Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title	Biomedical and Behavioral Research Innovations to Ensure Equity (BRITE) in Maternal and Child Health (R15)
Activity Code	R15 Academic Research Enhancement Award (AREA)
Announcement Type	New
Related Notices	August 6, 2015 - This PA has been reissued as PAR-15-319. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013. June 27, 2012 - See Notice NOT-HD-12-022. The purpose of this Notice is to clarify and update, Part 2, Section I. Funding Opportunity Description of the Areas of Research Focus.
Funding Opportunity Announcement (FOA) Number	PAR-12-093
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to increase the diversity of the pool of researchers involved in health equity research related to NICHD mission areas including infant mortality; Sudden Infant Death Syndrome (SIDS); child, adolescent, and/or adult obesity; uterine fibroids; pediatric and maternal HIV/AIDS prevention; violence prevention; health literacy; and outreach and information dissemination. The goal of the Biomedical and Behavioral Research Innovations To Ensure Equity (BRITE) in maternal and child health program is to stimulate maternal and child health equity research within institutions eligible for the Academic Research Enhancement Award (AREA) R15 program. Program priorities include AREA-eligible institutions that educate students from diverse backgrounds underrepresented in biomedical and behavioral science, including individuals from disadvantaged backgrounds, individuals from underrepresented racial and ethnic groups, and individuals with disabilities as a strategy to contribute to a diverse research workforce.

Posted Date	February 2, 2012
Open Date (Earliest Submission Date)	March 3, 2012
Letter of Intent Due Date	30 days before applicable receipt date.
Application Due Date(s)	April 3, 2012, October 11, 2012, (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 11, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2012, February/March 2013, February/March 2014
Advisory Council Review	August 2012, May 2013, May 2014
Earliest Start Date(s)	September 2012, July 2013, July 2014
Expiration Date	(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 12, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to increase the diversity of the pool of researchers involved in health equity research related to NICHD mission areas including infant mortality; Sudden Infant Death Syndrome (SIDS); child, adolescent, and/or adult obesity; uterine fibroids; pediatric and maternal HIV/AIDS prevention; violence prevention; health literacy; and outreach and information dissemination.

The goal of the Biomedical and Behavioral Research Innovations To Ensure Equity (BRITE) in maternal and child health program is to stimulate maternal and child health equity research within institutions eligible for the Academic Research Enhancement Award (AREA) R15 program. Program priorities include AREA-eligible institutions that educate students from diverse backgrounds underrepresented in biomedical and behavioral science, including individuals from disadvantaged backgrounds, individuals from underrepresented racial and ethnic groups, and individuals with disabilities as a strategy to contribute to a diverse research workforce.

The National Institutes of Health (NIH) recognize a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical, and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF), (see http://www.nsf.gov/statistics/wmpd/) and others, provide strong evidence that the lack of diversity remains an important problem that the entire research enterprise must actively address. There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to increase the diversity of the pool of scientists involved in health equity research related to NICHD mission areas including infant mortality; Sudden Infant Death Syndrome (SIDS); child, adolescent, and/or adult obesity; uterine fibroids; pediatric and maternal HIV/AIDS prevention; violence prevention; health literacy; and outreach and information dissemination. While the Institute currently promotes diversity in the workforce by engaging AREA-eligible institutions in NICHD research mission areas, there is a critical need to broaden the NICHD AREA grant portfolio to include a greater representation of institutions with students from diverse backgrounds underrepresented in research as a strategy for further increasing the diversity of the scientific research workforce and reducing health inequities.

Many AREA-eligible institutions (e.g., Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges and Universities (TCCUs)) provide unique opportunities for access to students from diverse backgrounds underrepresented in biomedical and behavioral research. For example, in 2008, the National Science Foundation (NSF) reported that 20% of bachelor’s degrees in science and engineering granted to African Americans were received at HBCUs and 32% of bachelor s degrees in science and engineering granted to Hispanics were received in high-Hispanic enrollment institutions. However, these institutions with largely untapped talent pools of students from underrepresented groups have not been major recipients of NIH support; thus, limiting opportunities for students to benefit from exposure to and participation in biomedical and behavioral research.

Further, individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds are disproportionately burdened by health disparities. There is limited evidence that individuals who have participated in the NIH administrative supplement program preferentially conduct research in areas related to health disparities or minority health. Expanding NICHD mission-related research opportunities for AREA-eligible institutions with students from diverse backgrounds underrepresented in research to seek new knowledge in maternal and child health equity research is an important strategy for increasing the pool of researchers involved in research pertinent to the NICHD mission.

The overall goal of the NICHD BRITE Program is to stimulate maternal and child health equity research in AREA-eligible institutions that educate students from diverse backgrounds underrepresented in biomedical and behavioral research. The objectives of the program are to: (1) provide support for investigators to conduct independent research pertinent to the NICHD mission; (2) encourage and enable the use of innovative ways to strengthen the research environment and investigator record of research accomplishments; and (3) expose students from diverse backgrounds underrepresented in biomedical and behavioral research to meritorious maternal and child health equity research.

BRITE grant awards will support meritorious small-scale, new projects in biomedical and behavioral maternal and child health equity research, including:

• Pilot research projects and feasibility studies
• Secondary analysis of available data sets

To increase opportunities for student exposure to research, investigators are strongly encouraged to implement one structured activity during each year of the grant award that extends research exposure to students outside of the investigator's normal laboratory and classroom setting. This annual structured activity may include journal clubs and research seminars on current topics and research opportunities in maternal and child health equity research. Applicants should provide a plan to address how these activities will be evaluated to measure the level of exposure to research, particularly among students from diverse groups underrepresented in research.

The AREA R15 program is a research grant program and not a training or fellowship program. Thus, applications should not focus on training objectives and training plans should not be provided. However, it is important for the applicant to describe the research activities in which students will participate.

To ensure the BRITE Program goals and objectives are being met, the NICHD will conduct a program evaluation five to seven years after the release of this FOA. At its discretion NICHD may continue, modify, or terminate the program at that time if it is determined that the need no longer exists or that the program is not making progress towards the goal of stimulating maternal child health equity research in AREA-eligible institutions that educate students from diverse backgrounds underrepresented in biomedical and behavioral research. The program evaluation will focus on investigator accomplishments and level of student exposure to maternal and child health equity research.

Key metrics to measure investigator accomplishments will include:

• Refereed articles as measured by citations and other indicators of recognition
• Presentations at national meetings that help enhance the reputation of the investigator’s research program and the NICHD relevant area of research
• Evidence of active pursuit of extramural grants and contracts to support future research goals

Key metrics to measure level of student exposure to maternal and child health equity research will include:

• Characteristics of students participating in BRITE activities (e.g., gender, race/ethnicity, disability status, class level, major course of study)
• Extent to which participation in BRITE activities increased interest in NICHD mission-related research

Infant Mortality

While infant mortality rates in the US have been declining over time, there still exist persistent disparate outcomes among racial/ethnic minority, low-income, and underserved populations. During 2004-2006, the rates among non-Hispanic Whites, non-Hispanic Blacks, and American Indians and Alaska Natives were 5.7, 13.5, and 8.3 per 1,000 live births, respectively. Differences in these rates have long been explained by disparities in the leading causes of infant mortality (e.g., low birth weight, preterm birth, SIDS). Risk factors such as lack of early prenatal care, smoking during pregnancy, prone sleep position, and low maternal education are also disproportionately experienced among racial/ethnic minority and low-income populations as well as individuals living in rural areas (e.g., southern Appalachia).

Sudden Infant Death Syndrome (SIDS)

Sudden Infant Death Syndrome (SIDS) is the leading cause of death among children ages one month to one year, accounting for 2,300 deaths in the US each year. Most SIDS deaths happen between the ages of 2 months and 4 months. While SIDS rates have declined more than 50% since 1992, primarily due to increased educational efforts through the Back to Sleep Campaign, racial/ethnic minorities remain disproportionately affected. American Indians and Alaska Natives have 2 to 3 times the rates of non-Hispanic Whites and non-Hispanic Blacks have 2 times the rates of non-Hispanic Whites. Behavioral, environmental, and contextual factors implicated in disparate SIDS outcomes include lack of or wrong provider advice, prone sleep position, soft sleep surfaces, loose bedding, overheating, exposure to cigarette smoke, bed sharing, preterm birth and low birth weight.

Child, Adolescent, and/or Adult Obesity

The obesity epidemic remains one of the most critical public health issues facing Americans. In 2007-2008, 34% of US adults and 17% of children and adolescents aged 2-19 years were reported as obese. Racial/ethnic minority, low-income, and underserved populations have significantly increased rates of obesity. For example, approximately 50% of non-Hispanic Black women and 43% of Hispanic women were characterized as obese in comparison to 33% of non-Hispanic White women. Non- Hispanic Black girls and Hispanic boys aged 6 to 19 years had the highest childhood obesity rates, 25.9% and 26.7%, respectively. Children and adults living in rural communities have significantly higher rates of obesity than their urban counterparts. These differences are exacerbated by high levels low education and low income among rural residents. Further, there is increasing evidence that obesity is more prevalent among youth with chronic physical and intellectual disabilities than youth without disabilities. A myriad of factors have been examined in relationship to the differential distribution of obesity. Such factors include access to fresh foods, exposure to fast food advertisements, consumption of sugar-sweetened beverages, cultural perceptions of food and body weight, physical activity, television/video game use, weight loss goals, breastfeeding, stress, and poverty.

Pediatric and Maternal HIV/AIDS Prevention

Perinatal HIV transmission from mother to child during pregnancy, labor and delivery, or breastfeeding account for the largest proportion of HIV infection and AIDS cases in children. Perinatal transmission is more common among racial/ethnic minorities such that 69% of diagnoses during 2004-2007 were among African Americans and 16% were among Hispanics. Further, women account for 25% of those living with HIV and African American women have HIV rates 15 times greater than that of White women. Targeted approaches to increase awareness of HIV status and awareness of antiretroviral therapy options among pregnant women are needed to reduce perinatal HIV transmission, particularly among racial/ethnic minorities who bear the greatest burden of disease. These efforts would need to consider the role of other relevant factors associated with HIV screening rates such as stigma, fear, language barriers, and poverty.

Uterine Fibroids

Uterine leiomyomas (uterine fibroids) are the most common tumors of the female reproductive tract, affecting around 77% of reproductive-age women. Uterine fibroids are associated with negative outcomes such as preterm labor, miscarriage, and infertility. Fibroid tumors are the leading cause of hysterectomies, accounting for more than 200,000 of these surgeries annually in the US alone. In comparison to White women, African American women are three times more likely to have fibroid tumors, more likely to receive diagnoses at younger ages, and have larger, more rapidly growing, and more frequently occurring tumors. African American women also have more severe symptoms such as severe menstrual symptoms, severe pelvic pain, and anemia resulting in significantly increased rates of hysterectomy. Factors such as diet, alcohol use, levels of vitamin D, and obesity have been explored to explain racial/ethnic disparities in uterine fibroids.

Violence Prevention

Youth violence is the second leading cause of death for young people between the ages of 10 and 24. Nearly 700,000 young people ages 10 to 24 were treated in emergency departments for violence-related injuries in 2008. In 2009, 32% of high school students reported being in a physical fight, 20% reported being bullied in the school environment, and 17.5% reported carrying a weapon such as a gun or knife in the past 30 days. Violence disproportionately affects youth from racial/ethnic minority populations and lesbian, gay, bisexual, and transgender (LGBT) students are at increased risk of victimization as a result of stigma related to their sexual orientation. Risk factors for youth violence include individual, family, peer/school, and community factors. Protective factors include connectedness to family or adults outside of the family and involvement in social activities.

Health Literacy, Outreach, and Information Dissemination

Health literacy as defined by Healthy People 2010 is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions . It is estimated that only 12 percent of English-speaking adults in the US have proficient health literacy skills. Limited health literacy has been linked to poor health outcomes, poor understanding of nutrition labels and prescription medication instructions, and increases in hospital visits and admissions. Low parental health literacy has been implicated in negative health outcomes among children. Racial/ethnic minorities, language minorities, and low socioeconomic populations are significantly impacted by limited health literacy which may also in turn account for higher rates of negative health outcomes within these groups. High rates of limited literacy among populations who suffer the greatest burdens of health disparities increases the priority for identifying effective sources of outreach and dissemination of health information within these populations. Such sources must be deemed trustworthy and easily accessible and information should be perceived as culturally relevant (e.g., Black radio).

An application for a BRITE award could include proposals for biomedical and/or behavioral research in areas including, but not limited to, the following:

• Studies that evaluate the role of individual-level health behaviors in disparate maternal and child health outcomes
• Studies that elucidate the role of social determinants (e.g., poverty) in disparate maternal and child health outcomes
• Studies that investigate the role of interactions among multiple factors in maternal and child health outcomes
• Studies that identify culturally- and age-appropriate strategies for improving health literacy and increasing dissemination of prevention messages among populations disproportionately affected by disparate health outcomes (e.g., racial/ethnic minority, low-income, disability, and underserved)

Funding Instrument	Grant
Application Types Allowed	New Resubmission Renewall The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Applicants may request a maximum of $300,000 direct costs plus applicable Facilities & Administrative (F&A) costs/indirect costs for the entire project period of up to three years. No more than $150,000 may be spent in any single year without prior approval from NICHD.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Some institutions provide unique opportunities for access to students from diverse backgrounds underrepresented in biomedical and behavioral research. Accordingly, NICHD strongly encourages applications from the following institutions: Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions (HSIs), and Alaska Native and Native Hawaiian-Serving Institutions.

In addition, all organizations must meet the following two criteria:

• The applicant organization must offer baccalaureate or advanced degrees in the biomedical or behavioral sciences.
• The applicant organization may not receive research grants and/or cooperative agreements from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in each of 4 of the last 7 years.
• Note that NIH research grants and cooperative agreements" includes all extramural awards designated by an activity code starting with R, P (except P20), M, T, K, or U, and also DP1, DP2, and D42. The following activity codes are excluded: C, S, and G.

Institutions with Multiple Schools or Colleges

For institutions composed of multiple schools or colleges, the criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university or college) as a whole, but by the individual school/college or aggregation of "other academic components" (as defined in this section) where the PD(s)/PI(s) has an appointment (e.g., School of Medicine, College of Nursing, etc.). Thus, each of the following should be considered independently when determining the financial eligibility of the applicant organization.

• Health professional school/college: Accredited public or non-profit private school that provides training leading to a degree related to the health sciences granted by that school (e.g., PhD, MD, DDS, MPT, DC, ND, RN, or equivalent degree). The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education.
• Includes schools or colleges of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry.
• Other academic component: Once the health professional schools have been excluded, other academic components refers to all remaining schools, colleges, and free-standing institutes of the institution taken as a SINGLE component.

To determine the eligibility of an institution, applicants should consult the list of ineligible schools/components on the AREA program website at http://grants.nih.gov/grants/funding/area.htm. If the name of the school does not appear on the list, it is likelyeligible to apply for AREA grants. Applicants should check with their own institutions if unsure.

An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution. However, applicants should keep the goals of the AREA program in mind when preparing the application, which include strengthening the research environment of the institution and exposing students to research.

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

For institutions/organizations proposing multiple PD(s)/PI(s), all PD(s)/PI(s) must have a primary faculty appointment at the AREA-eligible institution.

To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria.:

• The PD(s)/PI(s) must have a primary faculty appointment at an AREA eligible institution.
• The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH grant, including another AREA grant, at the time of award of an AREA grant (although he or she may be one of the project personnel for an active NIH grant held by another PD(s)/PI(s)).
• The PD(s)/PI(s) may not be awarded more than one AREA grant at a time (although he or she may hold successive new or competing renewal AREA grants).

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..

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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 into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Regina Smith James, M.D.
Director, Division of Special Populations (DSP)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, Maryland 20892-7510
Rockville, Maryland 20852 (for express/courier service)
Telephone: 301-435-2692
Email: rjames@mail.nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

In addition to the information requested in the instructions, provide the following information as a PDF attachment in the Facilities & Other Resources section on the Research and Related Other Project Information form.

• A profile of available students of the applicant school/academic component and any information or estimate of the number who have obtained abaccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences during the last five years.
• Applicants are strongly encouraged to include a description of the distribution of students from diverse backgrounds underrepresented in biomedical and behavioral research as part of the profile of available students of the applicant school/academic component.
• A description of the special characteristics of the school/academic component that make it appropriate for an AREA grant, where the goals of the AREA program are to: (1) provide support for meritorious research; (2) strengthen the research environment of schools that have not been major recipients of NIH support; and (3) expose available undergraduate and/or graduate students in such environments to research. Include a description of the likely impact of an AREA grant on the PD/PI and the research environment of the school/academic component.
• Although it is expected that the majority of the research will be directed by the applicant investigator and conducted at the grantee institution, limited use of special facilities or equipment at another institution is permitted. For any proposed research sites other than the applicant institution, provide a brief description of the resources. Collaborations with other investigators are also permitted if complementary expertise is required to accomplish the proposed specific aims.
• Applicants are strongly encouraged to include a statement of institutional support and letter(s) of commitment from investigator(s) at collaborating institutions as part of the Letters of Support.
• If relevant, a statement of institutional support for the proposed research project (e.g., equipment, laboratory space, release time, matching funds, etc.).

In addition to the information requested in the instructions, provide the following information in the Biographical Sketch that is attached to the Research and Related Senior/Key Person Profile form.

• The PD(s)/PI(s) should include a summary of his or her previous and/or current experience in supervising students in research in the Personal Statement.
• The PD(s)/PI(s) should indicate which peer-reviewed publications involved students under his or her supervision.

The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.

Complete only Budget Period 1 of either the PHS398 Modular Budget component or the R&R Budget component.

Applicants submitting an application with direct costs of $250,000 or less (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

• Applicants submitting an application with direct costs of $250,001 - $300,000 (total for all years) must use the Research & Related (R&R) Budget component.

PHS398 Modular Budget Component (direct costs of $250,000 or less):

Follow all instructions in the SF 424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

• Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must NOT EXCEED $250,000.
• Consortium F&A: If applicable, enter the actual consortium F&A (e.g., $3,271).
• Total Direct Costs: This field auto-calculates so no data entry is required.

Budget Period 1: Indirect Costs:

• If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs.
• If the F&A rate has not been established, enter None-will negotiate and include information for a proposed rate. Use the budget justification if additional space is needed.

Budget Justification: Please attach the Personnel Justification and Consortium Justification. If the requested budget requires any additional justification, attach an Additional Narrative Justification.

• Personnel Justification: Follow all instructions in the SF 424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD(s)/PI(s) should include undergraduate (preferably, if available) and/or graduate students in the proposed research to the extent practical. If students are available and will be involved in the research, indicate aspects of the proposed research in which they will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
• Consortium Justification: Follow all instructions in the SF 424 (R&R) Application Guide, but note that the Letter of Intent to establish a consortium must also be included in the Consortium Justification attachment.
• Other Costs: In addition to requesting costs to support the research project, applicants may request direct costs to support planning and evaluation of activities to increase student exposure to maternal and child health equity research. These costs may include, but are not limited to: administrative assistance to plan and coordinate annual structured activities (e.g. journal club, research seminar); purchase of software and supplies to be used for tracking and evaluating student participation (e.g. surveys, database).

R&R Budget Component (direct costs of $250,001 to $300,000):

Follow all instructions in the SF424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

• Direct Costs less Consortium F&A: This number must NOT EXCEED $300,000.
• Consortium F&A: If applicable, enter the actual consortium F&A (e.g., $3,271).

Budget Period 1: Indirect Costs:

• If the F&A rate agreement has been established, indicate the type of agreement. All appropriate exclusions must be applied in the calculation of the F&A costs.
• If the F&A rate has not been established, enter None-will negotiate and include information for a proposed rate. Use the budget justification if additional space is needed.

Budget Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD(s)/PI(s) should include undergraduate (preferably, if available) and/or graduate students in the proposed research to the extent practical. If students are available and will be involved in the research, indicate aspects of the proposed research in which they will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided.

Applicants may request direct costs to support planning and evaluation of activities to increase student exposure to maternal and child health equity research. These costs may include, but are not limited to:

• Administrative assistance to plan and coordinate annual structured activities (e.g. journal club, research seminar)
• Purchase of software and supplies to be used for tracking and evaluating student participation (e.g. surveys, database)

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

Research Strategy

• Applicants should provide a description of one annual structured student activity designed to expand exposure to maternal and child health equity research beyond the investigator’s normal laboratory and classroom setting. This annual structured activity may include journal clubs and research seminars on current topics and research opportunities in maternal and child health equity research.
• In addition to the evaluation plan for the independent research component of the award, applicants should also describe how student exposure to maternal and child health equity research will be measured. These evaluation plans should address characteristics of students participating in BRITE activities (e.g., gender, race/ethnicity, disability status, class level, major course of study) and the extent to which participation in BRITE activities increased interest in NICHD mission-related research. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program activity improvements.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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.

Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) 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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

The objectives of the R15 program are to (1) provide support for meritorious research, (2) strengthen the research environment of schools that have not been major recipients of NIH support, and (3) expose available undergraduate and graduate students in such environments to meritorious research. Preliminary data are not required for R15 application; however, they may be included if available.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to make an important scientific contribution to the research field(s) involved, to provide research opportunities to students, and to strengthen the research environment of the institution, 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.

Significance

Does the project address an important problem or a barrier to progress in the field? 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? If funded, will the AREA award have a substantial effect on the school/academic component in terms of strengthening the research environment and exposing students to research? Does the main theme of the application address an important area of maternal and child health equity research?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have suitable experience in supervising students in research? Do the PD(s)/PI(s), collaborators and other researchers demonstrate adequate knowledge of the maternal and child health equity area of research emphasis targeted as part of the research proposal? Does the PD(s)/PI(s) demonstrate that all of the necessary techniques and methods can be performed based on his/her previous experience and/or letters of collaboration?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Does the application provide sufficient evidence that the project can stimulate the interests of students so that they consider a career in the biomedical or behavioral sciences?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

In the absence of preliminary data, does the PD(s)/PI(s) demonstrate that the proposed techniques are feasible, reliable, and yield interpretable data, based on his/her experience (i.e., published studies) or peer-reviewed studies published in the field? Is the proposed structured activity to address student research exposure adequate to stimulate interest and knowledge regarding maternal and child health equity research among students from diverse backgrounds underrepresented in research? Will the evaluation plan for exposure to research adequately measure BRITE program participation among students from diverse backgrounds underrepresented in research?

Environment

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate the likely availability of well-qualified students to participate in the research project? Does the application provide sufficient evidence that students have in the past or are likely to pursue careers in the biomedical or behavioral sciences? Does the application demonstrate the diversity of the student population? Will the environment be appropriate for stimulating interest in maternal and child health equity research among faculty and students at the institution?

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

Progress reports for multiyear funded (MYF) awards are due annually on or before the anniversary of the budget/project period start date of the award. The reporting period for a MYF progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report through the eRA Commons are posted at http://grants.nih.gov/grants/policy/myf.htm.

A final progress report, 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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Della Brown White, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 435-2712
Email: whitede@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

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 Parts 74 and 92.