applicants are responsible for viewing their electronic application before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 (SAM). Additional information may be found in the Application Guide.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

• Will the administrative supplement target the population(s) identified in the funding announcement?
• Will the administrative supplement focus on rigorous research that is relevant to the health of women?
• Will the administrative supplement develop methods and leverage data sources to consider sex and gender influences that enhance research for the health of women?
• Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, NIH staff 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (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.

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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).

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmll 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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Victoria A. Cargill, M.D., M.S.C.E.
Office of Research on Women's Health (ORWH)
Telephone: 301-435-0971
Email: [email protected]

Steven Zullo, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 240-271-9007
Email: [email protected]

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

Melissa Gerald
National Institute on Aging
Telephone: 301-496-3136
Email: [email protected]

Juliane Caviston, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5094
Email: [email protected]

Elizabeth (Liz) Perruccio, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6178
Email: [email protected]

Candace Tingen, Ph.D.
National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email: [email protected]

Lanay M. Mudd, Ph.D.
National Institute of Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]

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

Trinh Ly, M.D.
National Institute on Deafness and Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: [email protected]

Dena Fischer, D.D.S., M.D.S., M.S
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: [email protected]

Robert Rivers, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-8415
Email: [email protected]

Lisa Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Tamara Lewis-Johnson, M.P.H., M.B.A.
National Institute of Mental Health (NIMH)
Telephone: 301-594-7963
Email: [email protected]

Joyce Hunter, Ph.D.
National Institute on Minority Health and Health Disparities
Telephone: 301-402-1366
Email: [email protected]

Amanda Melillo, Ph.D.
National Institute of General Medical Sciences
Telephone: 301-594-0943
Email: [email protected]

Sung Sug Yoon, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Jennifer Troyer, Ph.D.
National Human Genome Research Institute
Telephone: 301-480-3565
Email: [email protected]

Hua-Chuan Sim, M.D.
National Library of Medicine
Telephone: 301-594-4882
Email: [email protected]

Xenia Tigno, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email:[email protected]

Not Applicable

Financial/Grants Management Contact(s)

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

Monique Day
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4787
Email: [email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Donna R. Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Bryan S. Clark
National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Shelley Carow
National Institute of Complementary and Integrative Health (NCCIH)
Telephone:301-594-3788
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: [email protected]

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Carolyn Kofa
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7687
Email: [email protected]

Karen Robinson-Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

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

Priscilla Grant
National Institute on Minority Health and Health Disparities
Telephone: 301-594-8412
Email: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Jill Saletta
National Human Genome Research Institute
Telephone:301-827-0611
Email: [email protected]

Samantha Tempchin
National Library of Medicine
Telephone: 301-496-4222
Email: [email protected]

Taryn Cobb
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8025
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.